Content
In the staff position, the quality management officer (QMB) is responsible for documenting processes and reporting to management on effectiveness and promoting awareness of regulatory requirements. The basic requirement is knowledge of DIN EN ISO 13485. In medical technology companies, a large number of regulatory regulations must also be observed and adhered to, to which specific responsibilities and representatives are linked. The coordinating role of the QMB in the internal structure and process description in the QM system, the responsibility and authority as a “member of management” and the task within the framework of external audits and official inspections are explained using many examples.
Topic overview
- Qualification requirements for the QMB
- Commissioning, responsibility and authority
- The role as a staff position
- Function of the QMB in the context of moderation and awareness raising
- Delineation of responsibilities to the process owners
- Specific documentation requirements for the QM system
- Normative and regulatory requirements
- Internal audits – planning, qualification, implementation and reporting
- Behavior during inspections and audits by external bodies (e.g. authorities, FDA, etc.)
- Processes within the QMB department
target group
Quality management representatives and employees from the QM department.
Prior knowledge
Beginner seminar, knowledge of DIN EN ISO 9001 and/or DIN EN ISO 13485 are recommended.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
