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.
Back
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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