The National Accreditation Board for Certification Bodies (NABCB), India’s national accreditation body, has secured international equivalence for its accreditation programme for Medical Devices - Quality Management Systems (MDQMS) certification bodies by signing the Mutual Recognition Arrangement (MRA) of the Asia Pacific Accreditation Cooperation (APAC).

“Now any industry carrying ISO 13485 certificate with NABCB logo will be recognised in Asia Pacific region. The immediate beneficiary of this equivalence is the Indian industry which is exporting products to various Asia Pacific countries,” according to an official release of the Commerce & Industry Ministry. It can also be used by regulators for establishing confidence in certified units.

The MRA covers accreditation programme based on international standards, ISO 17021-1 and ISO 13485, the release said.

NABCB, a constituent Board of the Quality Council of India, is responsible for accreditation of certification, inspection and validation & verification bodies as per applicable international standards under an international system of equivalence.

APAC is the association of Accreditation Bodies and other bodies interested in the field of management systems, product, services, personnel and other similar certification programme in the Asia Pacific region. APAC is one of the five specialist bodies of the Asia Pacific Economic Cooperation (APEC).

MRA significance

This MRA signed by the two signifies that the accreditation of Medical devices - Quality Management Systems bodies by NABCB is now accepted as internationally equivalent within Asia Pacific Region. NABCB APAC MRA is a step towards signing the Multilateral Mutual Recognition Arrangement (MLA) of the International Accreditation Forum (IAF) which would confer worldwide equivalence to NABCB’s MDQMS certification bodies’ accreditation programme, the release said.

NABCB has already secured international equivalence for its accreditation programme for ISO 9001 certification bodies in 2002 and ISO 14001 certification bodies in 2007.

Accreditation reduces risk for business and its customers by assuring that accredited Conformity Assessment Bodies (CABs) are competent to carry out the work they undertake within their scope of accreditation.

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