Are definitive (reference) methods and Shewhart's principle the best approach towards accuracy?

The current state of quality control in clinical chemistry cannot be characterized as good; the appropriate description is acceptable. This statement is illustrated by results from quality control programmes. The influence of the matrix in which the analyte is embedded points to serious analytical deficiencies in the methods used in clinical chemistry. The abundant application of statistics is criticized and it is argued that such application can be avoided by improving the accuracy and precision of the analytical methods. Difficulty in defining a definitive method results from accuracy and 'true value' not being determinate. The approved IFCC definition of the reference method and the connection between this definition and the basis of quality control in clinical chemistry is discussed. The pioneering work of Shewhart on quality control in industry in the 1930s is revealed. It is pointed out that the main principle of this method, a continuous process of tracing and eliminating assignable sources of variation, should be the aim of quality control in clinical chemistry.