Hello everyone,
I was searching if I can find some thread for absence of crucial personnel, but I couldn't find any.
We are a medical device factory certified according to ISO: 13485 and we are facing an audit from the Certified Body in September, but without Production Manager (he resigned 4 months ago) and yet we can not find someone appropriate!!
We have issued preventive action according to which all the responsibilities "were transffered to the Plant Manager" (officially
). But neithter Plant Manager, nor someone else in the factory has appropriate education/training.
I'm wondering can this be a problem which can end up with NC from the Certified Body?
Thanks in advance!
I was searching if I can find some thread for absence of crucial personnel, but I couldn't find any.
We are a medical device factory certified according to ISO: 13485 and we are facing an audit from the Certified Body in September, but without Production Manager (he resigned 4 months ago) and yet we can not find someone appropriate!!
We have issued preventive action according to which all the responsibilities "were transffered to the Plant Manager" (officially
I'm wondering can this be a problem which can end up with NC from the Certified Body?
Thanks in advance!
