ISO13485:2016 7.5.6 Process Validation Responsibilities


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Hi Cove,

I require some help on a conversation I had with an Auditor.

As part of an audit finding we agreed that I would, as Quality Manager, go on a process validation course along with another member of staff.

The auditor has now said that I cannot be owner of process validation as I am the Quality Manager. I can find no reference in ISO13485:2016 that requires a separation of the roles of the quality manager and process validation. Can someone direct me as to why this would be necessary?

P.S we have a relatively small workforce



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The closest thing I can see is in 5.5.1:
Top management shall document 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.

Still, that seems like an arbitrary assertion by the auditor. It's best if you ask the auditor to cite the relevant clause and reason.

A related thread: Quality Staff - Independence (ISO 13485 Clause 5.5.1)
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