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Clinical Chemistry and Laboratory Medicine|November 13, 2019
Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validationRoseri Roelofsen-de Beer, Jos Wielders, Guilaine Boursier, et al.Clinical Chemistry and Laboratory Medicine|January 30, 2023
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics RegulationFlorent J L A Vanstapel, Matthias Orth, Thomas Streichert, et al.Pageof 2