CAPA ISO 13485 SOP & Template — MDSAP, FDA QMSR (Word)

CAPA ISO 13485 SOP & Template for FDA QMSR & MDSAP

This  CAPA ISO 13485 process package gives medical device manufacturers a complete, audit-ready corrective and preventive action system covering ISO 13485:2016 §8.5.2–8.5.3, FDA QMSR §820.100 (effective February 2026), and MDSAP expectations. It implements risk-based CAPA management the way auditors expect to see it — with priority assignment, structured root cause analysis, and documented effectiveness verification.

CAPA is the single most-cited weakness in FDA inspections and MDSAP audits worldwide. This package addresses it head-on, so your ISO 13485 corrective and preventive action process holds up under scrutiny.

What’s included

• SOP-CORE-04 — Corrective and Preventive Action (CAPA) Procedure: the full CAPA lifecycle with priority assignment (P1 / P2 / P3), root cause analysis methods (5-Why, Fishbone, Fault Tree Analysis), and effectiveness verification.
• F-CORE-04.1 — CAPA Template (Word): a comprehensive 11-section template covering Initiation, Triage, Risk-Based Prioritization (Severity × Frequency × Detectability = RPN), Root Cause Analysis, Corrective Actions, Preventive Actions, Effectiveness Verification, and Closure.

Risk-based CAPA prioritization

Unlike generic CAPA forms, this package applies a risk-based model — Severity × Frequency × Detectability (RPN) — to prioritize each CAPA as P1, P2 or P3. This is exactly the kind of objective, documented prioritization that Notified Bodies and MDSAP Auditing Organizations look for under ISO 13485 §8.5.

Regulatory alignment

The package satisfies the corrective and preventive action requirements of ISO 13485:2016, the FDA Quality Management System Regulation (QMSR, 21 CFR 820.100), and MDSAP — and reflects the latest MDCG guidance and EU MDR expectations. It is suitable for QMS build-out, remediation of audit findings, and preparation for FDA inspection or MDSAP certification.

Format & delivery

• Format: Microsoft Word — fully editable
• Updated: May 2026 — reflects EU MDR, FDA QMSR (Feb 2026) and the latest MDCG guidance
• Delivery: instant download after purchase
• Author: developed by a former Notified Body auditor and ISO 13485 Lead Auditor