ISO 15189

ISO 15189 is an international standard published by the International Organization for Standardization (ISO) that specifies general requirements for clinical laboratories to maintain a quality management system, ensure technical competence, and provide reliable results. ISO 15189 is based on ISO/IEC 17025 and ISO 9001.

ISO 15189 applies to clinical testing laboratories (private or public) examining human samples, regardless of size, number of employees, or the types of tests they perform.

System development involves these phases:

1. Identifying specialized criteria and guidelines for clinical laboratories.
2. Evaluating laboratory facilities, equipment, and practices for test performance against standard requirements.
3. Determining how to correct any deviations identified during evaluation.
4. Reviewing existing procedures and records where discrepancies exist and introducing new procedures/records where none exist.
5. Training staff on system requirements.
6. Implementing the system.
7. Reviewing and updating the system if needed.
8. Conducting an internal audit.

ISO 15189, like ISO/IEC 17025, does not mandate exclusive use of standard methods; non-standard or laboratory-developed methods may be used if validated. The laboratory can determine which human samples, tests, and measured properties are included in the accreditation scope.

Key prerequisites for effective ISO 15189 implementation include proficiency testing, equipment calibration, and measurement uncertainty assessment. Collaboration with a specialized consultant is typically necessary to create a functional, effective system meeting the standard’s requirements and adapted to the laboratory’s specific needs. ISO 15189 can be combined with other standards the laboratory applies or intends to adopt, allowing for a unified management system.

In Greece, accreditation is performed exclusively by ESYD (Hellenic Accreditation System), supervised by the Ministry of Development. The accreditation process includes assessing the laboratory’s legal compliance (operational requirements and relevant accreditation criteria), technical competence (staff, facilities, equipment), and evaluating both management system and implementation.

After successful evaluation, the Accreditation Body issues a four-year Accreditation Certificate. For any deviations, corrective actions must be completed before issuance. The Accreditation Certificate lists the accreditation scope in detail (types of human samples, test types/measured properties, methods).

The certificate remains valid if scheduled periodic evaluations (at least annual) confirm continued compliance with requirements.

Principal reasons for a laboratory pursuing ISO 15189 accreditation include:

• Ensuring reliability and validity of results
• Achieving formal recognition for carrying out clinical tests with documented competence and impartiality
• Improving internal organization and process efficiency
• Increasing public trust in clinical test results
• Strengthening competitive position in healthcare services
• Facilitating collaboration between labs and other organizations in exchanging information and expertise
• Heightening staff awareness of the importance of their tasks