Volume 5 · Issue 7 · July 2000

Contents

ISO 9000, ISO 9001 and ISO 9004 Elevated to FDISs
Year 2000 Family Races Toward Final Approval

By Charles A. Cianfrani, Joseph J. Tsiakals and John E. (Jack) West

From June 29 through July 8, 2000, ISO Technical Committee (TC) 176 held its 18th annual meeting in Kyoto, Japan. This meeting of the TC responsible for the ISO 9000 series was indeed a landmark event in the history of quality standards.

On July 7, 2000, 8 years of effort came to a conclusion in Kyoto with the elevation of ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 to Final Draft International Standard (FDIS) status.

The FDISs are expected to circulate for an up-or-down vote of approval by the TC 176 participating member bodies (P-members) beginning in September 2000. Assuming a successful ballot of the FDISs (two-thirds majority approval by the P-members), the revisions are expected to be published as International Standards by December 2000.

Elevation of the three Draft International Standards (DISs) to FDISs was the last major hurdle to be overcome in the long journey to update the current ISO 9000 series of quality assurance and quality management standards. It was the culmination of work begun in 1992, even before publication of the 1994 editions, that has involved hundreds of individuals from more than 40 P-members and 20 liaison organizations to TC 176.

Consistent Pair: From San Francisco DISs to Kyoto FDISs

Since their elevation to DIS stage in San Francisco in September 1999, the effort to move the core standards in the ISO 9000 Series–ISO 9001, ISO 9004 and ISO 9000–to the FDIS stage has been intense (for the titles of the FDISs, see the box below).

At the conclusion of balloting on the three DISs at the end of April 2000, although all three received a greater than 80% vote of approval from P-members, there were a total of 5 P-member votes of disapproval for ISO/DIS 9000 and 9 disapprovals each for ISO/DIS 9001 and ISO/DIS 9004. The US was among the minority of P-members that voted to disapprove ISO/DIS 9000 and ISO/DIS 9001 (see “TC 176 Votes to Approve All Three ISO 9000 DISs”, THE OUTLOOK, May 2000).

The Year 2000 Family

The three FDISs below each represent the merger and revision of several existing ISO 9000 standards into one, and their names differ from their predecessors.

• ISO/FDIS 9000:2000, Quality management systems–Fundamentals and vocabulary
• ISO/FDIS 9001:2000, Quality management systems–Requirements
• ISO/FDIS 9004:2000, Quality management systems–Guidelines for performance improvements

As a result of the work culminating in Kyoto, the US delegation reversed its votes of disapproval on the DISs of ISO 9000 and ISO 9001 and voted to elevate all three DISs to FDISs. Of the nine P-members who voted to disapprove of ISO/DIS 9001 in the balloting, only Japan maintained its vote of disapproval on ISO 9001 while Finland and Norway cast 2 of 3 abstentions (due primarily to the lack of enough delegation members to make a national decision).

All nine original P-members voting to disapprove of ISO 9004 switched their votes (4 P-members abstained), although France’s delegation decided to vote against elevating the revised ISO/DIS 9004 after voting to approve it in the balloting.

A total of 42 P-members and 11 Liaison members sent delegations to the meetings of TC 176 Subcommittee (SC) 2, Quality Systems, in Kyoto. These delegations provided an ample number of participants for the meetings of Working Group (WG) 18, which has been responsible for development and revisions to ISO 9001:2000 and ISO 9004:2000–the “consistent pair of quality assurance and quality management system standards”–and WG 18’s task groups (TGs).

The US delegates involved in the SC 2, WG 18 and TG meetings in Kyoto are listed in the box below.

US Delegates in SC 2, WG 18 and TG Meetings

• Charles A. Cianfrani
• Allan D. Small
• Joseph J. Tsiakals
• John E. Wes
• Lawrence A. Wilson

Approximately 3,300 comments were submitted in the balloting on the two DISs, all of which had to be addressed by WG 18 and its TGs. As reported previously, a TG had already met in May 2000 to begin the process of reviewing the comments on ISO/DIS 9004 and preparing to revise the DIS in those instances where the comments offered valid technical changes to improve the standard (see “ISO/DIS 9004 Demonstrates Increased Maturity in London”, THE OUTLOOK, May 2000). Similar activities were taking place among members of the TG reviewing comments on ISO/DIS 9001 and preparing to make valid technical changes.

Some of the technical changes made by the TGs writing ISO 9001 and ISO 9004 were also in response to the verification and validation processes employed within WG 18–the people that actually wrote the standards. For instance, the TGs evaluated 240 validation responses from 23 P-member countries. These internal verification and validation processes were specifically structured to assure that the new standards not only met the design specification requirements for the consistent pair, but also would satisfy user needs.

Minor But Important Technical Changes to the DISs

The technical changes made to both DISs of the consistent pair were very minor. The vast majority of the differences between the DISs and FDISs are in the following categories:

• Achieving compatibility between ISO 9001 and ISO 9004
• Increasing consistency within and between these standards, especially in the area of terminology
• Ensuring applicability to software and service organizations in addition to traditional hardware-focused (manufacturing) organizations
• Enhancing the “auditability” of and ease of implementation for ISO 9001.

Nevertheless, the technical changes made to ISO/DIS 9001 were important because they satisfied US objections that led to the initial vote of disapproval. Members of the US Technical Advisory Group (TAG) to 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:

• Work environment (Clause 6.4)
• Internal audit (Subclause 8.2.2)
• Control of nonconformity (Clause 8.3)
• Use of the terms “document” and “record” (throughout the clause structure).

