1X00415H01模块备件

1X00377H01

2质量管理体系实现示例
见表A.1。表A.2给出了实施支持的示例。
表A.1——质量管理体系实现活动
活动责任说明
1.向主要部门高管理层提供的信息
相关质量管理体系的要求
标准，以及组织和
质量管理体系设计顾问
发展
顾问
2.分析
组织的客户和其他相关方。
注：通常使用初始评估的结果
a） 为了确定组织的优势和劣势，
机会和威胁，
b） 理解并帮助定义其质量政策，以及
目标，
c） 作为规划质量管理体系的基础，
d） 评估所需资源的可用性，以：
实施质量管理体系，
e） 作为初始审计的基础，以及
f） 建立可衡量的目标。
组织的高管理层（顾问可以提供：
协助）
3.任命管理者代表和
确定政策、目标和
质量承诺。
组织的高管理层（顾问可以提供：
协助）
将此类目标参考到适当的水平，以及
组织内的职能。
4.深入分析组织结构、流程和，
通信渠道和现有接口。
管理者代表和顾问，以及
各职能负责人的合作
在组织内，确定所需的过程和责任
以实现质量目标。
序列的定义以及它们之间的相互作用
过程。
5.制定定义质量管理的计划
系统架构，用于识别和开发
质量管理体系所需的程序。到
评估实施的进度和质量
行动、适当的里程碑应在
计划。评估可参考：
a） 已准备的内容与
开发和合同目标，
b） 工作进度，以及
c） 组织的满意度（关于
质量管理体系提供的服务
顾问）。
管理者代表和顾问
6.审查所进行分析的结果，以及
事先准备好的计划。
组织的高管理层和顾问
7.确定实现以下目标所需的内部资源：
组织的质量目标。
组织（顾问可提供协助）
8.培训负责开发的人员
质量管理体系实现活动，
以及本组织的其他人员（“调解人”）
卷入的
管理者代表和顾问

1X00377H01

1X00377H01
2 Example of the realization of a quality management system See Table A.1. Table A.2 gives an example of implementation support. Table A.1 — Quality management system realization activities Description of activity Responsibility 1. Information to top management of the main requirements of the relevant quality management system standard, and the roles of the organization and the consultant in quality management system design and development. Consultant 2. Analysis of the needs and expectations of the organization's customers and other interested parties. NOTE The results of the initial evaluation are generally used a) to establish the organization's strengths and weaknesses, opportunities and threats, b) to understand and help to define its quality policy and objectives, c) as a basis for planning the quality management system, d) to assess the availability of the resources needed to implement the quality management system, e) as a basis for initial auditing, and f) for the establishment of measurable objectives. Organization's top management (consultant can provide assistance) 3. Appointment of a management representative and the establishment of definitions of policy, objectives and commitments for quality. Organization's top management (consultant can provide assistance) Reference of such objectives to appropriate levels and functions within the organization. 4. In-depth analysis of organizational structure, processes, channels of communication and existing interfaces. Management representative and consultant, with the cooperation of the persons in charge of the various functions within the organization Identification of the processes and responsibilities needed to achieve the quality objectives. Definition of sequence and interactions among such processes. 5. Set up of a plan for defining the quality management system architecture and for identifying and developing the procedures needed for the quality management system. To assess the progress and quality of the implemented actions, appropriate milestones should be defined within the plan. The assessments may refer to a) consistency between what has been prepared and developed and the contractual objectives, b) work progress, and c) satisfaction of the organization (with regard to the services provided by the quality management system consultant). Management representative and consultant 6. Review of the results of the analysis carried out and of the plan prepared in advance. Organization's top management and consultant 7. Identification of internal resources needed to achieve the organization's quality objectives. Organization (consultant can provide assistance) 8. Training of the persons responsible for developing activities for the quality management system realization, and of the organization's other personnel (“facilitators”) involved. Management representative and consultant