Comprehensive Compliance Matrix for Internal Audit Checklist

N

NextQuality

Has anyone created a comprehensive compliance matrix for internal audit checklist which includes 13485:2016, 820, 211, Canada, Japan, Australia and Brazil? We recently went through our first MDSAP audit and was pinged on not including all requirements on our internal audit checklist (we only had 13485:2016, 820, 211 and 11). If you have a checklist that is all inclusive, would you be willing to share with me?
 

shimonv

Trusted Information Resource
I haven't seen such a checklist in the public domain.
Honestly, I recommend that you work with the MDSAP Companion document. It's well written and covers all the items the inspector will look at. I think it's more interesting to work this way.

Shimon
 

barbierimarkh

Registered
Has anyone created a comprehensive compliance matrix for internal audit checklist which includes 13485:2016, 820, 211, Canada, Japan, Australia and Brazil? We recently went through our first MDSAP audit and was pinged on not including all requirements on our internal audit checklist (we only had 13485:2016, 820, 211 and 11). If you have a checklist that is all inclusive, would you be willing to share with me?

Have you located a MDSAP comprehensive checklist? If so, do you mind sharing?
 
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