ISO9000質量管理體系
ISO是世界最大的國際化組織。它成立于1947年2月23日。1980年國際標準化組織(ISO)正式批準成立了"質量管理和質量保證技術委員會" (TC176)，并著手于建立國際化的質量管理體系標準。1987年，適用于一切經濟實體、組織和機構的第一個國際質量管理標準--"IS09000族" 系列標準誕生。ISO9000標準是質量管理和質量保證的總稱。1994年推出第二版，2000年12月推出第三版，正式頒布ISO9000:2000版。原獲得的ISO9000:94版證書在2003年12月15日起自動作廢。
    ISO9000標準總結了各工業發達國家在質量管理方面的先進經驗，主要用于企業質量管理體系的建立、實施和改進，為企業在質量管理和質量保證方面提供指南。
    從1987年第一版ISO9000正式頒布以來，它以其廣泛的適用性和實效性被世界上數百萬家單位所接受并嚴格執行。是否擁有ISO9000證書，已成為衡量一個單位是否具有與國際管理行為接軌能力的最重要標志，以及是否能持續生產滿足顧客要求的產品的衡量標準。獲取ISO 9000注冊證書，已成為諸家渴望持續、良性發展的當務之急。
   根據ISO/TC176/SC2（國際標準化組織/質量管理和質量保證技術委員會/質量體系分委員會）的工作規劃，ISO9000：2008版標準將于2008年10月31日正式發布實施。盡管離發布實施之日還有幾個月時間，但廣大審核員和獲證組織對新版標準的新特點、新變化表現了極大的興趣。基于此，本文就ISO9001標準修訂的背景、修訂原則及ISO9000：2008新版標準主要變化的條款作簡要說明，以期獲證組織及時了解新版標準的新變化、新要求，盡早做好轉版準備。
   一、ISO9001：2000標準修訂的背景
   ISO9001：2000標準自2000年發布之后，ISO/TC176/SC2一直在關注跟蹤標準的使用情況，不斷地收集來自各方面的反饋信息。這些反饋多數集中在兩個方面：一是ISO9001：2000標準部分條款的含義不夠明確，不同行業和規模的組織在使用標準時容易產生岐義；二是與其他標準的兼容性不夠。到了2004年，ISO/TC176/SC2在其成員中就ISO9001：2000標準組織了一次正式的系統評審，以便決定ISO9001：2000標準是應該撤銷、維持不變還是進行修訂或換版，最后大多數意見是修訂。與此同時，ISO/TC176/SC2還就ISO9001：2000和ISO9001：2004的使用情況進行了廣泛的“用戶反饋調查”。之后，基于系統評審和用戶反饋調查結果，ISO/TC176/SC2依據ISO/Guide72:2001的要求對ISO9001標準的修訂要求進行了充分的合理性研究（Justification Study），并于2004年向ISO/TC 176提出了啟動修訂程序的要求，并制定了ISO9001標準修訂規范草案。該草案在2007年6月作了最后一次修訂。修訂規范規定了ISO9001標準修訂的原則、程序、修訂意見收集時限和評價方法及工具等，是ISO9001標準修訂的指導文件。
   二、ISO9001：2000標準修訂的原則
   了解新版標準修訂的原則將會使我們知道新版標準條款變化的“所以然”，這對正確理解新版標準條款的含義大有幫助。ISO9001：2000標準修訂規范明確規定了此次修訂的7條指導原則：
   1、ISO9000：2008標準的結構模式和過程方法維持與ISO9001：2000的規定相同。
   2、ISO9000：2008修訂后的標準必須保持通用性，并適宜于所有行業的不同規模、不同類型的組織。
   3、如可能，ISO9000：2008與ISO14001：2004標準的兼容性必須得到強化。
   4、ISO9000：2008必須保持ISO9001和ISO9004標準之間的協調一致性。
   5、ISO9000：2008標準的修訂僅限于使用戶的質量管理體系受到有限的影響，并且所有的修訂應該對用
  戶有顯著的好處。
   6、ISO9000：2008起草者應使用ISO9001：2000的支持工具包以助于識別需要澄清的問題。
   7、ISO9000：2008修訂后的標準草案應按照修訂規范進行驗證，并得到用戶的確認。
   除上述修訂過程必須遵循的原則，修訂規范還規定了標準起草的原則。具體如下：
     1) 維持標準的原始意圖不變。
     2) 標準不得帶有文化偏見。
     3) 標準行文簡潔，不得過度使用質量術語和專用術語，應使所有的相關方，而不只是質量專業人士，
      都能夠理解。
     4) 標準行文準確，含義清晰，易于達成共識以便消除歧義。
     5) 多用短句，在不使含義模糊不清的前提下，盡量減少用詞。
     6)保持使用含義一致的術語。與ISO/TC 176/SC 1共同解決術語問題。
     7)對ISO9001：2000標準的其他要求所提出的修改意見在實施前，必須考慮其效果。
     8)標準的要求要以可被審核的方式編寫。
     9)標準可以翻譯為其他語言。
     10)與其他管理體系標準和ISO/CASCO標準及指南的兼容性和一致性應予以適當考慮。

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.