2008版ISO 9001颁布后的体系工作建议

hnwang

    ISO 9001：2008版英文标准已经在2008年11月15日正式颁布了。已经建立符合2000版ISO 9001质量管理体系的组织应当如何做。这里给大家提出一些建议，供参考。

    1、预先学习。搞质量管理体系的工作者可以对新版标准自己先学习一下。如果手头没有标准，可以从从本网站上下载。我们国家中文版本还没有颁布，如果不能看英文版本的话，可以从本网站下载有些翻译版本参考，已经足够了。

    由于这次2008版相对2000版标准要求只是在文字上做了修饰和统一的协调更改，没有提出新的要求，如果原来对2000版标准理解正确，体系建立得比较好的话，这些修改的工作量应当不会很大，甚至没有什么需要修改的。

    2、组织学习。然后，组织ISO小组成员和内审员共同学习新版标准。如果原来没有建立ISO小组的。可以利用这个机会成立。

    3、文件评审。ISO小组组织文件的主管人员（通常每份质量管理体系文件应当指定负责的部门，该部门应当指定负责人。一般这次体系要求变更对技术性文件不会有什么影响的），根据新版标准对每份文件，包括质量手册、程序文件，作业指导书和记录用的空白表单，结合实际执行情况，做一次评审。把结果分成以下各类：

    情况  现有文件内容        实际执行、记录     工作量
     a）  符合新版标准              不符合新版标准         纠正措施
     b）  需修改或者补充            符合新版标准           文件修改
     c）  需修改或者补充             不符合新版标准        纠正措施
     d）现没有但实际需要文件     不符合新版标准         纠正措施

    注：尽管这次2008版相对2000版标准的意图没有变化，仍然用于合同和认证。没有增加新的要求。仅仅对标准的文字做了一些统一、修饰和注解。如果过去对2000版标准理解有偏差的话，讲会发现，似乎2008版要求扩大了，内容增加了。所以，建议认真阅读2008版标准和2000版标准的差别。有条件的话，建议您阅读英文原文，加以对比。有助于对标准的正确理解。利用这次转版机会，提升自己的质量管理体系有效性和效率。

    4、编写升版工作计划。ISO小组汇总以上情况，编制一份书面升版工作计划，经过总经理批准后，由管理者代表具体组织实施。

    几点说明：

    a）文件修改要符合标准4.2.3条要求。各种质量管理体系文件的修改必须按照自己的程序文件规定执行，该程序文件必须满足标准第4.2.3条要求。

    b）为了便于工作，文件数量可以调整。新版标准容许一个标准要求分散在几个文件中。譬如，不合格品处理8.3条，可以分别用进货、在制和交付后发现不合格品的三份处理程序来规定；也可以用一份文件来满足标准几条要求，甚至标准的几个要求。譬如，质量、环境保护、安全、健康等各个体系的文件和记录集中用一份程序文件来控制。总之，应当根据方便自己的原则来做，不要为了符合标准而做。

    c）凡纠正措施都应当符合标准第8.5.2条要求。如果原来有统一表单的，针对每一项不符合填写一份《要求采取纠正措施》表单。把所采取纠正措施的结果形成记录，包括对纠正措施有效性的评审记录，作为客观证据；也可以整个公司针对2008版升版工作汇总一份文件，也可以各个部门单独形成文件，公司汇总，作为管理评审的输入。

    d）利用这次升版机会完善和改进体系的有效性。把这次贯彻新版标准的工作当作一次体系改进的机会。这次改版主要是对标准要求的澄清，没有新的要求。但是，通过以前几年对标准的实践，加深了理解，有可能发现以往对标准的理解有不足的地方，可以通过建立纠正措施专题项目或者预防措施专题项目加以改进。

    e）注意体系完整性。如果因为原来对标准理解有问题，通过这次2008版来采取纠正措施，完善体系的时候一定要注意满足标准第5.4.2条体系连续性的要求。

    5、进行内审。根据情况，如果原来审核方案中规定做内审的时间恰当，可按照原来的安排，按照新版标准要求做一次内审；如果这次改动比较大，也可以增加一次内审，监视以上工作计划执行的效果如何。

    6、管理评审。按照原来计划，也可以新增加一次管理评审。根据以上内审结果以及其他有关管理评审输入，对体系的有效性、适宜性和充分性进行一次评审。完成升版工作。继续提出一些预防措施和纠正措施改进项目，继续改进，提高质量管理体系的有效性和效率。

    7.关于换证书问题。不需要专门为了换证书请认证公司来做审核。可以结合原来监督审核或原来证书到期换证审核同时进行。只要在2010年11月15日前换成2008版都是可以的。

    也就是从现在起到2010年11月15日为止，两种证书可以共存，证明的体系符合性是等同的。无论是哪年版本证书，内容都要符合2008版标准要求。2010年11月15日后，所有2000版证书都将失效了。

    8、关于新申请认证：建议就按照2008版来认证。因为，国家等同标准GB/T 19001：2008标准已经在2008年底颁布，2009年3月 1日起已经开始执行了。当然，认证机构的审核员 必须通过培训，考试，得到资格才能来做审核。因此，有的认证机构可能现在还不能发2008版证书。可以按照2000版认证，以后再通过监督审核 换取2008版证书。实际上，现在按照2000版认证，内容还是要满足2008版要求的。因为，2008版只是对2000版做进一步解释而已。原来2000版标准就应当满足现在2008版要求的。2009年11月15日以后，只能按照2008版认证，发2008版证书了。具体的应当和您们的认证机构联系。


