Control of Records Procedure - ISO 13485

Maintain structured, secure, and audit-ready records with our ISO 13485:2016 Clause 4.2 Control of Records Procedure Template. Accurate record-keeping is essential for ensuring traceability, regulatory compliance, and quality system effectiveness in medical device manufacturing. This ready-to-use procedure template provides a systematic approach for managing, storing, and controlling records, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Control of Records Procedure – Covers key ISO 13485:2016 Clause 4.2 requirements.

✔ Record Identification & Classification – Define record types, formats, and required retention periods.

✔ Storage, Access & Security Guidelines – Ensure confidentiality and integrity of electronic and physical records.

✔ Traceability & Retrieval Procedures – Maintain audit-ready documentation for regulatory inspections.

✔ Retention & Disposal Policies – Establish proper procedures for record retention and destruction.

✔ Regulatory Compliance Alignment – Ensure compliance with MDR, IVDR, FDA, and ISO 14971 risk management.

✔ Approval & Sign-Off Workflow – Assign responsibilities for record maintenance and verification.

✔ Editable Digital Format – Fully customizable for different business models and regulatory requirements.

This QMS planning procedure template is ideal for quality managers, regulatory professionals, and senior leadership, ensuring a structured, compliant, and effective approach to QMS development.

Download the ISO 13485:2016 QMS Planning Procedure Template today and strengthen your quality and regulatory compliance strategy!