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发表于 2008-5-23 14:58
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本帖最后由 hnwang 于 2009-3-3 11:37 编辑
这份资料是老的，2008版公布后，今天我上网查了，没有变化，还是这个版本。请使用者注意。考虑到有些人对监视测量装置控制理解存在的问题，我从国际标准化网站翻译这篇文章。供参考。此文不能作为审核的依据。翻译有差错，请指正。
颁布日期Date: 15 May 2006
ISO 9001 Auditing Practices Group
Guidance on:
ISO9001审核实践组指南
Auditing the control of monitoring and measuring devices
监视和测量装置控制的审核
The following information is provided as guidance for auditing the processes associated with control of monitoring and measuring devices, and to assist in the evaluation of justi-fications for the exclusion of clause 7.6 from the scope of an organization’s quality man-agement system.
以下信息只能作为指导审核员审核监视和测量装置控制有关的过程，帮助评估在质量管理体系的范围中是否能剪裁掉标准第7.6条要求。
In the auditing of monitoring and measuring processes, it is important for auditors to un-derstand the difference between “monitoring” and “measuring”:
在审核监视和测量装置控制过程的时候，很重要的一点就是要审核员理解监视和测量这两个术语之间有什么差别。
monitoring implies observing, supervising, keeping under review (using monitoring devices); it can involve measuring or testing at intervals, especially for the purpose of regulation or control.
监视这个术语用来说明观察、监督、保持评审（包括使用监视装置）；它可能包括通过间隔时间进行测量或者试验；特别用于条例或者控制目的而进行的。
measuring considers the determination of a physical quantity, magnitude or di-mension (using measuring equipment).
测量这个术语是考虑（用测量设备）来确定物理量；规模大小或者尺寸的大小
While “measuring equipment” is defined in ISO 9000 clause 3.10.4 as “measuring in-strument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process”, the standard only requires “measuring equipment” to be calibrated when it is used for measuring purposes “…to provide evidence of conformity of product to determined requirements” either by product or process measurements.
而“测量设备”这个术语在ISO9000第3.10.4条定义是“为了实现测量过程所必需的测量仪器、软件、测量标准、标准物质或者辅助设备或它们的组合”。标准仅仅要求，当它“……为了提供产品符合确定要求的证据” 被作为测量的目的而使用的“测量设备”必须校验的。
Equipment and devices may be used for indication, monitoring or measuring. The same equipment could be used for all these three functions.
设备和装置也许可能被用来作为指示用、监视或者测量用。相同的设备有可能使用于以下三种功能：
For example, in some industries, a pressure gauge may be used:-
例如，在某些工业领域，压力表有可能用来：
as an indicator (e.g. to ensure that the pressure is present);
作为一个指示装置（譬如，确保有压力存在）
as a monitoring device (e.g. to ensure that the pressure is stable and the process is under control); and
作为一个监视监视装置（也就是，确保压力是稳定的，压力处于受控制状态）还有
as measuring equipment (e.g. where the accurate value of the pressure is impor-tant for the quality of product).
作为一个测量设备（就是说，压力的准确数值对产品的质量来说是非常重要的）
However, the level of control depends on the intended use and determines whether or not it should be calibrated or validated. The depth and degree of such confirmation may vary, depending on the nature of products, services and related risks.
但是，对这些监视和测量装置的控制水平取决于它的意向用途和是否需要加以校准或确认来确定的。这种校验鉴定的深度和程度也是有所不同的，取决于产品、服务的性质以及面临的有关风险。
In cases where the organization makes use of measuring equipment, evidence should be obtained that the metrological needs related to the production or service processes have been properly identified/specified and that the measuring systems have been de-signed and are operated and maintained in such a way as to fulfil the applicable metro-logical needs.