    9、文件修改的两个小窍门：

      a）质量手册中这样写：“本公司质量管理体系符合ISO 9001：2000标准，并且随着该标准升版，符合先行有效版本。”如果您当时这样写法，既体现了您这质量管理体系的历史，又不需要修改了。

      b）如果您的文件是按照过程来写的，不是按照组织机构分工来写的。那么，只要有这个过程、作业，如果有岗位职责说明的话，那么，机构如何变动，文件不需要修改了。

    以上个人观点，仅供参考。





[ 本帖最后由 hnwang 于 2008-12-12 11:14 编辑 ]

dearpresent

王老师，体系工作者因您而精彩，谢谢给出的指点，我们公司已经着手开始搞了，我作为一个体系工程师能看到这样与时俱进的指点，太激动了。

guanla

强烈的顶！！！
谢谢王老师的建议。
我们决定针对2008版增加一次内审监视，然后再在明年1月份的管评中作为输入项进行评审。

ly344700

08版与现行版本还是有些不一样的，其中我看到最让我奇怪变动是：ISO9004在合同的情况下，可用于认证或者组织的成熟度评估
这意味着以后的体系认证可能会有很多公司追求9004吗？然后9004也逐渐变成现在9001一样的普遍情况？

dearpresent

成熟度评估是好事，因目前体系做的程度无法量化，永远只有两个答案Pass 和No pass，所以成熟度评估量化了是好事。应成为追求的目标。我已经有计划了。

鲤鱼

王老师，那么TS16949如何对应？

jakedzb

好人一生平安,谢谢你

yefeiling

b）如果原来没有文件，现在认为需要增加文件的，也作为3d情况处理。

请问老师，什么是3d。

hnwang

    1、TS16949如何对应？我没有查寻该技术规范的变更情况。通常ISO9001：2008版发布后，TS 16949也会有相应的更改。用户可以注意，自己决定如何应对。好在，换版都有很长时间让您们过渡的；

    2、如果原来没有文件，现在认为需要增加文件的，也作为1#帖子中第3条d情况处理。

    谢谢大家对我的鼓励和支持。

yefeiling

b）如果原来没有文件，现在认为需要增加文件的，也作为3d情况处理。

请问王老师，什么是3d。

hnwang

    前面已经回答了。是指1#帖子中的第3条的d款做法。

    也就是说，原来没有文件，现在看来必须要有文件，也就是“现在这样执行是不符合新版标准要求了”。提出来，作为纠正措施专题项目，填写一份《要求采取纠正措施》表单。按照标准第8.5.2条要求做。

    通常指定有关人员组成一个纠正措施小组，确定团队的组长

    a）先评审一下，原来没有文件，实际执行过程中遇到了什么问题，这些问题的后果是否有问题要处理？如果有问题，需要处理，就按照有关程序处理，做好记录；

    b）分析一下， 当时为什么没有确定要文件？原因是什么？查明原因后，针对原因采取相应措施。譬如，原来搞体系人认为这样情况不需要文件，而根据本单位实际情况来看，没有文件执行中遇到很多问题，现在有必要写文件。那么，查一下，类似的情况是否还有？如果有，一起解决。

    c）确定一共需要补充文件的有哪些？

    d）编写一份纠正措施计划。包括写文件，征求意见到发放文件；

    e）对有关人员按照新文件进行培训，做好记录；

    f）对新文件执行的情况做一次检查，必要时，作为内审内容，验证新文件发出后有效性。取得客观证据后，纠正措施小组做一个结论意见，写在《要求采取纠正措施》表单内，关闭纠正措施专题项目。

    g）评审是否有必要进一步改进。如果是，再填写一份《要求采取纠正措施》表单。按照程序建立专题项目，进行下去。

    以上就是按照8.5.2条要求做的。具体应当根据自己情况来策划、执行、检查和改进。

    以上个人观点，仅供参考。

[ 本帖最后由 hnwang 于 2008-10-21 13:20 编辑 ]

zengzeng

谢谢王老师

hnwang

    持续改进是永恒的质量管理原则。应当利用 换版机会提高自己的质量管理体系的有效性和效率。

Angela_cai

終於有時間可以上一下論壇了，累啊~~

hnwang

    应当利用 换版机会提高自己的质量管理体系的有效性和效率。体系搞好了，就不会那么累了。但是，您的担子会加重了，又会变累了。持续改进是永恒的质量管理原则。

janly216

看了之後,說不出是個什麽感覺,明白一些,又不明白.

是我太笨~!新版出來,還是不知道怎麽做.

有老師建議我們新版出來後修改質量手冊和程序文件.

但現在又推遲了,而我們馬上要內外審和管理評審了.怎麽處理?

hnwang

    1、但現在又推遲了,而我們馬上要內外審和管理評審了.怎麽處理?
外审是按照现在版本审核的。新版出来后有过渡时期的。不用急的。

    2、现在从网站上下载新版内容，可以按照它来检查自己的体系，完善体系。文件不一定马上修改的。

janly216

謝謝王老師指導...

