ISO 13485 · Expert · 13 min lesson
Capstone part 2: writing nonconformities, grading and the closing meeting
ISO 19011:2018 clauses 6.4.8 to 6.4.10, 6.5 and 6.7, applied to ISO 13485:2016 clauses 7.4.1, 8.2.4, 8.3 and 8.5.2
What you will learn
- Write a nonconformity with requirement, evidence and finding statements that another person could verify, and tell a weak draft from a compliant one.
- Choose the clause, decide whether findings are one or several, and grade them as observation, minor or major with a stated reason.
- Determine audit conclusions and run a closing meeting, including disagreement, the response timeline and follow-up.
Key takeaways
- A nonconformity states the requirement, the evidence and the finding, so that another person can verify it (ISO 19011 clause 6.4.8).
- Cite the most specific clause and group examples that share one gap; separate gaps are separate findings.
- Grade by impact, state the reason, and apply the scheme your programme specifies; observation, minor and major are common levels.
- The team agrees the conclusions before the closing meeting; the meeting confirms findings and agrees the response timeframe (clauses 6.4.9, 6.4.10).
- Closure needs the auditee's cause analysis (ISO 13485 clause 8.5.2) and follow-up that verifies effectiveness (ISO 19011 clause 6.7).
Free practice question
An auditor's draft finding for Corvane reads: 'Complaint handling is poor and should be improved.' At the closing meeting the quality manager asks which complaints, which clause and which record.
What is the main defect of the draft?
It is too short to be a finding.
Not quite. Length is not the test; ISO 19011 clause 6.4.8 expects findings supported by recorded evidence.
It holds an opinion and advice, and has no clause, record or fact the company can verify.
Correct. A finding needs a requirement, evidence and a factual statement under ISO 19011 clause 6.4.8, none of which appear.
It uses the wrong colour of ink.
Not quite. Presentation is not the defect; the missing verifiable content under clause 6.4.8 is.
It should have been written by the quality manager.
Not quite. Auditors write the findings after verifying evidence, and the auditee then responds with cause analysis under ISO 13485 clause 8.5.2.
Key terms
- nonconformity: Non-fulfilment of a requirement, stated with the requirement, the evidence and the finding.
- observation: A recorded weakness or improvement opportunity that has not yet breached a requirement.
- minor nonconformity: An isolated lapse where the system as a whole still works and risk to product is low.
- major nonconformity: Absence or failure of a required element, or a lapse likely to let non-conforming product reach users.
- closing meeting: The final meeting where the team leader presents findings and conclusions and agrees the response timeframe (ISO 19011 clause 6.4.10).
- audit conclusion: The outcome of the audit after considering the objectives and all findings (clause 3.10).
- correction and corrective action: Action to eliminate a detected nonconformity, and action to eliminate its cause (ISO 13485 clause 8.5.2).
- follow-up: Verification that agreed actions were completed and effective (ISO 19011 clause 6.7).
Official sources
- ISO 19011:2018 Guidelines for auditing management systems
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- IMDRF MDSAP: Medical Device Single Audit Program
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.