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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).
ISO/IEC 14908-2:2012 Part 2: Twisted pair communication; ISO/IEC 14908-3:2012 Part 3: Power line channel specification; ISO/IEC 14908-4:2012 Part 4: IP communication; ISO 14915 Software ergonomics for multimedia user interfaces ISO 14915-1:2002 Part 1: Design principles and framework; ISO 14915-2:2003 Part 2: Multimedia navigation and control
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
Download QR code; Print/export Download as PDF; Printable version; In other projects ... ISO 18000 – ISO 19999; ISO 20000 – ISO 99999. ISO 20000 – ISO 21999;
The International Organization for Standardization (ISO / ˈ aɪ s oʊ /; [3] French: Organisation internationale de normalisation) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries.
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 Standard ISO 15189:2007 for Accreditation of Medical Laboratory requires laboratories to continuously monitor and improve the quality of their facilities. [107] Advantages: [108] [109]
[7] [8] The ISO 9000 series of standards are probably the best known international standards for quality management, though specialized standards such as ISO 15189 (for medical laboratories) and ISO 14001 (for environmental management) also exist. [9] The business meanings of quality have developed over time. Various interpretations are given ...