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Volume 6 · Issue 1 · January 2001

Contents

The View From Three Officers of SC 2
How the ISO 9000:2000 Standards Were Developed

By Dr. John Davies, Dr. Jeffrey Hooper and Charles Corrie

The development of the Year 2000 revisions of the ISO 9000 series has broken new ground within ISO’s standardization activities on several counts. In drafting the Year 2000 ISO 9000 Series, the national delegations of experts participating in ISO Technical Committee (TC) 176 Subcommittee (SC) 2–responsible for the ISO 9000 quality management system (QMS) standards–have pioneered a new approach centered on quality management principles, project management, information technology and treating the revisions as a "product" to be researched, designed and developed, validated by users and accompanied by introduction and support materials and systems.

To ensure that ISO standards retain their market relevance, ISO requires them to be reviewed on a regular basis, with a maximum of five years permitted between completion of a revision and the next review. The results of such reviews by TCs can be decisions to confirm as-is, amend, revise or withdraw a standard.

SC 2 and Vision 2000

When you consider the popularity and widespread use of the generic ISO 9000 quality management system standards since their publication, TC 176/SC 2’s decisions based on the review of these standards was critical to their continuing usability and usefulness to organizations of all types.

This is particularly true today, when more than 350,000 certificates of registration to ISO 9001/2/3:1994 have been issued to organizations worldwide, several times this number of organizations have quality systems in conformance to their requirements and countless others are using ISO 9004:1994 to implement and maintain more comprehensive QMSs.

Back in 1990–three years after the initial publication of the ISO 9000 standards–TC 176, Quality Management and Quality Assurance, took the groundbreaking step of developing and publishing a strategic plan for its review program, entitled Vision 2000.

While other ISO TCs have used strategic plans, we believe TC 176 is the first to have made its strategic plans publicly available. The program outlined a number of key issues:

  • The timing and expected extent of revisions
  • The need to ensure the generic nature of the standards
  • The need to ensure forward compatibility between successive revisions of the standards
  • The need to prevent the proliferation of QMS standards.

It is our belief that the resulting ISO 9001:2000 and ISO 9004:2000–and the coordinated completion of ISO 9000:2000 in SC 1–not only maintain the usability and usefulness of the standards, but significantly enhance them.

TC 176’s strategic plan and the key issues derived from the review program account for the efficiency and effectiveness with which its experts were able to draft and complete work on the consistent pair of quality management standards.

A look at what SC 2 determined regarding those key issues will help you to understand the significance of what has been achieved and the reason the standards turned out the way they did.

Timing and extent of revisions

By 1990, relatively few countries had fully developed national quality infrastructures–the training organizations, registrars, accreditation bodies and national quality award programs. For instance, the decision to use the ISO 9000 standards in many developing countries was often made by businesses and other organizations responding to requests and/or suggestions from customers in developed nations for the use of ISO 9001/2:1994.

These organizations looked to the development of national infrastructures as a way of reducing registration costs and creating a national system that would be familiar with the local business culture. In many of these countries, governments felt the need to support these business and organizational decisions by providing the necessary infrastructure.

Consequently, there was pressure from many countries to limit the extent of any revision to allow these countries to develop their own infrastructure.

On the other hand, it had taken eight years for ISO/TC 176 to achieve the initial publication of the ISO 9000 standards, from the formation of the committee in 1979 to publication of the first standards in 1987. Many leading-edge organizations were critical of the standards and advocated that they be revised to reflect more progressive quality practices.

In trying to find a balance between these two different views, ISO/TC 176 agreed on a two-phase revision strategy–a first, limited revision phase to be followed by a second, more fundamental revision. The first phase was projected to be completed by 1992, and the second by 1996.

History has since shown the projections to have been rather optimistic, since the first phase was not completed until publication of the 1994 editions of the ISO 9000 standards, with the second phase only being achieved in 2000.

