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List of internal and external documents

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Guest user Created:   Mar 15, 2021 Last commented:   Mar 15, 2021

List of internal and external documents

If we have all documents saved in an electronic folder, do we have to have the List of Internal Documents?
What are the external documents?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 15, 2021

Yes, you need to have the List of internal documents. The purpose of this list is to catalogize all documents that have been created for the management system. It doesn't matter if they are in electronic or paper form. This list tells you which documents are currently in use, which version of that document is currently active, and since when. 

External documents are all documents that come into your company and are necessary for your work. This usually includes laws and regulations, contracts with suppliers and customers, and similar.

For more information on this subject, please see the following articles:

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Mar 15, 2021

Mar 15, 2021