Volume 7 · Issue 11 · November 2002

Contents

ISO 9001:2000 Advisory Group Meets to Support ISO 9000 Usage
Registrations Poor Indicator of ISO 9001:2000 Acceptance

At a time when the transition to ISO 9001:2000 may be accelerating while also moving in more than one direction as far as implementation goes, coordination of the activities of a wide range of organizations is critical to ensuring efficient support for the effective acceptance and use of the quality management system (QMS) requirements standard. Indications are that the number of registrations to ISO 9001:2000 do not reflect the true level of transition activity underway but that not all organizations presently registered to ISO 9001/2/3:1994 will remain registered when the transition period ends.

However, this situation means that effective implementation and dedicated use of QMSs meeting and exceeding ISO 9001’s requirements are more important to true ISO 9001:2000 acceptance than having many organizations simply complete the transition. Such acceptance will only be accomplished by strengthening the conformity assessment system while also providing greater support for implementers, users and auditors.

This significant conclusion led to the creation in May 2002 of the ISO 9001:2000 Advisory Group (IAG), an umbrella group of interested parties to the use of ISO 9001 and the rest of the ISO 9000 series of quality assurance and quality management standards.

The IAG met for a second time in Berlin on September 22, 2002, to continue its consideration of a number of issues surrounding the effective use of ISO 9001:2000 and the rest of the ISO 9000:2000 series. What is important to understand is that the IAG will not itself be taking any actions, but it will instead act as a coordinating body for a variety of groups and organizations that will take actions linked to QMS implementation auditing and use.

"As far as addressing the slow transition is concerned, that is a matter exclusively for the ISO 9001/2:1994-registered organizations themselves, their registrars and the accreditation body members of the IAF [International Accreditation Forum] to manage," noted Nigel H. Croft, Chairman of the International Standardized Testing Organization, who is serving as the ISO 9001:2000 IAG co-convenor in addition to being the ISO Technical Committee (TC) 176 Liaison Delegate to the IAF. "ISO 9000 and the IAG are not only about registration, and the IAG is not only looking at the transition to ISO 9001:2000.

"We in the IAG are looking at the whole ISO 9000 scenario and the threats and opportunities associated with it. Topics we are addressing include issues associated with auditor competence, registrar competence and integrity and accreditation of registrars by overseas accreditation bodies, as well as general issues of consumer understanding of ISO 9001:2000 and what the standard can and can’t do.

"The transition is only one aspect of the IAG’s work, and we need to put it into perspective. The uptake hasn’t been as fast as we had expected initially, though in general organizations have been receptive to the new standard itself. And the IAG can only recommend that its constituent member bodies, such as the IAF, take actions to improve the uptake."

In fact, one of the major results of the Berlin meeting was the reinforcement of the IAG’s belief that more needs to be done to ensure that registrars and their auditors are competent to conduct audits of process-based QMSs conforming to ISO 9001:2000.

"The IAG will not be developing ‘guidance’, since that is not its role," confirmed Dale Misczynski, senior advisor of the Industry Cooperation on Standards and Conformity Assessment (ICSCA). He is a representative of ICSCA to the IAG and spoke with THE OUTLOOK about the Berlin meeting. "Any guidance will be developed by the IAF through its Technical Committee."

In fact, THE OUTLOOK has learned that the IAF, consisting of 40 accreditation bodies worldwide, met in Berlin concurrent with the IAG, and approved a resolution calling for the development of a guidance document for QMS auditors that will focus on auditing of an ISO 9001:2000- and thus process-based QMS. In a communiqué from the 16th annual meeting of the IAF on September 21 and 26, 2002, the IAF stated:

The Joint IAF-ISO/TC 176-ISO/IEC CASCO ISO 9000 Advisory Group held its second meeting and further developed its terms of reference as well as identified activities currently being undertaken in support of the implementation of ISO 9001. The Annual Meeting approved the proposal that the Advisory Group should develop consensus on best practices for auditing of management systems, recognizing the need for innovation following the introduction of ISO 9001:2000 and the new ISO 19011.

