Corrective Action Register

This register lists every corrective action (CAPA) and tracks it from opening to effectiveness review and closure. ISO 13485:2016 clause 8.5.2 requires corrective action to be taken without undue delay to eliminate the cause of nonconformities and prevent recurrence, proportionate to their effects, and records of all investigations and actions taken.

What's Inside

• Purpose and Rules
• Status Summary
• CAPA Register
• Root Cause, Owner and Effectiveness
• Open CAPAs — Detail
• Supplier Corrective Action Requests
• Analysis
• Register Review

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clauses 5.6.2 and 8.5.2. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.