Nonconformance Management — 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 NC management system covering ISO 13485 §8.3, FDA QMSR §820.90, and MDSAP Chapter 6. Severity-driven response from detection through disposition and CAPA linkage.
What’s included:
- SOP-ISO-08 Nonconformance Management — detection sources, classification (Critical/Major/Minor), containment, RCA, disposition (Use-as-is/Rework/Repair/Scrap/Return/FSCA), CAPA linkage.
- F-ISO-08.1 Nonconformance Report (Word) — full NC lifecycle template with severity matrix, containment actions, RCA, disposition options, closure approvals.
Why this package: NC management is foundational. Without solid NC handling, CAPA and FSCA processes break down. This package operationalizes ISO 13485 §8.3 end-to-end.
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.