如何审核质量方针、目标和管理评审.doc

如何审核质量方针、目标和管理评审以下是国际标准化组织审核实践小组关于如何审核质量方针、目标和管理评审的指导文件。翻译出来供大家参考。Date:12 December 2005 ISO 9001 Auditing Practices GroupGuidance 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 对质量方针的审核The quality policy and its effective deployment can only be truly assessed based on the overall results of the audit. 只能等到整个审核有了结果以后才能对质量方针及其展开加以评估Audit methods should include: 审核的方法应当包括： 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) 和最高管理者面谈，理解他们对质量方针的制定和承诺。如何对最高管理者进行审核，另外有单独的指导文件。 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;通过管理评审记录来评价最高管理者在建立、贯彻、监视和完善质量方针方面的承诺和参与的情况。 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;评估管理者是否有效地把质量方针“翻译”成容易被大家理解的文字，让各个层次员工理解，而且和每个应当建立质量目标的职能/层次的地方都建立了质量目标。 Conducting interviews with personnel to verify if they have the required awareness, understanding and knowledge of the way the organizations quality policy relates to their own activity, regardless of the terms used by such people to express their understanding;通过和员工交谈来验证他们是否具有所要求的认识、理解而且懂得如何把质量方针和自己的工作联系起来了。不要计较这些员工使用什么术语来描述他们对质量方针的理解。 Seeking evidence of effective dissemination of the quality policy by appropriate communication.通过适当的沟通方式来寻求传布质量方针的客观证据。2. Auditing quality objectives对质量目标的审核Auditors need to verify that the organizations 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.审核员必须验证组织的整个质量目标已经确定，这些目标必须反映质量方针，而且，和整个商务目标应当是一致的、符合的，其中包括顾客的期望。如果不是这样的情况的话，审核员应当进一步评估最高管理者对质量所做的承诺。The fulfilment of quality objectives needs to be measurable and documented. 质量目标的达成必须可加以测量的而且必须形成文件。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.没有规定用什么方法来标识或者把质量目标形成什么样的文件，这些可以通过商务规划、管理评审的输出、年度的预算等方式都可以的。这就取决于审核员来判定这些目标是否得到充分的文件化了。The auditors should obtain evidence of the way the quality objectives are suitably cascaded throughout the organizations structure and processes, linking the general strategic objectives to management objectives and down to specific operational activities.审核员应当获取审核证据来验证这些质量目标是通过合适的途径在整个组织内部各个结构以及过程中加以落实下去，通过这些质量目标把总的战略目标和管理目标联系起来了，而且落实到特定的运营作业中去了。It is recommended that the documented quality objectives should be examined at the documentation review stage of the audit.推荐在审核第一阶段做文件评审的时候就检查形成文件的质量目标。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. 在审核完成之前，审核员应当对质量目标是否切实可行而且组织是否把这些质量目标落实到有关的负责人，以及为了实现这些目标所必须的资源是否落实感到满意。有关这方面的客观证据应当在组织的各个层次都能得到。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.质量目标不是静止不变的，而是需要调整的，以便能和当前的商务环境相适应，而且应当追求持续改进的。审核员应当验证，整个组织的业绩反映出质量方针的目的合理的满足了这些质量目标。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.审核员应当记住，目标的达成是可以定量或者定型测量的。审核员还应当记住，在质量方针和质量目标以及组织决定持续改进承诺之间应当有清楚的动态修订的联系环节的。3. Auditing Management Review对管理评审的审核ISO 9001:2000 requires top management to review the organizations 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.ISO9001：2000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分开开会来执行，但是，标准对这一点没有规定要求。最高管理者可以采用很多方式来评审质量管理体系，诸如对管理者代表，或者其他人的评审报告加以评审，也可以通过电子通讯方式或者作为日常的管理者会议中的一部分内容，譬如除了讨论ISO9001：2000以外，还讨论财务论预算和目标等内容，都是可以的。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.ISO9001：2000第5.6.2条规定了管理评审的输入过程以及主题内容应当包括在内。但是，在评审时有可能不仅仅这些唯一的主题，也许还有其他的主题作为整个商务活动同时加以评审的。审核员应当懂得管理评审的输入有可能有很多形式，诸如用报告、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, 改进计划和可能的措施 change of resources,资源的变更 revised business plans, 商务规划的修订 budgets.各种预算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求做的，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ISO9001：2000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 organizations business management process.The overall management review is complex process carried out at various levels in