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ISO/IEC 15189

 

ISO IEC 15189

ISO IEC 15189 basic aim of medical laboratory accreditation is to give assurance of test results for patient and health staff. Medical laborants , clinical researchers and practices before test and after test need some additional requirements.

Consequently , 212 number of technical committee ISO/IEC 15189:2003 deduced being unique standard ‘’Medical laboratory –special needs for quality and sufficiency ‘’ about ‘’ clinical test operations and used test system outside body’’.

SCOPE:

  • Establishing of ISO/IEC 15189

  • Measurement system analysis

  • process map and process management

  • measurement uncertainty

  • Calibration, validation and verification

  • Internal audit management

  • Authority foundation (NB) training

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