UNE-EN ISO 13485:2016

This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle including the design and development, production, storage and distribution, installation, or servicing of a medical device and the design, development or provision of associated activities (e.g. technical support). The quality management system of the organization demonstrates the ability to consistently meet customer and applicable regulatory requirements. It may also be used by suppliers or external parties that provide goods and quality management system related services to such organizations.The main objective of this International Standard is to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations providing medical devices. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001:2008 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001:2008 unless their quality management system conforms to all the requirements of ISO 9001:2008.