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发表于 2009-2-27 15:48
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本帖最后由 hnwang 于 2009-9-22 21:26 编辑
Secretariat of ISO/TC 176/SC 2 Date: 15 October 2008
国际标准化组织176委员会第2分委员会秘书处2008年10月15日
ISO 9000 Introduction and Support Package:
Guidance on 'Outsourced Processes'
、ISO 9000系列标准指导和支持文件包“外包过程的指导”
In conjunction with the publication of the International Standard ISO 9001:2008, ISO/TC 176/SC 2 has published a number of guidance modules:
配合ISO 9001：2008国际标准的发布，ISO/TC 176/SC 2 已经颁布了一系列指导文章如下：
Guidance on ISO 9001:2008 Sub-clause 1.2 'Application'1.2条”应用“的指导
Guidance on the Documentation requirements of ISO 9001:2008 文件化要求的指导
Guidance on the Terminology used in ISO 9001 and ISO 9004术语的使用的指导
Guidance on the Concept and Use of the Process Approach for management systems过程模式系统管理概念和应用的指导
Guidance on 'Outsourced Processes'“外包过程指导”
Together these are being made available as the ISO/TC 176/SC 2 ”ISO 9000 Introduction and Support Package”.现在已经可以获得这些指导和支持文件包。
Feedback from users of the standards will be used to determine whether additional modules should be developed, or if these published modules should be revised.根据使用者的反馈意见将决定是否需要另外编写文章，或者这些文章是否需要加以修改。
The modules, and further information on the ISO 9001:2008 standard, may be downloaded from the following web sites:
以上各种文章以及进一步的有关ISO 9001：2008标准的信息，可以从以下网站上下载：
www.iso.org
www.iso.org/tc176/sc2
C Corrie
For the BSI Secretariat of
ISO/TC 176/SC 2
1) Introduction引言
The aim of this document is to provide guidance on the intent of ISO 9001:2008 clause 4.1, regarding the control of outsourced processes.
本文的目的是针对标准ISO 9001:2008第4.1条中有关外包过程控制的意图提供指导。
ISO 9001:2008 clause 4.1 states: 标准第4.1条要求：
“Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
凡是组织所选择外包的任何影响产品符合性要求的过程，组织应确保对这些外包过程实施控制。对此类外包过程实施的控制类型和程度应在质量管理体系中加以定义。
NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.
注1：上述质量管理体系所需的过程包括管理活动、资源提供、产品实现、测量、分析和改进过程。
NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
注2： “外包过程”是组织质量管理体系所必需的，而组织选择由外部合伙者来执行的过程。
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process may be influenced by factors such as:
注3：确保对外包过程的控制不能免除组织对所有顾客、法令和法规要求符合性的责任。对外包过程所使用的控制类型和程度有可能受到如下因素的影响：
a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements;
a）外包过程对组织提供符合各项要求产品能力的潜在的影响；
b) the degree to which the control for the process is shared;
b）为了对过程进行控制的分享的程度；
c) the capability of achieving the necessary control through the application of clause 7.4.”
c）通过7.4条应用来达到必要的控制能力。
2) Guidance 指导
2.1) What is an “outsourced process”?
什么是“外包过程（outsourced process）”?
The Oxford English Dictionary defines the verb “outsource” as “to obtain….. by contract from a source outside the organization or area; to contract (work) out”
牛津英文字典对“外包”动词的解释是：“通过签订合同，从组织或者区域以外的来源获得……；把工作通过合同包出去。”
As now defined in ISO 9001:2008 Sub clause 4.1 NOTE 2, an “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
现在正如标准ISO 9001:2008第4.1条注2 中所说，“外包过程”是指对组织的质量管理体系来说必需要有的，但是，组织选择由某一个外部的当事人来执行的过程。
Note: ISO 9000:2005 clause 3.4.1 defines “process” as “set of interrelated or interacting activities which transforms inputs into outputs”.
注：ISO9000：2005标准第3.4.1条对“过程”的定义是，“一组将输入转化为输出的相互关联或相互作用的活动”。
An outsourced process can be performed by a supplier that is totally independent from the organization, or which is part of the same parent organization (e.g. a separate department or division that is not subject to the same quality management system). It may be provided within the physical premises or work environment of the organization, at an independent site, or in some other manner.
一个外包过程可能由完全独立于组织的供方执行，或者由同一母体组织中的某一部分组织（例如，不属于同一个质量管理体系中的某一个分开的部门或者事业部）执行的。这个供方在物理场所，或者工作环境来说，可以就在组织内部，也可以是独立的场地，或者其他某种方式。
2.2) Intent of Clause 4.1
标准第4.1条的意图
The intent of Clause 4.1 of ISO 9001:2008 is to emphasize that when an organization chooses to outsource (either permanently or temporarily) a process that affects product conformity with requirements (see ISO 9001:2008 clause 7.2.1), it can not simply ignore this process, nor exclude it from the quality management system.
ISO 9001:2008标准第4.1条的意图是强调，当组织选定把某一个过程，这个过程对产品质量要求（见ISO 9001:2008标准第7.2.1条）的符合性是有影响的，外包出去（不管是长久的还是临时的），那就不能简单忽视这个过程，也不能把这个过程从质量管理体系中加以剪裁掉。
The organization has to demonstrate that it exercises sufficient control to ensure that this process is performed according to the relevant requirements of ISO 9001:2008, and any other requirements of the organization’s quality management system. The nature of this control will depend on the importance of the outsourced process, the risk involved, and the competence of the supplier to meet the process requirements.
