ISO9001：2008標(biāo)準(zhǔn)常見問題的回答
FAQs on ISO 9001:2008
常見問題的回答
This list of Frequently Asked Questions (FAQs) has been prepared by ISO/TC 176/SC 2 to support the publication of ISO 9001:2008 and the revision of ISO 9004. Input has been obtained from experts and users of the ISO 9000 standards, expressed during seminars and presentations around the world.
本常見問題的回答是由ISO/TC 176/SC2編寫的，目的是為了支持：ISO 9001：2008的頒布和ISO 9004的修改。這些問題都是ISO 9000系列標(biāo)準(zhǔn)的使用者和專家們?cè)诟鞣N討論會(huì)議中以及全世界各地提出來的，
The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include new questions where appropriate. It is intended that this list will also provide a good source of information for new users of the standards.
這些常見問題的回答將會(huì)定期加以評(píng)審，確保其準(zhǔn)確性，同時(shí)，會(huì)相應(yīng)增加一些新的問題。其意圖還想給一些新的標(biāo)準(zhǔn)使用者提供一些良好的信息資源。
For the latest version of the FAQs, reference should be made to the open access web site at www.iso.org/tc176/sc2.
最新版本的常見問題的回答可以從公開網(wǎng)站的下列網(wǎng)址得到。
1. What is ISO? 什么是ISO ?
The International Organization for Standardization (ISO) was established in 1947 and is (currently) an association of approximately 157 members, which each represent their own country. ISO employs a system of Technical Committees, Sub-committees and Working Groups to develop International Standards. Besides the National Standards Bodies, ISO permits other international organizations that develop standards to participate in its work, by accepting them as Liaison members. ISO works in accordance with an agreed set of rules of procedure, the ISO/IEC Directives, which also include requirements on the presentation of standards.
國(guó)際標(biāo)準(zhǔn)化組織(ISO)是1947年建立的，目前大約有157個(gè)成員組成的協(xié)會(huì)，每個(gè)成員代表一個(gè)國(guó)家。ISO 應(yīng)用一個(gè)技術(shù)委員會(huì)系統(tǒng)，下面還有份委員會(huì)和工作組來開發(fā)國(guó)際標(biāo)準(zhǔn)。除了國(guó)家標(biāo)準(zhǔn)化組織外，ISO 還容許其他開發(fā)標(biāo)準(zhǔn)的各種國(guó)際組織，通過聯(lián)絡(luò)成員的身份參與工作。國(guó)際標(biāo)準(zhǔn)化組織按照一系列協(xié)商一致的程序規(guī)則進(jìn)行工作的，其中包括ISO/IEC 指令有關(guān)提出各種標(biāo)準(zhǔn)的各項(xiàng)要求。
2. Who are the National Standards Bodies, and who represents my country at ISO?
誰是我們國(guó)家的標(biāo)準(zhǔn)化組織代表國(guó)家參加ISO?
Please see the relevant page on ISO online that gives details, including contact information, of the National Standards Bodies.
有關(guān)誰代表您們國(guó)家參加國(guó)際標(biāo)準(zhǔn)化組織的問題，請(qǐng)查閱國(guó)際標(biāo)準(zhǔn)化組織網(wǎng)站，在那里您能得到詳細(xì)的信息，包括您們國(guó)家標(biāo)準(zhǔn)化組織的名稱和誰接觸的信息。
3. What are the ISO 9000 standards ? 什么是ISO 9000系列標(biāo)準(zhǔn)?
The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are approximately 25 documents in the collection altogether, with new or revised documents being developed on an ongoing basis.
(It should be noted that many of the International Standards in the ISO 9000 family are numbered in the ISO 10000 range.)
4. Who is responsible for developing the ISO 9000 standards? 誰負(fù)責(zé)開發(fā)ISO 9000系列標(biāo)準(zhǔn)?
ISO Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committees, are responsible for the development of the standards. The work is conducted on the basis of "consensus" among quality and industry experts nominated by the National Standards Bodies, representing a wide range of interested parties.
5. Where can copies of the standards be obtained? 我可以從哪里得到標(biāo)準(zhǔn)的文件?
Copies of the standards may be purchased from your National Standards Body (see list with contact details), or from ISO Central Secretariat through the ISO Store of by contacting the Marketing and Communication department (sales@iso.org). Many National Standards Bodies have them available in local-language versions.
6. Where can copies of the supporting ISO 9000 guidance notes or other documents be found ?
從哪里可以得到支持ISO9000 標(biāo)準(zhǔn)的指導(dǎo)文件或者其他有關(guān)文件?
Copies of the ISO 9000 Introduction and Support Package modules:
Guidance on ISO 9001:2008 Sub-clause 1.2 ’Application’
Guidance on the documentation Requirements of ISO 9001:2008
Guidance on the Terminology used in ISO 9001 and ISO 9004
Guidance on the Concept and Use of the Process Approach for management systems
Guidance on ’Outsourced Processes’
as well as details of the Quality Management Principles can be found at: www.iso.org/tc176/sc2
Copies of the ISO 9001 Auditing Practices Group guidance notes.
