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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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