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Quality Management System (QMS) Folder Structure - ISO 13485

Quality Management System (QMS) Folder Structure - ISO 13485

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ISO 13485:2016 QMS Template - Quality Management System Folder Structure

Enhance your Quality Management System with our ISO 13485:2016 compliant Quality Management System Folder Structure template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
  • Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
  • Compliance Assurance: Utilizing our template helps you maintain an effective folder structure, demonstrating robust quality management as required by ISO 13485:2016.

How Will the Folder Structure Help Me and My QMS?

This folder structure map for your ISO 13485:2016 +A11 2021 Quality Management System is designed to:

  • Keep Your QMS Organized: Provide the right structure to keep your Quality Management System organized and easy to navigate.
  • Clause-by-Clause Breakdown: The folder structure is broken down clause by clause, providing a clear structure for your procedures, records, forms, templates, and archived documents.
  • Facilitate Audits: Correspond to the record collection activities required to demonstrate that your system is working and data is being collected, making it easier for external and internal auditors to find the evidence they need.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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