TA的首页Guidance on 'Outsourced Processes'“外包過程指導”（轉載）
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.本文的目的是針對標準ISO 9001:2008第4.1條中有關外包程序控制的意圖提供指導。ISO 9001:2008 clause 4.1 states: 標準第4.1條要求：“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.凡是組織所選擇外包的任何影響產品符合性要求的過程，組織應確保對這些外包過程實施控制。對此類外包過程實施的控制類型和程度應在品質管制體系中加以定義。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：上述品質管制體系所需的過程包括管理活動、資源提供、產品實現、測量、分析和改進過程。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： “外包過程”是組織品質管制體系所必需的，而組織選擇由外部合夥者來執行的過程。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：確保對外包過程的控制不能免除組織對所有顧客、法令和法規要求符合性的責任。對外包過程所使用的控制類型和程度有可能受到如下因素的影響：a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements;a）外包過程對組織提供符合各項要求產品能力的潛在的影響；b) the degree to which the control for the process is shared;b）為了對過程進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）通過7.4條應用來達到必要的控制能力。2) Guidance 指導2.1) What is an “outsourced process”?什麼是“外包過程（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” 牛津英文字典對“外包”動詞的解釋是：“通過簽訂合同，從組織或者區域以外的來源獲得……；把工作通過合同包出去。”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.現在正如標準ISO 9001:2008第4.1條注2 中所說，“外包過程”是指對組織的品質管制體系來說必需要有的，但是，組織選擇由某一個外部的當事人來執行的過程。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標準第3.4.1條對“過程”的定義是，“一組將輸入轉化為輸出的相互關聯或相互作用的活動”。 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.一個外包過程可能由完全獨立於組織的供方執行，或者由同一母體組織中的某一部分組織（例如，不屬於同一個品質管制體系中的某一個分開的部門或者事業部）執行的。這個供方在物理場所，或者工作環境來說，可以就在組織內部，也可以是獨立的場地，或者其他某種方式。2.2) Intent of Clause 4.1標準第4.1條的意圖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標準第4.1條的意圖是強調，當組織選定把某一個過程，這個過程對產品品質要求（見ISO 9001:2008標準第7.2.1條）的符合性是有影響的，外包出去（不管是長久的還是臨時的），那就不能簡單忽視這個過程，也不能把這個過程從品質管制體系中加以剪裁掉。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. 組織不得不展示他們實施了充分的控制，確保這個過程是按照ISO 9001:2008標準有關要求，以及品質管制體系提出的其他任何要求在執行的。這個控制的性質要根據外包過程的重要性，所包含的風險，以及供方能否滿足過程各項要求的勝任能力來確定。 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.根據控制的性質，應當考慮到品質管制體系中對管理活動、資源提供、產品實現和測量、分析和改進有關的各個過程。接受外包過程的組織沒有必要一定要通過品質管制體系的認證，但是，他們必須能展示具有前面所提到的各個過程的能力。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)). 各種外包過程會和組織自己品質管制體系中的其他過程（這些其他過程可能是組織自己執行的，也可能本身也是外包的）發生相互的作用，這些過程的相互作用也必需加以管理（見ISO 9001:2008標準第4.1條a和b款）。2.3 Control of outsourced processes對外包過程的控制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) 外包過程的獲得，通常要同時通過ISO 9001:2008標準第7.4條《採購》和第4.1條《品質管制體系總的要求》兩條要求的應用，主觀上具有能力來達到必要的控制。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.正如注中所說的，在某些情況下，組織所“採購”的有可能不是傳統意義的外包過程。也許是，譬如說，正如本文第2.1條提到的，可能從集團公司總部的辦公室，或者從集團組織中另外一個事業部得到服務，根本沒有發生什麼財務方面的交易。但是，在這樣的情況下， ISO9001：2008標準第7.4條和第4.1條仍然應該適用。2.3.2) There are two situations that frequently need to be considered when deciding the appropriate level of control of an outsourced process:
當對某一個外包過程確定採取什麼恰當的控制水準的時候，有兩種情況常常必須加以考慮：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). 如果組織具有勝任能力，也能執行某一過程，但是，（由於商務或者其他的原因）選擇作為外包過程。 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. 在這種情況下，對程序控制所用的判別準則按理應該已經定義好了。如果有必要的話，就能把它轉化成對承擔該外包過程的供方的要求。b) When the organization does not have the competence to carry out the process itself, and chooses to outsource it.如果組織自己沒有勝任能力來實施這個過程，因而選擇外包。
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.在這種情況下，組織不得不確保，由執行外包過程供方所提出的各種控制是充分的。在某些情況下，對供方執行評估的時候，也許有必要請外單位的專家參加。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. 在組織和供方之間簽訂的合同中，針對外包過程明確規定某些控制方法，或者規定所有要加以採用的控制方法，這樣做法也許是方便的，甚至是必要的。外包過程潛在的影響是根據外包提供符合各項要求產品的能力。但是，這時應當小心，不要妨礙供方對外包過程所提出的創新建議。The organization’s control of the outsourced process has to be based on the need for product conformity to requirements. 組織必須根據產品相對各項要求的符合性的需要建立對外包過程的控制。Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. 確保對外包過程的控制不能免除組織對顧客、法令和法規所有要求符合性的責任。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.在某些情況下，也許不可能通過監視或者測量來驗證外包過程的輸出結果。在這樣的情況下，組織必需確保，對外包過程的控制中必須包括對過程的確認，使其符合ISO9001：2008第7.5.2條要求。
當對某一個外包過程確定採取什麼恰當的控制水準的時候，有兩種情況常常必須加以考慮：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). 如果組織具有勝任能力，也能執行某一過程，但是，（由於商務或者其他的原因）選擇作為外包過程。 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. 在這種情況下，對程序控制所用的判別準則按理應該已經定義好了。如果有必要的話，就能把它轉化成對承擔該外包過程的供方的要求。b) When the organization does not have the competence to carry out the process itself, and chooses to outsource it.如果組織自己沒有勝任能力來實施這個過程，因而選擇外包。
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.在這種情況下，組織不得不確保，由執行外包過程供方所提出的各種控制是充分的。在某些情況下，對供方執行評估的時候，也許有必要請外單位的專家參加。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. 在組織和供方之間簽訂的合同中，針對外包過程明確規定某些控制方法，或者規定所有要加以採用的控制方法，這樣做法也許是方便的，甚至是必要的。外包過程潛在的影響是根據外包提供符合各項要求產品的能力。但是，這時應當小心，不要妨礙供方對外包過程所提出的創新建議。The organization’s control of the outsourced process has to be based on the need for product conformity to requirements. 組織必須根據產品相對各項要求的符合性的需要建立對外包過程的控制。Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. 確保對外包過程的控制不能免除組織對顧客、法令和法規所有要求符合性的責任。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.在某些情況下，也許不可能通過監視或者測量來驗證外包過程的輸出結果。在這樣的情況下，組織必需確保，對外包過程的控制中必須包括對過程的確認，使其符合ISO9001：2008第7.5.2條要求。
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