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<item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 测量、分析和改进（8.5）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2521.html]]></link><description><blockquote><![CDATA[
	8.5&nbsp;Improvement&nbsp;改进

	&nbsp;

	8.5.1&nbsp;General&nbsp;总则

	&nbsp;

	The&nbsp;organizationshall&nbsp;identify&nbsp;and&nbsp;implement&nbsp;any&nbsp;changes&nbsp;necessary&nbsp;to&nbsp;ensure&nbsp;and&nbsp;maintain&nbsp;the&nbsp;continuedsuitability,&nbsp;adequacy&nbsp;and&nbsp;effectiv......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:44:02]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 测量、分析和改进（8.4）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2520.html]]></link><description><blockquote><![CDATA[
	8.4&nbsp;Analysis&nbsp;of&nbsp;data&nbsp;数据分析

	&nbsp;

	The&nbsp;organizationshall&nbsp;document&nbsp;procedures&nbsp;to&nbsp;determine,&nbsp;collect&nbsp;and&nbsp;analyse&nbsp;appropriate&nbsp;data&nbsp;todemonstrate&nbsp;the&nbsp;suitability,&nbsp;adequacy&nbsp;and&nbsp;effectiveness&nbsp;of&nbsp;the......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:43:41]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 测量、分析和改进（8.3）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2519.html]]></link><description><blockquote><![CDATA[
	8.3&nbsp;Controlof&nbsp;nonconforming&nbsp;product&nbsp;不合格品的控制

	&nbsp;

	8.3.1&nbsp;General&nbsp;总则

	&nbsp;

	The&nbsp;organizationshall&nbsp;ensure&nbsp;that&nbsp;product&nbsp;which&nbsp;does&nbsp;not&nbsp;conform&nbsp;to&nbsp;product&nbsp;requirements&nbsp;is&nbsp;identifiedand&nbsp;c......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:43:05]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 测量、分析和改进（8.2.1~8.2.6）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2518.html]]></link><description><blockquote><![CDATA[	8.2&nbsp;Monitoring&nbsp;and&nbsp;measurement&nbsp;监控和测量

	&nbsp;

	8.2.1&nbsp;Feedback&nbsp;反馈

	&nbsp;

	As&nbsp;one&nbsp;of&nbsp;themeasurements&nbsp;of&nbsp;the&nbsp;effectiveness&nbsp;of&nbsp;the&nbsp;quality&nbsp;management&nbsp;system,&nbsp;theorganization&nbsp;shall&nbsp;gather&nbsp;and&nbsp;m......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:41:17]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 产品实现（7.6）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2517.html]]></link><description><blockquote><![CDATA[
	7.6&nbsp;Controlof&nbsp;monitoring&nbsp;and&nbsp;measuring&nbsp;equipment&nbsp;监控和测量设备的控制

	&nbsp;

	
		The&nbsp;organizationshall&nbsp;determine&nbsp;the&nbsp;monitoring&nbsp;and&nbsp;measurement&nbsp;to&nbsp;be&nbsp;undertaken&nbsp;and&nbsp;the&nbsp;monitoringand&nbsp;measuring&nbsp;e......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:39:08]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 产品实现（7.5.1~7.5.11）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2516.html]]></link><description><blockquote><![CDATA[
	7.5&nbsp;Production&nbsp;and&nbsp;service&nbsp;provision&nbsp;生产和服务提供

	&nbsp;

	7.5.1&nbsp;Control&nbsp;of&nbsp;production&nbsp;and&nbsp;service&nbsp;provision&nbsp;生产和服务提供的控制

	&nbsp;

	Production&nbsp;andservice&nbsp;provision&nbsp;shall&nbsp;be&nbsp;planned,&nbsp;carr......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:36:00]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 产品实现（7.4）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2515.html]]></link><description><blockquote><![CDATA[
	7.4&nbsp;Purchasing&nbsp;采购

	&nbsp;

