Goals not met - CAPA required =NC is not the purpose of the standard. Unfortunately it is interpreted thus by both internal as well as external...
I understand the agony & having been on both sides of the table, understand the problem too well. I have been a QMS auditor with a major CB who...
ISO Guru, Your understanding is perfect.
Materials and component specification and also the designed operating range form a major part of the Design & development process. Any change to...
Human error is a top level "event" if we may call that. The occurrence of this event could have been due to a. Lack of awareness -...
This reply is related to a query on Quality Policy Quality policy is a stable document with few or no change. This is a top level statement that...
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