Copies of the sanctioned ISO/TC 176 sanctioned “Interpretations” of ISO 9001 can be found at: http://www.tc176.org/
7. Where can information be obtained on the ISO 9000 standards?
從哪里可以得到有關(guān)ISO9000系列標(biāo)準(zhǔn)信息?
There are a number of sources of information on the ISO 9000 quality management system standards, including ISO’s web site (www.iso.org), which carry information on the standards. Your National Standards Body should be able to provide copies of the standards, and registrars/certification bodies will be able to provide guidance on registration arrangements.
8. Why are the standards being revised?
為什么ISO9000系列標(biāo)準(zhǔn)在不斷修改的?
ISO’s formal review process:
Requires continual review to keep standards up to date. Must be initiated within 3 years of publication of a standard.
User inputs from:
A global user questionnaire/survey
A market Justification Study
Suggestions arising from the interpretation process
Opportunities for increased compatibility with ISO 14001
The need for greater clarity, ease of use, and improved translation
Current trends:
Keeping up with recent developments in management system practices.
9. Who is responsible for revising the standards?
誰負(fù)責(zé)修改ISO9000 系列標(biāo)準(zhǔn)的?
The revision process is the responsibility of ISO Technical Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) and is conducted on the basis of consensus among quality and industry experts nominated by ISO Member bodies, and representing all interested parties.
10. When will the revised standards be available?
什么時(shí)候能得到修改好的標(biāo)準(zhǔn)?
The revised quality management system standards (ISO 9000, 9001 and 9004) are scheduled as follows:
ISO 9000:2005 already published – no major changes expected for 2009
Current plan is for small changes to ISO 9001 (an “amendment”) to be published in November 2008.
More significant changes are planned for ISO 9004 (a “revision”) to be published in mid 2009.
ISO 9000：2005已經(jīng)在2005年修改好了。估計(jì)2009年不會(huì)有大的修改了;
ISO 90001：2008已經(jīng)修改好11月15日出版了。只是做一些小的補(bǔ)充修改而已;
ISO 9004有大的變動(dòng)，預(yù)期2009年出版。
11. How much is the implementation of the new standard going to cost?
貫徹新版標(biāo)準(zhǔn)將會(huì)花去多少費(fèi)用?
One of the goals of ISO/TC 176/SC 2 is to produce standards that will minimize any potential costs during a smooth implementation. Any additional costs may be considered as a value-adding investment. A key factor in the development of ISO 9001:2008 was to limit the impact of changes on users.
在開發(fā)ISO 90001：2008標(biāo)準(zhǔn)的時(shí)候有一個(gè)關(guān)鍵因素就是要限制更改對(duì)標(biāo)準(zhǔn)使用者帶來的影響。
12. Where can I obtain information on the revised standards?
我從哪里可以得到有關(guān)修改好標(biāo)準(zhǔn)的信息?
See the ISO Catalogue on ISO online web site that carries general information on the revision program. Your National Standards Body will give you additional information and the certification/registration bodies will be able to provide guidance on transitional arrangements in due course.
可以從ISO 的網(wǎng)站分類中得到有關(guān)標(biāo)準(zhǔn)修改一般的信息;
從您們國(guó)家的標(biāo)準(zhǔn)化組織那里可以得到一些附加的信息;
認(rèn)證機(jī)構(gòu)到時(shí)候會(huì)指導(dǎo)您如何過渡的具體安排?
13. Where can my organization go if it needs additional clarification or interpretation of the ISO 9001:2008 standard?
如果我想了解更加詳細(xì)的有關(guān)ISO9001：2008標(biāo)準(zhǔn)的說明和詮釋的話，我應(yīng)當(dāng)找誰?
The starting point for any individual request for an interpretation should be with the enquirer’s National Standards Body. ISO Central Secretariat and ISO/TC 176/SC 2 cannot accept direct requests from individuals for interpretations of the ISO 9000 standards. ISO/TC 176 has a Working Group that only accepts formal requests for interpretations from the National Standards Bodies. The agreed interpretations can be found at http://www.tc176.org/.
任何個(gè)人對(duì)標(biāo)準(zhǔn)的理解有問題應(yīng)當(dāng)向國(guó)家的標(biāo)準(zhǔn)化機(jī)構(gòu)咨詢。ISO秘書處和ISO/TC176委員會(huì)的SC2工作組不會(huì)接受個(gè)人提出的有關(guān)ISO 9000系列標(biāo)準(zhǔn)的任何問題。ISO/TC176委員會(huì)有一個(gè)工作組只接受您們國(guó)家標(biāo)準(zhǔn)化組織用統(tǒng)一表單提出的問題。統(tǒng)一作出解答，公布在下列網(wǎng)站上： http://www.tc176.org/.
