Volume 6 · Issue 5 · May 2001
Contents
Page 1...
ISO/DIS 19011 Vote: Positions Taken to Satisfy US Concerns
US Plans Support for ISO 9001:2000 Transition
Although its first meeting after publication of the "ISO
9000:2000 Series" should have been devoted to celebrating
its successful completion, the US Technical Advisory Group
(TAG) to ISO Technical Committee (TC) 176 focused instead
on ensuring the acceptance and effective use of ISO 9001:2000
and the other two core ISO quality management system (QMS)
standards.
In addition, recent developments involving ISO 19011,
Guidelines on quality and/or environmental management systems
auditing, elevated to Draft International Standard (DIS)
in late March 2001, may lead the US leadership on this standard
to recommend a "No" vote to ensure US issues with
the DIS are addressed.
The US TAG met March 21-22, 2001, in Reno, NV, with an understanding
that while a lot of "clean-up work" remained to
be done, the most critical task facing TC 176 since publication
of the first ISO 9000 standards in 1987 had been accomplished–publication
of three core QMS standards:
- ISO 9000:2000, Quality management systems–Fundamentals
and vocabulary
- ISO 9001:2000, Quality management systems–Requirements
- ISO 9004:2000, Quality management systems–Guidelines
for performance improvements.
The challenge facing the US TAG is to make the transition
to these revised standards easier, particularly for the many
organizations that have quality systems conforming and/or
registered to ISO 9001/2/3:1994. Every other group that develops
positions for its country on the ISO 9000 series, sends delegates
to TC 176 and promotes the use of the series faces the same
challenge.
While ISO 9001:2000 is easier to understand than ISO 9001:1994
and more closely resembles the processes and flow of most
organizations—and ISO 9000:2000 and ISO 9004:2000 are
more effective standards and more closely aligned to ISO 9001:2000
than their predecessors were to ISO 9001:1994—that will
not eliminate the implementation challenge many organizations
face.
With December 2003 a distant but nevertheless approaching
deadline, these organizations are trying to figure out how
to revise their existing quality systems to achieve ISO 9001:2000
conformance with the least disruption to the organization’s
operations and the least incursion of expenses. This second
factor has become increasingly important as organizations
around the United States are dealing with an economic slowdown.
Despite the fact that TC 176’s Subcommittee (SC) 2,
which is responsible for ISO 9001 and ISO 9004, is developing
a series of documents to help organizations make the transition
to ISO 9001:2000, the US TAG has decided to develop its own
support mechanisms for US organizations—although they
would be available to any organization worldwide that wanted
to use them—out of concern that SC 2’s efforts by
will not meet US needs adequately.
These support mechanisms were the subject of a joint meeting
of US Task Group (TG) 18, which developed US positions on
and provided US delegates to the work of SC 2’s Working
Group (WG) 18 (the WG that developed ISO 9001:2000 and ISO
9004:2000), and TG 9000, which served the same role for SC
1, the SC that developed ISO 9000:2000.
Supporting the Introduction and Support Package
Although the Secretariat of SC 2, the British Standards Institution
(BSI), has sought the input and feedback of the participating
member bodies (P-members) of SC 2, the Secretariat has taken
on responsibility for drafting and revising a series of documents
that are/will be available on BSI’s web site (www.bsi.org.uk/iso-tc176-sc2).
In addition to Frequently Asked Questions (FAQs) on the ISO
9000:2000 Series and several other general information documents,
SC 2 is developing four "modules" or brochures that
are/will be available for downloading free-of-charge and will
form what is being referred to as the ISO 9000:2000 "Introduction
and Support Package".
As a result of the TG 18/TG 9000 meeting in Reno and information
available since March 2001, the following is a brief look
at the status of the Introduction and Support Package modules.
Guidance on ISO 9001:2000 Clause 1.2 "Application"
This module has been published on ISO’s web site, although
a draft version was still on BSI’s web site at press
time. A reality of ISO 9001:2000 is that ISO 9002/3 are no
longer available as options for organizations that do not
engage in the full range of product/service development and
delivery activities. Instead, an organization must define
the scope of its QMS and explain/justify the exclusion of
any of the requirements in Section 7, Product Realization,
of ISO 9001:2000, in accordance with Clause 1.2, Scope—Application.
