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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

Management review meetings should be conducted at least annually, with documented evidence of attendance, agenda items, action items, and closure verification maintained in quality records.