American Association for Laboratory Accreditation

ISO 15189 Accreditation Program

A2LA's ISO 15189 Accreditation Program is currently the only US-based program offered by an ILAC MRA signatory that is recognized to provide accreditation to the ISO 15189:2012 Standard.  The ISO 15189 Accreditation Program provides accreditation to any laboratory performing moderate or high complexity testing as defined in 42CFR493. A2LA has designed this program not to replace but to complement the Clinical Laboratory Improvement Amendments (CLIA).  Laboratories that provide only waived or Provider Performed Microscopy (PPM) are not eligible for accreditation through A2LA; however, if a laboratory performs moderate or high complexity testing along with waived testing and/or PPM, A2LA will accredit the laboratory for all of this testing and microscopy, holding the laboratory to the high complexity requirements.

A2LA offers accreditation to clinical testing laboratories in the following specialities and subspecialties:

  • Histocompatibility
  • Microbiology
    • Bacteriology
    • Mycobacteriology
    • Mycology
    • Parasitology
    • Virology
  • Diagnostic Immunology
    • Syphilis Serology
    • General Immunology
  • Chemistry
    • Routine Chemistry
    • Special Chemistry
    • Urinalysis
    • Endocrinology
    • Toxicology
  • Clinical Cytogenetics
  • Flow Cytometry
  • Hematology
    • General Hematology
    • Coagulation
  • Immunohematology
  • ABO Group
    • Antibody Detection (transfusion)
    • Antibody Detection (non-transfusion)
    • Antibody Identification
    • Compatibility Testing
    • Rh Type
  • Pathology
    • Histopathology
    • Oral Pathology
    • Cytology
    • Molecular Pathology
  • Radiobioassay

Accreditation Requirements

Clinical laboratories applying within this program are assessed against the general criteria contained within ISO 15189:2012 Medical Laboratories - Requirements for Quality and Competence. Prior or concurrent accreditation to the CLIA Requirements is not mandatory for application within the A2LA ISO 15189 Accreditation Program.

Click on the "Download Application Documents" button to the right to obtain all documents relevant to the A2LA ISO 15189 Accreditation Program.

Acceptance/Recognition of Accreditation in this Field

Interested in learning how A2LA accreditation may be accepted internationally as well as domestically by federal, state and private sector entities? Click on the following links for more information:

Advisory Committee

A2LA has developed a Medical Testing Advisory Committee (MedTAC) to assist the Association by providing technical input on policy creation and decisions related to the clinical testing laboratory accreditation program. If you wish to participate on the MedTAC, we invite you to contact Amanda McDonald, Senior Accreditation Officer, at amcdonald@A2LA.org.