Medical devices Harmonizing quality management requirements - Quality management and the medical field A comparison between ISO 9001-2000 and ISO 13485

Ed Kimmelmann

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Medical devices Harmonizing quality management requirements - Quality management and the medical field A comparison between ISO 9001-2000 and ISO 13485

机译：医疗设备协调质量管理要求-质量管理和医学领域ISO 9001-2000与ISO 13485之间的比较

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This article discusses the key contents of ISO/DIS 13485-200X,Quality systems - Medical devices - System requirements for regulatory purposes,the revised quality management system standard for the medical device sector;and relates its contents to that of ISO 9001-2000 the newly revised generic quality management system standard.It outlines medical device sector quality management system issues created by ISO 9001-2000,and recommends courses of action for individual medical device organizations as they review,and possibly,revise their quality management systems to deal with evolving customer and regulatory requirements.

机译：本文讨论了ISO / DIS 13485-200X的关键内容，质量体系-医疗器械-法规目的系统要求，医疗器械行业修订的质量管理体系标准;并将其内容与ISO 9001-2000新修订的通用质量管理体系标准。它概述了ISO 9001-2000创建的医疗器械行业质量管理体系问题，并为各个医疗器械组织在审查时可能采取的措施提出了建议，并可能对其质量管理体系进行修订以应对不断发展的趋势客户和法规要求。

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《ISO Bulletin》 |2002年第7期|共4页
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Ed Kimmelmann;
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正文语种 eng
中图分类条例、规程、标准;计量学;国际组织;
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1. Medical devices Harmonizing quality management requirements - Quality management and the medical field A comparison between ISO 9001-2000 and ISO 13485 [J] . Ed Kimmelmann ISO Bulletin . 2002,第7期

机译：医疗设备协调质量管理要求-质量管理和医学领域ISO 9001-2000与ISO 13485之间的比较
2. Medical devices Harmonizing quality management requirements - Risk management and medical devices [J] . Alf. M. Dolan ISO Bulletin . 2002,第7期

机译：医疗设备协调质量管理要求-风险管理和医疗设备
3. ISO 13485: Medical Devices and Risk Management [J] . Aaron Troschinetz Quality . 2010,第1期

机译：ISO 13485：医疗设备和风险管理
4. AN UPDATE ON ISO 9001 AND ISO 13485 - HARMONIZATION OF THE MEDICAL DEVICE QUALITY STANDARDS: THE EVOLUTION OF ISO 13485 [C] . Kenneth A. Slickers ASQ(American Society for Quality)'s 56th Annual Quality Congress May 20-22, 2002 Colorado Convention Center . 2002

机译：ISO 9001和ISO 13485更新-医疗设备质量标准的协调统一：ISO 13485的发展
5. Understanding the differences between ISO 9001-2008 and the FDA quality system regulation for medical devices: A guide for quality professionals who need to adapt to an FDA regulated environment. [D] . Greetham, Dallas. 2010

机译：了解ISO 9001-2008与FDA医疗设备质量体系法规之间的差异：针对需要适应FDA法规环境的质量专业人员的指南。
6. Quality Management Systems in the Ambulant Sector: An Analytical Comparison of Different Quality Management Systems [O] . Marcus Gumpert, Jens-Peter Reese 2019

机译：流动部门的质量管理体系：不同质量管理体系的分析比较
7. PHP154 Product Quality Aspect in Reimbursement of Medical Devices: Comparison of Turkey Verse Europe [O] . Seyhun O., Erdogan E., Can H., 2014

机译：PHP154产品质量方面的医疗设备报销：土耳其诗歌欧洲的比较
8. Comparison of approaches to Total Quality Management. Including an examination of the Department of Energy's position on quality management [R] . Bennett, C. T. 1994

机译：全面质量管理方法的比较。包括审查能源部在质量管理方面的立场

Medical devices Harmonizing quality management requirements - Quality management and the medical field A comparison between ISO 9001-2000 and ISO 13485

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