MDSAP QMS F0005.2 .002管理评审议程表.docxVIP

MDSAP QMS Management Responsibility/Review Agenda Form Document No.: MDSAP QMS F0005.2.002 Page PAGE 2 of NUMPAGES 2 Uncontrolled when printed: For the most current copy, contact MDSAP@fda.hhs.gov Responsible Office/Division Document No.: MDSAP QMS F0005.2.002 Page: 1 of 1 Version Date: 2019-01-11 Effective Date: 2019-01-15 Title: MDSAP QMS Management Responsibility/Review Agenda Form Project Manager: Hiromi Kumada, PMDA Uncontrolled when printed: For the most current copy, contact MDSAP@fda.hhs.gov Date of Management Review Elements listed below are included in each management review: Follow-up actions from previous management reviews Suitability of policies and procedures Outcome of recent internal audits Effectiveness of previous actions taken Corrective actions and their resolution Assessments by external bodies Changes in the volume and type of the work Customer feedback Complaints MDSAP Resource Assessment Recommendations for improvement including other factors, such as quality control activities, resources and training Changes in Regulatory requirements that have been incorporated into MDSAP guidance and procedures [To add as necessary]