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Quality Digest

FDA Compliance

ISO 15189 Medical Laboratory Accreditation from A2LA

Published: Tuesday, June 26, 2007 - 21:00

(A2LA: Frederick, Maryland) -- The American Association for Laboratory Accreditation began adding medical laboratories to its accreditation offerings on June 1, 2007. “We see strong demand for an internationally recognized accreditation program in the medical laboratory industry,” says Peter Unger, A2LA president. “We offer a distinct approach to laboratory accreditation that, to date, has not been established for the medical laboratory community in the U.S.”

In addition to examining the technical aspects of a medical laboratory’s operation, the A2LA accreditation process will include a review of its management system. “We hold ourselves to the same expectations for competency that we hold our applicants to,” says Unger. “That is, we operate a management system to ISO requirements which is evaluated by external parties, resulting in our international recognition.”

General criteria for A2LA accreditation of medical laboratories are contained in ISO 15189, "Medical Laboratories—Particular Requirements for Quality and Competence." A2LA accreditation attests that a medical laboratory has demonstrated:

  • Competency to perform specific testing procedures
  • That its quality management system is documented, is fully operational, and addresses and conforms to all elements of ISO 15189
  • Adherence to any additional requirements established by A2LA including measurement traceability and laboratory participation in ongoing proficiency testing

To assist laboratories in preparing for accreditation to ISO 15189, A2LA is offering commercially available training courses in preparation and implementation of the quality management system and technical aspects of the standard.

For more information, visit www.a2la.org.


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