Risk Analysis as an Input in Management Review

F

freelovefest

#11
I think what the finding was is that you did not discuss risk management in relation to 5.6.2(h). If it was a 13485 audit, they would expect to see some discussion as to how you are planning on implementing the 14971:2007 revision which just came out this year. If nothing else, discuss it as a proposed change to the QMS. While compliance with 14971 is not explicit, The reason this is usually applicable is that most companies reference 14971 as the guide they use for performing risk management.

This is getting to be a pretty common finding in that most companies were unaware 14971 changed and have not made provisions for this, let alone implemented the revisions into thier risk management process. I could be off base here, but I think the auditor is right in his assessment, just maybe should have been more explicit about why.
 
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Y

YairP

#12
Re: Risk Analysis in Management Review

Even though ISO 13485 refers to ISO 14971 regarding how
to establish the risk management process and ISO 14971
does state that risk assessment and review is the
responsibility of "top management", I believe your auditor
is out of line because compliance with ISO 14971 is not a
requirement for certification to ISO 13485. :2cents:
All
The new Risk Management Standard - ISO 14971:2007, main change is responsibility of "top management", and if this standart is referred by your Design SOP (and most probably YES) than this referace is the source of your non-compliance.
 
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