MDSAP · Medium · 15 min lesson
Chapter 1 Management - eleven tasks: policy, representative, resources, outsourcing, risk planning and management review
MDSAP AU P0002 Audit Approach, Chapter 1 Management (11 tasks); ISO 13485:2016 clauses 4.1.5, 4.2.4, 4.2.5, 5.3 to 5.6, 6.2, 7.1, 7.2.1
What you will learn
- Audit the 11 Management tasks.
- Check outsourcing and regulatory knowledge.
- Write Management findings with grades.
Key takeaways
- Chapter 1 has 11 tasks, from QMS planning to authorized distribution; task 11 is a conclusion on top management commitment drawn at the end.
- Test people and records together: a perfect manual does not help if the representative cannot name what changed in the regulations.
- Outsourcing follows the product: a process that touches conformity must be on the current critical supplier list and controlled (clause 4.1.5).
- Management review must take regulatory changes and complaints as inputs and record decisions and actions (clauses 5.6.2 and 5.6.3).
- Write each finding with clause, document, evidence and a two-step MDSAP grade.
Free practice question
Tavish's management representative appointment letter names a person who left the company a year ago. The organization chart shows the same name.
Which task does this test and what is the gap?
Task 2: no valid documented appointment, so the role is not filled in practice
Correct. MDSAP Management task 2 requires a documented appointment and clause 5.5.2 requires a representative in post.
Task 11: top management is not committed
Not quite. Task 11 is a conclusion from many tasks, and the specific gap here belongs to MDSAP Management task 2.
Task 8: a document is obsolete
Not quite. Document control is a different task; the gap here is the appointment under clause 5.5.2.
Task 5: an outsourced process is missing
Not quite. Outsourcing has no connection to the appointment of the representative under clause 5.5.2.
Key terms
- management representative: The person appointed by top management with responsibility and authority for the QMS (clause 5.5.2).
- critical supplier list: List of outsourced processes and suppliers that affect product conformity, kept current (MDSAP Management task 5).
- risk acceptability criteria: Criteria approved by management for deciding which risks are acceptable (MDSAP Management task 7).
- management review: Planned review of the suitability and effectiveness of the QMS with recorded inputs and outputs (clause 5.6).
- authorized distribution: Controls ensuring only devices with marketing authorization are distributed (MDSAP Management task 10).
- top management commitment: A conclusion the auditor draws at the end from evidence in all other tasks (MDSAP Management task 11).
Official sources
- MDSAP AU P0002.009 MDSAP Audit Approach (FDA)
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
- Medical Device Single Audit Program (MDSAP) Frequently Asked Questions (FDA)
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
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.