ISO 9000:2000 Revision Process Reaches Final Draft Stage

Last stage before final approval

by John E. "Jack" West

The revision process for the ISO 9000 family is right on schedule, having reached the Final Draft International Standard (FDIS) stage. The FDIS is now out for the final ballot--the last stage prior to final approval.

The Draft International Standards (DIS) of ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 were submitted for international ballot from November 1999 to May 2000. All documents easily received positive votes to be elevated to the FDIS stage. However, more than 4,000 comments were received. These comments were sorted, and items critical to achieving full consensus on the documents were defined.

A meeting was held in Cairo, Egypt, to determine the key issues on ISO/DIS 9001:2000 and ISO/DIS 9004:2000 and delineate key issues on definitions in ISO/DIS 9000:2000.

A meeting in London followed to deal with needed improvements to DIS 9004:2000. Operating by e-mail, task groups worked out possible minor changes to text and definitions. With all of this preparatory work, the stage was set for finalizing consensus.

During intense early summer meetings in Kyoto, Japan, each critical item was resolved, and each comment received was considered. The process for resolving the issues proved to be a model of openness and transparency.

This work is a part of the process to update the ISO 9000 standards to create a modern family of fully consistent quality management system standards. The key standards involved are the following:

* ISO 9000:2000, Quality management systems--Fundamentals and vocabulary is a normative reference in both ISO 9001 and ISO 9004 and describes the basic fundamentals of quality management and quality management systems. The vocabulary of quality management systems is also included. Where terms are used in ISO 9001 and defined in ISO 9000, the required definition is that given in ISO 9000.

* ISO 9001:2000, Quality management systems--Requirements is the standard used to demonstrate conformity with a minimum quality management system. It is appropriate for certification or registration of a quality management system.

* ISO 9004: 2000, Quality management systems--Guidelines for performance improvement is intended as guidance for developing a quality management system focused on improving performance. It is fully compatible and can easily be used with ISO 9001:2000. It is not intended for and should never be used for certification purposes.

During preparation of the FDIS for ISO 9001:2000, a number of minor changes were made to improve clarity and intent, ensure applicability to service and software organizations, clarify definitions and improve auditability. Significant improvements were also made to ISO 9004:2000.

FDIS 9001:2000

The technical changes to ISO/DIS 9001 were very minor overall. On the other hand, they satisfied U.S. objections that led to the initial vote of disapproval. Members of the U.S. Technical Advisory Group (TAG) to Technical Committee (TC) 176 had raised several major and minor concerns related to ISO/DIS 9001 that the TAG as a whole agreed needed to be addressed. The six major issues involved the following areas of the DIS:

* The definition of "work environment" in DIS 9000 was very broad, and usage in DIS 9001 (clause 6.4) was not clear. Both issues were corrected.

* The clause of DIS 9001 on internal audit (subclause 8.2.2) had two problems. First, it recognized only auditing for conformity to ISO 9001 and did not address auditing of the organization's internal arrangements for meeting 9001. Second, the DIS requirements regarding auditor independence were unclear. Both issues were resolved.

* The clause on control of nonconformity (clause 8.3) was confusing. In fact, when taken literally, it would not have permitted decisions to use nonconforming items as is or scrap them. The clause was rewritten.

* The DIS also lacked adequate clarity as to when documents and records are required. In preparing the FDIS, use of the terms "document" and "record" was clarified throughout the clause structure. While the FDIS requirements are much clearer, the simplified documentation requirements of the DIS were retained.

Every U.S. concern--major and minor--was addressed in Kyoto, and all significant issues were resolved to the satisfaction of the U.S. delegates participating in task groups that drafted the FDIS documents.

Most of the key requirements were retained as described in earlier issues of Quality Progress. A few of the other minor changes made in creating FDIS 9001:2000 were:

* The clause relating to "Permissible exclusions" was clarified and renamed "Application."

* The location of text on control of documents and records was made more logical by moving it from clause 5 on management responsibility to clause 4, which covers the general documentation requirements.

* Determination of customer "needs and expectations" was changed to determination of customer "requirements" to align with the scope of ISO 9001.

* The requirement for measuring customer satisfaction was retained and clarified to mean measuring the customers' opinions of how well requirements have been met. This should be much easier to interpret than the DIS wording that required measurement of customer satisfaction and/or dissatisfaction.

* The confusing usage of "and/or" was eliminated so the DIS words "customer satisfaction and/or dissatisfaction" and "design and/or development" are now "customer satisfaction" and "design and development." This eliminates the translation difficulties associated with the term "and/or" and clarifies intent.

The concept of continual improvement was retained and clarified to retain a strong emphasis on improvement including the continual improvement of the quality management system. Such activities as top management commitment to ongoing improvement, setting of measurable objectives, corrective and preventive actions, and a strong emphasis on management review were all retained.

