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?
 
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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

QA RA Small Med Dev Company
Trusted Information Resource
#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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