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.