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Volume 8 · Issue 10 · October 2003

Contents

US TAG Prepares for ISO/TC 176 Meeting in Bucharest
US TAG Seeks Input on Future of QMS Standards

Should ISO 9001 and ISO 9004 stay just the way they are or is there room for improvements to make them even more useful to the organizations that use them? This was one of the issues discussed at the August 27-28, 2003, meeting of the US Technical Advisory Group (TAG) to ISO Technical Committee (TC) 176, at which the TAG prepared for the work to be accomplished when ISO/TC 176 meets in Bucharest, Romania, in late October 2003.

Approximately three years after TC 176 completed the revisions of the core ISO 9000 standards that were published as ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000, TC 176 will begin in Bucharest to prepare for a review of the “consistent pair of quality assurance and quality management standards” (ISO 9000:2000 is already being updated, as discussed below). The August 2003 meeting of the US TAG in Washington, DC, and the October meeting of ISO/TC 176 are occurring at a time when the majority of US—and many organizations worldwide—have not yet completed the transition to the latest revision of ISO 9001. This makes it important for the standards writers to understand the user community’s perspective, since the procrastination by so many ISO 9001/2/3:1994-registered organizations correlates to the real and perceived changes in ISO 9001:2000, Quality management systems—Requirements.

Based on the US meeting, the expectation is that most review and revision efforts on the consistent pair will involve ISO 9004:2000, Quality management systems—Guidelines for performance improvement. Any changes to ISO 9001:2000 when the next edition is issued are anticipated to be minor and driven by the “customer”—organizations using quality management systems (QMSs) conforming with ISO 9001:2000 that indicate the need for clarifications and additions to increase the value gained by use of ISO 9001. Indeed, the US TAG to ISO/TC 176 plans to increase its efforts to obtain input from the users of ISO 9001:2000, and even from those that are not using it because they have issues with it, before supporting any revisions to the contents of the standard.

Indeed, much of the focus of US Task Group (TG) 9001/9004 at the TAG meeting remained on ISO 9004-related developments and on guidance documents related to ISO 9001:2000 usage. Developments involving US TG 10001/10002 have already been covered (see “US to Push Process Focus for Dispute/Codes of Conduct NWIs”, THE OUTLOOK, September 2003), so what follows is a look at the results of the meetings of US TG 9001/9004 and of the US TAG and their impact on QMS users nationally and globally.

Japanese Documents Go Beyond 8 QM Principles in ISO 9004
On January 10, 2003, the Japanese Standards Association (JSA) published two Technical Reports (TRs) drafted by the Japanese Industrial Standards Committee (JISC). These have been distributed to the participating member bodies (P-members) of ISO/TC 176 for their consideration. The Japanese have requested feedback regarding the structure and concepts used in the two TRs. Each P-member, including the US TAG, was asked to provide its feedback to the head of the Japanese delegation to TC 176.

To provide such feedback, a breakout group of US TG 9001/9004 reviewed the TRs and presented an evaluation to the TG for the purpose of both providing feedback to the Japanese and determining whether the JIS TRs had content that should be considered when review of ISO 9004:2000 begins. You may find the following brief looks at the two TRs, which are designated as providing information only, useful in understanding what the future of quality management may be in terms of ultimate performance improvement.

TR Q 0005:2003, Guidelines for Sustainable Growth, provides management guidelines founded on 12 Quality Management Principles, as compared with the 8 in ISO 9000:2000 and ISO 9004:2000. The JISC identified these 12 principles “in view of the changes in thinking in organizational management, as well as changes in the environment surrounding many organizations.” The 12 Quality Management Principles identified and examined in JIS TR Q 0005 are:

  • Creating customer value—The organization should provide products (or services) in which customers recognize value.
  • Focus on social value—The organization should fulfill towards society its responsibility in public service, such as ethics, safety and protection of the environment.
  • Visionary leadership—The leader should establish vision, clear-cut policy to achieve division, guide and motivate people, and lead the organization in the appropriate direction.
  • Understanding core competence—The organization should be aware of its core competence, consisting of technologies, capabilities, and organizational climate that the organization possesses (and/or should possess).
  • Involvement of people—The organization should utilize the knowledge, skills, creativity, etc., of people in its activities.
  • Collaboration with partners—The organization should collaborate with partners to create value and win customer satisfaction.
  • Total optimization—The organization should build systems for total optimization, with attention to the ideals in each process.
  • Process approach—The organization should define the processes for creating values, assess their interrelationship, and administer and manage them, together with…applying these processes as a system.
  • Factual approach—The organization should make decisions based on facts.
  • Organizational and personal learning —The organization should encourage personal learning and utilize personal knowledge as organizational knowledge.
  • Agility—The organization should make decisions and act with agility in response to changes in the environment.
  • Autonomy—The organization should make decisions and take action based on its own values standards.

