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

The management of analytical quality depends on the careful evaluation of the imprecision (uncertainty) and inaccuracy (trueness) of laboratory methods and the application of statistical quality control procedures to detect medically important analytical errors that may occur during routine analysis. A system of quality standards is recommended to incorporate different types of requirements, such as clinical outcome criteria, analytical outcome criteria, and analytical performance criteria. For practical applications, all need to be translated into operating specifications for the imprecision, inaccuracy, control rules, and number of control measurements that are necessary to assure analytical quality during routine production of test results.