Dec 02, 2020 Last Updated 5:17 PM, Oct 16, 2020

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 Laboratories for Accreditation to ISO IEC 17025 2017

Click here to download Application Form & Questionnaire for Medical Laboratories for Accreditation to ISO 15189 2012

 

Notice of Transition to
ISO/IEC 17011:2017

    JANAAC has completed the transition to the revised ISO/IEC 17011 standard, as was demonstrated by the satisfactory results obtained from the most recent IAAC peer evaluation. As such, all our accreditation activities are being conducted in accordance with the requirements of the ISO/IEC 17011:2017 standard.



    Notice of Transition to
    ISO/IEC 17025:2017

    ILAC, in consultation with ISO, agreed on a three-year period for laboratories that demonstrate conformity to the ISO/IEC 17025 standard, to make the transition from ISO/IEC 17025:2005, to the ISO/IEC 17025:2017 version of the standard. A joint ILAC-ISO communique was issued indicating the transition period would end on November 30, 2020. Due to the outbreak of the coronavirus disease, ILAC and ISO agreed to extend the transition period to June 1, 2021. Accordingly, JANAAC requires its accredited laboratories to make this transition to the ISO/IEC 17025:2017 standard by June 1, 2021. After this date, accreditation to ISO/IEC 17025:2005 will no longer be valid. During this transition period, both revisions of the standard are equally valid and applicable. JANAAC will no longer accept applications for accreditation to the ISO/IEC 17025:2005 standard and is aiming to complete all transition assessments before September 30, 2020. All assessments (initial, re-assessments and interim assessments, including scope extensions) are being conducted using the revised standard, ISO/IEC 17025:2017. All accredited and applicant testing and calibration laboratories must have copies of the revised standard and should be well advanced in updating their activities to satisfy the new requirements in order to meet the transition timelines. Please contact JANAAC for any further information and clarification required.