TS EN ISO 15189

TS EN ISO 15189 is the standard that brings quality management and technical competence together for medical laboratories. Because laboratory results support clinical decisions, this field is concerned not only with analytical accuracy but also with staff competence, method suitability, traceability, record control, and the consistency of the service provided.

Quality and competence in the medical laboratory context

The specific focus of this document is the requirements medical laboratories can use when establishing their management systems and assessing their competence. It may also be used by laboratory users, regulatory authorities, and accreditation bodies when confirming or recognizing a laboratory’s competence. Point-of-care testing (POCT) is also within scope, which means the same quality and competence thinking applies when testing is performed at the clinical point of need rather than in a central laboratory.

Why this distinction matters

From a general technical perspective, medical laboratory quality runs across the full process chain, from pre-analytical steps through analysis and reporting. Competence is broader than instrument performance alone: it also includes human resources, method selection, internal organization, and the suitability of results for clinical use. That is why medical laboratory standards combine general quality management principles with technical requirements specific to laboratory practice.

• This standard specifies requirements for quality and competence in medical laboratories.
• It can be used to establish a management system and assess a laboratory’s own competence.
• It may serve as a basis for users, regulators, and accreditation bodies to confirm or recognize competence.
• It is also applicable to point-of-care testing (POCT).
• International, national, or regional regulations may apply to specific topics as well.