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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 +A11 2021

Quality Management System Folder Structure

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which, then be modified to suit your company branding/marketing requirements.

How will the folder structure help me and my QMS? 

This folder map for your ISO 13485: 2016 +A11 2021 Quality Management System have been designed to provide you with the right structure to keep your QMS organised and easy to navigate through.

The folder structure is broken down clause by clause, giving a structure for your procedures, records, forms, templates and archived documents.

These folders correspond to the record collection activities required to demonstrate that the system is working and data is being collected when your ISO 13485:2016 come up for audit. The external and internal auditors will be able to find what they need for their evidence with ease. 

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at

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