TS 16949, ISO 9000, ISO 9001, Quality Management, Free Quality Manual, Quality Procedure

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US TAG to TC 176 on
Quality Management and Quality Assurance
Jack West, Chairman

NEWS RELEASE
For Immediate Release July 7, 2000

ISO 9001:2000, ISO 9004:2000 AND
ISO 9000:2000 ADVANCE TO FDIS STAGE

Kyoto, Japan. At its meeting today in Kyoto, Subcommittee
(SC) 2, Quality Systems, of ISO Technical Committee 176,
Quality Management and Quality Assurance, voted in plenary
session to elevate the drafts of ISO 9001:2000, Quality
management systems-Requirements, and ISO 9004:2000, Quality
management systems-Guidelines for performance improvements,
to the Final Draft International Standard (FDIS) stage. In
addition, SC 1, Concepts and Terminology, voted to elevate
ISO 9000:2000, Quality management systems-Fundamentals and
vocabulary, to FDIS status.

There was only one negative vote cast by a participating
member body (P-member) on the elevation of ISO 9001 (Japan)
to FDIS and one on ISO 9004 (France), despite the fact that
there were nine votes of disapproval on each draft in the
balloting concluded in April. This reflects the extensive
work accomplished during the past several weeks to fully
address the comments of the P-members as well as an
extensive process during the meetings in Kyoto to ensure
that all comments were fully discussed and resolved to the
greatest extent possible. All of the US concerns were
resolved to the satisfaction of the delegation.

The FDIS stage for an ISO standard involves a circulation
to the P-members, for an up-or-down vote on approval of the
FDIS for publication as an International Standard. Unlike
earlier stages, members do not provide comments with their
votes, since no further revisions are to be made.

The three FDISs will be edited over the coming weeks by the
subcommittees in cooperation with the ISO Central
Secretariat and are expected to be available for ballot by
the P-members in early September. The target date for
issuance of the revised standards remains mid-November.

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FDIS Availability

You can purchase copies of the FDIS from ASQ. You can purchase
hard copies by contacting ASQ's customer service department at:
1-800-248-1946 or electronic copies by visiting the Quality Press
Bookstore at: http://qualitypress.asq.org.

The item number is T1700 and the price is: $100 list. At this
time, the drafts can only be purchased as a set of the 3 FDISs
for 9000, 9001 and 9004.

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FDIS Changes to ISO 9000:2000 Fundamentals and Vocabulary

The ISO 9000 Fundamentals and Vocabulary standard is considered a "normative" reference to ISO 9001:2000 and can be considered an extension to the Requirements standard. Definitions changed in the final draft version of ISO 9000:2000 are expected to be:

Work Environment

(DIS): a set of conditions under which a person operates.

Since this definition did not consider processes that operate without the direct involvement of a person, it will be changed to:

(FDIS): a set of conditions under which work is performed.

Process

(DIS): a system of activities which uses resources to transform inputs to outputs.

This definition was not consistent with the definition of a quality management system as a system of processes, so it will become:

(FDIS): a set of interrelated or interacting activities which transform inputs to outputs.

Another change was to place the "fundamentals" section before the "vocabulary" section (as would be expected by the document title).

The standard presents its vocabulary in a different manner than most dictionaries. Terms are shown in functional groupings that display their relationships.

For example, the system definition links to process, which in turn points to product and project. The product definition links to service, software, and offered product. These concept diagrams help readers more fully understand terms by showing their relationship to other terms.

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FDIS Changes to ISO 9001:2000 Requirements

The FDIS version of ISO 9001:2000 is expected to have some clause numbering changes, as well as, numerous text revisions.

For example, quality plan (5.5.5), document control (5.5.6), and record control (5.5.7) of the Management Responsibility section of the DIS version will be moved to Documentation Requirements in 4.2.2, 4.2.3, and 4.2.4, respectively. The old 5.5 Administration section will become Responsibility, Authority, and Communication.

Another numbering change is the movement of process validation from 7.5.5 in the DIS to 7.5.2 in the FDIS, along with a revised title of Validation of Special Processes.

A sampling of other expected changes include a new requirement on "outsourcing", design output to also provide information for purchasing, and the use of "objective" and "impartial" to replace "independent" in internal auditing.

