ISO 15189 specifies requirements for what in medical laboratories?

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Quality management and competence in medical laboratories. ISO 15189 sets the requirements for a lab to have a formal quality management system and to demonstrate technical competence in all its testing activities. It covers how the lab should plan, document, perform, and improve its processes to ensure reliable, accurate results, including how personnel are trained and evaluated, how equipment is calibrated and maintained, how methods are validated, and how results are traced back to appropriate standards. It also expects participation in external quality assessment and ongoing internal quality control, so performance stays consistent over time. Data encryption focuses on information security, safety training is important but only part of overall safety programs, and laboratory design is a consideration but not the central aim of this standard; the core emphasis is on quality management and the competence of the people and processes that generate lab results.