6.4.2 Selection, evaluation and improvement of the capabilities of suppliers and partners

The organization should establish and maintain processes to identify, select, and evaluate its suppliers and

partners, in order to continually improve their capabilities and to ensure that the products or other resources

they provide meet the needs and expectations of the organization.

In selecting and evaluating suppliers and partners, the organization should consider issues such as

their contribution to the organization's activities and ability to create value for the organization and its interested parties,

the potential for continually improving their capabilities,

the enhancement of its own capabilities that can be achieved through co-operation with the suppliers and partners, and

the risks associated in the relationships with the suppliers and partners.

Together with its suppliers and partners, the organization should seek to continually improve the quality, price

and delivery of products provided by the suppliers and partners, and the effectiveness of their management

systems, based on periodic evaluation and feedback of their performance.

The organization should continually review and strengthen its relationships with its suppliers and partners,

while considering the balance between its short- and long-term objectives.

6.4.2选择、评价和改进供方和伙伴的能力

组织应当建立并保持过程以识别、选择、评价其供方和伙伴，以持续提升他们的能力确保其提供的产品或者其他资源满足组织的要求或期望。在选择和评价供方或伙伴时，组织应当考虑下列：

他们对组织活动的贡献，为组织创造价值的能力、他们的利益相关方

潜力或者持续改进的能力

通过与其供方或者伙伴合作增强其自身的能力

与其供方或伙伴关系上存在的风险

组织应与其供方或者伙伴以定期的评价和业绩的反馈为基础，一道寻求持续提升质量、（降低）价格、产品运输、管理有效性。组织应当持续检查和加强与供方或者伙伴的关系，考虑短期和长期目标的平衡

6.5 Infrastructure

The organization should plan, provide and manage its infrastructure effectively and efficiently. It should

periodically assess the suitability of the infrastructure to meet organizational objectives. Appropriate

consideration should be given to

the dependability of the infrastructure (including consideration of availability, reliability, maintainability,

and maintenance support),

safety and security,

infrastructure elements related to products and processes,

the efficiency, cost, capacity and work environment, and

the impact of the infrastructure on the work environment.

The organization should identify and assess the risks associated with the infrastructure and take action to

mitigate the risks, including the establishment of adequate contingency plans.

NOTE For more information about environmental impacts, see ISO 14001 and other standards prepared by

ISO/TC 207.

6.5 基础设施

组织应当计划、提供、管理其基础设施的充分性和有效性。应当定期评估基础设施是否与组织目标相适应。应当考虑到：

基础设施的可靠性（包括考虑可用性，可靠性，可维护性，支持和维护）

安全和安保

与产品和过程相关的基础设施要素

有效性、成本、能力和工作环境、

基础设施对工作环境的影响

组织应当识别和评估与基础设施有关的风险，采取措施减低风险包括建立适当的应急计划

注：关于环境影响的更多信息请参阅ISO14001和ISO/TC207 的其他标准

6.6 Work environment

The organization should provide and manage a suitable work environment to achieve and maintain the

sustained success of the organization and the competitiveness of its products. A suitable work environment,

as a combination of human and physical factors, should include consideration of

⎯ creative work methods and opportunities for greater involvement to realize the potential of people in the

organization,

⎯ safety rules and guidance and the use of protective equipment,

⎯ ergonomics,

⎯ psychological factors, including workload and stress,

⎯ workplace location,

⎯ facilities for people in the organization,

⎯ maximization of efficiency and minimization of waste,

⎯ heat, humidity, light, airflow, and

⎯ hygiene, cleanliness, noise, vibration and pollution.

The work environment should encourage productivity, creativity and well-being for the people who are working

in or visiting the organization's premises (e.g. customers, suppliers, and partners). At the same time, the

organization should ensure that its work environment complies with applicable statutory and regulatory

requirements and addresses applicable standards (such as those for environmental and occupational health

and safety management).

