Volume 6 · Issue 10 · October 2001

Contents

ISO/TC 176 Meets to Plan Future Course for ISO 9000 Series
ISO 9001/4 Revisions Deferred; Sector Alignment Pushed

By Charles A. Cianfrani and John E. (Jack) West

Although ISO 9001:2000 and ISO 9004:2000 were published less than a year ago, agreement was reached only earlier this month to defer the start of formal revisions to these quality management system (QMS) standards for at least two years.

At the same time, the ISO technical committee (TC) responsible for the ISO 9000 series is moving to both plan well into the future as far as quality assurance and quality management standards go and to ensure the continued use of ISO 9001 as the generic QMS standard for sector-specific standardization activity.

More than 300 delegates from participating member bodies (P-members) and liaisons of ISO/TC 176 met in Birmingham, United Kingdom, for its annual meeting October 8-13, 2001. As members of the US delegation to the 19th meeting of TC 176, we played an active role in representing the interests of the US Technical Advisory Group (TAG) to TC 176, despite the inability of the full TAG to meet in September 2001 and deliberate on the issues before the TC because of the terrorist attacks of September 11 and the complications they caused.

The following is a firsthand report of the key activities and results of the meetings of the three active subcommittees (SCs) of the committee and is intended to help you understand what is occurring with regards to the ISO 9000 series and other international standards and documents relating to ISO 9001/4.

In addition to business matters discussed below, ISO/TC 176 recognized the long-term contributions of Peter Ford who recently passed away. Peter was the original Secretary of TC 176 and a long-time participant in standardization in Canada. We first encountered him during early work on the Canadian Z-299 series of QA standards. He was a fine leader in standards work and has been missed since his retirement a number of years ago.

Medical Device Sector to Remain Aligned; TC Plans for Future

Although the drafting and revision of ISO standards takes place on the SC level within a technical committee, matters of an administrative and inter-TC nature are often brought before the full TC.

With the publication of ISO 9001/4:2000 since the last TC 176 plenary meeting, a number of issues resulting from the impact of their publication were addressed by the full TC, most often with outcomes that suit the interests of the US TAG. The following 6 issues will have the most significant impact on a US and/or international level.

1. Medical Devices Standard to Remain Aligned

TC 176 has dealt successfully with the first potential situation where a sector-specific standard based on ISO 9001:1994 would not be fully aligned with ISO 9001:2000. WG 1 of ISO/TC 210, responsible for quality management standards in the medical devices sector, is in the midst of revising ISO 13485:1996, Quality management systems–Medical devices–System requirements for regulatory purposes, which is aligned with ISO 9001:1994.

Significant efforts were made in 2000 and earlier in 2001 by Jeffrey Hooper, Project Task Group Leader of Working Group (WG) 18 that was responsible for drafting ISO 9001/4:2000, and other TC 176 members to work with WG 1 to ensure the revised ISO 13485 aligns as fully as possible with ISO 9001:2000.

However, WG 1 of TC 210 issued a first committee draft (CD1) of ISO 13485 in April 2001 that only partially aligned with ISO 9001:2000 and retained some language used in ISO 9001:1994. WG 1 felt justified by the regulatory nature of the medical devices manufacturing sector to revise ISO 13485 to align partially with ISO 9001:2000.

TC 176 disagreed with this position, believing that ISO 13485 could be revised to fully align with ISO 9001:2000 while specifying additional requirements and qualifying ISO 9001 requirements so as to address regulatory concerns and still maintain ISO 9001:2000 conformance.

The fact is that ISO/CD1 13485 does not comply with the ISO Sector Policy found in Clause 6.8.2 of Part 2 of the new ISO directives, which basically prohibits ISO sector-specific standards from deviating from an ISO standard on which they are based. TC 176 invited the leadership of TC 210 to participate in the Birmingham meeting to find a solution that would avoid a violation of the ISO Sector Policy, and agreements were reached on a means for TC 210 to alter ISO/CD1 13485 to make it comply with the sector policy.

It is worth noting that the aerospace (AS/EN 9100) and telecommunications (TL 9000) sector standards based on ISO 9001:1994 that were developed outside of ISO have already been revised to align fully with ISO 9001:2000, and the revision of the automotive technical specification developed through TC 176 (TS 16949) has reached final draft status with full alignment. Other standards are or will soon be updated, with expectations that alignment will be the norm.

