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ISO9001:2008 Quality Management System Requirement

(2010-07-25 10:37:20)
标签:

iso9001

gb/t19001

国际标准

质量管理体系

企业管理

财经

分类: 标准规范
                                                
FAQs on ISO 9001:2008 /常见问题的回答
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.
本常见问题的回答是由ISO/TC 176/SC2编写的,目的是为了支持:ISO 9001:2008的颁布和ISO 9004的修改。这些问题都是ISO 9000系列标准的使用者和专家们在各种讨论会议中以及全世界各地提出来的,
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.
这些常见问题的回答将会定期加以评审,确保其准确性,同时,会相应增加一些新的问题。其意图还想给一些新的标准使用者提供一些良好的信息资源。
For the latest version of the FAQs, reference should be made to the open access web site at www.iso.org/tc176/sc2.
最新版本的常见问题的回答可以从公开网站的下列网址得到。
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.
国际标准化组织(ISO)是1947年建立的,目前大约有157个成员组成的协会,每个成员代表一个国家。ISO 应用一个技术委员会系统,下面还有份委员会和工作组来开发国际标准。除了国家标准化组织外,ISO 还容许其他开发标准的各种国际组织,通过联络成员的身份参与工作。国际标准化组织按照一系列协商一致的程序规则进行工作的,其中包括ISO/IEC 指令有关提出各种标准的各项要求。
2.    Who are the National Standards Bodies, and who represents my country at ISO?
谁是我们国家的标准化组织代表国家参加ISO?
Please see the relevant page on ISO Online that gives details, including contact information, of the National Standards Bodies.
有关谁代表您们国家参加国际标准化组织的问题,请查阅国际标准化组织网站,在那里您能得到详细的信息,包括您们国家标准化组织的名称和谁接触的信息。
3.    What are the ISO 9000 standards ? 什么是ISO 9000系列标准?
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? 谁负责开发ISO 9000系列标准?
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? 我可以从哪里得到标准的文件?
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 ?
从哪里可以得到支持ISO9000 标准的指导文件或者其他有关文件?
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?
从哪里可以得到有关ISO9000系列标准信息?
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?
为什么ISO9000系列标准在不断修改的?
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?
谁负责修改ISO9000 系列标准的?
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?
什么时候能得到修改好的标准?
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已经在2005年修改好了。估计2009年不会有大的修改了;
ISO 90001:2008已经修改好11月15日出版了。只是做一些小的补充修改而已;
ISO 9004有大的变动,预期2009年出版。
11.    How much is the implementation of the new standard going to cost?
贯彻新版标准将会花去多少费用?
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.
在开发ISO 90001:2008标准的时候有一个关键因素就是要限制更改对标准使用者带来的影响。
12.    Where can I obtain information on the revised standards?
我从哪里可以得到有关修改好标准的信息?
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.
可以从ISO 的网站分类中得到有关标准修改一般的信息;
从您们国家的标准化组织那里可以得到一些附加的信息;
认证机构到时候会指导您如何过渡的具体安排?
13.    Where can my organization go if it needs additional clarification or interpretation of the ISO 9001:2008 standard?
如果我想了解更加详细的有关ISO9001:2008标准的说明和诠释的话,我应当找谁?
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/.
任何个人对标准的理解有问题应当向国家的标准化机构咨询。ISO秘书处和ISO/TC176委员会的SC2工作组不会接受个人提出的有关ISO 9000系列标准的任何问题。ISO/TC176委员会有一个工作组只接受您们国家标准化组织用统一表单提出的问题。统一作出解答,公布在下列网站上: http://www.tc176.org/.
14.    Will my organization need a full reassessment once the revised standards are available?
当修改后标准颁布后,我们是否必须对自己的体系重新做一次审核?
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.
这是您们和认证机构之间的一个基本问题。ISO和IAF(国际认可论坛)已经协商一致,公布了一个过渡时间的公报?ISO/CASCO负责编写认证工作标准(ISO/IEC 17021),认可机构负责监视和批准该认可机构管辖范围内的认证机构来执行。
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.
希望认证机构能结合定期的监督审核来评估对新版标准ISO9001:2008的符合性,只有当现有证书到期换证审核的时候,会做全面的重新评估。但是,要注意到,ISO和IAF的过渡公报中规定,ISO9001:2008颁布后24个月以内ISO 9001:2000版证书必须升版。
15.    Will the revised standards be available in my national language immediately after they are published by ISO?
我们国家语言的修改后标准是否能马上得到?
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.
全世界各个国家的专家都积极参加标准修改,国际标准化组织的起草标准的工作委员会会帮助把国际标准很快翻译过渡的。
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.
