ISO9001:2008 7.6条款的理解与应用 哪些测量设备不合格需对产品进行重新检查
ISO9001: 20087.6 in terms of the understanding and application of measuring equipment for which unqualified products again check
GB/T19001标准7.6条款规定：“当发现设备不符合要求时，组织应对以往测量结果的有效性进行评价和记录。组织应对该设备和任何受影响的产品采取适当的措施。”根据这一规定，如果发现测量设备不合格，必要时需对使用该设备测量过的产品进行重新检查。但有些组织觉得具体实施起来比较困难、麻烦，并未实施有效控制，接受审核时往往以没有不合格测量设备为由来搪塞、回避。同时，有些审核员发现测量设备不合格也并未细究，不加区分地开出不符合报告。笔者认为，当发现测量设备不合格时，真正需要对产品进行追溯的仅仅是少数。
The GB / T19001 standard set of 7.6 terms:" when the equipment is found not to conform to requirements, the organization shall the validity of the previous measuring results of evaluating and recording. Tissue response to the equipment and any affected product to take appropriate measures." According to this provision, if the measuring equipment is found not qualified, when necessary for use of the device for measuring the product review. But some feel specific difficult to implement, trouble, did not carry out effective control, to accept the audit tend to not have not qualified measurement equipment for origin prevaricate, avoidance. At the same time, some measuring equipment is found not qualified auditors are not careful, do not distinguish to issue non-conformity report. The author thinks, when the measuring equipment is found not qualified, the real need for product traceability is just a few.
一、对几个关键词的理解
A few words, to understand
（一）设备不符合要求（本文称设备不合格）包括检定不合格，校准不符合要求，设备出现损坏、过载或误操作，可能使其预期用途无效的故障产生不正确的测量结果，超过规定的计量确认间隔，封印或保护装置损坏或破裂，以及暴露在有可能影响其预期用途的影响量中（如电磁场、灰尘）。
( a ) equipment does not meet the requirements (the paper says equipment unqualified ) including the test failed, calibration does not meet the requirements, equipment damage, overload or misoperation, may make its intended use invalid fault produce incorrect results, exceeding the prescribed metrological confirmation interval, seal or protection device is damaged or broken, as well as exposure in may affect its intended use ( such as the electromagnetic field, influence quantity of dust ).
（二）评价的主要目的是通过评价，确定是否需要对产品进行重新检查。
( two) the main purpose of the evaluation is the evaluation, determine the need for product review.
（三）采取适当的措施。
( three) take appropriate measures.
1.对于产品。必要时，对在厂产品重新追回检测（包括必要时对判为不合格的产品进行重新检测），对交付产品作出妥善处置。经重新检测，产品仍不合格应按“83不合格品的控制”进行处置。
1 for the product. When necessary, the factory products back testing ( including necessary to found unqualified products to detect ), for the delivery of products to make proper disposal. The product still unqualified to detecting, should press" 83 " the control of nonconforming product disposal.
2.对于设备。进行重新检定。校准、调整、维修，或予以降级、报废并更换成合格的设备。必要时，应采取调整检定、校准周期等纠正措施。
2 for equipment. To test. Calibration, adjustment, repair, or demoted, scrapped and replaced the qualified equipment. When necessary, should be taken to adjust the calibration, calibration cycle and corrective measures.
二、监视装置不符合要求时，仅需对装置本身作出相应处置
Two, monitoring device does not meet the requirements, it only need to make corresponding disposal device
（一）7.6条款提到的设备，仅指测量设备，而不包括监视装置。这里也没有提到监视结果，当然不包括对以往监视结果的有效性进行评价和记录。
( a ) 7.6 articles that mentioned equipment, only refers to the measurement equipment, and does not include monitoring device. There is no mention of the monitoring results, of course not included on previous results of monitoring the effectiveness of evaluating and recording.
