Corrective and Preventive Action — Process Package (ISO 13485)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Process Package
Complete CAPA system covering ISO 13485:2016 §8.5, FDA QMSR §820.100, and MDSAP Chapter 6. Includes risk-based prioritization (Severity × Frequency × Detectability), root cause analysis methods, effectiveness verification.
What’s included:
- SOP-CORE-04 Corrective and Preventive Action — full CAPA lifecycle with priority assignment (P1/P2/P3), RCA methods (5-Why, Fishbone, FTA), effectiveness verification.
- F-CORE-04.1 CAPA Template (Word) — comprehensive 11-section template covering Initiation, Triage, Risk-Based Prioritization (S×F×D = RPN), Root Cause Analysis, Corrective Actions, Preventive Actions, Effectiveness Verification, Closure.
Why this package: CAPA is the most-cited weakness in FDA inspections and MDSAP audits worldwide. This package implements industry best practices for risk-based CAPA management.
Format: Microsoft Word (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase
€69.00
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Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.