ISO 9001:2015, ISO 13485:2016, and CE Mark are quality management standards and certifications that help improve the capabilities of manufacturers and distributors of in-vitro diagnostic (IVD) reagents. These standards ensure that the products meet regulatory and customer requirements and are of high quality.
ISO 9001:2015 is a standard for quality management systems that applies to all types of organizations. It provides a framework for organizations to manage their processes and ensure customer satisfaction. By implementing ISO 9001, manufacturers and distributors of IVD reagents can improve their quality management system, enhance customer satisfaction, and increase efficiency in their manufacturing and distribution processes.
Horiba India Private Ltd. develops and sells in vitro diagnostic systems primarily for biological examination in medical laboratories around the world. Patients, doctors, private laboratories, clinics, and university hospitals are among the users who benefit from these automated analyzers. HORIBA’s expertise in vitro diagnostics is widely recognized in hematology, and it contributes to the health of tomorrow today. Their medical division looks into the Manufacturing and distribution of -Vitro Diagnostic Reagents; Manufacture, distribution, Installation, and post-sale support of In-vitro diagnostic and medical devices i.e., Clinical Chemistry Analyzer.
ISO Cert News gives Horiba India Private Ltd. good wishes to take a step towards fulfilling their vision of development and growth by receiving ISO 9001: 2015, ISO 13485:2016 certification, and a CE Mark from an IAS-accredited body.
ISO 13485:2016 is a standard specific to the medical device industry. It outlines the requirements for a quality management system in the design, development, production, installation, and servicing of medical devices. By implementing ISO 13485, manufacturers of IVD reagents can ensure that their products are safe, effective, and comply with regulatory requirements.
CE Mark is a certification that indicates that a product complies with the essential requirements of the European Union’s medical device regulations. It is mandatory for medical devices to be CE marked before they can be sold in the European market. By obtaining CE Mark certification, manufacturers of IVD reagents can demonstrate compliance with regulatory requirements and increase market access to European countries.
Together, these standards and certifications can help manufacturers and distributors of IVD reagents improve their capabilities by ensuring compliance with regulatory requirements, enhancing customer satisfaction, and increasing efficiency in their manufacturing and distribution processes.
