ASK JAN: Document Management

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ASK JAN: Document Management

机译：询问JAN：文档管理

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We are a medical device packaging start-up. Recently during our ISO 9001 pre-registration GAP audit, our auditor observed that we needed better document control of our records. The ISO 9001:2008 Clause 4.2. Documentation Requirements defines all documentation as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization's products and processes, the degree of formality of communication systems, and the level of communication skills within the organization, and the organizational culture. This includes any validation documentation that proves what was intended has been achieved. The documentation facilitates knowledge sharing within the organization to disseminate and preserve the organization's experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product. These documents can exist in many forms: 1. Paper; 2. Magnetic; 3. Electronic or optical computer disc; 4. Photograph; 5. Master sample.

机译：我们是一家医疗器械包装初创企业。最近，在我们的ISO 9001预注册GAP审核期间，我们的审核员发现我们需要对记录进行更好的文件控制。 ISO 9001：2008第4.2条。文档要求将所有文档定义为信息传输和通信的工具。文档的类型和范围将取决于组织的产品和流程的性质，沟通系统的形式化程度，组织内的沟通技巧水平以及组织文化。这包括任何证明已达到预期目的的验证文件。该文档有助于组织内的知识共享，以传播和保留组织的经验。一个典型的例子是技术规范，它可以用作设计和开发新产品的基础。这些文件可以以多种形式存在：1.纸张; 2.磁性; 3.电子或光学计算机光盘; 4.照片; 5.主样本。

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《Controlled Environments Magazine》 |2014年第3期|共1页
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Jan Eudy;
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中图分类计量学;
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1. ASK JAN: Document Management [J] . Jan Eudy Controlled Environments Magazine . 2014,第3期

机译：询问JAN：文档管理
2. Enterprise Document Management Suite 5.0: The essential document and file management solution [J] . InfoWorld . 2005,第51期

机译：企业文档管理套件5.0：基本文档和文件管理解决方案
3. Version, Privilege And Approval Control Of Design Document Management key information technologies for design document management Part 1 [J] . Gakuhito Hirasawa, Makoto Kataoka 日本建築学会计画論文集 . 2001,第545期

机译：设计文档管理的设计文档管理关键信息技术的版本，特权和批准控制，第1部分
4. Past and Present Infrastructure of Jan Mayen as Historical Documents [C] . Susan Barr NATO Advanced Research Workshop on Jan Mayen Island in Scientific Focus . 2004

机译：Jan Mayen的过去和目前基础设施作为历史文件
5. Nonprofit Endowments: Management Controls over Documenting Restrictions and Designations with Best Practices [D] . Whitham, Douglas A. 2018

机译：非营利性禀赋：管理控制通过最佳实践记录限制和指定
6. Development of a Document Management System for the Standardization of Clinical Laboratory Documents [O] . Sang-Hyun Hwang, Seon-Kyung Jung, Soo-Jin Kang, 2013

机译：开发用于临床检验文件标准化的文件管理系统
7. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation31This document was approved by the American College of Cardiology Board of Trustees in August 2001, the American Heart Association Science Advisory and Coordinating Committee in August 2001, and the European Society of Cardiology Board and Committee for Practice Guidelines and Policy Conferences in August 2001.32When citing this document, the American College of Cardiology, the American Heart Association, and the European Society of Cardiology would appreciate the following citation format: Fuster V, Rydén LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Lévy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol 2001;38:XX-XX.33This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org), the American Heart Association (www.americanheart.org), the European Society of Cardiology (www.escardio.org), and the North American Society of Pacing and Electrophysiology (www.naspe.org). Single reprints of this document (the complete Guidelines) to be published in the mid-October issue of the European Heart Journal are available by calling +44.207.424.4200 or +44.207.424.4389, faxing +44.207.424.4433, or writing Harcourt Publishers Ltd, European Heart Journal, ESC Guidelines – Reprints, 32 Jamestown Road, London, NW1 7BY, United Kingdom. Single reprints of the shorter version (Executive Summary and Summary of Recommendations) published in the October issue of the Journal of the American College of Cardiology and the October issue of Circulation, are available for $5.00 each by calling 800-253-4636 (US only) or by writing the Resource Center, American College of Cardiology, 9111 Old Georgetown Road, Bethesda, Maryland 20814. To purchase bulk reprints specify version and reprint number (Executive Summary 71-0208; full text 71-0209) up to 999 copies, call 800-611-6083 (US only) or fax 413-665-2671; 1000 or more copies, call 214-706-1466, fax 214-691-6342; or E-mail: pubauth@heart.org. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration With the North American Society of Pacing and Electrophysiology [O] . Fuster Valentin, Rydén Lars E., Asinger Richard W., 2001

机译：ACC / AHA / ESC治疗房颤患者指南31该文件于2001年8月获得美国心脏病学会董事会，2001年8月美国心脏协会科学咨询与协调委员会以及欧洲心脏病学会的批准以及实践指南和政策委员会会议（2001年8月）。32引用本文件时，美国心脏病学会，美国心脏协会和欧洲心脏病学会将赞赏以下引用格式：Fuster V，RydénLE，Asinger RW，Cannom DS，Crijns HJ，Frye RL，Halperin JL，Kay GN，Klein WW，LévyS，McNamara RL，Prystowsky EN，Wann LS，Wyse DG。 ACC / AHA / ESC治疗房颤患者的指南：美国心脏病学会/美国心脏协会实践指南工作组和欧洲心脏病学会实践指南委员会和政策会议的报告（制定指南委员会）用于房颤患者的治疗）。 J Am Coll Cardiol 2001; 38：XX-XX.33本文件可在美国心脏病学会（www.acc.org），美国心脏协会（www.americanheart.org），欧洲的万维网站点上找到心脏病学会（www.escardio.org）和北美起搏和电生理学会（www.naspe.org）。可致电+44.207.424.4200或+44.207.424.4389，传真+44.207.424.4433或写信给Harcourt Publishers，以获取本文档（完整的准则）的单份重印本（完整的准则），该印刷本将于10月中旬出版。欧洲心脏杂志，ESC指南–转载，英国伦敦詹姆斯敦路32号，NW1 7BY。短版（执行摘要和建议摘要）的单版重印在《美国心脏病学会杂志》十月刊和《循环》十月刊上，致电800-253-4636（仅美国），每本售价5.00美元。）或写信给美国心脏病学院资源中心，地址是：马里兰州贝塞斯达市Old Georgetown Road 9111，邮编20814。要购买批量转载，请指定版本和转载编号（执行摘要71-0208；全文71-0209），最多999份，致电800-611-6083（仅限美国）或传真413-665-2671； 1000或更多副本，请致电214-706-1466，传真214-691-6342;或电子邮件：pubauth@heart.org。美国心脏病学会/美国心脏协会实践指南工作组和欧洲心脏病学会实践指南和政策会议（制定房颤患者治疗指南委员会）的报告是与北方合作开发的美国起搏与电生理学会
8. Integrated Field and Office Tools for Bridge Management;Final rept. Jan 03-Jan 04 [R] . Adams, T. M., Dzienkowski, J., Juni, E., 2004

机译：用于桥梁管理的集成现场和办公工具;最终报告。 1月3日至1月4日

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