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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.
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.
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Following the increasing of Internet usage in Vietnam, many online encyclopedias were published. The two largest online Vietnamese-language encyclopedias are Từ điển bách khoa toàn thư Việt Nam, a state encyclopedia, and Vietnamese Wikipedia, a project of the Wikimedia Foundation.
ISO standards are thought to represent the best interests and needs of the broader global society. [8] ISO 9001 is a set of standards for quality management systems. [9] ISO 13485 is a set of standards, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. [10]
The Vietnamese Wikipedia (Vietnamese: Wikipedia tiếng Việt) is the Vietnamese-language edition of Wikipedia, a free, publicly editable, online encyclopedia supported by the Wikimedia Foundation. Like the rest of Wikipedia, its content is created and accessed using the MediaWiki wiki software.
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.