NABL releases NABL 136: specific criteria for X-Ray equipment

Quality assurance of medical diagnostic x-ray equipment


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.

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