Witnessed audits

Witnessed audits allow qualified MDSAP RA assessors  to verify that an AO effectively conducts their audits using the MDSAP Audit Approach and reports appropriately on the outcomes of audits. It is an essential assessment activity for building and maintaining confidence in the reliability of the third-party AO.    

During a witnessed audit, the AO’s audit team conducts the audit of the medical device manufacturer and the RAs’ assessment team observes the AO without interfering in the audit process. The RA Assessment team does not assist or coach the AO auditors, nor does it provide additional information to the AO audit team or collect information on their behalf.   

After the AO has issued the audit report, the RAs’ assessment team finalizes and shares their conclusions on the audit with the AO.   

The RA conclusions are not in relation to the compliance of the manufacturer to ISO 13485 and the relevant regulatory requirements. The RA’s conclusions only relate to the ability of the AO to audit against the requirements of the MDSAP.