Volume 5 · Issue 9 · September 2000

Contents

US TAG to TC 176 Meets as FDISs Circulate
US Leadership Recommends Three “Yes” Votes

The Final Draft International Standards (FDISs) of ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 began to circulate for a 2-month vote of approval on September 14, 2000, the concluding day of a meeting of the US Technical Advisory Group (TAG) to ISO Technical Committee (TC) 176, which is responsible for the ISO 9000 standards.

The leadership of the US TAG, which includes many of the US delegates to the TC 176 meeting in Kyoto that ended July 8, 2000, recommended that the TAG vote to approve all three FDISs. The recommendation was well-received by the meeting participants.

"I think that we got pretty much all the changes we wanted in the FDISs, which involved a couple of battles in Kyoto," declared John (Jack) E. West, Chair of the US TAG, during the TAG meeting September 13-14 in Crystal City, VA. "I think these standards represent a big improvement over what we had before."

US Task Groups (TGs) 9000 and 18, which develop US positions on ISO 9000 and ISO 9001/4 and support the US experts to the TC 176 groups responsible for drafting of these standards, held a joint meeting September 13, 2000.

The meeting discussed the changes to the three Draft International Standards (DISs) and whether those changes satisfied the US issues that resulted in votes of disapproval on ISO/DIS 9000 and ISO/DIS 9001–without creating new issues.

The US experts involved in the Kyoto deliberations covered the changes achieved in Kyoto that satisfied US concerns without producing new issues, as reported in the July 2000 issue of THE OUTLOOK.

Attendees at the joint meeting also obtained advance copies of ISO/FDIS 9001 and ISO/FDIS 9004, which were released to the TAG a day early to facilitate discussion and review of the FDISs during the TG 18 presentations and discussions.

Although there are some notable changes in the FDISs compared with the DISs, there were no surprises in terms of unexpected changes since Kyoto. Coverage of the FDISs, which will continue in future issues of THE OUTLOOK, begins on page 1.

The Future of TAG Activity

In fact, a significant issue following what is, for all purposes, completion of work on these standards was the follow-up work to be undertaken before and after their publication. TC 176 items still needing attention include:

• The Year 2000 Family Introduction Package–Working Group (WG) 18, responsible for drafting of the "consistent pair", is in the process of developing and/or reviewing draft documents to be used to help organizations understand the new standards and how to transition their ISO 9001/2/3:1994-based quality systems to ISO 9001:2000 conformance. These documents, which will be available free of charge, were intended to be completed and accessible when ISO 9000/1/4 were published later this year. However, some of these documents, including one introducing ISO 9000:2000, are still in the preliminary stages of development and may not be ready until early 2001.
• ISO 19011–The joint environmental auditing/quality auditing guidelines standard that will replace ISO 10011, Parts 1, 2 and 3, as well as the three ISO 14000 auditing guidelines standards (ISO 14010/11/12), is the next member of the Year 2000 Family expected to be completed (for more information on ISO 19011, see "Joint EA/QA Meeting Produces Consensus Position on ISO 19011" on page 6). It is likely that some TAG members who have been involved on TG 18 but have an interest in auditing issues will lend more support to TG 19011 in the future.
• Disposition of Other ISO 9000 Family Members–As noted in previous articles, the new editions of ISO 9000, ISO 9001 and ISO 9004 will formally replace 10 standards. While ISO 19011, ISO 10012 (metrology) and ISO 10013 (QMS documentation) will eventually replace another 6 standards, this still leaves a significant number (9) of standards to be "reconciled". There appears to be support throughout TC 176 and within the US TAG for the idea of addressing the future of each remaining ISO 9000 standard as it comes up for review and revision. These standards will face one of three options: revision to support the Year 2000 Family; transfer to another TC when there are technical similarities; or obsolescence.
• Sector-Specific Developments–The pilot project involving the international automotive sector will take another step when work on revision of ISO Technical Specification (TS) 16949:1999, which provides automotive sector-specific quality requirements linked to ISO 9001:1994, results in a draft TS linked to ISO 9001:2000 in early 2001. There is a strong possibility that other sectors may seek stronger interaction with TC 176 to ensure that revisions of sector-specific supplements to ISO 9001:1994 are properly aligned with the Year 2000 Family. For instance, TL 9000 (telecommunications) and AS9100 (aerospace) are being revised to align with ISO 9001:2000 at an even faster pace than TS 16949.
• Interpretations–Despite US opposition to the idea of developing a process for issuing interpretations of the intent of ISO 9001, TC 176 is moving to adopt this concept, which is inspired in part by the QS-9000 sanctioned interpretations program and efforts among TC 207 participating member bodies to issue "clarifications of intent" for ISO 14001. The US is maintaining its involvement in the ISO 9001 interpretations process as it develops.

THE OUTLOOK will provide detailed coverage of these activities and issues in future issues. However, they point to the fact that, although the work ahead for TC 176 and the US TAG may not be as monumental as revising a conformance standard used for registration purposes by 340,000+ organizations, a lot of significant work remains to be completed.

Healthcare ITA Workshop in October

In a related development, Ronald G. Berglund of Management Resources International, Inc., and a member of the ASQ Healthcare Division announced at the TAG meeting that an ISO proposal to hold a workshop to build consensus on a healthcare International Technical Agreement (ITA) had been "tentatively" approved in voting by the ISO Technical Management Board (TMB) member bodies.The TMB is expected to discuss the proposed workshop at its next meeting September 25-26, 2000, in Geneva, following the positive vote by ISO member bodies.

The proposal called for a workshop, open to all healthcare service providers and their organizations and other interested parties, that would seek to draft and develop consensus on a document providing guidance on the application of ISO 9004:2000 to healthcare organizations.

According to Berglund, the proposal was approved by a TMB member vote of 8 in favor, with 2 opposed and 2 abstentions. The two negative votes were cast by the UK and the US.

The proposal asked ISO member bodies to vote both on holding the workshop to try to develop a healthcare ITA and on having the Standards Council of Canada/Canadian Standards Association (SCC/CSA) host the workshop. Both items received positive votes and, if the TMB concurs with the votes, the workshop will be held October 26-27, 2000, at the GM Powertrain Training Center in Warren, MI. GM offered to host the workshop on behalf of SCC/CSA.

If the ITA workshop is approved, key healthcare industry organizations and customer groups will receive invitations. Grant Gillis of CSA will know as of September 28, 2000, what the TMB decision is. Gillis will be able to provide information and can be reached by phone (416-747-2272), fax (416-747-2473) or by e-mail (grantgillis@csa-international.org).

Additional coverage of issues involving ISO 9000 and sector-specific supplements to ISO 9001/4, including the ITA workshop, will be provided in future issues of THE OUTLOOK.

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