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ISO9000简介
                                       

ISO9000质量管理体系
ISO是世界最大的国际化组织。它成立于1947年2月23日。1980年国际标准化组织(ISO)正式批准成立了"质量管理和质量保证技术委员会" (TC176),并着手于建立国际化的质量管理体系标准。1987年,适用于一切经济实体、组织和机构的第一个国际质量管理标准--"IS09000族" 系列标准诞生。ISO9000标准是质量管理和质量保证的总称。1994年推出第二版,2000年12月推出第三版,正式颁布ISO9000:2000版。原获得的ISO9000:94版证书在2003年12月15日起自动作废。
    ISO9000标准总结了各工业发达国家在质量管理方面的先进经验,主要用于企业质量管理体系的建立、实施和改进,为企业在质量管理和质量保证方面提供指南。
    从1987年第一版ISO9000正式颁布以来,它以其广泛的适用性和实效性被世界上数百万家单位所接受并严格执行。是否拥有ISO9000证书,已成为衡量一个单位是否具有与国际管理行为接轨能力的最重要标志,以及是否能持续生产满足顾客要求的产品的衡量标准。获取ISO 9000注册证书,已成为诸家渴望持续、良性发展的当务之急。
   根据ISO/TC176/SC2(国际标准化组织/质量管理和质量保证技术委员会/质量体系分委员会)的工作规划,ISO9000:2008版标准将于2008年10月31日正式发布实施。尽管离发布实施之日还有几个月时间,但广大审核员和获证组织对新版标准的新特点、新变化表现了极大的兴趣。基于此,本文就ISO9001标准修订的背景、修订原则及ISO9000:2008新版标准主要变化的条款作简要说明,以期获证组织及时了解新版标准的新变化、新要求,尽早做好转版准备。
   一、ISO9001:2000标准修订的背景
   ISO9001:2000标准自2000年发布之后,ISO/TC176/SC2一直在关注跟踪标准的使用情况,不断地收集来自各方面的反馈信息。这些反馈多数集中在两个方面:一是ISO9001:2000标准部分条款的含义不够明确,不同行业和规模的组织在使用标准时容易产生岐义;二是与其他标准的兼容性不够。到了2004年,ISO/TC176/SC2在其成员中就ISO9001:2000标准组织了一次正式的系统评审,以便决定ISO9001:2000标准是应该撤销、维持不变还是进行修订或换版,最后大多数意见是修订。与此同时,ISO/TC176/SC2还就ISO9001:2000和ISO9001:2004的使用情况进行了广泛的“用户反馈调查”。之后,基于系统评审和用户反馈调查结果,ISO/TC176/SC2依据ISO/Guide72:2001的要求对ISO9001标准的修订要求进行了充分的合理性研究(Justification Study),并于2004年向ISO/TC 176提出了启动修订程序的要求,并制定了ISO9001标准修订规范草案。该草案在2007年6月作了最后一次修订。修订规范规定了ISO9001标准修订的原则、程序、修订意见收集时限和评价方法及工具等,是ISO9001标准修订的指导文件。
   二、ISO9001:2000标准修订的原则
   了解新版标准修订的原则将会使我们知道新版标准条款变化的“所以然”,这对正确理解新版标准条款的含义大有帮助。ISO9001:2000标准修订规范明确规定了此次修订的7条指导原则:
   1、ISO9000:2008标准的结构模式和过程方法维持与ISO9001:2000的规定相同。
   2、ISO9000:2008修订后的标准必须保持通用性,并适宜于所有行业的不同规模、不同类型的组织。
   3、如可能,ISO9000:2008与ISO14001:2004标准的兼容性必须得到强化。
   4、ISO9000:2008必须保持ISO9001和ISO9004标准之间的协调一致性。
   5、ISO9000:2008标准的修订仅限于使用户的质量管理体系受到有限的影响,并且所有的修订应该对用
  户有显著的好处。
   6、ISO9000:2008起草者应使用ISO9001:2000的支持工具包以助于识别需要澄清的问题。
   7、ISO9000:2008修订后的标准草案应按照修订规范进行验证,并得到用户的确认。
   除上述修订过程必须遵循的原则,修订规范还规定了标准起草的原则。具体如下:
     1) 维持标准的原始意图不变。
     2) 标准不得带有文化偏见。
     3) 标准行文简洁,不得过度使用质量术语和专用术语,应使所有的相关方,而不只是质量专业人士,
      都能够理解。
     4) 标准行文准确,含义清晰,易于达成共识以便消除歧义。
     5) 多用短句,在不使含义模糊不清的前提下,尽量减少用词。
     6)保持使用含义一致的术语。与ISO/TC 176/SC 1共同解决术语问题。
     7)对ISO9001:2000标准的其他要求所提出的修改意见在实施前,必须考虑其效果。
     8)标准的要求要以可被审核的方式编写。
     9)标准可以翻译为其他语言。
     10)与其他管理体系标准和ISO/CASCO标准及指南的兼容性和一致性应予以适当考虑。

