M
We had an auditor write a nonconformance stating the following:
5.6.2 Risk Management is not formally listed as a management review input item in Sect. 5.4.1 of the Management Review procedure.
I have been through ISO 13485 and 14969 and cannot find any requirement for this. Am I missing something or is my auditor mistaken for having written this nonconformance. If he is mistaken, then of course we screwed up by accepting it, but that's spilt milk.
Thoughts?
5.6.2 Risk Management is not formally listed as a management review input item in Sect. 5.4.1 of the Management Review procedure.
I have been through ISO 13485 and 14969 and cannot find any requirement for this. Am I missing something or is my auditor mistaken for having written this nonconformance. If he is mistaken, then of course we screwed up by accepting it, but that's spilt milk.
Thoughts?



