Quality Manual Template - ISO 13485

Develop a fully compliant and structured Quality Management System (QMS) with our ISO 13485:2016 Clause 4.2 Quality Manual Template. A Quality Manual is essential for outlining your organization’s commitment to quality, regulatory compliance, and process management, ensuring alignment with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820. This ready-to-use template provides a clear framework to document your QMS scope, objectives, procedures, and responsibilities, making it easier to achieve and maintain certification.

✔ Pre-Formatted Quality Manual Template – Covers key ISO 13485:2016 Clause 4.2 requirements.

✔ QMS Scope & Organizational Structure – Define business operations and quality objectives.

✔ Roles & Responsibilities of Key Personnel – Ensure accountability and leadership commitment.

✔ Documented Procedures & Process Interactions – Provide a structured overview of QMS workflows.

✔ Regulatory Compliance & Risk Management – Align with ISO 14971 risk-based approaches.

✔ Audit-Ready Documentation & Continuous Improvement Strategy – Maintain structured records for regulatory inspections.

✔ Approval & Sign-Off Sections – Assign responsibility for QMS oversight and verification.

✔ Editable Digital Format – Fully customizable for various medical device businesses and QMS scopes.

This Quality Manual Template is ideal for quality managers, regulatory teams, and medical device manufacturers, ensuring a structured, compliant, and effective QMS foundation.

Download the ISO 13485:2016 Quality Manual Template today and simplify your QMS implementation and certification process!