This is indeed the concept. In fact, Health Canada has indicated that by 2019 they will accept only audits conducted via MDSAP, rather than the current CMDCAS audits (based on ISO 13485).
There is extensive information about the MDSAP program posted on the FDA website:
Medical Device Single Audit Program (MDSAP) Pilot
Particularly interesting are the documents identified as Audit Model and the Companion Document, since these identify the areas where MDSAP audits need to go beyond ISO 13485 to address requirements of the participating countries. I do not believe these documents have yet been updated for ISO 13485:2016, but the expectation is that they will be updated for the revision to the standard - and they will be updated for any changes in country requirements.
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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
Original Message:
Sent: 04-05-2016 09:30
From: Lance Coleman
Subject: ISO Audits
I understand that it is possible to substitute a MDSAP audit from a certified provider for an FDA inspection. Is the same true for ISO 13485 audits?
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Lance Coleman
Quality Audit Program Manager
Ultradent Products Incorporated
South Jordan UT
United States
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