TC 176/SC 2 Communique


Fully vaccinated are you?
From: ISO Standards Discussion
Date: Wed, 19 Jul 2000 10:55:57 -0500
Subject: FYI: TC 176/SC 2 Communique (long message)

From: Dennis Arter

The following Communiqué was just issued by the ISO Technical Committee 176, Subcommittee 2. While it contains quite a bit of jargon, I hope you achieve an understanding of the efforts put forth in Japan to elevate the 9000, 9001, and 9004 to Final Draft Internal Standards (FDIS).

+++++++++++++++++++++++++++++++++ Document: ISO/TC 176/SC 2/N 521 Secretariat of ISO/TC 176/SC 2 Date: 14 July 2000

To the Members of ISO/TC 176/SC 2 - Quality Management and Quality Assurance/Quality Systems

Communiqué on the 23rd meeting of ISO/TC 176/SC 2 3 - 7 July 2000, Kyoto, Japan

1. Opening

The first item of business to be formally addressed by ISO/TC 176/SC 2 was the appointment of a Chairman. There was unanimous support among the members for Dr John Davies to continue in post, for a further 3 year term of office. This was later confirmed by the plenary meeting of ISO/TC 176.

2. DIS voting results and comments

Dr. Davies noted the "approval" voting results received against the DIS stage drafts of both ISO 9001:2000 and ISO 9004:2000, and stated he was pleased to note the response to these ballots from ISO member bodies, including from 8 member bodies that are not members of SC 2. He looked forward to moving forward to the FDIS stage at the end of the meeting.

Some 3300 individual comments were received against ISO/DIS 9001:2000 and ISO/DIS 9004:2000.

3. Verification and Validation

Additional input against the DISs was received from verification reports that had been produced by WG18 Task Group 1.8.1, and the validation programme that was conducted by WG 18 Task Group 1.8.2 with the assistance of the member bodies. 240 validation responses had been received from 23 countries.

The WG 18 validation programmes have been an outstanding success in providing valuable information to WG 18, from a differing perspective than the member body comments on the drafts.

SC2 would again offer its thanks to the member bodies and individual organizations who have participated in the validation programme, and in the preparation of comments on the DISs.

4. Review of Comments and Consensus Building

ISO/TC 176/SC 2/WG 18 conducted a full review of all the comments prior to developing the FDISs. This involved much analysis and preparation work by the members of WG 18 in advance of the Kyoto meetings, as well as an extended (9 day) meeting at Kyoto itself.

SC 2 and WG 18 had carefully planned a detailed consensus building process for the Kyoto meeting. This involved:

-- the establishment of a Consensus Facilitation Group, to clarify the specific concerns of national delegations and to facilitate the communication of those concerns for consideration by relevant task groups

-- the circulation of Interim-FDISs of 9001/ 9004 and a Partial-Interim-FDIS of ISO 9000:2000 (from ISO/TC 176/SC 1)

-- the cessation of WG 18 activities for a day, after the circulation of the Interim-FDISs of 9001/9004 and prior to the SC 2 Open Forum, to allow member body delegations an opportunity to review the Interim-FDISs

-- the preparation of a consolidated set of member body issues raised against the Interim-FDISs

-- the holding of an SC 2 Open Forum meeting mid-way through the period of the meetings, to obtain further member body input and comment on the Interim-FDISs, focusing on the consolidated set of member body issues

-- further WG 18 task group meetings to take account of the issues raised in the Open Forum

-- reports to the closing meetings of WG 18 and SC 2 to advise on changes to the Interim-FDISs since the Open Forum, including distribution of document N514R which contains all technical changes to the Interim-FDISs of 9001/9004 in response to member body issues

-- formal resolutions in the closing SC2 plenary meeting, to confirm the decision to move the drafts to the FDIS stage

SC 2 is pleased to note that these activities were well received by the members of SC 2, and that the FDIS objective was fully achieved.

Also, a number of member bodies that had submitted negative votes on the DISs indicated that these processes had enabled them to change their positions into positive support for going forward to the FDIS stage.

5. Liaison Assistance

WG 18 received good assistance from the liaisons to its work. Especially, the representatives of ISO/TC 176/SC 1, ISO/TC 176/SC 3 and ISO/TC 210 who had made key contributions. Similarly, it noted the assistance of representatives from liaison bodies and specific industry sectors, in bringing their particular perspectives forward for consideration.

6. Transition Planning, Product Introduction Package & Product Support

WG 18 Task Groups 1.9 and 1.10 reviewed the comments that had been received against the draft Transition Planning Guidance and draft Product Introduction Planning Guidance documents, before developing revised versions.

