Change Control Log Template - ISO 13485
Change Control Log Template - ISO 13485
Template Overview
Template Overview
Maintain full control and traceability of changes within your Quality Management System (QMS) with our ISO 13485:2016 Clause 4.2 Change Control Log Template. Managing document and process changes effectively is essential for ensuring regulatory compliance, risk mitigation, and audit readiness in medical device manufacturing. This structured change control log helps organizations track, assess, and document changes, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, and ISO 14971.
Key Features
Key Features
✔ Pre-Formatted Change Control Log – Covers key ISO 13485:2016 Clause 4.2 requirements.
✔ Change Description & Justification Section – Document what is changing and why.
✔ Impact Assessment & Risk Analysis – Evaluate how changes affect product quality, safety, and compliance.
✔ Approval & Sign-Off Workflow – Assign responsibility for review, approval, and implementation.
✔ Implementation & Verification Tracking – Ensure changes are tested, validated, and properly documented.
✔ Audit-Ready Documentation – Maintain comprehensive records for regulatory inspections.
✔ Editable Digital Format – Fully customizable for various medical device classifications and business needs.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use change control log is ideal for quality managers, regulatory teams, and compliance officers, ensuring a structured, compliant, and traceable change management process.
Download the ISO 13485:2016 Change Control Log Template today and improve your QMS change management 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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