6.6工作环境

组织应当提供并管理适当的工作环境，以获取和保持组织的持续成功和产品的竞争力。适宜的工作环境是人的因素和物理因素的结合体，包括创造性的工作方法更加投入以发挥员工的潜力。

安全规则和指导以及防护设备的使用，
人体工程学，
心理因素，包括工作量和压力，

工作场所的位置，
设施
最大化的效率和减少废物，
热，湿度，光照，气流，
卫生，清洁，噪音，振动和污染。

工作环境应当有助于提高产量、创造性、工作人员和访问人员（顾客、供方和伙伴）的健康。同时，组织应当确保其工作环境满足使用的法律法规标准（如环境和职业健康和安全管理的）要求

6.7 Knowledge, information and technology
6.7.1 General
The organization should establish and maintain processes to manage knowledge, information and technology
as essential resources. The processes should address how to identify, obtain, maintain, protect, use and
evaluate the need for these resources. The organization should share such knowledge, information and
technology with its interested parties, as appropriate.
6.7知识、信息和技术
6.7.1总则
组织应当建立并保持过程将知识、信息和及时作为关键资源进行管理。该过程应当指明如何识别、获取、保持、保护、使用和评价这些资源。必要时与利益相关方分享这些知识、信息和技术
6.7.2 Knowledge
Top management should assess how the organization's current knowledge base is identified and protected.
Top management should also consider how to obtain the knowledge required to meet the present and future
needs of the organization from internal and external sources, such as academic and professional institutions.
There are many issues to consider when defining how to identify, maintain and protect knowledge, such as
⎯learning from failures, near miss situations and successes,
⎯capturing the knowledge and experience of people in the organization,
⎯gathering knowledge from customers, suppliers and partners,
⎯capturing undocumented knowledge (tacit and explicit) that exists within the organization,
⎯ensuring the effective communication of important information content (particularly at each interface in the
supply and production chains), and
⎯managing data and records.
6.7.2知识
最高管理者应当评估组织当前的知识库是否得到了识别和保护。最高管理者应当考虑如何从内外部渠道（如学院、专业机构）获取满足组织当前和未来需要的知识。在界定如何识别、保持和保护知识的时候需要考虑：
从失败、近乎失败和成功中学习
从组织的员工那里获取知识和经验
从顾客、供方和伙伴处获取知识
在组织内整理不成文的知识（显性和隐形）
确保重要信息内容的有效沟通（特别是在供应和生产的每个接口）
管理数据和记录
6.7.3 Information
The organization should establish and maintain processes to gather reliable and useful data and for
converting such data into the information necessary for decision making.
This includes the processes needed for the storage, security, protection, communication and distribution of
data and information to all relevant parties. The organization's information and communication systems need
to be robust and accessible, to ensure their capabilities. The organization should ensure the integrity,
confidentiality and availability of information relating to its performance, process improvements, and on
progress towards the achievement of sustained success.
6.7.3信息
组织应当建立并保持过程搜集可靠和有用的数据，将其转化成决策所需的信息。该过程需要储存、保密、保护、沟通和传递数据和信息给所有相关方。组织的信息和沟通体系需要是强大和可接入的以确保其能力。组织应当确保其完整、保密性、有能力获取和业绩、过程改进、面向持续成功相关的信息。

6.7.4 Technology
Top management should consider technological options to enhance the organization's performance in areas
such as product realization, marketing, benchmarking, customer interaction, supplier relations and outsourced
processes. The organization should establish processes for the assessment of
⎯the current levels of technology inside and outside the organization, including emerging trends.
⎯economic costs and benefits,
⎯the evaluation of risks related to changes in technology,
⎯the competitive environment, and
⎯its speed and ability to react to customer requirements promptly, to ensure that it remains competitive.
NOTE For more information on how to protect knowledge, see ISO/IEC 27000 and other standards prepared by
ISO/JTC 1/SC 27 on information technology security techniques.
6.7.4技术
最高管理者应当考虑技术选项以增强组织在产品实现、市场、基准、顾客关系、供方关系、外包过程的表现。
组织应当建立过程评估下列：
组织内外部当前的技术水平和未来趋势
经济成本和效益，
相关的技术变革风险评估，
竞争环境
对顾客要求实时反映的速度和能力，以确保其保持竞争力
注：了解更多信息请参阅ISO/IEC27000和ISO/JTC 1/SC27提供的其他标准
6.8 Natural resources
The availability of natural resources is one of the factors that can influence an organization's sustained
success and ability to meet the requirements of its customers and other interested parties. The organization
should consider the risks and opportunities related to the availability and use of energy and natural resources
in the short and long term.
The organization should give appropriate consideration to the integration of environmental protection aspects
into product design and development, as well as to the development of its processes to mitigate identified
risks.
The organization should seek to minimize environmental impacts over the full life cycle of its products and its
infrastructure, from design, through manufacturing or service delivery, to product distribution, use and
disposal.
NOTE For more information, see ISO 14001 and other standards prepared by ISO/TC 207 on environmental
management.
6.8自然资源
组织获取自然资源的能力是其获得持续成功和满足顾客及相关方要求能力的影响因素之一。组织应当考虑短期的和长期的与资源和能源获取和使用相关的风险和机会。组织应当适当考虑在产品设计和使用中与环境保护的要求向一致，建立过程减低环保风险。组织应当在产品的全周期和基础设施上考虑环境影响最小化。（设计、制造、服务提供、产品运输、使用和丢弃）
注：关于环境影响的更多信息请参阅ISO14001和ISO/TC207 的其他标准

