ISO 13485 · Basic · 14 min lesson
Clause 8 - measurement, analysis and improvement (feedback, audits, nonconformity, CAPA)
ISO 13485:2016 clauses 8.1 to 8.5; EU MDR Article 87; 21 CFR part 803; FDA QMSR (21 CFR part 820)
What you will learn
- Explain how clauses 8.2.1 to 8.2.3 turn feedback and complaints into decisions, including reporting to authorities.
- Describe internal audit, monitoring of processes and product, and control of nonconforming product under clauses 8.2.4 to 8.3.
- Build a complaint record and a CAPA record with data analysis that an auditor can follow, and spot a weak one.
Key takeaways
- Clause 8.2.1 and 8.2.2: gather feedback and handle every complaint with investigation or justification and a recorded reportability decision.
- Clause 8.2.3: report to authorities under each market's law, for example MDR Article 87 and 21 CFR part 803, and keep records.
- Clause 8.2.4: plan internal audits on process importance and results, with objective and impartial auditors who do not audit their own work.
- Clause 8.3: control nonconforming product; concessions need justification, approval and a named authoriser; keep the ability to issue advisory notices.
- Clauses 8.4 and 8.5: analyse data for trends, then correct causes, verify the action and review its effectiveness.
Free practice question
Orlix receives a complaint that a pump delivered a bolus larger than set. The patient was not harmed. The complaint handler closes it as 'no harm, no action' without examining the returned pump or assessing reportability.
What is wrong under clauses 8.2.2 and 8.2.3?
Nothing: no harm means no obligations.
Not quite. Clause 8.2.2 requires investigation and a reportability decision regardless of outcome, as the event could recur with harm.
The complaint was not investigated and no reportability decision or justification is recorded.
Correct. Clause 8.2.2 requires investigation or justification, and clause 8.2.3 requires evaluating reportability.
The complaint should have been closed faster.
Not quite. Speed is not the defect; clause 8.2.2 requires a proper investigation and decisions even if slower.
Only the patient can decide whether to report.
Not quite. Clause 8.2.3 places the reporting decision procedure on the manufacturer, not the patient.
Key terms
- complaint: Written, electronic or oral communication alleging deficiencies in identity, quality, durability, reliability, usability, safety or performance of a device (ISO 13485 clause 3.4).
- corrective action: Action to eliminate the cause of a detected nonconformity and prevent recurrence (ISO 13485 clause 8.5.2).
- preventive action: Action to eliminate the cause of a potential nonconformity (ISO 13485 clause 8.5.3).
- concession: Permission to use or release product that does not conform to specified requirements, with justification and approval (clause 8.3.2).
- advisory notice: Notice issued after delivery to supply additional information or advise action regarding a device (ISO 13485 clause 3.1).
- rework: Action on nonconforming product to make it conform, assessed for adverse effect and re-verified (clause 8.3.4).
- internal audit: Planned, objective and impartial examination of the quality system by auditors who do not audit their own work (clause 8.2.4).
- effectiveness review: Check, against a criterion set in advance, that a corrective action removed the cause (clause 8.5.2).
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex
- eCFR - 21 CFR part 803, Medical Device Reporting
- FDA - Quality Management System Regulation (QMSR)
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.