ISO9001-GBT19001-2015FDIS中英文对照版

GB/T19001-2015, ISO 9001:2015 idt, (Version:FDIS)

Introduction引言

0.1General总则

The adoption of a quality management system is a strategic decision for an organization that can

help to improve its overall performance and provide a sound basis for sustainable development .

采用质量管理体系应该是组织的一项战略性决策，可以帮助组织改进其整体绩效，并为可持续发展计划提供良好的基础。

The potential benefits to an organization of implementing a quality management system based on this International Standard are:

对于根据本标准实施质量管理体系的组织来说，潜在的收益是：

a) the ability to consistently provide products and services that meet customer and applicable

statutory and regulatory requirements;

a) 稳定提供满足顾客要求和法律法规要求的产品和服务的能力；

b) facilitating opportunities to enhance customer satisfaction;

b) 获取增强顾客满意的机会；

c) addressing risks and opportunities associated with its context and objectives;

c) 应对与组织情境和目标相关的风险；

d) the ability to demonstrate conformity to specified quality management system requirements.

d) 证实符合质量管理体系特定要求的能力。

This International Standard can be used by internal and external parties.

本标准可用于内部和外部。

It is not the intent of this International Standard to imply the need for:

以下方面不是本标准的目的：

- uniformity in the structure of different quality management systems;

- 统一不同质量管理体系的结构；

- alignment of documentation to the clause structure of this International Standard;

- 统一本标准条款结构的文件；

- the use of the specific terminology of this International Standard within the organization.

- 在组织中使用本标准的特定术语。

The quality management system requirements specified in this International Standard are

complementary to requirements for products and services.

本标准所规定的质量管理体系要求是对产品要求的补充。

This International Standard the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

本标准采用过程方法，包括策划-实施-检查-改进（PDCA）循环和基于风险的思维。

The process approach enables an organization to plan its processes and their interactions.

过程方法使组织能够策划组织的过程及其相互作用。

The PDCA cycle enables an organization to ensure that its processes are adequately and managed, and that opportunities for improvement are determined and on.

PDCA循环使组织能够确保其过程得到充分的资源和管理，并确定和实施改进机会。

Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).

基于风险的思维能够使组织确定可能导致其过程和质量管理体系偏离所策划的结果的因素，采取预防性控制，以最小化负面影响并在机会出现时将机会利用最大化（见A.4条款）。

Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment.

To achieve this objective, the organization might find it necessary to adopt various forms of

improvement in addition to correction and continual improvement, such as , innovation and .

在日益变化和复杂的环境中，持续满足要求和应对未来的需求和期望是组织面临的挑战。要实现这个目标，组织可能发现除了纠正和持续改进以外，变革、创新和重组也是必要的。

In this International Standard, the following verbal forms are used:

本标准中采用了以下动词形式：

- “shall” indicates a requirement;

“应”表示要求；

- “should” indicates a recommendation;

“可”表示建议；

- “may” indicates a permission; “可以”表示允许；

- “can” indicates a possibility or a capability.

Information marked as “NOTE” is for guidance in understanding or clarifying the associated

requirement.

标注为“注”的信息是理解或说明相关要求的指南。

0.2 Quality management principles质量管理原则

This International Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each principle, a of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization’s performance when applying the principle.

本标准基于ISO 9000中阐述的质量管理原则，该阐述包括每项原则的说明、对组织的重要性、与该原则相关的益处的示例，以及应用该原则时改进组织绩效所采取的典型措施的示例。

The quality management principles are:

质量管理原则是：

- customer focus;

-以顾客为关注焦点；

- leadership;

- 领导力；

- engagement of people;

- process approach;

- 过程方法；

- improvement;

- 改进；

- evidence-based decision making;

- 基于事实的决策方法；

- relationship management.

0.3 Process approach过程方法

0.3.1 General总则

This International Standard promotes the of a process approach when ,

implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

Specific requirements considered essential to the adoption of a process approach are included in 4.4. 本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。采用过程方法须考虑的特定要求包含在4.4中。

Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results.

This approach enables the organization to control the interrelationships and interdependencies

among the processes of the system, so that the o …… 此处隐藏：4705字，全部文档内容请下载后查看。喜欢就下载吧 ……