In my opinion, you have a case of bad auditing on your hands. My recommendation is to turn the tables. If the auditor is suggesting a change, then one of two things is going on. The auditor understands a requirement that you are not meeting, so you have a nonconformity. In this case, the auditor should specify the requirement. The second case is that the auditor is putting her judgment in place of your, without being able to cite a requirement. This should be written as a suggestion, but should not be an audit nonconformity.
So my suggestion is to get the auditor to specify the requirement, which in this case would be the requirement for scope statements on various certificates. In general, I don't know of any requirements and they may very well be specific to the Notified Body.
You didn't say whether the auditor is internal, a customer, or a Notified Body. A Notified Body auditor should be able to cite the requirement. An internal auditor usually cannot and often falls into the opinion camp.
Regards,
Dan
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 02-27-2014 10:21
From: Elena Cavaliere
Subject: ISO 13485 Scope Statement
Hello,
I am wondering if anyone might be able to direct me to some information on the requirements for the scope statement for ISO13485 UKAS and Directive 93/42/EEC certificates.
I have found the appropriate document for ISO 13485 CMDCAS but no luck so far with the others. Our auditor is being quite stubborn with respect to generalizing some of verbiage and I would like some supporting documentation to accompany my proposal.
Thanks,
Elena
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Elena Cavaliere
Regulatory Affairs Specialist
Barrie ON
Canada
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