官方網站完全看不懂哦?!

hnwang

meny_yr

企业的体系一般在充分性和适宜方面做得相当好，但在有效性和效率方面关注度不够。因为定性的事务处理总是便于定量的问题解决，ISO9001现在在企业间的推行已经相当普及，但真正从中体会到它所带来实惠的没有几家企业；其实，并不如有些人所称ISO9001是制造废纸的活动，只是我们对质量体系管理的理解加重了质量体系，而疏略于管理。我觉得企业在推行质量体系或做质量体系管理时要注意一个本末的问题，事在人为，结果怎样不是体系本身怎样，是人没做好事，没有体系之前也有很成功的企业。所以，我认为一个再好的项目在没有合适的团队人选之前请千万别涉猎。
    非常谢谢王老师的分享，期待您更多精彩的分享！！
    “中国因分享而更加强大”——怡宝

马雪军

我们公司的ISO9001:2000版质量管理体系证书2009年上半年到期,
我以组织学习ISO小组,并对ISO9001:2000版所有的文件进行了修改评审发布!
现在正推动新版的执行(因我们把客户的一些特殊要求如:TS五大工具作为三层文件进行了完善),
问题是:ISO9001:2008还没正式发布,我们是否可以,在2009年申请ISO9001:2008的认证?
望各位老师指导!

hnwang

    1、ISO9001:2000版质量管理体系证书2009年上半年到期。换证审核的时候应当按照ISO9001：2008版审核了。

    2、根据国际标准化组织公布的信息，ISO9001：2008版标准年底前公布。网站上有消息是11月15日。反正快了。建议您们根据ISO9001：2008版FDIS可以评审一下现在的文件。做必要的修改。手册中可以声明，“本手册符合ISO9001：2008版标准要求。以后将会跟随标准版本的更新做相应更改”。这句话以后一直可以用下去，不用改了。


还可以参考：http://www.qilongtan.com/viewthread.php?tid=15242&highlight=

    以上个人观点，仅供参考。

sll0416

多谢王老师的提醒！

hnwang

yangtiaoxia

回21楼问题，新版没有正式发布，就没有哪家机构能够给你们做2008版的换证审核工作。必须等发布后才行，而不是根据年限的，如果2009年上半年还没有发布，那么你们还是拿2000版的证书。

hnwang

    2008版证书没有正式公布，认证机构不能发证书的。如果您现在按照2008版FDIS建立完善自己的体系，正好做监督审核的时候，可以和认证公司商量，按照2008FDIS来审核。符合后，他们会给您有份内部用的证明文件，证明满足FDIS。等正式颁布后，您根据这份证明，向认证公司去买证书。这样做法只是内部的。要和认证公司商量。可能会满足您们要求的。

    以上个人观点，仅供参考。

hnwang

从网站下载后翻译的，供参考。如果有不对，请指正。

Secretariat of ISO/TC 176/SC 2        Date:        15 October 2008
国际标准化组织ISO/TC 176/SC 220089年1015日发布的
Implementation Guidance for ISO 9001:2008

如何贯彻ISO9001：2008指南

CONTENTS

内容

1.0        INTRODUCTION
引言

2.0         BACKGROUND ON ISO 9001:2008 REVISION PROCESS
关于2008版ISO9001修改过程的背景

3.0      USER GROUPS
各种标准使用者组

4.0        IMPLEMENTATION GUIDANCE
贯彻指南

4.1          GENERIC GUIDANCE
一般贯彻指南

4.2          SPECIFIC GUIDANCE TO USER GROUPS
针对使用组的贯彻指南

5.0        FREQUENTLY ASKED QUESTIONS
常见问题

6.0        AUTHENTICITY OF INFORMATION REGARDING ISO 9001:2008
有关ISO 9001：2008信息的真实性
      

1. INTRODUCTION 引言

This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.

发布本贯彻指南是为了帮助使用者理解在新老版本标准共存期间必须考虑的一些问题。

While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.

已经考虑到新老版本的变更对使用者有限的影响，有些贯彻措施是有必要做安排的。

Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.

注：反映有限范围的变更，现在用术语“贯彻”来清楚地区别过去使用的，从1994版到2000版之间所用的术语“过渡”。因为当时对整个标准从头到尾有重大的变更。

A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.

2000版到2008版标准详细的差别对比见ISO9001：2008标准的附录B。.

ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.

已经开发的ISO9001：2008是为了更加清楚地解释现有的ISO9001：2000标准要求以及改进和ISO14001：2004标准之间的兼容性。ISO9001：2008没有增加新的要求，也没有改变ISO9001：2000标准原来的意图。

Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008

针对ISO9001：2008标准的认证不是“升版”，凡是已经按照ISO9001：2000认证的组织应当和针对ISO9001：2008新认证的具有相同的认证服务。

No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS

新版标准没有新的要求，但是，为了便于从理解ISO9001：2008标准中得到好处，按照ISO9001：2000认证的组织有必要考虑ISO9001：2008现在对标准的解释对他们现在的质量管理体系有没有影响，如果有影响的话，有可能对他们的质量管理体系做一些变更。



2. BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS
ISO9001：2008修订的背景

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

为了帮助各个组织能完整地理解新版：ISO 9001：2008标准，看看标准修改过程的内幕，知道这次修改是如何反映标准使用者提出的各种意见，以及考虑如何给他们提供收益以及对他们的发展带来好处， 也许会有帮助的。

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
        the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
        feedback from the ISO/TC 176/Working Group on “Interpretations”
        the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004” by ISO/TC 176/SC 2/WG 18 and similar national surveys.

