ISO 13485 (Clause 7.5) - Batch History Procedure Template

Maintain accurate and compliant batch records in your medical device manufacturing process with our ISO 13485:2016 Clause 7.5 Batch History Procedure Template. Proper batch history documentation is essential for ensuring product traceability, quality control, and regulatory compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR. This structured procedure provides a standardized approach to documenting manufacturing processes, inspections, and approvals, ensuring audit-ready compliance.

✔ Pre-Formatted Batch History Procedure – Covers key ISO 13485:2016 Clause 7.5 requirements.

✔ Batch Identification & Documentation Process – Define steps for recording batch details, product names, and production dates.

✔ Manufacturing Process Tracking – Ensure accurate documentation of materials, equipment, and operators involved.

✔ Inspection & Quality Control Requirements – Outline procedures for verifying compliance with acceptance criteria and testing protocols.

✔ Deviation & Non-Conformance Handling – Establish procedures for documenting discrepancies and corrective actions.

✔ Final Batch Release & Approval Workflow – Define responsibilities for batch approval and sign-offs.

✔ Traceability & Record-Keeping Guidelines – Maintain audit-ready documentation for regulatory inspections.

✔ Editable Digital Format – Fully customizable for various medical device manufacturing processes.

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

Download the ISO 13485:2016 Batch History Procedure Template today and enhance your manufacturing traceability and regulatory compliance!