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Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting

jkc3usc

Involved In Discussions
#1
ISO auditing - Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting.

Would you say this is true or false?
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#4
It depends on what was identified as a nonconformity. The severity of the nonconformity would be the driving element.

Here is my opinion on this: If something was noted during the audit, and was resolved before the end of the day, I would consider this and a non-issue. But, ISO13485 is not my forte and I could be way off.

Is this an Internal or External Audit?
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#7
Our auditor gave us permission to make corrections outside our CAPA process the same days of the audit takingplace.
 

QE1993

Involved In Discussions
#9
This is true, at least with out registrar.

I don't quite remember exactly what the circumstances were, but our auditor was finishing up our audit remotely (we suspect she has a side business going on and sometimes double books herself), so we never had an official in-person closing meeting. We got a 2 NCRs for not having any procedures for Purchasing and Control of Records. Um, excuse me, we most certainly DO have those procedures - this isn't our first rodeo and she's been auditing us for years so it was a very odd finding. Anyway, the registrar told us we still had to fill out the NCRs since they were recorded in the system (we didn't do a root cause or CA, just stated we did in fact have those procedures).
 
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