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The quality management officer (QMR) is responsible for documenting processes and reporting to management on the effectiveness and promotion of awareness of regulatory requirements. The basic requirement is knowledge of DIN EN ISO 13485. In medical technology companies in the medical technology industry, a large number of regulatory regulations must also be observed and complied with, to which special responsibilities and officers 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 the management" and the task in the context of external audits and official inspections are explained using many examples.
topic overview
- Requirements for the qualification of the QMB
- Mandate, Responsibilities and Authorities
- The role as a staff unit
- Function of the QMB in the context of moderation and awareness raising
- Delimitation 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 officers and employees from the QM department.
previous knowledge
beginner seminar; Knowledge of DIN EN ISO 9001 and/or DIN EN ISO 13485 is recommended.
KONTAKT:
Online
