Device History Record Procedure - ISO 13485

Ensure accurate, compliant, and audit-ready documentation of your medical device manufacturing process with our ISO 13485:2016 Clause 7.5 Device History Record (DHR) Procedure Template. A well-maintained DHR is essential for tracking each manufactured device, ensuring traceability, quality control, and regulatory compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR. This structured procedure provides a clear framework for managing DHR documentation, ensuring full traceability of manufacturing processes, materials, and inspections.

✔ Pre-Formatted Device History Record (DHR) Procedure – Covers key ISO 13485:2016 Clause 7.5 requirements.

✔ Step-by-Step DHR Documentation Process – Define requirements for recording manufacturing data, inspections, and test results.

✔ Lot & Serial Number Traceability – Ensure all products are tracked from production to distribution.

✔ Material & Component Documentation – Maintain records of raw materials and supplier details.

✔ In-Process & Final Inspection Logs – Ensure quality compliance through recorded test results.

✔ DHR Approval & Sign-Off Process – Assign responsibility for documentation review and release.

✔ Audit-Ready Format – Maintain structured, compliant, and accessible DHR records.

✔ Editable Digital Format – Fully customizable for different medical device classifications and production models.

This ready-to-use procedure template is ideal for quality managers, production teams, and regulatory professionals, ensuring structured, compliant, and traceable device history documentation.

Download the ISO 13485:2016 Device History Record (DHR) Procedure Template today and enhance your manufacturing traceability and regulatory compliance!