ISO 13485 Nonconformance Identification Exercise

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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
:topic: There are some people who prefer not to help with what they consider 'student home work'. Usually these people are those who have forgotten what it was like when they started out and knew virtually nothing. Personally, I see no problem in helping someone, including a student. Please keep responses on topic.

Thanks!
 

Roland Cooke

Quite Involved in Discussions
#3
The test is okay, but there isn't a huge amount of medical-device-specific stuff in there. That's understandable if the intent is to keep the test generic for students from all backgrounds, and strictly-speaking there aren't that many differences between ISO9001 and ISO13485 anyway.

Risk management and software validation are two key additions, and both are tested.

However a knowledgeable ISO9001 auditor isn't automatically a knowledgeable ISO13485 auditor, so I would have liked to have seen a few more (and punchier) ISO13485-specific questions nonetheless.
 
T

treesei

#5
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