ISO9000质量办理系统
ISO是天下最大的国际化构造。它建立于1947年2月23日。1980年国际尺度化构造(ISO)正式同意建立了"质量办理和质量包管技能委员会" (TC176),并动手于创建国际化的质量办理系统尺度。1987年,实用于统统经济实体、构造和机构的第一个国际质量办理尺度--"IS09000族" 系列尺度降生。ISO9000尺度是质量办理和质量包管的总称。1994年推出第二版,2000年12月推出第三版,正式公布ISO9000:2000版。原取得的ISO9000:94版证书在2003年12月15日起主动取消。
ISO9000尺度总结了各产业兴旺国度在质量办理方面的先辈履历,次要用于企业质量办理系统的创建、实行和改良,为企业在质量办理和质量包管方面提供指南。
从1987年初版[chū bǎn]ISO9000正式公布以来,它以其普遍的实用性和实效性被天下上数百万家单元所承受并严厉实行。能否拥有ISO9000证书,已成为权衡一个单元能否具有与国际办理举动接轨才能的最紧张标记,以及能否能继续消费满意主顾要求的产品的权衡尺度。获取ISO 9000注册证书,已成为诸家盼望继续、良性开展确当务之急。
依据ISO/TC176/SC2(国际尺度化构造/质量办理和质量包管技能委员会/质量系统分委员会)的事情计划,ISO9000:2008版尺度将于2008年10月31日正式公布实行。只管离公布实行之日另有几个月工夫,但宽大考核员和获证构造对新版尺度的新特点、新变革体现了极大的兴味。基于此,本文就ISO9001尺度修订的配景、修订准绳及ISO9000:2008新版尺度次要变革的条款作扼要阐明,以期获证构造实时理解新版尺度的新变革、新要求,尽早做恶化版预备。
一、ISO9001:2000尺度修订的配景
ISO9001:2000尺度自2000年公布之后,ISO/TC176/SC2不停在存眷跟踪尺度的利用状况,不停地搜集来自各方面的反应信息。这些反应少数会合在两个方面:一是ISO9001:2000尺度局部条款的寄义不敷明白,差别行业和范围的构造在利用尺度时容易发生岐义;二是与其他尺度的兼容性不敷。到了2004年,ISO/TC176/SC2在其成员中就ISO9001:2000尺度构造了一次正式的体系评审,以便决议ISO9001:2000尺度是应该打消、维持稳定照旧举行修订或换版,最初大少数意见是修订。与此同时,ISO/TC176/SC2还就ISO9001:2000和ISO9001:2004的利用状况举行了普遍的“用户反应观察”。之后,基于体系评审和用户反应观察后果,ISO/TC176/SC2根据ISO/Guide72:2001的要求对ISO9001尺度的修订要求举行了充实的公道性研讨(Justification Study),并于2004年向ISO/TC 176提出了启动修订步伐的要求,并订定了ISO9001尺度修订标准草案。该草案在2007年6月作了最初一次修订。修订标准划定了ISO9001尺度修订的准绳、步伐、修订意见搜集时限和评价办法及东西等,是ISO9001尺度修订的引导文件。
二、ISO9001:2000尺度修订的准绳
理解新版尺度修订的准绳将会使九游会晓得新版尺度条款变革的“以是然”,这对准确了解新版尺度条款的寄义大有协助。ISO9001:2000尺度修订标准明白划定了这次修订的7条引导准绳:
1、ISO9000:2008尺度的布局形式和历程办法维持与ISO9001:2000的划定相反。
2、ISO9000:2008修订后的尺度必需坚持通用性,并相宜于一切行业的差别范围、差别范例的构造。
3、如大概,ISO9000:2008与ISO14001:2004尺度的兼容性必需失掉强化。
4、ISO9000:2008必需坚持ISO9001和ISO9004尺度之间的和谐分歧性。
5、ISO9000:2008尺度的修订仅限于利用户的质量办理系统遭到有限的影响,而且一切的修订应该对用
户有明显的利益。
6、ISO9000:2008草拟者应利用ISO9001:2000的支持东西包以助于辨认必要廓清的题目。
7、ISO9000:2008修订后的尺度草案应依照修订标准举行验证,并失掉用户确实认。
除上述修订历程必需遵照的准绳,修订标准还划定了尺度草拟的准绳。详细如下:
1) 维持尺度的原始意图稳定。
2) 尺度不得带有文明成见。
3) 尺度行文简便,不得过分利用质量术语和公用术语,应使一切的相干方,而不但是质量专业人士,
都可以了解。
4) 尺度行文正确,寄义明晰,易于告竣共鸣以便消弭歧义。
5) 多用短句,在不使寄义含糊不清的条件下,只管即便增加用词。
6)坚持利用寄义分歧的术语。与ISO/TC 176/SC 1配合办理术语题目。
7)对ISO9001:2000尺度的其他要求所提出的修正意见在实行前,必需思索其结果。
8)尺度的要求要以可被考核的方法编写。
9)尺度可以翻译为其他言语。
10)与其他办理系统尺度和ISO/CASCO尺度及指南的兼容性和分歧性应予以得当思索。
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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