Integrated Quality Manual ISO 13485:2003 ISO 9001:2015



I need your help...I need to integrate our quality manual to comply with both ISO 13485:2003 and ISO 9001:2015
any suggestions? examples?


I looked at the attachments, but I get confused how actually combine the sections.

Big Jim

I wrote one of those a few months ago. The client wanted an integrated manual instead of using two manuals as they had done it the past. I cannot share it with you, but I can provides a hint on how to do it.

First, I wrote an ISO 9001:2015 manual. I referenced the sections of the standard each topic spoke to.

Then I went through the 13485:2015 standard (which uses the numbering sequence of ISO 9001:2008) and using a cross reference for identify how the elements correlated, added in the 13485 manual information in the corresponding position of ISO 9001:2015 and clearly referenced it as M with the 13485:2015 element number.

The client was very happy with the results. That gave them on manual and in essence one management system.

Good luck with it.


Just a comment that "quality manual" no longer exists in ISO 9001:2015. The intent of a "quality manual" is that you write something that describes about what your company does, how they do it, scope, context, interest parties, risk-based approach, metrics, measuring, PDCA, etc. etc. Don't regurgitate the standard.

With that said, ISO 13485:2016 read the first few sections 0 through 2 because a quality manual again takes on a more "what we do" approach. Take the core processes that your organisation and describe those. The describe the supporting processes, finally make sure you talk about all those things previously stated - what your company does, product they make, regulatory requirements, customer requirements, etc.

Big Jim

Just to be clear.

Although ISO 9001:2015 no longer has a requirement to have a quality manual it doesn't mean that one would not be desirable. You are required to determine what maintained documented information (documents, which can include a manual) you need to have an effective quality management system.

Further on that point, Nigel Croft, the chairman of TC 176 (the committee at ISO that wrote ISO 9001:2015), said that it is anticipated that most companies will still choose to have one.

I have not encountered any company that has chosen not to have one.

As far as "regurgitating the standard" is concerned, just because they structure a manual around the standard doesn't mean they regurgitate it. Many find it useful to structure the manual in such a way as to help them see how they are meeting the requirements.

Some sort of order to the documentation can help with having an orderly quality management system so there is less chaos.
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