Quality Management System (QMS) Folder Structure - ISO 13485
Quality Management System (QMS) Folder Structure - ISO 13485
Template Overview
Template Overview
Ensure efficient, structured, and compliant document management with our ISO 13485:2016 Folder Structure Download. Proper organization of Quality Management System (QMS) documentation is essential for maintaining traceability, audit readiness, and regulatory compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820. This pre-configured folder structure provides a logical, easy-to-use format to help manufacturers manage policies, procedures, records, and technical documentation effectively.
Key Features
Key Features
✔ Pre-Organized Folder Hierarchy – Aligned with ISO 13485:2016 QMS requirements.
✔ Dedicated Folders for Key Documentation:
✔Quality Manual & Procedures (Clause 4.2)
Risk Management & ISO 14971 Compliance
✔Design & Development Records (Clause 7.3)
✔Supplier & Purchasing Documentation (Clause 7.4)
✔Production & Process Control Files (Clause 7.5)
✔Post-Market Surveillance & CAPA Records (Clause 8.2 & 8.5)
✔ Consistent Naming & Filing System – Improve document accessibility and version control.
✔ Editable & Customizable Format – Adaptable for different device classifications and company needs.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use folder structure is ideal for quality managers, regulatory teams, and manufacturers, ensuring efficient, structured, and audit-ready document management.
Download the ISO 13485:2016 Folder Structure today and simplify your QMS documentation process!
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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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