Guest user Created: Oct 28, 2020 Last commented: Oct 30, 2020

Procedure for document and record control- the incoming mail register

Please can you assit me. With regards to the Procedure for document and record control- the incoming mail register.. I do not see an appendix for this document? Must I create it? Also how necessary is this section if there is only the managing director of the company and no other employees?

Tags: Product: ISO 13485/Procedure for Document and Record Control

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Kristina Zvonar Brkić Oct 30, 2020

No, there is no requirement in the ISO 13485:2016 standard to create an incoming mail register, especially for a small company like yours.

Here are some useful articles regard the documentation control:

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/
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/

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Oct 28, 2020

Oct 30, 2020

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