（二）监视装置通常用于监控被监视过程的过程状态，但过程状态具有不可重复性和不可再现性。对以前生产的产品可以重新进行检测，而对已过去的过程状态却不能倒过来重新进行监视。
( two) monitoring device usually used for monitoring the monitored process condition, but the state has not repeatability and reproducibility. Prior to the production of products to detect, and to have the past state of the process but not upside down to monitor.
三、哪些测量设备不合格需对产品进行重新检查
In three, which the measuring equipment is qualified for product review
《ISO9001审核实践工作组对ISO 9001：2000标准部分要求审核的指南性意见》指出，标准只要求当“为产品符合确定的要求提供证据”时，或产品或过程测量所需时，对测量设备进行校准。因此，只有这部分测量设备不合格时，才需考虑是否要对产品进行重新检查。
" ISO 9001 audit practices Working Group on ISO 9001 : 2000 standard requirements review guide opinions" points out that, if and when the" standard for the product to determined requirements provide evidence", or product or process required measurements, calibration for measurement instrument. Therefore, only that portion of the measuring equipment is qualified, only to consider whether to product review.
（一）用于监控工艺参数的测量设备不合格
( a ) for monitoring process parameters measurement equipment unqualified
1．用于监控非特殊过程的工艺参数的测量设备不合格时，生产的产品可能受影响，也可能不受影响。但由于其生产的产品是否合格是用其他测量设备进行检测的，当时的检测结果已经说明产品是否受影响，一般不需对产品进行重新检查。
1 for the monitoring of special process parameters measurement equipment unqualified, production of the product may be affected, may also not affected. But due to the production of the products are qualified by other measuring equipment testing, the test results has indicated that the product is affected, generally do not need to check again.
2.用于监控特殊过程的工艺参数的测量设备不合格时，则往往需要对产品进行重新检查。因为特殊过程的产品的某些特性难以验证，一般也只检验一些比较容易检验的项目（特性），而其中难以验证的特性主要通过过程确认和过程控制来确保符合要求。这种情况下，仅凭当时的检验结果一般不能判定产品中难以验证而未进行验证的特性是否已受影响。因此，需要对产品进行重新检查，但这时可能需要通过破坏性试验或不经济的检测方法进行。
2 for the monitoring of special process parameters measurement equipment unqualified, often need to check for product. Because of the special process of the product to verify some properties, generally only examine some of the easier test items ( characteristics), and in which it is difficult to verify the characteristics mainly through the process validation and process control to ensure compliance with the requirements. In this case, only the test results generally cannot decide products difficult to validate and not validated characteristics have been affected. Therefore, the need for the product reviewed, but this may need through destructive testing or not economical detection methods.
作出上述判断的主要依据是：该过程的产品的主要特性是否都已用其他适用的测量设备进行了检测，其检测设备是否都处于合格状态。因此，如果发现用于监控工艺参数的测量设备不合格，应进一步考虑和追踪以下几个方面的问题：
The judgment was based mainly on: the product of the process main characteristics are used by other applicable measurement equipment for the detection, the detection device is in qualified condition. Therefore, if used for monitoring process parameters measurement equipment failure, should be further considered and tracking problem of the following respects:
①该过程是否特殊过程；
This process is a special process;
②该过程的产品具有哪些主要特性，需要检测哪些项目；
In the process of product has which main characteristics, need to detect which items;
③该过程的产品的所有主要特性是否都能用其他适用的测量设备进行检测（可通过检查规定的检测项目及其相应的检测设备的检测能力分析确定）；
In the process of product of all major characteristics are to use other applicable measuring equipment for testing ( through inspection provisions testing projects and corresponding detection device capable of detecting analysis identified );
④该过程的产品的所有主要特性是否都进行了检测；
The process of the product of all the main characters are tested;
⑤用于检测该过程的产品特性的测量设备是否都处于合格状态。
The characteristics of the product that is used to detect the process of measuring equipment are in qualified condition.
根据以上5点，分析判断是否需要对该过程的产品进行重新检查。
According to the above 5 points, analysis and judgment is needed on whether the product of the process to check.
