Quality Management and Certification at BGS
|General QM system||ISO 9001|
|QM system for medical devices||DIN EN ISO 13485|
|Requirements for sterilization by radiation for health care products||EN ISO 11137|
|Licencing according to LMBestrV, Reference Numbers||NRW-GM01|
BGS works with a quality management system according to ISO 9001 and DIN EN ISO 13485. The system also fulfils the specification of EN ISO 11137 for the sterilization of health care devices. All the processes in the enterprise are laid down in a consistently used QM-system, in order to achieve our objectives all the time.
Thanks to the characteristics of our plants and our sophisticated precision processes, the services provided by BGS are fully reliable and highly reproducible. For complete traceability, we document each order from receipt of goods, through the irradiation process to re-delivery and maintain records for up to 10 years.
BGS is assuring the highest standards in treatment of all of their customers by the following principles:
- A stringent and refined Quality System, under continuous development and improvement since the 1980’s. The system defines the guidelines and rules of daily operation, maintaining and improving processes, equipment and providing transparency of the efficiency of the processes.
- We focus on our People, which are the most valuable asset to the company. We believe in motivation, knowledge and commitment as key factors of the success of the company, which we want to develop through training, valuation and consideration of the individual and by providing a culture of involvement, critical feed-back and open communication.
- We try to minimise potential errors in handling through the use of state-of-the art equipment and technology. This means e.g. the use of high-sophisticated, validated computer system to handle and track the goods of our customers, the use of automated product handling systems wherever feasible and clear separation of sterilised goods from un-sterile goods by a one-way system.