Document Control Procedure - ISO 13485

Maintain structured, secure, and audit-ready documentation with our ISO 13485:2016 Clause 4.2 Control of Documents Procedure Template. Proper document control is essential for ensuring traceability, version control, and regulatory compliance in medical device manufacturing. This ready-to-use procedure template provides a systematic approach for managing, approving, distributing, and updating controlled documents, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Control of Documents Procedure – Covers key ISO 13485:2016 Clause 4.2 requirements.

✔ Document Creation & Approval Workflow – Define responsibilities for document authorship and authorization.

✔ Version Control & Change Management – Ensure all document revisions are properly recorded and controlled.

✔ Access, Distribution & Retrieval Procedures – Maintain secure and controlled access to documents.

✔ Retention & Obsolescence Management – Establish document archiving, disposal, and review processes.

✔ Regulatory Compliance & Audit Readiness – Align with MDR, IVDR, FDA, and ISO 14971 risk management requirements.

✔ Approval & Sign-Off Sections – Assign responsibility for document verification and compliance tracking.

✔ Editable Digital Format – Fully customizable for various business needs and document management systems.

This control of documents procedure template is ideal for quality managers, compliance officers, and regulatory professionals, ensuring a structured, compliant, and effective document management system.

Download the ISO 13485:2016 Control of Documents Procedure Template today and enhance your QMS documentation and compliance strategy!