1、 對服務組織的審核指南 PAGE 22of NUMPAGES 22年修訂后的關于服務組織的審核指南International Organization for Standardization International Accreditation Forum Date: 5 June 2009日期：年月日ISO 9001 Auditing Practices GroupGuidance on:審核實踐組關于服務組織的審核指南Auditing service organizations1. Introduction引言Although ISO 9001 is intended to apply

2、to all kinds of organizations, regardless of type, size or product provided, there are a number of characteristics of service organizations that require specific attention during a third party audit.Consequently, this document aims to provide auditors with guidance on auditing the compliance of serv

3、ice organizations to the requirements of ISO 9001. Particular emphasis is given to the requirements of clause 7.3 Design and development, clause 7.5.2 Validation of processes for production and service provision and clause 8.3 Control of nonconforming product.盡管ISO9001標準的意圖可供所有類型的組織應用。不管什么類型、規模大小，或者

4、所提供的產品是什么。在這些組織中總會有某些服務組織的特性，這一點在進行第三方認證審核時，對這些服務特性的要求應當特別加以注意。于是，本文的目的是向審核員提供指導，如何對服務組織根據標準ISO9001進行符合性審核，特別要強調的是標準第7.3條設計和開發、第7.5.2條產生和服務提供過程的確認以及第8.3條不合格品的控制。2. Service Organizations服務組織According to ISO 9000, clause 3.4.2 Product: “Service is the result of at least one activity necessarily perfor

5、med at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following: an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired); an activity performed on a customer-supplied intangible

6、product (e.g. the income statement needed to prepare a tax return); the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); the creation of a pleasant ambience for the customer (e.g. in hotels and restaurants).”ISO 9000標準第3.4.2條對產品定義中有一個注2：“

7、服務通常是無形的，并且是在供方和顧客接觸面上至少需要完成一項活動的結果。服務的提供可涉及，例如：在顧客提供的有形產品（如維護的汽車）上所完成的活動；在顧客提供的無形產品（如為編寫稅款申報書所需的收益表）上所完成的活動；無形產品的交付（如知識傳授方面的信息提供）；為顧客創造氛圍（如在賓館和飯店中）。”Most organizations have an element of service in their product. This may range from almost 100% service (in the case of a law firm, for example), to a

8、 relatively small service component in the case of a manufacturing organization providing, for example, after-sales service.大多數組織在他們所提供的產品中具有服務的要素。這些服務要素所占的比重可以從100%（譬如律師事務所中）到在制造業組織中所提供的相對較小比例的服務，譬如售后服務。3. Auditing Guidance審核指南3.1 Design and development of the service服務的設計和開發When considering the ap

9、plicability or not of clause 7.3 of ISO 9001 to a service organization, it is important to remember the definition of “Design and development”, which, according to ISO 9000 clause 3.4.4 is the “set of processes that transforms requirements into specified characteristics”. Again, according to ISO 900

10、0 requirements are “needs and expectations that are stated, generally implied or obligatory”, and characteristics of the service are distinguishing features that can include: sensory (e.g. related to smell, touch, taste, sight, hearing) behavioral (e.g. courtesy, honesty, veracity) temporal (e.g. pu

11、nctuality, reliability, availability) ergonomic (e.g. physiological characteristic, or related to human safety) tangible (e.g. measurable characteristics; these may be eitherthe characteristics of the physical means used to deliver the service, e.g. the maximum speed of an aircraft, or of the enviro

12、nment in which the service is provided, e.g. the interior temperature or facilities of an aircraft).考慮某一個服務組織是否應該采用ISO9001標準第7.3條設計和開發這一條要求時，特別重要的是要記住ISO9000第3.4.4條對“設計和開發”所下的定義，“將要求轉換為產品、過程或者體系的規定的特性或規范的一組過程”。而其中的“要求”根據ISO9000標準的定義是“明示的、通常隱含的或者必須履行的需求或期望”。而服務的“特性”是指可區分的特征，這些特征可能包括：- 感官的（如，嗅覺、觸覺、味覺、

13、視覺、聽覺）- 行為的（如，禮貌、誠實、正直）- 時間的（如，準時性、可靠性、可用性）- 人體工效的（如，生理特性或者有關人身安全的特性）- 有形的（如，可測量的特性，這些特性也許是物理手段用來提供服務的，譬如飛機的速度，或者服務提供所處的環境，如飛機的內部溫度或者舒適性）It is quite common for organizations to consider only the tangible component of their product when addressing the requirements of clause 7.3, forgetting that the d

