Process Validation Procedure Template - ISO 13485

Ensure consistent, repeatable, and compliant manufacturing processes with our ISO 13485:2016 Clause 7.5 Process Validation Procedure Template. Process validation is critical for demonstrating that manufacturing and production processes consistently produce medical devices that meet regulatory and quality requirements. This structured procedure template provides a systematic approach for planning, executing, and documenting process validation activities, ensuring compliance with ISO 13485:2016, MDR, IVDR, FDA 21 CFR Part 820, and ISO 14971.

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

✔ Validation Planning & Acceptance Criteria – Define process validation scope, parameters, and success metrics.

✔ Installation Qualification (IQ), Operational Qualification (OQ), & Performance Qualification (PQ) – Ensure compliance with validation lifecycle requirements.

✔ Risk-Based Approach & ISO 14971 Integration – Identify potential risks and mitigation strategies.

✔ Revalidation & Change Management Process – Ensure ongoing process control and improvement.

✔ Verification, Documentation & Record-Keeping – Maintain structured audit-ready validation reports.

✔ Approval & Sign-Off Workflow – Assign responsibilities for validation execution and approval.

✔ Editable Digital Format – Fully customizable for different medical device production environments.

This ready-to-use process validation procedure is ideal for quality managers, validation engineers, and regulatory professionals, ensuring a structured, compliant, and effective validation system.

Download the ISO 13485:2016 Process Validation Procedure Template today and enhance your manufacturing quality and compliance!