ISO 13485 · Expert · 13 min lesson
Opening meeting, evidence collection and sampling - ISO 19011 clauses 6.4.3 and 6.4.7 and ISO 13485 clause 8.2.4
ISO 19011 (2026 edition) clauses 6.3.2, 6.4.3, 6.4.7, 6.4.8 and Annex A, ISO 13485:2016 clause 8.2.4
What you will learn
- Run an opening meeting that fixes scope, method and logistics.
- Choose sampling by risk and say exactly what was sampled.
- Tell audit evidence from information and verify it at the source.
Key takeaways
- The opening meeting confirms plan, scope, criteria, method, the sample statement and logistics (ISO 19011 clause 6.4.3).
- Plans state specific scope, period, sites and criteria; vague scope cannot be audited (clause 8.2.4; ISO 19011 clause 6.3.2).
- Only verifiable information is audit evidence; verify at the source and use two methods (ISO 19011 clause 6.4.7).
- Sample by risk: severity, change, history and spread across the period (clause 8.2.4; ISO 19011 Annex A).
- Record population, sample size, selection method and identifiers so another person could repeat the audit (clause 4.2.5).
Free practice question
At 9:00 the auditor of the Norvane design process arrives and the process owner says there is no time for an opening meeting, so please start with the records. The plan was emailed last week and nobody replied.
What should the auditor do?
Hold a brief opening meeting to confirm scope, criteria, method, the sample statement, access and the closing time, and record attendance.
Correct. ISO 19011 clause 6.4.3 sets these points for the opening meeting, and an unanswered email is not agreement on them.
Start with the records and explain the plan at the closing meeting.
Not quite. Explaining the plan only at the end removes the chance to agree scope, which clause 6.4.3 of ISO 19011 puts at the start.
Cancel the audit because the opening meeting was refused.
Not quite. Cancelling is out of proportion; clause 8.2.4 of ISO 13485 expects audits to proceed to plan, with the meeting kept short.
Treat the unanswered email as approval and carry on.
Not quite. Silence is not confirmation; ISO 19011 clause 6.4.3 expects the plan to be confirmed with the auditee in the meeting.
Key terms
- audit evidence: Records, statements of fact or other information that is relevant to the audit criteria and verifiable (ISO 19011 clause 3).
- audit criteria: The set of requirements used as a reference against which evidence is compared, such as clauses of ISO 13485 and own procedures (ISO 19011 clause 3).
- audit scope: The extent and boundaries of an audit, such as processes, sites and period (ISO 19011 clause 3).
- judgement sampling: Choosing items using auditor knowledge of risk, change and history rather than a statistical method (ISO 19011 Annex A).
- triangulation: Checking one point with at least two methods, such as interview, observation and record review (ISO 19011 clause 6.4.7).
- opening meeting: Meeting at the start of the audit that confirms plan, methods, sample statement and logistics (ISO 19011 clause 6.4.3).
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.