ISO 13485 · Expert · 13 min lesson
Capstone part 1: audit case file review of a fictional manufacturer, findings and evidence
ISO 19011:2018 clauses 3.7 to 3.10, 6.3 and 6.4.7 to 6.4.8, applied to ISO 13485:2016 clauses 4.2.4, 7.6, 8.2.2, 8.4 and 8.5.2
What you will learn
- Explain how audit criteria, audit evidence, audit findings and audit conclusions relate, and prepare a document review of a case file.
- Collect verifiable evidence by tracing a record trail and separate evidence from opinion, using a weak and a compliant record.
- Spot nonconformities and conforming practice in a manufacturer's case file and decide what to ask for next, using sampling with care.
Key takeaways
- An audit moves from criteria to evidence to findings to conclusions (ISO 19011 clauses 3.7 to 3.10).
- Audit evidence is verifiable; statements and impressions are leads until a record or observation confirms them (clause 6.4.7).
- Trace one item across records, such as complaint to corrective action to review; a broken link is a lead, not yet a finding.
- Clause 8.5.2 needs real cause analysis and an effectiveness review; clause 7.6 needs calibration and an assessment of earlier results.
- Record conformity as well as nonconformity, and state the sample, because sampling supports a limited statement.
Free practice question
During the Corvane audit you find that nine of fourteen yearly complaints concern connector leaks and arrived in the last quarter. SOP-C-710 requires a quarterly trend review. The folder holds reports for Q1 and Q2 only. The quality manager says the data is 'in her head'.
What is the best way to treat this lead?
Accept the statement, because the manager knows the data.
Not quite. A statement is not verified evidence under ISO 19011 clause 6.4.7, so accepting it leaves clause 8.4 untested.
Ask for the Q3 and Q4 trend reports, and if none exist record the gap against SOP-C-710 and clause 8.4.
Correct. Verifying with records first, then citing the procedure and clause 8.4, follows ISO 19011 clause 6.4.7 and 6.4.8.
Close the item as a minor opinion without recording it.
Not quite. Dropping a verifiable gap breaches the evidence-based approach in ISO 19011 clause 4 and misses clause 8.4.
Instruct the company to recall all connectors.
Not quite. Auditors record findings only; deciding on product action belongs to the manufacturer under ISO 13485 clause 8.3.
Key terms
- audit criteria: The set of requirements used as a reference against which evidence is compared (ISO 19011 clause 3.7).
- audit evidence: Verifiable records, statements of fact or other information relevant to the criteria (clause 3.8).
- audit finding: The result of evaluating the collected evidence against the audit criteria; it may show conformity or nonconformity (clause 3.9).
- audit conclusion: The outcome of an audit after considering the objectives and all findings (clause 3.10).
- document review: Review of documented information before the visit to judge adequacy against the criteria (clause 6.3.1).
- effectiveness review: A check, after a corrective action, that the action achieved its goal (ISO 13485 clause 8.5.2).
- calibration: Comparing equipment against traceable standards at set intervals (ISO 13485 clause 7.6).
- sampling: Examining part of the records or activities; it supports a limited statement about the whole.
Official sources
- ISO 19011:2018 Guidelines for auditing management systems
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- Regulation (EU) 2017/745 on medical devices (EUR-Lex)
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.