In a discussion after the August meeting, Jack West, Chair of the US TAG, pointed out to THE OUTLOOK that readers familiar with the eight Quality Management Principles of ISO 9000:2000 and ISO 9004:2000 will quickly note the absence of the concept of “continual improvement” in the Japanese TRs.

“In the TR Q 0005 model, the concept of improvement has been replaced with two new concepts,” explained West. “These are the concept of optimization—building systems that are optimal for the current situation—and the concept of personal learning, where people use personal and organizational knowledge to maintain optimal performance. They have incorporated the notions of innovation and creation, whereby systems, services, products or processes are adjusted as future needs emerge. While these concepts related to optimization can be equated to the idea of improvement, the words and their actual meanings are quite different.

“In plain language, it means that instead of putting a process in place, running it and fixing it as need be, you optimize the process and then learn based on changing operational conditions and market needs. This thinking is common in many organizations but completely unknown in others. Organizations that use these concepts make a decision to change their product, service or process in response to a perceived market need. And they may never use the word ‘improvement.’

“On the other hand, innovation can be thought of as being similar to incremental or breakthrough improvement, while creation can be thought of as creating a completely new product or process. TR Q 0005 indicates that both innovation and creation need to occur a number of times in the life of an organization. The trick to attaining sustainability is to allow sufficient organizational learning so that the timing is right for innovative and creative activities.”

TR Q 0006:2003, Quality Management System—Guidelines for Self-Assessment, contains 81 tables, most of which provide guidelines for self-assessment of the maturity level of aspects of an organization’s QMS in line with the guidelines for sustainable growth in TR Q 0005. In Clause 1.1, Scope—General, the TR states that it “provides guidelines to support effective and efficient self-assessment of [QMSs] in order to determine the level of maturity of the organization, identify principal areas requiring improvement, and boost upward growth of the [QMS].”

The tables in most cases consist of pairs following a maturity model approach. The first in each pair provides “assessment perspectives” (what aspect of a QMS you are assessing on the basis of planning/execution and performance results). The second defines the relative maturity level of the aspect being assessed, ranging from 1 to 5, with 1 being immature and 5 being very mature. “In using the TR, an organization would first prepare an organizational profile that would enable it to tailor the assessment to highlight the things most important to the organization’s ability to sustain growth over time,” noted West.

In an ISO 9001:2000 and ISO 9004:2000 environment focused on continual improvement of QMS effectiveness geared to performance improvement of the QMS and the organization, TR Q 0006 provides the means to self-assess how mature the QMS is at a given point in time, thereby allowing an organization to measure improvement over time based on a number of aspects. Meanwhile, TR Q 0005 provides guidance on the 12 principles of quality management identified by the drafters.

The US TG 9001/9004 breakout group that reviewed the two TRs reported the following that should be useful and of interest to all organizations using QMSs:

  • The 12 Quality Management Principles presented and explored in JIS TR Q 0005 address all 8 of the principles contained in ISO 9000:2000 and ISO 9004:2000 and that served as the foundation for developing ISO 9001:2000. What’s more, the group determined that 7 of the 12 Japanese principles go beyond what the ISO 9000 principles address, thereby presenting quality management concepts not presently covered in ISO 9004:2000.
  • The TG group recognized that a considerable amount of effort had been put into the Japanese TR documents and that they should be viewed as a learning opportunity for Working Group (WG) 18 of TC 176’s Subcommittee (SC) 2, Quality Systems. WG 18 is responsible for the drafting of ISO 9001:2000 and ISO 9004:2000 and will be leading the review of the two standards when that time arrives. Lawrence A. Wilson, a member of US TG 9001/9004 and the Convenor of the WG 18 task group that is responsible for ISO 9004, expressed a strong interest in the TRs at the US TG meeting, particularly because TR Q 0006 uses the maturity model approach.
  • The TRs should be viewed as potential inputs for the next revision of ISO 9004:2000; however, the concepts in TR Q 0005 reach very far beyond what ISO 9004:2000 provides. Therefore, it would be likely that WG 18 would consider some additions to ISO 9004 in line with what is in the TRs in the next revision, particularly in terms of self-assessment using a maturity model approach, but that many of the principles in TR Q 0005 that are new to ISO 9004 would probably need to be considered over a longer timeline, with possible incorporation into the subsequent edition of ISO 9004 (the ISO 9004:2010+ timeframe).
  • The structure of the TRs is quite different from that of ISO 9004:2000 and the present ISO 9004 structure should be retained.
  • The concept of orienting QMS guidelines language toward “management of business” terminology—so that Top Management and other levels of management in an organization would listen to the quality professionals, because they would then understand the terminology of the quality professionals—could increase the value of ISO 9004 and of the QMS to the organization and its leadership.
  • JIS TR Q 0006 appears geared to providing an ISO 9001+ “certification approach” by establishing a self-assessment protocol for QMS maturity measurement, so the potential exists that TR Q 0005 might become a conformity assessment document and lead to another form of QMS registration.

