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Verification and validation. Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000.
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 ...
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
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 ...
results of laboratory performance testing should connect with field performance; These connections or correlations may be based on published literature, engineering studies, or formal programs such as quality function deployment. Validation of the suitability of the test method is often required. [4]
There are different reasons for performing a round-robin test: determination the reproducibility of a test method or process; verification of a new method of analysis. If a new method of analysis has been developed, a round-robin test involving proven methods would verify whether the new method produces results that agree with the established method.
AOAC International's technical contributions center on the creation, validation, and global publication of reliable analytical test methods.Their areas of focus include, but are not limited to, safety of foods, beverages, dietary supplements, fertilizers, animal feeds, soil and water, and veterinary drugs. [3]
Inspection is a verification method that is used to compare how correctly the conceptual model matches the executable model. Teams of experts, developers, and testers will thoroughly scan the content (algorithms, programming code, documents, equations) in the original conceptual model and compare with the appropriate counterpart to verify how closely the executable model matches. [1]