Questions and Answers ISO 9001:2015

Wednesday, 12 November 2014
ASR Editor
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Question-and-answerWhen is new standard being released?

ISO 9000:2015 is due to be published with ISO 9001 in September 2015. Currently, member groups are voting on Final Discussion Draft (FDIS) of ISO 9001:2015. Comments or issues that surface as a result of the voting will be discussed and addressed before the new standard can be released. At the moment, it is anticipated the new version of ISO 9001 will be published some time during 2015 most likely in the third or fourth quarter.

Will the final version of the standard be significantly different from the DIS?

It is possible but tough to determine, as comments from over 90 countries have to be taken into account. ASR expects the that no major changes will take place so expect the new high level structure, its clause numbering, and additional requirements around organizational context and leadership will be retained.

Will the advent of ISO 9001:2015 impact AS 9100, ISO/TS 16949, ISO 13485, ISO 14001 registration?

It is anticipated the impact to other standards that use ISO 9001 as a base document will be downstream from the release of ISO 9001.

An AS 9100 aerospace committee has stated their rollout might be 1 year later as they will need time to adjust and review the ISO 9001:2015 changes.

IATF (Internal Automotive Task Force) has commented that they do not believe ISO 9001:2015 is prescriptive enough for ISO/TS 16949 and they may decide not to change at this time.
ISO 14001:2004 is under review and it is expected EMS will follow the ISO 9001 format. No comments have been made regarding timing of the release.

ISO 13485:2003 (medical devices) is probably not going to change exactly like ISO 9001:2015. The medical device standard was written to ensure that it followed FDA requirements (21 CFR 820) and other worldwide regulatory body requirements. ISO 13485:2003 potentially calls out for up to 17 documented procedures that dovetail with FDA requirements. ISO 13485 standard writers are beginning to review the new revisions to ISO 9001:2015 and no rollout dates have been made and no draft document available.

When will implementation and registration to ISO 9001:20015 be required?

In the past, organizations had 3 years to implement/registrar to the revised standard. It is expected organizations will be given the same amount of time once the standard is published.

We want to get started early, what should we do today?

First, obtain a copy of the most current draft and review it.

There is some value in understanding the new concept of "documented information" which replaces procedures, work instructions and records. Read the standard first and then go to Annex A of the standard to seek guidance and understanding of the meaning "maintaining documented information" and "retaining documented information".

Another major change to ISO 9001 is the word "risk" which is written throughout the new standard. It is important for organizations to understand the limits or boundaries where risk should be established and included in the QMS. Between the definition in Section 3.09 and Section 6.1 (draft) risk is defined as it pertains to "product conformity and customer satisfaction". In some cases, organizations are currently reviewing these issues but not labeling them as risk. Organizations may want to actually formalize their existing process and include it in the QMS prior to the release of ISO 9001:2015.

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