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发表于 2009-7-8 16:34
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本帖最后由 hnwang 于 2009-7-12 09:43 编辑
以下摘录自国际标准化组织的网站。供大家参考。
International Organization for Standardization International Accreditation Forum
Date: 5 June 2009
2009年6月5日
ISO 9001 Auditing Practices Group Guidance on:
Auditing Quality Policy, Quality Objectives and Management Review
如何审核质量方针、质量目标和管理评审
1. Auditing quality policy
审核质量方针
The quality policy and its effective deployment can only be truly assessed based on the overall results of the audit.
质量方针及其有效展开只能根据整体的审核结果来加以真实的评价。
Audit methods should include:
审核方法应当包括：
• Interviewing Top Management to understand their approach and commitment to quality; (click here to link to the guidance paper on the auditing of Top Management processes)
与最高管理者交谈，了解他们对质量的管理模式和承诺。（任何审核最高管理者另外有知道文件）
• Evaluating, through the records of management review, the commitment and involvement of Top Management in the establishment, implementation, monitoring and updating of the quality policy;
通过管理评审记录，评价最高管理者在建立、实施、监视和更新质量方针中所做的承诺及参与情况。
• Assessing whether Management has effectively “translated” the quality policy into understandable words and guidelines at all levels of the organization, with corresponding objectives at each applicable function / level;
评估管理层是否已有效地将质量方针用能够理解的词语和指示加以“翻译”而被组织各个层次理解，并在各个应用的职能/层次上都有对应的质量目标。
• Conducting interviews with personnel to verify if they have the required awareness, understanding and knowledge of the way the organization’s quality policy relates to their own activity, regardless of the terms used by such people to express their understanding;
与组织的员工进行交谈，验证他们是否具有所要求的质量意识，理解质量方针的方式是把组织的质量方针和他们自己的活动联系起来，不要在意他们用什么术语来表达他们的理解。
• Seeking evidence of effective dissemination of the quality policy by appropriate communication.
通过适当的沟通搜集有效地传达质量方针的证据。
2. Auditing quality objectives
审核质量目标
Auditors need to verify that the organization’s overall quality objectives have been defined, that they reflect the quality policy, are substantially coherent, aligned and compatible with the overall business objectives, including customer expectations. If this is not the case, the auditors should further evaluate Top Management commitment to quality.
审核员必需验证组织是否根据质量方针制定了总的质量目标，这些目标是否持续保持与组织商务目标的一致性，又包括顾客的各种期望。不然的话，审核员应当进一步评价最高管理者对质量的承诺。
The fulfilment of quality objectives needs to be measurable and documented.
质量目标的完成情况必需是可测量的，而且要形成文件。
There is no specified way of identifying or documenting quality objectives, as these may appear through business plans, management review outputs, annual budgets, etc. It is up to the auditors to satisfy themselves that the objectives are adequately documented.
质量目标并没有统一的标识或统一的文件化格式，它可以采用商务规划，管理评审输出，年度预算报告等形式，这些质量目标是否充分文件化了，由审核员自己来判定了。
The auditors should obtain evidence of the way the quality objectives are suitably cascaded throughout the organization’s structure and processes, linking the general strategic objectives to management objectives and down to specific operational activities.
审核员应当获得证据，质量目标如何采用适宜的方法，在整个组织机构和各个过程中加以分解的、是如何把总体战略目标和各种管理目标联系起来的，是如何分解落实到特定的操作活动的。
It is recommended that the documented quality objectives should be examined at the documentation review stage of the audit.
（审核必须分两步走）建议在文件审核阶段就应当检查文件化的质量目标。
Before the end of the audit, the auditors have to satisfy themselves that the quality objectives are realistic and relevant, and that the organization has assigned to responsible personnel the resources needed to meet their objectives. Evidence of this should be obtained at all levels of the organization.
在审核结束之前，审核员应当对组织的质量目标是切合实际的，与实际工作是有联系的，而且组织已为负责实现目标的人提供了必需的资源是满意的。而且应当从组织的各个层次获得这方面的证据。
Quality objectives are not static and need to be updated in the light of the current business climate and the quest for continual improvement. Auditors should verify that the overall performance of the organization reflects the aims of the quality policy and reasonably meets the quality objectives.
质量目标不是静止的，需要根据当前的商务环境和持续改进的要求进行及时更新。审核员应当验证，组织总体绩效是否反映出质量方针的目的，以及是否合理地满足了质量目标。
Auditors should keep in mind that the fulfilment of objectives can be measured in a quantitative or qualitative manner. They should also remember that there is a clear link between the dynamic aspects of revising the quality policy and the quality objectives and the commitment of the organization to continual improvement.
