Are MDSAP audits conducted by single or multiple auditors?
Are MDSAP audits conducted by single or multiple auditors?
Procedure MDSAP AU P0008 Audit Time Determination specifies how to determine the on-site audit duration in auditor-days. AOs decide how many auditors will compose the audit team. For instance, a 6 auditor-day audit could be completed in 3 days by a 2-auditor team. AOs are also required to take into account the competency of the audit team for the type of audit and the scope of products that are produced under the control of the manufacturer’s QMS.