The expected ISO/FDIS 9001:2000 clauses and a mapping to the current ISO 9001:1994 are:

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ISO 9001:2000 to ISO 9001:1994 Mapping

ISO 9001:2000	ISO 9001:1994
1. Scope	1
1.1 General	-
1.2 Permissible Exclusions	-
2. Normative Reference	2
3. Terms and Definitions	3
4. Quality Management System	-
4.1 General Requirements	4.2.1
4.2 Documentation Requirements	-
4.2.1 General	4.5.2, 4.5.3
4.2.2 Quality Manual	4.2.1
4.2.3 Control of Documents	4.5
4.2.4 Control of Quality Records	4.16
5. Management Responsibility	-
5.1 Management Commitment	4.1, 4.1.2.2, 4.2.1
5.2 Customer Focus	4.3.2
5.3 Quality Policy	4.1.1
5.4 Planning	-
5.4.1 Quality Objectives	4.1.1, 4.2.1
5.4.2 Quality Management System Planning	4.2.3
5.5 Responsibility, Authority, and Communication	-
5.5.1 Responsibility and Authority	4.1.2.1
5.5.2 Management Representative	4.1.2.3
5.5.3 Internal Communications	-
5.6 Management Review	4.1.3
5.6.1 General	4.1.3
5.6.2 Review Input	4.1.3
5.6.3 Review Output	4.1.3
6. Resource Management	-
6.1 Provision of Resources	4.1.2.2
6.2 Human Resources	-
6.2.1 Assignment of Personnel	4.1.2.2, 4.2.3, 4.18
6.2.2 Competence, Awareness, and Training	4.18
6.3 Infrastructure	4.1.2.2, 4.9
6.4 Work Environment	4.9
7. Product Realization	-
7.1 Planning of Product Realization	4.2.3, 4.9, 4.10.1
7.2 Customer-Related Processes	-
7.2.1 Determination of Product Requirements	4.3.2, 4.4.4
7.2.2 Review of Product Requirements	4.3
7.2.3 Customer Communication	4.3.2
7.3 Design and Development	-
7.3.1 Design and Development Planning	4.4.2, 4.4.3, 4.4.6, 4.4.7, 4.4.8
7.3.2 Design and Development Inputs	4.4.4
7.3.3 Design and Development Outputs	4.4.5
7.3.4 Design and Development Review	4.4.6
7.3.5 Design and Development Verification	4.4.7
7.3.6 Design and Development Validation	4.4.8
7.3.7 Design and Development Changes	4.4.9
7.4 Purchasing	-
7.4.1 Purchasing Process	4.6.1, 4.6.2
7.4.2 Purchasing Information	4.6.3
7.4.3 Verification of Purchased Products	4.6.4, 4.10.2
7.5 Production and Service Operation	-
7.5.1 Production and Service Operation Control	4.9, 4.10.3, 4.15.6, 4.19
7.5.2 Validation of Special Processes	4.9
7.5.3 Identification and Traceability	4.8, 4.10.5, 4.12
7.5.4 Customer Property	4.7
7.5.5 Preservation of Product	4.15
7.6 Control of Monitoring and Measuring Devices	4.11
8. Measurement, Analysis, and Improvement	-
8.1 General	4.10, 4.20.1
8.2 Monitoring and Measurement	-
8.2.1 Customer Satisfaction	-
8.2.2 Internal Audit	4.17
8.2.3 Monitoring and Measurement of Processes	4.9, 4.20.1
8.2.4 Monitoring and Measurement of Product	4.10, 4.20
8.3 Control of Nonconforming Product	4.13
8.4 Analysis of Data	4.14, 4.20
8.5 Improvement	-
8.5.1 Continual Improvement	4.1.3
8.5.2 Corrective Action	4.14.1, 4.14.2
8.5.3 Preventive Action	4.14.1, 4.14.3

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ISO 9001:1994 to ISO 9001:2000 Mapping

