ISO 15189 Standards

ISO 15189:2012 is a regulatory standard for medical labs. Its criteria help labs develop quality management systems and assess their own competence. The standard is also used by regulators, accreditation bodies and customers to confirm or recognize a lab’s competence.

The common components of the standard include document control, internal audits, occurrence management, and risk management. Compliance with ISO 15189 improves the overall quality of a laboratory’s services and products, which directly affects the quality of health care.