Incoming Inspection and Control — 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 incoming inspection system covering ISO 13485 §7.4.3, 21 CFR 820.80, ANSI/ASQ Z1.4 (sampling).
What’s included:
- SOP-ISO-25 Incoming Inspection and Control — sampling plans, CoA review, disposition (Accept/Quarantine/Reject), supplier feedback (SCAR).
- F-ISO-25.1 Incoming Inspection Plan and Report (Excel — 4 tabs) — 4 sample materials with sampling approaches (100%, AQL, reduced, CoA-only), 3 sample lot records.
- F-ISO-25.2 CoA / CoC Review Record (Word) — side-by-side specs vs CoA review for critical materials.
Why this package: Incoming inspection prevents downstream NCs. This package gives you a complete inspection + CoA review system.
Format: Microsoft Word | Excel (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.