Volume 6 · Issue 8 · August 2001

Contents

Preparing for the Future of ISO 9001:2000
A Registrar Q&A

The ISO 9001:2000 Transition–Question 6

Many organizations will be making the transition from ISO 9001/2/3:1994 to ISO 9001:2000 conformance and registration in the next 3 years. However, the requirements of ISO 9001:2000 and the steps an ISO 9001/2/3:1994-registered organization can–and cannot–take in a successful upgrade are not always clear for those used to the older editions of the quality system conformance standards.

Since March 2001, each month THE OUTLOOK has been submitting to representatives of several registrars a question on ISO 9001:2000’s requirements with consideration of making the transition from ISO 9001/2/3:1994. The purpose of these questions and answers is to make you, the reader, more comfortable with the new standard and aware of both what is required that must be addressed in upgrading your organization’s quality management system (QMS) and what should be considered in conducting the upgrade.

These registrar representatives have accepted an invitation to participate in this question and answer series to help bring a range of perspectives on the issues being addressed. In addition, Randy Dougherty, Director of Registrar Programs of the Registrar Accreditation Board (RAB), will be providing insights on some of these questions and the issues behind them in light of the answers from the registrars.

This month’s question received answers from four registrar representatives and RAB.

Question:

The Smith Organization has a quality system registered to ISO 9002:1994, and the contents of the quality manual follow the 20-clause structure of ISO 9001:1994’s Section 4, including the numbering. What is the best and most easy-to-understand way for the Smith Organization to revise its quality manual to conform to the requirements contained in Sections 4-8 of ISO 9001:2000?

Jim Scott, Vice President, Registration, AQSR International, Inc

If the Smith Organization’s existing ISO 9002:1994-registered quality system has been effective, it should not be necessary to recreate the quality manual.

If the organization has a mature documentation system, I would recommend that it prepare a matrix of the clauses and subclauses of ISO 9001:2000, Quality management systems–Requirements, with a complete cross-referencing of its requirements to Smith’s existing Level 1-4 ISO 9002:1994 quality system documentation.

Other changes to the manual will be required to satisfy new and changed requirements in ISO 9001:2000, particularly for an organization with an ISO 9002 system, but creating the matrix will allow the organization to easily see and make the other changes that are needed.

Rudy Frueboes, Technical Manager, DNV Certification

The quality manual must address each specific requirement of ISO 9001:2000 and its applicability within the Smith Organization’s scope and method of operation. The level of detail must extend to the subclause level (e.g., Subclause 7.3.3, Design and Development Outputs).

If a particular clause of Section 7, Product Realization, has been determined to be inapplicable to the scope of the Smith Organization’s operations, then it should be so noted in the quality manual. Justification for the exclusion per Clause 1.2, Scope–Application, must be clearly stated in the manual.

The quality manual must contain or reference the documented procedures of the organization’s QMS and describe the interaction of the processes included in the QMS. Simply put, the quality manual should address all processes associated with fulfilling QMS requirements. In satisfying Clause 4.1(a), Quality Management System–General Requirements, which requires an organization to identify the processes needed for the QMS, a flow chart specifying the processes and their interactions is one method that could be used to comply with Subclause 4.2.2(c), Documentation Requirements–Quality Manual, which requires the Smith Organization to describe the interaction between the QMS’s processes.

Considering what I noted above and the long-term implications of implementing and continually improving a QMS that is being revised from an ISO 9002:1994-registered quality system, it is my opinion and belief that the "best and most easy-to-understand way for the Smith Organization to revise its quality manual to conform to the requirements contained in Sections 4-8 of ISO 9001:2000" is to completely restructure its existing manual to follow the format of ISO 9001:2000.

A matrix may be used to correlate the existing lower level QMS documentation to the revised quality manual. It should be stressed that a complete revision of the quality manual to follow the format of the 2000 edition of ISO 9001 is not required by DNV Certification and, as such, each organization needs to determine how best to address the requirements to suit its own circumstances, including the Smith Organization.

Daniel Désilets, Director—Systems Registration (North America), Intertek Testing Services, N.A.

The best system is the system that best suits the needs of the Smith Organization! Therefore, if the organization is comfortable with its ISO 9002:1994-conforming 20-clause structure quality manual, it should stick with it.

On ISO’s web site (www.iso.ch), the following answer has been provided in the FAQ (Frequently Asked Questions) section to a question regarding whether an organization has to reorganize its documentation around the ISO 9001:2000 structure:

If your current quality management system is successfully implemented, satisfies the needs and objectives of your organization, reflects the way your organization works, addresses all of the new requirements, no changes are required. However, if your current documented system does not address all of the new requirements, additional documentation may be necessary.

Clause 4.1 of ISO 9001:2000 provides the recipe for developing a QMS that complies with the requirements of the standard. It is a straightforward, 6-step process that an organization should apply, followed by a gap analysis to establish its level of conformity with the requirements of ISO 9001:2000 from two standpoints: documentation and implementation.

