Master Document List Template - ISO 13485

Maintain full control over your Quality Management System (QMS) documentation with our ISO 13485:2016 Clause 4.2 Master Document List Template. Proper document management is essential for ensuring traceability, regulatory compliance, and audit readiness, helping medical device manufacturers meet the requirements of ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820. This structured template provides a centralized system for tracking, updating, and organizing controlled documents, ensuring consistency across quality, regulatory, and manufacturing processes.

✔ Pre-Formatted Master Document List – Covers key ISO 13485:2016 Clause 4.2 requirements.

✔ Document Identification & Version Control – Track document numbers, titles, revision history, and owners.

✔ Approval & Review Tracking – Maintain audit-ready records of document approvals and periodic reviews.

✔ Document Classification & Storage Locations – Ensure easy access and retrieval of key compliance records.

✔ Regulatory Alignment with MDR, IVDR & FDA – Keep documents in compliance with global regulatory expectations.

✔ Change Management & Obsolete Document Tracking – Maintain full document lifecycle traceability.

✔ Editable Digital Format – Fully customizable for different business models and QMS requirements.

This ready-to-use document control template is ideal for quality managers, compliance teams, and regulatory professionals, ensuring a structured, compliant, and efficient document management system.

This ready-to-use document control template is ideal for quality managers, compliance teams, and regulatory professionals, ensuring a structured, compliant, and efficient document management system.

Download the ISO 13485:2016 Master Document List Template today and enhance your document control and regulatory compliance!