The first steps have been taken, a quality management system according to DIN EN ISO 9001 or DIN EN ISO 13485 has been implemented externally or internally with external help. The processes, work instructions and forms fit, but now the system must be filled with life (records, such as protocols, reports, evaluations). Here, of course, all employees in the company have a duty, but one person needs to be in charge.
Changes in the processes described above must be updated in the process descriptions. These are the tasks of a quality management representative, or QMB for short.
The respective employees who carry out this process must be trained, etc. Often, in small to medium-sized companies, no one has the time for these tasks or the appropriate qualifications are lacking.
Appointing an external person can be the solution here. BEO BERLIN provides representative services for various roles for medical device manufacturers, Quality Manager service being one of them. Our employees are qualified and experienced.
