Quality Assurance
Orbisana Healthcare GmbH has been a recognized manufacturer and well-known retailer on the market for medical aids for many years. Thanks to many years of experience in the field patient care, Orbisana Healthcare GmbH develops and produces medical technology devices, aids, and consumables of the highest quality. Since the invention of the first electronic speech aid in 1958, we have established ourselves as a top manufacturer in the industry. The SERVOX brand is known worldwide for pioneering products of the highest quality.
In order to meet the demands of our target groups and customers while maintaining our corporate policy, we introduced the quality management system in accordance with EN ISO 13485:2016.
Corporate Policy and Quality Policy
The Orbisana Healthcare GmbH develops, manufactures, and distributes medical products and provides care for people through its services. In order to meet these requirements, we introduced and continue to maintain a quality-management system on the basis of current regulatory requirements and under observance of country-specific requirements. This results in established, reproducible, and controllable processes that are described in procedure guides.
The supreme corporate objective is to achieve the highest customer satisfaction possible based on the individual needs of our target customers and to ensure the compliance of our products with regulatory requirements. The fulfillment of this objective is the best guarantee for further expansion of our market position and strengthening of Orbisana Healthcare GmbH’s economic power. As a guideline for action at the Orbisana Healthcare GmbH, management regularly formulates quality goals. Then management checks whether these goals have been met in personal conversations with department leaders.
This quality policy is made available to every employee in a central QM system. The constant monitoring of regulatory norms and standards, and the maintenance of the quality-management system helps Orbisana Healthcare GmbH meet this high standard. The quality goals and quality policy are examined by management and the QM consultant at least once per year to determine if they are adequate. Employees are trained in the current standards to ensure that high product quality is maintained. The constant improvement of the service process for customers aims to ensure our customers are as satisfied as possible. This requires trusting cooperation between employees, customers, and suppliers.
Orbisana Healthcare GmbH is certified:
