Quality Policy Template - ISO 13485
Quality Policy Template - ISO 13485
Template Overview
Template Overview
Establish a clear, structured, and compliant Quality Policy with our ISO 13485:2016 Clause 5.3 Quality Policy Template. A well-defined Quality Policy is essential for ensuring organizational commitment to product safety, regulatory compliance, and continuous improvement in medical device manufacturing. This ready-to-use template provides a systematic framework to develop a policy that aligns with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820 requirements.
Key Features
Key Features
✔ Pre-Formatted Quality Policy Template – Covers key ISO 13485:2016 Clause 5.3 requirements.
✔ Commitment to Quality & Regulatory Compliance – Ensure alignment with medical device safety and effectiveness.
✔ Customer Focus & Continuous Improvement Principles – Emphasize product quality, risk management, and compliance.
✔ Organizational Responsibilities & Leadership Commitment – Clearly define management accountability.
✔ Integration with Quality Objectives & QMS – Link the Quality Policy to measurable goals.
✔ Audit-Ready Documentation & Regular Review Section – Maintain compliance through periodic updates.
✔ Editable Digital Format – Fully customizable for different business sizes and operational needs.
Why choose a QMS Template?
Why choose a QMS Template?
This Quality Policy template is ideal for quality managers, regulatory teams, and senior leadership, ensuring a structured, compliant, and effective quality commitment statement.
Download the ISO 13485:2016 Quality Policy Template today and strengthen your QMS compliance and business credibility!
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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