审核员应当牢记，质量目标的完成情况可以使用定量或者是定性的方式进行测量。他们还应当牢记，在质量方针、质量目标和组织对于持续改进的承诺之间存在着动态评审的联系。
3. Auditing Management Review
审核管理评审
ISO 9001 requires top management to review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review could be carried out at a separate meeting but this is not a requirement of the standard. There are many ways in which top management can review the quality management system such as receiving and reviewing a report generated by the management representative or other personnel, electronic communication or as part of regular management meetings where issues such as budgets and targets are also discussed.
ISO9001要求最高管理者，根据计划规定的间隔时间，对组织的质量管理体系进行评审。目的是为了确保该体系的持续适宜、充分和有效。这个管理评审有可能专门开会来执行，但这不是标准的要求。最高管理者可以采用很多方式来评审质量管理体系，诸如接受并且评审管理者代表，或其他人的报告，也可以通过电子通讯方式或者作为日常的各种管理者会议的一部分内容，这些日常管理会还会讨论财务预算和目标等都包括在内。
The management review is a process that should be conducted and audited utilizing the process approach.
管理评审是一个过程，应当按照过程的模式来执行并且加以审核。
ISO 9001 clause 5.6.2 specifies the inputs to the management review process and these topics shall be included. However, these are not the only subjects that can be included in a review. They might not be addressed individually or simultaneously but as part of an overall review of the business. Auditors should be aware that inputs could be in many forms such as reports, trend charts and so on.
ISO9001第5.6.2条规定了管理评审过程的输入，这些主题内容必须包括在内。但是，在评审的时候，有可能不仅仅这些主题，也许同时还要评审整个商务活动。审核员应当懂得，管理评审的输入有可能有很多形式，诸如各种报告、趋势分析图表以及其他各种形式。
As output from the management review process, there should be evidence of decisions regarding:-
作为管理评审的输出，应当有证据来证明对以下内容已经做了决定：
• change of quality policy and objectives,对质量方针和目标的变更。
• plans and possible actions for improvements, 各种改进计划和可能的措施
• change of resources, 资源的变更
• revised business plans, 修订后的商务规划
• budgets. 各种财务预算
Output is not only related to improvements or changes but could include decisions on other important issues such as plans to introduce new products.
输出不仅和改进或者变更有联系，还有可能是关于其他重要事项所做的决定，诸如计划引进新的产品等。
Records of management reviews are required but the format of these is not specified. Minutes of meetings are the most common type of record, but electronic records, statistical charts, presentations etc. could be acceptable types of records.
管理评审的记录一定要做的，但是，记录的形式没有特定的规定。会议纪要是常用的记录形式，但是，电子记录，统计图表、报告等其他记录形式也是可以接受的。
The management review process might also include elements of quality management system planning where changes to processes and systems are being considered. Where this is the case, the auditors should review whether or not the following points have been considered:-
也许管理评审的过程还包括对质量管理体系要素的规划，其中对过程、体系的变更加以考虑的。如果遇到这样的情况的话，审核员应当注意评审以下内容是否加以考虑了：
• Will changes to the management system or business as a whole have an impact on other parts of the system or business?
如果对整个质量管理体系或者商务做变更是否会影响到体系或者商务的其他部分？
• Are proposed changes evaluated before implementation?
建议所做的变更在执行之前是否加以评估？
• In preparing strategic plans, are issues such as those in 4.1 of the standard considered?
在编制战略规划的时候，是否考虑到ISO9001标准第4.1条要求？
• Are the controls needed identified before the outsourcing of a process is begun?
当有过程外包出去之前是否识别了各种必要的控制措施？
The management review process should not be an exercise carried out solely to satisfy the requirements of the standard and the auditors; it should be an integral part of the organization’s business management process. The overall management review is complex process carried out at various levels in the organization. It is always a two-way process, generated by top management with inputs from all levels in the organization. These activities could vary from daily, weekly, monthly, organizational unit meetings to simple discussions or reports.
管理评审过程不应当只是用来满足标准和审核员要求的一次练习；它应当作为一个组织整个商务管理过程的一部分。整个管理评审是一个复杂的过程，应当在组织各个层次内加以执行的。它总是一种双向互动的过程，由最高管理者发起，要求组织各个层次提出评审的输入。这些活动可以从组织按日、周、月的定期会议到专门针对某单一问题讨论或者报告的会议而有所不同。
Auditors should look for evidence that the inputs and outputs of the management review process are relevant to the organization’s size and complexity and that they are used to improve the business. Auditors should also consider how the organization’s management is structured and how the management review process is used within this structure.
审核员应当寻求各种客观证据，包括管理评审过程的输入和输出，这些都和组织的规模和复杂程度有关的，确信这些都是用来改进组织商务的。审核员还应当考虑组织的管理结构是什么样子的，组织的管理评审过程是如何在这些结构中运作的。
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