High-quality products and services are BioGnost’s first and foremost priority. That goal is achieved by the continuous enhancement of our products’ and services’ quality, as well as the ongoing education of all our employees.
In line with our priorities, we recognized the need to introduce a quality management system that would take the company’s products and business operations to the highest level. This would also result in both our employees’ and clients’ satisfaction. ISO 9001 standard was introduced in 2003, and in 2005 BioGnost was the first company in Croatia to introduce the ISO 13485 standard. We also recognized the need to conform to the European standards and our products bear the CE marking. Conducting business in accordance with the ISO 9001 and ISO 13485 standards, continuous development of new products and optimized business and manufacturing processes all contribute to the remarkable quality and reliability of BioGnost’s products.
BioGnost’s environmental management coordinates the rational consumption of natural resources and environmental protection. In order to make all manufacturing and business processes compliant with all the applicable laws and regulations regarding environment protection (valid in the Republic of Croatia and the European Union), BioGnost introduced the ISO 14001 environmental management system.
Quality management system according to ISO 9001 requirements is an international standard focused on process efficiency in order to achieve required business results. This norm promotes the adaptation of process approach in developing, applying and enhancing the efficiency of the quality management system. The goal is increasing customer satisfaction by fulfilling their demands. Our company has had an ISO 9001 certificate since 2003.
Download: ISO 9001:2015_EN
ISO 13485 is an internationally recognized norm for quality management system in medical devices industry. BioGnost was the first company to implement the ISO 13485 standard in Croatia, enabling registration of medical devices and assigning of the CE mark, facilitating further marketing of goods in the EU member states.
Download: ISO 13485:2016_EN
ISO 14001 is the most implemented international norm for environmental management. The certificate has helped for many years to reduce our ecological footprint and permanently reduce negative influence on the environment. The management system enables us to identify and control all the aspects of the environment, as well as to make it in accordance with all applicable laws and regulations.
Download: ISO 14001:2015_EN