ISO 13485 · Expert · 13 min lesson
Closing meeting, audit report and conclusions - ISO 19011 clauses 6.4.8 to 6.5 and ISO 13485 clause 8.2.4
ISO 19011 (2026 edition) clauses 6.4.8, 6.4.9, 6.4.10, 6.5.1, 6.5.2 and 6.7, ISO 13485:2016 clause 8.2.4
What you will learn
- Present findings and conclusions fairly at the closing meeting.
- Write an audit report that a reader can verify against evidence.
- Handle disagreement and pressure without changing the facts.
Key takeaways
- Findings compare verified evidence with criteria and carry an evidence reference and grade (ISO 19011 clause 6.4.8).
- The conclusion considers the objectives and all findings, and must never contradict them (ISO 19011 clause 6.4.9).
- The closing meeting presents strengths, findings and conclusion, and records agreement or diverging opinions (ISO 19011 clause 6.4.10).
- A verifiable report states scope, sample, evidence references, conclusion and distribution (ISO 19011 clause 6.5.1; ISO 13485 clause 4.2.5).
- Actions follow without undue delay and are verified, and results are reported (ISO 13485 clause 8.2.4; ISO 19011 clause 6.7).
Free practice question
A Halden report lists two major and three minor findings. The conclusion paragraph reads: overall, the cleaning and packing process is effective and compliant.
What is wrong with the conclusion?
It contradicts the findings; the conclusion must consider all findings and state how far the criteria were met.
Correct. ISO 19011 clause 6.4.9 requires conclusions to consider the audit objectives and all of the findings.
Nothing; conclusions are independent of findings.
Not quite. Conclusions are drawn from the findings under clause 6.4.9 of ISO 19011, so they cannot be independent.
It should be longer.
Not quite. Length is not the flaw; the contradiction with findings is, which clause 6.4.9 of ISO 19011 addresses.
It should be signed by the process owner.
Not quite. Auditee signature is not what clause 6.4.9 of ISO 19011 requires; the problem is the unsupported content.
Key terms
- audit finding: The result of evaluating collected audit evidence against audit criteria (ISO 19011 clause 6.4.8).
- audit conclusion: The outcome of an audit after considering the objectives and all findings (ISO 19011 clause 6.4.9).
- closing meeting: Meeting that presents findings and conclusions so they are understood and acknowledged and agrees the action plan timeframe (ISO 19011 clause 6.4.10).
- diverging opinion: A disagreement between audit team and auditee that is discussed and, if unresolved, recorded (ISO 19011 clause 6.4.10).
- audit report: Complete, accurate, concise and clear record of the audit with scope, findings, evidence and conclusions (ISO 19011 clause 6.5.1).
- audit follow-up: Verification that actions taken on findings were done and effective, with the result reported (ISO 13485 clause 8.2.4; ISO 19011 clause 6.7).
Official sources
- ISO 19011 Guidelines for auditing management systems (fourth edition, 2026; replaces the 2018 edition)
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- GHTF SG4 Guidelines for regulatory auditing of quality management systems of medical device manufacturers, Part 1: general requirements
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.