Does the audit process include daily review of areas of concern?
Does the audit process include daily review of areas of concern?
Yes. AOs must be in compliance with the requirements of IMDRF MDSAP WG N3, and N4, including the requirements of ISO/IEC 17021-1 and all other related MDSAP documents. ISO/IEC 17021-1, Sub-Clause 9.4.3.1- Conducting the opening meeting, requires that “during the audit, the client will be kept informed of the audit progress and any concerns.”