NABL clarifies that it has no Regulatory Powers

ISO 15189 applicable to medical laboratories.


Last Updated on September 13, 2021 by The Health Master

The National Accreditation Board for Testing and Calibration Laboratories (NABL), a constituent board of Quality Council of India, has clarified that it is a voluntary accreditation body and has no regulatory powers.

The clarification is to inform those in the industry and public who might take the accreditation board as a regulatory body.

Accreditation is the independent evaluation of conformity assessment bodies against recognised normative documents like standards, regulations etc. to carry out specific activities to ensure their impartiality, consistency of operation and competence.

Through the application of national and international standards, government, procurers and consumers can have confidence in the results of accredited Conformity Assessment Bodies, said the clarification issued by N Venkateswaran, CEO of NABL.

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NABL is a voluntary accreditation body and has no regulatory powers. Checking of compliance to the regulatory requirements falls under the purview of respective/applicable regulator,” said the Board.

“In all cases, it is the responsibility of laboratory to abide by the National & State statutory requirements, Acts, Ordnance, Rules, Regulations, Legal orders, Court Decisions / Orders issued by the Government, Statutory Bodies, Courts as applicable and in force from time to time,” it added.

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Laboratories are accredited to the applicable international standards, ISO/IEC 17025 in case of testing and calibration laboratories, and ISO 15189 applicable to medical laboratories.

Laboratory customers, regulatory authorities, organisations and schemes using peer-assessment, accreditation bodies, and others use these documents in confirming or recognising the competence of laboratories.

The results from accredited laboratories are used extensively by regulators for the public benefit in the provision of services that promote an unpolluted environment, safe food, clean water, energy, health and social care services.

Many government agencies have recognised the importance of credible accreditation schemes that are developed against internationally recognised standards.

NABL accreditation is increasingly being used by Regulators and Government to ascertain the quality of products. Accredited CABs can objectively state conformance of product or service to specified requirements.

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