US TG 9001/9004 resolved that the US approach to the review of ISO 9004:2000 once it begins will support the following approach:

  • Use the Japanese TRs as input to the review and revision process, but with an eye to long-term additions and increases.
  • While the self-assessment aspects of ISO 9004 would benefit from enhancement, it should retain its present structure and avoid moving toward a certification/registration scheme. As Jack West, Chair of the US TAG to TC 176, put it, “ISO 9004 should be how to make the journey, not just what you will have when you get there.”
  • More business-inclusive language should be emphasized in the next edition of ISO 9004, which would increase the acceptance of ISO 9004 and the QMS by management and would enhance QMS performance in organizations.
  • Rather than the present efforts to position ISO 9004:2000 as a stepping stone to Baldrige and EFQM levels of performance, ISO 9004 should be positioned as guidance that goes well beyond minimal performance levels and towards an excellence model in its own right.

Charles A. Cianfrani and Robert Peach, who led the breakout group examination of the Japanese TRs, were to provide a report to the head of the Japanese delegation before or at the Bucharest meeting. Additional coverage of the Japanese TRs will be provided in coming issues, along with a report on WG 18 discussions in Bucharest concerning plans for review of ISO 9004:2000.

ISO 9001:2000 and the Guidance Documents
Like ISO 9004:2000, the future of ISO 9001:2000 was a topic of discussion at the US TG 9004/9004 and TAG meetings in Washington. The US TG reached consensus on the following procedures that should be followed by WG 18 in considering any possible revisions to ISO 9001:

  1. Do not change the structure of ISO 9001:2000
  2. Develop a process for identifying sources of data that need to be reviewed to determine potential areas of weakness in ISO 9001:2000 (e.g., requirements that are not clear enough, leading to less than effective implementation of QMS requirements)
  3. Develop a process to review sector-specific derivatives of ISO 9001:2000 (e.g., AS9100, ISO/TS 16949:2002, TL 9000) to identify common add-on requirements to ISO 9001:2000 that might be appropriate for and desirable to include in a generic QMS
  4. Use the following criteria to evaluate proposals for the inclusion of any new or substantially changed requirements in ISO 9001:
    • There must be a demonstrated, data-driven need for the new/changed requirement
    • The proposed requirement must be able to survive an immediate vote on whether to proceed
    • The ultimate wording for any new/substantially changed requirement must undergo a verification and validation process and demonstrate its suitability, effectiveness and usefulness.

Although some consideration was given to potential additions and changes to the requirements in ISO 9001:2000 based on the experiences of US TAG members in the implementation and use of QMSs conforming with ISO 9001:2000, there was strong support for the need to only make revisions to ISO 9001 based on demonstrated data. THE OUTLOOK considers this an appropriate approach in light of the fact that ISO 9001:2000 requires an organization to satisfy the needs and expectations of its customers, and WG 18’s customers are the users of ISO 9001:2000 and ISO 9004:2000. Thus, WG 18 should collect data and feedback from both those already using ISO 9001 and ISO 9004 and those that are not but could in the future.