FDIS 9000:2000

Perhaps the most significant step forward made in the evolution from DIS to FDIS has been the improvements in the definitions of terms contained in ISO 9000. Those who studied the DISs carefully know that a number of terms had gaps between the definitions in ISO/DIS 9000 and the word usage in ISO/DIS 9001 and ISO/DIS 9004. These incompatibilities have largely been resolved.

FDIS 9004:2000

The 1994 ISO 9000 family also includes ISO 9004: Quality Management and Quality System Elements--Guidelines, which was intended as a full set of quality management system elements that could be used by any organization to develop a quality management system.

Use of the 1994 version of ISO 9004 could result in an organization developing a fully effective quality system focused not only on conformity of the product but also on improving the overall operations of the organization and its ability to meet customer needs.

Unfortunately, ISO 9004:1994 was developed independently from ISO 9001/2/3:1994. In fact, it was the responsibility of a different working group within the committee that developed the standards. For this reason, the form, format and even approach taken by the 1994 version of ISO 9004 were quite different from those taken by ISO 9001/2/3:1994. The documents were not fully aligned so that they could be easily read and used together.

This lack of consistency between ISO 9001 and ISO 9004 was corrected with early drafts of ISO 9004:2000. On the other hand, early drafts of ISO 9004:2000 were criticized as being too "immature" to use for performance improvement.

While the United States and others did not vote negatively on DIS 9004:2000, it was recognized that even at the DIS stage the document lacked the maturity needed for an international standard relating to performance improvement.

This situation is largely resolved with the FDIS. It still retains the alignment with ISO 9001:2000 but has been significantly expanded to provide additional examples of practices that organizations may wish to consider when pursuing performance improvement.

Final approval

At the closing plenary meetings in Kyoto, formal votes were taken on whether to elevate these three documents to the FDIS stage. The votes were overwhelmingly in favor with unanimous approval for ISO 9000, with only Japan voting negatively on ISO 9001 and only France voting negatively on ISO 9004.

This step sent the documents to an editing process and the final up or down vote to elevate the documents to international standards. We are now in the middle of that final voting period. If the vote is positive--and all indications are that it will be--there will be new standards in December.

The FDIS is now available for purchase from ASQ Quality Press.

JOHN E. "JACK" WEST is a professional management consultant in the areas of productivity and quality after being with Tenneco Inc. for 30 years. He served on the Board of Examiners for the Malcolm Baldrige National Quality Award and is now the chair of the U.S. TAG to ISO TC 176 and lead delegate for the United States to the International Standards Organization, known as ISO, committee responsible for the ISO 9000 family of quality management standards. He is co-author of ISO 9001:2000 Explained, published by ASQ Quality Press.

Standards Q&A

Q. We just received our certification to ISO 9001 and want to celebrate and promote our success in becoming registered. We don't want to misrepresent our certification. What promotional methods and language are appropriate?

A. There are some simple things to remember: don't be misleading, be specific, obtain permission if you use a registrar's name or logo, don't claim ISO 9000 certification for a product and don't use the ISO logo! Here are a few pointers:

* It is quite easy to be unintentionally misleading in your claims. For example, if the ABC manufacturing company has two plants, with one plant registered to ISO 9002 and the other not registered, it would be misleading for the registered plant to claim, "ABC is registered to ISO 9002." The stated claim in this case should be clearly restricted to the registered plant.

* Be very specific as to the standard you are using. For example, if you claim to be "registered to ISO 9000 by XYZ registrars," you are not providing potential customers with complete information. Quality management systems are usually registered to ISO 9001, ISO 9002 or ISO 9003. Each of these has a different scope. You should be specific in stating which of the three you mean. Remember, too, that the selection of the proper standard to use for registration is a matter of quality management system scope, and you should not imply that registration to one of the standards is better than registration to another.

* Don't claim to be "ISO certified" or "ISO registered." ISO does not certify or register quality management systems. It is appropriate, however, to claim that your quality management system is registered or certified.

* ISO does not permit use of its logo in promoting registration. This is quite appropriate since ISO itself does not perform certification or registration. Often certification bodies or registrars will permit use of their names or logos in such promotional materials. You should contact your registrar for permission and specific guidance.

* Remember that registration to ISO 9001, 9002 or 9003 relates to the quality management system. It does not imply certification of a specific product. Promotional material should never be written or used in a way that could be interpreted as a claim that a product is certified to any of these standards.

This is not an exhaustive list of do's and don'ts. Organizations having questions on promoting their registration to an ISO 9000 standard should talk to their registrars and obtain the ISO leaflet, "Publicizing Your ISO 9000 or ISO 14000 Certification." This document may be downloaded from the Web. The address is: www.iso.ch/9000e/pub9k14ke.pdf

Send your general questions about standards to StandardsQuestions@asq.org, and one of QP's "Standards Outlook" columnists will answer it.

If you would like to comment on this article, please post your remarks on the Quality Progress Discussion Board, or e-mail them to editor@asq.org.

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