SABEU’s focus is on total quality management principles. All of our operations are in line with the DIN EN ISO 9001 and DIN EN ISO 13485 standards and the applicable normative, legal and regulatory requirements.
For us, quality assurance is not just a business area, but a duty of all employees. The Computer Aided Quality (CAQ) system is networked across all locations and available at all times.
The management processes are documented and regulated in an Integrated Management System (IMS). The exact core contents are described in the Integrated Management Handbook, IMH.
In order to meet our customers’ requirements, our company is controlled by a central, fully integrated management system. It includes all operational divisions and is available at all times via a location-wide structure.
Work hygiene is an essential component of our production process in clean rooms. The effectiveness of the hygiene requirements is monitored and documented with regular controls of the particle count in the ambient air and microbiological analyses in accordance with GMP guidelines.
SABEU carries out the system qualification, process and product validation in accordance with the EU guide to Good Manufacturing Practice (GMP), Annex 15, using the sub-areas IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) and DoE (Design of Experiments).
Other validation procedures:
SABEU plans and implements validation protocols in consultation with the customers. First sample reports (PPA report – Production Process and Product Approval Report) as set forth in VDA [German Association of the Automotive Industry] Volume 2, Chapter 4 are compiled in order to assess the development states during the development process of the items.
The scope of all validation procedures is described in the validation schedules and can be specifically adjusted and prepared as needed to meet the customer’s needs.
At SABEU, work hygiene is an essential component of the production process in clean rooms. The effectiveness of the hygiene requirements is monitored and documented with regular controls of the particle count in the ambient air and microbiological analyses in accordance with GMP guidelines.
Our hygiene monitoring includes the regular surveillance of the manufacturing conditions in accordance with the EC guide to Good Manufacturing Practice (GMP) by:
The samples are analyzed by certified accredited laboratories.