Generic nature of the standards

The original standards were predominantly based around the quality programs being implemented by large manufacturing organizations. Increasingly, it was recognized that small organizations and organizations operating in the service and software sectors were also applying the standards or were interested in using them but found the manufacturing-oriented language and approach difficult to apply.

The revisions to the standards would need to take greater account of their needs and ensure that they could be applied to any size or type of organization, operating in any sector.

Forward compatibility

To maintain a stable user base, it was agreed that successive revisions of the standards should allow existing users to take an evolutionary, rather than revolutionary, approach to achieving conformity to the revised standards. The fundamental changes in the Year 2000 editions were made with this as one of the key objectives of the revision process.

Nonproliferation of QMS standards

In the early 1970s, organizations found their operations subject to a range of requirements imposed on them by multiple quality management programs. These were either sets of quality management requirements established in different industrial sectors or proprietary programs developed by specific customers.

They all had a high degree of commonality in the detail of their requirements but differed significantly in their presentation and the sequencing of those requirements, making it a bureaucratic headache at best for organizations to achieve conformance when subject to more than one.

During the 1970s, this led to the realization that such competing programs were not cost-effective or were sometimes counterproductive. Consequently, a number of countries established harmonized national QMS standards (e.g., the BS 5750 standards in the United Kingdom). These, in turn, were submitted for consideration by ISO/TC 176 during the initial development of the ISO 9000 standards.

The strategic intent of nonproliferation is therefore to ensure a high degree of acceptance of the standards by differing sectors and by organizations that would otherwise develop their own sets of QMS requirements.

ISO/TC 176 has worked closely with many different sectors during the development of the Year 2000 standards to maintain this intent. However, it is recognized that there is a continuing need for sector-specific guidance on the application of the generic QMS standards in those fields where additional requirements are critical to the industry. ISO/TC 176 has therefore established a sector policy and been working to assist specific sectors in developing quality management requirements supplements based explicitly on the ISO 9000 standards.

A sector organization must apply to TC 176 for sector status. However, the sector policy has yet to be ratified by the ISO Technical Management Board, so a sector having its own ISO TC is not required to apply for TC 176 sector status. The telecommunications industry–represented by the Quality Excellence for Suppliers of Telecommunications (QuEST) Forum–has considered applying for sector status, although the Forum has not yet decided to applied.

Vision 2000 in the Year 2000

Since 1990, ISO/TC 176’s strategy has continued to evolve to meet changing market needs. Examples of the reasons for this change include:

  • The advent of the ISO 14000 environmental management system standards and the need for compatibility with the ISO 9000 standards.
  • The need to more efficiently integrate the many standards within the ISO 9000 family, so as to produce a smaller, more value-adding set of standards.
  • The realization that only one ISO 9000 conformance standard is needed, permitting withdrawal of ISO 9002 and ISO 9003.
  • The need for improved "consistency" between ISO 9001 and ISO 9004.

During the early 1990s and the later stages of the 1994 revisions, SC 2 began consulting with ISO 9000’s "customers" and planning for the expected change. As a result, SC 2 took the pioneering step of issuing consultative documents (design specifications) outlining proposals for the main approach (the process approach), structure and contents of the future standards.

The design specifications proposed the way in which ISO 9001, ISO 9002 and ISO 9003 would be merged into a single standard. The design specifications were circulated for review in June 1995 and, following amendment, again in December 1995. The responses to these design specifications indicated a high degree of consensus on the proposals.

To confirm this formally, SC 2 issued for ballot a new work item proposal for a "consistent pair" of ISO 9001 and ISO 9004 standards, citing the design specifications as the basis for the work. The positive ballot result achieved in May 1996 enabled ISO/TC 176 to prepare for drafting of the standards.

WG 18: Project Management, Project Plan, Management Plan

The concept of a consistent pair of ISO 9001 and ISO 9004 standards led SC 2, which was responsible for their development, to review both its approach to this task and also to its own organizational structures. It appointed Dr. Jeff Hooper (USA) as Project Leader and established a Project Task Group to examine these issues and make recommendations.