鉴于质量管理体系系列标准对全世界的重要性,很多国家标准化组织已经开始在做翻译工作了。国际标准化组织只颁布英文和法文版本,如果您们从您们国家标准化组织那里已经得到您们国家文字的标准的话,我们希望这个翻译本只能同时或者等ISO标准正式颁布后尽快颁布。
For further details contact your National Standards Body.
更具体的情况请和您们国家标准化组织联系。
16.    Will my organization have to re-write all its documentation?
我们的体系文件必须重新写吗?
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相对2000版对体系的要求没有引进大的变更。但是,利用这次变更我们建议您们取得新版标准,看看有哪些问题得到澄清了。通过分析,如果发现您们现在对2000版标准的理解和ISO9001:2008澄清的有所不同,那么,就要分析一下对您们现在的文件有没有影响,如果有影响,那么做一个必要的安排,把文件修改一下。标准修订的时候,其意图将会对文件有少量或者没有任何影响。
17.    Will the revised standards address financial issues?
修改后的标准是否会涉及到财务问题?
Financial issues are not addressed in ISO 9001:2008, which is a requirements standard.
有关财务的各种问题不包括在ISO9001:2008标准中,标准只提出要求。
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.
标准ISO 100014:2006和ISO9004:2000质量管理体系改进的指导标准这两份国际标准强调执行和改进质量管理体系所必要的各种财务资源。
18.    What are the benefits of the revised standards?
标准修改会带来什么好处?
For ISO 9001:2008 the major benefits are:
对ISO9001:2008,主要的好处是:
Simple to use 使用简单
Clear in language 语言简洁
Readily translatable and easily understandable 容易翻译和理解
Compatibility with other management systems such as ISO 14001.和其他管理体系兼容,譬如和 ISO 14001环境管理体系兼容
For ISO 9004:
对ISO9004主要的好处是:
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系列标准使用者改进他们的质量管理体系。
指导组织创建一个符合下列要求的质量管理体系:
= 通过向他们的顾客提供各种产品,为他们的顾客创造价值;
= 为其他利益相关方创造价值;
= 平衡各个利益相关方的各种观点。
指导管理者如何领导组织向着维持成功。
让各个组织在现有质量管理体系的基础上向着和谐前进。
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标准主要是对现有ISO9001:2000标准做一些解释,有些更改只是为了改进和ISO 14001:2004的兼容。ISO9001:2008没有提出新的要求,也没有改变ISO9001:2000标准的意图。
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
相对ISO9001:2008不是一个“升版”的问题,已经通过ISO9001:2000认证的组织和通过新版ISO9001:2008认证是等同效果的。
All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B to ISO 9001:2008.
ISO9001:2008相对ISO9001:2000有哪些详细的变更,可以参考ISO9001:2008的附录B。
20.    What are the main benefits to be derived from implementing an ISO 9000 quality management system?
贯彻执行ISO9000系列标准将会带来什么主要的好处?
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.
贯彻执行ISO9000系列标准能给组织提高他们作业的价值的机会,让他们关注主要的各种过程,可以持续改进他们的工作业绩。这个系列特别标准强调让质量管理体系关注组织的各个过程,并且持续改进这些过程。这样做的结果,会让采用这些标准的组织取得商务上的成就,其中包括,让各类顾客和其他各个利益相关方的满意。
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.
组织的管理者应看到,采用质量管理体系各种标准是一种能为他们取得回报的商务投资,而不仅仅是为了取得一份证书而已。
Among the perceived benefits of using the standards are:
贯彻执行ISO9000系列标准能取得好处是:
The connection of quality management systems to organizational processes 把各个质量管理体系和组织的各个过程联系起来了
The encouragement of a natural progression towards improved organizational performance, via: 通过以下方式促使组织自然向着持续改进业绩的方向前进:
- the use of the Quality Management Principles采用质量管理八个原则
- the adoption of a "process approach"采用“过程模式”系统管理
- emphasis of the role of top management强调最高管理者的作用
- requirements for the establishment of measurable objectives at relevant functions and levels各个相关职能和层次建立可测量的目标的要求
- being orientated toward "continual improvement" and "customer satisfaction", including the monitoring of information on "customer satisfaction" as a measure of system performance.坚持“持续改进”和“顾客满意”的方向,包括把监视“顾客满意”的信息作为对体系性能的一种测量方法
- measurement of the quality management system, processes, and product使对质量管理体系、各个过程和产品的测量
- consideration of statutory and regulatory requirements.对法令和法规各项要求的考虑
- attention to resource availability关注资源的可获得性
21.    How will the implementation of the amended standard help my organization to improve its efficiency?
组织如何利用贯彻修改后标准来帮助提高我们的效率?
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的目的是确保组织的有效性(而效率不是必须)。至于改进组织的效率,最好是利用在贯彻ISO9001:2008标准的同时,贯彻标准ISO9004:2000。贯彻执行质量管理八个原则就是为了帮助组织持续改进的,它将使整个组织引向效率的提高。
