Implementation of quality system in the biomedical laboratories

SCOPE To study and to diffuse the better strategies for the planning and the validation of inner methods that assure the significance of the analytical data INTRODUCTION Today the ISO/IEC 17025 and the ISO 15189 are sure the better methodologies and internationally recognized in order to assure in the biomedical laboratories the appropriatness of the methods and the quality of the analytical data The ISO/IEC 17025 standard specifies the general requirements a laboratory has to met if it is to be recognized as competent to carry out tests and/or calibrations, including sampling. METHODOLOGY AND RESULTS The planning of an inner method can be constituted from following is made: Recognition of the requirements of the customer; Planning of the planning; Examination of feasibility; Realization of the plan; Re-examination of the planning; Verification of the planning; Validazione and emission of the method. Validation Parameters: In order to verify that an analytical method is adapted to the measure and therefore validate it is necessary to determine the following parameters: Limit of Rilevabilità (LdR o LOD) and quantification (LOQ) ; Linearity; Sensibility, Field of measure; Selectivity or specificity; Precision (Repeatability and/or Reproducibility) expressed in terms of Standard Deviation RDS, S or CV ; Exactitude (bias); Uncertainty of measure; Robustness in the comparisons of external infuences and/or sensibility intercrossed in the comparisons of coming from interferences from the matrix of the champion. REFERENCES Additional Essential Criteria for Quality Systems of Medical Laboratories Rob T. P. Jansen1, Vic Blaton, David Burnett, Wim Huisman, José M. Queraltó, Simone Zérah and Brian Allman Clin Chem Lab Med 1998; 36(4):249–25