MDSAP · Expert · 15 min lesson
Capstone A - mock MDSAP audit: planning, opening meeting, Management and Measurement chapters
MDSAP AU P0002 Audit Approach (audit sequence, chapters 1 and 3), AU P0008 audit time determination (sections 3, 5.2 and 5.3), ISO/IEC 17021-1 clause 9.4, ISO 13485:2016 clauses 4.1, 5.5, 5.6 and 8.2 to 8.5
What you will learn
- Plan a mock audit: set the scope, estimate audit time with the AU P0008 method and build a plan that follows the MDSAP audit sequence.
- Run the opening meeting and the interviews so that scope, method, sampling and grading are agreed and evidence, not assertion, is requested.
- Collect and record evidence in the Management and Measurement, Analysis and Improvement chapters, following linkages between them.
Key takeaways
- Audit time comes from the AU P0008 method: only applicable tasks count, each site is calculated separately, and Stage 1 adds 25 percent for initial certification.
- The audit sequence is Management, then Measurement, Analysis and Improvement, Design and Development, and Production and Service Controls, with Purchasing alongside and chapters 2 and 4 as supporting processes.
- The opening meeting confirms scope, plan, method, sampling, communication and how findings will be graded and reported.
- Ask for the record, not the assurance: trace a sample from the Management chapter into complaints, reporting and corrective action.
- Notes record document number, revision, job title, date and place, so that every finding can be found again.
Free practice question
Meridian has a main site and a packaging site. The draft time calculation counts only the main site, because the packaging site is small and the processes are the same.
What does AU P0008 require?
Calculate each site separately and add the times; sampling of manufacturing sites is not permitted.
Not quite. AU P0008 section 5.3.5 states that each site is calculated separately and then totalled.
Sample one site and extend the result to the other.
Correct. AU P0008 section 5.3.5 does not permit sampling of design and manufacturing sites.
Ignore small sites in the calculation.
Not quite. The MDSAP procedure AU P0008 contains no size exemption for sites that carry in scope activities.
Calculate time for the main site and add ten percent.
Not quite. The MDSAP procedure AU P0008 uses no flat ten percent; it adds per site according to applicable tasks.
Key terms
- audit sequence: The order in which the primary processes are audited: Management, Measurement, Analysis and Improvement, Design and Development, then Production and Service Controls.
- AU P0008: The MDSAP procedure for determining audit time, built from the applicable audit tasks of the seven processes and set adjustments.
- opening meeting: The first meeting of the audit, where scope, plan, method, communication and reporting are confirmed with top management.
- judgment based sampling: Selecting samples by following audit trails from one task into others, which the Audit Approach prefers to purely statistical selection.
- linkage: The documented connection between MDSAP processes, such as management review to complaint data, which the auditor follows to test consistency.
- supporting process: In the MDSAP sequence, chapters 2 and 4 (marketing authorization and adverse event reporting), audited mainly through linkages.
Official sources
- MDSAP AU P0002.009 MDSAP Audit Approach (FDA)
- MDSAP AU P0002.011 MDSAP Audit Approach (mdsap.global, July 2026 posting)
- MDSAP AU P0008.008 Audit Time Determination Procedure (FDA)
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
- MDSAP Audit procedures and forms (mdsap.global)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.