 

 

ISO9000 quality management system


ISO is the world's largest international organization. It was founded in 1947, on February 23. In 1980, the international organization for standardization (ISO) was officially approved the establishment of "quality management and quality assurance technical committee" (TC176), and begin to build international quality management system standards. In 1987, applies to all economic entity, organization and institutions of the first international quality management standards, "IS09000 family" series standard was born. Standard of ISO9000 quality management and quality assurance. In 1994, second edition, 2000, launched on December 3rd edition, launched formally promulgated ISO9000:2000. The original edition of ISO9000: certificate in 2003 to December 15 automatic invalid.
ISO9000 standard summarizes all industrialized countries in terms of quality management, the advanced experience, mainly used for enterprise quality management system, the establishment of implementation and improvement, for the enterprise in quality management and quality assurance provide guidelines.
Since 1987, since the first edition of ISO9000 formally promulgated, with its wide suitability and effectiveness of 10,000 units in the world is acceptable and strictly enforced. ISO9000 certificate, have already become a unit with international management behavior is the most important ability to practice, and whether can continue production to meet customer requirements of product standards. Obtain the ISO 9000 registration certificate, has become the benign development, to continue.
According to ISO/TC176 / SC2 (ISO/quality management and quality assurance system of quality/technical committee of planning commission) points work, ISO9000:2008 edition standard in 2008 will be officially released on October 31. Although released from the date of implementation and several months, but the inspector and the certification of the organization and the new standard showed great interest in changing. Based on this, the paper ISO9001 standard revision background, revised edition, principles and ISO9000 standard major changes in 2008, the terms to explain briefly the certification organizations understand promptly new standard of new changes, as do better edition, preparations.
First, a standard of ISO9001:2000, revision background
The standard of ISO9001:2000 in 2000 after the release, ISO/TC176 / SC2 in tracking the use of standard, constantly feedback information collected from all sides. Most of these feedback on two aspects: one is the standard of ISO9001:2000 the meaning unclear, different industries and organizations to use standard in the 1800s, Second is the compatibility with other standards. In 2004, the ISO/TC176 / SC2 in its members were the standard of ISO9001:2000 organized a formal system evaluation, in order to decide the standard of ISO9001:2000 is revoked, unchanged or should revise or change the edition, finally majority opinion is revised. Meanwhile, the ISO/TC176 / SC2 are ISO9001:2000 and 2004, the use of ISO9001: based on a wide range of "user feedback investigation". Based on the system, and user feedback survey results, according to ISO/TC176 SC2 / ISO/Guide72:2001 to ISO9001 standard revision required to make full Justification of rationality research (2004), and to the ISO/TC 176 puts the revised programmer start, and formulate the revised standard of ISO9001 standard. The draft in June 2007 a final revision. The revised standard of ISO9001 standard revision of the principles, procedures, revision opinion collection time limit and evaluation methods and tools, is ISO9001 standard revision instruction documents.
Second, ISO9001:2000 standard revision of the principle
Understand the principle of the revised standard will make us know the change of standard terms; "the honeyed" to correctly understand the meaning of the standard terms are of great help. The standard of ISO9001:2000 standard revision stipulates the revision of the 7 guiding principle:
1, 2008, the standard of ISO9000: structural model and process method to maintain the same provisions of ISO9001:2000.
2, 2008, ISO9000: revised standard must maintain generality, and suitable for all different scale, the industry of different types of organization.
3 and if possible, ISO9000:2008 and ISO14001:2004 standard compatibility must be strengthened.
April 2008, ISO9000: ISO9004 standard ISO9001 and must maintain the coordination between the consistency.
5, 2008, the revised standard of ISO9000: only by user's quality management system and all of the revision of use should be
Have significant benefits.
6, 2008 should be used drafter of ISO9000: ISO9001:2000 support kit to aid in the recognition of the need to clarify.
7, 2008 ISO9000: revised standard should be revised according to the draft specification and verified by users.
Besides the revised process must follow the principles, revised standard also provides a standard drafting principle. Specific as follows:
1) Maintain original intentions of the standard.
2) Standard shall not contain cultural prejudice.
3) Standard, not excessive use concise style terminology and special terms, the quality of the relevant party shall make all, not just quality professionals, can understand.
4) Standard style, meaning is clear, accurate consensus to eliminate to ambiguity.
In short, multi-purpose 5) does not make meaning under the premise of vague terms, decrease as far as possible.
6) Maintain consistent meaning. Use with ISO/TC 176 / SC to solve problems in terms of January.
7) On the standard of ISO9001:2000 requirements of other proposed amendment opinions before implementation, must consider the effect.
8) Standards to be written examination way.
9) Standards can be translated into other languages.
10) And other management system standards and ISO/CASCO standards and guidelines of the compatibility and uniformity should be appropriate consideration.

 

 

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