2. Interpretations

As a result of concerns raised by the United States and other P-members, TC 176 approved a resolution to not issue official interpretations at this time and to recommend to the TMB that the interpretations pilot presently underway be extended for a further year (see "US Prepares Auditing No Vote, Considers Yes on TS 16949:2000" on page 16 for a discussion of the US Task Group [TG] 18 perspective at its September 26 meeting). It was also agreed that, during the year’s extension of the pilot, the interpretation process will be improved and validated.

3. Liaison Forum

TC 176 maintains liaison status with a number of other ISO TCs and other standards writing groups because of the widespread use and adaptation of ISO 9001/4. Interaction among liaison members has been facilitated by the creation of a Liaison Forum at the last TC 176 meeting in Kyoto, Japan, in July 2000.

The Liaison Forum met in Birmingham to work on its terms of reference, which are expected to be completed by March 2002. There are a number of opportunities that the Forum may act on, including convergence or harmonization of the various sector management system standards based on or related to ISO 9001/4.

4. Efforts to Standardize Translations of Standards

With the growing use of the ISO 9000 standards in countries where English and French are not the primary languages used, a growing concern has been the variation that can occur when these standards are translated–even among two or more translations into the same language. As a result, TC 176 has worked with the ISO Council to establish task groups to develop "official translations" when a language is spoken in a number of different countries.

The Spanish Translation Task Group (STTG), which was formed during the drafting of the Year 2000 Family, has completed official translations of ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 into Spanish that all Spanish-speaking countries have adopted. The Comission Panamericana de Normas Técnicas, Venezuela (COPANT), and Mercosa have also agreed to adopt them.

The STTG is now working on translating other ISO 9000 standards and other documents, and TC 176 adopted a resolution at its closing plenary session to affirm an extension to the terms of reference of the STTG to include these additional documents. The United States has actively participated in this process.

The ISO Council has recently approved the creation of a task group within TC 176 to develop "official" ISO 9000 translations into Arabic. As with the STTG, the Arabic Translation Task Group (ATTG) will start by developing a single Arabic translation of ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000.

It is expected that each Arabic speaking country will adopt these standard translations, thus avoiding multiple translations. After these core documents are completed, the ATTG will continue its work and translate other appropriate TC 176 documents.

5. Horizon 2010

TC 176 approved "Horizon 2010", a strategic plan developed to guide the technical committee in maintaining and revising the ISO 9000 series and engaging in other activities relating to quality management and management systems.

The Detailed Planning Task Group (DTPG) was established to recommend actions, timing, resources and organization to carry out the strategic plan. The DPTG held its first meeting in Birmingham and developed a process for completing its planning assignment.

6. Clinical Laboratories

TC 176 discussed the draft international standard (DIS) of ISO 15189, which establishes requirements that clinical laboratories are to satisfy to achieve accreditation. ISO/DIS 15189 is based on ISO/IEC 17025:1999, which outlines requirements to be satisfied by laboratories in general for accreditation purposes.

However, ISO/IEC 17025 is presently based on the quality system requirements in ISO 9001:1994, although ISO/CASCO is planning to revise ISO/IEC 17025 in the near future to align its quality system requirements with ISO 9001:2000.

TC 176 agreed to support ISO 15189 under the expectation that it will be revised to remain aligned with ISO/IEC 17025 when the general laboratory accreditation standard is revised to align with ISO 9001:2000.

SC 1 Plans to Tie Up "Loose Terms"

SC 1, Concepts and Terminology, considered 13 issues, with 29 experts participating from 25 P-members, including 2 liaisons. Craig Johnson from the US delegation was appointed Convenor of WG 3, which deals with external liaison activities outside TC 176. This may result in a revitalization of a group that has not appeared to be effective in the recent past.

SC 1 also decided to prepare a Technical Report (TR) to be published after its next meeting that will include all the terms that the SC has worked on since the TC 176 meeting in July 2000. This TR is intended to incorporate terms and their definitions "left over" during the development of ISO 9000:2000, Quality management systems–Fundamentals and terminology. At the closing TC 176 plenary session, it was reported that, in addition to SC 1 terms, SC 1 intends to incorporate into this TR terminology developed by other groups within TC 176.

