[原创]关于2008版9000标准
<p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt;"><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">1.ISO9001:2008</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">的新标准将于</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">2008</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">年</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">10</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">月</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">31</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">目正式发布</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial; mso-ansi-language: EN-GB;">，</span><span lang="EN-GB" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-ansi-language: EN-GB;">2009</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial; mso-ansi-language: EN-GB;">年</span><span lang="EN-GB" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-ansi-language: EN-GB;">3</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial; mso-ansi-language: EN-GB;">月</span><span lang="EN-GB" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-ansi-language: EN-GB;">1</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial; mso-ansi-language: EN-GB;">日起正式实施</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;"><br/>2.</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">标准修改的较少，无理由需要</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">“</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">过渡阶段</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">”</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">，</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">ISO</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">将用</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">6</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">～</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">12</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">个月时间来结束</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">ISO9001:2000</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">版的使用。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>3.</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">对于大多数组织而言，通常正常的监督评审过渡即可，不需要额外时间。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>4.</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">审核员只要培训新版的修改之处即可。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>5.</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">以下为变更条款：</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>3.0</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">术语与定义，取消了供应链。（供方</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">-</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">组织</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">-</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">顾客）</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>4.1</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">增加了外包过程的控制，借助</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">7.4.1</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">的方法对外包方法进行管控。外包并不能减少组织需承担的责任。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>4.2.1</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">变更了一个单一的文件可以包括一个或多个程序的要求，一个文件化程序的要求也可以在多个文件中体现。（如纠正预防管理程序）</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>4.2.3</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">增加了</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">4.2.3f</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">确保对质量体系策划和运行所必要的外来文件得到识别，并控制其分发。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>5.5.2</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">管理者代表：即新标准要求管理者代表应是组织内的下属员工或合同制的全日制员工（不可兼职）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>6.2.1</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">基于教育、培训、技能和经验，从事影响产品质量符合性的工作人员应是能够胜任的（范围较大）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>6.2.2</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">能力、意识和培训：评价培训所要求的有效性</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">;</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">确保达到必要的能力（指实际操作方面的能力加严）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>6.3 </span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">增加了</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">6.3c:</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">增加了支持性服务（如运输</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">或通讯或信息系统</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">/ERP</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">系统</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">)</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">、策划、提供、维护全方面评价。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>7.2.1</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">与产品有关的要求的确定：增加了交付后的活动包括保修条款及履行合同的责任，如维修服务和辅助服务（如回收或产品的最终处置）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>7.5.1</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">生产和服务提供的控制：生产和服务包括产品的防护（包装</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">-</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">仓储</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">-</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">搬运</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">-</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">回收手册）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>7.5.2</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">生产和服务提供过程的确认：阐明确认特殊过程的重要性，特殊过程（如焊接、培训、热处理等）还有特殊工程的识别。（如：服务、焊工、司机、仪校工程师、内审员资格的确认）</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>7.5.4</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">顾客财产：增加了注解</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">-</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">阐明知识产权和私人信息为顾客财产（如保险公司，银行等）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>7.6</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">监视和测量装置的控制：增加了测量用计算机软件使用的要求（如公司的软件测试站使用的软件适宜性的验证及配置的管理）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>8.2.1</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">：监控顾客的感受可能包括从如下的来源输入，如顾客满意度调查、已提交产品质量信息、用户意见调查，失去业务的分析、表扬、保证声明、销售报告等。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>8.2.2</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">内部审核：增加了审核记录的保存范围（如内审计划、签到表、内审报告、查检表、不符合报告等记录）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>8.2.3</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">过程的监视和测量：</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">1.</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">删掉了最后一句话，即，</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">“</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">以确保产品的符合性</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">”2.</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">注解中增加了采用过程控制方法时需考虑的要点，此注释希望组织确定过程监视测量方法时需要考虑到应用的价值。（即范围加大包括：质量体系所有过程）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Arial;">
<br/>8.3 </span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial;">不合格品的控制：未满足顾客要求的不合格品，只有得到客户同意放行的条件才能放行，组织内部在未得到客户同意时不能放行，如放行是不符合标准要求的，要开立主要不符合项。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p> <p><font face="Arial">5.5.2</font><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: arial; mso-hansi-font-family: arial; mso-bidi-font-family: arial;">管理者代表：即新标准要求管理者代表应是组织内的下属员工或合同制的全日制员工（不可兼职）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: arial;">
</span></p><p></p><p>应该是可以兼职的。。。呵呵</p> 2000版的没作要求,现在更明确了! <p>你漏了个文件控制方面</p><p>2000要求文件有个保存期限</p><p>但是08版的要求对文件的处置</p><p>请确认！</p><p>再是08版与2000版本国际上标准质上没有多大改变，但是实际国家改变较多，因为翻译错误 呵呵</p><p>再是对外包的控制具体体现在7.4 与7.5.1 一大条款和一小条款</p><p>要考虑外包可能涉及关键工序的 </p><p>楼主认为呢？</p><p></p> <p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 18pt; mso-char-indent-count: 2.0; mso-line-height-rule: exactly; mso-list: l0 level1 lfo1; tab-stops: list 19.5pt;"><span lang="EN-US" style="mso-fareast-font-family: '';"><span style="mso-list: Ignore;"><font face="">你说的是这一条吗?g.<span style="FONT: 7pt "";"><font size="3">
</font></span></font></span></span><span style="FONT-FAMILY: 宋体; mso-ascii-font-family: ''; mso-hansi-font-family: '';">防止作废文件的非预期使用，<span style="COLOR: blue;">如果出于某种目的而保留作废文件，</span>对这些文件进行适当的标识。</span></p> 08版完善了2000版，对于我们企业来说，复杂了。 <p>9000标准应该是灵活运用,对企业来说更加细化和规范化才是真的!</p><p></p> <div class="msgheader">QUOTE:</div><div class="msgborder"><b>以下是引用<i>czwzyxl</i>在2009-3-18 15:05:25的发言：</b><br/><div class="msgheader">QUOTE:</div><div class="msgborder"><p><font face="Arial">5.5.2</font><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: arial; mso-hansi-font-family: arial; mso-bidi-font-family: arial;">管理者代表：即新标准要求管理者代表应是组织内的下属员工或合同制的全日制员工（不可兼职）。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: arial;"><br/> </span></p><p></p></div><p></p><p>应该是可以兼职的。。。呵呵</p></div><p>这是谁做的解释，有点歪批的味道。有话是“在本组织管理层中指定一名成员”，有人解释成“不可兼职”，这是基于对“本组织”的通常解读，可是在现代的企业经营中，所有的管理层成员都是专职的吗？我看不见得。但管理者代表必须是管理层中的一员，这是非常明确的，不是是下属员工就能行的。</p>
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