Medical Laboratory Accreditation Program (ISO 15189)
A2LA is accepting applications for accreditation to ISO 15189. 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 laboratory's performance including procedures, staff competence and reporting. It is available to all medical 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.
In addition to the technical documents list above, all medical testing laboratories seeking or maintaining A2LA accreditation must comply with all policy and requirements documents listed below. Where applicable, these documents must be completed prior to the start of the accreditation process.
- Order ISO 15189. The A2LA Board of Directors has issued a policy requiring all laboratories to have an official copy of ISO 15189.
- Print and complete the F651 - Application for Accreditation: ISO 15189 Medical Testing Laboratories. Provide A2LA with form F658 - Ownership Confirmation: ISO 15189 (see page 14-15 of the application), confirming that you have an official copy of ISO 15189. Once received, we can send you the ISO 15189 Assessor Checklist.
- Review the General Requirements for Accreditation including Part C, P604: Record and Material Retention Policy.
- Print, review, sign and submit the R652 - Conditions for Accreditation for Medical Testing Laboratories Meeting the ISO 15189 Requirements.
- Review the R653 - General Requirements: Proficiency Testing for Medical Testing Laboratories Meeting the ISO 15189 Requirements . Please investigate and participate in proficiency testing as soon as possible.
- Review the P102 - A2LA Policy on Measurement Traceability. To locate an acceptable source of calibration services, please search the A2LA Scopes of Accreditation. Alternatively, you can choose a calibration laboratory that is accredited by one of our mutual recognition arrangement partners.
- Review the Advertising Policy.
- If your laboratory performs specimen collection at sites other than your permanent laboratory premises, please review, complete and submit C660 - Specific Checklist: Medical Testing Program Specimen Collection Site Requirements. The C660 checklist will be provided to you once you have completed and returned Form 658 (see step 2).
- If your laboratory performs point of care testing, please review, complete and submit C613 - Specific Checklist: A2LA Medical Point of Care Testing (POCT). The C613 checklist will be provided to you once you have completed and returned Form 658 (see step 2).
- If your laboratory uses a Laboratory Information System to electronically collect, manage and/or report medical testing results, please review, complete and submit C614 - Specific Checklist: ISO 15189:2007 Requirements for Protection of Laboratory Information Systems (Annex B). The C614 checklist will be provided to you once you have completed and returned Form 658 (see step 2).
- Additional Policies that may be applicable:
