Internal Audit — 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 internal audit system covering ISO 13485:2016 §8.2.4, FDA QMSR §820.22, and ISO 19011 best practices. Risk-based audit planning, conduct, and follow-up.
What’s included:
- SOP-CORE-03 Internal Audit — risk-based audit programme planning, auditor independence, audit cycle (planning/conduct/reporting/follow-up), CAPA integration.
- F-CORE-03.1 Annual Audit Programme (Excel) — risk-based programme with prioritization matrix, schedule, status tracking.
- F-CORE-03.2 Audit Plan (Word) — per-audit plan with scope, criteria, methods, schedule.
- F-CORE-03.3 Audit Report (Word) — findings classification (Major/Minor/Observation), audit conclusion.
Why this package: Risk-based internal audits are mandatory under ISO 13485 + EU MDR. This package gives you an end-to-end audit system aligned with surveillance audit expectations.
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.