ISO 13485 Corrective and Preventive Action (CAPA) Auditor
Audits medical device QMS Corrective and Preventive Action (CAPA) records against ISO 13485 Clause 8.5.
Notice: engineering verification utility. Use test or de-identified data and verify results independently before relying on them.
How it works
Standard: ISO 13485 Clause 8.5 Corrective Action & Preventive Action
Formula: Verify root cause investigation, action implementation, and effectiveness verification
Checks: Mandatory CAPA lifecycle closure flags
Calculated locally in browser memory; nothing leaves your browser.
Deterministic local-first client-side execution. Provided as-is without warranty.