BGS works with a quality management system pursuant to ISO 9001 and DIN EN ISO 13485. The system also complies with the requirements of EN ISO 11137 for the sterilization of medical devices. Our certifications at a glance:
|General QM system||ISO 9001|
|QM system for medical devices||DIN EN ISO 13485|
|Requirements for the sterilization with rays for health care products||EN ISO 11137|
|Licensed according to the German LMBestrV, Reference numbers||NRW-GM01 NRW-GM02||D-BW-X-01|
|Reference Number Australian Health Authority AQUIS||AEI 001425|
All the processes in the company are laid down in a consistently used QM system, in order to achieve reliable results.
Due to the design of our plants and our finely-tuned processes, the services provided by BGS are fully reproducible and highly reliable. For complete traceability, we record each order from the receipt of goods through the irradiation process to re-delivery, and document such order in accordance with the regulatory requirements.
We have a stringent and sophisticated quality system that has been continuously developed since the 1980s. The system defines the guidelines and rules of daily tasks, continuity and improvement of processes and guarantees the efficiency of operations.
We focus our attention on our employees, as they are the most valuable asset of our company. We believe that motivation, knowledge and commitment are the key factors for the success of BGS, which we want to develop through training, appreciation and consideration of individual strengths and by providing a culture of involvement, constructive feed-back and open communication.
We minimize the occurrence of potential errors through state-of-the art facilities and technologies. This means that for example a highly sophisticated, validated computer system is used to handle and monitor the products of our customers, the use of automated plants wherever possible, as well as the clear separation of sterile and non-sterile products through a one-way system.