ISO9001:2000 - The Update II

Marc

Fully vaccinated are you?
Leader
From: JWest
Subject: Re: REQ: Proposed ISO 9001/Cox/Andrews/Oliveira/West

The following is the official communique from the ISO TC 176 SC 2 meeting held in Stockholm. It discusses the comments on Working Draft 3 and development of the first Committee Draft to be provided to the Participating Member Countries in Late July.

Jack West Chair, US TAG to ISO TC 176
---------------------------------------------
Communiqué from the 21st meeting of ISO/TC 176/SC 2 concerning the development of the Future editions of ISO 9001 and ISO 9004

During 29 June - 3 July 1998 ISO/TC 176/SC 2, its Working Group no. 18 (WG 18) and a number of subsidiary Task Groups met at the Royal Institute of Technology, in Stockholm, Sweden, to further the development of the next editions of the ISO 9001 and ISO 9004 standards. The meeting was well attended, with 96 experts being present, representing some 33 countries and 14 international liaison organizations.

The meeting focused on the following issues:

i) Comments against the third 'Working Drafts' of the standards
ii) The decisions of the June 1998 meeting of the ISO Technical Management Board (ISO/TMB)
iii) Co-ordination of the work of ISO/TC 176/SC 2 with that of ISO/TC 207/SC 1 Environmental Management Systems
iv) Co-ordination of the work of ISO/TC 176/SC 2 with that of ISO/TC 176/SC 1 Concepts and Terminology
v) Validation of the work
vi) The production of 'Committee Drafts'
vii) Improving communications viii) Scheduling of future work

1. Third Working Drafts

The April 1998 meeting of WG 18 resulted in the production of the third 'Working Drafts' of the future standards. These were circulated for comment to the experts who participate in the activities of WG 18.

Some 2,600 individual comments were returned against the drafts in advance of the meeting, with several hundred additional comments being delivered to the meeting. Nearly all the comments were submitted using a wordprocessor table template that had been agreed before the drafts were circulated. This allowed for rapid compilation and collation of the comments.

WG 18/Task Group 1.8.1 'Verification' met for several days in advance of the main meeting, to undertake a detailed evaluation of the comments submitted. The reports that TG 1.8.1 produced on the comments greatly assisted the drafting task groups in their work, enabling more rapid progress to be made. This also ensured that nearly all comments submitted were given due consideration.

The majority of comments indicated positive support for the structure and content of the drafts.

A number of comments sought clarity on the issue of how 'tailoring' of the future ISO 9001 standard will be conducted. This was in response to the planned withdrawal of the ISO 9002:1994 and ISO 9003:1994 standards, when the revised ISO 9001 and ISO 9004 standards are published.

Additionally, a number of comments requested improved harmonization between the terminology employed in the draft ISO 9001 and ISO 9004 standards and that defined in the draft of ISO/WD 2 9000:2000 Concepts and terminology.

2. ISO/TMB, ISO/TC 207/SC 1 and the Joint Task Group

All ISO Technical Committees are responsible to the ISO/TMB and are required to take due notice of its rulings.

At it meeting of 2-3 June 1998, the ISO/TMB passed a number of resolutions requiring ISO/TC 207 Environmental Management and ISO/TC 176 Quality Management and Quality Assurance to improve the co-ordination of their work efforts. This was in response to received views from industry, which has requested improved compatibility between the ISO 9000 and ISO 14000 environmental management systems standards.

During its meeting of 14 -21 June 1998, ISO/TC 207/SC 1 committed itself to undertaking a review of the ISO 14001 and ISO 14004 standards, in response to the ISO/TMB resolutions. This review will place emphasis on obtaining information regarding compatibility with the ISO 9000 standards, and is due to be completed in June 1999.

ISO/TC 207/SC 1 also re-confirmed its support for the activities of the Joint Task Group on Co-ordination (JTG) with ISO/TC 176/SC 2, and prepared a paper giving comments against the third working drafts of the ISO 9001 and ISO 9004 standards.

Subsequently, a meeting of the JTG was called for 26 - 27 June 1998 to discuss the comments prepared by ISO/TC 207/SC 1, and to examine further compatibility issues. A number of recommendations were made, which will be included in a report on the meeting.

Both the ISO/TC 207/SC 1 comments and an early release of the JTG recommendations were taken forward for WG 18 to consider.

ISO/TC 176/SC 2 is pleased to recognize the dedication of the ISO/TC 207/SC 1 members to the JTG, who willing gave their time to attend the meeting, at short notice, and almost immediately after their own plenary sessions.

3. ISO/TC 176/SC 1

Noting the comments that had been received on the need to harmonize the terms and definitions being used in the 9001 and 9004 drafts with those in the draft of ISO 9000 Concepts and terminology, ISO/TC 176/SC 2 and ISO/TC 176/SC 1 agreed to establish a liaison task team to address this issue.