SC 2 Pursues ISO 9001/4 Feedback But Not Revisions

Every expectation was that, when SC 2, Quality Systems, met in Birmingham, WG 18 would be disbanded after successful completion of ISO 9001/4:2000 in 2000. Instead, SC 2 directed WG 18 to begin the process of gathering feedback relating to customer use of ISO 9001/4:2000. It is envisioned that this will become the major work of WG 18 over the next few years and will be critical to the continuing success of ISO 9001/4 in the marketplace and to ensuring that future revisions to the QMS standards will satisfy the customer.

Indeed, SC 2 passed a resolution at its closing session that relates to these goals and should have the effect of providing a period of stability for ISO 9001 through 2005. Although ISO requires standards to be reviewed within five years of their latest publication and/or latest revision, SC 2 passed, after a great deal of discussion on the wording, a resolution that states WG 18 will "not start any formal revision of ISO 9001:2000" before the fourth quarter of 2003.

In effect, this will keep the formal process of drafting a replacement for ISO 9001:2000 from beginning before the transition period ends and will prevent a new edition from being published for approximately three years after the process begins.

SC 2 also stated its intention to:

• Promote the process approach embodied in ISO 9001/4:2000
• Encourage the use of ISO 9004:2000 with European Federation for Quality Management (EFQM), Malcolm Baldrige National Quality Award and Deming Prize criteria as a path to "Business Excellence"
• Continue to manage and support liaison activities
• Continue to use and improve the process approach
• Support sector applications through regular dialog with other sector groups and the participation of WG 18 members in the drafting/revising of sector-specific standards based on ISO 9001/4.

SC 2 also directed WG 18 to conduct periodic reviews of work on the revisions of ISO 10006 (project management) and ISO 10007 (configuration management). With WG 18 input, the task groups responsible for the revisions to ISO 10006 and ISO 10007 met in Birmingham, completed reviews of drafting work to date and recommended that their revised documents be circulated as CDs for ballot.

Revision of the Small Business Handbook (ISO 9000 for Small Businesses), which is designed to provide guidance to small businesses on how to implement and maintain a QMS in conformance with ISO 9001, is moving forward. SC 2 decided to circulate the existing draft for another 3-month consultation period and to invite SC 1 and the TC 176 Interpretations Group to provide input to the Handbook.

The expected publication date for the Handbook is not certain, although TC 176 P-members want to move this project forward on an accelerated basis because of the need for a revised edition of this handbook in their countries, where guidance and other resources to help with implementation in a small business are limited.

SC 3 Moves Forward on Several Revisions

SC 3, Supporting Technologies, engaged in a considerable amount of activity involving the revisions to standards and TRs. The following summarizes the main developments achieved by SC 3 and its TGs:

• ISO/DIS 10012–Its title was changed to ISO 10012, Measurement management system–Requirements for measurement processes and equipment, as WG 1 worked to address many of the issues contained in comments submitted on the DIS. SC 3 adopted a resolution that will result in the publication as a Final Draft International Standard (FDIS) WG 1’s output from the Birmingham meeting and a subsequent meeting in the first quarter of 2002.
• ISO/TR 10013, Guidelines for development of quality management system documentation–SC 3 passed a resolution commending Ira Epstein, Convenor of WG 8, and the other WG 8 members for their excellent work and disbanding the WG since its work had been successfully completed.
• ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000–WG 6 completed work on the draft of ISO/TR 10017, which will circulate for ballot. Once approved, this draft TR will replace an existing TR that provides guidance related to ISO 9001:1994.
• QMS Consultant Selection and Use–WG 9 has been assigned a New Work Item for completion of a guidance document regarding consultants. In Birmingham, the WG refined the draft document prepared earlier in 2001, and a resolution was passed to circulate the result of WG 9’s work as a CD for comment. The CD for comment has been retitled Quality management system consultants–Guidelines for the selection and the use of their services.

Finally, in the interest of continuing to promote commonality of purpose to the greatest extent reasonable, SC 3 passed a resolution proposing that TC 176 invite ISO/TC 207 to jointly investigate the desirability and feasibility of working together on standardization activities in the field of supporting technologies for quality and environmental management.

Charles A. Cianfrani is a US expert delegate to ISO/TC 176, SC 2, WG 18, the working group that wrote 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, is an RAB-Certified Quality Systems Auditor and is co-author of ISO 9001:2000 Explained. Mr. Cianfrani can be contacted by phone (610-566-8700) or e-mail (Cianfranic@aol.com).

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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