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ISO 15189:2022

ISO 15189:2022 – Medical Laboratories

ISO 15189:2022 is the international standard specifying the requirements for quality and competence in medical laboratories. Accreditation demonstrates that your laboratory operates an effective quality management system and is technically competent to deliver reliable examination results across the total testing process, supporting accurate patient care and confident clinical decision-making.

Who It Applies To

Medical and clinical laboratories that perform examinations on samples from the human body and need to demonstrate both quality management and technical competence to clinicians, patients, regulators, and healthcare partners.

  • Clinical and medical laboratories of any size or discipline
  • Hospital and diagnostic laboratories
  • Pathology laboratories, including anatomic and clinical pathology
  • Laboratory disciplines such as clinical chemistry, hematology, microbiology, immunology, molecular diagnostics, and histopathology
  • Multisite laboratory services operating under a shared quality system
  • Applicable point-of-care testing (POCT) programs

Assessment Steps

  1. 1Review of the quality management system and laboratory documentation against ISO 15189:2022
  2. 2Evaluation of personnel competence, training, authorization, and ongoing assessment records
  3. 3Assessment of facilities, environmental conditions, and equipment control including maintenance, calibration, and traceability
  4. 4Examination of pre-examination, examination, and post-examination processes across the total testing pathway
  5. 5Review of quality assurance and risk management, including internal quality control, external quality assessment, and patient risk considerations
  6. 6Witnessing of technical competence for examination procedures within the requested scope

Expected Outcomes & Deliverables

  • Accreditation for the approved scope of medical examinations
  • Formal recognition of laboratory quality and technical competence
  • Increased confidence in the reliability and validity of laboratory results
  • Strengthened control over the total testing process and patient safety
  • A clearly defined scope of accreditation listing disciplines and examinations
  • A foundation for continual improvement and international recognition

Apply for ISO 15189 Medical Laboratory Accreditation

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