Congratulations to “Horiba India Private Limited” for successfully achieving IOAS-accredited ISO 13485:2016 & SELF-accredited CE marking certification for Sales & Marketing and Post-Sales Support of Semi-Automatic Analyzer. With this accomplishment, they have manifested assurance towards Medical Devices Quality Management System (MD-QMS) and provide products that meet EU quality and safety standards.
ISO 13485 certification & CE Mark, ensures the efficiency of Horiba India Private Limited, in keeping the quality of the medical devices intact and delivering products that fulfill European Union’s directives and principles. This will bring confidence among the community that the “Horiba India Private Limited” assures environment friendly and good quality products and services to their employees as well as clients. ISO 13485:2016 is a proof of compliance with all the legislations that are aimed to assist the organizations in developing their own Medical Devices Quality Management Systems.
One of the expert auditors Mr. Praveen Kumar of the certification body recalls the certification experience as, “Smooth, collaborative, and highly professional”. He says, “The audit of their organization has been highly admirable and resilient. Also, with mutual coordination, we could successfully complete the certification process within the given time.”
There are various other ISO standards that can be applied for its enhanced credibility. These include ISO 9001 for Quality management, ISO 50001 for energy management, and so on.
SIS Certifications, which certified the Horiba India Private Limited for their analytical and measurement systems throughout the world, is accredited by both International Accreditation Services (IAS-IAF) and International Organization for Accreditation Services (IOAS). Several certifications, including and not limited to ISO 9001, ISO 14001, ISO 21001, ISO 37001, ISO 41001, ISO 45001, ISO 22301, ISO 50001, ISO 13485, ISO 22000, HACCP, ISO/IEC 27001 (ISMS), ISO/IEC 27701 (PIMS), IATF 16949, CMMI, GDPR, CE, RoHS, KOSHER, HALAL, Product Certifications, and training comes under the aegis of its services.