Last Updated on January 5, 2024 by The Health Master
Download NABL 136: The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released NABL 136: specific criteria for accreditation of quality assurance (QA) testing facilities for diagnostic radiology x-ray equipment.
The purpose of this document is to specify requirements for QA testing facilities for obtaining accreditation as per ISO/IEC 17025:2017 to carry out quality assurance activity of diagnostic radiology x-ray equipment during its life cycle.
It is also aimed to achieve uniformity in understanding requirements of the quality assurance testing facilities/assessors in assessment process so that the procedure for accreditation is smooth, seamless and aligned with the NABL policies for accreditation.
This document is also aimed to achieve uniformity in selection of QA equipment, testing methods, required facilities & environmental conditions, personnel with relevant qualification, training and experience, as per regulatory requirements and in accordance with ISO/IEC17025:2017.
This document defines the requirements that are to be complied by the DR- quality assurance testing facility seeking NABL accreditation as per ISO/IEC17025:2017 and other relevant documents for quality assurance (QA)/performance testing of medical diagnostic x-ray equipment.
Quality assurance of medical diagnostic x-ray equipment means systematic actions necessary to provide adequate confidence to the end-user that medical diagnostic x-ray equipment will perform satisfactorily in compliance with applicable test protocol/national/international standards specified by the relevant regulatory authority.
The objective of performing QA checks/tests of QA testing of diagnostic radiology x-ray emitting equipment is to ensure the accuracy of the diagnosis through the images obtained by such various diagnostic radiology equipments.
The QA tests are necessary to ensure that the functional performance of the equipment is similar to its baseline values and within the tolerance values as specified by regulatory authority.
Diagnostic radiology x-ray equipment covers all such medical diagnostic equipment that are generating x- ray and requiring quality assurance testing as per the requirements of regulating body.
NABL has been established with the objective of providing government, industry associations and industry in general with a scheme of conformity Assessment Body’s accreditation which involves third-party assessment of the technical competence of testing including medical and calibration laboratories, proficiency testing providers and reference material producers.
NABL mission is to strengthen the accreditation system accepted across the globe by providing high quality, value driven services.
Commercial Testing Laboratories
List of Laboratory instruments
New laws to be framed for Drugs, Cosmetics, Medical Devices
Govt may impose anti dumping duty on import of vitamin C…
USFDA to review use of Blood Disorder Therapy in children
B-Hub: Biopharma Hub to come up at Hyderabad’s Genome Valley
DCGI grants EUA to Truenat for Nipah virus tests in India
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
