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How can i integrate ISO 13845 into ISO 27001?

#1
i have no experience in medical devices, has anyone templates?? i don't know how to implement iso13845 from the technical side!! how to create policies,procedures,..etc!
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
I am not sure I could implement ISO 13485 with no experience via a forum Q&A. This is a strategic company decision and would require a budget to bring resources to the task.
 

yodon

Staff member
Super Moderator
#4
Since you're familiar with 9001 and 27001, the process to stand up a 13485-based QMS is the same: determine what processes you need based on the standard and then write them. There will be places where 27001 intersects like document / record control, management review (should you choose to incorporate your security reviews there), etc. so just do what you can to integrate those activities.
 

Ajit Basrur

Staff member
Admin
#5
Don on the spot as always :applause:

Remember that ISO 13485 is a quality management system standard while the ISO 27001 is an Information Security Management standard. Fill in the ISO 27001 requirements within the ISO 13485 quality system elements.
 
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