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9Performance evaluation 绩效评价

9.1Monitoring, measurement, analysis and evaluation 监视、测量、分析和评价

9.1.1 General总则

The organization shall determine:

a) what needs to be monitored and measured;

b) the methods for monitoring, measurement, analysisand evaluation needed to ensure valid results;

c) when the monitoring and measuring shall be performed;

d) when the results from monitoring and measurementshall be analysed and evaluated.

The organization shall evaluate the performance andthe effectiveness of the quality management system.

The organization shall retain appropriate documented information asevidence of the results..

组织应确定：

a) 所需要的监视和测量；

b) 所需的监视、测量、分析和评价方法，以确保有效的结果；

c) 实施监视和测量的时机；

d) 分析和评价监视和测量的结果的时机。

组织应评价质量管理体系绩效和有效性。

组织应保留适当的形成文件的信息作为结果的证据。

9.1.2 Customersatisfaction 顾客满意

The organization shall monitor customers’ perceptionsof the degree to which their needs and expectations have been fulfilled. Theorganization shall determine the methods for obtaining, monitoring andreviewing this information.

NOTE Examples of monitoring customerperceptions can include customer surveys, customer feedback on deliveredproducts and services, meetings with customers, market-share analysis,compliments, warranty claims and dealer reports..

组织应监视顾客对其要求和期望得到满足的程度的感受。组织应确定获取、监视和评审该信息的方法。

注：监视顾客感受的示例可以包括顾客调查、顾客对已交付产品或服务的反馈、顾客交流会议、市场占有率分析、赞扬、索赔担保和经销商报告。

9.1.3 Analysisand evaluation 分析和评价

The organization shall analyse and evaluateappropriate data and information arising from monitoring and measurement.

The results of analysis shall be used to evaluate:

a) conformity of products and services;

b) the degree of customer satisfaction;

c) the performance and effectiveness of the qualitymanagement system;

d) if planning has been implemented effectively;

e) the effectiveness of actions taken to address risksand opportunities;

f) the performance of external providers;

g) the need for improvements to the quality managementsystem.

NOTE Methods to analyse data can includestatistical techniques.

组织应分析、评价来自监视和测量的适当数据和信息。

应将分析结果用于评价：

a) 产品和服务的符合性；

b) 顾客满意程度；

c) 质量管理体系绩效和有效性；

d) 策划是否得到有效实施；

e) 所采取的应对风险和机会的措施的有效性；

f) 外部供方的绩效；

g) 质量管理体系改进的需求。

注：分析数据的方法可以包括统计技术。

9.2 Internal audit 内部审核

9.2.1 Theorganization shall conduct internal audits at planned intervals to provideinformation on whether the quality management system:

a) conforms to:

1) the organization’s ownrequirements for its quality management system;

2) the requirements ofthis International Standard;

b) is effectively implemented and maintained.

9.2.1 组织应按策划的时间间隔进行内部审核，以确定质量管理体系是否：

a) 符合：

1) 组织对其质量管理体系的要求；

2) 本标准的要求；

b) 得到有效实施和保持。

9.2.2 Theorganization shall:

a) plan, establish, implement and maintain an auditprogramme(s) including the frequency, methods, responsibilities, planningrequirements and reporting, which shall take into consideration the importanceof the processes concerned, changes affecting the organization, and the resultsof previous audits;

b) define the audit criteria and scope for each audit;

c) select auditors and conduct audits to ensureobjectivity and the impartiality of the audit process;

d) ensure that the results of the audits are reportedto relevant management;

e) take appropriate correction and corrective actionswithout undue delay;

f) retain documented information as evidence of theimplementation of the audit programme and the

audit results.

NOTE See ISO 19011 for guidance

9.2.2 组织应：

a) 策划、建立、实施和保持一个或多个审核方案，包括审核的频次、方法、职责、策划要求和报告编制，审核方案应考虑有关过程的重要性、影响组织的变化和以往审核的结果；

b) 确定每次审核的准则和范围；

c) 选择审核员和实施审核，确保审核过程的客观性和公正性；

d) 确保将审核结果报告给有关管理者；

e) 及时采取适当的纠正和纠正措施；

f) 保持形成文件的信息，作为审核方案实施和审核结果的证据。

注：见ISO 19011 管理体系审核指南。

9.3Management review 管理评审

9.3.1 General 总则

Top management shall review the organization’s qualitymanagement system, at planned intervals, to ensure its continuing suitability,adequacy, effectiveness and alignment with the strategic direction of the organization.

最高管理者应按策划的时间间隔评审组织的质量管理体系，以确保其持续的适宜性、充分性和有效性，并与组织的战略方向保持一致。

9.3.2 Managementreview input管理评审输入

The management review shall be planned andcarried out taking into consideration:

a) the status of actions from previousmanagement reviews;

b) changes in external and internal issuesthat are relevant to the quality management system;

c) information on the performance andeffectiveness of the quality management system, including trends in:

1) customersatisfaction and feedback from relevant interested parties;

2) the extentto which quality objectives have been met;

3) processperformance and conformity of products and services;

4)nonconformities and corrective actions;

5) monitoringand measurement results;

6) auditresults;

7) theperformance of external providers;

d) the adequacy of resources;

e) the effectiveness of actions taken toaddress risks and opportunities (see 6.1);

1. f)opportunities for improvement.

策划和实施管理评审时应考虑：

a) 以往管理评审的措施的状况；

b) 与质量管理体系有关的外部和内部的变更；

c) 质量管理体系绩效和有效性的信息，包括以下方面的趋势：

1) 顾客满意和来自相关方的反馈；

2) 质量目标的实现程度；

3) 过程绩效及产品和服务的符合性；

4) 不合格和纠正措施；

5) 监视和测量结果；

6) 审核结果；

7) 外部供方的绩效；

d) 资源的充分性；

e) 所采取的应对风险和机会的措施的有效性（见6.1）；

f) 改进机会。

9.3.3management review output 管理评审输出

The outputs of the management review shall includedecisions and actions related to:

a) opportunities for improvement;

b) any need for changes to the quality managementsystem;

c) resource needs.

The organization shall retain documented information as evidence of theresults of management reviews.

管理评审的输出应包括与以下方面有关的决定和措施：

a）改进的机会；

b) 质量管理体系变更的需求；

c) 资源需求。

组织应保留形成文件的信息，作为管理评审的结果的证据。

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