The IAG will be playing a key role in the development of this guidance, even if the IAF will draft the actual document. Consensus on this "Best Auditing Practices" approach will include IAF accreditation body, registrar and industry members, as well as representatives from ISO/TC 176 (responsible for ISO 9001:2000 and ISO 19011:2002 and the other ISO 9000 series standards) and ISO/CASCO.

In light of this development, it may be useful to gain a greater understanding of the IAG, the task it faces and how it may benefit your organization. Croft and Misczynski provided THE OUTLOOK with information about the IAG and its Berlin meeting. What follows provides a good sense of the two directions in which the transition may be moving, what it may mean to your organization and what the IAG member bodies may provide that will assist you in making an effective and value-added transition.

One Transition But Two Directions?
There appears to be two different directions being followed by organizations presently registered to ISO 9001/2/3:1994 but planning to make the transition:

1. Transitioning of QMSs and upgrading of 1994 certificates to ISO 9001:2000 and/or sector-specific requirements aligned with ISO 9001:2000
2. Transitioning of QMSs without planning to renew 1994 certificates.

Despite the slow transition so far, recent indications in the United States and worldwide are that the vast majority of organizations presently registered to ISO 9001/2:1994 or sector-specific requirements based on ISO 9001:1994 will be upgrading their certificates to ISO 9001:2000.

One point that Croft made is that the number of registrations to ISO 9001:2000, even 13 months before the end of the transition period, is a poor indicator at present of what is taking place in the ISO 9000 user community. While the vast majority of organizations registered to ISO 9001/2:1994 have not yet obtained an upgraded certificate for ISO 9001:2000, that does not mean the vast majority are not in the process. It simply means that the pressure to transition is not speeding up the rate at which ISO 9001:2000 certificates are issued and reported to registration databases.

"It seems that a large number of organizations are well on their way to implementing the changes, though they have not yet achieved the upgraded registration," explained Croft. "We need to remember that the criterion we are using is a ‘yes/no’ as far as certificates are concerned. Even if an organization has done 90% of the work needed to make the transition, until it successfully completes the ‘upgrade’ audit, it is still counted as a ‘no’, which can distort the statistics."

Croft acknowledged that there are several reasons that account for the slow transition so far, not all of which are bad. "For instance, I know of a number of organizations that are taking the opportunity to revamp their whole QMSs. Instead of asking, ‘What do I have to do to comply with the new standard?’, they are asking, ‘How can I take full advantage of the new standard to improve my organization and make the management system something that truly adds value?’ At a European Organization for Quality meeting held in the United Kingdom shortly after the IAG and IAF meetings, a representative of one such organization quoted Mae West’s immortal words: ‘If a thing’s worth doing, it’s worth doing slowly!’ I agree wholeheartedly."

However, not all organizations registered to ISO 9001/2:1994 are going to continue to hold registration certificates, even though most of these will transition their QMSs and go beyond the baseline conformity requirements of ISO 9001:2000. Misczynski serves as an advisor to ICSCA, an association that places high value on the effective use of QMSs and views ISO 9001:2000 as a baseline that is inadequate to compete in a world-class environment. "In general the ICSCA member companies operate quality management systems that exceed the requirements of ISO 9001:2000," affirmed Misczynski.

Thus, many ICSCA members view ISO 9001:2000 registration as an ineffective way to pursue real quality management, since an organization would be verifying conformity to an inadequate baseline. Misczynski told THE OUTLOOK that some organizations that are members of ICSCA have dropped or plan to let their ISO 9001/2:1994 registrations drop, because their QMSs already surpass ISO 9001:2000. "The members, in general, see little value from the registration process, and we are aware of several companies that are not planning to ‘upgrade’ their certificates."