Clause 1.2 states:
Where any requirement(s) of this International Standard
cannot be applied due to the nature of an organization and
its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity…are
not acceptable unless the exclusions are limited to requirements
within clause 7, and such exclusions do not affect the organization’s
ability, or responsibility, to provide product that meets
customer and applicable regulatory requirements.
The concern is that many organizations that did not previously
use ISO 9001:1994, whether or not they engaged in design and
development or other processes now covered in Section 7, are
expected to establish the scopes of their QMSs for ISO 9001:2000
conformance purposes. Thus, any application of ISO 9001:2000
that excludes one or more requirements of Section 7 needs
to be identified and stated and the exclusions justified so
that the claim of conformity will be acceptable to an organization’s
customers and registrar.
The intended purpose of this guidance document is to help
organizations understand how to define a QMS scope to satisfy
Clause 1.2. When the US TAG met in Reno, the module had not
yet been finalized and there were several issues on which
TG 18/TG 9000 had submitted requests for revisions, with plans
to take steps independent of SC 2 if the module was not revised
to satisfy the US issues.
Within the US TAG, a Product Support Initiative group has
been established that has developed and is using a Users Survey
to get feedback from ISO 9001:2000 users in the United States,
and one area that the survey addresses is establishing a scope
per Clause 1.2.
Guidance on the Documentation Requirements of ISO 9001:2000
This module has been published on ISO’s web site, although
a draft version was still on BSI’s web site at press
time. While much has been reported about the fact that ISO
9001:2000 specifies much fewer requirements for documented
procedures, the challenge for organizations will be to maintain
an effective and conforming QMS while eliminating and/or reducing
some of their existing documentation.
The fact is that many organizations, faced with determining
how and when to have documentation and documented procedures
to meet the requirements of ISO 9001:2000 and the needs/demands
of their operations and customers, will not be able to understand
how much is the right amount for their operations.
The intent of this module is to give an organization guidance
on assessing its need for documented procedures and documentation
to satisfy ISO 9001:2000 and what an organization should consider
as alternative means of maintaining a functioning and effective
QMS that suits the organization and its customers but is auditable
without the ISO 9001/2/3:1994-style "paper trail".
When TG 18/TG 9000 met in Reno, the module had not yet been
finalized, but the joint TGs agreed upon the need to address
several issues on which the US TAG had submitted comments.
While the TGs expected the final module to be a useful guide
for organizations worldwide, there was a desire to take several
actions to assist US organizations that are registered to
ISO 9001/2:1994 and need to make the transition to ISO 9001:2000
or that are implementing a formal QMS to ISO 9001:2000 for
the first time.
Sandy Liebesman, ISO Manager at Lucent Technologies and a
member of the TAG involved with the Product Support Initiative,
provided the following information about elements of the Product
Support Initiative:
- Develop a Internet-based tool for providing information
on ISO 9001:2000 implementation. The tool is called IDEAS
(Information, Discussion, Examples, Analysis and Sources).
Nancy Jennejohn of the University of Wisconsin—Stout
is the champion of this activity.
- Gather survey data on the difficulties of complying
with ISO 9001:2000, including cost, documentation and implementation
factors. Ron Berglund of MRI International is the champion
of this activity.
- Develop a set of case studies to supplement the survey
data. The case studies, to be developed under the leadership
of Joe Green of KVF Quad Corporation, will demonstrate how
a range of US organizations satisfied the requirements of
ISO 9001:2000.
Guide to the Terminology Used in ISO 9001:2000 and ISO
9004:2000
This module is still in the drafting stages, according to
the BSI and ISO web sites. It is intended to provide guidance
to organizations in countries where English or French are
not the commonly used language and there is therefore some
difficulty with certain terminology used in the consistent
pair, particularly those that are not defined in ISO 9000:2000.