Four experts from ISO/TC 176/SC 1, supported by the Secretary to ISO/TC 176/SC 1, attended the meetings of the task team during 30 June - 3 July 1998.

This work produced significant results and led to greatly improved understanding on the approaches the two sub-committees are taking towards the development and use of terminology within their respective standards.

ISO/TC 176/SC 2 is pleased to recognize the efforts of all the task teams members, especially those from ISO/TC 176/SC 1. The excellent team-working between all members has enhanced the potential for ISO/TC 176 to meet the needs of its customers, by the production of a coherent future family of ISO 9000 standards.

4. Validation of the drafts

The validation programme for the drafts of the standards has now commenced. A questionnaire inviting individual organizations to participate in the validation programme has been distributed to member bodies. To date, over 100 organizations have replied.

5. Committee Drafts

Even with the high levels of comment against the third working drafts, and the issues they raised, WG 18 was successful in producing 'Committee drafts' (CDs) of the future ISO 9001 and ISO 9004 standards as its main output of the meeting. These will be sent out to member bodies at the end of July 1998 for a four month review period, ending in November 1998. This review will be for comments only, not for a ballot.

(CDs are issued when it is considered that draft standards have reached a point of sufficient maturity to be circulated for review by the members of the full parent committee (or sub-committee) of a working group, instead of being restricted to review by the working group experts.)

This issue of 'tailoring' was reviewed in detail, and revised clauses on this matter will be given in the CDs.

The piloting of the use of a wordprocessor table template for the return of comments against the third working drafts has been reviewed and agreed to have been successful. It is intended that a similar template will be made available to members for the submission of comments against the CDs.

6. Improving communications

Noting the high levels of interest in the revisions to the ISO 9000 standards and the need to convey accurate information to prevent distortion in the market, WG 18 had already established a number of task groups to develop new product introduction programmes and supporting documentation.

ISO/TC 176/SC 2 has now decided to take this issue a stage further, and has established an open access internet web site to ensure delivery of such new product information in a timely manner. This may be found at the following address:

www.bsi.org.uk/iso-tc176-sc2

In order to assist member bodies in the compilation of their own comments against the CDs, a wordprocessor table template for the submission of comments will be posted to this web site.

7. Scheduling of future work

The results of a recent ballot by ISO/TC 176 indicated that ISO/TC 176/SC 2 should maintain an intensive schedule to develop the committee drafts (CDs) of the future ISO 9001 and ISO 9004 standards. Additionally, the ballot confirmed that the members of ISO/TC 176 wanted an extended consultation period for the CDs. This would allow greater opportunity to translate the CDs into other languages, prior to obtaining comment against them.

The resolutions of the June 1998 ISO/TMB meeting requested ISO/TC 176 and ISO/TC 207 to seek greater synchronization of their schedules (and of their sub-committees). It was considered that this would enhance opportunities for co-ordination efforts, to improve the compatibility of the ISO 9000 and ISO 14000 standards.

Noting these requirements, and comment by ISO/TC 207/SC 1, WG 18 proposed to ISO/TC 176/SC 2 that it should follow a revised schedule to include:

- Circulation of first CDs of the future ISO 9001 and ISO 9004 standards in July 1998, for a four month review period, purely for comment, followed by - Circulation of revised (second) CDs for a five month review period, to be concluded by a formal ballot.

WG 18 also noted that if the results of the ISO/TC 207/SC 1 review of the ISO 14001 and ISO 14004 standards suggested that amendments to those standards should be produced to improve compatibility with the ISO 9001 and ISO 9004 standards, then the revised schedule would offer a good opportunity for concurrent balloting of such amendments when the development of the future ISO 9001 and ISO 9004 standards reaches the Draft International Standards stage.

ISO/TC 176/SC 2 was pleased to be able to endorse this proposal.

ISO/TC 176/SC 2 would like to thank the Secretary to the ISO/TMB and the Secretary to ISO/TC 176/SC 1 for their valuable input into the development of the revised schedule.

It is now planned that all WG18 task groups will meet in January 1999, at which time the comments received against the first CDs will be reviewed and the second CDs prepared for ballot. A new task group on 'new product support' will also be established. In the meantime, the task groups involved in 'new product introduction' intend holding an interim meeting to continue their work.

ISO/TC 176/SC 2 will next meet in September 1999, when the ballot of the second CDs has been concluded and the ballot results are known.

In concluding this communiqué, the experts who attended the meeting in Stockholm wish to express their deepest gratitude to their hosts, the Swedish Standards Institute (SIS) and Standardiseringsgruppen (STG), who provided excellent facilities and support for the meeting. Additionally, they would wish to thank the sponsors to the meeting for supporting their work, and to thank Stockholm City Council for a wonderful reception at the City Hall.
 

