Integrating ISO 9001:2015 audits with ISO 13485:2016


I recently started working for a new employer. We are certified to both the ISO 9001:2015 and ISO 13485:2016 standards. They currently do one large audit to each of the standards once per year. My employer asked very early on if we can integrate the audits to help cover overlaps or similarities between the standards such as calibration. I would like to separate the large audits into several throughout the year to identify strengths and weaknesses and then plan upcoming audits based on the findings. For example, instead of auditing quality as a whole as they currently do (they audit Sales, Purchasing, Manufacturing, Management and Quality), I would like to audit the Calibration process as one audit while combining the requirements of the the two standards. Our audits currently state the auditing clause and applicable company documents for each question which makes it easier for me to see the overlaps. Is it acceptable to do so? I have already began the process, but before I get too deep into it, I'd like to know if there are are pitfalls to doing so or even reasons that may make it impossible.

Thank you.


Super Moderator
We're certified to both of those, too, and we do just a single audit (chunked up into 3 per year).

Philip B

Quite Involved in Discussions
Absolutely nothing to stop you doing this. Just make sure that you cite both standards in your audit scope.
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