TS EN ISO 15189

TS EN ISO 15189 is the standard for medical laboratories that addresses quality and competence together, linking technical reliability with the management conditions needed to deliver trustworthy laboratory services. In practical terms, it supports the consistency of test results used in patient care.

Why quality and competence are treated as one system

In a medical laboratory, quality is not limited to instrument performance or neat documentation. It spans the full testing pathway: specimen collection, identification, transport, analysis, result reporting, and when appropriate, interpretation. Competence refers to the laboratory’s ability to perform those activities correctly through qualified personnel, suitable methods, appropriate equipment, and controlled conditions. In this field, technical performance and management arrangements are closely linked.

The standard is based on the general framework of ISO/IEC 17025 and ISO 9001, but adapts that framework to the specific realities of medical laboratories. In general technical context, this means attention to traceability, quality control, appropriate handling of measurement uncertainty, and the reliability of results for clinical use. It provides a common structure for laboratory practice in the patient-care environment.

What the scope points to in practice

• Quality management provisions specific to medical laboratories
• Organisational and operational arrangements that support technical competence
• A combined view of the processes that influence test result reliability
• A common reference framework for quality and competence in medical laboratory services

This record represents a withdrawn TS EN ISO 15189 edition. It therefore reflects the historical edition and the technical approach of that period, rather than later revisions of the standard family.