Alliance of IVD manufacturer and medical laboratory for quality control of results
Pradella Marco
doaj +1 more source
การศึกษาครั้งนี้มีวัตถุประสงค์เพื่อศึกษา (1) กระบวนการก่อนการขอรับรองระหว่างการดําเนินการขอรับรอง และหลังการได้รับการรับรองคุณภาพตามมาตรฐาน ISO 15189:2012 และ (2) การจัดทําต้นแบบการจัดการคุณภาพตามมาตรฐาน ISO 15189:2012 ของห้องปฏิบัติการทางการแพทย์ กรณีศ ...
เหมือนฝัน วงศ์สุนทรเกษม
core +1 more source
Integration of the ISO 15189 quality management system in the undergraduate internship teaching of medical laboratory technology. [PDF]
Ma N +5 more
europepmc +1 more source
Trends in the Accreditation of Medical Laboratories by ISO 15189
In areas such as transfusion, transplantation, and sports medicine, laboratory results are critical to the diagnosis of pathologies. In order to minimize intra- and interlaboratory variability of results, it is equally important to harmonize quality management and technical practices in the medical laboratory.
openaire +1 more source
A Hybrid Qualitative-Quantitative FMEA Model for Risk Management in Clinical Laboratory Automation: A Case Study Integrating ISO 15189:2022. [PDF]
Wei M, Li M, Lin Y, Li B, Xue H, Xia Y.
europepmc +1 more source
Introduction. The ISO 15189:2022 standard guides the implementation of a specific quality management system for clinical laboratories. This standard allows you to obtain accreditation and demonstrate technical competence to ensure high-quality patient ...
Escobar, Miryam +3 more
core
The 'Double Helix' model of quality monitoring: Risk mapping of quality management system during initial ISO 15189 Implementation in a medical laboratory. [PDF]
Yang S, Zhou Y, Wang C, Luo M.
europepmc +1 more source
Risk management in POCT blood glucose monitoring: FMEA approach aligned with ISO 15189:2022. [PDF]
Luan X +6 more
europepmc +1 more source
Implementation of an ISO 15189 accredited next generation sequencing service for cell-free total nucleic acid (cfTNA) analysis to facilitate driver mutation reporting in blood: the experience of a clinical diagnostic laboratory. [PDF]
Werner R +6 more
europepmc +1 more source
Hybrid Mentorship of Medical Laboratories to Achieve ISO 15189:2012 Accreditation in Malawi: The University of Maryland Malawi Experience. [PDF]
Moyo H +22 more
europepmc +1 more source

