ISO13485 implementation - Are internal audits expected before stage 1 audit?

outdoorsNW

Quite Involved in Discussions
#1
We are planning to add IS013485 to our AS9100 QMS. I know you are expected to have finished a round of internal audits before certification, however I am finding conflicting information if this needs to be done before the stage 1 audit or between stage 1 and stage 2?
 
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Sidney Vianna

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#3
There is no cast-in-stone requirement that the cycle of internal audit against 13485 has to be completed before Stage 1. The ISO APG Paper states the following as one of the checks to be done during Stage 1:

"...evaluating if internal audits and management reviews are being planned and performed, and whether the level of implementation of the management system substantiates that the client is ready for the stage 2 audit. ..."
 

outdoorsNW

Quite Involved in Discussions
#4
It sounds like we should plan on having the internal audits complete before stage 1, However if a couple of audits are delayed for some reason, as long as we can show the auditor we have a plan to get them completed before stage 2 we are fine.
 
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