ISO 13485:2016 Customer Assessment OFI

FuzzyD

Registered
Hi All

We recently completed a QMS assessment / Audit from a future customer. The Customer did not have any findings however did issue a SCAR for some "Opportunities for Improvement". I am wondering if this SCAR for Improvements would classify as a complaint or just feedback? Or if this should be handled in another way to satisfy FDA requirements.

TIA

Fuzzy D
 

blackholequasar

The Cheerful Diabetic
Were any of the OFIs considered a reportable event as defined by the FDA requirements? Interesting that they SCAR'd you for OFIs, but I suppose that just means they would like a formal response on it.
 

FuzzyD

Registered
Were any of the OFIs considered a reportable event as defined by the FDA requirements? Interesting that they SCAR'd you for OFIs, but I suppose that just means they would like a formal response on it.

Black hole quasar. Thank you for the prompt. I think that I have just answered my own question in the fact that one of the OFI's did not satisfy requirements.

Greatly Appreciate your help!
 
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