In June 1996, the Project Task Group produced a report recommending that:

  • A project management approach be adopted to develop the standards
  • The standards be based on eight quality management principles, to be used in conjunction with the process management approach
  • A Project Plan be developed, including a work breakdown structure (WBS), task descriptions and project deadlines
  • A single working group (WG) should be established to perform the work, with subordinate task groups (TGs) for specific work items
  • The working processes and procedures, including details of reporting lines and the participation of experts, should be detailed in a comprehensive Management Plan.

SC 2 accepted these recommendations, requesting that the Project Task Group develop a Project Management Plan to be formally approved by SC 2 in November 1996.

The Management Plan defined the:

  • Meaning of a "consistent pair"
  • Project objectives and key issues
  • Responsibility and authority of the Project Leader
  • Organizational structure of work (macro level)
  • Processes for selection of participants
  • Reporting responsibilities.

SC 2’s approach differed from the typical approach, which does not involve a project management approach with a formal project plan that breaks down the work into a number of small tasks, many of which can operate concurrently.

The typical approach also does not involve customer surveys, verification and validation programs, product introduction and support and an extensive information technology (IT) support plan. The approach SC 2 took involved the customers more, involved more people in the development process, moved very quickly and built a very strong consensus supporting the revisions.

Subsequently, WG 18 was formally established to develop the future ISO 9001:2000 and ISO 9004:2000.

WG 18’s first task was to develop the Project Plan, which defined the following:

  • Detailed working group organization and staffing processes
  • Key processes for the development of the revised standards
  • Baseline documents to be considered by the WG (e.g., the design specifications)
  • Identified project risks
  • A WBS for the project and associated subtasks (see Figure 1)
  • A master schedule for individual tasks and the overall project.

The following key processes defined the Project Plan:

  • Project planning
  • Customer needs analysis
  • Human resource requirements
  • Communications and consensus-building
  • Task group operations
  • Verification and validation
  • Product introduction and support
  • Review and approval.

In developing the Project Plan, WG 18 broke new ground for ISO. Not only did it specify an extensive customer needs analysis phase at the start of the project and verification and validation programs during the project, it also specified the need for product launch and product support activities towards the end of the project (see Figure 1).

A key driver of the Project Plan was the limited time available in which to complete such a complex project if it was to adhere to ISO’s stipulated deadlines for the development of standards (approximately four years from a ballot approving the new work item proposal for a standard to publication of an International Standard).

Given these time constraints, it was necessary for many of the tasks to be performed concurrently. A master schedule was developed to monitor the progress of individual tasks against the project deadlines. This also determined that an aggressive schedule of WG 18 and TG meetings would have to be planned for the deadlines to be met.

For the drafting task, four TGs were established initially, each assigned responsibility for developing the text for one of the major "clause" sections of both ISO 9001 and ISO 9004. This enabled the achievement of good horizontal consistency between the two standards in their early drafts; however, it was not ideal for obtaining the vertical consistency needed within the individual standards.

Editor’s Note: THE OUTLOOK normally refers to 0-8 of ISO 9001:2000 and ISO 9004:2000 as Sections 0-8, with their subsections referred to as clauses. Because ISO refers to 0-8 as clauses and the authors are leaders of SC 2 and WG 18 of ISO/TC 176, the references below follow the ISO reference system.

Consequently, in late 1998, WG 18 decided to reorganize the four drafting TGs in the following fashion:

  • A single TG was given responsibility for Clauses 0-4 in both standards
  • A second TG was responsible for Clauses 5 and 6 in ISO 9001
  • A third TG was responsible for Clauses 7 and 8 in ISO 9001
  • A fourth TG was responsible for Clauses 5-8 in ISO 9004.

A Drafting Coordination Group was established to coordinate the work of the drafting TGs. Also, drafts of the consistent pair prior to the DIS (Draft International Standard) and FDIS (Final Draft International Standard) stages were produced during WG 18 meetings at which the TGs were working to obtain stronger consensus and rapid feedback. Early versions were also produced to facilitate translation into the national languages of ISO member bodies during the drafting process.