Marc

Fully vaccinated are you?
Leader
The ISO Draft proposal is in the Free Files directory.

There is an introduction (wd9001a.doc - I also saved as a pdf file named wd9001a.pdf)

Then there is the body of the DRAFT (wd9001b.doc - I also saved as a pdf file named wd9001b.pdf)

Enjoy!
--------------------
As of 10/2000 these are no longer posted.

[This message has been edited by Marc Smith (edited 12 October 2000).]
 

Marc

Fully vaccinated are you?
Leader
Another FYI:

From: Jorge Cuadros - cosapidata.com.pe
Subject: Re: Q: ISO in the Year 2000/King/Cuadros

Dear Graham and other members:
I hope this article wil be useful for you.
Regards Jorge
Quality assurance Manager
Industrial Brawns S.A. Lima-Peru +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

TC 176 surveys ISO 9000 user requirements for Year 2000 revisions In brief

The following article, which appears in the September/October 1998 edition of ISO 9000 News, presents the main findings of an ISO 9000 user survey carried out by the ISO Technical Committee responsible for the standards. Subcommittee 2 of ISO/TC 176 sought and received user input from around the world to help it identify market requirements of ISO 9000 as the core series is revised for publication in the Year 2000.

The current three "certification" standards – ISO 9001, ISO 9002 and ISO 9003 – and the quality management guidelines, ISO 9004-1 are to be replaced by a single quality assurance model and a quality management standard, designated, respectively, ISO 9001 and ISO 9004.

Among other questions, users were asked to give their priorities for improving on the current standards and incorporation in the revisions. The "top seven" improvements called for covered: simpler language and terminolgy, easier integration into one management system, continuous improvement, a process model approach, better compatibility with other management system standards, customer satisfaction and business orientation.

The author, Dr. Matt Seaver1), is a member of the Working Group responsible for the ISO 9000 user survey. A biochemist, he is a quality consultant working, in particular, for clients in the food industry. He is Director of International Safety Management Organisation Ltd, which specializes in the integration of quality management with occupational health and safety management systems. He is a member of ISO/TC 176/SC 2 Working Groups since 1992. 1) Matt Seaver, International Safety Management Organisation, Ltd., Corramacorra, Murrintown, Co. Wexford, Ireland.Tel. + 353 53 395 39. Fax + 353 53 396 19. Email: [email protected]

Planning for the current revision of the ISO 9000 core series started about three years ago. The body charged with the task of producing and updating quality standards, ISO Technical Committee 176, realized that such a major project would require a very disciplined approach if resources were to be used efficiently and the standards produced in the desired time frame.

It was decided to replace the three current quality assurance models – ISO 9001, ISO 9002 and ISO 9003 – and the current quality management guideline standard ISO 9004-1, with a "consistent pair" of standards: one dealing with quality assurance (requirements) and one with the broader topic of quality management.

Subcommittee 2 of the Technical Committee was restructured for this purpose. Working Groups 10, 11, 12, and 15 were replaced by a single Working Group (WG 18), set up under the direction of a project manager, Dr Jeff Hooper. The members of the old Working Groups were assigned to various Task Groups within the new WG 18. Each Task Group was given a very specific job to perform, and Task Groups would be dissolved, as necessary, once their task had been completed.

Unlike the 1994 revision, which was limited in scope, the Year 2000 revision is to be a major overhaul of the ISO 9000 core series. Since these are probably the best known and most used of all ISO standards, it is essential to have accurate input from users concerning their requirements for the revised standards.

ISO 9000 News readers may be aware that before starting the actual revision process, SC 2 produced a "product brief" for the proposed revised standards. The brief laid out requirements in very general terms, adequate as an initial specification for determining the overall approach and content of the standards. However, for the drafting process itself, a more detailed definition of requirements was needed. The job of determining the detailed requirements was assigned to Task Group (TG 1.2.2) – see box for membership details.

Task Group (TG 1.2.2) membership:

Denis Bolton, United Kingdom; JØrgen Clausen, Denmark; Osama El Meligey, Egypt; Peter Hofmann, Germany; Peter Kunc, Slovenia; Hector Rodriguez Becerra, Mexico; Matt Seaver, Ireland; Isabel Vidal i Planells, Spain;Yossi Winograd, USA.

The group initially produced a list of presumed requirements that users might have, based on the personal experience of WG 18 members and known opinions of users that have been expressed in print and elsewhere. That provided a useful starting point for the Working Group. Next, to get an accurate and up-to-date reaction from as wide a user base as possible, the Task Group prepared a detailed questionnaire.

