Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016?

al40

Quite Involved in Discussions
Has anyone done a comparison between ISO 9001:2015 and ISO 13485?

Thanks,
Al40
 

yodon

Leader
Super Moderator
Yes... but too much copyright information to be able to share.

Presuming you mean 13485:2016, there are a couple of tables at the back of the standard (Appendix B) that has mapping between 13485:2016 --> 9001:2015 and then between 9001:2015 --> 13485:2016.

Some of the mapping was a bit 'forced' in my opinion but I was able to use most of it.

Any particular question or challenge? (I haven't started the gap analysis between where I am now and where I need to be).
 

al40

Quite Involved in Discussions
Thanks,
I was just trying to get a overview of the differences between them where the new sections of 9001 2015 intersected with 13485:2016. Would still like to see what others have done.
Thanks,
Al40
 
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