ISO 9001:2015 vs ISO 13485:2016 Gap analysis

#1
Hi all,

I am conducting a Gap analysis for my company and am looking for some seasoned insight. We are currently ISO 9001:2015 certified and would like to obtain our ISO 13485:2016 certificate within the next 12-18 months. I have been reading through the standards, looking at information online, reading up on FDA CGMP and 21 CFR part 820 and honestly, it's a lot. I am familiar with our current ISO standard and practices but am worried because of how we (loosely) manage our current processes and facility.

We are a contract manufacturer so I am wondering what will truly apply to us. My understanding is that CGMP and 21 CFR part 820 will be the responsibility of our customer and not necessarily on us, however, because of the openness to regulatory bodies in ISO 13485 we should still be aligning with them. I am really looking for feedback from anyone who has gone through this process of proceeding from 9001 to 13485 and any tips and/or tools that will be useful in understanding and facilitating a smooth cross over.

Thanks!
 
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#2
#3
We will be building complete, finished medical devices and we may be responsible for some degree of sterilization, which I know if one of the key clause differences between 9001 and 13485. There is a lot of information that is being jostled around right now and unfortunately, until there are more concrete details, I think the gap analysis can only be very high level and not as specific as I'd like.

Thanks for the response :)
 
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