14、esign and development of the intangible product (the service itself) should be the main focus. Additionally, the organization will need to design how the service will be delivered to its customers.通常組織在考慮如何滿足標準第7.3條設計和開發 要求的時候，往往只考慮他們所提供產品的有形部分，往往忽視無形部分（服務本身）的設計和開發卻是主要的焦點所在。另外，組織還必須設計如何把這些服務提交給顧客。If

15、 the organization proposes to justify the exclusion of design and development from its QMS, the auditor should make a careful assessment of the justifications in light of the above. The auditor should also examine whether the organization has an effective design and development process that sufficie

16、ntly defines the characteristics of its service, and of its service delivery processes, that are needed to meet customer needs and expectations.假如組織判定他們的質量管理體系要把設計和開發要求裁剪掉的話，審核員應當仔細地評估他們的理由是否符合前面所提到的各個方面。審核員還應當檢查該組織是否具有有效的設計和開發過程，足以定義他們所提供的服務，以及服務的提供過程的各種特性，這些服務和服務的提供過程的特性必須滿足顧客的需求和期望。3.2 Validation

17、 of processes for production and service provision 產品和服務提供過程的確認In terms of the processes needed to realize the service, we can identify two types of service processes: those involving the customer in the realization of the service itself (real time delivery) and those in which the output is delivere

18、d to the customer after the realization of the process說到實現服務所必須的各種過程，我們可以把服務過程分為以下兩類：3.2.1在服務實現過程中涉及到顧客的（實時交付的服務過程），和3.2.2過程實現后再把過程的輸出提交給顧客的。Using the example of a hotel, the guest “check-in” and “check-out” processes would probably involve “real-time” delivery of the service, whilst the cleaning of

19、 the guests room would generally be “delivered” to the guest only after completion of the process (which could be subject to inspection and rework if necessary, to correct any nonconformities). 讓我們舉旅館服務的例子來說明，顧客進門和離開時所做的“登記”和“結帳”過程也許可以算是實時交付的服務過程，而對顧客所用房間的清理，一般算是后面一種，清理完成以后再“交付”給顧客使用的（對于后者，也許還可加以檢驗，

20、必要時還可加以返工，消除不符合要求的問題。Similar processes can also be found in manufacturing organizations providing services related to their products, for example, the handling of claims and warranties; the repair of products by the organizations service units; or product maintenance activities performed at a client

21、s facilities.在制造業組織中所提供的與他們產品有關的各種服務同樣可以發現以上類似的過程，譬如，對顧客的抱怨和要求索賠的處理過程；由組織的服務部門對產品進行修理的過程；或者，在顧客那里對產品所做的維護性服務過程。Those processes that involve real time delivery, and are carried out directly at the organization/customer interface can rarely (if ever) have their output (“the service”) verified by subse

22、quent monitoring or measurement before they are “delivered” to the customer. Therefore, such processes are indeed subject to validation according to the requirements of ISO 9001, clause 7.5.2. This is also essential in order to prevent nonconformities from occurring.有些過程，其中包括實時服務交付過程，是組織和顧客直接發生接觸的過程

23、，幾乎不可能（即使有也極少）對這個過程的輸出（服務）通過對過程結果監視或者測量好以后再“交付”給顧客的。因此，這樣的過程實際上是要根據標準ISO9001第7.5.2條要求加以確認的。其實質也就是為了預防不符合問題的發生。In order to ensure adequate control over the quality of the service to be provided, the auditor should:為了確保對將要提供的服務質量加以充分的控制，審核員應當：- understand the service characteristics, the service provi

24、sion processes, and their acceptance criteria, as defined by the organization (this should be done during the Stage 1 audit)理解服務的各種特性，理解服務提供過程，以及組織所定義的可接受的判別準則（這一點應當在審核的第一階段，也就是文件審核階段就完成了）。- determine whether validation of real-time service provision processes (or any other process that requires val

25、idation) has been performed and if this has taken into account the associated risks; 確定是否有需要對那些實時提供服務過程（或者其他任何需要做過程確認的）做過程確認，對這些過程有否做過過程確認。在做過程確認的時候有否考慮過有關的各種風險。- assess if the appropriate tools, training and empowerment have been provided to the personnel involved.評估是否向服務有關的人員提供了適當的工具，并且進行了培訓和授權。Fo

26、r many service industries, the service provided is instantaneous (i.e. via real- time processes), which does not readily allow for inspection before delivery of that service.Quality thinking says that the most cost-effective way of doing business is to apply the philosophy of “special processes” to

