9.3.1、总则
最高管理者应按照策划的时间间隔对组织的质量管理体系进行评审,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、管理评审输入
策划和实施管理评审时应考虑下列内容:
a)以往管理评审所采取措施的情况;
b)与质量管理体系相关的内外部因素的变化;
c)下列有关质量管理体系绩效和有效性的信息,包括其趋势:
1)顾客满意和有关相关方的反馈;
2)质量目标的实现程度;
3)过程绩效以及产品和服务的合格情况;
4)不合格及纠正措施;
5)监视和测量结果;
6)审核结果;
7)外部供方的绩效。
8)准时交付业绩;
d)资源的充分性;
e)应对风险和机遇所采取措施的有效性(见6.1);
f)改进的机会。
9.3.3、管理评审输出
管理评审的输出应包括与下列事项相关的决定和措施:
a)改进的机会;
b)质量管理体系所需的变更;
c)资源需求;
d)风险识别。
组织应保留成文信息,作为管理评审结果的证据。
9.3.1、General
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization.
9.3.2、Management Review Inputs
The management review shall be planned and carried out taking into consideration:
a. the status of actions from previous management reviews;
b. changes in external and internal issues that are relevant to the quality management system;
c. information on the performance and effectiveness of the quality management system, including trends in:
1.customer satisfaction and feedback from relevant interested parties;
2.the extent to which quality objectives have been met;
3.process performance and conformity of products and services;
4.nonconformities and corrective actions;
5.monitoring and measurement results;
6.audit results;
7.the performance of external providers;
8.on-time delivery performance;
d. the adequacy of resources;
e. the effectiveness of actions taken to address risks and opportunities (see 6.1);
f. opportunities for improvement.
9.3.3、Management Review Outputs
The outputs of the management review shall include decisions and actions related to:
a. opportunities for improvement;
b. any need for changes to the quality management system;
c. resource needs;
d. risks identified.
The organization shall retain documented information as evidence of the results of management reviews.