Document Control SOP + Templates — ISO 13485 & MDSAP Compliant

Document Control SOP + Templates — ISO 13485 & MDSAP Compliant

€69.00

SKU MDSAP-CORE-01 Categories , Tags , , , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

Process Package — Document and Record Control

A complete, audit-ready document control system covering all requirements of ISO 13485:2016 §4.2.4–4.2.5, MDSAP Chapter 1, and 21 CFR Part 11 for electronic records.

What’s included:

  • SOP-CORE-01 Document and Record Control — full standard operating procedure with cover page, control page, responsibilities matrix, document hierarchy, lifecycle workflow, periodic review process, retention table by jurisdiction, KPIs and 5 annexes including a complete document hierarchy reference.
  • F-CORE-01.1 Document Master List (Excel) — the single authoritative index of all controlled QMS documents, with conditional formatting for review dates, status dropdowns (Current / Under Revision / Obsolete / Draft), and a Tier Reference sheet for code consistency.
  • F-CORE-01.2 Document Change Request Form (Word) — DCO workflow from request through review, approval and distribution.
  • F-CORE-01.3 Record Destruction Authorization (Word) — with Legal Hold check and retention verification.

Why this package: Document control is the foundation of any QMS audit. This package gives you a system that survives both ISO 13485 surveillance audits and MDSAP audits, without rework when entering new markets.

Format: Microsoft Word + Microsoft Excel (fully editable)
Updated: May 2026 — reflects the latest QMSR transition (Feb 2026)
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.