Quality Management and Certification at BGS

CertificationWiehlBruchsalSaal
General QM systemISO 9001
QM system for medical devicesDIN EN ISO 13485
Requirements for sterilization by radiation for health care productsEN ISO 11137
Licencing according to LMBestrV, Reference NumbersNRW-GM01
NRW-GM02
D-BW-X-01
Reference Number
Australian Health
Authority AQIS
AEI 001425

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.

Download our certification documents

ISO 9001
DIN EN ISO 13485
EN ISO 11137
Japan PAL – Saal
Japan PAL – Wiehl

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