22.    What benefits are there to an organization implementing ISO 9004 ?
组织贯彻执行ISO9004:2000将会带来什么好处?
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:
假如组织组的质量管理体系中恰当地贯彻质量管理八原则,同时又用ISO9004,将会使整个组织的各个利益相关方得益。例如:
Customers and users will benefit by receiving the products (see ISO 9000:2005, Fundamentals and vocabulary) that are:
顾客和产品使用者通过接受产品而得到好处:(有关术语见ISO9000:2005)
Conforming to the requirements 符合各项要求;
Dependable and reliable 可信性和可靠性
Available when needed 需要时就能得到(可用性)
Maintainable 可维护性
People in the organization will benefit by:
组织的员工将得到好处:
Better working conditions 更好的工作环境
Increased job satisfaction 提高工作的满意度
Improved health and safety改进健康和安全
Improved morale 提高士气
Improved stability of employment 提高员工的稳定性
Owners and investors will benefit by:
老板和投资者将得到好处:
Increased return on investment 提高投资回报率
Improved operational results 提高营运结果
Increased market share 提高市场份额
Increased profits 提高利润率
Suppliers and partners will benefit by:
供方和合伙者将得到好处:
Stability 稳定性
Growth 成长率
Partnership and mutual understanding 合作和双方的理解
Society will benefit by:
社会将得到好处:
Fulfilment of legal and regulatory requirements法令和法规得到贯彻
Improved health and safety 提高健康和安全
Reduced environmental impact 降低对环境的影响
Increased security  提高治安
23.    Are the standards compatible with national quality award criteria?
系列标准是否和国家质量奖的准则兼容?
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:
系列标准在质量管理八原则基础上提出来的,这些原则和大多数质量奖的哲理和目标是一致的。这八个原则是:
Customer focus, 顾客为中心
Leadership, 领导
Involvement of people, 员工参与
Process approach, 过程模式
System approach to management,系统管理
Continual improvement, 持续改进
Factual approach to decision making, and根据事实做决定 ,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.
对环ISO9004要求组织执行自我评估作为他们的质量管理体系体系以及各个过程中的一部分,标准还包括附录来指导如何进行自我评估。这是和很多质量奖方案的做法是类似的。
24.    Why is the requirement for monitoring "customer satisfaction" included in ISO 9001?
为什么ISO9001标准要规定对“顾客满意”的监视要求?
"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.
“顾客满意”是任何组织为了评估他们的产品是否满足顾客需求和期望而推导出来的一种判别准则。它对监视顾客满意程度来说是必须要有的。对这方面的改进可以针对任何已经识别出来的问题或者关注点来采取措施。
25.    Can the standards improve "customer satisfaction"?
这些系列标准能改进“顾客满意”吗?
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.
系列标准中所描写的质量管理体系细节要求都是根据质量管理八个原则提出来的,其中包括“过程模式”和“顾客关注点”这两个原则。采用这些管理原则应当向顾客提供较高水平的信心,使人相信他们提供的产品将满足他们的需求,提高他们的满意。
26.    What is meant by "continual improvement"?
“持续改进”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.
“持续改进”是关注持续提高组织的有效性和/或效率以便实现组织的方针和目标的工作过程。持续改进(中的“持续”强调改进过程要求有积极进取的一步一步的考虑)是针对容易提高的顾客需求和期望以及为了确保对质量管理体系有一动态的进化。
27.    What is a process?
什么是过程?
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"?
什么是过程模式?
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?
其他管理体系可以采用过程模式吗?
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。“过程模式”是通用的管理原则,组织利用它可以在达到规定目标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“过程模式”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"?
是否任何组织都可以采用“过程模式”?
Yes. Many organizations already apply a "process approach" without recognizing it. They could achieve additional benefits by understanding and controlling it. 
是的。很多组织虽然自己还不知道,实际上已经采用了“过程模式”。如果他们理解了而且对这些过程加以控制好的话,还能得到更多的好处。
32.    Why should an organization apply the "process approach"?
为什么组织应当采用“过程模式”?
By applying the "process approach" an organization should be able to obtain the following types of benefits:
组织采用“过程模式”应当能获得下列类型的好处:
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"?
过程的“顺序”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.
通过过程和过程的顺序可以见到各个过程中每个过程相互之间的衔接,或者说连接,导致最后的输出结果。
