Quality Assurance

ISO 9001 Standard - ISO 9001 Standards

2012-01-03T04:45:00.000-08:00

ISO 9001 Standard - ISO 9001 Standards

Integrating Management Systems Within The ISO 9001 Standards

2011-11-28T05:35:00.000-08:00

Today’s free market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. Fair competition needs to be based on identifiable, clearly defined common references that are recognised from one country to the next. A standard, internationally recognised, developed by consensus among trading partners, serves as the language of trade. The International Organisation for Standardisation (ISO) has developed around 8700, mostly technical related standards on this basis. Standards Series such as ISO 9000, ISO 14000 and what is to be known as ISO 18000 and ISO 26000 are Management related. These standards contain generic guidelines for Management Systems in the area of Quality, Environment, Occupational Health & Safety and Human Resources.

ISO is a word derived from the Greek isos, meaning “equal”. ISO 9000 Standards are developed and updated by the International Organisation for Standardisation which has around 150 member bodies. A member body of ISO is the national body “most representative of standardisation in its country”.(eg. Germany – DIN, USA – ANSI, Australia – SAA).
More than 50 countries, as well as the European Community have adopted ISO 9000 which is recognised internationally as a benchmark for measuring quality in a trade context. Since its first issue in 1987, approximately 430?000 companies have been using ISO 9000. Being a standard coming from an organisation that is usually involved in the development of technical standards, ISO 9000 is often regarded as a document that belongs in the hands of a technician exposed to production line quality control. At a closer look, however, ISO 9000 Standard Series provide guidance in the development and application of Management Systems as well as Quality Control in Manufacturing and Administration.

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000?, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)

Read more on ISO 9001 Standard at http://www.iso9001store.com

Improve your performance management with new version of ISO 9001

2011-11-28T05:33:00.000-08:00

A quality management system enables you to manage your business processes effectively:

it is much more than a set of rules and procedures. When properly implemented and maintained, a QMS addresses the needs of your organisation and delivers tangible business benefits.

The new version of ISO 9001 has recently been published. One of the main aims of ISO 9001:2008 is to facilitate integration with other standards. Although there are no new requirements as such, there are some key clarifications to be taken into account.

There are three main objectives to the new standard:

Detail, clarify, improve the understanding of ISO 9001:2000 (previous version)

Improve compatibility with ISO 14001:2004 Simplify the way in which ISO 9001 can be integrated with other management system standards (such as OHSAS 18001)

There are no new requirements in the new standard:

The title, scope, and structure of the standard are unchanged

The process approach is confirmed

Compatibility with the latest revision of ISO 14001:2004 is maintained and improved upon

Preservation of the quality management principles included in ISO 9000:2000

There are five main areas to note. The relevant sections of the standard are noted in brackets.

1. A reinforcement of the notion of product conformity

2. Compatibility with other standards is evolving

3. A better understanding of outsourced processes

4. An editorial clarification of some requirements – for instance;

A reinforcement of the notion of product conformity2.3.4.

An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolving

• (6.4) work environment, including an explanatory note on work environment giving examples,

to help meet product conformity requirements

• (8.2.1) measurement of customer satisfaction, including a note broadening the scope beyond

satisfaction surveys to include other channels such as customer feedback5.

• (Introduction) the notion of risk

• (5.5.2) appointment of a management représentative

• (6.2.2) assessing the effectiveness of achieving compétence

• (8.5.2 et 3) assessing the effectiveness of corrective and preventive actions?

Some additional explanations regarding the requirements of the standard;An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolvingA reinforcement of the notion of product conformity.

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Management Review IN ISO 9001 Standard

2011-11-28T05:30:00.000-08:00

One of the most important factors in determining the success of an ISO 9001 implementation is management commitment and management understanding of what makes a good quality systems. Our turnkey Quality Management System (QMS) gives you everything you need to educate your entire company from top to bottom.

Management review is one of the key elements to building a sustainable quality system. To do this, management must be committed. This means that the management must do more than just say they are committed, they must allocate the resources to make sure that the company can continuously improve quality. Most quality systems fail from the top down! That is why external auditor almost always review the management review documentation every audit. External ISO 9001 auditors look for this commitment by evaluating the management review records. Management reviews should focus on both the quality of the products and the quality of the QMS. In general, it is very simple to maintain compliance of the management review portion of the standard. It can be done with a simple notebook that is maintained as a quality record. The Management review procedure includes a list of documentation that should be included in management review meeting. Management reviews should be done a least once per year and auditors like to see them quarterly.

Under ISO 9001, executive management has defined responsibilities. Although most of the work required to implement and maintain ISO certification is done below the executive level, ISO requires involve of personnel at the top of the organization.

It is the leader of an organization that set the goals and objectives for the quality of the company. It is also the leader that assigns resources (responsibility and authority) throughout the organization. Because of this, the leaders must be kept aware of the status of the quality system and product/service quality so they make good decision.
Much of how the company accomplishes these tasks is covered in the quality manual. Here are the 8 areas that should be address in the quality system to assure compliance to the ISO standard.

Top Management must:

Show A Commitment To The Customer

This requirement includes maintain records showing their commitment to the a customer focus, the quality system and the continuous improvement system. The use of a customer survey program is an excellent way to meet the ISO requirements for a customer focus. It is also an excellent way to keep in touch with your customers.

Make Quality Important

This includes communicating to the organization the importance of meeting the customer regulatory, legal needs as well as their produce or service needs (customer focus). Training and posting quality information around the building can do this.

Establish A Quality Policy

This should include a concise quality statement in conjunction with quality goals and a quality manual. The policy verbiage should include a commitment to continuous improvement. This information must be communicated to and understood by the entire organization.

Establish, Monitor And Update Quality objectives

These objectives should be measurable and should be relevant to all levels of the company. I recommend that they be publicly posted where everyone can see them and their status may also be posted.

Assign Resources

Ensure that resources are available to achieve the quality goals. This is the area where many companies do not meet the requirements but it is very hard to audit this general statement. Resources should be identified and planned. Planning includes manuals, procedure, work instructions and quality plans.

Assign Responsibility And Authority

Ensure that responsibilities and authorities are assigned and communicated to individuals. Responsibilities can be assigned as part of the personnel records ( see training summary sheet). Having authority means that the individual must be empowered to make changes.

Designate A Management Representative

This person will report the QMS status at periodic management reviews and promote awareness of the importance of meeting the customers needs. This is usually the quality, engineering or production manager.

Conduct Periodic Management Reviews

Management review meetings should include inputs from audits, customer feedback, process performance analysis, preventive and corrective actions system, follow-up from previous management meetings and areas for improvement. The output from the management reviews should include resource assignments, action targeting improvement of the products, processes and QMS.

The records for the management review are frequently audited so I recommend keeping a organized notebook with tabs for each management review. The creation of a check sheet (listing all the reports to be shown to top management) will make this periodic task simple to maintain. The check sheet can also be used to keep track of attendance and log feedback that is generated during the meeting.

Read more on ISO 9001 Standard at http://www.iso9001store.com

ISO 9001 Training

2011-07-16T15:59:00.000-07:00

Accreditation and certification is important for businesses these days and proving a competency can be important to gaining future contracts or orders. Some firms will only work with suppliers that are able to indicate they have a level of competency in certain areas and the best way to show this is through recognized training and accreditation. One such training program is the ISO 9001training program, which sets out to ensure quality management is taking place.

As well as the training course, the ISO 9001 training programcan provide great assistance in continually implementing the methods and lessons developed through the course. Every firm should be able to provide a policy manual with regards to the audit process and the management system. In addition to this, a procedures manual should be created in order to inform every employee of what they should be doing in the workplace.

If further instructions are needed, it may be of benefit to gain additional assistance in creating working instructions for the ISO 9001 training program. One of the most importantaspects of implementing ISO 9001 training is to ensure that a proper management structure is in place that can hopefully improve over time. There is no doubt that the business world is a very fluid place and changes occur all the time. Having a correct structure in place makes it easier to deal with changes, hopefully improving the long-term implementation and management of any system.

A major issue for any firm, especially in the current economic climate, relates to waste management and ISO 9001 training can help a firm with regards to this. Reducing waste will lower expenditure and is something that all companies should make consideration towards in their management systems. Improving the waste management system is likely to lead to an increase in gross revenue, which again is something that every firm should be aiming for.

Read more on ISO 9001 Standard at http://www.iso-9001-store.com

How To Acquire ISO 9000 Standards

2011-07-16T15:58:00.000-07:00

Companies dream of achieving success and recognition in their respective fields. That is why a lot of companies aim for certification of their management systems. Certification often gives companies an edge in their field, and the needed push for consumers to select their product or service. While this article covers the basics of getting ISO 9000 certification, you can learn much more about how to get this certification and how it benefits your business by taking relevantcourses in business management. If you don’t have time to attend a traditional school, consider online universities - they’re convenient and cost-effective!

ISO 9000 is a certification body that assesses a company’s quality management system against set standards. If a certain company passes their criteria, ISO grantsthem a certification that they have passed internationally recognized ISO standards. ISO 9000 is divided into 3 levels: ISO 9001, ISO 9002, and ISO 9003.

How do you go about acquiring this type of certification? Here are some steps to guide you in organizing an ISO 9000 certification.

Study the quality of your management systems. Preparation for an ISO certification with an evaluation of your own company’s management systems, procedures and standards. It is important to tap people from within the company to first make a realistic evaluation of the quality of management, procedures, and service that your business is offering.

Compare these with the ISO standards. Once you have completed your own evaluation, the next step is comparing it to the standards set by ISO 9000, according to the level you may want to apply for. It is crucial that your company takes important notice of the different things that need to be addressed in their system, may it be management procedures, regulations, or company practices.

Make the necessary adjustments. Upon recognizing the needed adjustments, then take the necessary actions to align your management systems and procedures to agree with the standards set by the ISO. Have these steps implemented and practiced, so that the changes can be adapted to gradually.

Have your quality management system evaluated. Once the needed changes have been realized, then it is time to request an outside audit by the registrar of the ISO certification body. An audit of your management systems will begin, and once approved, then you are certified to have met ISO’s requirements. ISO will then give you the certification, once they have approved the quality of your management system.

It’s also important to note that a company may opt not to get certification from ISO, but still use this standard to their advantage. Instead of requesting a certification from ISO, the company or business may form an ISO compliant management system and simply market your company as compliant with the ISO 9000 standard of choice.

High quality standards and procedures are key for any business or company. They promote a culture of excellence and hard work. And in return, this practice can improve company performance and sales. ISO accreditation will affirm the quality for which you want your company to be known. You can also keep company standards high by regularly taking continuing education courses in business.

Read more on ISO 9000 Standards at http://www.iso9000-standards.com

ISO 9001 Audit Checklist

2011-06-11T20:13:00.000-07:00

Whether an organization is implementing ISO 9001:2008 or just improving their quality management system, they will undoubtedly need to review and analyse their current systems and processes in order to identify gaps in compliance. Gap analysis requires that organizations review their existing processes, procedures and documentation, etc. The framework for this review technique is often provided in the format of an ISO 9001 audit checklist which many organizations and auditors consider to be an indispensable tool that actively supports the audit process.

The Advantages of the ISO 9001 Audit Checklist

Regular internal audits are carried out to ensure compliance is maintained and the ISO 9001 audit checklist comes in handy for this purpose. This is just one of many tools that are available from the auditors’ toolbox that help ensure the audit addresses the necessary requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits:

- Ensures the audit is conducted systematically
- Promotes audit planning
- Ensures a consistent audit approach
- Actively supports the organization’s audit process
- Serves as an aide memoire
- Provides a repository for notes collected during the audit process
- Ensures uniformity in the performance of different auditors
- Provides objective evidence

Structuring the Audit Checklist

One of the simplest methods of structuring the ISO 9001 audit checklist is by taking the applicable requirements from an organization’s policies, procedures and of course, from the standard itself, and turning each requirement into a question. Be sure to include the ‘organization shall’ requirements as well.

Add a section for comments, add check boxes for compliant or non-compliant and you can even add a column to note objective evidence and to provide an audit trial. Each element of the audit process should have customized checklists to serve as documentation outputs from the audit process itself.

This type of approach is primarily utilised by external auditors, including registration and certification body auditors, but the technique can equally be applied by any organization actively seeking to enhance their audit process.

Adding Value to the Checklist

Organizations should assess the potential value that the ISO 9001 audit checklist can bring in helping their audit process to develop. It’s worth remembering that a good checklist is no substitute for an enquiring mind and a good questioning technique.

If an internal auditor uses the checklist to ask narrowly focused questions then little benefit will be derived from the audit. If, on the other hand, the auditors conduct detailed preparation of the requirements of the process they intend to cover during the audit; the checklist then becomes an invaluable output for recording and communicating that preparation work.

Using the ISO 9001 audit checklist should not restrict the scope of audit activities, since that scope may change as a result of information actually collected during the audit. The key to unlocking the checklist’s value is the willingness of the organization to use it as a guide rather than being a slave to it.

Read more on ISO 9001 Standards at http://www.iso9001store.com

How To Meet ISO 9001 Quality Standards?

2011-06-11T20:12:00.000-07:00

In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can avoid the uncertainty, and that’s where ISO 9001 certification comes in.

Standardizing Quality Systems

The ISO, or International Organization for Standardization, was established in 1947 to develop international standards for everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created the auditing and certification process known as ISO 9001. This began the drive toward quality standards.

