The accreditation will enable TÜV SÜD to grant certifications for ISO 13485, ICMED 9000 and ICMED 13485
German safety and quality expert, TÜV SÜD, has received accreditation from National Accreditation Board for Certifying Bodies (NABCB) to grant certifications for ISO 13485, ICMED 9000 and ICMED 13485. NABCB is a part of Quality Council of India (QCI). TÜV SÜD is the first and only independent certification body till date in India to be accredited by NABCB to issue these certifications.
ISO 13485 specifies requirements for a quality management system that can benefit an organisation right from design to practical usage of medical devices and related services. ICMED 9000 certification consists of ISO 9001 plus additional requirements, whereas, ICMED 13485 includes ISO 13485 plus additional requirements. These certifications are covered under the ICMED (Indian Certification for Medical Devices) Scheme, which was introduced by the Quality Council of India with an aim to bring down cost and turnaround.
TÜV SÜD will also offer the unique MDSAP (Medical Device Single Audit Programme). The programme aims to help manufacturers get their devices into multiple global markets through a single audit.
TÜV SÜD’s ISO 13485; ICMED13485 and ICMED 9000 programme adheres to guidelines as per ISO 17021: 2011 and ISO 17065: 2012 for certification bodies providing audit and certification of management systems.
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