Quality & certification

Quality management and certification at BGS

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:

CertificationWiehlBruchsalSaal
General QM systemISO 9001
QM system for medical devicesDIN EN ISO 13485
Requirements for the sterilization with rays for health care productsEN ISO 11137
Licensed according to the German LMBestrV, Reference numbersNRW-GM01 NRW-GM02D-BW-X-01
Reference Number Australian Health Authority AQUISAEI 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.

BGS ensures highest standards for daily operations by way of the following principles:

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.