The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released a specific set of criteria for accrediting Quality Assurance (QA) testing facilities that evaluate diagnostic radiology x-ray equipment.
According to NABL, QA in this context refers to a series of systematic actions designed to give users confidence that medical diagnostic x-ray machines perform effectively and in line with applicable testing protocols and national or international standards set by regulatory bodies.
The purpose of QA testing for x-ray equipment is to ensure diagnostic accuracy based on the images produced by these machines. QA starts with performance evaluations during manufacturing, followed by acceptance testing once the equipment is installed at the user’s site typically conducted by the original equipment manufacturer (OEM) or an authorized supplier. These QA tests should continue at regular intervals, after any repairs, or whenever there’s a suspicion of malfunction.
NABL emphasizes that these tests confirm whether the equipment’s performance is consistent with its original (baseline) values and within acceptable limits as defined by the relevant authorities. The results, including any measurement uncertainties, should be communicated to the users and regulatory bodies.
The main goals of the new NABL document are:
- To define the criteria that QA testing facilities must meet to be accredited under ISO/IEC 17025:2017 for conducting QA on diagnostic radiology x-ray equipment throughout its operational life.
- To ensure consistent understanding among QA testing facilities and NABL assessors during the accreditation process, making it efficient and aligned with NABL’s overall policies.
- To standardize the selection of QA tools, testing procedures, environmental conditions, and the qualifications, training, and experience of personnel involved in QA testing, in accordance with both regulatory and ISO/IEC 17025:2017 requirements.
This document outlines the specific conditions that diagnostic radiology QA testing facilities must fulfill to obtain NABL accreditation. It serves as a supplement to ISO/IEC 17025:2017 by adding sector-specific requirements and should be used alongside the main ISO standard.