SABEU - Plastics and Membrane Technology
Phone: +1 (609) 661 2444
Headquarter: +49 5551 9101-00

General QA considerations

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.

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