Integrating Management Systems Within The ISO 9001 Standards

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.)

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Improve your performance management with new version of ISO 9001

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

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.

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ISO 9001 Training

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.

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How To Acquire ISO 9000 Standards

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.

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ISO 9001 Audit Checklist

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.

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How To Meet ISO 9001 Quality Standards?

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:

1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. Systems Approach to Management
6. Continuous improvement
7. Factual Approach to Decision-Making
8. 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.

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Identification of processes In ISO 9001

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.

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How To Obtain ISO 9001 Certificate

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.