DIN EN ISO 13485:2015-05

This International Standard specifies requirements for an organization that needs to demonstrate that its quality management system has the ability to manage the life-cycle of medical devices and associated activities consistently to meet customer and appropriate regulatory requirements. It may also be used by suppliers or external parties that provide goods and quality system related services to medical device 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 systems conform to all the requirements of ISO 9001:2008.