I have encountered a company that uses Notified Body "A" as their ISO 13485 auditor and NB "D" as their CE auditor to the MDD 93/42/EEC.
When I asked to review their last few CE audit reports, the company told me that NB "D" does not do on-site audits - they use the ISO audit reports from NB "A" as assurance of compliance.
I know there is no way an ISO 13485 audit report can be used to show compliance with the MDD 93/42/EEC because there are very significant differences.
My question is - has anyone ever encountered a NB that would use this practice? I really question it because the NB in question is reputable and I'm not really buying the company's explanation.
When I asked to review their last few CE audit reports, the company told me that NB "D" does not do on-site audits - they use the ISO audit reports from NB "A" as assurance of compliance.
I know there is no way an ISO 13485 audit report can be used to show compliance with the MDD 93/42/EEC because there are very significant differences.
My question is - has anyone ever encountered a NB that would use this practice? I really question it because the NB in question is reputable and I'm not really buying the company's explanation.