In addition to the drafting TGs, a supporting TG on Terminology was established to serve as a liaison to WG 1 of ISO/TC 176/SC 1, Concepts and Terminology. The WG 18 liaison TG to WG 1 was created to ensure consistency of ISO 9001/4:2000 with the development of ISO 9000:2000, Quality management systems–Fundamentals and vocabulary. Additionally, a TG was established to liase with TC 176’s SC 3, Supporting Technologies, on the other standards under revision or development in the ISO 9000 family.

Many other liaisons were established with key partners and stakeholders, including ISO/TC 207, Environmental Management, ISO/TC 210, Quality Management and Corresponding General Aspects for Medical Devices, the ISO Committee on Conformity Assessment (CASCO), the International Accreditation Forum (IAF), the International Automotive Task Force (IATF), Directorate General III Industry from the European Union and the ISO Central Secretariat, including its Public Relations and Standards departments.

It should be noted that the product support TGs plan to continue their activities beyond what might previously have been considered the end of the project, namely publication of the standards. They will continue for as long as there is an identified need to support the introduction of and transition to the new standards (see Critical Last Steps: Product Introduction and Support below).

The Challenge of Allocating Resources

When first established, WG 18 had a nominated membership of 31 principal experts and 40 experts from 27 ISO national member bodies and four liaison members. Given the large number of tasks to be performed, WG 18 needed to develop a formal system to ensure that these experts would be used to the best of their abilities.

Additionally, given the diversity of tasks and meetings scheduled, it was necessary for WG 18 to develop an internal management structure involving:

  • The Project Leader
  • A Planning and Operations Task Group, including Human Resources, Communication and Information Technology Leaders, as well as task group monitors
  • Task group monitors
  • Task group leaders
  • Task group members.

Each nominated member of WG 18 was required to complete a human resources profile form, which was used to create a database of experts’ experience. Along with basic contact information about each WG 18 member, the database required details about their background, including:

  • Stakeholder category (large or small businesses, profit/nonprofit)
  • Product background (hardware, software, processed materials, services)
  • Management systems experience (ISO 9000, ISO 14000, quality award programs or other systems)
  • Experience with standardization work, either in ISO or at the national level
  • Team leadership experience
  • Availability for attendance at meetings.

Collecting and assessing such data enabled WG 18 to balance its assignment of experts to TGs and to appoint the most qualified TG leaders. Determining the assignments was often a tremendous balancing act between the need to ensure participation on each TG by representatives from a wide range of national member bodies, with a wide range of backgrounds and experiences represented, and the need to maintain relatively small groups to maximize individual contribution and speed.

As the project continued, WG 18’s membership expanded until it reached a combined figure of approximately 130 experts from 37 national member bodies and 15 liaison members. TC 176 and ISO as a whole owe these experts a large debt of gratitude for their efforts. From its earliest days, WG 18 has consistently managed to have 90-100 experts attend every formal meeting, even though they usually lasted up to a week and occurred at a frequency of up to four meetings a year. This does not take into account the work these experts also were required to conduct inbetween meetings, often via e-mail and conference calls.

In addition, the many organizations that either directly or indirectly supported the work of WG 18 should be recognized. Meetings have been arranged, sometimes at short notice, with large demands for support in the form of facilities, computing, photocopying, etc. WG 18 has been truly delighted by the response of many organizations worldwide that have offered their assistance and participated in the project.

The Role of the Global User Survey

One of the most important aspects of this project was the effort to understand the needs of ISO 9000’s users. In the earliest stages of the project, a compendium of user needs was developed to summarize all that was known at that time. This was the basis for the early work as well as the plan to perform a global user survey.

