All documents required by QMS for ISO13485

This is not the list of internal documents. This is just a form where each manufacturer needs to put all their internal documents: https://advisera.com/9001academy/documentation/list-internal-documents/

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 article:

• 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/

If you need a list of all documents that is necessary to prove the compliance with ISO 13485:2016, please see following article:

• List of mandatory documents required by ISO 13485:2016 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

List of all documents that are part of our documentation toolkit, you can find on this link, under the headline Toolkit documents:

• ISO 13485:2016 Documentation Toolkit https://advisera.com/13485academy/iso-13485-documentation-toolkit/