ISO 13485 · Expert · 14 min lesson
Auditing clause 5: management commitment, planning and review
ISO 13485:2016 clauses 5.1 to 5.6 (5.4.1, 5.5.2, 5.6.1, 5.6.2, 5.6.3) and ISO 19011 audit practice
What you will learn
- Test commitment through evidence, not statements.
- Audit management review inputs and outputs.
- Check the management representative role.
Key takeaways
- Commitment under clause 5.1 is proven by records of policy, objectives, reviews and resources, not by statements.
- Quality objectives under clause 5.4.1 must be measurable, owned and consistent with the policy.
- The management representative under clause 5.5.2 needs real authority and reports on effectiveness.
- Management review under clause 5.6.1 happens at the documented interval with top management present.
- Review inputs follow clause 5.6.2 and must be complete and accurate against source data.
- Review outputs under clause 5.6.3 are recorded decisions with owners, dates and resources.
Free practice question
Halden Surgical's management review minutes MR-2026-01 list eight inputs with data. Under outputs the minutes state: none. The complaints input shows eleven complaints against seven the previous year and a repeat cleaning nonconformity from the last internal audit.
What is the best audit conclusion?
Conforming: outputs are optional if the system seems effective.
Not quite. Clause 5.6.3 requires recorded decisions and actions, so the outputs are not optional even when the system looks fine.
A suggestion only, because the meeting did take place.
Not quite. Holding a meeting does not meet clause 5.6.3; the standard requires recorded results with decisions and actions.
A nonconformity against clause 5.6.3: no decisions or actions were recorded despite worsening inputs.
Correct. Clause 5.6.3 requires outputs on improvement, product, regulation and resources, and the worsening trend makes the omission significant.
A nonconformity against clause 6.2, because staff lacked competence.
Not quite. Nothing in the minutes concerns competence under clause 6.2; the gap is the missing review outputs.
Key terms
- top management: The person or group that directs and controls the organization at the highest level (ISO 13485:2016 clause 3.1 and clause 5).
- management representative: A member of management appointed with responsibility and authority for the quality management system (ISO 13485:2016 clause 5.5.2).
- management review: Planned review by top management of the continuing suitability, adequacy and effectiveness of the system (ISO 13485:2016 clause 5.6.1).
- review output: Recorded decisions and actions on improvement, product, regulatory change and resources (ISO 13485:2016 clause 5.6.3).
- quality objective: A measurable target consistent with the quality policy and set at relevant functions and levels (ISO 13485:2016 clause 5.4.1).
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 19011 Guidelines for auditing management systems
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.