Internal Audit of ISO-9001, ISO 13485-2003, CE


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I am an AS9100 auditor, but I was qualified by a registrar to perform ISO 14001 and ISO13485 also. I perform a few audits to ISO 13485 a year.

I received a request for quote from a company to perform internal audit on their Certifications: ISO-9001, ISO 13485-2003 (camdcas), CE.

I have no problem with 9001 and 13485, but I know nothing about CE. Is there a checklist that I can use to perform internal audit on CE?

If auditing CE requires special knowledge and experience, I may just pass it on to someone else who is more qualified.

Thanks for your help.



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Re: Internal audit of ISO-9001, ISO 13485-2003 , CE

Auditing the requirements for CE Marking is not easy. The new MDD M5 requirements just came into force and there are many additional requirements.
Auditing to the MDD does not not only require knowledge of the MDD but also a general knowledge of harmonized standards.
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