Norma ISO 9001 2015

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Document: ISO/TC 176/SC 2/N 1147

Secretariat of ISO/TC 176/SC 2 Date: 3 June 2013

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

ISO/CD 9001

In accordance with the approved project plan for the revision of ISO 9001 (see SC2/N1089), please find the Committee Draft of ISO 9001 attached. This is being circulated to members for commenting and ballot (a ballot has been established on the ISO Balloting Portal for this). The closing date for the submission of comments and votes is:

10 September 2013

Please use the ISO commenting template for the submission of comments, and include the relevant CD line number against each comment, in the 2nd column. We know from past experience with previous revisions to ISO 9001 that we can expect a large number of comments at the CD stage. We

may therefore have to return any comments that are submitted without reference to line numbers, or if other parts of the template have not been completed correctly, as we might not be able to process them adequately.

During the development of this CD, ISO/TC 176/SC2/WG24 encountered three issues on which it needs specific input from SC2:

 the need to maintain the concept of allowing "exclusions" of specific requirements

 the use of the term "goods and services" instead of the term "product"

 the use of the term "improvement" instead of the term "continual Improvement"

A subsidiary ballot on these issues has been posted on the ISO Balloting Portal, also with a closing date of 10 September 2013. Attachment 1 provides additional information to give the context to these issues:

Please also note that whilst member bodies may choose to comment on any part of the text:

 any comments received on the revised quality management principles given in Annex A to the CD are likely to be rejected, as the QMPs have previously been approved by a separate SC2 and SC1 joint ballot.

 any proposed changes to specific elements of the “Annex SL” identical text should be supported

by very clearly stated justifications, which, if considered by WG24 to be appropriate, will be

referred back to SC2 for decision

We look forward to receiving your votes and comments on the CD. Yours sincerely

Charles Corrie

For the BSI Secretariat of

ISO/TC 176/SC 2

Attachment 1 to SC2/N1147

a) Exclusions

The current "exclusions" clause 1.2 in ISO 9001 was originally introduced following the decision to withdraw the ISO 9002 and ISO 9003 standards in 2000. A means had to be found to enable organizations with quality management systems that did not include all of the requirements of ISO

9001:2000 for technical reasons, but which had previously been able to meet the requirements of ISO

9002 or ISO 9003, to be able to claim conformity to the standard. The resulting solution was clause 1.2.

This Committee Draft has taken a different approach to the way in which its requirements are stated, when compared to the earlier editions of ISO 9001; consequently, there should no longer be any technical reasons for an organization's QMS not to be able to meet all the requirements of the future standard. This makes the need for such an exclusions clause redundant. For the time being, this Committee Draft includes text to permit "exclusions" (see lines 387 to 391), but this can be modified depending on the ballot results.

Please review the CD and decide if these requirements need to be maintained, or if they can now be removed. Note that if the results of the ballot indicate that the exclusions clause should no longer be maintained, then this will also require the Design Specification for this revision of ISO 9001 (see document SC2/N1088) to be amended, as Section 3, bullet e) states "The intent of clause 1.2 of ISO

9001:2008 shall be maintained in the revised standard.". This bullet e) would need to be deleted.

b) Goods and services

ISO 9001 has sought to be generic and applicable to all types of organization producing any type of product. However, feedback received on the current version of the standard has indicated that there is a perception that it continues to be biased towards manufacturing-type organizations with "hardware" products. The feedback has also indicated that the use of the single term "product" to cover services as well as physical products has been a hindrance to service organizations understanding and applying the standard.

In developing the Committee Draft ISO/TC 176/SC2/WG24 has therefore attempted to make it more truly generic, with a particular emphasis for organizations that provide services.

Noting that the ISO/IEC Directives themselves use the term "goods and services", ISO/TC 176/SC2/WG

24 has recommended that this term be adopted in place of the term "product".

The Committee Draft has been prepared using "goods and services".

Please review whether this change is acceptable to you.

c) Improvement

The recent revision of the Quality Management Principles (see SC2/N1145) has led to a change of one of the principles from "continual improvement" to just "improvement". ISO 9001 is being developed to make more explicit use of the quality management principles, so would need to move to just using the term "improvement" to be in alignment

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