The draft module reviewed prior to the Reno meeting contained
a listing of terminology that are considered difficult for
many organizations to define, whether or not they have personnel
who speak English or French.
When terminology is defined in ISO 9000:2000, the draft module
refers them to its listing in ISO 9000:2000 by number for
referencing purposes. When terminology is not included in
ISO 9000, the draft module cites the appropriate definition
for that term from the Oxford English Dictionary (OED), thereby
eliminating the other definitions available for that term.
The problem with this module is that it is intended for non-English/French
speakers and does not address problems that US users who speak
English have with some of the terminology in ISO 9001:2000
and ISO 9004:2000.
When TG 18/TG 9000 met in Reno, the joint TGs agreed upon
the need to move forward on the development of US materials
that would address the terminology problems for English-speaking
US users, even if SC 2 will have addressed several issues
on the module on which the US TAG had submitted comments.
A work group at the joint TG meeting examined the module and
came up with a list of "pain concepts"—terms
that cause confusion or that users have difficulty understanding
for QMS implementation purposes.
By the end of the joint TG meeting, the list of "pain
concepts" had been expanded to 10 (e.g., the confusion
over the differences between "corrective action"
and "preventive action"). The work group included
Art Gold, who led the US delegation to SC 1 for the drafting
of ISO 9000:2000, at least one other US delegate to SC 1 and
other TG 9000 and TG 18 members, and plans to continue work
on guidance to address the issues behind the "pain concepts".
"The problem with these ‘pain concepts’ is
actually twofold," explained Dennis Arter, a member of
the US TAG, ASQ’s volunteer coordinator for standards
and co-chair of the Standards Group Leadership Council, who
participated in the "pain concepts" work group.
"First, users in the US, like elsewhere, don’t
understand some of these important words in ISO 9001:2000
and ISO 9004:2000 and particularly don’t understand the
difference between some of them. Second, when someone
does tell them what these words mean and how they differ,
many don’t want to believe it because it may require
more work and revisions to their QMSs."
Guidance on the Process Approach to Quality Management
Systems
This module is still in the drafting stages, according to
the BSI and ISO web sites. It is intended to provide guidance
to organizations on how to apply and use the process approach
in implementing and maintaining an ISO 9001:2000-conforming
QMS. For many organizations, the process approach is a brand-new
way of thinking about quality systems and organizational processes
linked to ISO 9001, which previously treated system elements
as separate units to be implemented and maintained as independent
sets of requirements, not cross-functional processes.
When TG 18/TG 9000 met in Reno, the latest draft of the module
was reviewed by a working group in consideration of the issues
on which the US TAG planned to submit comments. The US TAG
and the working group agreed that the draft of the module
raised fewer issues than the other draft modules, but the
working group decided to also pursue development of concepts
for submission to SC 2 that would be developed to help US
organizations if the final module did not address the US comments.
THE OUTLOOK will provide a more detailed look at the
final drafts of the modules, which SC 2 may update in the
future, when all four have been made available on the BSI
and ISO web sites and will update the status of activities
by the joint TG 18/TG 9000 work groups as information becomes
available.
One fact that the US TAG will need to address at its next
meeting in Crystal City, VA, in September 2001 is whether
to dissolve TG 18 and TG 9000 at that time, since WG 18 is
expected to disband when TC 176 meets in October 2001 and
SC 1’s work on ISO 9000:2000 has been completed. The
feeling is that, even if these TGs are formally disbanded,
the work they are jointly undertaking is likely to continue
to completion.
ISO/DIS 19011: A US "No" Vote May Be Recommended
According to Klaus-Gunter Lingner of ISO, ISO/DIS 19011 is
scheduled to begin circulating to the P-members of TC 176/SC
3 and TC 207/SC 2, the quality and environmental auditing
standards SCs, in advance of a 5-month period of balloting
and comment. "Voting begins on 31 May and terminates
on 31 October 2001," noted Lingner.