"We must face the fact that some organizations may choose not to continue with their ISO 9001/2 registrations as a result of the transition," acknowledged Croft. "That could be because they are not ‘quality’ organizations and do not embrace the principles on which the new standards are based, making it difficult for them to make the transition. Or, as Dale has pointed out, it could be that they have decided that registration is no longer an important consideration for them, although they plan to continue to use the ISO 9000 standards as a basis for their quality management systems."

Croft believes that part of the problem with ISO 9001:2000 registration today may be due to the "overselling" of ISO 9000 in the past to organizations that did not really benefit from the standards, but needed the registration in order to do business. "There was one ‘infamous’ story several years ago about a group of folk dancers in Europe who achieved registration to be able to provide their services to the local government. In that case, I would certainly question the value of registration!

"Regarding the values of registration in the vast majority of cases, however, there is ample data available in publications like THE OUTLOOK and on the official ISO web site (www.iso.org) and others that demonstrate the success of organizations that have implemented ISO 9001:2000 in a ‘wholesome’ way. By ‘wholesome’, I mean when an organization applies the spirit, not just the letter, of the standard in implementing or revising a QMS. One thing that the IAG discussed in Berlin was the need to educate users of ISO 9000 about what registration to ISO 9001:2000 actually means, and what the standard can and can’t be expected to provide. There are several initiatives currently underway, including the IAF’s and ISO Central Secretariat’s communication functions."

If your organization is considering whether to continue its registration or let it lapse, it is important to consider whether one or more of its customers is going to continue to require QMS registration, which would make the transition a necessity. "From my own personal perspective, the large organizations I deal with in Europe and Asia are indicating that they will continue to require ISO 9001:2000 registration as a basis for supplier selection and evaluation," confirmed Croft.

Decisions this year by the Big Three and others in the automotive sector to require transitioning to ISO Technical Specification (TS) 16949:2002, which is aligned with ISO 9001:2000 and requires production and service part suppliers to TS-registered organizations to be registered to ISO 9001:2000, will have a major impact as the ISO 9001:2000 transition continues.

Customer requirements are likely to remain a major reason for organizations to be registered to ISO 9001 when the 2000 edition becomes the only choice. However, many organizations will continue to find internal value from having third-party assessments of QMS conformity and effectiveness, especially when ISO 9001:2000 is considered an adequate baseline for performance improvement within an organization.

Nevertheless, registration may not be worth keeping for a few organizations. While more than 90% of registered organizations likely will maintain registration, some may find registration inadequate because their systems go well beyond ISO 9001:2000’s requirements. A few others may find registration ineffective because third-party audits and a formal QMS fail to motivate and drive their management and employees to pursue QMS effectiveness and improvement.

What about organizations that choose to "retain" their ISO 9001/2:1994 certificates after the transition period? While this will happen temporarily in the US automotive sector because of the ISO-approved extended life of QS-9000, which includes the 20 clauses of ISO 9001:1994, there is little expectation that this practice will be considered in other sectors or will provide much practical value. Even QS-9000 certificates will have decreasing value over time as customer deadlines for transitioning to ISO/TS 16949:2000 approach and more and more suppliers have made the transition.

According to Croft, when the transition criteria were defined by a multifunctional group consisting of the IAF, the ISO Council Committee on Conformity Assessment (CASCO) and ISO/TC 176 in 1999, the group adopted a "macro" policy that would allow market forces to decide the details for themselves. "There are certainly no plans afoot to extend the transition period beyond December 15, 2003," advised Croft, who added, "It is really up to the market to decide if any eventual nonaccredited certificate to a standard that is more than 3 years out of date is of relevance in 2004! There is an old Latin phrase that says as much today as it did when first uttered: Caveat emptor! (Let the buyer beware!)"

