The basic step has been taken and a quality management system according to DIN EN ISO 9001 or DIN EN ISO 13485 has been implemented, what now?
The created processes, work instructions and forms fit, but now the system has to be filled with life (records, such as protocols, reports, evaluations). Of course, each person in the company is responsible for this, but one person should wear the hat and control it. Changes in the previously described processes must be updated in the process descriptions. The maintenance of the QM-documentation is usually taken over by a quality manager (QMB), i.e. an appropriately trained employee who carries out this process
Often, no one has time for these activities in small to medium-sized companies or they lack the appropriate qualifications. BEO BERLIN is happy to advise on the implementation and answer any questions that may arise. Furthermore, we offer a the service of ´a qualified employee as external QMB according to EN ISO 13485.