在考虑集中对管理体系标准修改意见之前，ISO/指南72：2001这份文件提供管理体系标准判断和发展的各种指南。它是一种《判断研究》作为一个提案，建议成立一个专题项目，收集各种有争议的具体资料和修改建议，以便争论。有关ISO 9001：2008标准发展，标准的使用者必须按照以下各个方面来确定：
# 对国际标准委员会第二分会（ISO/TC 176/SC2）在2003年到2004年对ISO 9001：2000标准所进行的正式的〈系统评审〉的各种结果。
#从ISO/TC 176/SC2关于〈标准解释〉得到的各种反馈。（译者注：〈标准解释〉是指该组织接受标准使用者提出的，对标准各种不同的理解后，由该组织做出统一解释的，在网站上公布的文件。）。
# 由ISO/TC 176/SC 2/WG 18 第18工作组在全世界范围广泛调查的结果〈关于ISO 9001和ISO 9004使用者的反馈调查报告〉中以及其他类似的由国家调查得到的各种结果。

The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
通过〈判断研究〉认识到，只要这样的补充对标准使用者所产生的影响是有限的话，有必要对标准加以补充，而且，所做的更改将仅仅是引导性的，这样做对标准使用者来说能得到明确的好处。

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.
ISO 9001：2008版标准修改补充的焦点在于提高对ISO 9001：2000版标准的清晰度，并且提高和ISO 14001：2004标准的兼容性。

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:
1)         No changes with high impact would be incorporated into the standard;  
2)         Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3)         Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
为了评估所提出各种更改相对影响和得到好处之间的关系，专门开发了一个工具帮助标准修改草案提出者来决定，什么样的更改应当考虑，并且帮助草案提出者验证草案对所识别的标准使用者的各种需求满足程度。为此，要应用以下各个原则：
1）不容许有会对标准有重大影响的更改；
2）凡是有中等程度影响的更改只能当这些更改同时会对标准使用者带来中等或高的好处的情况下，才能更改；
3）即使某项更改会带来低的影响，在执行更改前，必须向标准使用者提出，由他们来判定是有好处的， 才能更改。

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
        No changes or minimum changes on user documents, including records
        No changes or minimum changes to existing processes of the organization
        No additional training required or minimal training required
        No effects on current certifications
ISO 9001：2008版标准各种更改可以归类成以下各类：
1）对标准使用者的文件。包括记录没有更改或者小的更改；
2）对组织现有的过程没有更改或者小的更改；
3）没有附加的培训要求或者小量的培训要求；
4）对现在的认证没有影响。

The benefits identified for the ISO 9001:2008 edition fall into the following categories:
        Provides clarity
        Increases compatibility with ISO 14001.
        Maintains consistency with ISO 9000 family of standards.
        Improves translatability.

新版ISO 9001:2008标准带来如下好处：
1）提供清晰度；
2）提高和ISO 14001：2004标准的兼容性；
3）维持ISO 9000系列标准的一致性；
4）提高了可翻译性。

3. USER GROUPS
各种标准使用者组

3.1 Individual organizations using ISO 9001 (including industry associations)

使用ISO9001的各个组织（包括工业协会）

a) Current Users of ISO 9001:2000
现在ISO9001：2000使用者

This user group is defined as having completed or being in the process of implementing ISO 9001:2000, regardless of whether they are certified or not, or whether they intend to be certified or not.

这组使用者是指已经通过或者正在贯彻执行ISO9001：2000的组织，不管他们已经通过认证或者不考虑通过认证的组织。

b) New Users
新使用者

A New User is defined as an organisation that is either beginning to use ISO 9001:2000 or ISO 9001:2008 for the first time or is a potential user of the standard in the future.

新使用者是指开始第一次使用ISO9001：2000或者ISO9001：2008的组织或者该标准未来的使用者。

c) Users of Industry Sector Schemes, based on ISO 9001:2000

根据ISO9001：2000为基础制定工业方案的使用者（指TS、TL、AS等编制者——译者）

This user group is defined as those using quality management system programmes based on ISO 9001:2000 that include additional quality management system requirements, that can either be certified or accredited under the guidance of a particular Industry Sector Scheme (e.g. ISO/TS 16949 Quality systems – Automotive suppliers – Particular requirements for the application of ISO 9001:2000).

这类使用者是指根据ISO9001：2000作基础提出一些附加质量管理体系要求方案的组织。不管是否根据该特定的工业方案（就是ISO/TS 16949汽车行业——应用ISO9001：2000标准的特定要求）通过认证或者认可的。

3.2 Other user groups

其他使用者组

These are defined as being:

这些包括：

a) National Standards Bodies (NSBs)国家标准化组织
b) Accreditation Bodies (ABs)认可组织
c) Certification/Registration Bodies (CB/RBs)认证/注册组织
d) Trainers and Consultants培训和咨询组织

4. IMPLEMENTATION GUIDANCE

贯彻指南

4.1 Generic guidance

一般贯彻指南

All  users groups are strongly advised to note the Joint IAF-ISO communiqué for Implementation of accredited certification to ISO 9001:2008, which details the agreed implementation plan for accredited certification as follows:
Accredited certification to ISO 9001:2008 shall not be granted until the publication of ISO 9001:2008 as an International Standard.
Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or re-certification audit against ISO 9001:2008.

