ISO 13485 · Basic · 14 min lesson
Complaint handling and corrective action - clauses 8.2.2, 8.3 and 8.5.2
ISO 13485:2016 clauses 8.2.2, 8.2.3, 8.3.1, 8.3.2, 8.3.4 and 8.5.2, with the definitions of clause 3
What you will learn
- Run a complaint from receipt to decision under clause 8.2.2: record it, decide whether it is a complaint, investigate or justify not investigating, and judge reportability.
- Separate nonconforming product control (clause 8.3), correction and corrective action, and use the clause 8.5.2 steps from cause to effectiveness review.
- Compare a weak and a compliant complaint or CAPA record and answer what the auditor asks.
Key takeaways
- Clause 8.2.2 requires a documented, timely complaint procedure: record, evaluate, investigate or justify, decide on reporting, handle product, decide on action.
- A complaint is any communication alleging a deficiency in a released device, whatever the channel (clause 3.4).
- Nonconforming product is controlled under clause 8.3; a correction deals with the product, not the cause.
- Corrective action under clause 8.5.2 runs from review and cause to implementation, no-adverse-effect check and effectiveness review.
- Good records show how the team decided; the auditor reads evidence, dates and names, not intentions.
Free practice question
Corvane's sales representative receives an email from a ward manager saying a Tidewell set connector leaked during an infusion. The representative replies with thanks and forwards the email to a colleague. No record is opened. Three weeks later the same hospital sends a similar message.
What does clause 8.2.2 require when the first email arrives?
Wait for a second report before opening a record.
Not quite. Clause 8.2.2 requires timely handling of each communication, so waiting for a pattern leaves the first report unrecorded and uninvestigated.
Record it, evaluate whether it is a complaint, and proceed to investigation and a reportability decision.
Correct. Clause 8.2.2 a) to d) sets receiving, recording, evaluating, investigating and judging reportability for every such communication.
Answer the nurse and keep the matter in sales email.
Not quite. Clause 8.2.2 requires records within the quality system, and sales email does not give the traceable evaluation that the clause expects.
Open a record only if the hospital demands it.
Not quite. The obligation in clause 8.2.2 does not depend on the reporter asking, since the organisation must act on any allegation.
Key terms
- complaint: A written, electronic or oral communication alleging a deficiency in a released device or related service (clause 3.4).
- nonconformity: Non-fulfilment of a requirement (clause 3); product that does not meet requirements is controlled under clause 8.3.
- correction: Action to eliminate a detected nonconformity, such as scrapping or reworking a lot; it does not remove the cause.
- corrective action: Action to eliminate the cause of a detected nonconformity and prevent its recurrence (clause 8.5.2).
- concession: Permission to use or release product that does not conform, allowed only with justification, approval and regulatory compliance (clause 8.3.2).
- root cause: The underlying system condition that produced the nonconformity, supported by evidence, not a person's mistake.
- effectiveness review: Checking, against criteria set in advance, that a corrective action actually prevented recurrence (clause 8.5.2 f).
- CAPA: Corrective and preventive action: the quality system process of clauses 8.5.2 and 8.5.3.
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- Regulation (EU) 2017/745, Article 2 definitions (corrective action, recall, serious incident)
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.