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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
The sub-clause 7.3.10 of ISO 13485:2016 requires a manufacturer of a medical device to maintain (and control) a design and development file for a medical device to document the design history of a medical device. This file shall also contain records for changes in design and development (per device type or family).
ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 ...
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
The International Organization for Standardization (ISO / ˈ aɪ s oʊ /; [3] French: Organisation internationale de normalisation; Russian: Международная организация по стандартизации) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member ...
Download as PDF; Printable version; In other projects Wikimedia Commons; Wikidata item; ... ISO 18000 – ISO 19999; ISO 20000 – ISO 99999. ISO 20000 – ISO 21999;
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.