On January 30, 2023, ROSSA’s management was awarded ISO 9001 and ISO 13485 certificates.
ISO is an international quality standard. They are being developed for various fields: medicine, IT security, environmental management or energy consumption. Each area has its own designation of standards. The ISO certificate helps the company to set up business processes and work more efficiently.
ISO 9001 – Quality management system Sets requirements for company management and quality management. The main principle is customer orientation. It is important for the company that its customers remain satisfied with the products and service, therefore, the main attention in the regulation is paid to the “company → consumer” bundle.
ISO 13485 – quality system of medical products Medical devices are medical devices that are needed to help patients. The ISO 13485 series is aimed at reducing the risks of producing low-quality materials.
The certificate specifies the requirements for quality management systems in the medical equipment industry. The rules are suitable for the production of different types of products, including reagents. In addition to quality control, the standards prescribe after-sales control, complaints handling and the creation of a suitable infrastructure for the production of sterile medical products.
ISO certificates are reputation. People and corporations tend to trust more those who work according to the rules and comply with the norms of international standards.