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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 ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Piping and instrumentation diagram of pump with storage tank. Symbols according to EN ISO 10628 and EN 62424. A more complex example of a P&ID. A piping and instrumentation diagram (P&ID) is defined as follows: A diagram which shows the interconnection of process equipment and the instrumentation used to control the process.
The MP4 file format was generalized into the ISO base media file format (ISO/IEC 14496-12:2004 or ISO/IEC 15444-12:2004), which defines a general structure for time-based media files. It is used as the basis for other file formats in the family such as MP4, 3GP, and Motion JPEG 2000). [8]
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).