ISO 13485 Quality Management System for Medical Devices

• The Standard can be applied by Organizations involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, repair and provision of corresponding activities (eg. technical support).
• The requirements of ISO 13485 Standard are applicable to Organizations, regardless of their size and type.
• ISO 13485 can also be used by suppliers or external parties that provide medical devices.

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.