强烈建议各种使用者组注意IAF-ISO 关于贯彻ISO9001：2008标准进行认证的联合公报，双方协商一致如下：

Validity of certifications to ISO 9001:2000

ISO9001：2000的认证的有效性

One year after the publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008.
Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

ISO9001：2008标准颁布一年后必须按照ISO9001：2008认证（新认证或者换证认证）。ISO9001：2008标准颁布24个月以后，所有按照ISO9001：2000认证证书失效。

Figure 1 - Implementation timetable for ISO 9001:2008, for all user groups

图1：（略）

To benefit from the clarifications introduced into ISO 9001:2008, users (from all user groups) should note the recommendations given in the table below. Recommendations for specific user groups are given in section 4.2 further down.

为了从ISO9001：2008标准的解释得到好处，标准使用者（包括所有使用者）应当注意以下的各种建议。针对特定使用者组还要注意4.2条后面的建议。

        Get acquainted with the new edition of the standard. Use Annex B in ISO 9001:2008 to facilitate identification of the clarifications

从新版ISO9001：2008后面附录B中识别和理解有哪些变化。

        Was your former interpretation of ISO 9001:2000 different from the clarifications provided by ISO 9001:2008 ?

搞清楚，您们以往对ISO9001：2000标准的理解和ISO9001：2008有什么不同？

        If not, communicate to both internal and external parties the conclusion and results of your implementation of ISO 9001:2008.

假如没有什么不同，把您们贯彻ISO9001：2008的意见和结果告诉内部和外部有关方。

        If yes, determine the impact of the clarifications of the new version on your current use of ISO 9001 and plan any necessary remedial actions.

假如有不同，确定通过新版本的解释认清楚以后对您们现在使用ISO9001有什么影响，然后，做一个计划如何采取必要的弥补措施。

        Use the Plan-Do-Check-Act methodology to manage the implementation of your remedial actions, but keep in mind the timeframe provided in Figure 1.

采用PDCA方法来管理您们的弥补措施，但是，记住，时间上要符合图1的规定。

Note that the actions may need to vary according to your user group (see 4.2 below).

注意这些措施针对您们不同的使用者组有可能是不同的（见下面4.2条）：

4.2        Guidance for specific user groups

特定使用者组的指南

These recommendations complement the generic guidance to all user groups given in section 3.0 above.

以下是对前面第3.0条所有使用者组一般贯彻指南的补充建议。

4.2.1        Organizations using ISO 9001:2000

使用ISO9001：2000的组织

a) Current users

现在的使用者

Organisations that are already certified to ISO 9001:2000 should contact their certification/registration bodies (CB/RB) to agree a programme for analysing the clarifications in ISO 9001:2008 in relation to their individual quality management systems and for upgrading their certificates.

已经通过ISO9001：2000认证的组织应当和他们的认证机构联系，达成一致意见如何分析ISO9001：2008标准中所澄清的问题和他们自己质量管理体系的关系，以便更换他们的证书。

Certified organizations should bear in mind that ISO 9001:2000 certificates have the same status as new ISO 9001:2008 certificates during the co-existence period.

已经通过认证的组织应当记住，ISO9001：2000证书在新老版本共存期间和ISO9001：2008的证书是等效的。

Organizations in the process of certification to ISO 9001:2000 should change to using ISO 9001:2008 and apply for certification to it.

正在申请按照ISO9001：2000认证的组织应当马上变更，按照ISO9001：2008来认证了。

b) New users

新的使用者

New users should start by using ISO 9001:2008.

新使用者应当开始用ISO9001：2008。

c) Industry Sector Schemes

各个工业方案组织

Users of specific sector schemes are recommended to refer to the organization that is responsible that sector scheme’, e.g. for:
•        ISO/TS 16 949 refer to the IATF,
•        TL 9000 refer to the QuEST Forum
•        AS 9000/ EN 9100 refer to the IAQG

建议各个特定的工业方案组织和以下的组织规定办理：
         •        ISO/TS 16 949：IATF,
                  TL 9000 ：QuEST Forum
•                 AS 9000/ EN 9100： IAQG

4.2.2        National Standards Bodies

国家标准化组织机构

        Information regarding the 2008 edition of ISO 9001 should be communicated to standard users, in a timely manner, by the national standards bodies (NSBs). It is recommended that NSB actions be synchronized with the information flows from ISO and ISO/TC 176.

国家标准化组织机构应当及时把2008版ISO9001有关信息沟通给标准的使用者。建议应当和国际标准化组织和176技术委员会同步进行。

NSBs are responsible, at a national level, for communicating the issues regarding the changes from ISO 9001:2000 to ISO 9001:2008 to all interested parties and for providing translations of the new edition of the standard in their national languages. It is recommended that they coordinate their communications regarding these issues with other local interested parties (for example: ABs, CB/RBs, professional quality associations, etc.).

国家标准化组织机构负责国家层次向所有关心这问题的有关方面沟通有关ISO9001：2000到ISO9001：2008的变更的问题，并且提供本国家语言新版标准的翻译版本。建议他们和其他利益相关方（譬如，认可机构、认证和注册机构、专业的质量协会等）协调有关这方面信息。
        
Translation Issues - If a requirement for translation of the new standards exists, the translation process should be started as early as possible, in order to provide the equivalent national edition as soon as possible.

