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I think I'm happy with what is required as far as the DMR goes but just what would the FDA expect to see when they ask for our QSR?
The regulation states:
The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including but not limited to the records required by 820.40
A previous employer handed an FDA inspector a list of non product specific documents e.g. Policy documents, Process documents and Work Instructions for activities like Goods Inwards, Training, Purchasing etc. and was told 'That's not a QSR, that's just a list of documents'
So, Just what IS a QSR?
The regulation states:
The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including but not limited to the records required by 820.40
A previous employer handed an FDA inspector a list of non product specific documents e.g. Policy documents, Process documents and Work Instructions for activities like Goods Inwards, Training, Purchasing etc. and was told 'That's not a QSR, that's just a list of documents'
So, Just what IS a QSR?
Just our interpretation, but has been well received by both FDA and NB's