ISO 9001:1994	ISO 9001:2000
1. Scope	1
2. Normative Reference	2
3. Definitions	3
4.1 Management Responsibility 4.1.1 Quality Policy 4.1.2 Organization 4.1.2.1 Responsibility and Authority 4.1.2.2 Resources 4.1.2.3 Management Representative 4.1.3 Management Review	- 5.1, 5.3, 5.4.1 - 5.5.2, 6.2.1 5.1, 6.1,6.2.1, 6.3 5.5.3 5.6, 8.5.1
4.2 Quality System 4.2.1 General 4.2.2 Quality System Procedures 4.2.3 Quality Planning	- 4.1, 4.2.2, 5.1, 5.4.1 4.2, 5.4.2, 6.2.1, 7.1
4.3 Contract Review	5.2, 7.2
4.4 Design Control	7.2.1, 7.3
4.5 Document and Data Control	4.2.3
4.6 Purchasing	7.4
4.7 Control of Customer-Supplied Product	7.5.3
4.8 Product Identification and Traceability	7.5.2
4.9 Process Control	6.3, 6.4, 7.1, 7.5.1, 7.5.5, 8.2.3
4.10 Inspection and Testing	7.1, 7.4.3, 7.5.1, 7.5.2, 8.1, 8.2.4
4.11 Inspection, Measuring, and Test Equipment	7.6
4.12 Inspection and Test Status	7.5.2
4.13 Control of Nonconforming Product	8.3
4.14 Corrective and Preventive Action	8.4, 8.5.2, 8.5.3
4.15 Handling, Storage, Packaging, Preservation, and Delivery	7.1, 7.5.4
4.16 Control of Quality Records	4.2.4
4.17 Internal Quality Audits	8.8.2
4.18 Training	6.2.1, 6.2.2
4.19 Servicing	7.1, 7.5.1
4.20 Statistical Techniques	8.1, 8.2.3, 8.2.4, 8.4

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ISO 9001/2/3 Registrations in USA Continue to Grow

Mid-2000 registrations to ISO 9001/2/3 are up 19% in the USA the past year to a total of more than 32,000 certificates. Registrations to QS-9000 (automotive sector) are up 15% in the USA to more than 5000 certificates, while AS9000 registrations (aerospace sector) are up almost 50% to nearly 200 certificates.

The worldwide total of ISO 9001/2/3 certificates issued last year was 343,643. This was a 26.4% increase over the previous year.

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ISO TC 176 COMMUNIQUE Kyoto, Japan - INTRODUCTION

The 18th meeting of ISO/TC 176 was held at the Kyoto
International Conference Hall (KICH) Kyoto, Japan with working
sessions running from June 29th to July 9th, 2000. The work
done over the period mobilized the expertise of over 300
delegates from 46 countries. The opening plenaries of the
Technical Committee (TC) and Subcommittees (SCs) were preceded
by meetings of the TC and SC Officers, the ISO/TC 176
Chairman's Strategic Advisory Group, the ISO/TC 176 Project
Management Group and the Delegation Leaders of ISO/TC 176.
These first meetings positioned the issues that would be
discussed throughout the week.

The following initiatives were emphasized:

(1) progression of the ISO 9000, 9001, 9004 standards to FDIS
stage and circulation of ISO 10012 as a Committee Draft 3 for
comment and approval as a DIS;

(2) approval of a new strategic planning process and initial
thinking related to the key issues facing the committee and
the strategic intents to address them;

(3) finalization of the proposed ISO 9000 Sector Policy and
formation of a liaison forum for sectors interested in
particular applications of ISO 9001 and/or 9004;

(4) progression of product support activities for the Year
2000 family, including the approval of an international
interpretations process;

(5) finalization of the text of the quality management
principles brochure;

(6) progression on the Spanish translations of ISO 9000
documents;

(7) progression of cooperative approaches with other ISO
technical and policy committees and IAF.

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ISO TC 176 COMMUNIQUE - DOCUMENT PROGRESS - Subcommittee 1: ISO 9000

ISO/TC176/SC1 held its opening plenary session on July 3rd ,
2000, and closing session on July 7th, 2000. The meetings were
attended by 46 experts representing 20 countries, some of whom
were actively involved with SC2/WG 18 as liaisons both before
and after the main SC 1 meetings. WG1 addressed 1100
individual comments against ISO/DIS 9000, supported by WG2 and
WG3. Through the hard work of the experts and liaison
representatives, the document was moved forward to FDIS with
resolution of the most contentious areas of comment. The FDIS
document will now be circulated for ballot, consistent with
the time frames for ISO/FDIS 9001 and 9004.

