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Clause 4 in ISO 9001:2015 and AS9100 Rev D

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Guest user Created:   Aug 11, 2017 Last commented:   Aug 11, 2017

Clause 4 in ISO 9001:2015 and AS9100 Rev D

About clause 4 of the new ISO9001:2015. what is needed to fulfill this requirement? I am already ISO and AS so how does this cross reference with the 2008?
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AS9100 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

AS9100 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Mark Hammar Aug 11, 2017

Answer:
Much of clause 4 is new to ISO 9001 and was not present in the ISO 9001:2008 version. in particular:
4.1 is about understanding the organisation and its context. This requires you to determine what internal and external issues affect your QMS and is new.
4.2 is about understanding the needs and expectations of interested parties. This requires you to identify the parties interested in your QMS and what their needs and expectations are, and is also new.
4.3 is about the scope of the QMS and while this is not new it does require you to consider the scope with the knowledge from 4.1 & 4.2; so a review of the scope is a good idea.
4.4 is about understanding the processes in the QMS. This is very similar to the previous version with the addition of a few things such as addressing the risks and opportunities for the processes.

While 4.1 & 4.2 do not require you to keep documented i nformation it is a good idea to keep your listing of issues, interested parties and their needs so that you can review it for updates as time goes on. A procedure on how you accomplish this might also be needed so that everyone understands how you intend to perform these review.

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Aug 11, 2017

Aug 11, 2017

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