27、ALL processes: the more the organization gets its processes right, the less the organization needs to worry about the outcome of their processes.Therefore it is very unlikely that this clause can be excluded.對很多服務行業，服務的提供是屆時instantaneous進行的（也就是“實時real- time”的提供過程），不可能通過檢驗符合要求以后再提供的。從質量觀點來說，成本最有效的角度做

28、法，就是把所有過程都當作“特殊過程”處理的哲學思想。一個組織中根據這個原則處理的過程愈多，那么，愈少擔心他們的過程輸出會出什么問題。因此，看來標準這一條要求似乎很難加以刪減的。3.3 Control of nonconforming product不合格品的控制In the cases of service processes directly involving the customer, “the control of nonconforming product” (clause 8.3) is the way the organization deals with nonconformi

29、ties in the service provision until the appropriate corrective action is defined and implemented. 當服務提供過程中直接涉及到顧客的情況下，當服務提供過程發生不符合問題時就用標準第8.3條“不合格品的控制”來處理，一直要處理到明確規定了適當的糾正措施，而且糾正措施加以執行為止。Where a nonconformity is identified, the auditor should examine:凡是不符合問題加以確定了，審核員應當檢查以下內容： whether the personnel i

30、nvolved are sufficiently empoweredwith the authority to decide the disposition of the service, for example: 該服務涉及人員是否充分得到授權來決定服務問題的處置，譬如：- to immediately terminate the service立即終止服務- to replace the service provided更換所提供的服務- to offer an alternative 提供另外方式的服務 the organizations customer claims and comp

31、laints processes組織對顧客投訴和索賠的處理過程 any temporary corrections that are implemented to mitigate the effect of the nonconformity (e.g. refund, credit, upgrade, etc.)是否有臨時的糾正做法，減輕不符合問題所造成后果的影響（如，償還、承諾以后償還、用更高級的替換等） the identification, segregation and replacement of the relevant service equipment, service p

32、roviders and environment.識別出與不符合有關的服務設備、提供服務的人員和環境，及時采取隔離和更換措施。This will enable the auditor to judge whether the control of such nonconforming product is effective. 這將有助于審核人員判斷對不符合問題的控制是否有效。Note: In such situations the quality management system should have provisions to capture data on the nonconfor

33、mities and to feedback information, at the appropriate managementlevel,for the effective definition and implementation of corrective actions. 注：在這樣的情況下，質量管理體系應當在適當的管理層次具有各種方法和手段來收集有關不符合問題的數據資料，把信息反饋給相應的管理層次，以便他們有效地定義和執行糾正措施。For cases in which the output of the service is delivered after the realizat

34、ion of the process, “control of nonconforming product” may be based on usual monitoring and inspection techniques. Evidence will need to be sought of the adequacy and effective implementation of these techniques.對于讓過程實現以后再把過程的輸出提交給顧客的那一類服務過程，對“不符合問題的控制”可以采用通常采用的監視和檢驗技術。必須見到有客觀證據來證明這些監視和檢驗技術的充分性以及有效地

35、加以執行。以下摘譯自國際標準化組織網站資料 發布日期 2005年7月30日（供參考，如有不對，請指正。從這份資料可以看到如何對待第7.5.2條過程確認的剪裁。）1.引言盡管ISO9001：2000標準的意圖可供所有類型的組織應用。不管什么類型、規模大小，或者所提供的產品是什么。在這些組織中總會有某些服務組織的特性，這一點在進行第三方認證審核時，對這些服務特性的要求應當特別加以注意。于是，本文的目的是向審核員提供指導，如何對服務組織根據標準ISO9001：2000標準進行符合性審核，特別要強調的是標準第7.3條設計和開發、第7.5.2條產生和服務提供過程的確認以及第8.3條不合格品的控制。2.服

36、務組織ISO 9000：2000標準第3.4.2條對“產品”定義中有一個注2：“服務通常是無形的，并且是在供方和顧客接觸面上至少需要完成一項活動的結果。服務的提供可涉及，例如：在顧客提供的有形產品（如維護的汽車）上所完成的活動；在顧客提供的無形產品（如為編寫稅款申報書所需的收益表）上所完成的活動；無形產品的交付（如知識傳授方面的信息提供）；為顧客創造氛圍（如在賓館和飯店中）。”大多數組織在他們所提供的產品中具有服務的要素。這些服務要素所占的比重可以從100%（譬如律師事務所中）到在制造業組織中所提供的相對較小比例的服務，譬如售后服務。3.審核指南3.1服務的設計和開發考慮某一個服務組織是否應該

