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
Thanks
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
Thanks