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ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
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).
CLSI participates in the development of international standards as the Secretariat of ISO Technical Committee (TC) 212, clinical laboratory testing and in vitro diagnostic test systems. This responsibility was delegated to CLSI by the American National Standards Institute (ANSI), an ISO member body. CLSI also serves as the administrator for the ...
Issued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration. CoC
An example of a Levey–Jennings chart with upper and lower limits of one and two times the standard deviation. A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well. The distance from the mean is measured in standard deviations.
It is built to connect systems in a laboratory, such as laboratory information management systems, electronic lab notebooks, chromatography software and laboratory devices such as balances, pipettors and various other analytical instruments. Enhancing the first standard SiLA 1.x by adopting proven concepts and applying already existing open ...
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.