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Table of Contents - Food and Drug Administration

Responsible Office/Division Document No.: MDSAP QMS Page: 1 of 6 Version Date: 2019-01-11 Effective Date: 2019-01-15 Title: MDSAP QMS Management Responsibility and Management Review Procedure Project Manager: Hiromi Kumada, PMDA Uncontrolled when printed: For the most current copy, contact Table of Contents 1. Purpose/Policy 2. Scope 3. Definitions/Acronyms 4. Authorities/Responsibilities 5. Procedures 6. Forms 7. Reference Documents 8. Document History Approval Sign-Off Sheet 1. Purpose/Policy MDSAP Management performs periodic reviews to determine its continuing suitability, adequacy and effectiveness of the quality management system (QMS) in achieving the stated quality objectives. This procedure establishes the method and level by which management reviews are performed within MDSAP. This document defines: who is involved, and what their responsibilities are: schedule for management review meetings, and periodic review of the quality system itself, etc.

Responsible Office/Division Document No.: MDSAP QMS P0005.003 Page: 1 of 6 Version Date: 2019-01-11 Effective Date: 2019-01-15 Title: MDSAP QMS Management Responsibility and Management Review

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  Administration, Drug, Food and drug administration, Food

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