ISO 13485 (Clause 4.2) - Document Review Guidance Template
ISO 13485 (Clause 4.2) - Document Review Guidance Template
Template Overview
Template Overview
Maintain compliance with ISO 13485:2016 Clause 4.2 – Documentation Requirements by implementing a structured Document Review Process. Our Document Review Guidance Template provides a standardized approach to reviewing, approving, and maintaining controlled documents within your Quality Management System (QMS), ensuring consistency, traceability, and regulatory compliance.
Key Features
Key Features
✔ Pre-Formatted Document Review Guidance – Covers key ISO 13485:2016 Clause 4.2 requirements.
✔ Step-by-Step Document Review Process – Define responsibilities and approval workflows.
✔ Criteria for Document Acceptance – Ensure documents meet regulatory, quality, and operational requirements.
✔ Version Control & Change Management Guidance – Maintain full traceability of document revisions.
✔ Roles & Responsibilities Section – Assign accountability for document review, approval, and updates.
✔ Audit & Compliance Readiness Checklist – Ensure documentation is QMS and audit-ready.
✔ Editable Digital Format – Fully customizable for different medical device classifications and company requirements.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use guidance template is essential for quality managers, regulatory teams, and document control personnel, helping to streamline document control processes, improve compliance, and enhance operational efficiency.
Download the ISO 13485:2016 Document Review Guidance Template today and ensure a structured, compliant, and effective documentation process!
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Additional information
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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