Guest
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?
Assign topic to the user
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
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/
Comment as guest or Sign in
Oct 28, 2020
Oct 30, 2020
Oct 30, 2020