	7.4.1Purchasing&nbsp;process&nbsp;采购过程

	The&nbsp;organizationshall&nbsp;document&nbsp;procedures&nbsp;(see&nbsp;4.2.4)&nbsp;to&nbsp;ensure&nbsp;thatpurchased&nbsp;product&nbsp;conforms&nbsp;to&nbsp;specified&nbsp;purchasing&nbsp;information......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:34:57]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 产品实现（7.3.1~7.3.10）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2514.html]]></link><description><blockquote><![CDATA[	7&nbsp;Product&nbsp;realization

	7&nbsp;产品实现

	7.3&nbsp;设计和开发

	7.3&nbsp;Designand&nbsp;development&nbsp;设计和开发

	7.3.1&nbsp;General&nbsp;总则

	The&nbsp;organizationshall&nbsp;document&nbsp;procedures&nbsp;for&nbsp;design&nbsp;and&nbsp;development.

......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:31:39]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 产品实现（7.2）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2513.html]]></link><description><blockquote><![CDATA[
	7&nbsp;Product&nbsp;realization

	7&nbsp;产品实现

	&nbsp;

	&nbsp;

	7.2&nbsp;Customer-related&nbsp;processes&nbsp;与顾客有关的过程

	&nbsp;

	7.2.1&nbsp;Determination&nbsp;of&nbsp;requirements&nbsp;related&nbsp;to&nbsp;product&nbsp;与产品有关的要求的确定

	The&nbsp;......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:29:56]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 产品实现（7.1）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2512.html]]></link><description><blockquote><![CDATA[
	7.1&nbsp;Planning&nbsp;of&nbsp;product&nbsp;realization&nbsp;产品实现策划

	&nbsp;

	The&nbsp;organizationshall&nbsp;plan&nbsp;and&nbsp;develop&nbsp;the&nbsp;processes&nbsp;needed&nbsp;for&nbsp;product&nbsp;realization.&nbsp;Planningof&nbsp;product&nbsp;realization&nbsp;shall&nbsp;be&nbsp;consistent&nbsp;wi......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:26:31]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 资源管理（6.1~6.3）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2511.html]]></link><description><blockquote><![CDATA[
	6&nbsp;Resourcemanagement

	6&nbsp;资源管理

	&nbsp;

	6.1&nbsp;Provision&nbsp;of&nbsp;resources&nbsp;资源供给

	The&nbsp;organizationshall&nbsp;determine&nbsp;and&nbsp;provide&nbsp;the&nbsp;resources&nbsp;needed&nbsp;to:

	组织应当确定并提供以下所需资源:

	a)......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:25:51]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 管理职责（5.5~5.6）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2510.html]]></link><description><blockquote><![CDATA[
	5&nbsp;Management&nbsp;responsibility

	5&nbsp;管理职责

	&nbsp;

	5.5&nbsp;Responsibility,&nbsp;authority&nbsp;and&nbsp;communication&nbsp;职责，权限和沟通

	&nbsp;

	5.5.1&nbsp;Responsibility&nbsp;and&nbsp;authority&nbsp;职责和权限

	Top&nbsp;managementshall&nbsp;......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:25:05]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 管理职责（5.1~5.4）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2509.html]]></link><description><blockquote><![CDATA[
	5&nbsp;Management&nbsp;responsibility

	5&nbsp;管理职责

	&nbsp;

	5.1&nbsp;Management&nbsp;commitment&nbsp;管理承诺

	Top&nbsp;managementshall&nbsp;provide&nbsp;evidence&nbsp;of&nbsp;its&nbsp;commitment&nbsp;to&nbsp;the&nbsp;development&nbsp;and&nbsp;implementationof&nbsp;the&nbsp;qualit......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:23:32]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 文件要求（4.2.4~4.2.5）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2508.html]]></link><description><blockquote><![CDATA[
	4.2&nbsp;Documentation&nbsp;requirements&nbsp;&nbsp;文件要求