14. Will my organization need a full reassessment once the revised standards are available?
當(dāng)修改后標(biāo)準(zhǔn)頒布后，我們是否必須對(duì)自己的體系重新做一次審核?
This is primarily an issue between your organization and your registration/certification body. ISO/TC 176 is working with the IAF (International Accreditation Forum) and ISO/CASCO (the ISO Policy Committee for Conformity Assessment) in order to provide relevant information in a timely manner. ISO/CASCO is responsible for the standards to which the Certification Bodies work (ISO/IEC 17021), and the Accreditation Bodies are responsible for monitoring and approving the performance of Certification Bodies within their geographical area.
這是您們和認(rèn)證機(jī)構(gòu)之間的一個(gè)基本問題。ISO和IAF(國(guó)際認(rèn)可論壇)已經(jīng)協(xié)商一致，公布了一個(gè)過渡時(shí)間的公報(bào)?ISO/CASCO負(fù)責(zé)編寫認(rèn)證工作標(biāo)準(zhǔn)(ISO/IEC 17021)，認(rèn)可機(jī)構(gòu)負(fù)責(zé)監(jiān)視和批準(zhǔn)該認(rèn)可機(jī)構(gòu)管轄范圍內(nèi)的認(rèn)證機(jī)構(gòu)來執(zhí)行。
It is expected that conformity to the new ISO 9001:2008 standard will be evaluated by certification bodies during regular surveillance visits and that full reassessment will only take place once current certificates expire. However, it should be noted that ISO and the IAF have agreed that all certificates to ISO 9001 should be upgraded to ISO 9001:2008 within 2 years of publication of the amended standard.
希望認(rèn)證機(jī)構(gòu)能結(jié)合定期的監(jiān)督審核來評(píng)估對(duì)新版標(biāo)準(zhǔn)ISO9001：2008的符合性，只有當(dāng)現(xiàn)有證書到期換證審核的時(shí)候，會(huì)做全面的重新評(píng)估。但是，要注意到，ISO和IAF的過渡公報(bào)中規(guī)定，ISO9001：2008頒布后24個(gè)月以內(nèi)ISO 9001：2000版證書必須升版。
15. Will the revised standards be available in my national language immediately after they are published by ISO?
我們國(guó)家語(yǔ)言的修改后標(biāo)準(zhǔn)是否能馬上得到?
The active participation of experts from around the world in the preparation of the new standards, and the broad distribution of the draft standards, will facilitate the timely translation of the International Standards.
全世界各個(gè)國(guó)家的專家都積極參加標(biāo)準(zhǔn)修改，國(guó)際標(biāo)準(zhǔn)化組織的起草標(biāo)準(zhǔn)的工作委員會(huì)會(huì)幫助把國(guó)際標(biāo)準(zhǔn)很快翻譯過渡的。
Given the global importance of the quality management system standards, many National Standards Bodies are already working on the translation issue. ISO itself will publish the new standards in English and French, but if national language translations of the standards are currently available from your National Standards Body, we expect that they will have the translation of the revised standards ready at the time of publication by ISO or very soon thereafter.
鑒于質(zhì)量管理體系系列標(biāo)準(zhǔn)對(duì)全世界的重要性，很多國(guó)家標(biāo)準(zhǔn)化組織已經(jīng)開始在做翻譯工作了。國(guó)際標(biāo)準(zhǔn)化組織只頒布英文和法文版本，如果您們從您們國(guó)家標(biāo)準(zhǔn)化組織那里已經(jīng)得到您們國(guó)家文字的標(biāo)準(zhǔn)的話，我們希望這個(gè)翻譯本只能同時(shí)或者等ISO標(biāo)準(zhǔn)正式頒布后盡快頒布。
For further details contact your National Standards Body.
更具體的情況請(qǐng)和您們國(guó)家標(biāo)準(zhǔn)化組織聯(lián)系。
16. Will my organization have to re-write all its documentation?
我們的體系文件必須重新寫嗎?
No. ISO 9001:2008 doesn’t introduce major changes to the requirements, when compared to ISO 9001:2000. However, to benefit from the changes, we suggest you get acquainted with the new version of the standard and the clarifications introduced. If, during your analysis of the clarifications you find there are differences from your current interpretation of ISO 9001:2000, then you should analyse the impact on your current documentation and make the necessary arrangements to update it. It is intended that the amendment of ISO 9001 will have minimal or no impacts on documentation.
不需要。ISO9001：2008相對(duì)2000版對(duì)體系的要求沒有引進(jìn)大的變更。但是，利用這次變更我們建議您們?nèi)〉眯掳鏄?biāo)準(zhǔn)，看看有哪些問題得到澄清了。通過分析，如果發(fā)現(xiàn)您們現(xiàn)在對(duì)2000版標(biāo)準(zhǔn)的理解和ISO9001：2008澄清的有所不同，那么，就要分析一下對(duì)您們現(xiàn)在的文件有沒有影響，如果有影響，那么做一個(gè)必要的安排，把文件修改一下。標(biāo)準(zhǔn)修訂的時(shí)候，其意圖將會(huì)對(duì)文件有少量或者沒有任何影響。
17. Will the revised standards address financial issues?
修改后的標(biāo)準(zhǔn)是否會(huì)涉及到財(cái)務(wù)問題?