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ISO TC 176 COMMUNIQUE - DOCUMENT PROGRESS - Subcommittee 2 - ISO 9001 and ISO 9004

ISO/TC 176/SC 2 opening and closing meetings were also July
3rd and 7th respectively, however many of the SC2/WG 18 task
groups met from June 29th until July 9th. The meetings were
attended by experts from 42 Member bodies and 11 Liaison
members. During the almost two weeks of meetings, 3300
individual comments submitted against ISO/DIS 9001:2000 and
ISO/DIS 9004:2000 were reviewed and dispositioned. Progress on
the revisions was assisted by the use of innovative approaches
to building consensus including the formation of a Consensus
Facilitation Group and the holding of an open forum for
discussion of key issues. Also key to the review were the over
240 validation responses received from organizations in 23
countries.

By resolution, SC2 elevated the revised DIS drafts to Final
Draft International Standard (FDIS) status. The FDISs are
anticipated to be circulated for ballot, after translation, in
early September, 2000. The FDIS ballot is expected to close in
November, 2000.

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ISO TC 176 COMMUNIQUE - DOCUMENT PROGRESS - Subcommittee 3 - ISO 19011

SC3/WG1 on Quality Assurance for Measuring Equipment produced
a committee draft 3 (CD 3) of ISO 10012. This document will
now be sent out for comment and ballot as a DIS. Publication
of ISO 10012 is scheduled for early 2002. SC 3 representatives
were also actively involved in SC2/WG 18/TG 1.10 in order to
ensure that ISO 19011, the joint environmental and quality
auditing standard, currently at CD 2, is adequately covered in
the committee's product support efforts.

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ISO TC 176 COMMUNIQUE - DOCUMENT PROGRESS - Project Management Group (PMG)

Several documents managed by the PMG have advanced through
work completed in Kyoto.

(a) Quality Management Principles Brochure

The final text of the Quality Management Principles brochure
was developed and will be now be published in conjunction with
ISO Central Secretariat.

(b) Selection and Use brochure

Due to the need to base the brochure's contents on the FDIS
text of the core standards, the project team did not
officially meet in Kyoto. However, the project leader met with
SC2/WG 18/TG 1.10 in order to coordinate the brochure's
development with the rest of the product support material
being developed.

(c) Spanish Translations

The Spanish Translation Task Group (STTG) progressed its
development of an international Spanish language version of
the ISO 9000 family and it was resolved that ISO/TC 176 ask
ISO TMB to consider the documents produced as the official ISO
Spanish versions.

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ISO TC 176 COMMUNIQUE - PRODUCT SUPPORT

Work continued on activities targeted at meeting the needs of
users as they begin to work with the new standards. Taking a
holistic approach to product support, the committee is
developing coordinated communications and marketing materials
that will eventually extend from the 'core' (ISO 9000, 9001,
9004 and 19011) to the 'family' of ISO 9000 standards. For
example, a Product Introduction Package (PIP) is now under
development that will be composed of a number of guidance
modules on the 'Process Approach', 'Documentation',
'Terminology', 'Self-Assessment' and 'the Application of 9001
(previously the 'permissible exclusions'). It is hoped that
this material in combination with other product introduction
and transition guidance will provide answers to the most
commonly asked questions related to the new editions.

Recognizing that some users will require a more formal
response from the committee, an international interpretations
process has now been approved by the TC membership. Following
review by the ISO/TMB, the process will move to implementation
in conjunction with the broader product support activities.

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ISO TC 176 COMMUNIQUE - STRATEGIC PLANNING

The Chairman's Strategic Advisory Group (CSAG), held the
second in a series of meetings designed to develop a new
strategic plan for ISO/TC 176 activities. Building on a CSAG
workshop held in March, a Strategic Planning Task Group
(SPTG), composed of delegates nominated by member bodies,
furthered the initial work. The overall development process
leading to ratification of the plan at the next committee
plenary (Birmingham, UK, September 2001) was approved by the
committee.

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ISO TC 176 COMMUNIQUE - SECTOR ISSUES

Comments that had been submitted against the proposed sector
policy (previously approved as document N299R2) were
dispositioned in Kyoto. The committee resolved to send the
approved sector policy to the ISO/TMB for inclusion in the ISO
Directives, noting that the policy is intended to apply to all
ISO documents, including the new category of Industry
Technical Agreements (ITA).

The committee also created a forum for liaisons with existing
or planned applications of ISO 9001 and/or ISO 9004. This new
group will report to the CSAG and will examine opportunities
to promote the harmonization and alignment of sector needs and
the convergence of sector solutions, in accordance with the
approved sector policy.

