DIN EN ISO 13485:2016-08

The standard has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" (secretariat: ANSI, USA), in collaboration with Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" (secretariat: NEN, Netherlands) with the collaboration of German experts. The responsible national committee is Working Committee NA 063-01-13 AA "Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte" ("Quality management and corresponding general aspects for medical devices") at DIN Standards Committee Medicine (NAMed). The standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including development, production, storage and distribution, installation, or servicing of a medical device and development or provision of associated activities. This standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Fundamental technical revision has been carried out compared to DIN EN ISO 13485:2012-11. This includes in particular: - adaptation to ISO 9001:2008; - revision of the definitions; - revision of the documentation requirements; - integration of a risk-based approach; - inclusion of requirements for validation of the use of computer software; - revision of requirements for infrastructure as well as working environment; - expansion of requirements for product realization; - revision of requirements for measurement, analysis and improvement. The relationship between ISO 13485:2016 and ISO 9001:2015 is presented in an informative annex. The standard supports essential requirements of EU Directives 90/385/EEC on active implantable devices, 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostic medical devices.