P
palebluedot
Hello!
I am working as a "Quality Systems Associate", but performing all the duties of a normal quality manager. I am running our QMS in conformance with the ISO 13485 standard, and I'm pretty new to it all (been in my position 4 months).
We recently conducted our internal audit near the end of October, and I just received the list of NCRs. The audit report also lists suggested corrective actions for each NCR. My question is:
Do I need to actually open a separate CAPA report for each NCR found during our internal audit (there were 19)?
That seems pretty unnecessary for some of these NCRs, which have been corrected with something as simple as labeling some materials with "Do Not Use". However, if I do not write up a CAPA report for each non-conformance, how do I show proof that the corrective actions have been put in place?
Any help is much appreciated!
I am working as a "Quality Systems Associate", but performing all the duties of a normal quality manager. I am running our QMS in conformance with the ISO 13485 standard, and I'm pretty new to it all (been in my position 4 months).
We recently conducted our internal audit near the end of October, and I just received the list of NCRs. The audit report also lists suggested corrective actions for each NCR. My question is:
Do I need to actually open a separate CAPA report for each NCR found during our internal audit (there were 19)?
That seems pretty unnecessary for some of these NCRs, which have been corrected with something as simple as labeling some materials with "Do Not Use". However, if I do not write up a CAPA report for each non-conformance, how do I show proof that the corrective actions have been put in place?
Any help is much appreciated!