Improving Customer Satisfaction

Companies choose to implement ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.

Enhancing Company Performance

Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both time and money.

Developing Best Practices

Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous improvement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and identifying the main elements needed in a good quality system:

Customer Focus
Leadership
Involvement of People
Process Approach
Systems Approach to Management
Continuous improvement
Factual Approach to Decision-Making
Mutually Beneficial Supplier Relationship

Building Stable Processes

ISO 9001 policies, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help on the way to certification.

Auditing a Company System

In the certification process, an independent registrar will perform an on-site audit of a company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.

Meeting Company and Customer Needs

On the way to certification, a business can meet its ISO needs by:

Using well-defined processes and procedures to build stable processes
Training in the audit and certification process
Continuously improving with ISO 9001 standards

Noticing the Difference

With complete procedures manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way to ISO 9001 certification. Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.

Read more on ISO 9001 Standards at http://www.iso9001store.com

Identification of processes In ISO 9001

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Identiication Of Processes In ISO 9001 Standards

1. Distinguishing between the concepts of a process and an activity

If an auditee cannot distinguish between the concepts of a process and an activity, the auditor can briefly explain the differences by using the guidance (clause 2.4) and definition ((3.4.1) in ISO 9000 as background information. The auditor must be able to adapt to the auditee’s situation. It is the auditor’s responsibility to understand the auditee’s systems and approach.

During the audit, the auditor should determine whether there is a problem of difference of terminology only, or whether there is a lack of real implementation of the process approach by the auditee. There may be a need to issue an NCR if the auditee is not fully implementing the requirements stated in ISO 9001, Clause 4.1. If this is simply a terminology problem, there should be no need to issue an NCR, if all the requirements of in Clause 4.1 are satisfied.

The auditee has the right to use its own terminology, provided the requirements of the standard are met. The auditor should mentally develop a cross-reference list to ensure consistency and better understanding.

2. A process has defined objective(s), input(s), output(s), activities, and resources If the auditee does not understand that a process must have defined (but not necessarily measurable) objective(s), input(s), output(s), activities, and resources, the auditor should try reformulating the questions to the auditee avoiding the use of QM jargon, e.g. Can you explain to me your operations here? What are the basic jobs carried out in your department? What information do you need to start your work? Where does it come from? Who receives the result of your work? How do you know if you’ve done your job correctly? etc..

This should help the auditor to establish whether the processes (as per ISO 9001) are already defined, have clear inputs, outputs, objectives and so on.

3. Processes should be analysed, monitored and/or measured, and improved

If after applying the audit techniques outlined above, there is an absence of any records or other proof to demonstrate that the processes are analysed, and/or monitored, and/or measured, and/or improved, there would appear to be non-conformity with part of ISO 9001 Clause 4.1.

4. The auditee/auditor considers that each clause or sub-clause of ISO 9001

must be defined as a separate process If the auditor considers this as the right approach, he should refer to relevant ISO documents,

(notably the ISO/TC 176/SC 2 document N544 ISO 9000 Introduction and Support Package:

Guidance on the Concept and Use of the Process Approach) which clearly indicates the contrary.

If the auditee considers this as the right approach, it is recommended that the techniques outlined

in section 2 (above) should be used.

5. Is the process approach as described in the ‘Introduction’ to ISO 9001 a requirement of the standard?

The description of the process approach in the ‘Introduction’ to ISO 9001 is purely informative and does not introduce a set of additional requirements by itself. Clause 4.1 specifies the steps necessary to implement a process approach with regard to quality management system processes, the Notes to clause 4.1 providing examples of processes needed for the quality

management system. Audit methodologies must be oriented, accordingly, towards analyzing the processes of the organization.

Read more on ISO 9001 Standards at http://www.iso9001store.com

How To Obtain ISO 9001 Certificate

2011-03-02T05:22:00.000-08:00

ISO 9000 is a group of internationally recognized standards regarding quality management systems, laid down by the International Standard Organization. Previously divided into different standards like ISO 9001, ISO 9002, ISO 9003, they are now revised and combined into one simplified standard which covers all aspects, known as ISO 9001:2000. Another review is in process, but according to experts not many changes are expected.

How important is ISO 9001 for your business? Or do you really need ISO 9001 certification? The answer to these questions depends on your nature of business and future plans. ISO certification can prove to be very helpful and is quite necessary if you are planning to go global. It provides your business with much needed credibility and improves your company’s overall impression. If you are operating in a highly competitive market, ISO certification can be a competitive advantage. However, acquiring ISO 9001 certification is very expensive and it all depends on your business nature, needs and more importantly the availability of funds.

Will it improve your product’s quality?
ISO 9001 certification has no direct affect on product’s quality; it mainly deals with quality management systems. Although implementing these standards may improve the final product quality and reduce cost, it should not be used to measure a product’s quality or business’s profitability.

Obtaining ISO 9001 certification:
After the management has decided that having an ISO 9001 Certificate can be fruitful for the business. Some senior person, who is well informed of ISO standards, should be made in charge of all this process. ISO certification requires businesses to write down all procedures, job descriptions, different department functions, etc in accordance with ISO standards. Next step is the implementation. Start with educating the employees; tell them about the importance and significance of ISO certification, once motivated, they should be directed on how they can help in acquiring certification? Perform internal audits frequently to check if everybody is following the procedures. Make corrective actions when some error is found. If needed, you can hire an advisory service as well.

Issuance of Certificate:
International standard organization (ISO) doesn’t provide any certification itself. These certifications are issued by registered bodies that are entitled to do so. After some business has taken all necessary steps and their quality management system is in accordance with ISO guidelines, they can apply for the certification. Some representative from these registration bodies will visit the workplace or factory and observe the procedures. If satisfied, they will provide an ISO certification which is valid for three years.

Document and Data Control in ISO 9000 & ISO 14001

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The organization shall establish and maintain procedures for controlling all documents and data required by ISO 9000 & ISO 14001

a) they can be located;

b) they are periodically reviewed, revised as necessary, and approved for adequacy by authorized personnel;

c) current versions of relevant documents and data are available at all locations where operations essential to the effective functioning of the OH&S system are performed;

d) obsolete documents and data are promptly removed from all points of issue and points of use, or otherwise assured against unintended use;

e) archival documents and data retained for legal or knowledge preservation purposes, are suitably identified.

Accidents, incidents, non-conformances and corrective and preventive action

The organization shall implement and record any changes in the documented procedures resulting from corrective and preventive action.

Documents required by the ISO 9000 & ISO 14001 shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements.

The organization shall establish, implement and maintain procedure[s] to:

a) approve documents for adequacy prior to use;

b) review and update as necessary and re-approve documents;

c) ensure that changes and the current revisions status of documents are identified;

d.) ensure that relevant versions of applicable documents are available at points of use;

e.) ensure that documents remain legible and readily identifiable;

f.) ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the ISO 9000 & ISO 14001 management system are identified and their distribution controlled, and

g.) prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose.

ISO 9001 Standards – Quality Policy and Objectives

2010-10-27T06:25:00.002-07:00

ISO 9001 Standards – Quality Policy and Objectives

A ISO 9001 Standards quality policy and its corresponding quality objectives are established to direct the organization towards two specific goals of a quality management system:

-Provision of products – goods and services – that meet customer and applicable legal requirements, and

- Enhancement of customer satisfaction

The quality policy and the objectives are also a means of controlling the quality management system’s processes. Simply, if you want to control a process, assign an objective to it (or more) and make sure it is aligned to the quality policy, then monitor and measure the process’ performance against the assigned objective. You need to provide adequate resources to the process to ensure that it is capable of achieving the objective. You continually improve the whole process by upgrading the objective, make corrective and preventive actions or introduce innovation to it. Corrective action addresses an undesirable situation’s cause in order to prevent its recurrence. Preventive action, by contrast, addresses the probable cause of a potentially undesirable situation. This is what the quality policy and objectives are supposed to do. They provide focus, direction and control.

The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties. When an organization has established a quality policy and a set of operational objectives, this means the only thing left to do is to design or plan the necessary processes or tasks that can realize those objectives. Therefore, the processes determine if the objectives will be met in full, partially or not at all. This is where the ISO 9001 standard play a critical role in specifying the required processes and the operating criteria. This is what ISO 9001 is all about. It even specifies criteria for the policy and the objectives.

A quality policy needs to satisfy the following requirements:

It is appropriate to the purpose of the organization,
It includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
It provides a framework for establishing and reviewing quality objectives,
It is communicated and understood within the organization, and
It is reviewed for continuing suitability

Quality objectives must be established in order to enable the organization to comply with requirements and continually improve the effectiveness of the quality management system. Quality objectives must achieve four things:

Enable the organization to meet customer requirements
Enable the organization to enhance customer satisfaction
Enable the organization to comply with all legal requirements applicable to the product
Continually contribute to the effectiveness of the quality management system

Therefore, when you are in the meeting room with your management brainstorming on the appropriate objectives, have these four points in mind.

ISO 9001:2000 requires that management periodically review changes to both the policy and objectives. An organization’s objectives must be measurable and its processes designed to meet those objectives. An organization’s overall business goals, quality objectives and quality policy are all interrelated and must work together to achieve business improvement. To do this, it’s necessary to understand which processes are key to achieving business goals and align those processes with the quality objectives. It means aligning business goals, quality objectives and process measures to create real improvement. And it means using process mapping. Process mapping involves more than just flow charting. Among other things, it can manage and improve processes by illustrating process measures as well as process flows and interactions. One process-mapping method begins by involving the people who work in the process. Another entails mapping the process as is, taking action to improve it and then preparing a final map of the improved process.

Process owners are directly responsible for the attainment of the objectives. They must be given adequate resources, including competent human resources. They need to review the objectives periodically to ensure the key performance indicators are heading towards their objectives on schedule. If not, they need to initiate corrective actions and if the risks of non-achievement are visible, take preventive actions to control them and steer the KPI’s back on course.

Examples of quality objectives:

Production rejects <>
Machine breakdown <>
Returned products = 0/mth
Purchasing >95% on-time delivery
Inventory damage = 0/mth

Conclusion: ISO 9001 requires that the quality management system achieves its objectives in order to realize the quality policy.

IMPLEMENTATION OF ISO 9001 STANDARD IN EDUCATION

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IMPLEMENTATION OF ISO 9001 STANDARD IN EDUCATION

international standards pertaining to ISO 9000 (1987) family. The implementation of this last standard grows continuously, either in Europe or in the world. In the period from 2001 to 2003, there was a slight stagnation, which was the consequence of the organisations having to adapt to the requests of ISO 9001:2000 edition of the standard. Croatia also actively participates in this trend, which show that at the end of 2004, organisations were certified, of which 970 of them were from Croatia.

The economy has already met with various endeavours and concepts to build aneffective quality management system. From the historical point of view, the most importantones are Deming Prize (1950), followed by Malcom Baldrige National Award (1987) andinternational standards pertaining to ISO 9000 (1987) family. The implementation of thislast standard grows continuously, either in Europe or in the world, as shown in the picture1. In the period from 2001 to 2003, there was a slight stagnation, which was theconsequence of the organisations having to adapt to the requests of ISO 9001:2008 editionof the standard. Croatia also actively participates in this trend, as illustrated by figures fromthe table 2, which show that at the end of 2004, 670,399 organisations were certified, ofwhich 970 of them were from Croatia.

The implementation of the stated standard in educational activities took a somewhat slower pace. Trends in Croatia do not completely follow the World ones . The 2002 and 2003 stagnation, which, as already mentioned, was mainly caused by transfer from one issue of the standard to the next one, had no particular impact to Croatia, partially because the data for Croatia includes standards from both the previous and the new issue of the ISO 9001 standard.

Aligning At ISO 9001 Standard Requirements

2010-10-27T06:24:00.000-07:00

Aligning At ISO 9001 Standard Requirements

In conformity with the explanations of international series of standards elaborated in the 2008 year, the

implementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be done

in every kind of organization, indifferent of its field of activity , size or number of personnel. This means that

SMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to their

limited resources. The success of this action depends on more elements, mainly, the following ones:

· Strong commitment and decision of top management;

· Adopting an organization structure accordingly both with business plan of SME, and with the

requirements and guides of standards from quality management field, too.

This means that SME (sector in continuously development in Romania starting from 1990) can align to

these requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources.

The success of this demarche depends on several elements, mainly, the following:

· The decision and the strong commitment of the top management ;

· Adopting an organizational structure according to the business plan of SMEs, but also with the
requirements and the directions of the norm/standards in the quality management field.

· Accurate planning of the implementation project of a quality management system

· Allocation of the m a t erial, financial and human resources necessary for developing and

maintaining of the system;

· Suitable training of the personnel of the organization for the documentation and implementation of the system, but also for its supervising;

· Maintaining of an efficient communication and collaboration with business partners, first, with the

suppliers and the clients of SMEs, but also with other interested parts, including their own

personnel;

And one more remark: the success of a quality management system in a SME depends on endowment degree and on technological level of the equipments and working and controlling installation of the processes.

