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In a decisive move towards ensuring the highest standards of medical laboratory accreditation, the National Accreditation Board for Testing and Calibration Laboratories (NABL) has mandated the implementation of NABL 112A by medical laboratories latest by December 31, 2025.
NABL CEO N. Venkateswaran emphasized that compliance with the updated requirements will be verified during the subsequent onsite assessment, reinforcing the commitment to quality, competence, and international standardization.
The updated NABL 112A document aligns with the latest International Standard ISO 15189:2022 and has been meticulously tailored to suit the Indian context. This revision aims to make the accreditation process more accessible and efficient for both NABL assessors and medical laboratories while ensuring synchronization with global best practices.
"NABL documents are regularly updated to keep pace with the latest technical advancements and international standards. The new issue of NABL 112A has been specifically designed to be user-friendly for both NABL assessors and laboratories. I sincerely appreciate the enthusiasm and dedication demonstrated by NABL members in making this revision a success. I also extend my heartfelt gratitude to all stakeholders whose invaluable inputs have enabled us to achieve this milestone. Special thanks to the Chairman of NABL for his continuous inspiration and expert guidance throughout this endeavour," said Venkateswaran.
The revised NABL 112A sets forth specific criteria for medical testing laboratories seeking accreditation. It mandates that laboratories fulfill the requirements outlined in this document in conjunction with ISO 15189:2022, which defines the essential elements for ensuring quality and competence in medical laboratories. Where ISO 15189:2022 is self-explanatory, NABL 112A does not reiterate those clauses or subclauses, streamlining the compliance process for laboratories.
Furthermore, medical laboratories are required to adhere to all relevant national, regional, and local laws and regulations in addition to the NABL-specific criteria. This comprehensive approach ensures that accredited laboratories uphold the highest standards of operational excellence and regulatory compliance.
With the implementation deadline set for December 31, 2025, medical laboratories across India have been urged to take proactive steps to align with the NABL 112A requirements. The onsite assessments following the deadline will serve as a critical checkpoint to validate compliance and reinforce the mission of NABL to enhance the quality and reliability of medical laboratory services in the country.
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