NC Management Bundle – ISO 13485 & FDA 21 CFR 820.90 Compliant

Complete 7-document toolkit for nonconforming product control. Includes SOP, forms, tracking log with dashboard, and a filled example showing best practices.

What's included:

✅ NC SOP – Complete procedure for identification, segregation, and disposition (5 pages)

✅ NC Form – Comprehensive NCR template with all required sections

✅ NC Example (PDF) – Filled example with realistic scenario and learning points

✅ NC Tracking Log (Excel) – Master register with KPI dashboard and auto-calculations

✅ NC Assessment Matrix (Excel) – Classification guide and disposition decision tree

✅ NC-to-CAPA Guide – When and how to escalate nonconformities to CAPA

✅ Quick Reference Card – One-page NC process overview

Compliance: ISO 13485:2016 Clause 8.3 | FDA 21 CFR 820.90

Format: Editable .docx, .xlsx, and .pdf files