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[ISO9000] 展示符合标准

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发表于 2009-7-9 10:55:29 | 显示全部楼层 |阅读模式
以下摘录自国际标准化组织网站,供参考。

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:

Demonstrating conformity to the standard

展示符合标准

“Performing the audit to the standard's clauses” versus “Performing the audit to the auditee’s processes”
“针对标准条款作审核”还是“针对被审核方的过程作审核”

When assessing conformity to the standard, audit checklists may not be sufficient
当评估是否符合标准的时候,根据审核检查单可能就不充分了。

At the end of an audit, the auditor should be in a position to know whether all requirements of the standard are satisfied or not.

      当审核结尾的时候,审核员处于这样的地步:应当知道,标准所有的要求是否满足了,还是没有满足。

Trying to show compliance to a standard often brings people back to using checklists, where an auditor is able to check-off the requirements of the standard one-by-one, making sure that all the requirements have been covered. This basic approach of filling out a checklist is an easy way to ensure that all requirements of the standards have been checked. However, considering the approach of the ISO 9001, performing an audit from a generic checklist might prevent an auditor from collecting evidence of effective interfacing between processes.

      当人们试图看看是否符合标准的时候,往往会回头检查一下审核检查单,因为,利用检查单,审核员可以一条要求一条检查标准要求,确信已经都检查过了。凡是检查单内每条内容都有了,也就确保所有要求都检查过了,这是最最容易的做法。但是,考虑到ISO 9001的管理模式,利用通用的检查单来作审核,审核员有可能忽视收集过程和过程之间有效相互作用的客观证据了。

In some situations, completely moving away from the checklist (or audit question list) might not be possible, particularly if the organization needs to provide evidence of compliance to the standard to third parties (e.g. regulators, conformity assessment bodies).

      在某些情况下,完全按照检查单检查(或问题清单),特别是组织必须向独立第三方(就是注册机构、符合性评估机构)提供客观证据来证明符合标准,根本不可能的。

It is important to use a checklist in an appropriate way and at an appropriate time, i.e. as a tool to help keep track of the requirements of the standard to be covered.

      把检查单作为工具,在适用的时间,用适用的途径,帮助您跟踪轨迹,以便涵盖所有要检查的标准要求,这是很重要的。


What is adequate sampling?
       什么算是充分的抽样呢?

There is no statistical or mathematical formula to establish the right number of samples to be taken during an audit. Defining the number of samples (e.g. one, five, or even more samples of records for a particular requirement) to be taken to confirm conformity to the requirements is not efficient and does not ensure conformity. It is of course a fact that by increasing the number of samples taken, an auditor will have greater confidence regarding the actual status of the implementation of the QMS. "Adequate" sampling in this context would refer to a level of sampling taken during on-site interviews and record reviews that give sufficient confidence that the auditee's QMS is implemented as described.

      审核的时候,究竟抽样数量多少是正确的,没有统计和数学方面的公式可以用来确定。确定抽样数量(就是针对特定要求,抽一个、五个或更多)以便符合要求是不充分的,也是不能确保符合性的。当然,实际上抽样数量提高,审核员对质量管理体系实际贯彻情况的信心也就更大些。这个“充分”抽样数量是要参照现场审核交谈和对记录评审,根据这些所描述出的被审核方质量管理体系贯彻水平来确定的。

Multi-site sampling, or sampling of the organizational units of a company, are covered in IAF MD 1:2007 Certification of Multiple Sites Based on Sampling, along with the required on-site auditor days and sampling formula for multi-sites.

      对多现场的抽样,或公司多单位的抽样,应当按照IAF MD 1:2007文件,根据多现场所要求的现场审核人工天数的规定来确定的。

The auditor needs to perform interviews and check records and evidence during the interview. The number of samples to be taken depends on the complexity of the process being audited, and on the quality of information received from the auditee during the interview. It is also important that the auditor maintains the schedule outlined in the audit plan. At the end of the day, the auditor needs to feel comfortable that the samples and the objective evidence seen are representative, in order to draw appropriate conclusions regarding the implementation of the QMS.

      审核员必须执行交谈,而且在交谈过程种要检查各种记录和证据。要抽取样本的数量取决于被审核过程的复杂性,以及交谈时候从被审核方得到的各种信息来确定的。还有一点很重要,就是要确保审核计划规定的时程进度。到审核的最后一天,审核员必须感到,抽取的样本和得到的客观证据是有代表性的,关于这个质量管理体系的执行情况是可以的出适当的结论的。

Recording audit information
记录审核信息

ISO 19011 and the ISO/IEC 17021 explain what an audit report should contain. However, it is important that the audit reports to the auditee only contain important information for the auditee, e.g. information on possible improvements, positive observations, and non-conformities to the standard. Merely reiterating and explaining the requirements of the standard is unlikely to be what the auditee is looking for.

      ISO 19011 和 ISO/IEC 17021解释,审核报告应当包括哪些内容。但是,很重要的一点是,给被审核方的报告只包括被审核方所关心的,也就是可加以改进的,正面的和不符合标准的重要信息。很少解释和说明标准要求本身,这不是被审核方所寻求的。

There may also be a requirement for the auditor to demonstrate the sequence in which the audit was performed, sometimes called the audit trail. Using audit notes is a very efficient way for an auditor to record the audit. The main disadvantage of using audit notes is that they tend to be a very personal way of recording information during an audit, and the levels of recording detail and styles will vary greatly from one auditor to another.

      对审核员来说,也许还有一个要求,要战展示这次审核是按照什么顺序进行的,有时候,把这叫作循迹审核。利用审核笔记作记录的方式对审核员来说已经足够了。利用审核笔记主要的不足地方是,不同的审核员有不同的记录信息的途径,以及记录的详细程度和方式。

A checklist can ensure some uniformity in the performance of the auditors.  However, auditors should never forget to spend their time auditing, not filling out checklists or taking notes.

      检查单可以确保审核员的工作在某种程度上的一致性。但是,审核员应当不要忘记,把时间放在审核上,而不是填写检查单或作笔记。
发表于 2009-8-12 11:44:50 | 显示全部楼层
发表于 2009-8-12 15:54:49 | 显示全部楼层
谢谢王老师的耕耘,我们可以在内审中值得借鉴。
发表于 2009-8-25 12:53:11 | 显示全部楼层
审核的过程者最重要的,审核的笔记仅仅作为审核结果
发表于 2009-11-16 09:10:47 | 显示全部楼层
 楼主| 发表于 2009-11-16 09:37:04 | 显示全部楼层
5# samuel001_guo


谢谢,希望具体指明英译汉不对之处,包括笔误在内,以便纠正。
发表于 2010-4-2 17:43:04 | 显示全部楼层
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