In conformity with the explanations of international series of standards elaborated in the 2000 year, theimplementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be donein every kind of organization, indifferent of its field of activity , size or number of personnel. This means thatSMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to theirlimited resources. The success of this action depends on more elements, mainly, the following ones:· Strong commitment and decision of top management;· Adopting an organization structure accordingly both with business plan of SME, and with therequirements and guides of standards from quality management field, too.This means that SME (sector in continuously development in Romania starting from 1990) can align tothese requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources. Thesuccess of this demarche depends on several elements, mainly, the following:· The decision and the strong commitment of the top management ;· Adopting an organizational structure according to the business plan of SMEs, but also with therequirements and the directions of the norm/standards in the quality management field.· Accurate planning of the implementation project of a quality management system· Allocation of the m a t erial, financial and human resources necessary for developing andmaintaining of the system;· Suitable training of the personnel of the organization for the documentation and implementation ofthe system, but also for its supervising;· Maintaining of an efficient communication and collaboration with business partners, first, with thesuppliers and the clients of SMEs, but also with other interested parts, including their ownpersonnel;And one more remark: the success of a quality management system in a SME depends on endowmentdegree and on technological level of the equipments and working and controlling installation of the processes.

A transparent quality management system, well conceived and applied, with adequate trained and motivated personnel, will be efficient and if technological level of endowments (working, supervising, measuring and monitoring equipments of the processes and product, working environment and infrastructure) will be comparable with the level of endowment of the top firms in the same activity area, as of the organization we refer to.

So, adopting a quality management system based on the requirements of the ISO 9001 standard is a strategic decision of the top management of an organization, much more for the management of SME that first of all has to analyse very well all the necessary resources, to put in balance both the necessary costs of the implementation and sustaining in function of a quality management system and the benefits brought, then to decide advisedly. Developing a quality management system gives both direct benefits and a contribution at the cost and risk management, being important not only for organization but also for the satisfaction of its clients and other interested parts.

The decision of designing and implementation of a quality management system in SME is influenced by proposed objectives, by the demand of the market, by products and services offered, as well as by objectives tendency of developing and the continuously improving of the performances of the processes of any organization.

A quality management system contains two essential elements. First, the most critical, refers to human resources and the other necessary resources for constant delivery of the adequate products and services to the client. Second refers to the existence of “documented quality management system” that is, usually, defined by documented policies, objectives, plans, processes, procedures and fabrication standards. The documented quality management system has to reflect the planning and carrying on the activities, made by SME. Both for the audit reported to the ISO 9001 standard’s requirements but also for improving activities, will need to generate adequate registrations to document the effective performance and to demonstrate the concordance.

Top management of SME has to be aware that the implementation of a quality management system according to this standard has to be approached as a project, to which are assigned resources and which has to be managed by a defined schedule.

First step is represented by defining the objectives of the schedule with an accent on those that will bring benefits for SME. For each objective must be defined the way in which will be measured his achievement, as well as the reference level. Schedule must also establish:

· An identification, documentation and continue improving system of SME’s processes;

· Stages that must be carried out for achieving the objectives regarding to the quality of the product and for long-term improving of a quality management system of SME;

After establishing the objectives, the next decision of the top management of SME refers to the type of approaching that will appeal to [3].

There are two ways of approaching:

a) to design the whole quality management system and then to be implemented;

b) to evaluate the processes and to appeal to improving techniques to build the system step by step, starting from existing elements.

The advantage of designing the whole quality management system is represented by obtaining a distinct structure, the main disadvantage being the tendency of a theoretical approach, separated from the realities and practices of SMEs. The performances of the personnel can also suffer because of the necessity to apply simultaneous a great number of new procedures.

The essential advantage of step by step approach is that if through evaluation of processes are determined both the adequate practices and the less acceptable, the efforts can be focused on those areas that ensure a maximum benefit. This approach has the disadvantage of the tendency to achieve a quality management system that is not so well structured and so is more difficult to understand and to apply by the personnel of SME.

The optimum approach represents a combination of the two variants. So, initially it is good to be established a general structure of the quality management system and then to be established frame models for documentation of the processes. Implementation activities will have in view identification and solving the problems and then the improving key processes of SME.

Indifferent the approaching way, top management of SME can decide if the conceiving and implementation project of the quality management system will be carried out through internal forces, or will be carried out external appealing to a specialised advising. In case they appeal to an advising firm, must exist an abiding collaboration between the two firm and a well tuned up contract to which will be affixed a plain schedule, with responsibilities and achievement terms.

Designing and implementation project of the quality management system cannot ensure solving all the problems. Changing the culture of an organization takes time and patience. Project must be accomplished through a well defined series of phases, with well established terms and with objectives that can be reached.

Active Implication Of The Implementation Of Quality Management System

2010-10-27T06:23:00.001-07:00

Active Implication Of The Implementation Of Quality Management System

Successful implementation of a quality management system is conditioned by implication of the top management of SME. ISO 9001 gives a special importance of the commitment of the top management obviously defining its role in the quality management system. It is underlined the promoting the leadership principle in practice as a base for operational the others principles of the quality management system.

The commitment and active implication of the top management are essential for developing, implementation and maintaining an efficient and efficacy quality system management, having as a final purpose ensuring an increasing clients’ satisfaction.

To achieve such a desideratum, top management must consider the following actions:

· defining the visions, policies and strategic objectives of SME;

· direct participation of the management to improving projects;

· obtaining the feedback regarding efficiency and efficacy of the processes of making the products;

· developing an environment that encourages the involving of the personnel;

· ensuring the necessary resources for achieving the objectives.

Top management defines the methods of the performances of SME to determine the stage of achievement the objectives.

These methods must allow the evaluation:

· financial performances of SME;

· performances of the processes of SME;

· client’s satisfaction, personnel’s and other interested parts’ satisfaction;

· other success factors identified by management.

Information that results from such evaluations are used as incoming elements for the analysis done by management for continue improving of the quality management system, that must ensure the base for improving

the performances of SME.

In this way, top management can demonstrate its commitment through:

· understanding the necessities and present expectations and client’s perspective;

· promoting policies and objectives for increasing the awareness and implication of the personnel in SME;

· adopting the principle of continue improving as a base principle for the processes of SME.

· Rigorous planning of all processes of SME and to operate the changes;

· ensuring an adequate background to satisfy the requirements of the interested parts.

Top management has to involve directly in identification the processes of fabrication the products because these are directly tied by SME’s success. Also, a special attention must be paid on identification of those reliance processes that affects either the efficacy and efficiency of the processes of fabrication of the products of SME, or the necessities and expectations of the interested parts.

The management of SMEs should ensure that the processes are carried out as an efficacious and efficient net. For this it should be analyzed and got at its best the interaction of all processes. In this purpose it must consider the following aspects:

· ensuring the sequence and interaction between processes are in that way designed so they allow getting the desired results;

· ensuring that incoming and outgoing elements are obvious defined and are kept under control;

· monitoring the incoming and outgoing elements to check if the processes are correlated and carried out efficacious and efficient;

· identification and administrate the risks and to turn to account the opportunities of improving

performances;

· doing the analysis of the information for continuously improving of the processes;

· designating the responsible of the processes;

· ensuring that every process is managed so that it allows the achievement of the established objectives;

· defining the necessities and expectations of the interested parts.

Top management can present proves regarding its commitment for developing and implementation of the quality management system as well as for continuously improving of its efficacy through:

· communication of the importance of satisfaction of the clients’ requirements in SME, as well as legal requirements;

· defining the policy and objectives regarding the quality;

· managing the analysis of the quality management system;

· ensuring the necessary resources for the achievement of the objectives.

One of the main tasks that top management has to accomplish refers to defining the policy in the quality field. There is no form of standard presentation, but the policy must be in such way formulated so it ensure:

· getting client’s satisfaction as a main goal;

· clarifying the way in which it is ensured the quality of the products and services of SME;

· explicit commitment of the management regarding continue improving of the quality;

· assuming by the management the responsibility regarding the achievement of the objectives regarding quality.

Policy will be implemented through the objectives regarding the quality, that should be measurable. The more participation of the top management is more direct and more visible, the more the necessary period will be shorter for establishing and implementation of the quality system management, on one hand because of the availability of the resources and on the other hand because of a less bureaucratic approach that top management of SME has in this case.

When it is decided the implementation of a quality management system or it is approved an improving schedule of this, it is vital to exist an obvious understanding of the estimated duration and necessary resources from the management. Often, the initiatives regarding the quality management system fail because of this commitment is missing, especially from the top management.

Why do organizations implement ISO 9000 systems?

2010-10-27T06:22:00.000-07:00

Why do organizations implement ISO 9000 systems?

More often than not, organizations get ISO 9000 because certain customers force them or encourage them to. In many market sectors—electronics, pulp and paper, telecommunications, automobile manufacturing, defense—major customers have mandated ISO 9000 registration to their key suppliers. Similarly, some overseas regulatory bodies mandate ISO 9000 for the makers of qualitysensitive products (such as medical devices).

Many of these major customers impose ISO 9000 systems in place of, or in addition to, specific quality programs, requirements, specifications, and so on that have been in place for many years. The ISO 9000Standard becomes a key part of the relationship between the customer and its suppliers.

ISO 9000 is not, however, meant to replace customer-specific requirements in any market segment. Rather, ISO 9000 is meant to be a floor: a basic set of generic requirements. They are generic enough to apply to virtually all supplier/customer relationships anywhere in the world. It matters not the size of the supplier, the location of the customer, or the nationalities involved.

In some industrial segments, formalized standards have been created, adding to the generic ISO 9000requirements additional clauses that are industry specific. Examples include:

_ Automotive (QS-9000).

_ Aerospace (AS-9000).

_ Telecommunications (TL-9000).

To the extent that ISO 9000 replaces customer-specific quality programs and supporting audit/oversight activities, it can relieve both customers and suppliers of a great deal of redundancy, duplication, and waste of resources. The fundamental requirements are understood, agreed to, and (usually) confirmed by objective third-party audit. This gives customers confidence in the integrity and effectiveness of their supplier’s basic quality practices. The customer and supplier can then invest their energies and resources in agreeing to and working on the specific requirements unique to their relationship.

To some, ISO 9000 sounds like a mandatory, gun-to-your-head, my-way-or-the-highway program. For many suppliers, it is exactly that (“get ISO 9000 or get lost”). For many others, it is perceived that way:

“They’re trying to tell us how to run our businesses.”

But the goal of ISO 9000 is not to strengthen customers’ control over how their suppliers run their businesses. The goal is to give customers confidence in the ability of suppliers to meet their needs, resulting in satisfied customers, and growing and prosperous suppliers.

Admittedly, implementing ISO 9000 does not guarantee this. Like most things, what you get out of it depends on what you put into it. You can implement a compliant ISO 9000 system that is all cost and no benefit and it’s even possible to pass registration audit this way. This happens, usually, when the supplier’s approach is to try to:

_ Squeak by.

_ Do just enough to get registered.

_ Get this thing done without changing how we work.

But suppliers who implement ISO 9000 fully—to the spirit, as well as the letter—can and do achieve real benefits.

Different Between Quality Assurance & Quality Control

2010-08-30T05:59:00.001-07:00

QA: Quality Assurance is the process which are having their eyes on the process to provide the assurity of the quality. like doing the testing at the time of development, giving the review comments and forced the developers to fixed the defects of the requirement, designed, coding and testing phase is the Quality Assurance.

Quality Control: Before delivering the product to make sure that all the documentation are provided, product has meet with the requirement criteria, all the SDLC phase are met with the exit criteria is the Quality control.

Difference between Quality Control and Quality Assurance?

	Quality Control	Quality Assurance
Definition	QC is about checking at the end of some development process (e.g. – a design activity) that we have built quality in i.e. that we have achieved the required quality with our methods.	QA is about having an overall development and management process that provides right environment for ensuring quality of final product.
Description	QC is like testing a module against requirement specification or design document, measuring response time, throughput etc.	QA gives us added assurance that the whole producing or checking process is properly planned and executed and thus maintaining high quality.
What it does	To check that the modern methods of software development are largely designed to ensure right quality is achieved. QC checks that these methods are in place and to discover where they are not then corrections are to be made.	It gives us added assurance that the while producing / checking process is being properly planned and executed and hence is keeping high our chances of producing software of required quality.
Stages	Define features and levels Define feature check procedure Carrying out the check procedure Record the result take and record any corrective action taken.	1. Determination of quality policy through Quality Management System 2. Checking that predetermined Quality control activities are being properly taken care off.
Best carried out on	QC is best carried out on products	QA is best carried out on process.
Phase of implementation	QC should take place at every stage of SDLC.	QA should be done at end of every SDLC i.e. when product building is complete.
Technique	Structured walkthrough, Fagan Techniques are some of QC techniques.	Quality policy defined and generally implemented in the form of Quality Management System is used to carry out QA.

As per ISO 9000 Standards:

Quality Control means – The Operational Techique and activities that are used to fullfill requirements of Quality,

Quality Assurance means – All Those planned and systematic activites implemented already , to provide adequate confidence that an entity will fulfillrequirements of Quality.

The following table can explain in detail:

QC QA

Product Process

Reactive Pro-active

Line Function Staff Function

Find the defects Prevent the defects

e.g.

