ISO 15189: medical laboratory quality and competence

ISO 15189 sets requirements for quality and competence in medical laboratories. In the U.S. it does not replace CLIA certification.

Relationship

A U.S. lab may hold CLIA certification, CAP accreditation and ISO 15189 accreditation together.

General guidance, not legal advice. Requirements depend on industry, jurisdiction and test purpose; confirm with the relevant agency.