EN ISO 13485: A clearly defined quality standard in international business
Nowadays, fulfilment of clearly defined quality standards in business – and particularly in international business – is becoming ever more important. Part of this is the ability to adapt to changing markets and customer requirements and constantly develop new learning and improvement processes.
EN ISO 13485, as a quality management system for medical devices, describes requirements for regulatory purposes and describes the development, implementation and maintenance of a quality management system for medical device manufacturers and suppliers.
The standard contains detailed requirements for a quality management system which fulfils both customer requirements and the requirements for all life cycle stages of a medical device, including its components and the original raw materials used in manufacture, along with any related services.