Our company is focused on the satisfaction of our customers and the high quality of our services. In order to fulfil this quality claim, we have our company monitored annually by the German Institute for Audits and Certifications of Management Systems (Deutsche Gesellschaft zur Zertifizierung von Managementsystemen [DQS Med GmbH]) within the context of the ISO 9001, ISO 13485 as well as the ISO 11137 certification.
This year’s surveillance audit was carried out over a total of seven days in February 2022 at the three BGS locations Wiehl, Bruchsal and Saal a.d. Donau. As in previous years, BGS meets all the requirements of the aforementioned standards DIN EN ISO 9001, DIN EN ISO 13485 and DIN EN ISO 11137.
A summary of the certifications
DIN EN ISO 9001
- DIN EN ISO 9001 is an international standard which attests a high quality claim towards customers and third parties.
- The certification serves as a specifications catalogue for our quality management system.
- By complying with and implementing the test criteria, BGS benefits from optimised in-house processes, conservation of resources and increased customer and employee satisfaction.
- The goal of the standard is to understand and implement the demands placed on the company by interested parties.
DIN EN ISO 13485 and DIN EN ISO 11137
- DIN EN ISO 13485 is an international standard for the quality management system of medical devices whose objective is patient safety. It contains detailed demands on topics such as the architecture, manufacture and placing of medical devices on the market, and it establishes the basis for cooperation between manufacturers and suppliers.
- In addition, DIN EN ISO 11137 determines the requirements for the development, validation and routine control of the application of a radiation sterilization process for medical devices.
In implementing the changeover to the Medical Device Regulation (MDR), it is crucial in medical technology to have a critical supplier with certified quality management as this is relevant for registration. Both certifications furnish proof of the reliability and safety of the radiation sterilization service provided by BGS.
We are very pleased with the excellent results of the audit and will continue to have our company’s processes and structures reviewed through annual surveillance audits and certification measures in order to continuously develop our competence and expertise. You will find further information on our certifications here.