Amendments In NABL Policy For QA Testing Of Diagnostic Radiology X-Ray Equipment (NABL 136)

The National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued a key amendment to its policy document NABL 136, titled “Specific Criteria for Accreditation of Quality Assurance Testing Facilities for Diagnostic Radiology X-Ray Equipment.” The amendment, effective from April 4, 2025, brings significant enhancements aimed at aligning with updated regulatory requirements and ensuring improved quality assurance (QA) practices for diagnostic radiology.

In this blog, we’ll explore what the amendment entails, why it was necessary, and how it impacts QA Testing Facilities and the broader diagnostic imaging industry.

Purpose Of NABL 136

NABL 136 provides sector-specific criteria for accreditation of QA testing facilities involved in ensuring the performance and safety of diagnostic X-ray equipment, per ISO/IEC 17025:2017. These facilities play a critical role in healthcare by maintaining the accuracy and safety of imaging devices used in medical diagnostics.

What’s New In The April 2025 Amendment?

The latest amendment—Amendment No. 01—updates several clauses across the document. Here’s a summary of the notable changes:

1. Wider Scope of Accreditation

QA facilities can now apply for accreditation across a broader set of diagnostic equipment, including:

• Radiography (Fixed, Portable, Mobile, Handheld)
• CT and CBCT
• Mammography including Tomosynthesis
• Dental Imaging Systems (IOPA, OPG, RVG, etc.)
• Interventional Radiology & Fluoroscopy units

2. Stricter Infrastructure Requirements

• More detailed infrastructure and equipment lists are now included to ensure uniform testing capabilities. This includes specific phantoms and sensors tailored to different imaging modalities.

3. Updated Personnel Requirements

• Technical staff must have a minimum of 6 months’ experience and complete a certified QA training program (e.g., by BARC or an AERB-recognized institute).
• Roles for report reviewing and authorization must be assigned to qualified individuals.

4. Enhanced QA Reporting Obligations

• Facilities must retain raw data and QA reports for a minimum of 5 years.
• Any unusual findings, such as radiation leakage, must be reported to the Atomic Energy Regulatory Board (AERB) immediately.

5. Improved Management Systems

• QA facilities are required to maintain comprehensive Quality Manuals, including standard operating procedures (SOPs), calibration protocols, and safety guidelines.
• Internal quality controls such as intra-lab comparisons and functional checks, are mandatory to validate results.

6. Test Witnessing Procedures

• NABL assessment teams will now verify technical competence by witnessing on-site QA tests during accreditation audits.

Why This Amendment Was Needed

The amendment was formulated based on inputs from the AERB and a technical committee to address growing complexity in radiological technologies and align with evolving regulatory and safety standards. With increasing emphasis on radiation safety and diagnostic accuracy, these changes help:

• Improve testing consistency
• Ensure patient and worker safety
• Enhance trust in radiological practices and equipment

Who Is Affected?

This amendment impacts:

• Independent QA Testing Labs
• Hospitals and Diagnostic Centers with in-house QA
• OEMs and authorized suppliers
• Government and private health institutions seeking NABL accreditation

All such facilities must now revisit their QA protocols, documentation, staff training, and infrastructure to comply with the latest criteria.

Next Steps For QA Testing Facilities

To align with the amended NABL 136:

1. Review the amended policy document in full.
2. Update equipment inventory to match listed requirements.
3. Train technical staff as per the new qualification criteria.
4. Revise SOPs and quality manuals for compliance.
5. Coordinate with NABL for surveillance, reassessment, or reapplication for accreditation.

Conclusion

The April 2025 amendment to NABL 136 underscores NABL’s commitment to maintaining the highest standards of diagnostic safety and performance. As diagnostic imaging continues to advance, so too must the protocols and policies that ensure its reliability.

For QA Testing Facilities, the timely implementation of these updates will not only ensure compliance but also build trust with healthcare providers and patients alike.

Major Amendments in NABL 136

[You can download the official NABL Notification PDF from here]