Every US concern–major and minor–was addressed, and all major issues were resolved during the creation of the FDIS of ISO 9001 to the satisfaction of the US delegates participating in TG drafting of the FDIS documents.

In addition to the satisfactory resolution of the major US concerns, we were also pleased to provide assistance in making the following improvements:

• Contributed new language to ISO/FDIS 9001 that clarifies the difference between product and process validation
• Helped achieve reinsertion of the powerful language requiring organizations to “carry out the production and service provision under planned and controlled conditions....”

Subclause 1.2, Permissible Exclusions, was clarified and the title was changed to Applications, although these clarifications were really very minor. A related draft document, Guidance on “Permissible Exclusions” to ISO 9001:2000–which was circulated for comment prior to the Kyoto meeting–was modified to address the comments and will go out for another round of review and comment.

We were also pleased that ISO/FDIS 9001 retains two characteristics central to the consistent pair’s future success:

• Emphasis on an organization’s responsibility to decide what documented procedures are required for its QMS. ISO 9001:1994 requires 18 documented procedures while ISO/FDIS requires only 6.
• Explicit requirements for an organization to address both customer satisfaction and continual improvement in ways that are appropriate for the organization.

As for the future of the sector-specific standards based on ISO 9001, TC 176 approved Resolution 9, the establishment of a Liaison Forum, in its closing plenary session. The forum is to “promote harmonization and alignment of sector needs and the convergence of sector solutions, in accordance with the TC 176 sector policy....”

The Secretary of TC 176 was asked to prepare and circulate the terms of reference for this forum for comment by the TC 176 members. We view this as a very positive move by both TC 176 and its liaison members.

Although the US TAG had no major technical issues with the “other partner” in the consistent pair–ISO/DIS 9004–the US saw every concern it had raised on the DIS addressed and resolved to our satisfaction.

Unlike ISO 9001, which states minimum QMS requirements, ISO 9004 has been structured to provide guidelines to organizations for QMS performance improvement. It is based on the quality management principles defined in ISO 9000:2000, and ISO 9004 is intended to be used by an organization to expand the breadth and depth of the QMS’s application throughout the organization.

ISO/FDIS 9004 also provides significantly expanded attention to indicating how an organization can improve its processes in order to achieve effective and efficient performance.

A new and unique feature of ISO 9004:2000 is its Annex A, Guidelines for Self-Assessment. The self-assessment approach described in Annex A is intended to provide an organization with a simple, easy-to-use approach to determining the relative degree of maturity of its QMS and to identify areas for improvement. The self-assessment also can be useful to measure progress against objectives and to reassess the continuing relevance of those objectives.

It is interesting to note that there was only one vote against elevating ISO/DIS 9004:2000 to FDIS status–and that was because the French delegation believed that the revised DIS did not go far enough in describing the methods and techniques organizations could consider for inclusion in their QMSs. The members of the WG 18 task group responsible for drafting ISO 9004, however, had to draw a line somewhere regarding how much material to include in the document, and the overwhelming consensus opinion is that users will find the “new” ISO 9004 a much more useful and easy-to-use standard than its 1994 predecessor.

THE OUTLOOK will be providing ongoing coverage of developments involving the Year 2000 Family and the materials being developed to assist organizations with the transition from the 1994 editions. Detailed guidance on the use of the soon-to-be published standards will also be provided.

BIOGRAPHIES

Charles A. Cianfrani is a US expert delegate to ISO/TC 176, SC 2, WG 18, the working group writing ISO 9001/4:2000. Mr. Cianfrani is Managing Director of the Customer Focused Quality Group at ARBOR, Inc., in Media, PA, and has led implementation of ISO 9001-compliant processes on five continents. He is a Fellow of the American Society for Quality (ASQ), holds BS, MS and MBA degrees, is an ASQ CQE, CRE and CQA and is an RAB-Certified Quality Systems Auditor. Mr. Cianfrani can be contacted by phone (610-566-8700) or e-mail (Cianfranic@aol.com).

Joseph J. Tsiakals is a US expert delegate to ISO/TC 176, SC 2, WG 18, the working group writing ISO 9001/4:2000. He is also the Senior Director of Corporate Quality Assurance at Amgen, Inc., a pharmaceutical firm in Thousand Oaks, CA. Previously, he was with Baxter International in various positions including Vice President of Corporate Quality Systems. He also served as the lead US delegate to TC 176, SC 2, for the development of ISO 9001:1994 and was one of the founding members of TC 210, responsible for ISO 13485 and other ISO medical device quality standards. Mr. Tsiakals has more than 25 years of experience in quality management and quality engineering, and is a member of the Board of Directors of the Registrar Accreditation Board. He also served as a Senior Examiner for the Malcolm Baldrige National Quality Award for five years.

John E. (Jack) West is Chair of the US Technical Advisory Group and the lead US delegate to ISO/TC 176, the technical committee responsible for the ISO 9000 family of quality management standards. Mr. West is a quality professional who has helped organizations improve productivity and quality and has led implementation of internal TQM assessment processes based on the Baldrige Award criteria as well as Cost of Quality processes. He has nearly 30 years of experience with Tenneco, Inc., in a wide variety of industries. In 1993 and 1994, Mr. West served as Tenneco’s Director of Quality for European operations in Brussels and served from 1990 to 1993 on the Board of Examiners for the Malcolm Baldrige National Quality Award. Mr. West has authored many papers and articles, is co-author of ISO 9001:2000 Explained, is a member of the Board of Directors of the Registrar Accreditation Board (RAB) and is a member of THE OUTLOOK’s Editorial Advisory Board.

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