《ISO/TC176 SC2 外包过程指南（译文）》“识别”和“控制”外包过程的指南

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1)Introduction
绪论

The aim of this document is to provide guidance on the intent of ISO 9001:2000 clause 4.1, regarding the control of outsourced processes.
' L1 a% R9 A9 x4 k1 y2 F本文目的是为ISO9001：2000条款4.1关于外包过程控制条款提供一个指南。

ISO 9001:2000 clause 4.1 states:
“Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes.  Control of such outsourced processes shall be identified within the quality management system.”
$ z6 `* N+ i$ b% U& y" BISO9001：2000 4.1条款规定：
! _  b+ X: z5 W1 S) J4 e针对组织所选择的任何影响产品符合要求的外包过程，组织应确保控制这些过程，对这些外包过程的控制应在质量管理体系中进行识别。

2) Guidance
指南
2.1) What is an “outsourced process”?
  \+ }* h& \8 w  G: y什么是外包过程？
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”
5 z) v* L- b0 T& d: A牛津英语辞典定义了动词“outsource” “外包”意思是：“牛津英语字典定义动词为“用组织或区域外源合同。。。获得签约”

Within the context of ISO 9001:2000 an “outsourced process” is a process that the organization has identified as being needed for its quality management system, but one which it has chosen to be carried out by an external party.
ISO9001：2000条文里的“outsourced process”是一个被组织识别为他的质量管理体系中所必要的过程，只是选择由外部机构来完成。

Note: ISO 9000:2000 clause 3.4.1 defines “process” as “set of interrelated or interacting activities which transforms inputs into outputs”.
8 h) b: _( o9 O  _; p/ v注：ISO9000：2000 3.4.1条款定义“过程”为“把输入转化为输出的一组相互关系和相互作用的活动”。

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.
一个外包过程可以被一个更确切的说是相对组织来说完全独立的供应商来履行，或相同母组织的其他部分（例如：单独的部门或子公司，换句话说就是没有执行同一个质量体系）。它的提供场所可以是组织的实物场所或者某个工作环境，例如某个独立的处所或者任何其他方式。

2.2) Intent of Clause 4.1
条款4.1的目的

The intent of Clause 4.1 of ISO 9001:2000 is to emphasize that when an organization chooses to outsource (either permanently or temporarily) a process that affects product conformity with requirements (see ISO 9001:2000 clause 7.2.1), it can not simply ignore this process, nor exclude it from the quality management system.
ISO9001：2000条款4.1的目的是强调档一个组织选择外包（长期的或临时的）一个影响产品符合要求（见ISO9001：2000条款7.2.1）的过程时，不能忽视这个过程，也不能把他排斥在质量管理体系之外。
9 j& }' M0 p2 |# _: l% T2 cThe organization has to demonstrate that it exercises sufficient control to ensure that this process is performed according to the relevant requirements of ISO 9001:2000, and any other requirements of the organization’s quality management system. The nature of this control will depend, among other things, on the importance of the outsourced process, the risk involved, and the competence of the supplier to meet the process requirements.
组织必须证明它对这个过程履行ISO9001：2000相关条款和组织质量管理体系的其它要求发挥了充分的控制。控制的方式取决于其他的事情，例如外包过程的重要性，有关的风险以及预防符合过程要求的能力。
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 9001:2000 clause 4.1 (a) and (b)).
. F8 t8 e1 W1 |8 v外包过程要与组织质量管理体系的其它过程相符合（这里的其它过程可以被组织自行完成或者是外包过程），它们的相互作用也一样被管理。（见ISO9001：2000 条款4.1（a）和（b）。

2.3 Control of outsourced processes
外包过程的控制

2.3.1) The acquisition of outsourced processes will normally be subject to the requirements of both ISO 9001:2000 clause 7.4 (Purchasing) and clause 4.1 (General Requirements)
外包过程的获得通常将会是即受ISO9001：2000条款7.4（采购）也受条款4.1（总要求）的支配。

NOTE: In some situations, the organization might not “purchase” the outsourced process in the traditional sense. As mentioned in 2.1 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. Under these circumstances, however, ISO 9001:2000 Clauses 7.4 and 4.1 are still applicable.
注：某些情况，组织可能不按照传统理解去“采购”外包过程，正如上文2.1所提及的他可能会，例如说：从总公司或集团的其它分公司接受服务，这其中并没有任何的现金业务发生，在这些情况下，无论如何，ISO9001：2000条款7.4和4.1仍然适用。

2.3.2) There are two situations that frequently need to be considered when deciding the appropriate level of control of an outsourced process:
0 W- |1 K2 c2 c, t+ p1 x7 |8 V以下两种情况需要经常地考虑决定外包过程的恰当的控制等级

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).

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.

当一个组织有能力和力量进行一个过程，但选择外包这个过程（出于商业或其它考虑）。这种情况下，过程控制标准应该已经被定义，在必要的时候可以转换成对供方外包过程的要求。

b) When the organization does not have the competence to carry out the process itself, and chooses to outsource it.

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.
当组织没有能力去自行进行这个过程并且选择把它外包。

在这种情况下，组织应确保外包过程的供应商提出的控制（措施）是足够。某些情况下，可能还必须让外部专家对涉及的这一过程评价

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.  Care should be taken, however, not to inhibit the supplier from proposing innovations to the outsourced process.
   在组织和供应商的合同中去定义一些或者全部的方法用来控制外包过程是比较方便的，甚至是必须的。应注意，不管怎样，都不要遏制供应商对于改善外包过程的计划。

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 9001:2000 clause 7.5.2.
   在某些情况下可能无法通过后续监测或测量去验证外包过程的输出。在这些情况下，组织需要确保对外包过程进行控制包括了按照 ISO 9001:2000 条 7.5.2 要求对过程进行验证（确认）。

wxsunhao

学习了

一剑封喉

ISO 9001:2000

善学分子

good , and i have learnt a lot although there is some difference in requirements between ISO9001, 2000 and ISO 9001,2008

Henry.y

不管是2000版本还是2008版本其精髓是一样的。值得学习。

pcq

学习{:soso_e181:}