The Smith Organization should then determine what it will do to "fill the gap". This part is relatively simple, although it has to be performed by well-informed people in order to be successful. While ISO 9001:2000 is relatively simple, it takes some time and effort to really understand the "nature and extent" of its requirements. Therefore, before undertaking this task, the Smith Organization should ensure that those assigned to this task are knowledgeable. Training and publications on this subject are numerous. Furthermore, outsourcing of this service may also be a good alternative.

In trying to "fill the gap", organizations need to be careful "how" as well as "where" in the system they are going to "add" the new requirements of ISO 9001:2000. Nevertheless, the sensitive part relates to those requirements of ISO 9001/2:1994 that are no longer required by the 2000 version. Before taking these requirements out of its system, the Smith Organization should seriously consider the impact of deleting these requirements. Examples of ISO 9001:1994 requirements that could be deleted include the need for purchasing documents, several of the "exotic" requirements in Clause 4.11, Control of Inspection, Measuring and Test Equipment, and periodic assessment of product in storage in ISO 9001:1994. If such a requirement provides added value to the organization, it should be maintained since nothing in ISO 9001:2000 conflicts with what is required in ISO 9001/2:1994 and vice versa.

The same principle applies to the need for procedures. In large organizations, it is felt that most procedures should and will be maintained whether or not they are no longer required by ISO 9001:2000. In smaller organizations, the decision to maintain or not maintain procedures should be based on the risk associated with the process itself and the level of comfort of the users with the said procedure.

There is no doubt that ISO 9001:2000 offers the Smith Organization and all others the possibility of making its QMS documentation much lighter. However, organizations must remember that the purpose of the documentation is to help them maintain their systems. Trying to make it too "light" may result in a "loss of control", even if it is an ISO 9001:2000 conforming QMS.

A. Joseph Falcsik, Certification Director, SRI Quality System Registrar

Organizations that have a fully functional ISO 9001/2/3:1994-registered quality system have several methods available for converting their quality manual to conform with ISO 9001:2000.

One method the Smith Organization could choose would be to retain the quality manual from its current ISO 9002-registered quality system and develop/implement any additional requirements to meet ISO 9001:2000. A customized matrix could then be developed or the organization might consider using Annex B of ISO 9001:2000, Correspondence Between ISO 9001:2000 and ISO 9001:1994, to develop an appropriate cross-reference matrix.

Another method would be to revise and update all documentation that was initially developed and implemented to conform with ISO 9002:1994 (policies, procedures and work instructions) and transfer/renumber the documents utilizing the aforementioned Annex B to guide the reorganization.

A third method worth mentioning would be for the Smith Organization to go back to the "drawing board" and literally follow the ISO 9001:2000 documentation requirements as noted under Clause 4.2, particularly the quality manual specifications in Subclause 4.2.2.

The current trend in the ISO 9000 community is to initially upgrade an ISO 9001/2-registered quality system to meet the revised requirements of ISO 9001:2000 by applying the first method (developing a matrix and cross-referencing) and adding any ISO 9001:2000 requirements that an organization’s quality system does not already address. The Smith Organization, and/or your organization for that matter, may be registered to ISO 9002:1994 but have a quality system that already exceeds what is required by ISO 9001:2000 because of customer requirements or internal efforts to improve its QMS.

When the ISO 9001/2/3:1994-registered system appears to be well-transitioned and internal audits prove out its continued effectiveness, a final conversion could then be developed and implemented.

Commentary Randy Dougherty, Director of Registrar Programs, RAB

I have obtained the following comments from Norm Siefert, one of RAB’s accreditation auditors, in response to Question 6.

The ultimate extent of action by the Smith Organization or any other organization registered to ISO 9002:1994 will depend largely upon its size and the complexity and distribution of its existing quality manual. Considerations that must be addressed before revising the quality manual can be summed up in the following questions:

• Is the organization multisite with a common quality system?
• Is the quality manual’s distribution all hard copy or electronic?
• How complex is the quality system and the manual?
• Is the quality manual truly a stand-alone policy document or does it involve second- and third-tier documents and all types of cross-references?

Further, the Smith Organization must consider the extent of retraining, and the value thereof, that must occur depending on the extent of document changes.

For many organizations that have a 20-clause structuring at the core of its quality manual, documentation and communications–with the traditional numbering of Level I, II and III documents–an easy-to-understand approach that should be considered may consist of the following steps:

1. Establish a steering committee to review the existing manual to assure inclusion of applicable new specific ISO 9001:2000 requirements.
2. Use the ISO 9001:1994 to ISO 9001:2000 cross-reference included as Annex B in ISO 9001:2000 as a guide to analyzing the reorganization of clauses and requirements.
3. Make content changes to the quality manual as needed.
4. Add to the organization’s existing quality manual the cross-reference index from ISO 9001:2000.
5. Retrain employees on the organization’s manual content changes and the reasons for the changes.

There are other methods the Smith Organization could apply, but this is one alternative that would work well.

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