ISO 13485 vs. ISO 9001
I would like to know what are the similarities and differences between the two standards. I have experience with ISO 9001 and I have to implement ISO 13485. Could I rely to ISO 9001 or I need to get acquainted with this standard in detail?
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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
No, you can not relay completely to ISO 9001:2015 because ISO 13485 does not have the same structure as ISO 9001 (ISO 9001:2015 has 10 sections, while ISO 13485 still have 8). Also, ISO 13485 has some specific requirements (like requirements for sterilization, implantable medical devices, service or installation). So, you need to get acquainted in details with ISO 13485:2016.
For more information please read the following articles:
ISO 9001 vs. ISO 13485 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
What are the ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/
What are the requirements for Production and service provision process in ISO 13485 https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/
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Oct 18, 2019