Can CROs participate in MDSAP? What about Certified Quality Auditors?

The MDSAP includes the use of AOs, also known as Certification Bodies or Registrars. While an AO could also act as a Contract Research Organization (CRO), this would require special controls in the organization’s management system to ensure the impartiality and independence of the AO and compliance with the requirements of IMDRF/MDSAP WG/N3. The Threat to Impartiality procedure also provides further information on limits within which an AO must operate in order to satisfy impartiality requirements with regards to consulting.

The operation of an impartial and independent certification program requires several individuals to fill various positions within an AO. Consequently, an independent Certified Quality Auditor may not individually apply for recognition under the MDSAP. Should an auditor who meets the competency and other criteria for auditors (e.g. absence of conflict of interest) become employed or work on a contract basis for an AO that auditor may be qualified to perform MDSAP audits as long as the AO is authorized or recognized under MDSAP.