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Apr. 24, 2018

Sysmex Obtains Certification under ISO Guide 34, the International Standard for the Competence of Reference Material Producers
-Initiatives toward Further Standardization and Quality Improvement of Clinical Testing-

Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces its accreditation under the international standard ISO Guide 34 (General requirements for the competence of reference material producers).
It is important for laboratories to ensure traceability1, in order to ensure the quality of their test results. Laboratories ensure traceability through routine calibration and quality control. The standard materials used in this calibration are referred to as “reference materials.” Certification under ISO Guide 34 provides international verification that Sysmex possesses the technical competence to supply reference materials of an appropriate quality.

In recent years, demand has grown to improve the quality of test results in the field of clinical testing. To this end, there has been a global surge in the number of laboratories obtaining certification under ISO 15189 (Medical laboratories—requirements for quality and competence). In some countries, including Australia, New Zealand and Taiwan, obtaining such certification has become mandatory. Consequently, to augment the quality of laboratory test results the provision of calibration services2, external quality control services, and maintenance and inspection services by accredited institutions has grown increasingly important. At the same time, demand has increased for certified reference materials, which serve as the foundation of traceability.

Sysmex provides products to customers in more than 190 countries and regions around the world, and recognizes the significant responsibility it bears to provide a stable supply of highly reliable products. For this reason, for more than 20 years we have maintained a traceability chain of blood cell count results in the hematology field that is traceable to the reference measurement protocols recommended by the International Council for Standardization of Hematology (ICSH) and the Clinical and Laboratory Standards Institute (CLSI) in the hematology field.

In recent years, based on this traceability chain, Sysmex received certification in February 2014 under ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) and ISO/IEC 17043 (Conformity assessment—General requirements for proficiency testing), verifying that Sysmex meets international standards for the quality of the calibration services and external quality control services it provides with its automated hematology analyzers. In addition, in March 2015 we obtained certification under ISO 15195 (Laboratory medicine—Requirements for reference measurement laboratories), the international standard verifying that a reference measurement laboratory possesses the high technological levels to perform the reference measurement procedures required for traceability in the field of clinical testing. Based on these standards, we have provided customers with various services to enhance the quality of test results.

To reinforce Sysmex’s quality control system related to test results of the Company’s instruments in the hematology field, Sysmex International Reagents Co., Ltd., a subsidiary that produces reference materials, has obtained certification under ISO Guide 34 (General requirements for the competence of reference material producers). ISO Guide 34 verifies Sysmex International Reagents as a calibration institution with the technological competence to supply reference materials of an appropriate quality. This is the first such accreditation in Japan in the hematology field.

Through this accreditation, Sysmex has received certification under the principal ISO standard related to data assurance, which should lead to an enhanced objective reliability of the Company’s products and services. At the same time, laboratory customers can use reference materials based on international standards, enabling global verification of our competence to provide appropriate test data.

By providing products and services whose high quality is certified by third-party institutions, Sysmex promotes the global standardization of in vitro diagnostics and helps ensure that customers and patients obtain reliable test results.  

Overview of ISO Guide 34 (General requirements for the competence of reference material producers)
Entity: Laboratory of Assay Value Assignment, Ono Factory, Sysmex International Reagents Co., Ltd.
Certification date: March 26, 2018
Certification number: RMP00030
Scope of certification: Hematology and cells: XN CAL and XN CAL PF
Remarks: First accreditation in Japan in the hematology field


References
Press release dated March 18, 2014
Sysmex Accredited for ISO/IEC 17025 and ISO/IEC 17043 Calibration Laboratory and Proficiency Testing Provider
—Initiatives toward Further Standardization of Clinical Testing and Quality Improvement—
http://www.sysmex.co.jp/en/corporate/news/2014/140318.html
 
Press release dated May 19, 2015
Sysmex Accredited for ISO 15195 Laboratory Medicine—Requirements for Reference Measurement Laboratories
—Initiatives toward Further Standardization of Clinical Testing and Quality Improvement—
http://www.sysmex.co.jp/en/corporate/news/2015/150519.html
 
Terminology
1 Traceability:
To assure that the routine testing results in a laboratory are traceable to the reference measurement procedure through an unbroken chain. A calibration certificate with a symbol mark is allowed that measured quantity value of customers’ blood cell counters are traceable to reference measurement procedures. 
 
2 Calibration service:
This service compares the measurement values of customers' blood cell counters with standard analyzers in the Reference Measurement Laboratory, and calibration certificates are issued to indicate the accuracy of those measurement values.
 

*Information contained in the press release is current as of the date of the announcement,
but may be subject to change without prior notice.

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