TS EN ISO 15189

TS EN ISO 15189 addresses the link between quality management and technical competence in medical laboratories. It provides a framework for laboratories to establish the management processes that support reliable results and to assess their own competence; it may also be used by laboratory customers, regulatory authorities and accreditation bodies when confirming or recognizing laboratory competence.

Why quality and competence are assessed together in medical laboratories

AS GENERAL TECHNICAL CONTEXT, quality management in a medical laboratory covers the processes that make testing consistent and traceable, from specimen reception through analysis, reporting and record control. Competence refers to the technical suitability of the laboratory’s personnel, methods, equipment, measurement uncertainty, quality control practices and result interpretation. These two aspects reinforce each other: a well-managed system supports correct technical work, and technically competent performance strengthens confidence in the results issued by the laboratory.

How this standard is typically used

• To help medical laboratories structure and improve their quality management systems
• To support self-assessment of laboratory competence
• To provide a reference for customers, regulators and accreditation bodies when evaluating competence
• To group the expectations for reliable and consistent medical laboratory services into a common framework

This record represents a standard focused on medical laboratories, and it is useful for understanding the quality approach used across disciplines such as clinical chemistry, haematology, microbiology and immunology. Its emphasis is not only on performing tests, but on demonstrating that testing capability within a sustainable and auditable system. The listing is now withdrawn, but the subject remains important for anyone working with medical laboratory quality and competence concepts.