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ISO TC 176 COMMUNIQUE - COOPERATION WITH OTHER BODIES

The Committee passed a number of resolutions relating to its
interaction with other bodies that are increasingly important
to the work program of the committee, ISO and users in
general. In particular, ISO/TC 207, ISO/CASCO, ISO/DEVCO and
ISO/COPOLCO, were invited to participate in the strategic
planning activities of TC 176. In addition, particular
emphasis was placed on the need to develop closer links with
DEVCO in order to ensure effective participation of developing
countries in the work of TC 176.

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ISO TC 176 COMMUNIQUE - CONFORMITY ASSESSMENT

Further action was taken in Kyoto on the framework of
cooperation with ISO/CASCO. This framework currently addresses
strategic, operational and national activities and the intent
is that it be submitted for joint approval by the members of
both committees.

Recognizing the need for more consistent messages on issues of
conformity assessment outside of ISO, a framework of
cooperation will now also be pursued with IAF. In addition,
building on the success of previous joint communications
between ISO/TC 176, ISO/CASCO, and IAF, the committee resolved
to formalize a standing working group to meet on issues of
joint concern.

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ISO TC 176 COMMUNIQUE - IN CLOSING

The members of ISO/TC 176, Subcommittees 1, 2, 3 and all of
the Working Groups, Task Groups and Project Groups assembled
at the 18th meeting in Kyoto, Japan, express their sincere
gratitude to the host, JISC, and the organizer, JSA, for the
outstanding efforts of the organizing committee and staff. The
committee also thanks the City of Kyoto and all the sponsors
for providing the environment and resources which greatly
facilitated the significant progress made.

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ISO 9000:2000 Process Measurement/Improvement

Figure 1 of ISO 9001:2000 (the "Process-Based Quality Management
System") depicts how the new standard focuses on both "compliance" and
"improvement". The following narrative explains:

Assuming that what you "Say You Do" (Document) meets the intent of the standards, both
the 1994 and 2000 versions require you to "Do What you Say" (Implement) and
"Prove It" (Comply).

The biggest change for 2000 is that you also must "Improve It" (Perform).

In order to improve you must have "baseline" performance measures to gage improvement
against. So how do you get started?

Develop at least one key performance measure for each QMS process (or element)
Gather baseline performance data
Set goals or objectives for improvement based on baseline performance data
Identify processes most in need of improvement
Develop/implement actions based on greatest need
Measure results to see if actions taken achieved the desired results.

So what should you measure? There are at least two key measures be established
for each QMS process or element:

Effectiveness (or ineffectiveness) Measure - i.e. something that measures whether (or not)
you achieved the overall objective or desired outcome of a particular process; and

Efficiency (or inefficiency) Measure - i.e. something that measures how well (or poorly)
resources were utilized to achieve the results measured in 1).

For example:

Clause 6.2.2: Training Processes: Key measures of effectiveness: %
employees fully trained and qualified and/or % corrective actions resulting
from a lack of training. Key measures of efficiency: % of training
completed rated by attendees as marginally satisfactory or worse.

Clause 7.2: Customer Related Processes. Key measures of effectiveness: %
customer satisfaction and/or the # of customer complaints. Key measures of
efficiency: resources dedicated to customer-related processes and/or
resources devoted to investigating/resolving customer complaints.

Clause 7.3: Design Control Processes. Key measure(s) of effectiveness:
Product/Service Performance Measures. Key measures of efficiency:
resources devoted to design function and/or resources devoted to design
changes resulting from product failures reported from the field.

Clause 7.4: Purchasing Control Processes: Key measures of effectiveness:
Supplier performance measures and/or the # corrective actions resulting from
incorrect, misidentified or poor quality purchased material. Key measures of
efficiency: resources involved in processing returns and/or supplier
corrective actions.

Clause 7.5: Operations Control Processes: Key measures of effectiveness:
Product / Service Quality Measures. Key measures of efficiency: defect
rate, % scrap, rework, equipment downtime; inventory accuracy, % operations
where work instructions or automated process controls are in place.

In any case, the measures chosen should be easy to come up with and track. Like most
of what ISO has always required - it's not rocket science - just good, down
to earth common sense stuff.

Best of luck in the "Move from Conformance to Performance"

Your Quality Partners at ISO-Online

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