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7Support支持

7.1Resources资源

7.1.1 General 总则

The organization shall determine and provide theresources needed for the establishment, implementation, maintenance andcontinual improvement of the quality management system.

The organization shall consider:

a) the capabilities of, and constraints on, existinginternal resources;

b) what needs to be obtained from external providers.

组织应确定和提供建立、实施、保持和持续改进质量管理体系所需的资源。

组织应考虑：

a) 现有内部资源的能力和局限；

b) 需要从外部供方获取的资源。

7.1.2 People 人

The organization shall determine and provide thepersons necessary for the effective implementation of its quality managementsystem 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。

7.1.3Infrastructure基础设施

The organization shall determine, provide and maintainthe infrastructure necessary for the operation of its processes and to achieveconformity of products and services.

NOTE Infrastructure can include:

a) buildings and associated utilities;

b) equipment, including hardware and software;

c) transportation resources;

d) information and communication technology.

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。

注：基础设施可包括：

a) 建筑物和相关的设施；

b) 设备，包括硬件和软件；

c) 运输资源；

d) 信息和通讯技术。

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

The organization shall determine, provide and maintainthe environment necessary for the operation of its processes and to achieveconformity of products and services.

NOTE A suitable environment can be acombination 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,light, airflow, hygiene, noise).

These factors can differ substantiallydepending on the products and services provided.

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。

注：适宜的环境可以是人文的因素和物理的因素的组合，例如：

a) 社会的（如不歧视、平和、不对抗）；

b) 心理的（如降低压力、倦怠预防、情感保护）

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，这些因素可能有显著的差异。

7.1.5Monitoring and measuring resources 监视和测量资源

7.1.5.1General

The organization shall determine and provide theresources needed to ensure valid and reliable results when monitoring ormeasuring is used to verify the conformity of products and services torequirements.

The organization shall ensure that the resourcesprovided:

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

b) are maintained to ensure their continuing fitnessfor their purpose.

The organization shall retain appropriate documentedinformation as evidence of fitness for purpose of the monitoring andmeasurement resources.

7.1.5.1 总则

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) 与所进行的监视和测量活动的具体类型相适应；

b) 得到保持以确保其持续满足使用要求。

组织应保留适当的形成文件的信息，作为监视和测量资源满足使用要求的证据。

7.1.5.2Measurement traceability

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

a) calibrated or verified, or both, at specifiedintervals, or prior to use, against measurement standards traceable tointernational or national measurement standards; when no such standards exist,the basis used for calibration or verification shall be retained as documentedinformation;

b) identified in order to determine their status;

c) safeguarded from adjustments, damage ordeterioration that would invalidate the calibration status

and subsequent measurement results.

The organization shall determine if the validity ofprevious measurement results has been adversely affected when measuringequipment is found to be unfit for its intended purpose, and shall take appropriateaction as necessary.

7.1.5.2 测量的追溯性

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) 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形成文件的信息；

b) 具有标识，以确定其校准状态；

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。

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 Organizationalknowledge 组织知识

The organization shall determine the knowledgenecessary for the operation of its processes and to achieve conformity ofproducts and services.

This knowledge shall be maintained and be madeavailable to the extent necessary.

When addressing changing needs and trends, theorganization shall consider its current knowledge and determine how to acquireor access any necessary additional knowledge and required updates.

NOTE 1 Organizational knowledge is knowledgespecific to the organization; it is gained by experience. It is informationthat is used and shared to achieve the organization’s objectives.

NOTE 2 Organizational knowledge can be basedon:

a) internal sources (e.g. intellectualproperty; knowledge gained from experience; lessons learned from failures andsuccessful projects; capturing and sharing undocumented knowledge andexperience; the results of improvements in processes, products and services);

b) external sources (e.g. standards; academia;conferences; gathering knowledge from customers or external providers).

