ISO9001-GBT19001-2015FDIS中英文对照版(2)

图2展示了第4章到第10章分别与PDCA的关联。

The Figure 2 - Representation of the structure of this International Standard in the PDCA cycle

图2：本标准中的 PDCA 循环

The PDCA cycle can be briefly described as follows:

PDCA模式可以简要描述如下：

- Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies;

Plan – 策划：根据顾客要求和组织方针，为提供结果建立体系目标及其过程，以及所需的资源；

- Do: implement what was planned;

Do – 实施：实施所策划的（安排）；

- Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements and report the results;

Check – 检查：根据方针、目标和要求，对过程、产品和服务进行监视和测量（适用时），并报告结果；

- Act: take actions to improve performance, as necessary.

Act – 处置：必要时，采取措施，以改进过程绩效。

0.3.3 Risk-based thinking基于风险的思维

Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management

system. The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity.

为实现有效的质量管理体系，基于风险的思维（见A.4条款）是必要的。基于风险的思维的概念在本标准的以往版本中一直是没有言明的，包括如实施预防措施以消除潜在不合格、分析发生的不合格并采取与不合格的影响相适应的措施防止其再发生。

To conform to the requirements of this International Standard, an organization needs to plan and

implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects.

为符合本标准的要求，组织需要策划和实施应对风险和机会的措施。应对风险和机会是为提高质量管理体系有效性、实现改进的结果并防止负面影响建立基础。

Opportunities can arise as a result of a situation favourable to achieving an intended result, for

example, a set of circumstances that allow the organization to attract customers, develop new products

and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have

positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.

机会可以形成有益于实现预期结果的状况的结果，例如，让组织吸引顾客、开发新产品和服务、减少浪费或改进生产效率的一系列情况。应对机会的措施还可以包括对相关风险的考虑。风险是不确定的影响，这种不确定可能是正面或负面的影响。来自风险的负面偏离可以提供机会，但不是风险的所有负面影响都能产生机会。

0.4 Relationship with other management system standards与其他管理体系标准的关系

This International Standard applies the framework developed by ISO to improve alignment among its International Standards for management systems (see Clause A.1).

本标准采用了ISO 为改进其管理体系国际标准间的一致性而开发的框架（见A.1条款）。

This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards.

本标准能够是使组织应用过程方法，再加上PDCA循环和基于风险的思维，使其质量管理体系与与其他管理体系标准的要求保持一致或整合。

This International Standard relates to ISO 9000 and ISO 9004 as follows:

- ISO 9000 Quality management systems - Fundamentals and vocabulary provides essential

background for the proper understanding and implementation of this International Standard;

- ISO 9004 Managing for the sustained success of an organization - A quality management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard.

本标准与 ISO 9000 和 ISO 9004 相关联：

ISO 9000 质量管理体系 基础和术语 为本标准的正确理解和实施提供了必要的背景

ISO 9004 组织持续成功的管理 一种质量管理方法 为选择超越本标准要求的发展的组织提供了指南 Annex B provides details of other International Standards on quality management and quality

management systems that have been developed by ISO/TC 176.

附录B 提供了ISO TC/176 开发的与质量管理和质量管理体系有关的其他标准的信息。

This International Standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management.

本标准不包括针对其他管理体系的特定要求，如环境管理、职业健康安全管理或财务管理。

Sector-specific quality management system standards based on the requirements of this

International Standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this International Standard within the particular sector ISO/FDIS 9001:2015(E)

已开发了一部分基于本标准要求的特定行业的质量管理体系标准，这些标准中的某些标准规定了附加的质量管理体系要求，而其他标准限于为本标准在特定行业内的应用提供指南。

在 ISO/TC 176/SC 2 公开获取网站找到本标准和 ISO 9001:2008 标准条款的对照矩阵表。

A matrix showing the correlation between the clauses of this edition of this International Standard and the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at:

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