Quality & Environmental Policy
Quality & Environment is not only about the quality of the products and where they originate from, but also about quality and environmental factors at every stage of the process. Our ambition is to understand our customers’ needs so that we can offer high-quality products and solutions tailored to each individual customer.
For us, quality means providing you with a positive experience as a customer of IVUS Medical. Therefore, we have procedures and documentation in place across all areas of our operations to ensure that you receive the best possible service. At the same time, we acknowledge that procedures and documentation can never replace a great customer experience, which we actively support through flexibility and open dialogue.
Quality Policy
We are proud to operate an ISO 9001 and ISO 13485 certified quality management system, which we continuously develop to ensure ongoing customer satisfaction and value creation. We work purposefully toward ambitious improvement goals across all functions and levels of the organization.
Our quality policy defines the framework for our quality objectives. We establish and review our operational quality goals at least once a year to ensure the targeted development of our products and services.
IVUS Medical ApS is committed to delivering the highest possible level of quality in the distribution, service, and support of our products. Quality and compliance with all relevant regulatory and customer requirements—including Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), ISO 9001, and ISO 13485—form the foundation of our efforts. IVUS Medical ApS continuously measures, maintains, and improves our quality management system and its effectiveness. Our success in achieving these objectives is systematically evaluated through the results of our processes.
ISO 9001 & 13485 certification
Environmental Policy
The purpose of implementing Environmental Management in accordance with ISO 14001 is to enable us to:
- Work proactively with sustainability
- Assess environmental and climate-related risks within our organization
- Provide management with assurance that our environmental and climate objectives are achieved
ISO 14001:2015 places increased emphasis on a life-cycle perspective. In addition, we work in alignment with the United Nations Sustainable Development Goal No. 12: Responsible Consumption and Production.
Accordingly, and as far as possible within the specific conditions of our industry, we increasingly take into account the entire life cycle of our products. This includes assessing the environmental and climate impact of products during production, transportation, use, and end-of-life disposal.
We apply this focus in our collaboration with manufacturers and suppliers, as well as in the production and development of IVUS, our own product line, which has been developed in close cooperation with doctors and nurses.
