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May. 19, 2015

Sysmex Accredited ISO 15195 Laboratory medicine - Requirements for reference measurement laboratories
- Initiatives toward Further Standardization of Clinical Testing and Quality Improvement -

  Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announced its accreditation under the international standard ISO 15195; Laboratory medicine - Requirements for reference measurement laboratories.
  This ISO 15195 accreditation provides international recognition for the ability to conduct reference measurement procedures with regard to traceability1 in the field of hematology that Sysmex provides. Sysmex is the first organization in Japan to receive ISO 15195 accreditation in the hematology field.

  Recently, the field of clinical testing has met with strong demand for improvement in the quality of test results according to ISO International Standards, including ISO 15189 (Medical laboratories-Requirements for quality and competence). In addition, international organizations such as the Joint Committee for Traceability in Laboratory Medicine (JCTLM) are working with the development of certified reference materials and reference measurement procedures for clinical testing.
 

  Over the past 21 years, Sysmex has ensured the traceability chain for hematology testing, based on the reference measurement procedures of the International Council for Standardization of Hematology (ICSH) and the Clinical and Laboratory Standards Institute (CLSI). Based on the activities for ensuring this traceability chain, Sysmex received ISO/IEC 17025 accreditation as a calibration laboratory in February 2014. Sysmex provides calibration service2 for automated hematology analyzers that meets international standards.
 

  In March 2015, Sysmex received ISO 15195 accreditation as a reference measurement laboratory for clinical testing. ISO 15195 (Laboratory medicine-Requirements for reference measurement laboratories) is the International Standard that a reference measurement laboratory has a higher order of capability in reference measurement procedures with regard to traceability in the field of clinical testing.
  The ISO 15195 accreditation which Sysmex received demonstrates that Sysmex has the capability to conduct reference measurement procedures according to the ISO International Standard with regard to traceability in the hematology field. Sysmex is the first organization in Japan to receive this accreditation in the hematology field.
 

  In accordance with the ISO/IEC 17025 accreditation in February 2014 and the current ISO 15195 accreditation, Sysmex provides customers with a calibration service based on reference measurement procedures certified to international standards.
  A calibration certificate that Sysmex issues is accepted as a globally recognized document that ISO 15189 requires to ensure traceability and traceable calibration.
 

  Contributing to the standardization of clinical testing and quality improvements, Sysmex aims to continue delivering reassurance to customers and patients with regard to clinical testing results.


 

Overview of Accreditation under the ISO 15195 International Standard as a Reference Measurement Laboratory for Clinical Testing
 

Entity:

Reference Measurement Laboratory, Sysmex Corporation

  Certification date:

March 17, 2015

  Certification number: RCL00440
  Scope of certification: M19 number concentration
(Red blood cell count, white blood cell count, platelet count, hematocrit value, hemoglobin concentration)  
  Remarks: First accreditation in Japan in the area of blood cell count 


Reference
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
 

 

1 Traceability:

To assure that the routine testing results in a laboratory are traceable to the reference measurement procedure through an un-broken 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:

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.

*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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