Review Article

Ann Lab Med 2017; 37(5): 365-370

Published online September 1, 2017

Copyright © Korean Society for Laboratory Medicine.

International Organization for Standardization (ISO) 15189

Frank Schneider, M.D.1, Caroline Maurer, M.T.2, and Richard C. Friedberg, M.D.3

College of American Pathologists 15189 Committee1; College of American Pathologists 15189 Program2; College of American Pathologists3, Northfield, IL, USA

Correspondence to: Caroline Maurer
College of American Pathologists, 325 Waukegan Road, Northfield, IL 60093, USA
Tel: +1-847-832-7451 Fax: +1- 847-832-8451 E-mail:

Received: March 6, 2017; Revised: May 10, 2017; Accepted: June 8, 2017

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189.

Keywords: ISO 15189, Quality management, Laboratory accreditation, College of American Pathologists