ISO 13485 – ISO 9001 Differences Include: Background This is going to be a relatively high level summary of the differences, and for any company needing to implement ISO 13485, I highly recommend conducting an in depth Gap Analysis between your ISO 9001 QMS and the requirements of ISO 13485, before starting the implementation process. This encouraged me to write this article, and outline the key differences between the two standards, that should be considered by any company who has a ISO 9001:2015 QMS, and wants to meet the medical device quality management system requirements and obtain ISO 13485:2016 Certification. Although, if a company already has a quality management system in place and certified to ISO 9001, it should take less effort to implement ISO 13485 than starting from scratch, but there are still some significant differences between the two standards that will likely need to be addressed. The reality is of course that it will almost certainly involve more effort than just booking a certification audit.
In my experience helping company’s implement the ISO 13485 Quality Management System, I have come across those that already have a ISO 9001 quality system in place, and they believe it should only involve a certification audit to achieve implementation of ISO 13485 and obtain Certification. (Lead Auditor & Trainer – ISO 13485:2016 – MD-QMS)