37、采用ISO9001：2000標準第7.3條“設計和開發”這一條要求時，特別重要的是要記住ISO9000：2000第3.4.4條對“設計和開發”所下的定義，“將要求轉換為產品、過程或者體系的規定的特性或規范的一組過程”。而其中的“要求”根據ISO9000：2000標準的定義是“明示的、通常隱含的或者必須履行的需求或期望”。而服務的“特性”是指可區分的特征，這些特征可能包括：- 感官的（如，嗅覺、觸覺、味覺、視覺、聽覺）- 行為的（如，禮貌、誠實、正直）- 時間的（如，準時性、可靠性、可用性）- 人體工效的（如，生理特性或者有關人身安全的特性）- 有形的（如，可測量的特性，這些特性也許是物理手段用

38、來提供服務的，譬如飛機的速度，或者服務提供所處的環境，如飛機的內部溫度或者舒適性）通常組織在考慮如何滿足標準第7.3條“設計和開發” 要求的時候，往往只考慮他們所提供產品的有形部分，往往忽視無形部分（服務本身）的設計和開發卻是主要的焦點所在。另外，組織還必須設計如何把這些服務提交給顧客。假如組織判定他們的質量管理體系要把設計和開發要求裁剪掉的話，審核員應當仔細地評估他們的理由是否符合前面所提到的各個方面。審核員還應當檢查該組織是否具有有效的設計和開發過程，足以定義他們所提供的服務，以及服務的提供過程的各種特性，這些服務和服務的提供過程的特性必須滿足顧客的需求和期望。3.2產品和服務提供過程的確

39、認說到實現服務所必須的各種過程，我們可以把服務過程分為以下兩類：3.2.1在服務實現過程中涉及到顧客的（實時交付的服務過程），和3.2.2過程實現后再把過程的輸出提交給顧客的。讓我們舉旅館服務的例子來說明，顧客進門和離開時所做的“登記”和“結帳”過程也許可以算是實時交付的服務過程，而對顧客所用房間的清理，一般算是后面一種，清理完成以后再提交給顧客使用的（對于后者，也許還可加以檢驗，必要時還可加以返工，消除不符合要求的問題。在制造業組織中所提供的與他們產品有關的各種服務同樣可以發現以上類似的過程，譬如，對顧客的抱怨和要求索賠的處理過程；由組織的服務部門對產品進行修理的過程；或者，在顧客那里對產品

40、所做的維護性服務過程。有些過程，其中包括實時服務交付過程，是組織和顧客直接發生接觸的過程，幾乎不可能（即使有也極少）對這個過程的輸出（服務）通過對過程結果監視或者測量好以后再“提交”給顧客的。因此，這樣的過程實際上是要根據標準ISO9001：2000第7.5.2條要求加以確認的。其實質也就是為了預防不符合問題的發生。為了確保對將要提供的服務質量加以充分的控制，審核員應當：理解服務的各種特性，理解服務提供過程的各種特性，以及它們的組織所定義的可接受的判別準則（這一點應當在審核的第一階段，也就是文件審核階段就完成了）。確定是否有需要做過程確認的那些實時提供服務過程（或者其他任何需要做過程確認的），

41、對這些過程有否做過過程確認。在做過程確認的時候有否考慮過有關的各種風險。評估是否向服務有關的人員提供了適當的工具，并且進行了培訓和授權。對很多服務行業，服務的提供是屆時instantaneous進行的（也就是“實時real- time”的提供過程），不可能通過檢驗符合要求以后再提供的。從質量觀點來說，成本最有效的角度做法，就是把所有過程都當作“特殊過程”處理的哲學思想。一個組織中根據這個原則處理的過程愈多，那么，愈少擔心他們的過程輸出會出什么問題。因此，看來標準這一條要求似乎很難加以剪裁的。3.3 不合格品的控制當服務提供過程中直接涉及到顧客的情況下，當服務提供過程發生不符合問題時就用標準第8

42、.3條“不合格品的控制”來處理，一直要處理到明確規定了適當的糾正措施，而且加以執行為止。凡是已經被發現的不符合問題，審核員應當檢查以下內容：1）該服務涉及人員是否充分得到授權來決定服務問題的處置，譬如，立即終止服務更換所提供的服務提供另外方式的服務2）應當檢查組織針對顧客投訴和索賠的處理過程檢查是否有臨時的糾正做法，減輕不符合問題所造成后果的影響（如，償還、承諾以后償還、用更高級的替換等）識別出與不符合有關的服務設備、提供服務的人員和環境，及時采取隔離和更換措施。這將有助于審核人員判斷對不符合問題的控制是否有效。注：在這樣的情況下，質量管理體系應當在適當的管理層次具有各種方法和手段來收集有關不

