Quality Policy of BIOSTER, a.s. for the year 2024

 

BIOSTER, a. s. is an established Czech producer of medical devices made from oxidised cellulose, designed to stop bleeding and facilitate treatment of chronic wounds, and marketed mainly under the trademarks Traumacel, Traumastem, Emoxicel and Celstat. BIOSTER also provides radiation sterilization and packaging services.

The management of the company has decided to uphold their professional and innovative approach with modern principles of company management and BIOSTER has been certified in accordance with ČSN EN ISO 13485:2016, ČSN EN ISO 9001:2016 and GMP. In accordance with the requirements of these quality management systems for maintenance and improvement, management announces the following quality policy, applying to and mandatory for all employees of the company:

  1. To always focus on top quality, maximum effectiveness and real needs of customers, and deliver products and services that fulfil the expectations and requirements of our customers as well as requirements of legislation.
  2. To continue to improve the quality of existing products and services.
  3. To expand to new markets and to develop itself.
  4. To use resources efficiently and to create an optimal environment for the processes to function.
  5. To continue efforts to increase the expertise of employees at all levels and to support awareness of the importance of their activities, contributions and responsibilities.
  6. To support long-term cooperation with a number of academic facilities, emphasising the company´s own research, development and continuous product innovation.

 

In order to preserve the effectiveness of the management system, management is committed to determining direction, to provide resources and to support the established management system by promoting and monitoring internal quality objectives and process key performance indicators (KPI).