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Mar. 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 -

  Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces its accreditation under the international standards ISO/IEC 17025 and ISO/IEC 17043. Sysmex is the first company in Japan to receive ISO/IEC 17043 accreditation - not only in clinical testing but among all industries.
  These accreditations provide international recognition for the quality of the Calibration Service1 and External Quality Assessment Program2 that Sysmex provides.

  Recently, the field of clinical testing has met with strong demand for improvement in the quality of test results. Worldwide interest in international standards has increased as a result and a growing number of clinical laboratories have received ISO 15189 (Medical laboratories - Requirements for quality and competence) accreditation. In some countries such as Australia, New Zealand and Taiwan, this accreditation has become mandatory.

  For the past 20 years, Sysmex has maintained the traceability chain3 of blood cell count results in the hematology field, which is traceable to the reference measurement procedures recommended by ICSH (International Council for Standardization of Hematology), and has been providing the calibration service to its customers. Furthermore, SNCS®4 and eQAPi®5 - Sysmex's unique services that employ an IT- provided external quality assessment program for urinalysis, hematology, clinical chemistry, immunology, and other testing to support clinical laboratories improve the quality of their test results. In addition, by ISO 15189 consultation to clinical laboratories, we are working toward the standardization of clinical testing and quality improvement.

  Sysmex was accredited for ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) for our calibration service for Sysmex hematology analyzers.
  Sysmex was also accredited for ISO/IEC 17043 (Conformity assessment - General requirements for proficiency testing) for its SNCS/eQAPi external quality assessment programs for urinalysis, hematology, clinical chemistry, immunology and other testing. Sysmex is the first organization in Japan to receive this accreditation, not only in the clinical testing field but across all industries.

  As an ISO accredited Calibration Laboratory and Proficiency Testing Provider, Sysmex continues to provide customers with high-quality services. Customers can use the calibration certificates and external assessment reports we provide as globally recognized certifications for ISO 15189 requirements.

  Contributing to the standardization of clinical testing and quality improvements, Sysmex aims to continue delivering reassurance to its customers and shaping the advancement of healthcare.

Overview of Accreditations Acquired

 

ISO/IEC 17025
(General requirements for the competence of testing and calibration laboratories)

ISO/IEC 17043
(Conformity assessment - General requirements for proficiency testing)

Entity

Reference Measurement Laboratory,
Sysmex Corporation

Quality Control Services,
Sysmex Corporation

Certification date

February 14, 2014

February 12, 2014

Certification number

RNL00440

PTP00010

Scope of certification

M19.2 Number concentration
M19.3 Mass concentration
(Red Blood Cell count, White Blood Cell count, Platelet count, Hematocrit value, Hemoglobin concentration)

M51 Medical testing
(urinalysis, hematology, clinical chemistry , immunology, other testing)

Remarks

First accreditation in Japan in the area of blood cell count.

First accreditation in Japan in all industries

Note
1
In this service, measurement values of customers' blood cell counters are compared with standard analyzers in the Reference Measurement Laboratory, and calibration certificates are issued to indicate the accuracy of those measurement values.
Quality assessment process that evaluates the quality of routine testing in clinical laboratories, by statistically comparing the results of same samples delivered to participating laboratories. The results are returned to the laboratories and are utilized for improvement.
3 To assure that the routine testing results in a laboratory are traceable to the reference measurement procedure through an un-broken chain.
4 An abbreviation for Sysmex Network Communication Systems, SNCS® is an online support program that connects the Customer Support Center and customers' instruments via Internet to provide real-time external quality assessment, scientific information, and monitoring instrument conditions.
5 A large-scale real-time external quality assessment program for fields including hematology, immunology, as well as clinical chemistry. This service also involves analyzing the results of measurement data real-time, which contributes to improve the accuracy of everyday testing.

*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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