43、符合問題的數據資料，把信息反饋給相應的管理層次，以便他們有效地定義和執行糾正措施。對于讓過程實現以后再把過程的輸出提交給顧客的那一類服務過程，對“不符合問題的控制”可以采用通常采用的監視和檢驗技術。必須見到有客觀證據來證明這些監視和檢驗技術的充分性以及有效地加以執行。Date: 30 July 2005ISO 9001 Auditing Practices GroupGuidance on:Auditing service organizations1. IntroductionAlthough ISO 9001:2000 is intended to apply to all kinds o

44、f organizations, regardless of type, size or product provided, there are a number of characteristics of service organizations that require specific attention during a third party audit.Consequently, this document aims to provide auditors with guidance on auditing the compliance of service organizati

45、ons to the requirements of ISO 9001:2000. Particular emphasis is given to the requirements of clause 7.3 Design and development, clause 7.5.2 Validation of processes for production and service provision and clause 8.3 Control of nonconforming product.2. Service OrganizationsAccording to ISO 9000:200

46、0, clause 3.4.2 Product: “Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following: an activity performed on a customer-supplied tangible product

47、 (e.g. automobile to be repaired); an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); the creation of ambience f

48、or the customer (e.g. in hotels and restaurants).”Most organizations have an element of service in their product. This may range from almost 100% service (in the case of a law firm, for example), to a relatively small service component in the case of a manufacturing organization providing, for examp

49、le, after-sales service.3. Auditing Guidance3.1 Design and development of the serviceWhen considering the applicability or not of clause 7.3 of ISO 9001:2000 to a service organization, it is important to remember the definition of “Design and development”, which, according to ISO 9000:2000 clause 3.

50、4.4 is the “set of processes that transforms requirements into specified characteristics”. Again, according to ISO 9000:2000 requirements are “needs and expectations that are stated, generally implied or obligatory”, and characteristics of the service are distinguishing features that can include: se

51、nsory (e.g. related to smell, touch, taste, sight, hearing) behavioral (e.g. courtesy, honesty, veracity) temporal (e.g. punctuality, reliability, availability) ergonomic (e.g. physiological characteristic, or related to human safety) tangible (e.g. measurable characteristics; these may be eitherthe

52、 characteristics of the physical means used to deliver the service, e.g. the maximum speed of an aircraft, or of the environment in which the service is provided, e.g. the interior temperature or facilities of an aircraft).It is quite common for organizations to consider only the tangible component

53、of their product when addressing the requirements of clause 7.3, forgetting that the design and development of the intangible product (the service itself) should be the main focus. Additionally, the organization will need to design how the service will be delivered to its customers.If the organizati

54、on proposes to justify the exclusion of design and development from its QMS, the auditor should make a careful assessment of the justifications in light of the above. The auditor should also examine whether the organization has an effective design and development process that sufficiently defines th

55、e characteristics of its service, and of its service delivery processes, that are needed to meet customer needs and expectations.3.2 Validation of processes for production and service provision In terms of the processes needed to realize the service, we can identify two types of service processes: t

56、hose involving the customer in the realization of the service itself (real time delivery) and those in which the output is delivered to the customer after the realization of the processUsing the example of a hotel, the guest “check-in” and “check-out” processes would probably involve “real-time” del

57、ivery of the service, whilst the cleaning of the guests room would generally be “delivered” to the guest only after completion of the process (which could be subject to inspection and rework if necessary, to correct any nonconformities). Similar processes can also be found in manufacturing organizat

58、ions providing services related to their products, for example, the handling of claims and warranties; the repair of products by the organizations service units; orproduct maintenance activities performed at a clients facilities.Those processes that involve real time delivery, and are carried out di

59、rectly at the organization/customer interface can rarely (if ever) have their output (“the service”) verified by subsequent monitoring or measurement before they are “delivered” to the customer. Therefore, such processes are indeed subject to validation according to the requirements of ISO 9001:2000

60、, clause 7.5.2. This is also essential in order to prevent nonconformities from occurring.In order to ensure adequate control over the quality of the service to be provided, the auditor should:- understand the service characteristics, the service provision processes, and their acceptance criteria, a