文件类型Document Type 品质管理体系程序QMS PROCEDURE 应用范围Application Scope通用 GENERAL修订记录 REVISION HISTORY 版本Rev. 修改内容 Revised Contents 作者 Author 生效日期EFF. Date A Initial releasing with ISO/TS16949 requirementsXXXNov.07,2006B Change the title from “改正和预防行动程序Corrective and Preventive Action Procedure” to “纠正和预防措施程序Procedure for Corrective & Preventive Action”XXXJan.10th, 2009C Revised the procedure to meet ISO13485 regulations (China) & CFR21 FDA 21 CFR QSR(Quality System Regulation) 820 (USA) requirements XXX 15-07-2014 文件审批 APPROVAL 本文件须经相关部门工程师（或主管）签批，请作者指定。This document shall be reviewed by ISO Coordinator and. The author shall determine. 编写部门ORIGINATE DEPT. 相关部门RELEVANT DEPT. 部门名称DEPT. TITLE QA Manufacturing Machining Engineering PE 工程师姓名NAME OF ENGINEER 工程师签署SIGNATURE 经理姓名NAME OF MANAGER 经理签署SIGNATURE 管理者代表签署SIGNATURE OF M.R. Ditto 总经理签署SIGNATURE OF GM. 拒签理由 Reason of reject: 文件分发 DISTRIBUTION 部门 DEPT. 数量 Q’TY部门 DEPT. 数量 Q’TY部门 DEPT. 数量 Q’TYEngineering Assembly OFF QA 1 Plating Sourcing HR Stamping Finance Maintenance Molding 1 目的 Purpose本程序规范了为消除存在或潜在的不合格而采取纠正预防措施的流程，以确保类似不合格不再发生或潜在不合格的发生，促进质量管理体系的持续改进。This procedure define the process of taking corrective and or preventive actions to Eliminate existing or potential non-conformity, to prevent similar non-conformity from Reoccurring or occurring of potential non-conformity. Promote continuous Improvement of quality systems. 2 范围 Scope 本程序适用于公司质量管理体系范围内纠正和预防措施的制定、实施与验证。This procedure is applicable to the formulation, implementation and verification of Corrective action and preventive action ...
