医疗产品历史纪录控制讲述.doc

NSU-2402-QC-005 Rev:C Page  PAGE 7 of  NUMPAGES 7 Nypro Plastics Molding Rev.Date.Total Pages.Products (Suzhou) Co., Ltd.版本日期总页码　C2007.02.077Title: Control of Device History recordPrepared by/DateReviewed by/DateApproved by/Date医疗产品历史纪录控制编制/日期审核/日期批准/日期Doc No: NSU-2402-QC-005Frank Li Yookie Wang Yong CW  CONTENTS PAGE CONTENTS 1 AMENDMENT HISTORY 2 1.0 PURPOSE 3 2.0 SCOPE 3 3.0 DEFFNICATIONSABBREVIATION 3 4.0 RESPONSIBILITIES AND AUTHORITIES 3 5.0 PROCEDURE 4-5 6.0 QUALITY RECORD 6 7.0 QUALIFICATIONS AND TRAINING 7 8.0 ASSOCIATED PROCEDURES AND REFFERENCES 7  耐普罗塑胶模具(苏州)有限公司Nypro Plastics Molding Products (Suzhou) Co., Ltd. Amendment History Amendment History 修改历史记录Change Date 变更日期 Rev. No. 版本 编号 Description of Changes 变更说明Prepared by: 编写人Approved by: 批准人 2006-2-14AInitial release SissiLuke2006-5-09BAmended point no. 6.3Zeng DefangLuke2007-2-07CAmended point no. 4.0,5.0,8.0Frank li Yong 1.0 PURPOSE 目的 To establish and maintain procedures to meet the requirements of CFR 820.184, to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of the respective part. 按照CFR 820.184 的要求建立和维护程序，以确保与DMR和产品的要求一致的每批 或者每单元的产品历史记录的维护。 2.0 SCOPE 范围 DHR will be prepared only for medical products 只适用于医疗产品。 3.0 DEFINITIONS ABBREV IATIONS 定义和缩写 3.1 DHR Device History Record, based on the requirements of DMR, basically a lot-specific f