Supplier 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 supplier management system covering ISO 13485 §7.4, EU MDR Art. 10(9), 21 CFR 820.50, MDSAP Chapter 4. 3-tier classification (Critical/Significant/Standard).
What’s included:
- SOP-ISO-22 Supplier Management — qualification, classification, performance monitoring, re-evaluation cycle.
- F-ISO-22.1 Supplier Evaluation Form (Word) — initial qualification + periodic re-evaluation.
- F-ISO-22.2 Approved Supplier List (Excel — 3 tabs) — master register with 6 sample suppliers, dual conditional formatting (Classification + Status).
- F-ISO-22.3 Supplier Quality Agreement (Word) — bilateral agreement with 17-row M/S/B responsibility matrix, notification timelines (60d/90d/24h/48h), audit rights, retention.
Why this package: Supplier issues cause downstream NCs and complaints. This package gives you an end-to-end supplier qualification + quality agreement 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.