ISO 13485 · Medium · 13 min lesson
Management review in practice: data, decisions, actions and records
ISO 13485:2016 clauses 5.6.1, 5.6.2, 5.6.3 and 4.2.5
What you will learn
- Prepare management review input data as trends and rates that support decisions.
- Turn inputs into recorded outputs with an owner, date and resource, and judge suitability, adequacy and effectiveness with reasons.
- Follow up actions, keep the review records required by clauses 5.6.1 and 4.2.5, and spot a weak review.
Key takeaways
- Hold the review at the documented planned interval, with top management present and a pre-read pack sent in advance.
- Input data needs baselines, rates, trends and a conclusion, not bare counts.
- Conclude on suitability, adequacy and effectiveness with reasons, accepting a partial no where the data shows one.
- An output is a decision with an owner, a date, a resource and a check of effect (clause 5.6.3).
- Keep an action log and file signed minutes with the data pack as records under clauses 5.6.1 and 4.2.5.
Free practice question
Tarvik's procedure says the management review is held yearly. The last review was in March 2024, and the current date is October 2025. No extraordinary review was held and no reason is recorded. The quality manager says the board was busy.
How should an auditor treat this against clause 5.6.1?
As a nonconformity: the review was not held at the documented planned interval.
Correct. Clause 5.6.1 requires the review at documented planned intervals, and the documented yearly interval was missed.
As compliant, because the board was busy.
Not quite. Clause 5.6.1 has no exception for availability; the interval must be followed or formally changed.
As compliant because a review happens eventually.
Not quite. Clause 5.6.1 requires planned intervals, so a late review does not meet the documented plan.
As acceptable if a presentation exists.
Not quite. A presentation is not a review at the planned interval as clause 5.6.1 requires.
Key terms
- management review: Planned review by top management of the quality system's suitability, adequacy and effectiveness (clause 5.6).
- review input: Information provided to the review, such as complaints, audits and process data (clause 5.6.2).
- review output: Recorded decisions and actions from the review on improvement, product, regulation and resources (clause 5.6.3).
- suitability: Whether the quality system fits the organisation and its products.
- adequacy: Whether the quality system covers what the standard and the regulations require.
- effectiveness: Whether the quality system achieves planned results.
- action log: A list of review decisions with owner, due date, status and evidence of closure.
- records: Controlled documents that state results achieved or provide evidence of activities (clause 4.2.5).
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- FDA, Quality Management System Regulation (QMSR) final rule, effective 2 February 2026
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.