Question

if a medical device plant does not keep a 'quality records register' is it non-conformant with ISO 13485:2016 and 21 CFR 820 documentation ?

Answer 1

As per the requirement of Sub part - M of Sec 820.186 quality system record of 21 CFR 820, each manufacturer is supposed to keep a quality system record.

Also Sec 4.2.5 Control of Records of ISO 13485:2016 states that records should be maintained as evidence of conformity to quality management system and also to ensure effective functioning of QMS.

So clearly a quality record register or log needs to be maintained failing which the company would become non-conformant with the quality management systems mentioned.