ISO 9001:2000
新版中英文条文范例文件
Contents
0 Introduction
0.1 General
0.2 Process approach
0.3 Relationship with ISO 9004
0.4 Compatibility with other
management systems
1 Scope
1.1 General
1.2 Application
2 Normative reference
3 Terms and definitions
4 Quality management system
4.1 General requirements
4.2 Documentation requirements
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and
communication
5.6 Management review
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
目 录
页次
0.简介
0.1 概述……………………………
2
0.2 过程导向………………………
2
0.3 与ISO 9004之关系……………
5
0.4 与其它管理系统的兼容性……
5
1.范围
1.1总则……………………………
7
1.2应用……………………………
7
2.引用标准……………………………
8
3.术语和定义…………………………
8
4.质量管理系统
4.1一般要求………………………
9
4.2文件化要求……………………
10
5.管理责任
5.1管理者承诺……………………
12
5.2顾客导向………………………
12
5.3质量政策………………………
12
5.4规划……………………………
13
5.5责任、职权与沟通……………
13
5.6管理审查……………………
14
6.资源管理
6.1资源的供应……………………
15
6.2人力资源………………………
15
6.3基础建设………………………
16
6.4工作环境………………………
16
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service
provision
7.6 Control of monitoring and
measuring devices
8 Measurement, analysis and
improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming
product
8.4 Analysis of data
8.5 Improvement
7.产品实现
7.1产品实现的规划………………
17
7.2顾客相关的过程………………
17
7.3
设计
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和开发……………………
19
7.4采购……………………………
22
7.5生产和服务供应………………
23
7.6量测和监控仪器的管制………
25
8.量测、
分析
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和改善
8.1概述……………………………
27
8.2量测和监控……………………
27
8.3不符合产品管制………………
29
8.4资料分析………………………
30
8.5改善……………………………
30
Introduction
0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
0.2 Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
0. 简介
0.1 概述
质量管理系统的导入需要组织的策略决定。一个组织的质量管理系统的设计与实施受不同需要、特定目标、提供产品使用的过程、组织规模大小与结构而影响。这并非意味着本标准含盖质量管理系统的架构一致化或文件一致化。
在本国际标准明确说明质量管理系统是对产品要求的补充。
本标准中“备注”的内容是对标准要求的理解和解释的指导性意见。
本标准也能用于内部和外部(包括验证机构)评审组织满足客户、法规和组织自身要求的能力。
在起草本国际标准时,考虑了在ISO 9000 及9004:2000中所述的质量管理定理。
0.2 过程导向
本国际标准鼓励以过程导向来发展、实施和改善质量管理系统的有效性,以藉由符合顾客要求来强化顾客的满意。
For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
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