翻译问题——如果要求翻译成新版本标准的话，翻译过程应当尽量早开始，以便能尽快提供等同使用的国家版本的标准。

An NSB should analyse if there are interpretation problems in the national ISO 9001:2000 version due to former translation problems. In affirmative cases the NSB should carry out an extensive translation of the standard. If interpretation divergences still remain, the NSB is recommended to apply for clarification to the “ISO/TC 176  Interpretations Working Group” using the established “Interpretations” process.

国家标准化组织应当分析以往ISO9001：2000国家版本中是否存在翻译方面的各种问题。在肯定情况下，国家标准化组织应当延伸标准翻译工作。如果解释方面还有歧义的话，建议国家标准化组织利用ISO/TC 176 解释小组已经建立的“解释”渠道向他们提出来，请求他们解释。

If an NSB has no translation problem with its version of ISO 9001:2000 it can use Annex B to ISO 9001:2008 as a quick guide for preparing its translation of the standard.

如果国家标准化组织在ISO9001：2000的翻译方面不存在什么问题的话，那么可以利用ISO9001：2008附录B来快速翻译ISO9001：2008标准。

4.2.4        Accreditation Bodies

认可机构

ABs should refer to the joint IAF-ISO communiqué for the implementation of accredited certification to ISO 9001:2008 (see 4.1 above).

认可机构应当按照IAF-ISO联合公报规定贯彻ISO9001：2008的认可认证工作（见前面4.1条）。

4.2.5        Certification Bodies

认证机构

CBs should refer to the joint IAF-ISO communiqué for the implementation of accredited certification to ISO 9001:2008 (see 4.1 above).

认证机构应当按照IAF-ISO联合公报规定贯彻ISO9001：2008的认可认证工作（见前面4.1条）。

CBs should remember that certificates of conformity to ISO 9001:2008 and/or its national equivalent adoptions can only be issued after the official publication of the amended standard.

认证机构应当记住，只能等ISO9001：2008正式颁布后才能按照ISO9001：2008标准和/或他们国家等同标准进行符合性认证并颁发证书。

It is important that accredited certification bodies ensure that their auditors are aware of the clarifications introduced in ISO 9001:2008, and their implications, prior to conducting audits to that standard.

经过认可的认证机构必须确保他们的审核员理解了ISO9001：2008所做的变更解释，以及它们的实际运用，然后才能从事审核工作，这一点非常重要。

4.2.6        Training Bodies and Consultants

培训和咨询机构

All trainers and consultants should be aware of the clarifications in ISO 9001:2008. All training bodies and consultants are recommended to determine the need for updating training programs and documentation, or any other changes necessary, to the services they provide.

所有的培训和咨询机构应当懂得ISO9001：2008所做变更的解释。建议所有
培训和咨询机构确定一下如何更新他们的培训方案以及文件，或其他任何必要的变更，以便提供他们的服务。

5.0        FREQUENTLY ASKED QUESTIONS

经常提出的问题

While this Implementation Guidance provides recommendations on a number of issues facing the different user groups during the co-existence period, it does not address more general questions about the ISO 9000 standards. Instead ISO/TC 176/SC 2 has prepared a set of frequently asked questions (FAQs) to provide such advice.

在新老版本标准共存期间，面对不同的标准使用者组遇到的一系列问题，本贯彻指南中没有包括更加一般性的问题。这些问题可以从ISO/TC176/SC2已经有的《经常提出的问题》（FAQ）的渠道来解决。

It is expected that the FAQs will be updated on a more regular basis than this Implementation Guidance. For the latest version of the FAQs, reference should be made to the open access web site at www.iso.org/tc176/sc2

《经常提出的问题》将会及时按照规定来更新有关本指南的问题。最新版本的《经常提出的问题》可以通过互联网的网站www.iso.org/tc176/sc2 获得。

6.0        AUTHENTICITY OF INFORMATION REGARDING ISO 9001:2008

有关ISO9001：2008信息真实性

The first point of contact for information regarding the requirements of ISO 9001:2008 should be your National Standards Body (for a listing of ISO’s member National Standards Bodies, see www.iso.org/iso/about/iso_members.htm).   

有关ISO9001：2008信息，首先和您们国家的标准化机构联系（参加国际标准化组织的各国家标准化组织的目录可以从以下网站中获得：www.iso.org/iso/about/iso_members.htm  ）

Other recommended sources of information are:

其他推荐的信息来源有：

•        ISO’s web site www.iso.org provides general information regarding ISO 9001:2008 and the ISO 9004 revision programme (as well as details of its member National Standards Bodies).  

国际标准化组织的网站 www.iso.org 提供有关ISO9001：2008和ISO9004修改方案的信息（也包括其成员国国家标准化组织的具体信息）。

•        The ISO/TC176 web site www.tc176.org  provides more specific information on the structure and work programme of ISO/TC176, and on the formal “interpretations” issued on ISO 9001

国际标准化组织176技术委员会的网站  www.tc176.org提供更加特定的有关176技术委员会的机构和工作方案的信息，以及有关ISO9001正式“解释”的信息。

•        The ISO/TC176/SC2 web site, www.iso.org/tc176/sc2  provides detailed information on the ISO 9001/9004 revision program, updated on a regular basis.

