ISO 15189:2022, titled Medical laboratories — Requirements for quality and competence, is an international standard developed by ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems). It specifies requirements for both quality management systems and technical competence in medical laboratories, supporting the delivery of reliable and clinically useful laboratory results that are essential for patient diagnosis, monitoring, and treatment.

The standard is applicable to medical laboratories seeking to establish, implement, and improve their management systems and demonstrate competence. It supports recognition of laboratory capability by patients, healthcare providers, regulators, and accreditation bodies. ISO 15189 also includes specific provisions for point-of-care testing (POCT), ensuring that tests performed near the patient are managed within a controlled quality framework.

ISO 15189:2022 replaces ISO 15189:2012 and incorporates requirements previously contained in ISO 22870 (POCT), which has been withdrawn following publication of the revised edition.

The standard integrates both managerial and technical requirements, emphasizing:

• Risk-based thinking in laboratory processes

• Impartiality and patient-focused services

• Control of examination processes and results

• Competence of personnel and validation of methods

ISO 15189 aligns with related laboratory and healthcare standards, including:

• ISO 22367 (risk management in medical laboratories)

• ISO 15190 (laboratory safety)

• ISO 20658 (sample collection, transport, and reception)

Through these links, laboratories are encouraged to manage risks and opportunities, improve system effectiveness, reduce the likelihood of incorrect results, and minimize potential harm to patients, personnel, and the environment.

The standard supports global comparability of laboratory results, facilitates cooperation between laboratories and healthcare providers, and promotes harmonized examination practices.

For accreditation purposes, laboratories typically seek recognition from accreditation bodies operating in accordance with ISO/IEC 17011. The structure of ISO 15189:2022 reflects modern conformity-assessment principles and is compatible with standards such as ISO/IEC 17025, while remaining specifically tailored to the medical laboratory environment.

For further details about ISO 15189, you can visit the official website of the International Organization for Standardization (ISO) here: ISO 15189 Medical laboratories — Requirements for quality and competence.

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