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.
ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.