Volume 5 · Issue 7 · July 2000
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)
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
SeriesISO 9001, ISO 9004 and ISO 9000to the FDIS
stage has been intense (for the titles of the FDISs, see the
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 systemsFundamentals
- ISO/FDIS 9001:2000, Quality management systemsRequirements
- ISO/FDIS 9004:2000, Quality management systemsGuidelines
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 Frances
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 9004:2000the consistent pair of quality
assurance and quality management system standardsand
WG 18s 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
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 18the 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)
- 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
- 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 concernmajor and minorwas 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 9001:2000which
was circulated for comment prior to the Kyoto meetingwas
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 pairs future success:
- Emphasis on an organizations 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 pairISO/DIS
9004the 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 QMSs 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 statusand 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.
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 Tennecos 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 OUTLOOKs Editorial Advisory Board.
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