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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.
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.
According to the 1999 Standards, [1] validation is the process of gathering evidence to provide "a sound scientific basis" for interpreting the scores as proposed by the test developer and/or the test user. Validation therefore begins with a framework that defines the scope and aspects (in the case of multi-dimensional scales) of the proposed ...
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 ...
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.
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 ...