QC QA

Walkthrough Quality Audit

Testing Defining Process

Inspection Selection of tools

Checkpoint Review Trainings

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

2010-08-30T05:58:00.000-07:00

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

1. ISO 9000 Introduction, a Process approach.

2. Gap Analysis: Schedule the Gap Analysis, Conduction and ISO 9001 Gap Analysis.

3. Prepare a Project Plan: The Team approach, Steering Team, Task Teams.

4. Train employees on ISO 9001: Mamagement Overview, Employee awareness, Keeping them informed.

5. Document your system: How much Documentation do you need, Importance of Documentation control

6. Implement the QMS in your Organization:Training on new procedures, Training of internal auditors.

7. Audit your QMS: Train internal Auditors, Conduct Internal Audits.

8. ISO 9001:2008 Registration Audit: Selecting a Registrar and then go ahead with registration.

Process Approach In ISO 9001 Standards

2010-08-30T05:57:00.000-07:00

The process approach was introduced into ISO 9001 with the year 2000 version of the standards.

Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.

2.4. Verify the process and its activities against its planned objectives
3. Implementation and measurement of the process
4. Analysis of the process
5. Corrective action and improvement of the process Implementation
This document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.
In addition to the guidance documents, ISO maintains a web site with “official interpretations” of

approach was introduced into ISO 9001 with the year 2000 version of the standards.
Prior versions used an element approach. The document Guidance on the concept and use of the process approach for managementsystems describes to process approach and offers an implementation paradigm.
1. Identification of processes of the organization
1.1. Define the purpose of the organization
1.2. Define the policies and objectives of the organization
1.3. Determine the processes in the organization
1.4. Determine the sequence of the processes
1.5. Define process ownership
1.6. Define process documentation
2. Planning of a process
2.1. Define the activities within the process
2.2. Define the monitoring and measurement requirements
2.3. Define the resources needed

ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.
Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.
Auditing Practices
The ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS)experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance(ISO/TC 176) and the International Accreditation Forum (IAF).
The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.
The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.

Integrating Management Systems Within The ISO 9001 Standards

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ISO is a word derived from the Greek isos, meaning “equal”. ISO 9000 Standards are developed and updated by the International Organisation for Standardisation which has around 150 member bodies. A member body of ISO is the national body “most representative of standardisation in its country”.(eg. Germany – DIN, USA – ANSI, Australia – SAA).
More than 50 countries, as well as the European Community have adopted ISO 9000 which is recognised internationally as a benchmark for measuring quality in a trade context. Since its first issue in 1987, approximately 430?000 companies have been using ISO 9000. Being a standard coming from an organisation that is usually involved in the development of technical standards, ISO 9000 is often regarded as a document that belongs in the hands of a technician exposed to production line quality control. At a closer look, however, ISO 9000 Standard Series provide guidance in the development and application of Management Systems as well as Quality Control in Manufacturing and Administration.

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000?, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)

Quality Management System Preliminary Gap Analysis

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Quality Management System Preliminary Gap Analysis

Decide on a number from 0 to 5 for each item below. The scoring criteria are given in a table at the end. 1 to 5 Make notes to explain your score for future reference.

1. Have you established, documented, implemented and now maintain a Quality Management System (QMS) to any system including ISO 9001?

2. Have you identified the processes needed for your QMS and

a. the sequence of your production and service delivery processes,

b. the criteria and methods needed to ensure the processes are effective, and3. Do you have

c. have the resources and the information you need to support the processes?

d. a Quality Manual including your Quality Policy and quality objectives, and

e. written procedures and work instructions?

4. Do your records provide evidence that your business processes are effective?6. Has your Top Management communicated the importance of meeting customer and other business requirements to all the employees?9. Are your quality objectives measurable?

5. Is your Top Management committed to the development and implementation of a new QMS (i.e. based on the 2008 version of ISO 9001)?

7. Has your Top Management made a commitment to ensure your customers’ requirements are top priority?

8. Do your quality objectives include requirements for production and delivery?

10. Have the responsibilities and authorities of managers and employees been defined and communicated to them?

11. Does your management have the drive and resources needed

a. to implement, and maintain a QMS and continually improve its effectiveness, and

b. to enhance customer satisfaction by meeting customer requirements?

12. Does your organization have procedures to select competent personnel for work activities?

13. Does your organization provide training or take other action to help develop your people?

14. Does your organization provide adequate:

a. buildings, workspace and utilities,

b. process equipment, and

c. supporting services such as transport or communication?

15. When you receive a customer order do you review it for

a. requirements specified by the customer, including the delivery and post-delivery activities,

b. requirements not stated by the customer but necessary for specified use or known and intended use, and

c. statutory and regulatory requirements related to the product?

16. Do you inform your customers concerning

a. product information,

b. enquiries, contracts or order handling, including changes, and

c. channels for customer feedback and complaints?

17. Does your organization plan and control product design and development activities?

18. Does your organization maintain records of design or development review, verification and validation activities and resulting action?

19. Does your organization inspect or otherwise confirm that purchased products, materials, components and services conform to your specified purchase requirements?

20. Does your organization select suppliers depending on how important the purchased product is for production?

21. Does your organization evaluate suppliers (subcontractors or vendors) based on their ability to satisfy your requirements?

22. Do you ensure production has

a. the information that describes the characteristics of the product,

b. the necessary work instructions,

c. suitable equipment, and

d. the monitoring and measuring devices needed?

23. Does your organization regularly confirm that your production and service processes are capable of consistently meeting your requirements?

24. Are parts, components, subassemblies and products identified throughout production or service delivery?

25. Are monitoring and measurement requirements clearly shown with the status of the product?

26. Where traceability is a requirement, does production keep records of unique product identification?

27. Do you care for and protect customers’ property under your control or being used by your people?

28. Do you look after your product (including the parts or components) during both production and delivery to the customer, by providing suitable identification, packaging, storage, preservation and handling?

29. Do you have instructions needed to identify inspection or monitoring activities to be done during production or service delivery and the devices to be used?

30. Is your measuring equipment:

a. Calibrated or verified at specified intervals, or prior to use?

b. Adjusted or re-adjusted as necessary?

c. Identified to enable the calibration status to be determined?

d. Safeguarded from adjustments that would invalidate the measurement result?

e. Protected from damage and deterioration during handling, maintenance and storage?

31. Does your organization monitor customer information that shows you have satisfied customer requirements?

32. Does your organization conduct internal quality audits at planned intervals?

33. Does your organization use suitable methods to monitor and, where practical, measure the performance of your processes?

34. Does your organization inspect or measure the characteristics of finished products and record the results?

35. Does your organization identify nonconforming products and review them for disposition?

36. Does your organization collect and analyze data to assess the suitability and effectiveness of the QMS?

37. Does your organization use data to evaluate or identify where continual improvement of the QMS can be made?

38. Does your organization continually improve the effectiveness of the QMS?

39. Does your organization take corrective action to eliminate the causes of problems and to prevent their recurrence?

40. Does your organization determine and eliminate potential nonconformities in order to prevent their occurrence?

To score this table:

0 – You do not understand what is required or believe it is necessary

1 – Your organization does not perform this activity

2.- You understand this activity is a good thing to do but do not do it

3 – You do this sometimes

4 – You do this but not very well

5 – You do this quite well.

Add all the points together.

150 – 200

You are almost ready to complete your ISO 9001 QMS and apply for certification/

registration.

100 – 149

You are ready to implement the QMS. This will likely improve your business results.

0 – 99

You have a lot to do but should begin. You could consider seeking help from a

consultant or specialist.

Different Between Quality Assurance & Quality Control

2010-04-08T08:15:00.001-07:00

Difference between Quality Control and Quality Assurance?

	Quality Control	Quality Assurance
Definition	QC is about checking at the end of some development process (e.g. – a design activity) that we have built quality in i.e. that we have achieved the required quality with our methods.	QA is about having an overall development and management process that provides right environment for ensuring quality of final product.
Description	QC is like testing a module against requirement specification or design document, measuring response time, throughput etc.	QA gives us added assurance that the whole producing or checking process is properly planned and executed and thus maintaining high quality.
What it does	To check that the modern methods of software development are largely designed to ensure right quality is achieved. QC checks that these methods are in place and to discover where they are not then corrections are to be made.	It gives us added assurance that the while producing / checking process is being properly planned and executed and hence is keeping high our chances of producing software of required quality.
Stages	Define features and levels Define feature check procedure Carrying out the check procedure Record the result take and record any corrective action taken.	1. Determination of quality policy through Quality Management System 2. Checking that predetermined Quality control activities are being properly taken care off.
Best carried out on	QC is best carried out on products	QA is best carried out on process.
Phase of implementation	QC should take place at every stage of SDLC.	QA should be done at end of every SDLC i.e. when product building is complete.
Technique	Structured walkthrough, Fagan Techniques are some of QC techniques.	Quality policy defined and generally implemented in the form of Quality Management System is used to carry out QA.

As per ISO 9000 Standards:

Quality Control means – The Operational Techique and activities that are used to fullfill requirements of Quality,

Quality Assurance means – All Those planned and systematic activites implemented already , to provide adequate confidence that an entity will fulfillrequirements of Quality.

The following table can explain in detail:

QC QA

Product Process

Reactive Pro-active

Line Function Staff Function

Find the defects Prevent the defects

e.g.

QC QA

Walkthrough Quality Audit

Testing Defining Process

Inspection Selection of tools

Checkpoint Review Trainings

Environment Awareness

2010-02-24T01:53:00.000-08:00

Save OUR EARTH!!! Go For ISO 14001 Standards - Environmental Management System. If all companies implement ISO 140001 Standards - Environmental Management System in the organization, it will help us to protect our environment.

Implement Quality Management System

2010-01-16T17:25:00.000-08:00

Implement Quality Management System

Implementation of ISO 9000 affects the entire organization right from the start. If pursued with total dedication, it results in 'cultural transition' to an atmosphere of continuous improvement.
The process of implementing ISO 9000 depends on:
􀂃 a. The sophistication of your existing quality program,
􀂃 b. The size of your organization, and
􀂃 c. The complexity of your process.

The 14 essential steps, briefly described below, are to be followed through in order to implement ISO 9000 quality management system successfully.
Step 1: Top management commitment
Step 2: Establish implementation team
Step 3. Start ISO 9000 awareness programs
Step 4: Provide Training
Step 5. Conduct initial status survey
Step 6: Create a documented implementation plan
Step 7. Develop quality management system documentation
Step 8: Document control
Step 9. Implementation
Step 10. Internal quality audit
Step 11. Management review
Step 12. Pre-assessment audit
Step 13. Certification and registration
Step 14: Continual Improvement

Quality Management System Requirements

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Quality Management System Requirements
The ISO 9001:2008 standard is meant to be generic and applicable to all kinds of organizations. Therefore, organizations from both the public and private sectors, including non-governmental organizations can benefit from the ISO 9000 quality management system model, regardless of whether they are small, medium or large organizations. The immediate benefit that can be realized from the implementation of ISO 9000 is the collective alignment of the activities of internal processes that are focused towards the enhancement of customer satisfaction which will result in many other benefits, whether internal or external. The magnitude of these benefits are determined by how effective the processes are in achieving its objectives.

How Quality Management System is implemented?

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How Quality Management System is implemented?

The terms ‘establish’, ‘document’, ‘implement’, ‘maintain’ and ‘improve’ are used in the ISO 9000 Standard as though this is a sequence of activities when in reality, in order to establish a system it has to be put in place and putting a system in place requires two separate actions:
- Design the Quality Management System using a process that transforms the system requirements into specific characteristics that results in a clear definition of all the processes that meet the system requirements.
- Construct the system using a process that documents, installs, commissions and integrates the processes to deliver the required business outputs.
The way in which these phases of quality system development are related is
illustrated in the management system process model shown in Figure 4.1. This diagram has some important features. Note that the design input to the system comprises internal and external requirements. On the right side there are four improvement routes:
- Improvements in conformity during operation of the system arise through
enforcing policy and practices – doing what you say you do
- Improvements in conformity during system construction arise through
enforcing policy and design rules on the system – reworking the system to
comply with the established policies and objectives
- Improvements in efficiency during system construction arise through
finding better ways of implementing the system design – shorter, less
wasteful routines, less complexity, lower skill levels, fewer resources
- Improvements in effectiveness arise as a result of identifying different
policies and objectives – higher targets, new objectives, new requirements,
regulations, and new technologies.
As indicated above, establishing a system means designing and constructing it, which can be referred to as system development. System design is dealt with under Identifying processes. Constructing the system covers documentation, resourcing, installation, commissioning, qualification and integration.