However, the US leadership on this standard is strongly considering
the need to recommend a "No" vote on the DIS ballot
to ensure continuing US issues with the auditing guidelines
standard are resolved. As reported previously, the Joint Working
Group on Quality and Environmental Auditing (JWG) reached
agreement in Sydney, Australia, in late March 2001 to elevate
the third Committee Draft (CD3) of ISO 19011 to DIS. But it
was done with the expectation that participating member bodies
(P-members) of the TC 176 and TC 207 auditing SCs would be
able to submit comments with votes of approval that would
be addressed when the JWG meets after the conclusion of balloting
(see "ISO 19011 Receives Elevation to Draft International
Standard", THE OUTLOOK, April 2001).
According to Gary L. Johnson, Environmental Engineer at the
US Environmental Protection Agency (EPA), a representative
of the US TAG to TC 207 (ISO 14000) and a US delegate to the
JWG, the US leadership on auditing from both US TAGs did receive
an advance copy of the DIS in late April 2001 and found that
there is still a need for improvements to satisfy US concerns.
"In Clause 7.4, Education, Work Experience, Audit Training
and Audit Experience, Table 1 in the third CD contained the
title ‘Recommended Education, Training and Work and Audit
Experience’ and 7.4 had other references to Table 1 as
‘recommended’ auditor criteria that was the subject
of much debate in Sydney when the JWG last met," recalled
Johnson.
"Well, ‘recommended’ from CD3 has been replaced
in Table 1 with ‘illustration of indicators,’ which
is an improvement but does not eliminate the concerns with
all the wording in Clause 7.4 and Subclause 7.6.4, Setting
the Indicators, which states that for ‘auditors conducting
certification audits…, these should be the minimum indicators.’
This still could be construed to consider Table 1 the set
of criteria to be used."
In addition, John Stratton, a lead US delegate to the JWG
and member of the US TAG to TC 176 and its TG 19011, has been
given indications that the agreement in Sydney to permit P-members
to vote to approve the DIS with the understanding that comments
submitted would be addressed prior to elevating ISO 19011
to final draft international standard (FDIS) may not be permitted
due to ISO rules. Standards writing procedures within ISO
call upon TCs to address the comments submitted on a DIS (or
FDIS) only when a P-member has voted to disapprove of the
DIS. The idea is that any revisions to be contemplated on
a late-stage document should be done only to increase the
consensus support for the final International Standard.
"We think that ISO 19011 is about 85% of the way there,
but that there is a need to improve the remaining 15% where
the US delegates and the other auditing experts in both TAGs
have concerns with Table 1 and the wording relating to it,"
emphasized Stratton. "If we vote to disapprove of the
DIS, it will be done only to ensure our comments are addressed
by the JWG, not because we oppose the whole draft standard."
Other Developments of Note
Two other issues of note were discussed in Reno that are
briefly discussed as follows:
ISO 9000 "Interpretations" Process
TC 176 has been in the process of developing a work group
to address questions for the "Clarification of Intent"
of the drafters of the ISO 9000 standards, particularly ISO
9001:2000. The process has been moving along slowly and has
now reached the stage where a Clarifications Process Work
Group (CPWG) has been formed, with Morgan T. Hall serving
as the US representative to the CPWG. Brazil is the CPWG Convenor
and a "Brazilian pilot" was conducted that involved
the submission of a question to test the CPWG process. "Unfortunately,
the test involved a question that had been submitted to the
‘interpretations system’ developed by a P-member,
and the answer the national system produced was not necessarily
correct, making it difficult to have confidence in the answer
that came out of the Brazilian pilot," detailed Hall.
The CPWG process will involve submission of questions by
P-members to TC 176, which will pass a question to an ad hoc
group made up of a few CPWG members. The question and ad hoc
group’s answer will then be evaluated and commented on
by the full CPWG, with revisions and reviews to be conducted
until consensus is achieved.
The question and answer will then be submitted for balloting
by the CPWG, with a 75% vote of approval required. "It
is expected that the process will likely take approximately
a year and a half to produce a clarification once a question
is submitted, so the effectiveness of the process will not
be determined for a while," concluded Hall.