	&nbsp;

	4.2.4&nbsp;Control&nbsp;of&nbsp;documents&nbsp;文件控制

	Documentsrequired&nbsp;by&nbsp;the&nbsp;quality&nbsp;management&nbsp;system&nbsp;shall&nbsp;be&nbsp;controlled.&nbsp;Records&nbsp;are&nbsp;aspecial&nbsp;type&nbsp;of&nbsp;docum......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:22:30]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485-2016中英文对照 一般要求（4.1.4~4.1.6）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2507.html]]></link><description><blockquote><![CDATA[
	Quality&nbsp;management&nbsp;system

	质量管理体系

	4.1&nbsp;General&nbsp;requirements&nbsp;一般要求

	&nbsp;

	&nbsp;

	4.1.4&nbsp;The&nbsp;organizationshall&nbsp;manage&nbsp;these&nbsp;quality&nbsp;management&nbsp;system&nbsp;processes&nbsp;in&nbsp;accordance&nbsp;with&nbsp;ther......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:21:45]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证辅导---ISO13485医疗器械—质量管理体系—用于法规的要求（附录A）]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2506.html]]></link><description><blockquote><![CDATA[
	附录A(资料性附录)

	ISO&nbsp;13485:2003&nbsp;和ISO&nbsp;13485:2016对比

	&nbsp;

	ISO13485:2016&nbsp;条例：前言

	与ISO&nbsp;13485：2003相比的变化：说明第三版ISO13485的变化

	&nbsp;

	ISO13485:2016条例：引言0.1&nbsp;总则

	与IS......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-05-01 11:20:39]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] 如果迎接ISO 13485:2016转版审核？]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2499.html]]></link><description><blockquote><![CDATA[
	条款4&mdash;&mdash;质量管理体系
	条款4.1&mdash;&mdash;总要求
	你需要提供如下信息：
	&bull;&nbsp;文件化组织的角色
	&bull;&nbsp;增加基于法规和风险的控制方法的意识
	&bull;&nbsp;外包过程的控制
	&bull;&nbsp;变更管理
......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-04-30 16:19:43]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] 企业如何建立ISO13485质量管理体系]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2497.html]]></link><description><blockquote><![CDATA[	ISO13485质量管理体系&nbsp;与环境、质量管理体系在体系建立上也有许多相似之处。对不同组织，由于其组织特性和原有基础的差异，建立ISO13485质量管理体系&nbsp;的过程不会完全相同。但总体而言，组织建立ISO13485质量管理体系......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-03-02 10:46:58]]></pubDate></item><item><title><![CDATA[[ISO13485咨询] ISO13485认证实施条件]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2496.html]]></link><description><blockquote><![CDATA[	ISO13485是适用于医疗器械法规环境下的质量管理体系标准，其全称是《医疗器械质量管理体系&nbsp;用于法规的要求》。1996年ISO13485首次发布，当时该标准不是独立标准，而是要与ISO9001:1994联合使用。由于医疗器械是救死扶......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-03-02 10:43:18]]></pubDate></item><item><title><![CDATA[[ISO13485咨询]  ISO13485认证咨询流程]]></title><link><![CDATA[http://www.mdr-ce.com/html/pfrz/view2495.html]]></link><description><blockquote><![CDATA[
	&nbsp;&nbsp;ISO13485认证咨询流程如下：
	&nbsp;&nbsp;&nbsp;&nbsp;识别要求(4.1)&rarr;实施培训(4.2)&rarr;策划建立体系(4.3)&rarr;运行体系(4.4)
	&nbsp;&nbsp;&nbsp;&nbsp;1、识别医疗器械企业质量管理体系的特殊要求
	&nbsp;&nbsp;&nbsp;&nbsp;医疗器械是一种特殊的商品，是救死扶伤......]]></blockquote></description><author><![CDATA[]]></author><pubDate><![CDATA[2018-03-02 10:36:45]]></pubDate></item></channel>
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