ISO 13485
What is ISO 13485?
The ISO 13485 standard sets a frame for a quality management system for medical devices. It is the most important standard for medical devices.
ISO 13485:2016 standard sets frames for a quality management system of an organization involved in the life cycle of medical devices. The standard focuses on the requirements that an organization must meet to indicate that the medical device the organization manufactures and and/or its other activities comply with the requirements of the relevant regulations and the customer needs.
The quality management system requirements defined in the standard support the product’s technical, safety and performance requirements, which arise from customer needs and legal requirements. ISO 13485 contains requirements for quality management systems and its related document control, management, managements responsibility, resource management, product realization as well as measurement, analysis, and improvement.
Certification of ISO 13485 quality management system
Organizations involved in the medical device operator chain (manufacturers, distributors, and subcontractors) can certify their quality management system if they wish, i.e., get it evaluated by an external party and have a certificate issued by it. For manufacturers of medical devices, the certification of the quality management system is part of the conformity assessment carried out by the notified body according to the regulations. A certified, ISO 13485 standard compliant quality management system is a requirement – set by EU legislation for the manufacturers of IIa, IIb and III class devices (MDR) or B, C, D (IVDR) class devices.