One effort by the US TAG to collect and analyze data regarding the implementation and use of ISO 9001:2000 and ISO 9004:2000 is the ISO 9000:2000 Product Support Initiative (PSI). The PSI has been focused on several efforts aimed at collecting information and/or providing guidance to US organizations using the QMS standards, including:

  • The ISO 9001:2000 and ISO 9004:2000 Surveys. The ISO 9001:2000 Survey, which is available for completion online (http://standardsgroup.asq.org/news/psi/index.html), has been completed by approximately 285 organizations, and the ISO 9004:2000 Survey has been completed by an even larger number. These survey results have been used initially to develop informational materials for the user community, such as the ISO Curves entry on page XX. While these data collection efforts will primarily prove valuable in US efforts to prepare for the review of ISO 9001:2000 and ISO 9004:2000, the US TAG would like to see a greater number of responses as the transition period ends, since the number of US organizations now registered to ISO 9001:2000 has topped 12,000. One project that the PSI is working on is a revamping of the present ISO 9001:2000 Survey, which has 38 questions, both to reduce the number of questions, thereby making it quicker and easier to answer, and to focus on user experiences with ISO 9001:2000 that would be useful to the US delegates to WG 18. The intent is to have the questions probe what requirements of ISO 9001:2000 were the most difficult to implement, which produced the greatest benefit and which need to be changed. In the future, the PSI Survey data will be used to identify strengths of ISO 9001:2000 that need to be preserved and weaknesses that might need to be addressed. However, the PSI members agreed at the August meeting to wait on making any final decisions until after the meeting of WG 18 in Bucharest, since there may be indications of where the need for future information is needed.
  • The ISO 9001:2000 Case Studies. As of August 27, 2003, 1 PSI case study had been completed and published on the PSI web page and 46 were in development. The case studies involve completion of a more comprehensive survey, with the completed responses used to draft case studies showing how specific organizations implemented ISO 9001:2000, what the challenges were, what the benefits have been and what new or changed requirements in ISO 9001:2000 have produced positive results or need to be reconsidered. One area where the PSI members meeting in Washington concluded that there is a need for future case studies to delve more is continual improvement and how organizations are satisfying this requirement. The case studies are designed to create a repository of in-depth analyses of implementation efforts for the use of the US TAG in developing US positions on issues regarding ISO 9001:2000 and for the use of those organizations implementing ISO 9001:2000 that need guidance based on the experiences of others. In addition, consideration was given to the idea of having registrar auditors complete the Survey or a specialized version of it after January 1, 2004, when the transition will have concluded and auditors should have some breathing room to digest and share what they experienced in the previous three years.
  • The PSI IDEAS Q&A. Intended primarily to provide a range of perspectives on requirements of ISO 9001:2000 that have been found to cause difficulty for users making the transition—so as to provide guidance by sharing the perspectives of users, standards experts and auditors on a given question each month—the Q&A series consisted of 14 entries at the time of the PSI meeting (Question 16 and its responses are published on page 31 and will soon be posted on the PSI web page). The PSI agreed on the need to begin to shift the focus of the IDEAS Q&A as December 2003 approaches from issues related to transitioning from ISO 9001/2:1994 to requirements of ISO 9001:2000 that will remain challenges of conformity as time goes on, such as continual improvement, measurable objectives and customer satisfaction.

In effect, the PSI remains a valuable initiative for both the US TAG and its delegates to ISO/TC 176 and the ISO 9000:2000 user community, although efforts are being taken to evolve the PSI to meet upcoming needs.

While TC 176 will begin to prepare for the review process in Bucharest, ISO 9001:2000 guidance remains a center of activity for WG 18 and SC 2 as a whole, with three guidance documents in development or revision. The Introduction and Support Package of guidance brochures, which WG 18 created for release with ISO 9001:2000 to address the most significant changes from ISO 9001/2:1994, contains two that are under revision.

The first, Guidance on ISO 9001:2000 Clause 1.2 ‘Application’, was assigned to WG 18 TG 1.15 at the TC 176 plenary meeting in October 2002, because feedback from users indicated a need to re-examine some of the guidance in the brochure. In a presentation, Cianfrani reported that TG 1.15 found that one of the examples provided of the “application” of ISO 9001:2000—so as to demonstrate how to set the scope of a QMS when certain requirements in Section 7, Product Realization, are excluded by virtue of the fact that the organization does not engage in the process covered by the requirements—was found to be incorrect.

However, TG 1.15 has not completed much work since revising some of the examples at the October 2002 meeting, so US TG 9001/9004 considered whether the revised brochure is even needed. Two questions were raised at the TG meeting. First, should WG 18 be working on these guidance documents, since they relate to conformity with the requirements of ISO 9001:2000? Second, is the brochure as presently written worth revising and making available to organizations using ISO 9001:2000?