These will now be taken forward as part of the overall Product Support initiatives from SC2/WG 18. In particular, the Product Introduction Planning Guidance will now be expanded into a Product Introduction Package by the addition of a number of guidance modules on the 'Process Approach', 'Documentation', 'Terminology', 'Self-Assessment' and 'the Application of 9001 (had been permissible exclusions).

SC2 was pleased to note the recognition given to its work by the joint ISO/TC 176-ISO/CASCO-IAF group, by the adoption of elements of the Transition Planning Guidance in their joint communiqué of September 1999.

SC2 was also pleased to note the active participation of ISO/TC 176/SC 1, ISO/TC 176/SC 3 and TC 176/PMG 'Interpretations' team in the development of the Product Introduction Package and Product Support activities

SC2 considers that such co-operation will enable it to fulfill a request from ISO/TC 176/PMG to enhance the promotion of the whole family of ISO 9000 standards, particularly the standards that will form the core of the future ISO 9000 family.

WG 18/TG 1.10 progressed its planning for Product Support activities after the publication of the revised standards, including assisting member bodies in their individual ISO 9000:2000 'Launch'' activities. . In response to a direct request from TC 176/PMG, TG 1.10 expanded its Product Support activities to include the entire ISO 9000 Family.

These groups have been absolutely groundbreaking from ISO's more traditional perspective, and we would like to recognize their creativity in uncharted waters. We would also like to thank ISO Central Secretariat, through Roger Frost (Editor ISO 9000 & ISO 14000 News), for the very positive encouragement and support they have given us.

7. Editing Process

Significant effort was made after the San Francisco meeting to improve the process for editing the draft standards. Specifically, Pauline Jones, the ISO Central Secretariat editor for ISO/TC 176, participated actively in Kyoto in the editing of the FDISs of 9000, 9001 and 9004. Pauline's participation greatly improved the readability and consistency of the drafts and greatly accelerated the editing process, keeping us on target to achieve our year 2000 publication target. We would like to thank Pauline for her teamwork and valuable contributions to the development of these FDISs.

8. Resolutions

ISO/TC 176/SC 2 adopted 9 resolutions. These included items concerning:

- A request to ISO/TC 176 to re-confirm Dr. Davies as Chairman

- The confirmation of existing liaison arrangements

- The adoption of the WG 18 "Production Introduction Package" and related guidance modules as a formal ISO/TC 176/SC 2 document

- A proposal to encourage the ISO/TC 176 - ISO/CASCO - IAF group (and other organizations), to participate in the development of the Product Introduction Package, and to align their own documentation with it. Also to confirm SC2's commitment to co-operating proactively on this matter, particularly by the nomination of representatives to the ISO/TC 176 - ISO/CASCO - IAF group.

- A resolution to thank and respond to the ISO/TMB/SIG for its comments on the DISs (via its resolution no. 7 from its 1 April 2000 meeting).

- Agreement to proactively liaise with ISO/IEC JTC1 SC 7 and to participate in the planned revision work for ISO 9000-3.

- An expression to ISO/TMB of the concern that the draft ISO Guide 72 does not sufficiently address the "process approach" and the "process model" used in the future ISO 9001:2000 and ISO 9004:2000. Additionally, a request that the ISO/TMB/Ad Hoc Group should be invited to revise the draft Guide to more explicitly address these issues.

- The advancement of ISO/DIS 9001:2000 and ISO/DIS 9004:2000 to the FDIS stage.

9. In closing

With the promotion of the 9001 and 9004 drafts to the FDIS stage, SC2 has reached a significant milestone in its work. This has largely been due to the tremendous efforts of the member bodies, the members of WG 18, the Task Group Leaders, the Planning and Operations Task Group (POTG) members, and especially the WG 18 Project Leader, Dr. Jeff Hooper. Some members even expressed the view that it would not have been possible for SC2 to have reached its current position on the drafts without his individual vision and leadership. We are indebted to him, and the others for our success.

SC2 would also like to thank JISC, JSA and the sponsors for their magnificent support and assistance during the course of the meeting. Long days and late nights have been imposed on them, as well as months of pre-planning work. Their efforts were crucial to the success of the meeting.

Finally, SC2 looks forward to meeting with its experts again in 2001, when it will consider the results of the ongoing review of SC 2 standards and documents in the ISO 9000 family, and progress in the WG 18 Product Support activities.


Dennis Arter, US Standards Group on QEDS

David Mullins

I'm trying to get some info from ISO.

Apparently the ballot on FDIS doesn't close until mid-November.

ISO are a bit light on in the communication department!


David Mullins

Th latest from ISO - verbatim:

The press release posted at the following address gives as much detail as
I know. If we can't publish the standard by Christmas, we'll postpone

That particular press relaease has been around since 14Sept. and states the Ballot closes on 14 November, with publication in December.

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