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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 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 ...
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 ...
ON Semiconductor Awarded ISO 13485 Certification for its Advanced Packaging Facility Quality management system standard signifies company's design and manufacturing procedures and capabilities for ...
ModusLink Receives ISO 13485 Certification for Medical Device Manufacturers —Leading manufacturers of consumer-oriented medical devices certify ModusLink according to their ISO-based quality ...
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.
Roki Sasaki strikes out 5, tops out at 99 mph in Dodgers spring training debut. Weather. Weather. AccuWeather. Early March storm to raise flood risk in Northeast US, southern Canada. Weather.
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related to: iso 13485 certification