Implementation of quality system in the biomedical laboratories

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SCOPETo study and to diffuse the better strategies for the planning and the validation of inner methods that assure thesignificance of the analytical dataINTRODUCTIONToday the ISO/IEC 17025 and the ISO 15189 are sure the better methodologies and internationally recognized inorder to assure in the biomedical laboratories the appropriatness of the methods and the quality of the analytical dataThe ISO/IEC 17025 standard specifies the general requirements a laboratory has to met if it is to be recognized ascompetent to carry out tests and/or calibrations, including sampling.METHODOLOGY AND RESULTSThe planning of an inner method can be constituted from following is made: Recognition of the requirements of thecustomer; 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 todetermine 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 StandardDeviation RDS, S or CV ; Exactitude (bias); Uncertainty of measure; Robustness in the comparisons of external infuencesand/or sensibility intercrossed in the comparisons of coming from interferences from the matrix of the champion.REFERENCESAdditional Essential Criteria for Quality Systems of Medical LaboratoriesRob T. P. Jansen1, Vic Blaton, David Burnett, Wim Huisman, José M. Queraltó, Simone Zérah and Brian Allman ClinChem Lab Med 1998; 36(4):249–252
Lingua originaleEnglish
Stato di pubblicazionePublished - 2007


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