Quality Staff - Independence (ISO 13485 Clause 5.5.1)

[Timothy1]

Clause 551 of 13485 asks for
"Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks".

Does it mean that the Quality staff need to be independent of Production? The company's total head count is only 6. Presently the Production manager acts as the Quality manager. They cannot afford an independent Quality manager.

Pl share your experience/ inputs

Tim

[MIREGMGR]

The requirement isn't for absolute independence. It's for enough independence and authority to perform the required tasks.

The rule is intended to avoid having the quality function subservient to some other function with possibly conflicting goals. If the production manager is also the quality manager, the two functions are at equal levels.

Of course it's incumbent upon that person to do both jobs with equal commitment, but I wouldn't think an auditor of a small organization would have a problem with such an arrangement.