The Application document is likely to be worked on by WG 18 in Bucharest, but the US TG felt that this document should be sent for review and concurrence by ISO’s Committee on Conformity Assessment (CASCO) and/or the International Accreditation Forum (IAF) if it is intended for publication. The US TG also was in consensus that the document should continue to be worked on, but only as input to the ISO 9001:2000 revision process and to any application guide that may be needed in the future.

The second document, Guidance on the Concept and Use of the Process Approach for Management Systems, was determined to be in need of revision because the guidance was not provided in language that was as helpful as it could be in explaining the process approach to quality management and how it works in a QMS—guidance that could also be useful for implementing an ISO 14001-conforming environmental management system or other management systems. As noted in previous articles, the concept of a process approach has been difficult for QMS implementers to implement and especially for quality auditors to evaluate because of the differences from the clause-based approach of ISO 9001/2:1994.

Lorri Hunt, Chair of US TG 9001/9004 and US delegate to WG 18, attended an Editing Group meeting in London in March 2003 at which the text was rewritten to improve the guidance in and readability of the document. The revised draft was circulated for review and comment after the March 2003 meeting and comments have been submitted to the task group revising the document. It is expected that revision of the document may be completed in Bucharest and circulated for final review and approval among TC 176 P-members, although it will not be known until after Bucharest what the outcome is.

A US TG 9001/9004 breakout group evaluated the latest draft and recommended several changes, including the following:

  • The document was originally supposed to be two documents—one providing ISO 9001:2000-related process approach guidance and one on the generic process approach—but the scope should be limited to ISO 9001:2000. However, the guidance should remain generic enough so as to be useful with any type of management system standard using the process approach model, such as ISO 14001.
  • Clause 3, Types of Processes, needs to be rewritten because the present wording relates more to the elemental approach in ISO 9001:1994 than the process approach as embodied in ISO 9001:2000.
  • The document needs a conclusion to summarize the process approach concept or to link back to the concept of continual improvement.

The third document, Guidance on “Outsourced Processes”, is a new document that is being developed by TG 1.15 to address the concept of “outsourcing” in Clause 4.1 of ISO 9001:2000, particularly in relation to purchasing as addressed in Clause 7.4. Cianfrani, who is a US delegate to WG 18 and served on the drafting of ISO 9001:2000, reported to US TG 9001/9004 that ISO/TC 176 has received a number of requests for a definition of the term “outsourcing” since ISO 9001:2000 was published. SC 2 and SC 1, Terminology, have both been seeking a suitable definition for this term, but without success. In October 2002, WG 18 decided to address this issue by developing guidance on the concept of outsourcing, instead of trying to find an explicit definition for the term, with agreement that this work should be presented as a new ISO 9000 Introduction and Support Package guidance module.

The first draft of the outsourcing guidance document was circulated to SC 2 P-members for comment in December 2002, and the comments were reviewed by WG 18, with a second draft having been developed. This second draft was circulating for comment when US TG 9001/9004 met, and comments were due back to WG 18 by September 26, 2003. WG 18 is likely to address the comments on the second draft of the outsourcing guidance document during the TC 176 plenary meeting in Bucharest, but the US TAG consensus was that the second draft does not effectively clarify the meaning of outsourcing or the distinction between outsourcing and purchasing in ISO 9001:2000 terms. The TAG agreed that the document is not needed and that work on it should be cancelled. (For some US perspectives on this issue, see the 15th question in the PSI IDEAS Q&A series, which is posted on the PSI web page and was published in the September 2003 issue of THE OUTLOOK.)

Revising ISO 9000:2000 and Other ISO 9000 Standards
The fact is that the standards in the ISO 9000 series, like all ISO standards, are dynamic sets of guidance or requirements that change in response to user needs. Several ISO 9000 standards have been revised or are under revision and were the subject of activity and/or reports at the US TAG meeting in August 2003. The most well-known of these standards is one of the core standards in the ISO 9000:2000 series and the first of these to be revised.

SC 1 is drafting Amendment to ISO 9000:2000, Quality management systems—Fundamentals and vocabulary, a working draft (WD) of which circulated in May 2003 for a 2-month period of review within SC 1. The WD may be elevated to committee draft (CD) by the conclusion of the Bucharest meeting in late October 2003. Art Gold, Chair of the US TG to SC 1, reported to the US TAG that, technically, this revision to ISO 9000:2000 is being treated as an amendment to, not a full revision of, the standard. “The focus of the ISO 9000:2000 amendment is the updating of the terms to reflect terminology in new standards, such as ISO 19011:2002, and in revised standards,” explained Gold.