国际标准化组织176技术委员会第二工作组的网站www.iso.org/tc176/sc2提供更加具体的有关ISO9001/ISO 9004修改方案的情况，而且定期更新的。

[ 本帖最后由 hnwang 于 2008-11-15 21:10 编辑 ]

jblau

According to press release by ISO, ISO/TS 16949:2002 will continue to be use for 1 year. This mean by 15/11/2009, they have to decide whether to turn it into an international standard or drop it

hsm198311

建议论坛专门组织在线学习,学习2008版9001/9004标准,在线讨论,由专家给予解答,这样,一方面大家加深了对标准的理解,另一方面也增加了论坛的人气.一举两得.

teaiken

thank you very much

hnwang

    谢谢。

hy88662006

学到了呀.不过还有一事请教王老师 因为我们今年新增做,OHSAS18001体系,所以我个复评在11月已进行,那么重新发证书应在2008年月12月底.那我们不是很惨呢.

hnwang

    不惨呀。只要您的质量管理体系符合2008版要求，您自己的质量手册中宣布：“本组织的质量管理体系符合ISO 9001：2000建立的，而且随着该标准的换版而及时变更，确保符合当时现行有效版本。”

    a）有这样一句话，以后既可以反映您的质量管理体系历史，又可以保留这句话不用随着版本变更而去改了。

    b）在2年的过渡时期内，2000版证书和2008版证书是等效的。因为，2008版没有新要求；只是澄清一下要求的内容。原来2000版标准就应当满足这些要求的。


    以上个人观点，仅供参考。


[ 本帖最后由 hnwang 于 2008-11-20 10:22 编辑 ]

zhoukebai

多謝啦,學習并引以為用.

hnwang

hnwang

ISO网站下载的，10月份公布的如何贯彻ISO9001：2008的文章
Introduction and support package:
Implementation guidance for ISO 9001:2008

Document: ISO/TC 176/SC 2/N836
October 2008


1.    Introduction

This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.

While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.

Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.

A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.

ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.

Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008

No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS


2.    Background to the ISO 9001:2008 revision process

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001, Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
feedback from the ISO/TC 176/Working Group on “Interpretations”
the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004” by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

No changes with high impact would be incorporated into the standard;   
Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

No changes or minimum changes on user documents, including records
No changes or minimum changes to existing processes of the organization
No additional training required or minimal training required
No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:

Provides clarity
Increases compatibility with ISO 14001.
Maintains consistency with ISO 9000 family of standards.
Improves translatability.

3.    User groups


3.1    Individual organizations using ISO 9001 (including industry associations)


a)    Current Users of ISO 9001:2000

This user group is defined as having completed or being in the process of implementing ISO 9001:2000, regardless of whether they are certified or not, or whether they intend to be certified or not.


b)    New Users

A New User is defined as an organisation that is either beginning to use ISO 9001:2000 or ISO 9001:2008 for the first time or is a potential user of the standard in the future.


c)    Users of Industry Sector Schemes, based on ISO 9001:2000

This user group is defined as those using quality management system programmes based on ISO 9001:2000 that include additional quality management system requirements, that can either be certified or accredited under the guidance of a particular Industry Sector Scheme (e.g. ISO/TS 16949 Quality systems – Automotive suppliers – Particular requirements for the application of ISO 9001:2000).


3.2    Other user groups

These are defined as being:

National Standards Bodies (NSBs)
Accreditation Bodies (ABs)
Certification/Registration Bodies (CB/RBs)
Trainers and Consultants

4.    Implementation guidance


4.1    Generic guidance

All users groups are strongly advised to note the Joint IAF-ISO communiqué for Implementation of accredited certification to ISO 9001:2008, which details the agreed implementation plan for accredited certification as follows:

Accredited certification to ISO 9001:2008 shall not be granted until the publication of ISO 9001:2008 as an International Standard.
Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or re-certification audit against ISO 9001:2008.
Validity of certifications to ISO 9001:2000
One year after the publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008.
Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.



Figure 1 - Implementation timetable for ISO 9001:2008, for all user groups


To benefit from the clarifications introduced into ISO 9001:2008, users (from all user groups) should note the recommendations given in the table below. Recommendations for specific user groups are given in section 4.2 further down.


>> Get acquainted with the new edition of the standard. Use Annex B in ISO 9001:2008 to facilitate identification of the clarifications

>> Was your former interpretation of ISO 9001:2000 different from the clarifications provided by ISO 9001:2008 ?

>> If not, communicate to both internal and external parties the conclusion and results of your implementation of ISO 9001:2008.

>> If yes, determine the impact of the clarifications of the new version on your current use of ISO 9001 and plan any necessary remedial actions.

>> Use the Plan-Do-Check-Act methodology to manage the implementation of your remedial actions, but keep in mind the timeframe provided in Figure 1.
Note that the actions may need to vary according to your user group (see 4.2 below).



4.2    Guidance for specific user groups

These recommendations complement the generic guidance to all user groups given in section 3.0 above.


4.2.1    Organizations using ISO 9001:2000


a)    Current users

Organisations that are already certified to ISO 9001:2000 should contact their certification/registration bodies (CB/RB) to agree a programme for analysing the clarifications in ISO 9001:2008 in relation to their individual quality management systems and for upgrading their certificates.

Certified organizations should bear in mind that ISO 9001:2000 certificates have the same status as new ISO 9001:2008 certificates during the co-existence period.

