Volume 5 · Issue 9 · September 2000
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
"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
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 9001without 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
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 PackageWorking
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 19011The 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 MembersAs
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;
- Sector-Specific DevelopmentsThe 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.
- InterpretationsDespite 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
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 (firstname.lastname@example.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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