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Management Responsibility

Quality policy and objectives under MO 169​

Top management of the manufacturing site must establish, document, and communicate a quality policy that is appropriate to the purpose of the organisation and includes commitments to:

  • Compliance with applicable regulatory requirements including MO 169
  • Continual improvement of the QMS effectiveness

Quality objectives must be established at relevant functions and levels, and must be measurable and consistent with the quality policy.

Management representative​

Management must designate a member of management who, irrespective of other responsibilities, has responsibility and authority for:

  • Ensuring that the QMS is established, implemented, and maintained
  • Reporting to top management on the performance of the QMS
  • Promoting awareness of regulatory requirements throughout the organisation

For foreign manufacturers, the management representative must be accessible to PMDA — English-language communication must be possible either directly or through the MAH.

Management review​

Top management must review the QMS at planned intervals. Management review inputs must include:

  • Results of internal audits and supplier audits
  • Customer feedback and complaints
  • Process performance and product conformity data
  • Status of CAPA
  • Changes that could affect the QMS
  • Post-market surveillance data (particularly important for demonstrating MO 169 / GPSP integration)

Management review outputs must include decisions and actions related to improvement, resource needs, and changes to the QMS.