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:
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:
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.