对服务组织的审核指南Word格式.docx

1、审核实践组关于服务组织的审核指南Auditing service organizations1. Introduction引言Although ISO 9001 is intended to apply 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

2、.Consequently, this document aims to provide auditors with guidance on auditing the compliance of service 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 serv

3、ice provision and clause 8.3 Control of nonconforming product.尽管ISO9001标准的意图可供所有类型的组织应用。不管什么类型、规模大小，或者所提供的产品是什么。在这些组织中总会有某些服务组织的特性，这一点在进行第三方认证审核时，对这些服务特性的要求应当特别加以注意。于是，本文的目的是向审核员提供指导，如何对服务组织根据标准ISO9001进行符合性审核，特别要强调的是标准第7.3条设计和开发、第7.5.2条产生和服务提供过程的确认以及第8.3条不合格品的控制。2. Service Organizations服务组织According

4、 to ISO 9000, 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 tangib

5、le product （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

6、a pleasant ambience for the customer （e.g. in hotels and restaurants）.”ISO 9000标准第3.4.2条对产品定义中有一个注2：“服务通常是无形的，并且是在供方和顾客接触面上至少需要完成一项活动的结果。服务的提供可涉及，例如：在顾客提供的有形产品（如维护的汽车）上所完成的活动；在顾客提供的无形产品（如为编写税款申报书所需的收益表）上所完成的活动；无形产品的交付（如知识传授方面的信息提供）；为顾客创造氛围（如在宾馆和饭店中）。”Most organizations have an element of service in

7、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 example, after-sales service.大多数组织在他们所提供的产品中具有服务的要素。这些服务要素所占的比重可以从100%（譬如律师事务所中）到在制造业组织中所提供的相对较小比例的服务，譬如

8、售后服务。3. Auditing Guidance审核指南3.1 Design and development of the service服务的设计和开发When considering the applicability 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 o

9、f processes that transforms requirements into specified characteristics”. Again, according to ISO 9000 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

10、 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 characteristics of th

11、e 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）.考虑某一个服务组织是否应该采用ISO9001标准第7.3条设计和开发这一条要求时，特别重要的是要记住ISO9000第3.4.4条对“设计和开发”所下的定义，“将要求转换为产品、过程或者体系的规定的特

12、性或规范的一组过程”。而其中的“要求”根据ISO9000标准的定义是“明示的、通常隐含的或者必须履行的需求或期望”。而服务的“特性”是指可区分的特征，这些特征可能包括：- 感官的（如，嗅觉、触觉、味觉、视觉、听觉）- 行为的（如，礼貌、诚实、正直）- 时间的（如，准时性、可靠性、可用性）- 人体工效的（如，生理特性或者有关人身安全的特性）- 有形的（如，可测量的特性，这些特性也许是物理手段用来提供服务的，譬如飞机的速度，或者服务提供所处的环境，如飞机的内部温度或者舒适性）It is quite common for organizations to consider only the tang

13、ible component 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.通常

14、组织在考虑如何满足标准第7.3条设计和开发 要求的时候，往往只考虑他们所提供产品的有形部分，往往忽视无形部分（服务本身）的设计和开发却是主要的焦点所在。另外，组织还必须设计如何把这些服务提交给顾客。If 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 shoul

15、d also examine whether the organization has an effective design and development process that sufficiently defines the characteristics of its service, and of its service delivery processes, that are needed to meet customer needs and expectations.假如组织判定他们的质量管理体系要把设计和开发要求裁剪掉的话，审核员应当仔细地评估他们的理由是否符合前面所提到的

16、各个方面。审核员还应当检查该组织是否具有有效的设计和开发过程，足以定义他们所提供的服务，以及服务的提供过程的各种特性，这些服务和服务的提供过程的特性必须满足顾客的需求和期望。3.2 Validation of processes for production and service provision 产品和服务提供过程的确认In terms of the processes needed to realize the service, we can identify two types of service processes: those involving the customer in

17、 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 process说到实现服务所必须的各种过程，我们可以把服务过程分为以下两类：3.2.1在服务实现过程中涉及到顾客的（实时交付的服务过程），和3.2.2过程实现后再把过程的输出提交给顾客的。Using the example of a hotel, the guest “check-in” and “ch

18、eck-out” processes would probably involve “real-time” delivery 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）. 让我们举旅

