Hi all,
Just finished hosting an ISO 13485:2016 audit with a registrar.
The auditor wrote a non-conformance for not having quality objectives in the "CAPA" and "internal audit" areas (although these topics were presented in the management review).
Is it mandatory to have these objectives??
I was puzzled...
please advise
Sue
Just finished hosting an ISO 13485:2016 audit with a registrar.
The auditor wrote a non-conformance for not having quality objectives in the "CAPA" and "internal audit" areas (although these topics were presented in the management review).
Is it mandatory to have these objectives??
I was puzzled...
please advise
Sue