Management Responsibility
Management responsibility is a foundational chapter of both KGMP and ISO 13485:2016 (Section 5).
Key requirements
- Quality policy — documented, communicated, and understood at all levels
- Quality objectives — measurable and aligned with the quality policy
- Management representative — designated with authority for QMS maintenance
- Management review — scheduled at planned intervals; inputs and outputs documented
- Resource provision — top management ensures adequate resources for QMS maintenance
During MFDS inspection
MFDS inspectors will review:
- Quality manual and quality policy
- Management review records (minutes, action items, closure evidence)
- Organisational chart and delegation of quality authority
- Evidence that quality objectives are monitored and achieved