ISO Accreditation Comes to America: Are Labs Ready to Embrace an International Quality Management System?
MedSun: Newsletter #34, March 2009

By: Malone, Bill
American Association of Clinical Chemistry (AACC)
Clinical Laboratory News

The College of American Pathologists (CAP) recently rolled out an optional accreditation program based on the ISO 15189 standard for medical labs. The primary benefit of using ISO standards comes from following its comprehensive and highly structured approach for quality management, while also allowing labs to employ tools like Lean or Six Sigma. However, CMS is not ready to make ISO standards a required part of lab accreditation under CLIA.

Additional Information:

ISO Accreditation Comes to America: Are Labs Ready to Embrace an International Quality Management System? Malone, Bill. American Association of Clinical Chemistry (AACC), Clinical Laboratory News. January 2009.
http://www.aacc.org/publications/cln/2009/january/Pages/CovStory1Jan09.aspx


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