Audits FAQs

Responses to commonly asked questions related to MDSAP Audits.

When should AOs employ technical expert for audits?

Information on MDSAP AO engagement of technical expert.

How should AOs apply the audit approach when sites are not responsible for all QMS activities?

Information on application of the MDSAP Audit Approach to dispersed site responsibilities.

How should AOs treat “virtual” manufacturers?

Information on audits of “virtual” manufacturers.

Should a remote-audited facility be included on the certificate?

Information on sites able to be recorded on the MDSAP certificates.

What is the primary benefit of the "campus" concept for multi-site organizations undergoing QMS audits?

Information on main benefit of the “campus” concept.

What is the definition of a "campus" in the context of multi-site QMS audits?

The definition of a “campus” under the MDSAP.

Do MDSAP audits cover European requirements?

Information on European requirements and MDSAP Audit Approach.

Can non-participating RAs have access to MDSAP audit reports? How can the veracity of certificates be confirmed?

Information on how non-participating RAs can access MDSAP audit reports and verify MDSAP certificates.