|
In a move to redefine standards in the medical imaging landscape, the National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued an amendment to its Specific Criteria for Accreditation of Quality Assurance Testing Facilities for Diagnostic Radiology X-Ray Equipment. This amendment incorporates crucial updates based on feedback from the Atomic Energy Regulatory Board (AERB) and technical committees, impacting both public and private diagnostic infrastructure across India.
With patient safety and diagnostic accuracy at its core, NABL accreditation is awarded under ISO/IEC 17025:2017, ensuring competent performance of laboratories conducting testing and calibration. These revised guidelines aim to establish a unified, rigorous quality framework for facilities involved in quality assurance (QA) testing of diagnostic X-ray equipment, including radiography, CT, mammography, and fluoroscopy machines.
According to NABL, “These amendments are crucial to maintaining safety, uniformity, and international parity in quality standards for diagnostic radiology equipment throughout their lifecycle from manufacturing and installation to post-repair evaluations.”
Major highlights of the amendment include widened scope of accreditation. QA testing facilities can now seek accreditation for a broader range of radiological equipment including mobile, dental, interventional, and vehicle-mounted X-ray units.
It also includes expanded equipment list. A comprehensive catalogue of required test equipment such as CTDI phantoms, mamo sensors, alignment tools, and focal spot testers must now be maintained with strict calibration traceability per NABL 142 standards.
It stipulates stricter personnel requirements. Technical staff must now demonstrate specific educational qualifications, minimum 6-month work exposure, and mandatory QA training recognized by the AERB. Facilities must conform to acts like the Atomic Energy Act (1962), AE(RP)R-2004, and the AERB Safety Code, with penalties for non-compliance possibly affecting accreditation status.
Emphasis has been placed on on-site test witnessing during assessments and the use of internal quality controls and inter-laboratory comparisons (ILCs) to verify test result validity.
With a nationwide push for modernizing healthcare infrastructure under initiatives like Ayushman Bharat, this amendment ensures diagnostic imaging facilities meet world-class standards in safety and performance. Not only does this bolster clinical diagnostic accuracy, but it also aligns India’s QA frameworks with global expectations critical for international collaborations and tele-diagnostics.
Healthcare providers, OEMs, and independent QA labs now face tightened responsibilities to ensure radiological equipment performs optimally and safely across hospitals, clinics, and remote diagnostic centers.
Standardizing QA across all types of radiology equipment helps ensure the safety of both patients and technicians. It also raises the bar for testing facilities to upgrade their processes and documentation.
“QA testing facilities are urged to review the updated criteria thoroughly, align infrastructure, documentation, and personnel credentials with the revised guidelines. It has also been urged to ensure timely submission of updated applications and supporting documents to NABL. Facilities must also prepare for NABL audits where test witnessing at operational sites is now a pivotal part of the assessment process. This amendment is a transformational step in strengthening India’s diagnostic radiology framework, fostering trust, transparency, and technical excellence in medical imaging,” according to an official.
|