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。

这些知识应得到维护并在需要时易于获取。

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新。

注1：组织知识是组织的特定知识，是获得的经验，是实现组织目标所使用和分享的信息。

注2：组织知识可以基于：

a) 内部资源（如：知识产权、从经验获得的知识、从失败和成功项目中获得的教训、获取和分享非文件化知识和经验、过程、产品和服务的改进结果）；

b) 外部资源（如：标准、学术交流、会议以及从顾客和供方收集的知识）。

7.2Competence 能力

The organization shall:

a) determine the necessary competence of person(s)doing work under its control that affects the performance and effectiveness ofthe quality management system;.

b) ensure that these persons are competent on thebasis of appropriate education, training, or experience;

c) where applicable, take actions to acquire thenecessary competence, and evaluate the effectiveness of the actions taken;

d) retain appropriate documented information asevidence of competence.

NOTE Applicable actions can include, forexample, the provision of training to, the mentoring of, or the reassignment

of currently employed persons; or the hiringor contracting of competent persons.

组织应：

a) 确定在组织控制下从事影响质量管理体系绩效和有效性工作的人员的必要能力；

b) 基于适当的教育、培训或经验，确保这些人员是胜任的；

c) 适用时，采取措施以获取所需的能力，并评价这些措施的有效性；

d) 保留适当的形成文件的信息作为能力的证据。

注：适用的措施可以包括，如为现有员工提供培训、辅导或重新分配工作，雇佣或外包胜任的人员。

7.3Awareness 意识

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

a) the quality policy;

b) relevant quality objectives;

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

d) the implications of not conforming with the quality management systemrequirements.

组织应确保在组织控制下工作的有关人员意识到：

a) 质量方针；

b) 相关的质量目标；

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) 不符合质量管理体系要求可能引发的后果。

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7.4Communication 沟通

The organization shall determine the internal andexternal communications relevant to the quality management system, including:

a) on what it will communicate;

b) when to communicate;

c) with whom to communicate;

d) how to communicate;

e) who communicates.

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) 沟通的内容；

b) 沟通的时机；

c) 沟通的对象；

d) 如何沟通；

e) 谁负责沟通。

7.5Documented information 形成文件的信息

7.5.1 General 总则

The organization’s quality management system shallinclude:

a) documented information required by thisInternational Standard;

b) documented information determined by theorganization as being necessary for the effectiveness of the quality managementsystem.

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

— the size of organization and its type ofactivities, processes, products and services;

— the complexity of processes and theirinteractions;

— the competence of persons.

组织的质量管理体系应包括：

a) 本标准要求的形成文件的信息；

b) 组织确定的为确保质量管理体系有效运行所需的形成文件的信息。

注：不同组织的质量管理体系形成文件的信息的程度可以因以下方面而不同：

--组织的规模、活动、过程、产品和服务的类型；

--过程及其相互作用的复杂程度；

-- 人员的能力。

7.5.2 Creatingand updating 编制和更新

When creating and updating documented information, theorganization shall ensure appropriate:

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

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

c) review and approval for suitability and adequacy.

在编制和更新形成文件的信息时，组织应确保适当的：

a) 标识和说明（例如：标题、日期、作者、文件编号等）；

b) 格式（例如：语言、软件版本、图示）和媒介（例如：纸质、电子）；

c) 评审和批准以确保适宜性和充分性。

7.5.3 Controlof documented Information 形成文件的信息的控制

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

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

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

7.5.3.1 应对质量管理体系和本标准所要求的形成文件的信息进行控制，以确保：

a) 在需要使用文件之处和之时能获得适用的文件；

b) 文件得到充分地保护（如防止泄密、使用不当、缺损）。

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

a) distribution, access, retrieval and use;

b) storage and preservation, including preservation oflegibility;

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

d) retention and disposition.

Documented information of external origin determinedby the organization to be necessary for the planning and operation of thequality management system shall be identified as appropriate, and becontrolled.

Documented information retained as evidence ofconformity shall be protected from unintended alterations.

NOTE Access can imply a decision regarding thepermission to view the documented information only, or the

permission and authority to view and changethe documented information.

7.5.3.2 适用时，组织应实施以下活动对形成文件的信息进行控制：

a) 分发、获取、检索和使用；

b) 储存、保护，包括保存易读性；

c) 更改的控制（如：版本控制）；

d) 保留和处置。

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。

作为符合性证据保留的形成文件的信息应妥善保存以防止其非预期的失效。

注：获取是指有关形成文件的信息访问许可的决定，或访问和更改形成文件的信息的许可和权力。

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