At present, the WD of the amendment contains 17 terms that are new to ISO 9000:2000, represent modifications from present definitions for terms in ISO 9000:2000 or are replacements of existing definitions to reflect terms and definitions in the following standards that have been issued/revised or will soon be:

  • ISO/CD2 10005, Quality management—Guidelines for quality plan
  • ISO 10007:2003, Quality management systems—Guidelines for configuration management
  • ISO 10012:2003, Measurement management system—Requirements for measurement processes and measuring equipment
  • ISO/CD 10019, Guidelines for the selection of quality management system consultants and use of their services
  • ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing.

What was clear at the meeting of the US TAG and is clear within SC 1 is that SC 1 and its maintenance of ISO 9000:2000 represent an opportunity for greater standardization among the standards. In other words, because SC 1 has played a critical role within TC 176 in drafting definitions, with input from WG 18, for terms used in ISO 9001:2000 and ISO 9004:2000, SC 1 can and should play a similar role in future standards drafting activities within TC 176 and other committees.

“At present, we are trying to get SC 1 members who understand the terminology in ISO 9000:2000 to serve on working groups developing other standards that relate to the ISO 9000 series,” confirmed Craig Johnson, who serves as TC 176/SC 1/WG 3 liaison to ISO TCs other than TC 176 that are developing standards related to ISO 9000. Johnson noted that this was particularly important with the Joint Technical Committee (JTC) that is circulating a New Work Item (JTC 1/SC 7 NWI on Vocabulary).

“The goal is to ensure that these working groups have access to an SC 1 expert, who will help these drafters quickly overcome the same terminology issues that were dealt with by SC 1 when drafting ISO 9000:2000,” confirmed Johnson. He indicated that these SC 1 experts could provide editorial assistance to other standards drafters to ensure consistency among standards and to ease the drafting process within ISO.
It is likely that SC 1 will issue a CD for the Amendment to ISO 9000:2000 and will advance the idea of SC 1 experts being available to drafting WGs for other standards. The US TAG as a whole supported this role for SC 1, which could prove beneficial in avoiding conflicts in terminology usage and definitions among standards that organizations might use in connection with one another.

One standard that is reaching a critical revision point is ISO 10005. The revision to the guidelines for quality plans standard reached second CD stage in May 2003 at a WG meeting in London. ISO/CD2 10005 went through a period of balloting and comment that concluded on September 12, 2003. Indeed, ISO/CD2 10005 was the subject of a US TG 9001/9004 breakout session that finalized the US comments that were submitted on September 12, 2003. Based on a report by Cynthia Koopman of Boeing, the US working group for ISO 10005 recommended approval for elevation to DIS provided that the US comments that have been submitted are incorporated regarding the need for a provision to identify, designate and prioritize critical characteristics.

It was also reported to the US TAG that ISO/DIS 10018, Complaints handling—Guidelines for organizations, has a good core basis but needs to bring newer ideas and concepts to the user community. The report indicated that ISO/DIS 10018 takes an older approach to complaints handling than that used by most organizations in developed countries today, which will not satisfy many customers having complaints in today’s marketplace. The US TAG has identified improvements that would make ISO 10018 a more effective guidance document.

A number of other ISO 9000 standards are nearing completion or remain in development or revision, and THE OUTLOOK will provide information on the results from the TC 176 meeting in Bucharest.

Finally, ISO/TC 176 is preparing to launch an ISO 9001:2000 Interpretations Program, which has been at the pilot stage of development since shortly after ISO 9001:2000 was published. However, the US TAG to ISO/TC 176 is not sure that the Interpretations Program is an effective tool for US organizations, since the interpretations produced during the pilot phase would not necessarily be all that useful to US organizations. It was reported to the US TAG that there are three options available for the US response, ranging from a vote of approval with full US participation in the Interpretations Program to a vote of disapproval with no US participation.

It will not be known until TC 176 meets in Bucharest when the formal launch of the Interpretations Program will begin and where and if any of pilot interpretations and any future interpretations will be posted on an Internet web site or otherwise made available to organizations seeking guidance on the intent of ISO 9001:2000’s requirements. While the US TAG is considering several options, it would be inappropriate to report any final US position until the program is formally launched and a US TAG decision has been made.

THE OUTLOOK will provide reports from the TC 176 meeting in Bucharest on the Interpretations Program and other developments.