Introduction of Sysmex Activities and Services for Quality Assurance of Clinical Tests

Abstract

　Sysmex Corporation is a leading provider of analyzers, reagents, and quality-controlled samples for various fields of testing, including Hematology, Urinalysis, Hemostasis, Immunology, and Life Science. We also supply controls for Clinical Chemistry and Serology to laboratories that perform specimen examinations in Japan.

　In addition to our product offerings, we provide comprehensive services to support quality assurance in laboratories. These services include assistance with ISO 15189 certification, calibration of blood cell analyzers, and external quality assessments across all testing fields. By offering these services, we aim to instill confidence in laboratories and help them maintain and improve the quality of their specimen examinations.

　In this article, we will focus on two key efforts in our quality assurance services:

　External Quality Assessment Management: We utilize a network-based system to manage external quality assessments.

　Quality Management Systems (QMS) for quality assurance services: Our quality management systems for quality assurance services have been certified by three international standards; ISO/IEC 17043, ISO/IEC 17025, and ISO 15195.

　Through these initiatives, Sysmex Corporation is committed to supporting laboratories in maintaining high standards of quality assurance.