What is ISO 13485 certification? ISO 13485 Standard includes the requirements for the implementation of a Quality Management System for medical devices. The structure of the Standard and the requirements are similar to those of international Quality Standard ISO 9001. Their main differences are the requirements for monitoring records for each product, the risk management in all process stages, the monitoring of infrastructure maintenance, the documented procedures for the work environment, the service provision, the customer feedback as well as keeping interested parties informed.