The article considers the structure of analytical errors in clinical diagnostic laboratory analysis from the position of GOST R ISO 15189-2009 "Laboratories of medicine. Particular requirements to quality and competence". The key value of metrologic traceability of analyses is emphasized. The role of official standard patterns, control materials and statistical methods applied in quality analysis are discussed. The international experience and applied methodical procedures to implement requirements of ISO 15189 concerning validation and verification of analytical quality are presented. The approaches of protocols E3 23-A, ER 15-A2, N59-A in the sphere of USA laboratory medicine developed by the institute of clinical and laboratory standards are demonstrated. The review of referent patterns and methods is given. The problem of optimization of requirements to quality of production for laboratory diagnostic is discussed. The expedience of organization of the National institute of laboratory standards is substantiated.