Financial issues are not addressed in ISO 9001:2008, which is a requirements standard.
有關(guān)財(cái)務(wù)的各種問題不包括在ISO9001：2008標(biāo)準(zhǔn)中，標(biāo)準(zhǔn)只提出要求。
The ISO 10014:2006 and ISO 9004:2000, Guidelines for performance improvements standards will emphasize the financial resources needed for the implementation and improvement of a quality management system.
標(biāo)準(zhǔn)ISO 100014：2006和ISO9004：2000質(zhì)量管理體系改進(jìn)的指導(dǎo)標(biāo)準(zhǔn)這兩份國(guó)際標(biāo)準(zhǔn)強(qiáng)調(diào)執(zhí)行和改進(jìn)質(zhì)量管理體系所必要的各種財(cái)務(wù)資源。
18. What are the benefits of the revised standards?
標(biāo)準(zhǔn)修改會(huì)帶來什么好處?
For ISO 9001:2008 the major benefits are:
對(duì)ISO9001：2008，主要的好處是：
Simple to use 使用簡(jiǎn)單
Clear in language 語(yǔ)言簡(jiǎn)潔
Readily translatable and easily understandable 容易翻譯和理解
Compatibility with other management systems such as ISO 14001.和其他管理體系兼容，譬如和 ISO 14001環(huán)境管理體系兼容
For ISO 9004:
對(duì)ISO9004主要的好處是：
Facilitates improvement in users’ quality management systems.
Provides guidance to an organization for the creation of a quality management system that:
- creates value for its customers, via the products it provides
- creates value for all other interested parties
- balances all interested-party viewpoints.
Provides guidance for managers on leading their organization towards sustained success.
Forward compatibility to allow organizations to build on existing quality management systems.
便于ISO9000系列標(biāo)準(zhǔn)使用者改進(jìn)他們的質(zhì)量管理體系。
指導(dǎo)組織創(chuàng)建一個(gè)符合下列要求的質(zhì)量管理體系：
= 通過向他們的顧客提供各種產(chǎn)品，為他們的顧客創(chuàng)造價(jià)值;
= 為其他利益相關(guān)方創(chuàng)造價(jià)值;
= 平衡各個(gè)利益相關(guān)方的各種觀點(diǎn)。
指導(dǎo)管理者如何領(lǐng)導(dǎo)組織向著維持成功。
讓各個(gè)組織在現(xiàn)有質(zhì)量管理體系的基礎(chǔ)上向著和諧前進(jìn)。
19. What are the main changes in ISO 9001:2008?
ISO9001：2008的主要更改是什么?
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended 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.
ISO9001：2008標(biāo)準(zhǔn)主要是對(duì)現(xiàn)有ISO9001：2000標(biāo)準(zhǔn)做一些解釋，有些更改只是為了改進(jìn)和ISO 14001：2004的兼容。ISO9001：2008沒有提出新的要求，也沒有改變ISO9001：2000標(biāo)準(zhǔn)的意圖。
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
相對(duì)ISO9001：2008不是一個(gè)“升版”的問題，已經(jīng)通過ISO9001：2000認(rèn)證的組織和通過新版ISO9001：2008認(rèn)證是等同效果的。
All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B to ISO 9001:2008.
ISO9001：2008相對(duì)ISO9001：2000有哪些詳細(xì)的變更，可以參考ISO9001：2008的附錄B。
20. What are the main benefits to be derived from implementing an ISO 9000 quality management system?
貫徹執(zhí)行ISO9000系列標(biāo)準(zhǔn)將會(huì)帶來什么主要的好處?
The ISO 9000 standards give organizations an opportunity to increase value to their activities and to improve their performance continually, by focusing on their major processes. The standards place great emphasis on making quality management systems closer to the processes of organizations and on continual improvement. As a result, they direct users to the achievement of business results, including the satisfaction of customers and other interested parties.
貫徹執(zhí)行ISO9000系列標(biāo)準(zhǔn)能給組織提高他們作業(yè)的價(jià)值的機(jī)會(huì)，讓他們關(guān)注主要的各種過程，可以持續(xù)改進(jìn)他們的工作業(yè)績(jī)。這個(gè)系列特別標(biāo)準(zhǔn)強(qiáng)調(diào)讓質(zhì)量管理體系關(guān)注組織的各個(gè)過程，并且持續(xù)改進(jìn)這些過程。這樣做的結(jié)果，會(huì)讓采用這些標(biāo)準(zhǔn)的組織取得商務(wù)上的成就，其中包括，讓各類顧客和其他各個(gè)利益相關(guān)方的滿意。
The management of an organization should be able to view the adoption of the quality management system standards as a profitable business investment, not just as a required certification issue.
