Non Conformity in ISO 13485 Certification Body Audit

Non Conformity in ISO 13485 Certification Body Audit

A major nonconformity is can be a failure of the  following:

1) A total absence in the fulfilment of a requirement.

2) Repetition of a previous nonconformity

3) Failure to address a previously identified minor nonconformity

4) Shipment of non-conforming product.

A minor nonconformity is described as a single lapse in the fulfilment of a particular clause in the standard.