Documenting A Quality Management System

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Documenting A Quality Management System

The ISO 9000 Standards requires the organization to document a quality management system in accordance with the requirements of ISO 9001. A document (according to ISO 9000 clause 2.7.1) is information and its supporting medium. A page of printed information, a CD ROM or a computer file is a document, implying that recorded information is a document and verbal information is not a document.
Clause 4.2 requires the management system documentation to include certain types of documents and therefore does not limit the management system documentation to the types of documents listed.
As a management system is the means to achieve the organization’s objectives, and a system is a set of interrelated processes, it follows that what has to be documented are all the processes that constitute the system.
While there is a reduction in emphasis on documentation in ISO 9001:2008 compared with the 1994 version, it does not imply that organizations will need less documentation to define their management system. What it does mean is that the organization is left to decide the documentation necessary for effective operation and control of its processes. If the absence of specific documentation does not adversely affect operation and control of processes, such documentation is unnecessary.
Before ISO 9000 came along, organizations prospered without masses of
documentation and many still do. Those that have chosen not to pursue the
ISO 9000 path often only generate and maintain documents that have a useful purpose and will not produce documents just for auditors unless there is a legal requirement. Most of the documentation that is required in ISO 9000 came about from hindsight – the traditional unscientific way organizations learn and how management systems evolve.
ISO 9000 contains a list of valid reasons for why documents are necessary as below:
- To communicate requirements, intentions, instructions, methods and results effectively
- To convert solved problems into recorded knowledge so as to avoid having
to solve them repeatedly
- To provide freedom for management and staff to maximize their contribution to the business
- To free the business from reliance on particular individuals for its effectiveness
- To provide legitimacy and authority for the actions and decisions needed
- To make responsibility clear and to create the conditions for self-control
- To provide co-ordination for inter-departmental action
- To provide consistency and predictability in carrying out repetitive tasks
- To provide training and reference material for new and existing staff
- To provide evidence to those concerned of your intentions and your actions
- To provide a basis for studying existing work practices and identifying
opportunities for improvement
- To demonstrate after an incident the precautions which were taken or which should have been taken to prevent it or minimize its occurrence
If only one of these reasons make sense in a particular situation, the
information should be documented. In some organizations, they take the
view that it is important to nurture freedom, creativity and initiative and
therefore feel that documenting procedures is counterproductive. Their view is that documented procedures hold back improvement, forcing staff to follow routines without thinking and prevent innovation. While it is true that blindly enforcing procedures that reflect out-of-date practices coupled with bureaucratic change mechanisms is counter productive, it is equally shortsighted to ignore past experience, ignore decisions based on valid evidence and encourage staff to reinvent what were perfectly acceptable methods.
Question by all means, encourage staff to challenge decisions of the past, but
encourage them to put forward a case for change. That way it will cause
them to study the old methods, select the good bits and modify the parts that are no longer appropriate. It is often said that there is nothing new under the sun – just new ways of packaging the same message.

Develop Quality Management System Documentation In ISO 9000 Standards

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develop Quality Management System Documentation In ISO 9000 Standards

Documentation is the most common area of non-conformance among organizations wishing to implement ISO 9000 quality management systems. As one company pointed out: “When we started our implementation, we found that documentation was inadequate. Even absent, in some areas. Take calibration. Obviously it’s necessary, and obviously we do it, but it wasn’t being documented. Another area was inspection and testing. We inspect and test practically every item that leaves here, but our documentation was inadequate”.
Documentation of the quality management system should include:
1. Documented statements of a quality policy and quality objectives,
2. A quality manual,
3. Documented procedures and records required by the standard ISO 9001:2008, and
4. Documents needed by the organization to ensure the effective planning, operation and control of its processes.

Quality documentation is generally prepared in the three levels indicated below that follows. Use ISO 10013:1995 for guidance in quality documentation.

Level A: Quality manual
States the scope of the quality management system, including exclusions and details of their justification; and describes the processes of the quality management system and their interaction. Generally gives an organization profile; presents the organizational relationships and responsibilities of persons whose work affects quality and outlines the main procedures. It may also describe organization’s quality policy and quality objectives.

Level B: Quality management system procedures
Describes the activities of individual departments, how quality is controlled in each department and the checks that are carried out.

Level C: Quality documents (forms, reports, work instructions, etc.)
1. Work instructions describe in detail how specific tasks are performed; include drawing standards, methods of tests, customer’s specifications, etc.
2. Presents forms to be used for recording observations, etc.

Continual improvement in the quality management system

2009-11-22T01:03:00.001-08:00

Continual Improvement In The Quality Management System

The ISO 9001 standard requires the organization to continually improve the effectiveness of the quality management system in accordance with the requirements of ISO 9001 and to implement action necessary to achieve planned results and continual improvement of the identified processes.

ISO 9000 defines continual improvement as a recurring activity to increase the ability to fulfil requirements. As the organization’s objectives are its requirements, continually improving the effectiveness of the quality management system means continually increasing the ability of the organization to fulfil its objectives.

If the performance of a process parameter is currently meeting the standard that has been established, there are several improvement actions you can take:

Raise the standard e.g. if the norm for the sales ratio of orders won to all orders bid is 60%, an improvement programme could be developed for raising the standard to 75% or higher

Increase efficiency e.g. if the time to process an order is within limits, identify and eliminate wasted resources

Increase effectiveness e.g. if you bid against all customer requests, by only bidding for those you know you can win you improve your hit rate

You can call all these actions improvement actions because they clearly improve performance. However, we need to distinguish between being better at what we do now and doing new things. Some may argue that improving efficiency is being better at what we do now, and so it is – but if in order to improve efficiency we have to be innovative we are truly reaching new standards. Forty years ago, supervisors in industry would cut an eraser in half in the name of efficiency rather than hand out two erasers. Clearly this was a lack of trust disguised as efficiency improvement and it had quite the opposite effect. In fact they were not only increasing waste but also creating a hostile environment.

Each of the improvement actions is dealt with later in the book and the subject of continual improvement addressed again under Quality planning.

There are several steps to undertaking continual improvement:

1. Determine current performance

2 Establish the need for change

3 Obtain commitment and define the improvement objectives

4 Organize diagnostic resources

5 Carry out research and analysis to discover the cause of current performance

6 Define and test solutions that will accomplish the improvement objectives

7 Product improvement plans which specify how and by whom the changes will be implemented

8 Identify and overcome any resistance to change

9 Implement the change

10 Put in place controls to hold new levels of performance and repeat step one

For more information, please visit http://www.iso9001-standard.us

ISO 9000 Quality Assurance Policy

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ISO 9001 Quality Policy

The standard requires the quality policy to be appropriate to the purpose of the organization.

The purpose of an organization is quite simply the reason for its existence and as Peter Drucker so eloquently put it there is only one valid definition of business purpose: to create a customer”(Drucker, Peter F., 1977)2 . In ensuring that the quality policy is appropriate to the purpose of the organization, it must be appropriate to the customers the organization desires to create. It is therefore necessary to establish who the customers are, where the customers are, what they buy or wish to receive and what these customers regard as value. As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9001 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to quality policy.

Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’

– thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.

In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the quality policy.

One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision. Omitting the strategy may not ensure uniformity of approach and direction.

The standard requires that the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system.

A commitment to comply with requirements means that the organization should undertake to meet the requirements of all interested parties. This means meeting the requirements of customer, suppliers, employees, investors, owners and society. Customer requirements are those either specified or implied by customers or determined by the organization and these are dealt with in more detail under clauses 5.2 and 7.2.1. The requirements of employees are those covered by legislation such as access, space, environmental conditions, equal opportunities and maternity leave but also the legislation appropriate to minority groups such as the disabled and any agreements made with unions or other representative bodies. Investors have rights also and these will be addressed in the investment agreements. The requirements of society are those obligations resulting from laws, statutes, regulations etc.

An organization accepts such obligations when it is incorporated as a legal entity, when it accepts orders from customers, when it recruits employees, when it chooses to trade in regulated markets and when it chooses to use or process materials that impact the environment.

The effectiveness of the management system is judged by the extent to which it fulfils its purpose. Therefore improving effectiveness means improving the capability of the management system. Changes to the management system that improve its capability i.e its ability to deliver outputs that satisfy all the interested parties, are a certain types of change and not all management system changes will accomplish this. This requirement therefore requires top management to pursue changes that bring about an improvement in performance.

Scope Of The Quality Management System

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Scope Of The Quality Management System

The ISO 9001 standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion. The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.

Under ISO 9001:2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the quality management system.

It is sensible to describe the scope of the quality management system so as to ensure effective communication. The scope of the quality management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor. Why you need to justify specific exclusions is uncertain because it is more practical to justify inclusions.

The scope of the quality management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.

It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’.

It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable.

For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.

How long does it take to implement ISO 9001?

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It depends on you and your company. The very fastest is 2-3 months because most ISO 9001 registrars require at least 2 months ISO 9001 track record before the certification audit.
More realistically: if you have a relatively small company (say, less than 20 employees), if your employees are motivated and if they don’t oppose change, if you have the backing of all senior executives, if you and other managers are ready to put some significant time and efforts into this endeavor, and if you use a really good ISO 9001 quality manual template (a sample ISO 9000 quality manual that you can modify to make it your own ISO 9000 quality manual), then you may be able to get certified in as short as 3-4 months; templates for ISO 9000 forms are an additional time-saver. Some companies are significantly slower, with 6-12 months not being unusual.
However, companies that write their ISO 9001 quality manual and their ISO 9001 quality procedures from scratch, rather than base them on a proven sample ISO 9001 quality manual, often take up to 2 years or longer.

Why is ISO 9000 Important?

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ISO 9000 is important because of its orientation. While the content itself is useful and important, the content alone does not account for its widespread appeal.
ISO 9000 is important because of its international orientation. Currently, ISO 9000 is supported by national standards bodies from more than 150 countries. This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard of excellence.
ISO is also important because of its systemic orientation. We think this is crucial. Many people wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesn’t go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality management system, you will never achieve a world-class standard of quality.
Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9000 is important.

Templates for Quality Manuals and Forms

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Using templates for ISO 9001 quality manuals, procedures and forms can have huge benefits for an organization. Templates are usually in the form of existing and proven manuals, procedures and forms. Follow the link for more information on the use of Templates.
The ISO 9000 quality manual and the ISO 9000 quality procedures are a vital part of any ISO 9001 quality system.
You can get a huge head start by purchasing a good template quality manual (a sample quality manual that you can
use as a good example and that you can modify to make it your own quality manual). There are numerous
companies that sell ISO 9000 quality manuals that you can use as templates to create your own quality manual.
We urge you to carefully evaluate them before making a purchase decision as we found the majority to be
convoluted, bureaucratic and cumbersome.

SUMMARY OF CHANGES TO ISO 14001:2004

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SUMMARY OF CHANGES TO ISO 14001:2004
ISO 14001:2004 aims to clarify the 1996 edition and align it more closely with the ISO 9001:2000 standard. Some clauses have not been modified for content but have been rewritten to align ISO 14001:2004 with the format, wording, and layout of ISO 9001:2000 and to enhance the compatibility between the two standards.
References in Annex A of the standard are aligned with the numbering in the standard for ease of use. Annex B of the standard identifies similarities and associations between ISO 9001:2000 and ISO 14001:2004.
An important change in wording throughout the revised standard appears in requirements that previously stated that an organisation shall “establish and maintain”; these have now been changed to “establish, implement and maintain”.
Throughout the standard the word “personnel” in the original standard is replaced with “persons working for or on behalf of the organisation” in the revised standard. This is included to ensure that external contractors and applicable suppliers are included under the requirements of certain clauses.
In developing, implementing and maintaining the organisation’s EMS, significant environmental aspects, applicable legal requirements and other requirements to which the organisation subscribes must be considered, and management must ensure the availability of resources.
There are additional paragraphs in the introduction, which generally cover:
• the aim of the ISO 14001:2004 standard is to enhance compatibility with ISO 9001:2000;
• alignment is improved between clause references and supporting Annexes. For example, 4.3.3 and A.3.3 both deal with objectives, targets and programme(s), and 4.5.5 and A.5.5 both deal with internal audit;
• an explanation of the Plan-Do-Check-Act (PDCA) model used in ISO 9001:2000;
• the use of the process approach is promoted in alignment with ISO 9001:2000;
• possible alignment and integration with other management systems is reviewed

ISO 9001 & ISO 14001 Blog

2009-09-22T05:48:00.000-07:00

Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/
http://www.iso14000store.com/blog
http://www.iso9001-standard.us

ISO 9000 and ISO 14000 in plain language

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Both “ISO 9000” and “ISO 14000” are actually families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management systemconforms to the standard).
ISO 9000 is primarily concerned with “quality management“. In the everyday context, like “beauty”, everyone may have his or her idea of what “quality” is. But, in the ISO 9000 context, the standardized definition of quality refers to all those features of a product (or service) which are required by the customer. “Quality management” means what the organization does to ensure that its products or services satisfy the customer’s quality requirements and comply with any regulationsapplicable to those products or services.
ISO 14000 is primarily concerned with “environmental management”. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.
In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental management.
Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work. In other words, they both concern processes, and not products – at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product.
In the case of ISO 9000, the efficient and effective management of processes is, for example, going to affect whether or not everything has been done to ensure that the product satisfies the customer’s quality requirements. In the case of ISO 14000, the efficient and effective management of processes is going to affect whether or not everything has been done to ensure a product will have the least harmful impact on the environment, at any stage in its life cycle, either by pollution, or by depleting natural resources.
However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organization’s activities on the environment (ISO 14000). In both cases, the philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in the relevant ISO 9000 or ISO 14000 standards.

Quality Assurance in ISO 9001 Standards

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Quality Assurance in ISO 9001 Standards

The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by— its business environment, changes in that environment, or risks associated with that environment,— its varying needs,— its particular objectives,— the products it provides,— the processes it employs,— its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying theassociated requirement.This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to theproduct, and the organization’s own requirements.The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.

ISO 9001 – Compatibility with other management systems

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ISO 9001 – Compatibility with other management systems
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.

