So, I need a reality check from my fellow Covers. First, let me preface this by saying that I work in the medical device industry and have for years. I've been auditing suppliers for 5 years, using both ISO 9001 and ISO 13485, as appropriate. I've always understood that the auditor must use criteria known to the auditee (registered to ISO 9001, audit them to ISO 9001, etc.) and not something with which they are unfamiliar.
In an industry where some suppliers are registered to ISO 9001, some registered to ISO 13485, some registered to both, and still some not registered to either, would you say that it is fair practice to audit a supplier registered to ISO 9001 against ISO 13485 requirements? I'm just curious to see what others may think is appropriate here.
Thanks in advance....
In an industry where some suppliers are registered to ISO 9001, some registered to ISO 13485, some registered to both, and still some not registered to either, would you say that it is fair practice to audit a supplier registered to ISO 9001 against ISO 13485 requirements? I'm just curious to see what others may think is appropriate here.
Thanks in advance....