組織的管理者應(yīng)看到，采用質(zhì)量管理體系各種標(biāo)準(zhǔn)是一種能為他們?nèi)〉没貓?bào)的商務(wù)投資，而不僅僅是為了取得一份證書而已。
Among the perceived benefits of using the standards are:
貫徹執(zhí)行ISO9000系列標(biāo)準(zhǔn)能取得好處是：
The connection of quality management systems to organizational processes 把各個(gè)質(zhì)量管理體系和組織的各個(gè)過程聯(lián)系起來了
The encouragement of a natural progression towards improved organizational performance, via: 通過以下方式促使組織自然向著持續(xù)改進(jìn)業(yè)績(jī)的方向前進(jìn)：
- the use of the Quality Management Principles采用質(zhì)量管理八個(gè)原則
- the adoption of a "process approach"采用“過程模式”系統(tǒng)管理
- emphasis of the role of top management強(qiáng)調(diào)最高管理者的作用
- requirements for the establishment of measurable objectives at relevant functions and levels各個(gè)相關(guān)職能和層次建立可測(cè)量的目標(biāo)的要求
- being orientated toward "continual improvement" and "customer satisfaction", including the monitoring of information on "customer satisfaction" as a measure of system performance.堅(jiān)持“持續(xù)改進(jìn)”和“顧客滿意”的方向，包括把監(jiān)視“顧客滿意”的信息作為對(duì)體系性能的一種測(cè)量方法
- measurement of the quality management system, processes, and product使對(duì)質(zhì)量管理體系、各個(gè)過程和產(chǎn)品的測(cè)量
- consideration of statutory and regulatory requirements.對(duì)法令和法規(guī)各項(xiàng)要求的考慮
- attention to resource availability關(guān)注資源的可獲得性
21. How will the implementation of the amended standard help my organization to improve its efficiency?
組織如何利用貫徹修改后標(biāo)準(zhǔn)來幫助提高我們的效率?
ISO 9001:2008 aims at guaranteeing the effectiveness (but not necessarily the efficiency) of the organization. For improved organizational efficiency, however, the best results can be obtained by using ISO 9004 in addition to ISO 9001:2008. The guiding quality management principles are intended to assist an organization in continual improvement, which should lead to efficiencies throughout the organization.
ISO9001：2008的目的是確保組織的有效性(而效率不是必須)。至于改進(jìn)組織的效率，最好是利用在貫徹ISO9001：2008標(biāo)準(zhǔn)的同時(shí)，貫徹標(biāo)準(zhǔn)ISO9004：2000。貫徹執(zhí)行質(zhì)量管理八個(gè)原則就是為了幫助組織持續(xù)改進(jìn)的，它將使整個(gè)組織引向效率的提高。
22. What benefits are there to an organization implementing ISO 9004 ?
組織貫徹執(zhí)行ISO9004：2000將會(huì)帶來什么好處?
If a quality management system is appropriately implemented, utilizing the eight Quality Management Principles, and in accordance with ISO 9004, all of an organization’s interested parties should benefit. For example:
假如組織組的質(zhì)量管理體系中恰當(dāng)?shù)刎瀼刭|(zhì)量管理八原則，同時(shí)又用ISO9004，將會(huì)使整個(gè)組織的各個(gè)利益相關(guān)方得益。例如：
Customers and users will benefit by receiving the products (see ISO 9000:2005, Fundamentals and vocabulary) that are:
顧客和產(chǎn)品使用者通過接受產(chǎn)品而得到好處：(有關(guān)術(shù)語(yǔ)見ISO9000：2005)
Conforming to the requirements 符合各項(xiàng)要求;
Dependable and reliable 可信性和可靠性
Available when needed 需要時(shí)就能得到(可用性)
Maintainable 可維護(hù)性
People in the organization will benefit by:
組織的員工將得到好處：
Better working conditions 更好的工作環(huán)境
Increased job satisfaction 提高工作的滿意度
Improved health and safety改進(jìn)健康和安全
Improved morale 提高士氣
Improved stability of employment 提高員工的穩(wěn)定性
Owners and investors will benefit by:
老板和投資者將得到好處：
Increased return on investment 提高投資回報(bào)率
Improved operational results 提高營(yíng)運(yùn)結(jié)果
Increased market share 提高市場(chǎng)份額
Increased profits 提高利潤(rùn)率
Suppliers and partners will benefit by:
供方和合伙者將得到好處：
Stability 穩(wěn)定性
Growth 成長(zhǎng)率
Partnership and mutual understanding 合作和雙方的理解
Society will benefit by:
社會(huì)將得到好處：
Fulfilment of legal and regulatory requirements法令和法規(guī)得到貫徹
Improved health and safety 提高健康和安全
Reduced environmental impact 降低對(duì)環(huán)境的影響
Increased security 提高治安
23. Are the standards compatible with national quality award criteria?
系列標(biāo)準(zhǔn)是否和國(guó)家質(zhì)量獎(jiǎng)的準(zhǔn)則兼容?