19、馆服务的例子来说明，顾客进门和离开时所做的“登记”和“结帐”过程也许可以算是实时交付的服务过程，而对顾客所用房间的清理，一般算是后面一种，清理完成以后再“交付”给顾客使用的（对于后者，也许还可加以检验，必要时还可加以返工，消除不符合要求的问题。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

20、 products by the organizations service units; or product maintenance activities performed at a clients facilities.在制造业组织中所提供的与他们产品有关的各种服务同样可以发现以上类似的过程，譬如，对顾客的抱怨和要求索赔的处理过程；由组织的服务部门对产品进行修理的过程；或者，在顾客那里对产品所做的维护性服务过程。Those processes that involve real time delivery, and are carried out directly at the org

21、anization/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, clause 7.5.2. This i

22、s also essential in order to prevent nonconformities from occurring.有些过程，其中包括实时服务交付过程，是组织和顾客直接发生接触的过程，几乎不可能（即使有也极少）对这个过程的输出（服务）通过对过程结果监视或者测量好以后再“交付”给顾客的。因此，这样的过程实际上是要根据标准ISO9001第7.5.2条要求加以确认的。其实质也就是为了预防不符合问题的发生。In order to ensure adequate control over the quality of the service to be provided, the a

23、uditor should:为了确保对将要提供的服务质量加以充分的控制，审核员应当：- understand the service characteristics, the service provision processes, and their acceptance criteria, as defined by the organization （this should be done during the Stage 1 audit）理解服务的各种特性，理解服务提供过程，以及组织所定义的可接受的判别准则（这一点应当在审核的第一阶段，也就是文件审核阶段就完成了）。- determin

24、e whether validation of real-time service provision processes （or any other process that requires validation） has been performed and if this has taken into account the associated risks;确定是否有需要对那些实时提供服务过程（或者其他任何需要做过程确认的）做过程确认，对这些过程有否做过过程确认。在做过程确认的时候有否考虑过有关的各种风险。- assess if the appropriate tools, trai

25、ning and empowerment have been provided to the personnel involved.评估是否向服务有关的人员提供了适当的工具，并且进行了培训和授权。For 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

26、 the most cost-effective way of doing business is to apply the philosophy of “special processes” to 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 e

27、xcluded.对很多服务行业，服务的提供是届时instantaneous进行的（也就是“实时real- time”的提供过程），不可能通过检验符合要求以后再提供的。从质量观点来说，成本最有效的角度做法，就是把所有过程都当作“特殊过程”处理的哲学思想。一个组织中根据这个原则处理的过程愈多，那么，愈少担心他们的过程输出会出什么问题。因此，看来标准这一条要求似乎很难加以删减的。3.3 Control of nonconforming product不合格品的控制In the cases of service processes directly involving the customer, “t

28、he control of nonconforming product” （clause 8.3） is the way the organization deals with nonconformities in the service provision until the appropriate corrective action is defined and implemented. 当服务提供过程中直接涉及到顾客的情况下，当服务提供过程发生不符合问题时就用标准第8.3条“不合格品的控制”来处理，一直要处理到明确规定了适当的纠正措施，而且纠正措施加以执行为止。Where a nonco

29、nformity is identified, the auditor should examine:凡是不符合问题加以确定了，审核员应当检查以下内容： whether the personnel involved are sufficiently empoweredwith the authority to decide the disposition of the service, for example: 该服务涉及人员是否充分得到授权来决定服务问题的处置，譬如：- to immediately terminate the service立即终止服务 to replace the ser

30、vice provided更换所提供的服务 to offer an alternative 提供另外方式的服务 the organizations customer claims and complaints processes组织对顾客投诉和索赔的处理过程 any temporary corrections that are implemented to mitigate the effect of the nonconformity （e.g. refund, credit, upgrade, etc.）是否有临时的纠正做法，减轻不符合问题所造成后果的影响（如，偿还、承诺以后偿还、用更高级

31、的替换等） the identification, segregation and replacement of the relevant service equipment, service providers and environment.识别出与不符合有关的服务设备、提供服务的人员和环境，及时采取隔离和更换措施。This will enable the auditor to judge whether the control of such nonconforming product is effective. 这将有助于审核人员判断对不符合问题的控制是否有效。Note: In such situations the quality management system should have provisions to capture d