ISO 13485 (Clause 7.5) - Batch History Record Template

Maintain full traceability and regulatory compliance in medical device manufacturing with our ISO 13485:2016 Clause 7.5 Batch History Record Template. Batch history records (BHR) are essential for documenting the manufacturing, testing, and release of each product batch, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR. This structured template provides a systematic approach to batch documentation, ensuring that all critical processes and quality checks are recorded accurately.

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

✔ Batch Identification & Product Details Section – Record batch number, product name, and production date.

✔ Manufacturing Process Documentation – Track key steps, equipment used, and operator details.

✔ Inspection & Quality Control Logs – Ensure compliance with acceptance criteria and testing requirements.

✔ Non-Conformance & Deviation Reporting – Document any discrepancies and corrective actions taken.

✔ Final Batch Release & Approval Section – Capture release authorization and sign-offs.

✔ Audit-Ready Record Keeping – Maintain full compliance for regulatory inspections and product recalls.

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

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

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