Volume 6 · Issue 10 · October 2001
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)
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
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
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
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 systemsMedical devicesSystem
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
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.
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 years
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
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
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 translatedeven 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
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
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
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 systemsFundamentals
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
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
- 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 10012Its title was changed to ISO 10012,
Measurement management systemRequirements 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 1s
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 documentationSC 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 9001:2000WG 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 UseWG 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 9s work as a CD for comment.
The CD for comment has been retitled Quality management
system consultantsGuidelines 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 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
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