ISO9001-GBT19001-2015FDIS中英文对照版(5)

b) the integrity of the quality management system;

b) 质量管理体系的完整性；

c) the availability of resources;

c) 资源的获得；

d) the allocation or reallocation of responsibilities and authorities.

d) 职责和权限的分配与再分配。

7 Support 支持【6】

7.1 Resources资源【6】

7.1.1 General 总则【6.1】

The organization shall determine and provide the resources needed for the establishment,

implementation, maintenance and continual improvement of the quality management system.

The organization shall consider:

组织应确定和提供建立、实施、保持和改进质量管理体系所需的资源。

组织应考虑：

a) the capabilities of, and constraints on, existing internal resources;

a) 现有内部资源的能力和局限；

b) what needs to be obtained from external providers.

b) 需要从外部供方获取的资源。

7.1.2 People 人员【6.1】

The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

组织应确定和提供质量管理体系有效实施及过程的运行和控制所需的人员。

7.1.3 Infrastructure基础设施【6.3】

The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.

组织应确定、提供并维护为达到产品和服务符合要求的过程的运行所需的基础设施。

NOTE Infrastructure can include:

注：基础设施可包括：

a) buildings and associated utilities;

a) 建筑物和相关的设施；

b) equipment including hardware and software;

b) 设备（包括硬件和软件）；

c) transportation;

c) 运输资源；

d) information and communication technology.

d) 信息和通讯技术。

7.1.4 Environment for the operation of processes 过程运行环境【6.4】

The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.

组织应确定、提供并维护过程的运行和达到产品和服务的符合性所需的环境。

NOTE A suitable environment can be a combination of human and physical factors, such as:

a) social (e.g. non-discriminatory, calm, non-confrontational);

b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);

c) physical (e.g. temperature, heat, humidity, humidity, light, airflow, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.

注：适宜的环境可以是人的因素和物的因素的组合，例如：

a) 社会的（如不歧视、平和、不对抗）；

c) 物理的（温度、热度、湿度、照明、空气流通、卫生、噪音）

根据所提供的产品和服务，这些因素可能有很大的不同。

7.1.5 Monitoring and measuring resources 监视和测量资源【7.6】

7.1.5.1General总则【7.6】

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided:

当监视或测量用于产品和服务符合特定要求的证据时，组织应确定和提供所需的资源以确保有效和可靠的结果。

组织应确保所提供的资源：

a) are suitable for the specific type of monitoring and measurement activities being undertaken;

a) 与所进行的监视和测量活动的具体类型相适应；

b) are maintained to ensure their continuing fitness for their purpose.

b) 得到维护以确保其持续满足使用要求。

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

组织应保持适当的文件化信息，作为监视和测量资源满足使用要求的证据。

7.1.5.2 测量的追溯性【7.6】

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:

对测量有追溯性要求或组织认为是提供测量结果的有效性信心的必要部分时，测量设备应：

a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards;

when no such standards exist, the basis used for calibration or verification shall be retained as

documented information;

a) 对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前进行检定或校准，或两者都进行。当不存在上述标准时，应保留作为校准或检定依据的文件化信息；

b) identified in order to determine their status;

b) 具有标识，以确定其校准状态；

c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

c) 防止可能使校准状态和后续测量结果失效的调整、损坏或退化。

The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take

appropriate action as necessary.

当发现测量设备不能满足其预期使用要求时，组织应确定以往测量结果的有效性是否受到不利影响，必要时，采取适当的纠正措施。

7.1.6 Organizational knowledge 组织知识【NEW】

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

组织应确定过程的运行和达到产品和服务的符合性所需的知识。

knowledge shall be maintained, and made available to the extent necessary.

这些知识应得到维护并在需要时易于获取。

When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge.

在应对变化的需求和趋势时，组织应考虑现有的知识，确定如何获取必要的附加知识和所需的更 …… 此处隐藏：4504字，全部文档内容请下载后查看。喜欢就下载吧 ……