Audits FAQs

Responses to commonly asked questions related to MDSAP Audits.

What happens to a manufacturer when the AO recognition is revoked?

Information on contracting with another MDSAP AO and MDSAP RA considerations.

If a manufacturing site is already under regulatory action with an MDSAP RA, can they participate in the MDSAP?

Information on MDSAP participation for manufacturers under regulatory action.

How do manufacturers show they have been successfully audited under the MDSAP?

Information on issue of MDSAP certification documents.

If an AO issues a negative final report, can the manufacturer still sell in MDSAP jurisdictions?

Information on RA action when a manufacturer has not met QMS or other regulatory requirements.

Can MDSAP RAs void audits by an AO due to inadequate methods? If so, will manufacturers need another audit?

Information on MDSAP and RA audit mechanisms, including special audits.

Do manufacturers seeking MDSAP certification need to comply with regulations in jurisdictions where they do not market?

Information on jurisdictions where manufacturers need to be compliant with regulations.

Who assigns a particular auditor? The MDSAP AO or RA?

Information on how auditors are assigned.

Are MDSAP audits conducted by single or multiple auditors?

Information on how audit time and the number of auditors required is determined.