Written by Industry update : NABL 112A & NABL 112B
National Accreditation Board for Testing and Calibration Laboratories (NABL) is an accreditation body that provides accreditation service to Conformity Assessment Bodies including medical testing laboratories. On December 18,2024, the following documents were issued by NABL.
1 – NABL 112A – Specific Criteria for Accreditation of Medical Laboratories
NABL 112 is a Specific Criteria for Accreditation of Medical Laboratories, prepared by a Technical Committee, which is aligned as per ISO 15189
NABL documents are updated at regular intervals to keep pace with the latest technical developments and to synchronize with the International Standards.
NABL has released NABL 112A which elaborates the requirements of International Standard ISO 15189:2022 as applicable to Indian setting. The document has been designed to make it user friendly for both NABL assessors and laboratories
This document specifies the criteria for the medical testing laboratories for obtaining NABL accreditation. Medical testing laboratory shall fulfill the requirements of this document in addition to the requirements of the ISO 15189:2022 – “Medical laboratories –Requirements for quality and competence”. This specific criteria document shall be used in conjunction with ISO 15189:2022..
2 – NABL 112 B – Guidance document for Medical Laboratories
NABL has issued 112B Document on 18th December 2024. This document shall provide guidance to medical testing laboratories for the following aspects:
– Operation of sample collection centres / facilities
– Sample format for preparing the scope of accreditation
– Lot verification
– Algorithm for Automated Selection and Reporting of Results
– Sample format for competency assessment
– Examples for the type of sample and their stability for Clinical Biochemistry parameters
Click the buttons given below to read the documents in detail.
Source: https://nabl-india.org/