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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 ...
This template is within the scope of WikiProject Engineering, a collaborative effort to improve the coverage of engineering on Wikipedia. If you would like to participate, please visit the project page, where you can join the discussion and see a list of open tasks. Engineering Wikipedia:WikiProject Engineering Template:WikiProject Engineering ...
The sections of a user manual often include: A cover page; A title page and copyright page; A preface, containing details of related documents and information on how to navigate the user guide; A contents page; A Purpose section. This should be an overview rather than detail the objective of the document
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).
Geometrical Product Specification and Verification (GPS&V) [1] is a set of ISO standards developed by ISO Technical Committee 213. [2] The aim of those standards is to develop a common language to specify macro geometry (size, form, orientation, location) and micro-geometry (surface texture) of products or parts of products so that the language can be used consistently worldwide.
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