The standards are based on 8 Quality Management Principles, which are aligned with the philosophy and objectives of most quality award programs. These principles are:
系列標(biāo)準(zhǔn)在質(zhì)量管理八原則基礎(chǔ)上提出來的，這些原則和大多數(shù)質(zhì)量獎(jiǎng)的哲理和目標(biāo)是一致的。這八個(gè)原則是：
Customer focus, 顧客為中心
Leadership, 領(lǐng)導(dǎo)
Involvement of people, 員工參與
Process approach, 過程模式
System approach to management,系統(tǒng)管理
Continual improvement, 持續(xù)改進(jìn)
Factual approach to decision making, and根據(jù)事實(shí)做決定 ，和
Mutually beneficial supplier relationships. 供需互利
ISO 9004 recommends that organizations perform self-assessments as part of their management of systems and processes, and includes an annex giving guidance on this approach. This is similar to many quality awards programmes.
對(duì)環(huán)ISO9004要求組織執(zhí)行自我評(píng)估作為他們的質(zhì)量管理體系體系以及各個(gè)過程中的一部分，標(biāo)準(zhǔn)還包括附錄來指導(dǎo)如何進(jìn)行自我評(píng)估。這是和很多質(zhì)量獎(jiǎng)方案的做法是類似的。
24. Why is the requirement for monitoring "customer satisfaction" included in ISO 9001?
為什么ISO9001標(biāo)準(zhǔn)要規(guī)定對(duì)“顧客滿意”的監(jiān)視要求?
"Customer satisfaction" is recognized as one of the driving criteria for any organization. In order to evaluate if a product meets customer needs and expectations, it is necessary to monitor the extent of customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns.
“顧客滿意”是任何組織為了評(píng)估他們的產(chǎn)品是否滿足顧客需求和期望而推導(dǎo)出來的一種判別準(zhǔn)則。它對(duì)監(jiān)視顧客滿意程度來說是必須要有的。對(duì)這方面的改進(jìn)可以針對(duì)任何已經(jīng)識(shí)別出來的問題或者關(guān)注點(diǎn)來采取措施。
25. Can the standards improve "customer satisfaction"?
這些系列標(biāo)準(zhǔn)能改進(jìn)“顧客滿意”嗎?
The quality management system details that are described in the standards are based on Quality Management Principles that include the "process approach" and "customer focus". The adoption of these principles should provide customers with a higher level of confidence that products will meet their needs and increase their satisfaction.
系列標(biāo)準(zhǔn)中所描寫的質(zhì)量管理體系細(xì)節(jié)要求都是根據(jù)質(zhì)量管理八個(gè)原則提出來的，其中包括“過程模式”和“顧客關(guān)注點(diǎn)”這兩個(gè)原則。采用這些管理原則應(yīng)當(dāng)向顧客提供較高水平的信心，使人相信他們提供的產(chǎn)品將滿足他們的需求，提高他們的滿意。
26. What is meant by "continual improvement"?
“持續(xù)改進(jìn)”是指什么意思?
Continual improvement is the process focused on continually increasing the effectiveness and/or efficiency of the organization to fulfil its policies and objectives. Continual improvement (where "continual" highlights that an improvement process requires progressive consolidation steps) responds to the growing needs and expectations of the customers and ensures a dynamic evolution of the quality management system.
“持續(xù)改進(jìn)”是關(guān)注持續(xù)提高組織的有效性和/或效率以便實(shí)現(xiàn)組織的方針和目標(biāo)的工作過程。持續(xù)改進(jìn)(中的“持續(xù)”強(qiáng)調(diào)改進(jìn)過程要求有積極進(jìn)取的一步一步的考慮)是針對(duì)容易提高的顧客需求和期望以及為了確保對(duì)質(zhì)量管理體系有一動(dòng)態(tài)的進(jìn)化。
27. What is a process?
什么是過程?
Any activity or operation, which receives inputs and converts them to outputs, can be considered as a process. Almost all activities and operations involved in generating a product or providing a service are processes.
For organizations to function, they have to define and manage numerous inter-linked processes. Often the output from one process will directly form the input into the next process. The systematic identification and management of the various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the ‘process approach’ to management.
For further information, refer to the paper Guidance on the Concept and Use of the Process Approach, available from www.iso.org/tc176/sc2.
28. What is the "process approach"?
什么是過程模式?
The "process approach" is a way of obtaining a desired result, by managing activities and related resources as a process. The "process approach" is a key element of the ISO 9000 standards. For further guidance, please refer to the ISO 9000 Introduction and Support Package module: Guidance on the Concept and Use of the Process Approach for management systems.
29. Can the "process approach" be applied to other management systems?
其他管理體系可以采用過程模式嗎?
Yes. The "process approach" is a generic management principle, which can enhance an organization’s effectiveness and efficiency in achieving defined objectives.
