ISO 15189:2012 Accreditation of Medical Laboratories

ISO 15189 describes the rules to be followed and criteria to be met for the verification of quality and competence in medical laboratories. The standard, which was first published in 2012, was later revised in 2022. The standard “ISO 15189:2022 Medical laboratories - Requirements for quality and competence” enables medical laboratories to evaluate their competence while developing their management systems. The 15189 Accreditation of Medical Laboratories standard also applies to the certification or recognition of the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

International, national or regional regulations or requirements may also apply to certain topics included in the standard. For more detailed information about the standard and certification process, you can contact Aşan Danışmanlık.

ISO 15189:2022 Scope

Medical laboratories activities are provided within an ethical and governance framework that recognizes healthcare providers´ obligations to the patient. These activities are carried out in a timely manner to meet the needs of all patients and their caregivers. Activities include examination requests, patient preparation, patient identification, sample collection, transportation, processing of patient samples, etc. Likewise, the ion of tests suitable for the intended use, examination of samples, sample storage and interpretation, reporting of results and providing recommendations to laboratory users are among the medical laboratory activities. These activities may include communicating results to the patient, arranging for emergency testing, and reporting critical results, depending on laboratory size and scope.
While ISO 15189 is designed for use in currently recognized medical laboratory disciplines, it can be effectively applied to other healthcare services such as diagnostic imaging, respiratory therapy, physiological sciences, blood banks, and transfusion services. Use of the standard facilitates collaboration between medical laboratories and other services, assists in the exchange of information and harmonization of methods and procedures.

We can list the items of the standard as follows:
      1 Scope
      2 Normative references
      3 Terms and definitions
      4 General requirements
          4.1 Impartiality
          4.2 Privacy
          4.3 Requirements for patients
      5 Structural and governance requirements
          5.1 Legal entity
          5.2 Laboratory manager
          5.3 Laboratory activities
          5.4 Structure and authority
          5.5 Goals and policies
          5.6 Risk management
      6 Resource requirements
          6.1 General
          6.2 Staff
          6.3 Facilities and environmental conditions
          6.4 Equipment
          6.5 Equipment calibration and metrological traceability
          6.6 Reagents and consumables
          6.7 Service agreements
          6.8 Outsourced products and services
      7 Process requirements
          7.1 General
          7.2 Pre-review processes
          7.3 Inspection processes
          7.4 Post-inspection processes
          7.5 Ineligible work
          7.6 Control of data and information management
          7.7 Complaints
          7.8 Continuity and emergency preparedness planning
      8 Management system requirements
          8.1 General requirements
          8.2 Management system documentation
          8.3 Control of management system documents
          8.4 Control of records
          8.5 Actions to address risks and opportunities for improvement
          8.6 Improvement
          8.7 Nonconformities and corrective actions
          8.8 Evaluations
          8.9 Management reviews
      Appendix A: Additional requirements for Point of Care Test (POCT)
          A.1 General
          A.2 Governance
          A.3 Quality assurance program
          A.4 Training program
      Appendix B: Comparison of ISO 9001:2015 and ISO 15189:2022
      Appendix C: Comparison of ISO 15189:2012 and ISO 15189:2022
      Source

Why is ISO 15189 Important?

The purpose of the ISO 15189 standard is to increase the well-being of patients and the satisfaction of laboratory users by relying on the quality and competence of medical laboratories. The standard contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. The benefits of this approach include increasing the efficiency of the management system, reducing the possibility of invalid results; reducing harm to patients, laboratory personnel, the public and the environment, etc. Risk management requirements in ISO 15189, with ISO 22367 principles; laboratory safety requirements are in line with ISO 15190 principles. In addition, sample collection and transport requirements comply with ISO 20658.