Corrective action

A documented response to a monitoring finding that has met an escalation trigger in the PMM plan. Corrective actions range from operational adjustments (updating instructions for use or deployer configurations) through technical modifications (retraining or recalibrating the AI system) to regulatory actions (Article 73 serious-incident reporting or Article 43 re-assessment). All corrective actions must be logged in the monitoring system's records and, where they affect the risk profile or intended purpose of the system, must feed the Article 9 risk management update.

A specific, actionable change made in response to a validated root cause or contributing factor, intended to prevent the failure, or the class of failure it belongs to, from recurring. A corrective action that addresses only the symptom originally observed, rather than a validated cause, is a mitigation, not a fix.

A fix committed in the review, in strict form: a specific change, a named owner, a due date, and a verification of how you will know it worked. Divided into symptom fixes (stop this exact incident) and class fixes (stop the family). An action missing owner, date, or verification is a wish, a someday, or a hope.

The documented steps an organization takes to fix a nonconformity and prevent its recurrence. Minor nonconformities are typically resolved through a corrective-action plan rather than blocking the certificate.

Action taken to eliminate the cause(s) of a nonconformity and to prevent its recurrence (prEN 18286, definition 3.1.6). When an internal audit, management review, post-market monitoring report, or incident investigation finds that a QMS requirement is not being met, the QMS must include a process for raising, investigating, implementing, and verifying corrective actions. The corrective action record is one of the most direct pieces of evidence that the QMS is functioning as a learning system rather than as static documentation.