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ISO 15189. 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 quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory. Quality control (QC) is a measure of precision, or how well the measurement system reproduces the ...
ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but require the laboratory to justify using a particular method. In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant ...
The OECD Principles of Good Laboratory Practice (GLP) cover the testing of chemicals or chemical products in non-clinical settings, either in laboratory conditions or environmental settings, such as greenhouses and field experiments. These principles exclude studies involving human subjects.
Analytical quality control. Analytical quality control (AQC) refers to all those processes and procedures designed to ensure that the results of laboratory analysis are consistent, comparable, accurate and within specified limits of precision. [1] Constituents submitted to the analytical laboratory must be accurately described to avoid faulty ...
Jeremy Gruber, Council for Responsible Genetics In the US, newborn screening (NBS) is mandated in all states, though parents may decline the screening process based on religious beliefs or philosophical reasons in some states. Few parents opt of the program due to health concerns, and a lack of awareness of the ability to opt-out. After the initial testing is complete, the residual dried blood ...
ISO 9000 family. The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) which help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. [1]
Clinical and Laboratory Standards Institute. The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.