MDSAP QMS F0002.2.003新文档的建议.pdfVIP

Document No.: Page: 1 of 3 MDSAP QMS F0002.2.003 Responsible Office/Division Version Date: Effective Date: 2019-01-11 2019-01-15 Title: Project Manager: MDSAP QMS New Document Proposal Hiromi Kumada, PMDA (NDP) Template Preparation Guidelines Table of Contents [Expand Table of Contents as Necessary] 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 [Mandatory] 1. Purpose/Policy State the objective or reason for the procedure. The purposed of this procedure is to … (define, describe, identify, provide, outline, establish) (guidance, guidelines, and requirements) for: [Purpose is mandatory/Policy is optional] 2. Scope Specify area, function or personnel involved. This procedure… (encompasses or applies to) (all, any, each): [Mandatory] 3. Definitions/Acronyms Add definitions that are procedure specific or assist in clarifying the procedure. [Mandatory] 4. Authorities/Responsibilities List authorities and responsibilities for all personnel who will use the procedure. [Mandatory] Uncontrolled when printed: For the most current copy, contact MDSAP@fda.hhs.gov MDSAP QMS New Document Document No.: MDSAP Page 2 of 3 QMS F0002.2.003 Proposal (NDP) Template Preparation Guidelines 5. Procedures Describe who, what, when, and how. List actions. Any optional section that does not have content will be annot