Feb 20, 2024 Last Updated 7:28 PM, Jan 29, 2024

Laboratory Accreditation

Laboratory Accreditation

JANAAC provides ISO 15189 accreditation to medical laboratories and ISO/IEC 17025 accreditation to laboratories offering testing and calibration services.

Medical laboratory services are important to patient care, and erroneous test findings can result in incorrect decisions by doctors and/or their patients. Accredited medical laboratories can readily demonstrate compliance to defined standards and best practices and provide the assurance of competence in the analyses that they undertake. The ISO 15189:2012 standard describes the requirements for quality and competence in medical laboratories. Accreditation to this standard therefore attests to the capability of the organization to provide the service request and provides confidence in their abilities to meet the needs of all clients, patients and the clinical personnel responsible for their care.

Testing and calibration laboratories offer services which influence local commerce and international trade, as objective evidence must be provided that commodities, infrastructure and materials - whether at ports of entry or in the local market - meet relevant standards and are safe for use. These include a wide range of products such as food, water, pharmaceuticals, construction material and electronics. The ISO/IEC 17025 standard is vital in the accreditation exercise as it speaks to the competence of the laboratories in providing testing services and the reliability of the results. Test results from accredited laboratories are more readily accepted worldwide and will mitigate the need for re-testing leading to improved health and safety and also the facilitation of international trade.

Accreditation Requirements

Laboratories are assessed against the general criteria found within ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories or ISO 15189 Medical Laboratories Requirements for Quality and Competence. Laboratories are also expected to be in compliance with local stipulations and accepted best practice.

A revised ISO/IEC 17025 standard was published in November 2017. Testing and calibration laboratories that have already been accredited to the 2005 revision of the ISO/IEC 17025 International Standard have until November 2020 to transition their accreditation to the 2017 revision of the ISO/IEC 17025 International Standard. However, testing and calibration laboratories which now wish to become accredited must do so in conformity to the 2017 revision of the standard.

Click here to download Application Form & Questionnaire for Testing Labs for Accreditation to ISO/IEC 17025:2017
Click here to download Application Form & Questionnaire for Calibration Labs for Accreditation to ISO/IEC 17025:2017
Click here to download Application Form & Questionnaire for Medical Laboratories for Accreditation to ISO 15189:2012

Medical Laboratory
Transition Implementation Policy

ILAC, in consultation with ISO, has agreed on a three-year period for medical laboratories that demonstrate conformity to the ISO 15189:2012 standard, to make the transition from the ISO 15189:2012, to the ISO 15189:2022 standard.

The Jamaica National Agency for Accreditation (JANAAC), in keeping with this communique, requires its accredited medical laboratories to make this transition by December 6, 2025. After this date, accreditation to ISO 15189:2012 will no longer be valid.

During this transition period, both revisions of the standard are equally valid and applicable. JANAAC will facilitate the use of internal documents that will feature compliance with both versions of the standard until December 31, 2024.

Medical Laboratories may continue to submit applications for accreditation to the ISO 15189:2012 up to September 30 2023, in which case, initial assessments must be concluded by March 31, 2024.

After September 30, 2023, JANAAC will no longer be accepting applications for ISO 15189:2012 accreditation.

After December 31, 2024, all assessments (initial, re-assessments and interim assessments, including scope extensions) will be conducted using the revised standard, ISO 15189:2022... Read more