ISO 9001:2008 Requirements – Resource Management

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ISO 9001:2008 Requirements – Resource Management
6.1 Provision of ResourcesDetermine and provide the resources necessary to:? Implement and maintain the quality management system? Continually improve the effectiveness of the system? Enhance customer satisfaction by meeting customer requirements6.2 Human Resources6.2.1 GeneralEnsure people performing work affecting conformity to product requirements are competent based on the appropriate education, training, skills, and experience.NOTE: Conformity to product requirements can be affected directly, or indirectly, by personnel performing any task within the quality management system.6.2.2 Competence, Training, and AwarenessThe organization must:? Determine the competency needs for personnel? Provide training (or take other actions) to achieve the necessary competence? Evaluate the effectiveness of the actions taken? Inform employees of the relevance and importance of their activities? Ensure they know their contribution to achieving quality objectives? Maintain education, training, skill, and experience records
6.3 Infrastructure Determine, provide, and maintain the necessary infrastructure to achieve product conformity. Infrastructure includes, as applicable:? Buildings, workspace, and associated utilities? Process equipment (both hardware and software)? Supporting services (such as transport, communication, or information systems)6.4 Work EnvironmentDetermine and manage the work environment needed to achieve product conformity.NOTE: The term “work environment” relates to those conditions under which work is performed, including physical, environmental, and other factors such as noise, temperature, humidity, lighting, or weather.

ISO 9001:2008 FAQ

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ISO 9001:2008 FAQ
What Is The ISO 9001: 2008 Standard?
The latest edition of the ISO 9001 standard ISO 9001: 2008, Quality Management Systems – Requirements, was officially published by (ISO) the International Organization for Standardization on November 14, 2008. It is the fourth edition of the ISO 9001 standard since it was first published in 1987.
Who Is Responsible For Revising The standards?
The ISO Technical Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) is responsible for the revision process in collaboration with consensus among quality and industry experts nominated by ISO Member bodies, and representing all interested parties.
Does ISO 9001:2008 Have Additional Requirements Beyond ISO 9001:2000 ?
This latest (4th) edition of ISO 9001 contains no new requirements compared to the (3rd) year 2000 edition, which it replaces. What it does is provide clarification to the existing requirements of ISO 9001:2000 based on eight years’ experience of worldwide implementing of the standard and introduces changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.
The clarifications and changes in ISO 9001:2008 represents fine-tuning, rather than a thorough overhaul. It focuses on changes that organizations might make to better comply with the spirit of the standard without adding, deleting, or altering its requirements. The changes are minor in nature and address such issues as the need to clarify, provide greater consistency, resolve perceived ambiguities, and improve compatibility with ISO 14001. The numbering system and the structure of the standard remain unchanged. As a result, the new standard looks much like the old standard.
ISO has grouped the changes incorporated in this ISO 9001:2008 edition into the following categories:- No changes or minimum changes on user documents, including records- No changes or minimum changes to existing QMS processes- No additional training required or minimal training required- No effects on current certifications
In contrast, the 3rd edition, ISO 9001:2000 published in 2000, represented a major overhaul of the standard, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.
Then Why Was It Necessary To Introduce This Revision?All ISO standards – currently more than 17 400 – are periodically reviewed. To ensure that ISO standards are maintained at the state of the art, ISO has a rule requiring them to be periodically reviewed and a decision taken to confirm, withdraw or revise the documents. The review process must be initiated within 3 years of publication of a standard. The review considers several factors such as technological evolution, new methods and materials, new quality and safety requirements, or questions of interpretation and application.
The review of ISO 9001 resulting in the 2008 edition was carried out by subcommittee SC 2 of ISO/TC 176. This subcommittee, which is responsible for the ISO 9000 family, unites expertise from 80 participating countries and 19 international or regional organizations, plus other technical committees.
This review has a number of inputs that help it:
A global user questionnaire/survey
A market Justification Study
Suggestions arising from the ISO/TC 176 interpretation process
Opportunities for increased compatibility with ISO 14001
The need for greater clarity, ease of use, and improved translation
Current trends – keeping up with recent developments in management system practices.
How Does The New ISO 9001 Edition Affect Existing ISO 9001 QMS’s?
As organizations start looking at ISO 9001:2008, they will wonder to what extent the changes might affect them. To a large extent, the new standard will not result in significant change to existing quality management systems (QMS).
ISO/TC 176 was careful in not making change for change sake. In the case of editorial changes, this was especially true. This could have lead to a false impression that there was a change in requirements, carrying greater significance than was intended. In those instances, when the committee members couldn’t come to a consensus in determining if a change added or deleted a requirement, they opted to retain the existing text. They decided it was better to err on the side of caution rather than to contribute to any misunderstanding in the marketplace.
The changes that have been incorporated into this edition of the ISO 9001 standard include changes that should lead to a better understanding across a broader range of product types, including service organizations; use of deliberate wording to minimize the potential for incorrect user interpretation; and reflect nuances of similar concepts. Lastly, some of the changes to specific clauses were made based on the 2004 International User Feedback Survey. This survey was conducted after the publication of ISO 9001:2000 and had invited respondents to identify areas they most wanted to see improved.

Structure Of ISO 9001

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ISO 9001 was first published in 1987. Later, it went through three revisions in 1994, 2000 and 2008. The latest version version of the ISO 9001 standard was published on 14th November 2008. This is the structure of the standard:
Clause 1 Scope
Clause 2 Normative reference
Clause 3 Terms and definitions
Clause 4 Quality management system
Clause 5 Management responsibility
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement

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ISO 9001:2008 General Requirements

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ISO 9001:2008 General Requirements

4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standards. The organization
shall determine the processes needed for the quality management system and their application throughout the organizations,
determine the sequence and interaction of these processes,
determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
monitor, measure (where applicable) and analyze these processes, and
implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
NOTE 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.
NOTE 2: An outsourced process is identified as one being needed for the organization’s quality management system, but chosen to be performed by a party external to the organization.
NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such asa) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,b) the degree to which the control for the process is shared;c) the capability of achieving the necessary control through the application of clause 7.4.
Clause 4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall includedocumented statements of a quality policy and quality objectives,
a quality manual,
documented procedures and records required by this International Standard,
documents including records, needed determined by the organization to be necessary to ensure the effective planning, operation and control of its processes
NOTE 1: Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to the size of organization and type of activities, the complexity of processes and their interactions, and the competence of personnel.
NOTE 3: The documentation can be in any form or type of medium.
4.2.2 Quality Manual
The organization shall establish and maintain a quality manual that includes the scope of the quality management system, including details of and justification for any exclusions (see 1.2), the documented procedures established for the quality management system, or reference to them, and a description of the interaction between the processes of the quality management.
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
to approve documents for adequacy prior to issue,
to review and update as necessary and re-approve documents,
to ensure that the changes and the current revision status of documents are identified,
to ensure that relevant versions of applicable documents are available at points of use,
to ensure that documents of external origin are identified and their distribution controlled, and
to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
4.2.4 Control of records
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. Records shall remain legible, readily identifiable, and retrievable.

Migration to ISO 9001:2008

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Migration To ISO 9001:2008The International Accreditation Forum (IAF) and the International Organization forStandardization (ISO) have agreed on an implementation plan to ensure a smooth transition ofaccredited certification to ISO 9001:2008, the latest version of the world’s most widely usedstandard for quality management systems (QMS). The details of the plan are given in the jointcommuniqué by the two organizations which appears below.Like all of ISO’s more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that itis maintained at the state of the art and a decision taken to confirm, withdraw or revise thedocument.ISO 9001:2008, which is due to be published before the end of the year, will replace the year2000 version of the standard which is implemented by both business and public sectororganizations in 170 countries. Although certification is not a requirement of the standard, theQMS of about one million organizations have been audited and certified by independentcertification bodies (also known in some countries as registration bodies) to ISO 9001:2000.ISO 9001 certification is frequently used in both private and public sectors to increaseconfidence in the products and services provided by certified organizations, between partnersin business-to-business relations, in the selection of suppliers in supply chains and in the rightto tender for procurement contracts.ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing andcertification. These services are performed independently of ISO by certification bodies. ISOdoes not control such bodies, but does develop voluntary International Standards toencourage good practice in their activities on a worldwide basis. For example, ISO/IEC17021:2006 specifies the requirements for bodies providing auditing and certification ofmanagement systems.Certification bodies that wish to provide further confidence in their services may apply to be“accredited” as competent by an IAF recognized national accreditation body. ISO/IEC17011:2004 specifies the requirements for carrying out such accreditation. IAF is aninternational association whose membership includes the national accreditation bodies of 49economies.ISO technical committee ISO/TC 176, Quality management and quality assurance, which isresponsible for the ISO 9000 family of standards, is preparing a number of support documentsexplaining what the differences are between ISO 9001:2008 and the year 2000 version, whyand what they mean for users. Once approved, these documents will be posted on the ISOWeb site – probably in October 2008.
ISO (International Organization for Standardization) and the IAF (International AccreditationForum) have agreed an implementation plan to ensure a smooth migration of accreditedcertification to ISO 9001:2008, after consultation with international groupings representingquality system or auditor certification bodies, and industry users of ISO 9001 certificationservices.ISO 9001:2008 does not contain any new requirementsThey have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008only introduces clarifications to the existing requirements of ISO 9001:2000 based on eightyears of experience of implementing the standard world wide with about one millioncertificates issued in 170 countries to date. It also introduces changes intended to improveconsistency with ISO14001:2004The agreed implementation plan in relation to accredited certification is therefore thefollowing:Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO9001:2008 as an International Standard.Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issuedafter official publication of ISO 9001:2008 (which should take place before the end of 2008)and after a routine surveillance or recertification audit against ISO 9001:2008.Validity of certifications to ISO 9001:2000One year after publication of ISO 9001:2008 all accredited certifications issued (newcertifications or recertifications) shall be to ISO 9001:2008.Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issuedto ISO 9001:2000 shall not be valid.

Continual improvement in the quality management In ISO 9001

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Continual improvement in the quality management system and its processes In ISO 9001
The standard requires the organization to continually improve the effectiveness of the quality management system in accordance with the requirements of ISO 9001 and to implement action necessary to achieve planned results andcontinual improvement of the identified processes.
ISO 9000 defines continual improvement as a recurring activity to increase the ability to fulfil requirements. As the organization’s objectives are its requirements, continually improving the effectiveness of the management system means continually increasing the ability of the organization to fulfil its objectives.
This requirement responds to the Continual Improvement principle. If the management system is enabling the organization to accomplish its objectives when that is its purpose, why improve? The need for improvement arises out of a need to become more effective at what you do, more efficient in the utilization of resources so that the organization becomes best in its class. The purpose of measuring process performance is to establish whether or not the objectives are being achieved and if not to take action on the difference. If the performance targets are being achieved, opportunities may well exist to raise standards and increase efficiency and effectiveness.
If the performance of a process parameter is currently meeting the standard that has been established, there are several improvement actions you can take:Raise the standard e.g. if the norm for the sales ratio of orders won to all orders bid is 60%, an improvement programme could be developed for raising the standard to 75% or higherIncrease efficiency e.g. if the time to process an order is within limits, identify and eliminate wasted resources Increase effectiveness e.g. if you bid against all customer requests, by only bidding for those you know you can win you improve your hit rate
You can call all these actions improvement actions because they clearly improve performance. However, we need to distinguish between being better at what we do now and doing new things. Some may argue that improving efficiency is being better at what we do now, and so it is – but if in order to improve efficiency we have to be innovative we are truly reaching new standards. Forty years ago, supervisors in industry would cut an eraser in half in the name of efficiency rather than hand out two erasers. Clearly this was a lack of trust disguised as efficiency improvement and it had quite the opposite effect. In fact they were not only increasing waste but also creating a hostile environment.
Each of the improvement actions is dealt with later in the book and the subject of continual improvement addressed again under Quality planning in Chapter 5. There are several steps to undertaking continual improvement (Juran, J. M., 1995)12 .1 Determine current performance2 Establish the need for change3 Obtain commitment and define the improvement objectives4 Organize diagnostic resources5 Carry out research and analysis to discover the cause of currentperformance6 Define and test solutions that will accomplish the improvementobjectives7 Product improvement plans which specify how and by whom the changeswill be implemented8 Identify and overcome any resistance to change9 Implement the change10 Put in place controls to hold new levels of performance and repeat step one.

Preparing the ISO 9001 quality manual

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The standard requires a quality manual to be establishedand maintained that includes the scope of the qualitymanagement system, the documented procedures or refer-ence to them and a description of the sequence andinteraction of processes included in the quality manage-ment system.
ISO 9000 defines a quality manual as a documentspecifying the quality management system of an organi-zation. It is therefore not intended that themanual be a response to the requirements ofISO 9001. As the top-level document describingthe management system it is a system descriptiondescribing how the organization is managed.Countless quality manuals produced to satisfy ISO 9000 :2008, were nomore than 20 sections that paraphrased the requirements of the standard.Such documentation adds no value. They are of no use to managers, staff orauditors. Often thought to be useful to customers, organizations would gainno more confidence from customers than would be obtained from theirregistration certificate.
This requirement responds to the System Approach Principle.A description of the management system is necessary as a means of showinghow all the processes are interconnected and how they collectively deliver thebusiness outputs. It has several uses as :a means to communicate the vision, values, mission, policies and objectivesof the organizationa means of showing how the system has been designeda means of showing linkages between processesa means of showing who does whatan aid to training new peoplea tool in the analysis of potential improvementsa means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes toachieve them, the manual provides a convenient vehicle for containing suchinformation. If left as separate pieces of information, it may be more difficult tosee the linkages.The requirement provides the framework for the manual. Its content maytherefore include the following:1 Introduction(a) Purpose (of the manual)(b) Scope (of the manual)(c) Applicability (of the manual)(d) Definitions (of terms used in the manual)2 Business overview(a) Nature of the business/organization – its scope of activity, its productsand services(b) The organization’s interested parties (customers, employees, regulators,shareholders, suppliers, owners etc.)(c) The context diagram showing the organization relative to its externalenvironment(d) Vision, values(e) Mission3 Organization(a) Function descriptions(b) Organization chart(c) Locations with scope of activity4 Business processes(a) The system model showing the key business processes and how they areinterconnected(b) System performance indicators and method of measurement(c) Business planning process description(d) Resource management process description(e) Marketing process description(f) Product/service generation processes description(g) Sales process description(h) Order fulfilment process description5 Function matrix (Relationship of functions to processes)6 Location matrix (Relationship of locations to processes)7 Requirement deployment matrices(a) ISO 9001 compliance matrix(b) ISO 14001 compliance matrix(c) Regulation compliance matrices (FDA, Environment, Health, Safety,CAA etc.)8 Approvals (List of current product, process and system approvals)

Scope of the ISO 9001 quality management system

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The standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion.
The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.
Under ISO 9000 :2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because itoperated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the management system.
This requirement responds to the System Approach Principle.It is sensible to describe the scope of the management system so as to ensure effective communication. The scope of the management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor.
Why you need to justify specific exclusions is uncertain because it is more practical tojustify inclusions.
The scope of the management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’. It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable. For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.

ISO 9001 Video

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Watch ISO 9001 Video at http://www.youtube.com/watch?v=G8WI2MgyS7w

ISO 9000 vs Quality

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ISO 9000 was conceived to bring about an improvement in product quality. It
was believed that if organizations were able to demonstrate they were
operating a quality system that met international standards, customers would
gain greater confidence in the quality of products they purchased. It was also
believed that by operating in accordance with documented procedures, errors
would be reduced and consistency of output ensured. If you find the best way
of achieving a result, put in place measures to prevent variation, document it
and train others to apply it, it follows that the results produced should be
consistently good.

The requirements of the standard were perceived to be a list of things to do
to achieve quality. The ISO co-ordinator would often draw up a plan based on
the following logic:
1. We have to identify resource requirements so I will write a procedure on
identifying resource requirements
2. We have to produce quality plans so I will write a procedure on producing
quality plans
3. We have to record contract review so I will write a procedure on recording
contract reviews
4. We have to identify design changes so I will write a procedure on identifying
design changes

The requirements in the standard were often not expressed as results to be
achieved. Requirements for a documented procedure to be established resulted
in just that. Invariably the objectives of the procedure were to define something
rather than to achieve something. This led to documentation without any clear
purpose that related to the achievement of quality. Those producing the
documentation were focusing on meeting the standard not on achieving quality.
Those producing the product were focusing on meeting the customer
requirement but the two were often out of sync. As quality assurance became
synonymous with procedures, so people perceived that they could achieve
quality by following procedures. The dominance of procedures to the exclusion
of performance is a misunderstanding of the implementers. The standard
required a documented system that ensured product met specified requirements – a
clear purpose. Once again the implementers lost sight of the objective. Or was it
that they knew the objective but in order to meet it, the culture would have to
change and if they could get the badge without doing so, why should they?

Issuing a procedure was considered to equate to task completed. Unfortu-
nately, for those on the receiving end, the procedures were filed and forgotten.
When the auditor came around, the individual was found to be totally
unaware of the ‘procedure’ and consequently found noncompliant with it.
However, the auditor would discover that the individual was doing the right
things so the corrective action was inevitably to change the procedure. The
process of issuing procedures was not questioned, the individual concerned
was blamed for not knowing the procedure and the whole episode failed to
make any positive contribution to the achievement of quality. But it left the
impression on the individual that quality was all about following procedures.
It also left the impression that quality was about consistency and providing
you did what you said you would do regardless of it being in the interests of
satisfying customers, it was OK. One is left wondering whether anyone
consulted the dictionary in which quality is defined as a degree of excellence?

Another problem was that those who were to implement requirements were
often excluded from the process. Instead of enquiring as to the best way of
meeting a requirement, those in charge of ISO 9000 implementation assumed
that issuing procedures would in fact cause compliance with requirements. It
requires a study of the way work gets done to appreciate how best to meet a
requirement. Procedures were required to be documented and the range and
detail was intended to be appropriate to the complexity of the work, the
methods used and the skills and training needed. The standard also only
required work instructions where their absence would adversely affect quality.
It is as though the people concerned did not read the requirement properly or
had no curiosity to find out for themselves what ISO had to say about
procedures – they were all too ready to be told what to do without questioning
why they should be doing it.

More often than not, the topics covered by the standard were only a sample
of all the things that need to be done to achieve the organization’s objectives.
The way the standard classified the topics was also often not appropriate to the
way work was performed. As a consequence, procedures failed to be
implemented because they mirrored the standard and not the work. ISO 9000
may have required documented procedures but it did not insist that they be
produced in separate documents, with titles or an identification convention
that was traceable to the requirements.

Critics argue (Seddon, John, 2000)3 that ISO 9000 did not enable organiza-
tions to reduce variation as a result of following the procedures. It is true that
ISO 9000 did not explain the theory of variation – it could have done, but
perhaps it was felt that this was better handled by the wealth of literature
available at the time. However, ISO 9000 did require organizations to identify
where the use of statistical techniques was necessary for establishing,
controlling and verifying process capability but this was often misunderstood.
Clause 4.14 of ISO 9001 required corrective action procedures – procedures to
identify variation and eliminate the cause so this should have resulted in a
reduction in variation. The procedures did not always focus on results – they
tended to focus on transactions – sending information or product from A to B.
The concept of corrective action was often misunderstood. It was believed to be
about fixing the problem and preventive action was believed to be about
preventing recurrence. Had users read ISO 8402 they should have been
enlightened. Had they read Deming they would have been enlightened but in
many cases the language of ISO 9000 was a deterrent to learning. Had the
auditors understood variation, they too could have assisted in clarifying these
issues but they too seemed ignorant – willing to regard clause 4.20 as not
applicable in many cases.

Clause 4.6 of the undervalued and forgotten standard ISO 9000 –1 starts with
‘The International Standards in the ISO 9000 family are founded upon the
understanding that all work is accomplished by a process.’ In clause 4.7 it starts
with ‘Every organization exists to accomplish value-adding work. The work is
accomplished through a network of processes’ In clause 4.8 it starts with ‘It is
conventional to speak of quality systems as consisting of a number of elements.
The quality system is carried out by means of processes which exist both within
and across functions’ Alas, few people read ISO 9000–1 and as a result the
baggage that had amassed was difficult to shed especially because there were
few if any certification bodies suggesting that the guidance contained in ISO
9000 –1 should be applied. Unfortunately, this message from ISO 9000 –1 was not
conveyed through the requirements of ISO 9001. ISO 9001 was not intended as
a design tool. It was produced for contractual and assessment purposes but was
used as a design tool instead of ISO 9000 –1 and ISO 9004 –1.

ISO 9001:2008 Documentation Requirements

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ISO 9001:2008 Documentation Requirements
ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”
ISO 9001:2008 Clause 4.2.1 General explains that the quality management system documentation shall include:
documented statements of a quality policy and quality objectives;
a quality manual
documented procedures required by this International Standard
documents needed by the organization to ensure the effective planning, operation and control of its processes, and
records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.
Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:4.2.3 Control of documents4.2.4 Control of records8.2.2 Internal audit8.3 Control of nonconforming product8.5.2 Corrective action8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3
Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:- Quality policy (clause 4.2.1.a)- Quality objectives (clause 4.2.1.a)- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:- Process maps, process flow charts and/or process descriptions- Organization charts- Specifications- Work and/or test instructions- Documents containing internal communications- Production schedules- Approved supplier lists- Test and inspection plans- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.

ISO 9000 — a way of managing for conformance

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Quality assurance, according to the Standard, is a way of managing that prevents non-conformance and thus “assures quality”. This is what makes ISO 9000 different from other standards: it is a management standard, not a product standard. It goes beyond product standardisation: it is standardising not what is made but how it is made. To use standards to dictate and control how organisations work was to extend the role of standards to new territory. To take such a step we might have firstly established that any such requirements worked — that they resulted in ways of working which improved performance.
Yet the plausibility of this Standard, and the fact that those who had an interest in maintaining it were (and still are) leading opinion, prevented such enquiries. In simple terms the Standard asks managers to say what they do, do what they say and prove it to a third party.
ISO 9000 (1994) paragraph 1: “The requirements specified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through servicing.”
To put it another way, the Standard asserts that preventing non-conformance achieves customer satisfaction. But does it? Of course it matters to customers that a product works. But there is no guarantee that the Standard will ensure even that. Furthermore, customers take a total view of an organisation — how easy it is to do business with — in respect of all things of importance to each and every customer.
ISO 9000 requires managers to “establish and maintain a documented quality system as a means of ensuring that product conforms to specified requirements”. Loosely translated this is “say what you do”. Management is supposed to “define and document its policy for quality . . . including its commitment to quality”.
What management would not declare its commitment to quality? But would they know what it means? Would they argue (as they should) that quality management is a different and better way to do business, or would they believe that ISO 9000 will take care of quality? The Standard encourages managers to think of “quality” and “business as usual” as separate and distinct. It helps managers avoid the revelation that quality means a wholly different view of management. Instead, the organisation “shall appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility” [for ISO 9000]. At a practical level this means only one executive might decide he or she had better learn a thing or two about quality. However, would being responsible for ISO 9000 lead to learning about quality or simply enforcing the ISO 9000 regime in an organisation?
Key to the regime is auditing. The Standard requires organisations to conduct internal quality audits to “verify whether quality activities comply with planned arrangements”. This can be loosely translated as “do you do as you say?” and the purpose of the audit is to see that you do. It was not until the 1994 review that the words were changed to “quality activities and related results”. It was a Standard which was rooted in the philosophy of inspection: fifteen years after its initial promulgation the promoters sought to extend the focus to results. But results or improvements assessed by what means? Inspection. By the time the Standard was adopted world-wide, quality thinking had moved a long way from the philosophy of inspection. It is now understood, at least by a few, that quality is achieved through managing the organisation as a system and using measures which enable managers to improve flow and reduce variation (which we explore in chapters 5 and 7). The defenders argue that there is nothing stopping a company having ISO 9000 and implementing methods for managing flow and reducing variation, but where are such companies? Few of the companies we researched, formally and informally, knew anything about this thinking. The Standard does not talk about it; moreover, the Standard effectively discourages managers from learning about it by representing quality in a different way.
According to ISO 8402 (quality vocabulary), quality is:
“The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.”
Everything we have learned about ISO 9000 suggests that the people who created this definition were thinking about the things which need to be controlled, those things which “bear on its ability . . .”. The builders of the Standard assumed that customer needs would be listed in contractual agreements between the supplier and customer. ISO 9000 has a “make” logic — procedures for “how you do what you do” — and a “control” logic — check to see that it is done. It is a relic of the era when contractual agreements were perceived to be an important device for regulating the behaviour of suppliers. In these ways, ISO 9000 encouraged “planning for quality”.
Planning for quality sounds plausible, but it assumes many things: that the plan is the right plan, that it is feasible, that people will “do it”, that performance will improve. It is an approach which, paradoxically, leads to poor decisions. Planners of quality systems, guided by ISO 9000, start with a view of how the world should be as framed by the Standard. Understanding how an organisation is working, rather than how someone thinks it should, is a far better place from which to start change of any kind.

ISO 9000 vs Quality

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Establishing a ISO 9001 records procedure

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The standard requires records to remain legible, readily
identifiable and retrievable and that a procedure defines
the controls needed for the identification, storage,
protec- tion, retrieval, retention time and disposition of records.
Records have a life cycle. They are generated during
which time they acquire an identity and are then
assigned for storage for a prescribed period. During
use and storage they need to be protected from
inadvertent or malicious destruction and as they
may be required to support current activities or
investigations, they need to be brought out of storage
quickly. When their usefulness has lapsed, a decision is made as to whether to
retain them further or to destroy them.
Readily retrievable means that records can be obtained on demand within a
reasonable period (hours not days or weeks) Readily identifiable means that
the identity can be discerned at a glance.
Although the requirement implies a single procedure, several may be
necessary because there are several unconnected tasks to perform. A procedure
cannot in fact ensure a result. It may prescribe a course of action which if
followed may lead to the correct result, but it is the process that ensures the
result not the procedure.
The revised requirement omits several aspects covered in clause 4.16 of the
1994 version.
Collection of records is now addressed by Analysis of data (clause 8.4)
Indexing of records is a specific form of identification and is therefore
already addressed
Access is now addressed by the requirement for record retrieval
Filing is a specific form of storage and is therefore already addressed
You may only need one procedure which covers all the requirements but this
is not always practical. The provisions you make for specific records should be
included in the documentation for controlling the activity being recorded. For
example, provisions for inspection records should be included in the inspection
procedures; provisions for design review records should be included in the
design review procedure. Within such procedures you should provide the
forms (or content requirement for the records), the identification, collection/
submission provisions, the indexing and filing provisions. It may be more
practical to cover the storage, disposal and retention provisions in separate
procedures because they may not be type-dependent. Where each department
retains their own records, these provisions may vary and therefore warrant
separate procedures.
Unlike prescriptive documents, records may contain handwritten elements and
therefore it is important that the handwriting is legible. If this becomes a
problem, you either improve discipline or consider electronic data capture.
Records also become soiled in a workshop environment so may need to be
protected to remain legible. With electronically captured data, legibility is often
not a problem. However, photographs and other scanned images may not
transfer as well as the original and lose detail so care has to be taken in
selecting appropriate equipment for this task.
Whatever the records, they should carry some
identification in order that you can determine what
they are, what kind of information they record and
what they relate to. A simple way of doing this is to
give each record a reference number and a name or
title in a prominent location on the record.

