ISO9001-GBT19001-2015FDIS中英文对照版(6)

The organization shall ensure that persons doing work under the organization’s control are aware of:

组织应确保在组织控制下工作的有关人员意识到：

a) the quality policy;

a) 质量方针；

b) relevant quality objectives;

b) 相关的质量目标；

c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance;

c) 他们对质量管理体系有效性的贡献，包括改进绩效的益处；

d) the implications of not conforming with the quality management system requirements.

d) 不符合质量管理体系要求可能引发的后果。

7.4 Communication 沟通【5.5.3】

The organization shall determine the internal and external communications relevant to the quality management system including:

组织应确定与质量管理体系有关的内部和外部沟通，包括：

a) on what it will communicate;

a) 沟通的内容；

b) when to communicate;

b) 沟通的时机；

c) with whom to communicate;

c) 沟通的对象；

d) how to communicate.

d) 如何沟通；

e) who communicates.

e) 谁负责沟通。

7.5 Documented information 文件化信息【4.2】

7.5.1 General 总则【4.2.1】

The organization’s quality management system shall include

组织的质量管理体系应包括：

a) documented information required by this International Standard;

a) 本标准要求的文件化信息；

b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.

b) 组织确定的为确保质量管理体系有效运行所需的文件化信息。

NOTE The extent of documented information for a quality management system can differ from one organization to another due to:

- the size of organization and its type of activities, processes, products and services;

- the complexity of processes and their interactions;

- the competence of persons.

注：不同组织的质量管理体系文件化信息的程度可以因以下方面而不同：

a) 组织的规模、活动、过程、产品和服务的类型；

b) 过程及其相互作用的复杂程度；

c) 人员的能力。

7.5.2 Creating and updating 编制和更新【4.2.3 4.2.4】

When creating and updating documented information the organization shall ensure appropriate:

在编制和更新文件时，组织应确保适当的：

a) identification and description (e.g. a title, date, author, or reference number);

a) 标识和说明（例如：标题、日期、作者、文件编号等）；

b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);

b) 格式（例如：语言、软件版本、图示）和媒介（例如：纸质、电子）；

c) review and approval for suitability and adequacy.

c) 评审和批准以确保适宜性和充分性。

7.5.3 Control of documented Information 文件化信息的控制【4.2.3 4.2.4】

7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:

7.5.3.1 应对质量管理体系和本标准所要求的文件化信息进行控制，以确保：

a) it is available and suitable for use, where and when it is needed;

a) 在需要使用文件之处和之时能获得适用的文件；

b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

b) 文件得到充分地保护（如防止泄密、使用不当、缺损）。

7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:

7.5.3.2 适用时，组织应实施以下活动对文件化信息进行控制：

a) distribution, access, retrieval and use;

a) 分发、获取、检索和使用；

b) storage and preservation, including preservation of legibility;

b) 储存、保护，包括保持清晰；

c) control of changes (e.g. version control);

c) 更改的控制（如：版本控制）；

d) retention and disposition.

d) 保留和处置。

Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled. 组织所确定的策划和运行质量管理体系所需的外来文件应得到适当的识别和控制。

NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.

注：获取是指有关文件化信息浏览许可的决定，或浏览和更改文件化信息的许可和权力。

8 Operation 运行

8.1 Operational planning and control 运行的策划和控制【7】

8.1 运行的策划和控制

The organization shall plan, implement and control the processes, as outlined (see 4.4), needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.1, by:

组织应策划、实施和控制满足产品和服务提供要求所需的过程（见4.4），并实施第6章确定的措施： a) determining the requirements for the products and services;

a) 确定产品和服务的要求；

b) establishing criteria for:

1) the processes;

2) the acceptance of products and services;

b) 建立以下准则：

1) 过程；

2) 产品和服务接收。

c) determining the resources needed to achieve conformity to the product and service requirements;

c) 确定为达到产品和服务符合要求所需的资源；

d) implementing control of the processes in accordance with the criteria;

d) 按照准则实施过程控制；

e) determining and keeping documented information to the extent necessary:

1) to have confidence that the processes have been carried out as planned;

2) to demonstrate the conformity of products and services to their requirements.

e) 确定和保持必要的文件化信息：

1) 确信过程已按照策划予以实施；

2) 证实产品和服务与其要求的符合性。

NOTE “Keeping” implies both the maintaining and the retaining of documented information.

注：“保持”是指文件化信息的维护和保留。

The output of this planning shall be suitable for the organization’s operations.