Organizations in the process of certification to ISO 9001:2000 should change to using ISO 9001:2008 and apply for certification to it.


b)    New users

New users should start by using ISO 9001:2008.


c)    Industry Sector Schemes

Users of specific sector schemes are recommended to refer to the organization that is responsible that sector scheme’, e.g. for:

ISO/TS 16 949 refer to the IATF,
TL 9000 refer to the QuEST Forum
AS 9000/ EN 9100 refer to the IAQG

4.2.2    National Standards Bodies

Information regarding the 2008 edition of ISO 9001 should be communicated to standard users, in a timely manner, by the national standards bodies (NSBs). It is recommended that NSB actions be synchronized with the information flows from ISO and ISO/TC 176.

NSBs are responsible, at a national level, for communicating the issues regarding the changes from ISO 9001:2000 to ISO 9001:2008 to all interested parties and for providing translations of the new edition of the standard in their national languages. It is recommended that they coordinate their communications regarding these issues with other local interested parties (for example: ABs, CB/RBs, professional quality associations, etc.).

Translation Issues - If a requirement for translation of the new standards exists, the translation process should be started as early as possible, in order to provide the equivalent national edition as soon as possible.

An NSB should analyse if there are interpretation problems in the national ISO 9001:2000 version due to former translation problems. In affirmative cases the NSB should carry out an extensive translation of the standard. If interpretation divergences still remain, the NSB is recommended to apply for clarification to the “ISO/TC 176, Interpretations Working Group” using the established “Interpretations” process.

If an NSB has no translation problem with its version of ISO 9001:2000 it can use Annex B to ISO 9001:2008 as a quick guide for preparing its translation of the standard.


4.2.4    Accreditation Bodies

ABs should refer to the joint IAF-ISO communiqué for the implementation of accredited certification to ISO 9001:2008 (see 4.1 above).


4.2.5    Certification Bodies

CBs should refer to the joint IAF-ISO communiqué for the implementation of accredited certification to ISO 9001:2008 (see 4.1 above).

CBs should remember that certificates of conformity to ISO 9001:2008 and/or its national equivalent adoptions can only be issued after the official publication of the amended standard.

It is important that accredited certification bodies ensure that their auditors are aware of the clarifications introduced in ISO 9001:2008, and their implications, prior to conducting audits to that standard.


4.2.6    Training Bodies and Consultants

All trainers and consultants should be aware of the clarifications in ISO 9001:2008. All training bodies and consultants are recommended to determine the need for updating training programs and documentation, or any other changes necessary, to the services they provide.


5.0    Frequently asked questions

While this Implementation Guidance provides recommendations on a number of issues facing the different user groups during the co-existence period, it does not address more general questions about the ISO 9000 standards. Instead ISO/TC 176/SC 2 has prepared a set of frequently asked questions (FAQs) to provide such advice.

It is expected that the FAQs will be updated on a more regular basis than this Implementation Guidance. For the latest version of the FAQs, reference should be made to the open access web site at www.iso.org/tc176/sc2


6.0    Authenticity of information regarding ISO 9001:2008

The first point of contact for information regarding the requirements of ISO 9001:2008 should be your National Standards Body (for a listing of ISO’s member National Standards Bodies, see www.iso.org/iso/about/iso_members.htm).   

Other recommended sources of information are:

ISO’s Web site provides general information regarding ISO 9001:2008 and the ISO 9004 revision programme (as well as details of its member National Standards Bodies).
The ISO/TC176 Web site www.tc176.org provides more specific information on the structure and work programme of ISO/TC176, and on the formal “interpretations” issued on ISO 9001
The ISO/TC176/SC2 Web site, www.iso.org/tc176/sc2 provides detailed information on the ISO 9001/9004 revision program, updated on a regular basis.

janly216

08版出台的時候煩請置頂通知....

謝謝!

白玫瑰

王老师太厉害了～谢谢～

zhangwolf

08版的体系标准已经下来了吗？那位有的话发上来先学习一下

hnwang

    本网站上就有了。请自己查一下。

zxiangyang88

谢谢指教

hnwang

zhangwolf

谢谢王老师。

hnwang

hhl2008

今天才发现这么一个网站，挺不错的，对我的工作帮助很多。谢谢！

hnwang

sunny.qacon

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zhangwolf

回王老师：
7.关于换证书问题。不需要专门为了换证书请认证公司来做审核。可以结合原来监督审核或原来证书到期换证审核同时进行。只要在2010年11月15日前换成2008版都是可以的。

    也就是从现在起到2010年11月15日为止，两种证书可以共存，证明的体系符合性是等同的。都要符合2008版标准要求。2010年11月15日后，所有2000版证书都失效了。
有效时间是2010年还是2009年？还有王老师关于换证书我这有一个疑问麻烦您请答一下，先谢过了。证书是不是必须在这个时间之前换证，无论证书是否在有效期？另外换证是不是只需作出更改就可以？

hnwang

    1、公报说：2010年11月15日后2000版证书失效。那么，这之前有效的。我是这样理解的。不信请问您的认证机构。

    2、证书是有有效期的，超过有效期，别谈了。现在认证，公司给您发的证书按照一般有效期三年，那么，到2010年11月15日后不会再有效了。您会再申请按照2000版认证吗？不会了。除非有什么特殊的理由。

    3、换证书事请问您的认证机构。总是要花钱的。至少证书费用。是否能换，还要看您的体系监督审核的情况如何。

    以上个人观点，仅供参考。

zhangwolf

谢谢！