可以的。“過程模式”是通用的管理原則，組織利用它可以在達(dá)到規(guī)定目標(biāo)方面提高有效性和效率。
30. How can the PDCA cycle be used in the "process approach"?
如何在“過程模式”中使用PDCA?
The PDCA cycle is an established, logical, method that can be used to improve a process.
This requires:
(P) planning (what to do and how to do it),
(D) executing the plan (do what was planned),
(C) checking the results (did things happened according to plan) and
(A) act to improve the process (how to improve next time).
The PDCA cycle can be applied within an individual process, or across a group of processes.
31. Can any organization apply the "process approach"?
是否任何組織都可以采用“過程模式”?
Yes. Many organizations already apply a "process approach" without recognizing it. They could achieve additional benefits by understanding and controlling it.
是的。很多組織雖然自己還不知道，實(shí)際上已經(jīng)采用了“過程模式”。如果他們理解了而且對(duì)這些過程加以控制好的話，還能得到更多的好處。
32. Why should an organization apply the "process approach"?
為什么組織應(yīng)當(dāng)采用“過程模式”?
By applying the "process approach" an organization should be able to obtain the following types of benefits:
組織采用“過程模式”應(yīng)當(dāng)能獲得下列類型的好處：
The integration and alignment of its processes to enable the achievement of its planned results.
An ability to focus effort on process effectiveness and efficiency.
An increase in the confidence of customers and other interested parties as to the consistent performance of the organization.
Transparency of operations within the organization.
Lower costs and shorter cycle times through effective and efficient use of resources.
Improved, consistent and predictable results.
The identification of opportunities for focused and prioritized improvement initiatives.
The encouragement and involvement of people, and the clarification of their responsibilities.
The elimination of barriers between different functional units and the unification of their focus to the objectives of the organization.
Improved management of process interfaces.
33. What is meant by the “sequence” of processes and their "interactions"?
過程的“順序”和“相互作用”是指什么意思?
The "sequence" of processes shows how the processes follow, or link, to each other to result in a final output.
通過過程和過程的順序可以見到各個(gè)過程中每個(gè)過程相互之間的銜接，或者說連接，導(dǎo)致最后的輸出結(jié)果。
For example, the output from one process may become the input of the next process or processes.
舉例說，某一個(gè)過程的輸出可能是下一個(gè)過程，或者幾個(gè)過程的輸入。
The "interactions" show how each process affects or influences one or more of the other processes. For example, the monitoring or controlling of a process may be established in a separate process.
“相互作用”是表示每個(gè)過程是如何影響或者讓其他一個(gè)或者幾個(gè)過程產(chǎn)生結(jié)果的。舉例說，對(duì)某一過程的監(jiān)視或者控制活動(dòng)可能是靠另外一個(gè)過程來執(zhí)行的。
34.How can the processes in an organization be determined?
如何確定組織中各種過程?
Identify the organization’s intended outputs, and the processes needed for achieving them. These will need to include processes for Management, Resources, Realization and Measurement and Improvement.
先認(rèn)定組織有哪些意向的輸出，為了得到這些輸出，必須要有哪些過程。這些過程中有可能包括管理過程、資源過程、產(chǎn)品實(shí)現(xiàn)過程和測(cè)量和改進(jìn)過程。
Identify all process inputs and outputs, along with the suppliers and customers, who may be internal or external.
Identify the sequence and interactions of the processes.
識(shí)別所有過程的輸入是什么，輸出是什么，同時(shí)識(shí)別各個(gè)供方和顧客，可能是內(nèi)部和或者外部的。
35.Should an organization define and document all its processes?
組織是否應(yīng)當(dāng)定義所有的過程，并且加以文件化?
The main purpose of documentation is to enable the consistent and stable operation of an organization’s processes.
文件化的主要目的是確保組織中各個(gè)過程能穩(wěn)定的操作，而且確保一致性
Although statutory, standards’ or customer requirements may require certain documentation, there is no defined “catalogue”, or list of processes that has to be documented in ISO 9001, apart from the 6 indicated ones.
盡管法令、標(biāo)準(zhǔn)、或者顧客的各種要求有可能要有某些文件。但是，ISO 9001標(biāo)準(zhǔn)中，除了指定有六個(gè)必須文件化的以外，沒有規(guī)定，哪“類”過程，或者哪些清單中的過程必須形成文件。
The organization should determine which processes are to be documented on the basis of:
組織應(yīng)當(dāng)自己根據(jù)以下方面來確定哪些過程必須文件化：
The size of the organization and type of its activities, 組織的規(guī)模以及他們作業(yè)的類型。
The complexity of its processes and their interactions,他們過程的復(fù)雜性以及這些過程的相互作用。
The criticality of the processes and 這些過程的重要性，以及
Availability of competent personnel.作具有勝任能力人員的可獲得情況
A number of different methods can be used to document processes, such as graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods.
