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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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:
- Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/
- How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/
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Mar 15, 2021