This was designed to find out the views of users of the ISO 9000 standards towards the proposed pair of quality assurance and quality management standards. The list of presumed user needs was used as the basis for the questions. The questionnaire addressed a number of general issues in relation to quality management systems, in addition to the actual text of the standards. The following box shows the main headings of the questionnaire, which was sent to all ISO national member bodies for distribution in their country.

*Contents of the questionnaire

-General guidance on the completion of the questionnaire.
-Respondent profile information.
-Questions related to the overall approach of the proposed new pair of quality assurance and quality management standards.
-Questions related to the interaction of quality management systems and environmental management systems.
-Characteristics of the quality management and quality assurance standards as documents.
-Comments on individual sections of the 1994 versions regarding their importance and the difficulty in interpreting the requirements.
-Feedback on the questionnaire itself.
 

Marc

Fully vaccinated are you?
Leader
Latest Info I can find:

Subject: FYI: Press Release from US Standards Group
Date: Mon, 24 Aug 1998 09:48:09 -0600
From: ISO Standards Discussion

US Prepares for Wide Review of ISO 9000:2000 Committee Draft Review

The International Organization for Standardization (ISO) requires the regular review and update of all ISO standards in order that they reflect current industry practice. In keeping with this requirement, the 1994 edition of the key documents in the ISO 9000 series are undergoing their periodic review and revision.

All ISO standards go through the following phases during their development:

Working Draft (WD)
Committee Draft (CD)
Draft International Standard (DIS)

Drafts at any stage may be circulated multiple times until the required ISO consensus is reached.

The first Committee Drafts of the new standards are available for purchase from ASQ Customer Service. In order to facilitate review and comment by the public of all three drafts, ISO/CD 9000, ISO/CD 9001 and ISO/CD 9004, the documents are being packaged as a single set. The purpose of making these drafts available to the public is to achieve as much feedback as possible from current users and to facilitate their adoption as American National Standards. At least two further drafts are expected prior to publication of the new Standards, and ASQ will keep you up to date as the standards develop and drafts are issued and made available for additional public review. The US public is invited to take the opportunity to comment. Copies of the documents may be obtained from ASQ Customer Service by calling our toll-free number 1-800-248-1946. The item number is T1200, and the cost of the draft is $30. If you are in the US, comments should be sent to the American Society for Quality to the attention of the Standards Coordinator. To be of greatest impact, comments should be provided electronically ([email protected]) using the form available for downloading from the Standards Group Website (*** DEAD LINK REMOVED ***. While electronic means is best, comments may also be sent by fax to: 414-272-1734, or mailed to:

Standards Coordinator, ASQ
P.O. Box 3005
Milwaukee, WI 53201-3005.

Please do not send multiple copies by fax, mail and electronic
means.

Projected timetable for delivery of the revisions to ISO 9000,
9001 and 9004:

1. The Committee Draft for comment to be issued by mid-August
1998
2. The Second Committee Draft to be available in the second
quarter of 1999.
3. The Draft International Standard to be available in the
fourth quarter of 1999.
4. The new Standard is expected to be published late in the
fourth quarter of 2000.

How the Standard is being changed

Over the past few years ISO has received feedback from users of the 9000 series standards. A design brief was developed and research conducted. Feedback was received from 1100 users and more than 80% wanted the new standard to:

Employ a process approach
Be compatible with other management systems
Include continuous improvement
Fit stakeholder needs
Be user and customer friendly

ISO 9002 and ISO 9003 and their corresponding US adoptions will be withdrawn and incorporated into the new ISO 9001, to provide a single requirements standard. There will be four core standards comprising the series:

ISO 9000: Concepts and Terminology
ISO 9001: Requirements for Quality Assurance "To provide
confidence as a result of demonstration in
product/service conformance to established
requirements".
ISO 9004: Guidelines for Quality Management of Organizations
"To achieve benefits for all stakeholders through
sustained customer satisfaction".
ISO 10011: Guidelines for Auditing Quality Management Systems
(not yet available)

In order to ensure that systems created by the new single requirements Standard are flexible enough to meet any organizations individual activities, certain clauses in the revised ISO 9001 may not be applicable to all organizations.

Implementation

It is not intended that the newly structured Standards will require organizations to substantially revise their existing quality systems.

The aim is for the Standards to provide a process-oriented structure, showing four main clause headings of ISO 9001 and ISO 9004:

Management Responsibility
Resource Management
Management of Process
Measurement, Analysis and Improvement

Ongoing participation in the revision process:

The US Technical Advisory Group (TAG) to ISO/TC 176 is the vehicle by which the US contributes to this revision process. This group meets regularly to review the draft documents and consolidate US input and positions on these documents. If you are interested in participating in this process by regularly attending meetings and providing organizational representation from your company or industry association, applications for TAG membership are available from the ASQ Standards Administrator or Coordinator.
 
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