FATE of the ISO 9000 Standards/Publications
Bob Peach of Robert Peach & Associates, led the TAG through
a review of FATE (Future Actions to Extend/Eliminate), a reference
to what is happening as a result of the publication of ISO
9000:2000, ISO 9001:2000 and ISO 9004:2000.
Table 1 on the previous page provides a look at the activities
already accomplished, under way or expected in the near future.
"The intent is to leave ISO 9000 as a small group of
core standards, with a number of Technical Reports and other
publications to support organizations using the core,"
remarked Peach. Indeed, ISO formally announced on April 26,
2001, the withdrawal of four ISO 9000 standards after P-members
had the opportunity to raise objections to their elimination
from the series and raised none.
The US TAG is also interested in providing the same assistance
and feedback to the US TAG to TC 207 on the revisions to ISO
14001:1996 and ISO 14004:1996 as its SubTAG 1 gave to US TG
18 during the revisions on ISO 9001 and ISO 9004. THE OUTLOOK
will provide information on the support materials being developed
both on the US and ISO level as they are completed.
Table 1. FATE of ISO QMS Standards and Other Publications
Core Standards (draft status if not yet published)
ISO 9000:2000, ISO 9001:2000, ISO 9004:2000 and ISO/DIS
19011:2001 (see accompanying article for titles)
ISO/CD3 10012, Measurement control system (Note: US has
objections to this draft and may vote to disapprove)
Decision to Discontinue or Replace Already Made
ISO 8402:1994, Quality management and quality assurance—Vocabulary
ISO 9000-1:1994, Quality management and quality assurance
standards—Part 1: Guidelines for selection and use
ISO 9000-2:1997, Quality management and quality assurance
standards—Part 2: Generic guidelines for the application
of ISO 9001, ISO 9002 and ISO 9003
ISO 9001:1994, Quality systems—Model for quality assurance
in design, development, production, installation and servicing
ISO 9002:1994, Quality systems—Model for quality assurance
in production, installation and servicing
ISO 9003:1994, Quality systems—Model for quality assurance
in final inspection and test
ISO 9004-1:1994, Quality management and quality system
elements—Part 1: Guidelines
ISO 9004-2:1991, Quality management and quality system
elements—Part 2: Guidelines for services
ISO 9004-3:1993, Quality management and quality system
elements—Part 3: Guidelines for processed materials
Other Standards to Be Discontinued
ISO 9004-4:1993, Quality management and quality system
elements—Part 4: Guideline for quality improvement
ISO 10005:1995, Quality management—Guidelines for
quality plans
ISO 10011-1:1993, Guidelines for auditing quality systems—Part
1: Auditing*
ISO 10011-2:1991, Guidelines for auditing quality systems—Part
2: Qualification criteria for quality systems auditors*
ISO 10011-3:1991, Guidelines for auditing quality systems—Part
3: Management of audit programs*
ISO 10012-1:1992, Quality assurance requirements—Part
1: Management of measuring equipment†
ISO 10012-2:1997, Quality assurance requirements—Part
2: Control of measurement processes†
Responsibility Transferred
ISO 9000-3:1997, Quality management and quality assurance
standards—Part 3: Guidelines for application of ISO
9001:1994 to the development, supply, installation and maintenance
of computer software (transferred to JTC/SC 7)
Revise and Publish as Technical Reports (TRs)
ISO 10013:1995, Guidelines for developing quality manuals
(presently ISO/FDIS TR 10013, Guidelines for quality management
system documentation)
ISO/TR 10014:1998, Guidelines for managing the economics
of quality
ISO 10015:1999, Quality management—Guidelines for
training
ISO 10017, Guidance on statistical techniques for ISO 9001:1994
Under Review
ISO 10006:1997, Quality management—Guidelines to quality
in project management
ISO 10007:1995, Quality management—Guidelines for
configuration management
Handbook for Small Business (as SME [Small and Medium-Sized
Enterprise] Handbook)
To Be Revised to Align With ISO 9001:2000
ISO/TS 16949:1999, Quality systems—Automotive suppliers–Particular
requirements for the application of ISO 9001:1994
* After publication of ISO 19011. † After publication
of ISO 10012:200X.
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