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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 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.
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 ...
Vietnam Standards (TCVN, Vietnamese: Tiêu chuẩn Việt Nam, lit. 'Standards of Viet Nam'), or the Vietnamese National Standards ( Vietnamese : Tiêu chuẩn Quốc gia Việt Nam , lit. 'National Standards of Vietnam'), are the national standards of Vietnam issued by the Vietnam Standard and Quality Institute , part of the Directorate for ...
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.
Originally, many thước of varying lengths were in use in Vietnam, each used for different purposes. According to Hoàng Phê (1988), [1] the traditional system of units had at least two thước of different lengths before 1890, [2] the thước ta (lit. "our ruler") or thước mộc ("wooden ruler"), equal to 0.425 metres (1 ft 4.7 in), and the thước đo vải ("ruler for measuring ...
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The ISO 13485 standard is a derivative of the ISO 9001 standard. It 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 requirements and regulatory requirements applicable to those devices and services.