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Review
. 2017 Sep;37(5):365-370.
doi: 10.3343/alm.2017.37.5.365.

International Organization for Standardization (ISO) 15189

Frank Schneider  1 , Caroline Maurer  2 , Richard C Friedberg  3
Affiliations
Review

International Organization for Standardization (ISO) 15189

Frank Schneider et al. Ann Lab Med. 2017 Sep.

Abstract

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: College of American Pathologists; ISO 15189; Laboratory accreditation; Quality management.

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Conflict of interest statement

No potential conflicts of interest relevant to this article were reported.

References

    1. Schneider F, Maurer C. ISO 15189. In: Qihui Z, Siegal GP, editors. Quality management in anatomic pathology: Strategies for assessment, improvement, and assurance. Northfield, IL: College of American Pathologists; 2017. pp. 185–193.
    1. ISO 15189. Medical laboratories - Requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization; 2012.
    1. Clinical and Laboratory Standards Institute. QMS01-A4: Quality management system: A model for laboratory services; Approved guideline. 4th ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.
    1. Okes D. Root cause analysis: The core of problem solving and corrective action. Milwaukee, WI: ASQ Quality Press; 2009.
    1. Ford A. At Henry Ford, 36 lab sites now under ISO umbrella. CAP Today () 2013 Nov 13;50 http://www.captodayonline.com/at-henry-ford-36-lab-sites-now-under-iso-u...

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