可以采用很多種不同的方法來對(duì)過程加以文件化，諸如，用圖形來表示、書寫作業(yè)指導(dǎo)書、檢查單、流程圖、目視媒介，或者電子方式。
36.How much detail is required in process documentation?
過程文件化的詳細(xì)程度有什么要求?
The extent of detail is likely to depend upon factors such as:
詳細(xì)的程度可能取決于以下各個(gè)因素，諸如：
the size of an organisation and its types of activities, 組織的規(guī)模以及他們作業(yè)的類型。
the complexity of its processes and their interactions, and 他們過程的復(fù)雜性以及這些過程的相互作用。
the competence (level of education, training, skills and experience) of its personnel.他們的員工在(教育文化程度、培訓(xùn)、各種技能和經(jīng)驗(yàn))決定的勝任能力。
37. Is there a standard way of describing a process?
描述過程的途徑，是否有標(biāo)準(zhǔn)的方法?
No, there is no standard way to describe a process. It depends on the culture, management style, staff literacy, personal attributes and their interactions.
沒有標(biāo)準(zhǔn)的描述過程的方法。這取決于文化、管理的風(fēng)格、工作人員的寫讀能力、人員的歸屬和他們的相互作用。
A process may be described using a flow chart, block diagram, responsibility matrix, written procedures or pictures.
也許可以用流程圖、方框圖、職責(zé)矩陣、書面的程序或圖形來描述。
Process flowcharts or block diagrams can show how policies, objectives, influential factors, job functions, activities, material, equipment, resources, information, people and decision making interact and/or interrelate in a logical order.
各種流程圖或者方框圖可以從邏輯順序來說明方針、目標(biāo)、各種影響因素、崗位職能、各種作業(yè)、材料、設(shè)備、資源、信息、人員和做決定的相互作用和/或者相互關(guān)系。
38.What should an organization do to adopt the "process approach"?
采用“過程模式”的組織應(yīng)當(dāng)做什么?
To adopt the "process approach" an organization should apply the following steps:
采用“過程模式”的組織應(yīng)當(dāng)應(yīng)用如下各個(gè)步驟：
Identify the processes of the organization, 確定組織的各個(gè)過程。
Plan the processes, 對(duì)這些過程加以策劃。
Implement and measure the processes,執(zhí)行和測(cè)量這些過程。
Analyse the processes, 分析這些過程。
Improve the processes.改進(jìn)這些過程。
39. What is a "process owner"?
什么叫過程主管?
A person who is given the responsibility and authority for managing a particular process is sometimes referred to as the "process owner".
It may be useful for an organization’s Management to appoint individual "process owners" and to define their roles and responsibilities; these should include the responsibility for ensuring the implementation, maintenance and improvement of their specific process and its interactions.
It should be noted, however, that ISO 9001:2008 does not specifically require the appointment of "process owners".
40.How can a process be measured?
過程如何加以測(cè)量的?
There are various methods of measuring process controls and process performance, ranging from simple monitoring systems up to sophisticated statistically based systems (e.g. statistical process control, or SPC, systems). The selection and use of any particular method will be dependent on the nature and complexity of an organization’s processes and products. The effectiveness of an individual process may be measured by the conformity of its output or product to customer requirements. Its efficiency may be measured from its use of resources. In all cases the measurement of the process determines if its (measurable) objectives have been achieved. Sometimes it only requires monitoring to confirm process operations.
對(duì)過程各種控制和過程性能的測(cè)量有各種各樣的方法，從簡(jiǎn)單的對(duì)系統(tǒng)進(jìn)行監(jiān)視到復(fù)雜的統(tǒng)計(jì)為基礎(chǔ)的各種系統(tǒng)(也就是統(tǒng)計(jì)過程控制，或者叫SPC、系統(tǒng)的)。針對(duì)某特定方法的選擇和應(yīng)用取決于組織的過程和產(chǎn)品的本質(zhì)和復(fù)雜性。針對(duì)某個(gè)過程，可以通過對(duì)過程輸出的符合性，或者產(chǎn)品相對(duì)顧客各項(xiàng)要求的符合性的來測(cè)量它的有效性。在所有的情況下，通過過程的測(cè)量來確定過程的(可測(cè)量的)目標(biāo)已經(jīng)達(dá)到。有時(shí)候，只要求對(duì)過程加以監(jiān)視，符合過程的操作要求就可以了。
Typical factors that are useful to consider when identifying measures of process control and process performance include:
當(dāng)識(shí)別過程控制的測(cè)量以及過程性能測(cè)量的時(shí)候，考慮以下這些典型的因素是很有用的：
Conformity with requirements, 對(duì)要求的符合性。
Customer satisfaction, 顧客滿意。
Supplier performance, 供方的業(yè)績(jī)
On time delivery, 及時(shí)交付
Lead times, 預(yù)定時(shí)間
Failure rates, 失效率
Waste, 廢品率
Process costs.過程各種成本
Incident frequency 事故發(fā)生頻率
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