The chances are that the review board uses ISO 14671 for 'guidance' and hystorically they are a lot pickier than ISO 9001 review boards for example. The auditor gets to do extra work (and doesnt get paid for) if the review board rejects the audit package or asks for additional information. To shine some light on WHY the finding was issued. There is no requirement in ISO 13485 that the organization has to comply with the 'guidance' of ISO 14971 or with auditor's interpretations of the standard. Guidance is needed to compensate for lack of knowledge. ![]() Note 3 under 7.1 says to look at ISO 14971 for guidance. ![]() Click to expand.I suggest that you dispute the finding with the registrar.
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