Internal Audit Assessment Criteria - ISO 13485:2016

[Miller K]

Hello,

apologies if this is a daft question, but I'm still a bit of a newbie when it comes to QMS stuff. A recent BSI Auditor wrote the following in an NC report, can anyone explain what it actually means??

There was no evidence that assessment criteria used was according to ISO 13485:2016 and other applicable standards

Thanks in anticipation of your help.

Keith.

 

[ScottK]

Hi. Welcome to the Cove.
Can you give us some more information so we can get the context?
Like what clause(s) this was written against?
Or more of the write up for this NC

I could throw some guesses but want to be sure we're going down the wrong path.

 

[Miller K]

Thanks for the welcome and replying to my thread.

The statement taken directly from the Assessment report was as follows:-
The internal audit process is not fully effective as audit plan did not take
into consideration status and importance of the areas to be audited, and
results from previous audits. Further there was no evidence that
assessment criteria used was according ISO 13485:2016 and other
applicable standards.

Our assessor then went on to say:-
Internal audit schedule QF035 has no consideration about importance of
area to be audited and outcome from previous audits.
AC001 to AC0020 checklist and Audit Reports 249-250 did not include
audit criteria according ISO 13485 (and other applicable standards, if
any).

QF035 is our Audit Schedule and AC001 and AC0020 are two of our Internal Audit Checklists. Could it be something as ridiculously simple as not having ISO 13485 referenced at the top of the checklists??

Thanks,

Keith.

 

[AndyN]

Thanks for the welcome and replying to my thread.

The statement taken directly from the Assessment report was as follows:-
The internal audit process is not fully effective as audit plan did not take
into consideration status and importance of the areas to be audited, and
results from previous audits. Further there was no evidence that
assessment criteria used was according ISO 13485:2016 and other
applicable standards.

Our assessor then went on to say:-
Internal audit schedule QF035 has no consideration about importance of
area to be audited and outcome from previous audits.
AC001 to AC0020 checklist and Audit Reports 249-250 did not include
audit criteria according ISO 13485 (and other applicable standards, if
any).

QF035 is our Audit Schedule and AC001 and AC0020 are two of our Internal Audit Checklists. Could it be something as ridiculously simple as not having ISO 13485 referenced at the top of the checklists??

Thanks,

Keith.

Can you sanitize them and post them for review?

 

[Miller K]

View attachment 20250

Not sure if this will work, but here goes.

 

[AndyN]

Sorry - I was thinking of your audit documents... My bad for not being clear.

 

[Miller K]

View attachment 20251


I suspect this is what you meant.

Cheers,

Keith

 

[Miller K]

Don't worry, it was me being stupid.

 

[AndyN]

View attachment 20251


I suspect this is what you meant.

Cheers,

Keith

OK, I can see now what the BSI auditor was alluding to.

I'd suggest the problem lies in using such a "canned" checklist. Is this approach what you were taught in auditor training?

 

[Miller K]

Yes, its a system I've inherited from a predecessor and don't really know how to start changing it for the better.