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La Rivista Italiana della Medicina di Laboratorio 2020 Marzo;16(1):50-9

DOI: 10.23736/S1825-859X.20.00046-8

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: Italian

ISO accreditation of sampling points and networked laboratories

Marco PRADELLA

SIPMeL, Castelfranco Veneto, Treviso, Italia



The SIPMeL Q12BC1 recommendation document represents the transposition of the ISO/TS 20658: 2017 standard and highlights its most significant and perhaps critical points, in light of the exponential increase in the sampling points for laboratory tests, the evaluation of which for accreditation may present significant difficulties. SIPMeL recommendations for sampling points and networked laboratories can be used as of now for ISO management and accreditation. ISO/TS 20658: 2017 takes up the ISO 15189 standard points relevant for the pre-examination phase, provides some details and examples, helps not to neglect them in the accreditation assessments. The SIPMeL recommendations consider that ISO has built an entire package of standards for the pre-examination phase, in particular for tests with molecular techniques and for devices to be used for sampling, as well as the recent European EFLM recommendations for venous sampling. SIPMeL also reports critical points such as the pre-examination processes relevant to the execution laboratory, the availability of first aid measures and the continuous training of personnel (ECM), the IT infrastructure and its suppliers, the labeling and acceptance phases or refusal of unsuitable samples, finally quality indicators such as the number of inappropriate requests for examinations.


KEY WORDS: Accreditation; ISO 15189; ISO 20658, Sampling

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