Differences and Relationships Between ISO 15189 and ISO 17025 Accreditation Systems

Main DifferencesDimension    ISO 15189    ISO 17025Applicable Objects    Medical laboratories (testing, pathology, etc.)    All testing/calibration laboratoriesContent Focus    Entire process before, during, and after testing; sample management, critical values, reference intervals    Testing methods, result validity, measurement uncertainty, calibrationPersonnel Requirements    Emphasis on clinical expertise (medical qualifications of laboratory physicians and quality supervisors)    Emphasis on technical operational capabilities of testing personnelSamples    Patient samples (biosafety, uniqueness, storage)    Testing samples (materials, products, etc.)Document Reporting    Test reports are for doctors/clinicians and require medical judgment    Test reports are for clients and require measurement uncertaintyRisk Orientation    Medical risk assessment (impact of misdiagnosis risk on patients)    Technical/result compliance risksTypical Accreditation Bodies    CNAS (in accordance with ISO 15189)    CNAS/ILAC mutual recognition (in accordance with ISO 17025)

 

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