ISOTC 176SC 2N 630R3 对“外包”的解释

Document: ISO/TC 176/SC 2/N 630R3

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Secretariat of ISO/TC 176/SC 2 Date: 15 October 2008



ISO 9000 Introduction and Support Package:
Guidance on 'Outsourced Processes'
ISO 9000介绍和支持包：外包过程指南

In conjunction with the publication of the International Standard ISO 9001:2008, ISO/TC 176/SC 2 has published a number of guidance 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'


Together these are being made available as the ISO/TC 176/SC 2 ”ISO 9000 Introduction and Support Package”.

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.

The modules, and further information on the ISO 9001:2008 standard, may be downloaded from the following web sites:

www.iso.org
www.iso.org/tc176/sc2


C Corrie
For the BSI Secretariat of
ISO/TC 176/SC 2


1) Introduction 介绍

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.
本文的目的是对ISO 9001:2008 4.1条款关于外包过程控制提供指南

ISO 9001:2008 clause 4.1 states:
ISO 9001:2008 4.1条款规定：
“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.针对组织所选择的任何影响产品符合要求的外包过程，组织应确保对其实施控制。对此类外包过程控制的类型和程度应在质量管理体系中加以规定。
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与管理活动、资源提供、产品实现和测量、分析和改进有关的过程。
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：外包过程是经组织识别为质量管理体系所需的，但选择由组织的外部方实施的过程。
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并不免除组织满足顾客和法律法规要求的责任。对外包过程控制的类型和程度可受下列因素影响：
a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements; 外包过程对组织提供满足要求的产品的能力的潜在影响；
b) the degree to which the control for the process is shared; 对外包过程控制的分担程度；
c) the capability of achieving the necessary control through the application of clause 7.4.” 通过应用7.4 条款实现所需控制的能力。

2) Guidance 指南

2.1) What is an “outsourced process”? 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” 牛津英语字典定义动词“外包”为“用组织或区域外源合同。。。获得；签约”
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ISO 9001:2008 4.1条款注2 规定“外包过程”是经组织识别为质量管理体系所需的，但选择由组织的外部方实施的过程。
Note: ISO 9000:2005 clause 3.4.1 defines “process” as “set of interrelated or interacting activities which transforms inputs into outputs”.
注：ISO 9000:2005 3.4.1条款规定“过程”为“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.
外包过程由供应商完成，供应商是完全独立于组织之外，或者具有相同母公司的一部分（即，不受相同质量管理体系制约的不同部门或公司）。外包过程可以在组织的房屋里或工作环境下，在独立现场，或以某种其他方式完成。

2.2) Intent of Clause 4.1 条款目的

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.
4.1条款的目的是强调但组织选择影响产品与要求（见ISO9001:2008 7.2.1条款）符合性的（临时的或永久性的）外包过程时，不能简单忽略该工程，更不能把它排除在质量管理体系之外。
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. 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.
组织得证明进行了足够的控制以保证该过程是按照ISO 9001:2008相关要求和组织质量管理体系其它要求运行的。控制程度依赖于外包过程的重要性，所及风险，以及供应商满足质量管理体系的能力。外包过程不需要进行质量管理体系的认证，但得证明上述过程的能力。
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)).
外包过程与组织质量管理体系内其它过程相互作用（这些其他过程由组织自己完成，或它们也可能是外包过程）。这些相互作用也需要管理（见ISO 9001:2008 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 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)
采购外包过程通常受通过执行7.4（采购）和4.1（总要求）要求所必要的控制能力的制约。
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.
如上注释所述，在某种情况下，组织可以不按传统意义上的方式“采购”外包过程；例如，组织可以接受公司总部或集团其它分公司的服务，而没有发生现金业务（见上面2.1）。但是，在此情况下，ISO 9001:2008 7.4和4.1条款仍然适应。
2.3.2) There are two situations that frequently need to be considered when deciding the appropriate level of control of an outsourced process:
在对外包过程选择控制程度时，需要经常考虑以下两种情形：
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). 当组织有能力执行过程，但选择了外包那个过程（处于商业或其他原因）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. 在此情况下，如果必要，该外包过程的控制准则应该已经规定好了，可以移植为对外包过程供应商的要求。

b) When the organization does not have the competence to carry out the process itself, and chooses to outsource it.但这种没有能力执行过程而选择外包。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.在此情况下，组织得保证外包过程供应商提出的控制是适宜的。在某些情况下，有必要让外部专家进行评价。

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. 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.
在组织与供应商的合同中规定所使用的外包过程控制的某些或全部方法，可能是方便的，或者甚至是必要的。外包过程的潜在影响取决于外包提供符合要求产品的能力。但应该注意，不要限制供应商对外包过程进行革新。
The organization’s control of the outsourced process has to be based on the need for product conformity to requirements.
组织对外包过程的控制是基于产品对要求符合性的需要的。
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并不免除组织满足顾客和法律法规要求的责任。
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，外包过程不能由后续的监视或测量加以验证。在此情况下，组织需要保证按照ISO9001:2008 7.5.2条款规定，对外包过程的控制包括过程验证