S
It is always a difficult area when an auditor has a strong opinion which differs from that of the client - or in the case of products being sold to multiple companies - other auditors. In these cases it is often useful to go back to the specification defining the requirements. With the 'new' answer, I would quite strongly question how the person in charge of a production department head could be considered to have the necessary degree of independence to authorise a final release, so I am with Ajit on this one. Do you know how experienced your auditor was in this field?
The auditor (covering ISO 9001, ISO 13485 and MDD93/42/EC) was exceeding experienced – and was adamant he was correct. I think the ‘logic’ was that although Quality signed off the product i.e. it passed testing, met specification etc, the final checks involved – “did final paperwork (actual and electronic) match the original order?” In this case as I said, the head of production who initiated despatch to the customer was seen as final sign off. I have now made this point clear in a modified production job description and procedure.
Steve

