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发表于 2013-8-7 23:25:34
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2009年修订后的关于服务组织的审核指南
International Organization for Standardization International Accreditation Forum
Date: 5 June 2009
日期:2009年6月5日
ISO 9001 Auditing Practices Group Guidance on:
ISO9001审核实践组关于服务组织的审核指南
Auditing service organizations
1. 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. 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 service 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 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 tangible 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 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 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 of 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 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 either the 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).
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 tangible 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 should 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 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 “check-out” processes would probably involve “real-time” delivery of the service, whilst the cleaning of the guest’s 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 products by the organization's 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。
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