Ann Lab Med.  2017 Sep;37(5):365-370. 10.3343/alm.2017.37.5.365.

International Organization for Standardization (ISO) 15189

• Schneider
• Maurer C
• Friedberg

• KMID: 2383911
• DOI: http://doi.org/10.3343/alm.2017.37.5.365

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.

Keyword

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

MeSH Terms

Accreditation
Risk Management

Reference

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