ISO 13485 - Check List
ISO 13485 - Check List
Template Overview
Template Overview
Ensure your medical device Quality Management System (QMS) meets ISO 13485:2016 requirements with our ISO 13485:2016 Checklist Template. This comprehensive checklist provides a structured framework to help organizations assess compliance, identify gaps, and implement corrective actions, ensuring readiness for certification, audits, and regulatory inspections. Designed for manufacturers, quality teams, and regulatory professionals, this checklist simplifies QMS implementation and maintenance.
Key Features
Key Features
✔ Pre-Formatted ISO 13485:2016 Compliance Checklist – Covers all clauses and requirements.
✔ Clause-by-Clause Compliance Tracking – Evaluate documentation, processes, and implementation status.
✔ Gap Analysis & Corrective Action Tracking – Identify non-conformities and plan improvements.
✔ Risk-Based Approach & Process Validation – Ensure compliance with ISO 14971 risk management principles.
✔ Internal Audit & Certification Readiness Section – Track audit results, findings, and corrective actions.
✔ Regulatory Alignment with MDR, IVDR & FDA – Ensure conformity with global medical device regulations.
✔ Editable Digital Format – Fully customizable for different QMS scopes and business needs.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use checklist is ideal for quality managers, regulatory consultants, and auditors, ensuring an organized, structured, and efficient approach to ISO 13485 compliance.
Download the ISO 13485:2016 Checklist Template today and streamline your certification process with confidence!
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Additional information
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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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For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.