医疗产品历史纪录控制.doc.docVIP

Nypro Plastics Molding Rev. Date. Total Pages. Products (Suzhou) Co., Ltd. 版本 日期 总页码 　 C 2007.02.07 7 Title: Control of Device History record Prepared by/Date Reviewed by/Date Approved 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-005 Frank 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 2006-2-14 A Initial release Sissi Luke 2006-5-09 B Amended point no. 6.3 Zeng Defang Luke 2007-2-07 C Amended point no. 4.0,5.0,8.0 Frank li Yong 1.0 PURPOSE 目的’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。 DEFINITIONS ABBREV IATIONS 定义和缩写 3.1 DHR Device History Record, based on the requirements of DMR, basically a lot-specific file or the production lot record. A document is needed to establish the contents of the DHR. 产品制造历史记录，基于DMR的需求，基本上是一个基于专用批或者生产批次的记录。需要一个文件来建立DHR的内容。 3.2 QD Quality Department