CAPA SOP + Template — ISO 13485, MDSAP & FDA QMSR Compliant

Process Package — Corrective and Preventive Action (CAPA)

A complete CAPA system covering ISO 13485:2016 §8.5.2–8.5.3, MDSAP Chapter 1–2, and FDA QMSR expectations. CAPA is the most-cited finding area in regulatory audits — this package addresses it head-on with a lifecycle-complete template and a procedure that integrates risk-based prioritization.

What’s included:

• SOP-CORE-04 CAPA — full procedure with 9-stage lifecycle (Initiation → Triage → Prioritization → RCA → Action Plan → Implementation → Effectiveness → Closure → Reporting), risk-based prioritization with RPN (Severity × Frequency × Detectability), 6 RCA methodologies, integration with vigilance and audit findings.
• F-CORE-04.1 CAPA Template (Word, 11 pages) — single combined template covering ALL CAPA stages: Section 1 Initiation+Source, Section 2 Triage+Containment, Section 3 Risk Prioritization with explicit S/F/D scoring, Section 4 RCA (5-Whys AND Ishikawa 6M categories), Section 5 Action Plan, Section 6 Implementation, Section 7 Effectiveness Verification (post-implementation periods per priority), Section 8 Closure with lessons learned.

Why this package: CAPAs are where audits fail. This template guides users through the steps most often executed weakly: Root Cause Analysis (S4) and Effectiveness Verification (S7). P1/P2/P3 prioritization automates resource allocation. Lessons-learned linkage to Management Review closes the loop.

Format: Microsoft Word
Updated: May 2026 — includes FDA QMSR (Feb 2026) alignment
Delivery: Instant download after purchase