Which standard specifies particular requirements for quality and competence in medical laboratories?

• A. ISO 15189:2007
• B. ISO 17025
• C. ISO 9001
• D. CLIA

Answer: (A)

In medical laboratories, ensuring both quality and competence requires a standard that is built specifically for clinical testing. ISO 15189 provides that focus by outlining a quality management system plus technical requirements tailored to medical labs. It covers how the lab is organized, how personnel are qualified, how methods are validated and verified, how equipment is calibrated and maintained, and how results are produced, verified, and reported. It also emphasizes traceability, quality control, participation in external quality assessment, proper specimen handling, biosafety, and continual improvement. Meeting these requirements helps a lab consistently generate accurate, reliable results that clinicians can trust.

Other options don’t fit as precisely. ISO 17025 targets testing and calibration laboratories in general, not specifically medical labs. ISO 9001 offers a broad quality management framework applicable to many industries but lacks the technical, laboratory-specific criteria. CLIA is a U.S. regulatory program, not an international standard, and it focuses on compliance rather than the international quality and technical requirements outlined in ISO 15189.