（二）生产作业人员使用的测量设备不合格
( two) the production staff using measurement equipment unqualified
所谓对产品重新检查，无非是用合格的测量设备对原来使用不合格测量设备测量过的产品进行重新测量。因此：
The so-called product review, it is use of qualified measurement equipment to the original use of substandard measuring equipment measuring the products were measured again. Therefore:
1.如果生产作业人员使用的测量设备不合格，由于其自检后还需经检验人员进行专检，这时只要检验人员使用的测量设备是合格的，其检验结果就可以说明生产作业人员使用的测量设备不合格是否已对产品造成影响，当时就应根据检测结果作出相应处置，不存在是否需要进行重新检查的问题。
1 if the production staff used measurement equipment failure, due to its self is by checking personnel to carry out special inspection, this time as long as the inspection personnel using the measurement device is qualified, the test result can explain the production staff used measurement equipment unqualified is the product caused by impact, then it should be based on detection results the corresponding disposal, there is no need to check the problem.
2.特殊情况下，生产作业人员自检后，检验员不再进行专检，这时生产作业人员使用的测量设备不合格需要对产品进行重新检查。
2 special cases, production personnel after self-test, inspector not only check, then the production staff used measurement equipment unqualified product review needed.
（三）用于检验和试验的测量设备不合格
( three) used for the inspection and test measurement equipment unqualified
1.企业为加强控制对同一产品安排了多次检验，而各次检验的项目都相同，这时只要最后一次检验或试验所使用的测量设备合格，即使前面各次检验使用的测量设备不合格，也不需要进行重新检查。
1 enterprises to strengthen the control on the same product arranged repeatedly tested, and the test items are the same, then as long as the last inspection or testing using measurement equipment qualification, even in front of each testing using measurement equipment unqualified, do not need to check.
2.多次检验中各次检验的项目都不同，而用于各次检验的测量设备不合格，都需进行重新检查。
2 times of test in the inspection items are different, and for the inspection measuring equipment is not qualified, are required to check.
3.对同一产品只安排了一次检验，而用于检验该产品的测量设备不合格，必须对该产品进行重新检查。
3 for the same product is only arranged a test, and are used to examine the product measurement equipment unqualified, the product must be reviewed.
4．通常情况下，用于最终检验的测量设备不合格时，需对产品进行重新检查。
4 normally, for final inspection measuring equipment unqualified, the product to check.
（四）在线检测设备不合格
( four) online testing equipment unqualified
一般情况下，需要对产品进行重新检查。当然，这种情况相对比较复杂，需要对后续的检测项目和检测措施进行分析后才能确定。分析的思路与上述相同。
In general, the need for the product to check. Of course, this situation is relatively complex, need for follow-up testing project and testing measures are analysed in order to determine. Analysis of the train of thought and the same.
综上所述，仅仅当“为产品符合确定的要求提供证据或产品或过程测量所需”的测量设备不合格时，才需对测量结果的有效性进行评价，但通过评价可以发现，真正需要对产品进行重新检查的可能只是少数。当测量设备用于监控工艺参数时，如用于监控非特殊过程的工艺参数，通常情况下不需要进行重新检查，而用于监控特殊过程的工艺参数则往往需要进行重新检查。生产作业人员使用的测量设备不合格时，一般情况下不需要进行重新检查；检验部门／人员使用的测量设备不合格时，多数情况下需要进行重新检查。
To sum up, only when "the product to determined requirements provide evidence or product or process measurements required" measuring equipment unqualified, only need to evaluate the effectiveness of the measurement results, but can be found through evaluation, really need the product to check may be one of the few. When measuring equipment used for monitoring process parameters, such as for monitoring of special process, typically do not need to be reexamined, and used for monitoring of special process parameters often needs to check. Production staff used measurement equipment unqualified, generally do not need to check; inspection departments / personnel using measurement equipment unqualified, in most cases to check.