组织不得不展示他们实施了充分的控制，确保这个过程是按照ISO 9001:2008标准有关要求，以及质量管理体系提出的其他任何要求在执行的。这个控制的性质要根据外包过程的重要性，所包含的风险，以及供方能否满足过程各项要求的胜任能力来确定。
Based on the nature of the control, it should consider the processes referred to quality management system for management activities, provision of resources, product realization and measurement, analysis and improvement. The outsourced organization does not necessarily have to have a certified Quality Management System, but it has to demonstrate the capability of the previously mentioned processes.
根据控制的性质，应当考虑到质量管理体系中对管理活动、资源提供、产品实现和测量、分析和改进有关的各个过程。接受外包过程的组织没有必要一定要通过质量管理体系的认证，但是，他们必须能展示具有前面所提到的各个过程的能力。
Outsourced processes will interact with other processes from the organization's quality management system (these other processes may be carried out by the organization itself, or may themselves be outsourced processes). These interactions also need to be managed (see ISO 9001:2008 clause 4.1 (a) and (b)).
各种外包过程会和组织自己质量管理体系中的其他过程（这些其他过程可能是组织自己执行的，也可能本身也是外包的）发生相互的作用，这些过程的相互作用也必需加以管理（见ISO 9001:2008标准第4.1条a和b款）。
2.3 Control of outsourced processes
对外包过程的控制
2.3.1) The acquisition of outsourced processes will normally be subject to the capability of achieving the necessary control through the application of requirements of both ISO 9001:2008 clause 7.4 (Purchasing) and clause 4.1 (General Requirements)
外包过程的获得，通常要同时通过ISO 9001:2008标准第7.4条《采购》和第4.1条《质量管理体系总的要求》两条要求的应用，主观上具有能力来达到必要的控制。
As mentioned in the Note, in some situations, the organization might not “purchase” the outsourced process in the traditional sense; it might, for example, receive the service from a corporate head office or from another division within a group of organizations, without any monetary transaction taking place (see 2.1 above). Under these circumstances, however, ISO 9001:2008 Clauses 7.4 and 4.1 are still applicable.
正如注中所说的，在某些情况下，组织所“采购”的有可能不是传统意义的外包过程。也许是，譬如说，正如本文第2.1条提到的，可能从集团公司总部的办公室，或者从集团组织中另外一个事业部得到服务，根本没有发生什么财务方面的交易。但是，在这样的情况下， ISO9001：2008标准第7.4条和第4.1条仍然应该适用。
2.3.2) There are two situations that frequently need to be considered when deciding the appropriate level of control of an outsourced process:
当对某一个外包过程确定采取什么恰当的控制水平的时候，有两种情况常常必须加以考虑：
a) When an organization has the competence and ability to carry out a process, but chooses to outsource that process (for commercial or other reasons).
如果组织具有胜任能力，也能执行某一过程，但是，（由于商务或者其他的原因）选择作为外包过程。
In this situation the process control criteria should already have been defined, and can be transposed into requirements for the supplier of the outsourced process, if necessary.
在这种情况下，对过程控制所用的判别准则按理应该已经定义好了。如果有必要的话，就能把它转化成对承担该外包过程的供方的要求。
b) When the organization does not have the competence to carry out the process itself, and chooses to outsource it.
如果组织自己没有胜任能力来实施这个过程，因而选择外包。
In this situation the organization has to ensure that the controls proposed by the supplier of the outsourced process are adequate. In some cases it may be necessary to involve external specialists in making this evaluation.
在这种情况下，组织不得不确保，由执行外包过程供方所提出的各种控制是充分的。在某些情况下，对供方执行评估的时候，也许有必要请外单位的专家参加。
2.3.3) It may be convenient, or even necessary, to define some or all of the methods to be used for control of the outsourced processes in a contract between the organization and the supplier. The potential impact of the outsourced process is based on the outsourcing’s capability to provide product that conforms to requirements. Care should be taken, however, not to inhibit the supplier from proposing innovations to the outsourced process.
在组织和供方之间签订的合同中，针对外包过程明确规定某些控制方法，或者规定所有要加以采用的控制方法，这样做法也许是方便的，甚至是必要的。外包过程潜在的影响是根据外包提供符合各项要求产品的能力。但是，这时应当小心，不要妨碍供方对外包过程所提出的创新建议。
The organization’s control of the outsourced process has to be based on the need for product conformity to requirements.
组织必须根据产品相对各项要求的符合性的需要建立对外包过程的控制。
Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements.
确保对外包过程的控制不能免除组织对顾客、法令和法规所有要求符合性的责任。
2.3.4) In some situations it might not be possible to verify the output from the outsourced process by subsequent monitoring or measurement. In these cases, the organization needs to ensure that the control over the outsourced process includes process validation in accordance with ISO 9001:2008 clause 7.5.2.
在某些情况下，也许不可能通过监视或者测量来验证外包过程的输出结果。在这样的情况下，组织必需确保，对外包过程的控制中必须包括对过程的确认，使其符合ISO9001：2008第7.5.2条要求。
以上翻译，仅供参考。如有不对，欢迎指正。 |
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谢谢王老师提供的学习资料。
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