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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2015, Vol. 03 ›› Issue (04): 221-224. doi: 10.3877/cma.j.jssn.2095-5820.2015.04.007

Special Issue:

• Laboratory Accreditation • Previous Articles     Next Articles

Accreditation of medical laboratory and validation/verification: the changes of ISO 15189:2011 requirement for validation/verification

Zhenhua Yang   

  • Received:2015-09-01 Online:2015-11-28 Published:2015-11-28
  • Contact: Zhenhua Yang
  • About author:
    Corresponding author: Yang Zhenhua, Email:

Abstract:

This paper compares the requirement of validation/verification in the 2nd edition ISO 15189:2007 with the 3rd edition ISO 15189:2011; there are important changes in the 3rd edition. Implementing the requirement in new edition would promote the medical laboratory to do more technical work, and make in vitro diagnostic manufacturers provide a fully study report of validation for measuring system/measurement procedure.

Key words: Validation, Verification, ISO 15189

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