如何审核质量方针、质量目标和管理评审

International Organization for Standardization International Accreditation Forum

Date: 5 June 20092009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 theguidance 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 theestablishment, 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 andguidelines 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 ofthe way the organization’s quality policy relates to their own activity, regardless of the terms used by such people to expresstheir 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. Ifthis 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 areadequately 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’sstructure and processes, linking the general strategic objectives to management objectives and down to specific operationalactivities.

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 theaudit.

（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, andthat the organization has assigned to responsible personnel the resources needed to meet their objectives. Evidence of thisshould 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 continualimprovement. Auditors should verify that the overall performance of the organization reflects the aims of the quality policyand 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. Theyshould also remember that there is a clear link between the dynamic aspects of revising the quality policy and the qualityobjectives 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 ensureits continuing suitability, adequacy and effectiveness. The review could be carried out at a separate meeting but this is not arequirement of the standard. There are many ways in which top management can review the quality management systemsuch 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 simultaneouslybut as part of an overall review of the business. Auditors should be aware that inputs could be in many forms such asreports, 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 tointroduce 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 mostcommon 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 toprocesses and systems are being considered. Where this is the case, the auditors should review whether or not thefollowing 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 orbusiness?

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 andthe auditors; it should be an integral part of the organization’s business management process. The overall managementreview is complex process carried out at various levels in the organization. It is always a two-way process, generated by topmanagement 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 theorganization’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。

审核的⽬的不是为了查不符合项。是否判定不符合，应当根据审核的⽬的，审核⽤的准则，还有不符合的客观事实来确定。并不是所有的不符合都要开不符合报告。譬如，当您发现某产品不符合，您是做体系审核。被审核⽅对不符合产品按照体系程序在操作，体系仍然是符合的；不应当再开不符合报告了。同样道理，当您发现⽬标没有达成，看他们是否已经知道，是否正在采取措施，是否执⾏体系程序有关的规定。如果是，也就是符合体系的要求了；反之，当然要开不符合报告。凡是审核发现不符合，开出不符合报告，⼀定要采取纠正措施，从体系完善的⾓度来看，这样的体系完善后，同类问题不应当再次发⽣。提⾼了体系有效性和效率（如果有要求的话），这样审核就起到了增值作⽤，达到体系审核的⽬的了。

当您发现⽬标没有达到，已经晚了。应当通过审核发现趋势有可能⽬标完不成，就应当提出来，采取措施了。这⾥的⽬标包括进度⽬标值。新版本的AS 9100第5.2条增加要求：最⾼管理者必须确保产品符合性和及时交付业绩被测量，如果策划的结果不能达到，或将不能达到时，必须采取适当的措施。