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The consortium for Standardization in Lab Automation (SiLA) is a not-for-profit membership organization formed by software suppliers, system integrators and pharma/biotech companies. It develops and introduces new device and data interface standards allowing rapid integration of lab automation hardware and data management systems. Highly ...
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.
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).
Laboratory Data Model (LAB) The Lab standard is used for the exchange of laboratory data between labs and CROs; Case Report Tabulation Data Definition Specification (CRT-DDS) Also referred to as "define.xml", a machine readable version of the regulatory submission "define.pdf". Clinical Data Acquisition Standards Harmonization (CDASH) [6]
Green Tea standard reference. Certified reference materials (CRMs) are 'controls' or standards used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments. [1] A certified reference material is a particular form of measurement standard.
A functional specification is a kind of requirement specification, and may show functional block diagrams. [citation needed] A design or product specification describes the features of the solutions for the Requirement Specification, referring to either a designed solution or final produced solution. It is often used to guide fabrication ...
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 ...
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.