每当组织把它当作测量设备使用的时候，必须要有客观证据来证明，和生产或者服务过程有关的计量必需要求已经确定，而且加以文件规范，还要确保，测量系统已经设计以及维持在这样的应当采用的计量要求条件下进行运作和维持。
Auditors should confirm that, in addition to providing the necessary calibration records and assuring the related measurement uncertainty and traceability, the organization is aware of and has implemented, as appropriate, a metrological confirmation system as described in ISO 10012 adequate to the extent and types of the measurements per-formed.
审核员应当肯定，除了提供必要的校验记录以及确保有关的测量不确定性和可追溯性情况下，组织还必须懂得以及正确得到贯彻，恰当的符合ISO10012要求的计量鉴定系统能充分满足所做测量工作的类型和程度的要求。
Some organizations such as Hotels, Restaurants, Education Centers, Consultants, Pub-lic Services, among others, perform monitoring and measuring activities utilizing as “monitoring or measuring devices” surveys, examination papers, questionnaires, statis-tical reports, etc, due to the nature of their product.
有些组织，譬如旅馆、饭店、教育中心、咨询机构、公共服务机构以及其他类似的组织，由于他们的这些产品的性质决定了，在执行监视和测量工作的时候使用的“监视和测量装置”的名称是叫调查提纲、考试卷、问卷、统计汇总报告等等。
These “devices” should be controlled and validated accordingly to ensure that they pro-vide consistent means of monitoring and measurement of the processes, prod-uct/service and customer satisfaction.
这些“装置”应当加以控制的，也必须做相应的有效性确认，以便确保它们能提供一致的手段来监视和测量这些工作过程、产品/服务和顾客的满意。
It is appropriate to address these “devices” whilst auditing conformance with clause 8.2 “Monitoring and Measurement”. If an organization can demonstrate appropriate controls of such devices under this clause, an auditor needs to realize that not all the require-ments related to Clause 7.6 may be applicable for such “devices”.
当审核第8.2条“监视和测量”符合性的时候，也要适当注意这些“装置”。如果某一组织能恰当地展示如何对这些装置按照标准第7.6条要求加以控制的，审核员必须认识到，并不是和7.6条要求中所有的要求适用于这类“装置”的。
The auditor needs to understand how the organization performs process control and the impact that the information, obtained from using these “devices”, has on this process control.
审核员必须理解组织是如何执行过程控制的，以及利用这些“装置”获得的信息对过程控制的后果的影响都得到了控制。
When the impact is relevant, auditors should evaluate issues such as:
当这些影响有关系的话，审核员应当按照如下要求来评估这个问题：
- How the organization validates that “the monitoring and measuring device” is consistent with the monitoring and measurement requirements.
组织是如何确认该“监视和测量装置”符合各项监视和测量要求的
- How the organization assures the information validity.
组织是如何评估所得到信息有效性的
- The competence of the responsible to design “the monitoring and measuring de-vice”
负责设计这些“监视和测量装置”人员的能力如何
- How the organization validate the consistency of the results
组织如何确认这些结果的
From the description above, the organization should be able to decide whether or not all or part of the requirements of clause 7.6 may be excluded. It is stressed that just be-cause an organization does not have measuring equipment that needs to be calibrated does not mean that it can automatically exclude compliance with the whole of clause 7.6; to do so would require that it also does not use any monitoring devices or monitoring equipment.
根据以上的描述，组织应当能决定标准第7.6条是否整条要求或者部分要求可加以剪裁了。必须强调一下，不能仅仅认为组织没有必须加以校验的测量设备就自动把第7.6条要求加以剪裁掉了，这样做的话，也就意味不会采用任何监视装置和监视设备来监视标准各项要求了。
Additional explanation and examples are given in the ISO Handbook: ISO 9001:2000 for Small Businesses – What to do, Advice from ISO/TC 176.
进一步说明这个问题以及有关的例子可以从国际标准化组织ISO/TC 176编写的小组织如何贯彻采用ISO9001：2000指南这本小册子中得到。
[ 本帖最后由 jolan456 于 2008-6-15 22:52 编辑 ] |
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发表于 2008-5-23 20:35
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