1994 –2000 Differences

Previously the standard
covered retrieval in four
ways. It required:
(a) that quality records be

made available for
evaluation by the
customer or his
representative for an
agreed period, where
agreed contractually

Records can take various forms – reports contain-

ing narrative, computer data, and forms containing
data in boxes, graphs, tables, lists and many others.
Where forms are used to collect data, they should
carry a form number and name as their identifica-
tion. When completed they should carry a serial
number to give each a separate identity. Records
should also be traceable to the product or service
they represent and this can be achieved either within
the reference number or separately, provided that the
chance of mistaken identity is eliminated. The
standard does not require records to be identifiable
to the product involved but unless you do make such
provision you will not be able to access the pertinent
records or demonstrate conformance to specified
requirements.

Implementing ISO 9000 Quality Management System

2009-08-27T17:47:00.000-07:00

Step 7. Develop quality management system documentationStep 8: Document controlStep 9. ImplementationStep 10. Internal quality auditStep 11. Management reviewStep 12. Pre-assessment auditStep 13. Certification and registrationStep 14: Continual ImprovementStep 1: Top Management CommitmentThe top management (managing director or chief executive) should demonstrate a commitment and a determination to implement an ISO 9000 quality management system in the organization. Without top management commitment, no quality initiative can succeed. Top management must be convinced that registration and certification will enable the organization to demonstrate to its customers a visible commitment to quality. It should realize that a quality management system would improve overallbusiness efficiency by elimination of wasteful duplication in management system.The top management should provide evidence of its commitment to the development and implementation of the quality management system and continually improve its effectiveness by:a. Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,b. Defining the organization’s quality policy and make this known to every employee,c. Ensuring that quality objectives are established at all levels and functions,d. Ensuring the availability of resources required for the development andimplementation of the quality management system,e. Appointing a management representative to coordinate quality management system activities, and Conducting management review.The top management should also consider actions such as:1. Leading the organization by example,2. Participating in improvement projects,3. Creating an environment that encourages the involvement of people.This type of top management commitment may be driven by:1. Direct marketplace pressure: requirements of crucial customers or parentconglomerates.2. Indirect marketplace pressure: increased quality levels and visibility among competitors.3. Growth ambitions: desire to exploit market opportunities.4. Personal belief in the value of quality as a goal and quality management systems as a means of reaching that goal.The top management should identify the goals to be achieved through the quality management system. Typical goals may be:• Be more efficient and profitable• Produce products and services that consistently meet customers’ needs andexpectations• Achieve customers satisfaction• Increase market share• Improve communications and morale in the organization• Reduce costs and liabilities• Increase confidence in the production systemStep 2. Establish Implementation TeamISO 9000 is implemented by people. The first phase of implementation calls for the commitment of top management – the CEO and perhaps a handful of other key people.The next step is to establish implementation team and appoint a ManagementRepresentative (MR) as its coordinator to plan and oversee implementation. Its members should include representatives of all functions of the organization -Marketing, Design and development, Planning, Production, Quality control, etc.In the context of the standard, the MR is the person within the Organization who acts as interface between organization management and the ISO 9000 registrar. His role is, in fact, much broader than that. The MR should also act as the organization’s “quality management system champion,” and must be a person with:
1. Total backing from the CEO,2. Genuine and passionate commitment to quality in general and the ISO 9000 qualitymanagement system in particular,3. The dignity – resulting from rank, seniority, or both – to influence managers and others of all levels and functions,4. Detailed knowledge of quality methods in general and ISO 9000 in particular.The members of the implementation team should also be trained on ISO 9000 quality management systems by a professional training organization.
Step 3. Start ISO 9000 Awareness ProgramsISO 9000 awareness programs should be conducted to communicate to theemployees the aim of the ISO 9000 quality management system; the advantage it offers to employees, customers and the organization; how it will work; and their roles and responsibilities within the system. Suppliers of materials and components should also participate in these programs.The awareness program should emphasize the benefits that the organization expects to realize through its ISO 9000 quality management system. The program should also stress the higher levels of participation and self-direction that the quality management system renders to employees. Such a focus will go far to enlist employee support and commitment.The programs could be run either by the implementation team or by experts hired to talk to different levels of employees.Step 4. Provide TrainingSince the ISO 9000 quality management system affects all the areas and all personnel in the organization, training programs should be structured for different categories of employees – senior managers, middle-level managers, supervisors and workers. The ISO 9000 implementation plan should make provision for this training. The training should cover the basic concepts of quality management systems and the standard and their overall impact on the strategic goals of the organization, the changed processes, and the likely work culture implications of the system. In addition, initial training mayalso be necessary on writing quality manuals, procedures and work instruction; auditing principles; techniques of laboratory management; calibration; testing procedures, etc.When in-house capacity to carry out such training is not available, it may be necessary to participate in external training courses run by professional training organizations.Alternatively, an external training institution could be invited to conduct in-house training courses.
Step 5. Conduct Initial Status SurveyISO 9000 does not require duplication of effort or redundant system. The goal of ISO 9000 is to create a quality management system that conforms to the standard. This does not preclude incorporating, adapting, and adding onto quality programs already in place. So the next step in the implementation process is to compare the organization’s existing quality management system, if there is one — with the requirements of thestandard (ISO 9001:2008).For this purpose, an organization flow chart showing how information actually flows (not what should be done) from order placement by the customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow chart of activities in each department should be prepared.With the aid of the flow charts, a record of existing quality management system should be established. A significant number of written procedures may already be in place.Unless they are very much out of date, these documents should not be discarded.Rather, they should be incorporated into the new quality management system.Documents requiring modification or elaboration should be identified and listed. Thisexercise is some times referred to as ” gap analysis”. During these review processes,wide consultation with executives and representatives of various unions andassociations within the organization is required to enlist their active cooperation.In the review process, documents should be collected, studied and registered for further use, possibly after they have been revised. Before developing new quality management system documentation, you need to consider with which quality requirements or department you should start. The best is to select an area where processes are fairly well organized, running effectively and functioning satisfactorily.The basic approach is to determine and record how a process is currently carried out.We can do this by identifying the people involved and obtaining information from them during individual interviews. Unfortunately, it often happens that different people will give different, contradicting versions of a process. Each one may refer to oral instructions that are not accurate or clear. This is why the facts are often not described correctly the first time around, and have to be revised several times.Once it has been agreed how to describe the current process, this process has to be adapted, supplemented and implemented according to the requirements of the quality standard (ISO 9001:2008). This requires organizational arrangements, the drawing up of additional documents and possible removal of existing documentation (e.g. procedures, inspection/test plans, inspection/test instructions) and records (e.g.inspection/test reports, inspection/test certificates).In introducing a quality management system, the emphasis is on the improvement of the existing processes or the re-organization of processes.In general, the steps to follow are the following:Ascertain and establish the following:What is the present operation/process? What already exists?
Analyze the relevant sections of the quality standard – ISO 9001:2000:What is actually required? If necessary, supplement and change operational arrangements in accordance with the standard, develop documents and records, and describe operations/processes:What is the desired operation/process?Figure 1: Steps in introducing a quality management systemThe above gap analysis can be done internally, if the knowledge level is there. Or aformal pre-assessment can be obtained from any one of a large number of ISO 9000consulting, implementing, and registration firms.Step 6. Create a Documented Implementation PlanOnce the organization has obtained a clear picture of how its quality management system compares with the ISO 9001:2008 standard, all non-conformances must be addressed with a documented implementation plan. Usually, the plan calls for identifying and describing processes to make the organization’s quality management system fully in compliance with the standard.The implementation plan should be thorough and specific, detailing:???? Quality documentation to be developed???? Objective of the system???? Pertinent ISO 9001:2008 section???? Person or team responsible???? Approval required???? Training required???? Resources required???? Estimated completion dateThese elements should be organized into a detailed chart, to be reviewed andapproved. The plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities. Once approved, the Management Representative should control, review and update the plan as the implementation process proceeds.Typical implementation action plan is shown in Figure 2. Use ISO 10005:1995 for guidance in quality planning
Step 7. Develop Quality Management System DocumentationDocumentation is the most common area of non-conformance among organizations wishing to implement ISO 9000 quality management systems. As one company pointed out: “When we started our implementation, we found that documentation was inadequate. Even absent, in some areas. Take calibration. Obviously it’s necessary, and obviously we do it, but it wasn’t being documented. Another area was inspection and testing. We inspect and test practically every item that leaves here, but our documentation was inadequate”.Documentation of the quality management system should include:???? Documented statements of a quality policy and quality objectives,???? A quality manual,???? Documented procedures and records required by the standard ISO 9001:2008, and???? Documents needed by the organization to ensure the effective planning, operation and control of its processes.Quality documentation is generally prepared in the three levels indicated in the box that follows. Use ISO 10013:1995 for guidance in quality documentation.
In small companies, the above levels of documentation could be presented in one manual; otherwise, separate manuals should be prepared.A list of the documents to be prepared should be drawn up and the responsibility for writing the documents should be assigned to the persons concerned in various functional departments. They should be advised to prepare the drafts within a specific time frame.Step 8: Document ControlOnce the necessary quality management system documentation has been generated, a documented system must be created to control it. Control is simply a means of managing the creation, approval, distribution, revision, storage, and disposal of the various types of documentation. Document control systems should be as simple and as easy to operate as possible — sufficient to meet ISO 9001:2008 requirements and that is all.Document control should include:???? Approval for adequacy by authorized person (s) before issue,???? Review, updating and re-approval of documents by authorized person (s),???? Identification of changes and of the revision status of documents,???? Availability of relevant versions of documents at points of use,???? Identification and control of documents of external origin,???? Assurance of legibility and identifability of documents, and???? Prevention of unintended use of obsolete documents.The principle of ISO 9000 document control is that employees should have access to the documentation and records needed to fulfil their responsibilities.Step 9. ImplementationIt is good practice to implement the quality management system being documented as the documentation is developed, although this may be more effective in larger firms. In smaller companies, the quality management system is often implemented all at once throughout the organization. Where phased implementation takes place, the effectiveness of the system in selected areas can be evaluated.It would be a good idea initially to evaluate areas where the chances of a positive evaluation are high, to maintain the confidence of both management and staff in the merits of implementing the quality management system.The implementation progress should be monitored to ensure that the qualitymanagement system is effective and conforms to the standard. These activities include internal quality audit, formal corrective action and management review.Step 10. Internal Quality AuditAs the system is being installed, its effectiveness should be checked by regular internal quality audits. Internal quality audits are conducted to verify that the installed quality management system:
???? Conform to the planned arrangements, to the requirements of the standard (ISO 9001:2008) and to the quality management system requirements established by your organization, and???? Is effectively implemented and maintained.Even after the system stabilizes and starts functioning, internal audits should be planned and performed as part of an ongoing strategy.A few staff members should be trained to carry out internal auditing. Use ISO 19011 for guidance in auditing, auditor qualification and programmes.Step 11. Management ReviewWhen the installed quality management system has been operating for three to six months, an internal audit and management review should be conducted and corrective actions implemented. The management reviews are conducted to ensure the continuing suitability, adequacy and effectiveness of the quality management system.????The review should include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.The input to management review should include information on:???? Results of audits,???? Customer feed back,???? Process performance and product conformity,???? Status of preventive and corrective actions,???? Follow-up actions from previous management reviews,???? Changes that could affect the quality management system, and???? Recommendations for improvements.Management reviews should also address the pitfalls to effective implementation, including lack of CEO commitment, failure to involve everyone in the process, and failure to monitor progress and enforce deadlines.Step 12. Pre-assessment AuditWhen system deficiencies are no longer visible, it is normally time to apply for certification. However, before doing so, a pre-assessment audit should be arranged with an independent and qualified auditor. Sometimes certification bodies provide this service for a nominal charge. The pre-assessment audit would provide a degree of confidence for formally going ahead with an application for certification.Step 13. Certification and RegistrationOnce the quality management system has been in operation for a few months and has stabilized, a formal application for certification could be made to a selected certification agency. The certification agency first carries out an audit of the documents (referred to as an “adequacy audit”). If the documents conform to the requirements of the quality standard, then on-site audit is carried out. If the certification body finds the system to be working satisfactorily, it awards the organization a certificate, generallyfor a period of three years. During this three-year period, it will carry out periodic surveillance audits to ensure that the system is continuing to operate satisfactorily.Step 14: Continual ImprovementCertification to ISO 9000 should not be an end. You should continually seek to improve the effectiveness and suitability of the quality management system through the use of:???? Quality policy???? Quality objectives???? Audit results???? Analysis of data???? Corrective and preventive actions???? Management reviewISO 9004:2008 provides a methodology for continual improvement.

ISO 9000 Series and Six Sigma

2009-08-27T03:33:00.000-07:00

ISO (International Organization for Standardization) 9000 series standards were first published in 1987, revised in 1994, and re-revised in 2000 by the ISO. The 2000 revision, denoted by ISO 9000:2000, has attracted broad expectations in industry.
As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.
The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.
Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the
American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.
Some people are wondering if the ISO 9000:2000 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.
The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:2000 stan
dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.
The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.