What Is the ISO 9001:2000 IAG and Its Mission?
You may be wondering what the ISO 9001:2000 IAG is and what it will be doing to help the ISO 9000 user community get the most out of use of the ISO 9000 standards. According to Croft and Misczynski, the IAG is a forum of sorts for organizations and associations relating to QMS conformity assessment and related issues. The membership includes Trevor N. Smith, International Chairman of ISO/TC 176; Katrina Altoft, Secretary of TC 176; the IAF accreditation body members (e.g., representatives of the Registrar Accreditation Board, the United Kingdom Accreditation Service and the Japan Accreditation Board for Conformity Assessment) as well as its certification body/registrar association members of IAF—e.g., Independent International Organization for Certification (IIOC), the International Certification Network (IQNet), the Japan Association of Certification Bodies (JACB), the Association of British Certification Bodies (ABCB), the IAAR (representing US accredited registrars); and representatives of the IAF, ISO/CASCO and the International Auditor Training and Certification Association (IATCA).

Other participants include Vijay K. Mediratta, Secretary General of Quality Council of India, Marisol Valenzuela, Executive Director of the International Accreditation Registry, Misczysnki and Croft. "The membership of the IAG was formed at the Denver meeting in May 2002 and is currently limited to that group," said Misczynski.

As for what the IAG will do, Misczynski and Croft both indicated that the group has no enforcement or even guidance-development authority, but will provide a means of discussing issues and recommending actions to one or more of the group’s members. "The ‘IAG’ group is very much in its infancy," suggested Croft. "Keep in mind that the first exploratory workshop that gave rise to the group was held in Denver only 6 months ago, where we tried to bring together the major interested parties and identify the strengths and weaknesses of ISO 9000 as a whole, and the opportunities and threats associated with the transition to the ISO 9000:2000 family.

"The sharing of information among member organizations is critical to the group’s mission. In Berlin, we collated information on the many initiatives that are currently underway in this arena, to ensure that all the component members of the group were aware of things that the others are doing. We also discussed related ISO developments, such as the publication of ISO 19011, Guidelines for quality and/or environmental management systems auditing, the revision of ISO Guide 62 (used as a basis for the accreditation of registrars), and the development underway of ISO 10019, Guidance for the selection and utilization of quality management system consultants.

"In total we came up with more than 20 initiatives that are currently in progress. The next step will be to match up those initiatives with the ‘SWOT’ analysis we did in Denver and identify gaps that need to be addressed. Again, let me emphasize that any tasks that need to be carried out will be done under the umbrella of one of the component member organizations of the IAG, not by the IAG itself."

As an example, Croft mentioned activity by the IAG involving auditor competency with ISO 9001:2000, which involves a process-based approach to quality management. "In Berlin, we did identify auditor competence as a critical factor in the success of the new standards and know that many auditors have difficulty in understanding the new ‘process approach’ both in terms of ISO 9001:2000 and the auditing technique," reported Croft, who added that the IAG did consider what role ISO 19011 will play in helping auditors. "The new standard will go some way in dealing with auditor competence issues."

Croft provided the following list of "draft terms of reference" that have been agreed upon for the tasks of the IAG:

• Monitor the credibility of ISO 9001:2000 in its role for registration and provide feedback for each of the component members of the group, as appropriate
• Provide a forum for discussion of user satisfaction and to call for action by component members of the group, as necessary, when complaints or indications of concern are identified
• Identify issues that indicate the need for official ISO/TC 176 "interpretations" to ISO 9001:2000 or specific IAF or ISO guidance documents
• Provide feedback to ISO/TC 176 on the acceptance of its standards and provide inputs for eventual future revisions
• Provide a catalyst for ISO member bodies and accreditation body members of the IAF to stimulate similar "shadow" committees on a local or regional basis.

An initial result of the IAG meetings in Denver and Berlin will be the introduction of a guidance document by the IAF to help third-party auditors increase the effectiveness of their audits. This will be done by increasing auditor understanding of how auditing of a process-based QMS is conducted. THE OUTLOOK will provide ongoing coverage of the IAG’s efforts and related developments within its member bodies.

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