Medical Laboratory Accreditation Program
(ISO 15189)
A2LA is proud to announce it is adding medical laboratories to its accreditation offerings. A2LA is accepting applications for accreditation to ISO 15189 beginning June 1, 2007. The addition of the ISO 15189 program at A2LA will provide medical laboratories with an additional level of recognition of the excellent service provided to their customers.
In addition to examining the technical aspects of a laboratory’s operation, the A2LA accreditation process includes a review of the management systems.
General criteria for A2LA accreditation of medical laboratories are contained in ISO 15189:2007, 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 system is documented, is fully operational, and addresses and conforms to all elements of ISO 15189:2007
- that it is operating in accordance with the required quality system
- adherence to any additional requirements established by A2LA
Accreditation is based on A2LA’s assessment of a medical laboratories performance including procedures, staff competence and reporting. It is available to all medical laboratories.
A2LA welcomes applications for the accreditation of all types of laboratories.
To assist laboratories in preparing for accreditation to ISO 15189, A2LA will be offering commercially available training courses in preparation and implementation of the quality management system and technical aspects of the standard.
Typical Steps in Planning for Accreditation
Medical Testing Accreditation Process
ISO 15189 Accreditation Application
ISO 15189 General Requirements
Medical Testing Proficiency Testing Requirements
F311 – HIPAA Business Associate Agreement
F312 - Scope of Accreditation Selection List: ISO 15189 Medical Testing Laboratories
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The American Association for Laboratory Accreditation |
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