The global user survey gathered input from 1,120 participants in 40 countries and identified the following significant user needs:

  • Common structuring of ISO 9001 and ISO 9004 based on the process model
  • Increased compatibility of ISO 9001 with ISO 14001
  • A provision for excluding certain ISO 9001 requirements
  • Requirements for continual improvement
  • Suitability for and applicability to all sizes of organizations in any sector
  • Easy to transition from the 1994 editions to the Year 2000 standards.

Product Verification and Validation

Another key feature in the development of ISO 9001 and ISO 9004 was the use of verification and validation programs, as shown in Figure 2. Verification involved the internal comparison of the draft standards with WG 18’s specifications for the standards to ensure the draft TGs were consistent with our own specifications. Beginning with early working drafts and proceeding through each Committee Draft (CD) and the DIS version of the standards, a WG 18 TG performed this verification activity and provided valuable direction and feedback to the drafting TGs.

Validation was managed by the same WG 18 TG as verification. Validation involved reviews of the draft standards by users and potential users to provide the drafting TGs with direct feedback on how well the documents were meeting user needs and on the impact of the new standards on user organizations. Validation was performed on each CD and the DIS versions of the standards.

As an example of what the drafting TGs gained from this activity, key validation and impact assessment findings at the DIS stage included the following:

  • Several areas needed more improvement, including documentation requirements, guidance on excluding requirements and the relationship between ISO 9001 and ISO 9004.
  • An important use foreseen for ISO 9004 was QMS self-assessment.
  • The key benefits of the revisions were the process approach, customer satisfaction and continual improvement.
  • Several requirements needed restating to make them easier to audit.

Critical Last Steps: Product Introduction and Support

Product introduction and support is another important feature in the development of ISO 9001 and ISO 9004. More than 350,000 quality systems worldwide are registered to ISO 9001/2/3:1994, which creates a substantial need for a "product introduction", transition planning guidance and product support. For many months, work on product introduction and support has been undertaken concurrently with the drafting of the standards.

This work has included frequently asked questions, an executive abstract and revision summary, a presentation package, transition planning guidance, press releases, articles in ISO 9000 + ISO 14000 News and other publications, brochures and introduction and guidance modules on the application of ISO 9001:2000 (previously known as "permissible exclusions"), documentation, the process approach model and terminology. While some of this material has been distributed by mail, intensive use has been made of the web.

One set of useful documents that will be available on the SC 2 and ISO Central Secretariat web sites listed below is the "Introduction and Support Package". This package will consist of the following modules:

  • Transition Planning Guidance
  • ISO 9001 Clause 1.2 Application Guidance
  • ISO 9001:2000 Documentation Guidance
  • Process Approach Guidance
  • Terminology Guidance.

Final versions of these modules should be completed and posted by early March 2001.

Of particular note is the transition policy that was jointly developed by ISO/TC 176, ISO/CASCO and the IAF to make clear "the rules of the road" for migrating from the 1994 series to the new standards. The most important feature of the transition policy is that the validity of all accredited certificates of registration to ISO 9001:1994 (and ISO 9002 and ISO 9003) will terminate three years after the publication date of ISO 9001:2000, or December 15, 2003.

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Communication

The project approach, with about 30 operating TGs, required excellent and structured communication to operate smoothly. The communication objective was to provide clear and relevant information to all WG 18 stakeholders to facilitate decisions, actions and consensus-building.

WG 18 produced a detailed communication matrix that stipulated what needed to be communicated to whom, when and how. In addition to very well-structured internal communication, we also had a careful external communication review and approval process.

Essential to the smooth operation of the project management approach was the extensive use of a WG 18 web site provided by the Standards Council of Canada (SCC) in conjunction with the ISO/TC 176 Secretariat, which is held by SCC and operated on the latter’s behalf by the Canadian Standards Association International (CSAI). This restricted-access web site had folders for the use of individual TGs as well as a folder for the whole of WG 18. The site proved to play a major role in internal communication.

Besides the internal WG 18 web site, extensive use was made of e-mail, and internal standards were established for Microsoft Word and PowerPoint attachments. Comments were submitted electronically on all drafts using an electronic template, which greatly accelerated the process of collecting and collating comments.

