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Difference between list of internal documents and list of type of records
Looking at the first folder “00”, what is the difference between list of internal documents and list of type of records?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Jul 30, 2020
The list of internal documents are all documents that you will prepare for your Quality management system (documented procedures). Records are documents that arise as a result of some work, testing, reports, and similar.
For more information, please see the following articles:
- 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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