Accreditation(s) & Approval(s)

Accredited by National Accreditation Board for Certification Bodies – NABCB, India

Zenith is accredited by National Accreditation Board for Certification Bodies – NABCB, India for ISO 9001, ISO 13485, ICMED 9000 and ICMED 13485 Management System Certification schemes.

The Accreditation Status and Scope can be viewed for QMS at https://nabcb.qci.org.in/zenith-quality-assessors/# and for MD-QMS at https://nabcb.qci.org.in/mdqms/qm062/

Accredited by International Accreditation Service – IAS, USA

Zenith is accredited by International Accreditation Service – IAS, USA for ISO 13485, ISO 22000 and FSSC 22000 Management System Certification Schemes.

The Accreditation Status and Scope can be viewed at  www.iasonline.org or vide quick link at https://www.iasonline.org/wp-content/uploads/2017/05/MSCB-128-Cert.pdf

License from Foundation FSSC for FSSC 22000 V 6.0.

The status of our License can be viewed at https://www.fssc22000.com/certification-body/zenith-quality-assessors-private-limited/  

Approved as per MDR 2017 by Central Drugs Standard Control Organisation – CDSCO (Govt. of India)

In extension, Zenith Quality Assessors Pvt. Ltd. is a registered Notified Body with Central Drugs Standard Control Organisation (CDSCO – Govt. of India) under provisions Medical Device Rules 2017 to carry out audit of manufacturing site under the provision of said rules [See sub-rule (6) of rule 13].

REGISTRATION CERTIFICATE ISSUED by Central Drugs Standard Control Organisation (CDSCO – Govt. of India) FOR NOTIFIED BODY can be viewed vide quick link “Registration certificate of notified body“

Provisional Approval from Quality Council Of India (QCI) for Indian Certification of Medical Devices (ICMED) 13485 Plus Scheme

The status of our approval can be viewed at https://padd.qci.org.in/wp-content/uploads/2024/04/List-of-Provisionally-Approved-CBs.pdf