Quality Management
THE FRAMEWORK: ISO 9001
Vogelbusch Biopharma has had an ISO 9001 quality management system in place since 1998. It is based on an established quality policy as well as a quality management handbook, which we also issue to our clients on an as-needed basis.
In keeping with our quality policy, every single employee contributes to the quality of our products and services through his or her own performance.
PROCESS DESCRIPTIONS
All quality-relevant processes are described in detail in corresponding instructions for procedures. There are detailed work and inspection instructions where needed, which are updated on a regular basis and continuously improved. To this end, we implemented our own improvement and corrective procedure for assessing abnormalities, and establishing and carrying out appropriate corrective measures once the causes have been analyzed.
PROJECT QUALITY PLAN
Because our jobs are generally handled as projects and because every project is unique, we compile a project quality plan for each one. This describes in depth the standards and the scope of testing to be applied in the projects, as well as the responsibilities to assigned, in particular the interfaces with other companies participating in the project.
QUALITY CONTROL
All documents are subject to the TWO PAIRS OF EYES principle, in other words, they are checked by the author as well as another individual and approved by signing. Acceptance inspections (FAT/SAT) with subcontractors and incoming goods inspections are part of the daily routine of our employees, as is calibration and servicing of measuring equipment. The relevant records and documentation are available to our clients.