For example, the output from one process may become the input of the next process or processes.
举例说,某一个过程的输出可能是下一个过程,或者几个过程的输入。
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”是表示每个过程是如何影响或者让其他一个或者几个过程产生结果的。举例说,对某一过程的监视或者控制活动可能是靠另外一个过程来执行的。
34.    How can the processes in an organization be determined?
如何确定组织中各种过程?
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.
先认定组织有哪些意向的输出,为了得到这些输出,必须要有哪些过程。这些过程中有可能包括管理过程、资源过程、产品实现过程和测量和改进过程。
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.
识别所有过程的输入是什么,输出是什么,同时识别各个供方和顾客,可能是内部和或者外部的。
35.    Should an organization define and document all its processes?
组织是否应当定义所有的过程,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确保组织中各个过程能稳定的操作,而且确保一致性
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.
尽管法令、标准、或者顾客的各种要求有可能要有某些文件。但是,ISO 9001标准中,除了指定有六个必须文件化的以外,没有规定,哪“类”过程,或者哪些清单中的过程必须形成文件。
The organization should determine which processes are to be documented on the basis of: 
组织应当自己根据以下方面来确定哪些过程必须文件化:
The size of the organization and type of its activities, 组织的规模以及他们作业的类型。
The complexity of its processes and their interactions,他们过程的复杂性以及这些过程的相互作用。
The criticality of the processes and 这些过程的重要性,以及
Availability of competent personnel.作具有胜任能力人员的可获得情况
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.
可以采用很多种不同的方法来对过程加以文件化,诸如,用图形来表示、书写作业指导书、检查单、流程图、目视媒介,或者电子方式。
36.    How much detail is required in process documentation?
过程文件化的详细程度有什么要求?
The extent of detail is likely to depend upon factors such as:
详细的程度可能取决于以下各个因素,诸如:
the size of an organisation and its types of activities, 组织的规模以及他们作业的类型。
the complexity of its processes and their interactions, and 他们过程的复杂性以及这些过程的相互作用。
the competence (level of education, training, skills and experience) of its personnel.他们的员工在(教育文化程度、培训、各种技能和经验)决定的胜任能力。
37.     Is there a standard way of describing a process?
描述过程的途径,是否有标准的方法?
No, there is no standard way to describe a process. It depends on the culture, management style, staff literacy, personal attributes and their interactions.
没有标准的描述过程的方法。这取决于文化、管理的风格、工作人员的写读能力、人员的归属和他们的相互作用。
A process may be described using a flow chart, block diagram, responsibility matrix, written procedures or pictures.
也许可以用流程图、方框图、职责矩阵、书面的程序或图形来描述。
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.
各种流程图或者方框图可以从逻辑顺序来说明方针、目标、各种影响因素、岗位职能、各种作业、材料、设备、资源、信息、人员和做决定的相互作用和/或者相互关系。
38.    What should an organization do to adopt the "process approach"?
采用“过程模式”的组织应当做什么?
To adopt the "process approach" an organization should apply the following steps:
采用“过程模式”的组织应当应用如下各个步骤:
Identify the processes of the organization, 确定组织的各个过程。
Plan the processes, 对这些过程加以策划。
Implement and measure the processes,执行和测量这些过程。
Analyse the processes, 分析这些过程。
Improve the processes.改进这些过程。
39.    What is a "process owner"?
什么叫过程主管?
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?
过程如何加以测量的?
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.
对过程各种控制和过程性能的测量有各种各样的方法,从简单的对系统进行监视到复杂的统计为基础的各种系统(也就是统计过程控制,或者叫SPC、系统的)。针对某特定方法的选择和应用取决于组织的过程和产品的本质和复杂性。针对某个过程,可以通过对过程输出的符合性,或者产品相对顾客各项要求的符合性的来测量它的有效性。在所有的情况下,通过过程的测量来确定过程的(可测量的)目标已经达到。有时候,只要求对过程加以监视,符合过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: 
当识别过程控制的测量以及过程性能测量的时候,考虑以下这些典型的因素是很有用的:
Conformity with requirements, 对要求的符合性。
Customer satisfaction, 顾客满意。
Supplier performance, 供方的业绩
On time delivery, 及时交付
Lead times, 预定时间
Failure rates, 失效率
Waste, 废品率
Process costs.过程各种成本
Incident frequency 事故发生频率
 
ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement
ISO9001:2008 <wbr>Quality <wbr>Management <wbr>System <wbr>Requirement

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