TS EN ISO 15189

TS EN ISO 15189 is the Turkish-adopted edition of the standard that links quality management with technical competence in medical laboratories. It provides a framework aimed not only at producing correct results, but also at managing laboratory activities in a controlled, traceable and consistent way. In medical laboratory practice, quality and competence cannot be separated, because every step from specimen handling to analysis, verification and reporting can affect patient care.

What quality and competence mean in a medical laboratory

The standard specifies requirements for medical laboratories as they develop their management systems and assess their competence. It is also used by laboratory users, regulatory authorities and accreditation bodies to confirm or recognize laboratory competence. In practical terms, it addresses the relationship between laboratory organization, staff competence, suitability of methods, equipment management and the reliability of reported results. Point-of-care testing, commonly known as POCT, is also within its scope.

Scope in practical terms

Medical laboratories support diagnosis, monitoring and disease management across disciplines such as clinical chemistry, hematology, microbiology and immunology. In general technical context, standards of this type help laboratories build an environment that reduces error, improves consistency and supports comparability of results. The focus here is on the management and competence arrangements that make dependable testing possible, rather than on prescribing the detailed procedure for each individual assay. The document also notes that international, national or regional regulations may apply to specific topics covered by it.

• Provides a framework for management system control and process consistency.
• Used as a reference for assessing laboratory competence.
• Applies to point-of-care testing as well as central laboratory settings.
• Supports evaluation by regulatory and accreditation bodies.