ISO 13485 · Expert · 13 min lesson
Interviewing, observation and remote audits - ISO 19011 clauses 6.2.3 and 6.4.7 and ISO 13485 clause 8.2.4
ISO 19011 (2026 edition) clauses 6.2.3, 6.4.7, 6.4.8 and Annex A, ISO 13485:2016 clause 8.2.4, IAF MD 4:2025
What you will learn
- Use open questions and silence to draw out real practice.
- Combine interview, observation and record trails and verify every key statement.
- Plan remote audit methods and state their limits in the report.
Key takeaways
- Open questions, silence and summarising back produce descriptions you can verify; leading questions produce agreement (ISO 19011 clause 6.4.7).
- Use interview, observation and record trails together; a mismatch between them is the lead (clause 6.4.7).
- Record interviews by role, date, topic and how the answer was verified; protect individuals (clause 4.2.5).
- Decide remote feasibility first and plan technology, access and confidentiality (ISO 19011 clause 6.2.3, Annex A).
- State what could not be verified remotely and plan to close the gap; do not conclude beyond the evidence (clause 8.2.4).
Free practice question
An auditor at Tessaro asks a line operator: you follow the cleaning procedure every time, right? The operator says yes. The auditor records cleaning procedure followed, conforming.
What is wrong with this approach?
The question is leading and the answer is a statement that was not verified by observation or records.
Correct. ISO 19011 clause 6.4.7 requires verification, and clause 8.2.4 of ISO 13485 requires objective audits.
Nothing; operators are the best source of evidence.
Not quite. Operators are a valuable source, but clause 6.4.7 of ISO 19011 requires their statements to be verified before they count.
The question should have been asked of the manager.
Not quite. The level of the person does not fix the flaw; the issue is leading style and missing verification under clause 6.4.7.
The auditor should have recorded the answer as an observation.
Not quite. An answer is not an observation; ISO 19011 clause 6.4.7 treats observation as a separate method.
Key terms
- open question: A question starting with how, what or show me that cannot be answered yes or no and invites a description of practice (ISO 19011 Annex A).
- leading question: A question that contains the expected answer and invites agreement rather than a description (ISO 19011 Annex A).
- triangulation: Checking one point with two or more methods, such as interview, observation and records (ISO 19011 clause 6.4.7).
- record trail: Following one item or event through linked records to test that identifiers, dates and signatures agree (ISO 13485 clause 4.2.5).
- remote auditing method: Conducting audit activities from a place other than the auditee location, which can be a virtual location (ISO 19011 clause 3).
- audit feasibility: The determination at initiation of whether objectives can be met, including information access and resources (ISO 19011 clause 6.2.3).
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
- IAF MD 4:2025 Mandatory document for the use of information and communication technology (ICT) for auditing/assessment 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.