13485医疗器械内审员现在有新版吗

No

it does not sound Japanese Do you really mean CHAEBOL CHAEBOL is Korean for 财阀 Japanese pronounciation ZAIBATSU Definition of the term is as follows: 财阀 Chaebol en /wiki/Chaebol 财阀 Zaibatsu en /wiki/Zaibatsu 财阀 Chaebol gcsfckeioacjp/class/2004_14969/slides/09/ 财阀 Zaibatsu ja /wiki/%E8%B2%A1%E9%96%A5 财阀 zh /wiki/%E8%B2%A1%E9%96%A5 Hope that helps!

肯定唔系(我亚爸系日语老师)

[ONS]DCⅡPC__中文

原帖地址：>

您好，ISO 13485 医疗器械内审员已经有新版了，就是2016年正式公布了，现在都是以英文版为主，中文版的都是专家自己翻译出来的。您可以看的懂英文就尽量看英文会比较好一点。

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies) The work of preparing International Standards is normally carried out through ISO technical committees Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1 In particular the different approval criteria needed for the different types of ISO documents should be noted This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights ISO shall not be held responsible for identifying any or all such patent rights Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

The committee responsible for this document is Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices

This third edition of ISO 13485 cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised It also incorporates the Technical Corrigendum ISO 13485:2003/Cor1:2009 A summary of the changes incorporated into this edition compared with the previous edition is given in Annex A

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