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Volume 6 · Issue 5 · May 2001

Contents

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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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