Definition Deviation and Nonconformity - What is difference?

SpartanBio

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#1
Hi,

I'm sure that this is posted somewhere but I can't find it so I apologize in advance. My company is a medical device manufacture and we are struggling with deviations. I have found some great posts detailing the definition of one and the difference between a deviation and a non-conformance what I am looking for is where in the standards (21CFR820 and ISO 13485) deviations are referenced. We currently don't have a procedure on how to deal with deviations and I want to make sure that I consider the appropriate requirements when writing the procedure.

thanx:
 
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isoalchemist

#3
:2cents: I don't think you will find a specific reference in 21CFR820 or ISO13485. I did a word search in 21CFR and it doesn't appear.

A deviation is a potential outcome of a nonconformance that make something allowable and hence conforming. I see no specific references.
 
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