MDSAP QMS P0005.003质量管理体系管理职责和管理评审程序.pdfVIP

Document No.: Page: 1 of 6 MDSAP QMS P0005.003 Responsible Office/Division Version Date: Effective Date: 2019-01-11 2019-01-15 Title: MDSAP QMS Management Project Manager: Hiromi Kumada, PMDA Responsibility and Management Review Procedure 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. 2. Scope This procedure applies to the MDSAP internal quality management system. MDSAP management reviews will include routine (at least once a year) and if necessary ad hoc reviews of summary reports, trend analyses, and abstracts of quality management system activities such as audit/assessment results, corrective action of nonconformities including continual improvement and control of documented information, etc. Individual issues of high importance or high risk may be presented at management review meetings, or may necessitate a special ad hoc meeting to keep MDSAP management informed regarding critical issues and to obtain support for problem resolution.