ISO 14971

ISO 14971 describes a process for identifying hazards, estimating and evaluating risk, controlling risk, and watching production and post-production information.

ISO 13485 requires risk management throughout the quality system and points at ISO 14971. MDSAP task 1.7 samples planning and review of that process. The risk management file is not the same document as a CAPA, though a CAPA can change a risk control.

HAVGATE does not publish a standalone risk-management authoring module. Audit tasks can sample an existing risk file. Record the file's location in the finding if the auditor reviewed it.