Continual improvement of a MDQMS based on ISO 13485
What this domain tests
This domain tests how the MDQMS improves itself. The exam emphasizes corrective and preventive action, root-cause analysis, effectiveness verification, change control, and the use of quality objectives, audits, data, and management review.
Core rules and concepts
- Improvement is not only CAPA. It includes quality policy, objectives, audit results, data analysis, management review, and changes to processes or devices.
- Corrective action addresses an existing nonconformity. It requires investigating cause, determining action, implementing it, and reviewing effectiveness.
- Preventive action addresses potential nonconformity. It should be proportionate to the risk of the problem.
- Do not confuse correction with corrective action. Replacing a failed component is a correction; removing the cause of the failure is corrective action.
- Change control must assess risk, regulatory impact, validation needs, and document updates before implementation.
- Effectiveness checks need objective evidence, a defined timeframe, and a responsible owner.
Worked example
A device fails final inspection because a supplier changed a resin without notice. The correction is to quarantine and rework affected units. The corrective action is to investigate the supplier change, update the supplier agreement and incoming verification, assess regulatory impact, and verify over three lots that failures stop. Simply retraining the inspector would miss the supplier cause.
Traps that cost marks
Closing CAPA at implementation without effectiveness evidence; using the same root cause repeatedly; treating preventive action as a synonym for risk management; and implementing changes without updating documents, training, or validation.