The need for a system of quality standards for modern quality management

The management of analytical quality depends on the careful evaluation of t he imprecision (uncertainty) and inaccuracy (trueness) of laboratory method s and the application of statistical quality control procedures to detect m edically important analytical errors that may occur during routine analysis . A system of quality standards is recommended to incorporate different typ es of requirements, such as clinical outcome criteria, analytical outcome c riteria, and analytical performance criteria. For practical applications, a ll need to be translated into operating specifications for the imprecision, inaccuracy, control rules, and number of control measurements that are nec essary to assure analytical quality during routine production of test resul ts.