The National Accreditation Board for Testing and Calibration Laboratories (NABL) on January 05, 2026, issued amendment in the Specific Criteria for Accreditation of Medical Imaging.
The National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued Amendment No. 04 to its specific criteria document NABL 135 on January 5, 2026, marking a significant transition in the accreditation framework for Medical Imaging–Conformity Assessment Bodies (MI-CABs). This amendment formally shifts accreditation requirements away from earlier standards and aligns them with current global best practices.
A key feature of the amendment is the complete transition from ISO 15189:2012 to ISO 15189:2022, with all references to the older standard removed. Consequently, all Medical Imaging CABs are now required to comply with the 2022 standard, which places greater emphasis on risk management, patient safety, and quality assurance. The revised criteria apply uniformly across all diagnostic imaging modalities, including X-Ray, USG, MRI, CT, and PET-CT.
Additionally, Amendment 04 introduces important definitional and administrative updates. In line with earlier policy decisions, the term “Authorized Signatory” continues to be replaced with “personnel responsible for report, review, and release of results”, reinforcing clarity in professional responsibility and accountability in clinical reporting.
[Notification No. NABL 135]