Since the number of comments received at every stage of the development process was very large (e.g., more than 6,000 individual comments were submitted on the first CD), the use of these information and communication technology tools yielded significant benefits in productivity.

Finally, the wealth of product introduction and support material, along with key information on the progress of the drafts and publication of the International Standards, has been made as accessible to the current and potential user groups via posting on three public web sites:

These web sites will provide information on the Year 2000 standards and on future developments involving the ISO 9000 series that your organization will benefit by knowing. Therefore, it is recommended that you check them frequently, especially in the coming months as additional guidance documents and other introduction products are completed.

What Lies Ahead for SC 2?

Completion of ISO 9001:2000 and ISO 9004:2000 is an important accomplishment, but SC 2 now needs to evaluate many other ISO 9000 standards, both to make sure they remain relevant after the Year 2000 standards have been published and to ensure they are revised to meet user needs in their own right. SC 2 has also been engaging in a review of the supporting standards, which has involved several different approaches.

SC 2 is currently establishing TGs to review the following standards and make detailed recommendations on changes needed, if any:

  • ISO 10006:1997, Quality management–Guidelines to quality in project management
  • ISO 10007:1995, Quality management–Guidelines for configuration management
  • ISO Handbook–ISO 9000 for Small Businesses.

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, is expected to be transferred to ISO/IEC JTC 1/SC 7. SC 2 delegates are already attending meetings of a TG established by SC 7 for the revision of this standard to bring it into line with ISO 9001:2000.

As part of its review, SC 2 conducted a ballot on the standards. Since the ballots were fairly close on some standards, SC 2 will consider at its next major meeting what action to take on:
  • l 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
  • In addition, SC 2 remains active in providing assistance to:
  • ISO/CASCO for the conformity assessment standards
  • ISO/TC 34 for the food industry and the development of ISO 15161 (relating HACCP to ISO 9001:2000)
  • ISO/TC 207 for the EMS standards
  • ISO/TC 210, which is revising ISO 13485, the medical device standard for the application of ISO 9001:2000
  • Many other ISO and/or IEC committees, liaison groups, sector groups, etc.

Note that ISO Technical Specification (TS) 16949:1999 was produced at the TC 176 level, not the SC level. However, all 3 SCs were asked to send representatives to the TG that developed the automotive TS. When requested, SC 2 will do the same for the update to align it with ISO 9001:2000 that is under way.

SC 2 faces an active schedule in 2001 and beyond. THE OUTLOOK will continue to provide information on developments that will affect the work of SC 2–and what your organization can use to maximize your ISO 9000-based QMS.

Editor’s Note: This article is an edited, expanded version of one that appeared in the January/February 2001 issue of ISO 9000 + ISO 14000 News and is published here with the kind permission of the International Organization for Standardization (ISO). Visit ISO’s web site (www.iso.ch) for information on ISO 9000, ISO 14000 and many other standards.

Dr. John Davies is Chairman of ISO/TC 176/SC 2, which is responsible for the development of ISO 9001:2000 and ISO 9004:2000. He is Vice President of the Institute of Quality Assurance (IQA) in London, the United Kingdom. Dr. Davies can be contacted by phone (+ 44 20 7245 6722), fax (+ 44 20 7245 6755) or e-mail (iqa@iqa.org).

Dr. Jeffrey Hooper is Project Leader of WG 18, which is responsible for the development of ISO 9001:2000 and ISO 9004:2000. Dr. Hooper is Managing Vice President of Information Technology for Lucent Technologies Enhanced Services in Warren, NJ, the United States of America.

Charles Corrie is Secretary of ISO/TC 176/SC 2, held by the British Standards Institution (BSI) in London, the United Kingdom. Mr. Corrie can be contacted by phone (+ 44 20 8996 9000), fax (+ 44 20 8996 7400) or e-mail (charles.corrie@bsi-global.com).

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