7 Process management

7.1 General

Processes are specific to an organization and vary depending on the type, size and level of maturity of the organization. The activities within each process should be determined and adapted to the size and distinctive features of the organization.The organization should ensure the proactive management of all processes, including outsourced processes,to ensure that they are effective and efficient, in order to achieve its objectives. This can be facilitated byadopting a “process approach” that includes establishing processes, interdependencies, constraints and

shared resources.Processes and their interrelationships should be reviewed on a regular basis and suitable actions should be taken for their improvement.The processes should be managed as a system by creating and understanding the networks of processes,their sequences and interactions. The consistent operation of this system is often referred to as the "systems

approach to management". The network can be described in a map of the processes and their interfaces.

NOTE For further information on the “process approach”, see the related quality management principle in Annex B of this International Standard, as well as ISO 9000 and the ISO 9000 “Introduction and Support Package” document Guidance on the Concept and Use of the Process Approach for management systems[34].

7过程管理

7．1总则

过程依据组织的类型、规模、成熟程度的不同而不同。每个过程中的活动应当被确定，并与组织的规模和特点相适应。组织应当确保主动管理所有的过程，包括外包过程以保证其对于实现目标的充分性和有效性。可以通过“过程方法”来促进它，包括建立过程、过程的相互关系、限制因素和分享资源、过程及其内在联系应当加以定期审查。采取适当的措施进行提升。通过创造和了解过程的网络结构、过程的后果和相互作用，过程应当被当做一种系统来进行管理。该系统的一致行动通常被称作“管理的系统方法”该网络能够描绘过程及其接口的图表。

注：想了解关于“过程方法”的更多信息，参考本标准的附录B和iso9000

7.2过程的策划和控制

组织应当确定和策划其过程，定义提供持续满足顾客和其他利益相关方不断增长的要求和期望的产品所需的职能。过程的策划和控制应当与组织的战略相一致，进行管理活动、提供资源、产品实现、监视、测量和审查活动。在过程的策划和控制中应当考虑：

分析组织的环境

市场发展的短期和长期预测

利益相关方的需求和期望

需要达到的目标

法律法规要求，
潜在的金融和其他风险，

过程的输入和输出

过程和其他过程的相互作用

资源和信息

活动和方法

要求或者需要的记录

监测测量和分析

改进和预防措施

提升或者创新活动

过程的策划应当考虑到组织对于获得新技术、开发新产品、增加价值的需要。

7.3 Process responsibility and authority
For each process, the organization should appoint a process manager (often referred to as the “process owner") with defined responsibilities and authorities to establish, maintain, control and improve the process and its interaction with other processes. The process manager could be a person or a team, depending on the nature of the process and the organization's culture.
The organization should ensure that the responsibilities, authorities and roles of process managers are recognized throughout the organization, and that the people associated with the individual processes have the competences needed for the tasks and activities involved.
7.3过程的职责和权力
对每个过程，组织应当任命过程负责人（过程所有人）给予建立、保持、控制和提升过程的和（管理）与其他过程相互作用的权力和职责。过程负责人可以是一个人或者一个团队，取决于过程的实际和组织的文化。组织应当确保过程负责人的职责、权力和角色在组织内被认可，与每个过程有关的员工有足够的能力履行过程包含的活动和职责。
8 Monitoring, measurement, analysis and review
8.1 General
To achieve sustained success in an ever-changing and uncertain environment, it is necessary for the organization to regularly monitor, measure, analyse and review its performance.
8监测、测量、分析和检查
8.1总则
为了在不断变化和不确定的环境中实现持续成功，组织必须持续持续监测、测量、分析和检查其表现。
8.2 Monitoring
Top management should establish and maintain processes for monitoring the organization's environment, and for collecting and managing the information that is necessary for
⎯identifying and understanding the present and future needs and expectations of all relevant interested parties,
⎯assessing strengths, weaknesses, opportunities and threats,
⎯determining the need for alternative, competitive or new product offerings,
⎯evaluating current and emerging markets and technologies,
⎯anticipating current and expected changes in statutory and regulatory requirements,
⎯understanding the labour market and its effect on the loyalty of people in the organization,
⎯understanding the social, economic, ecological trends and local cultural aspects relevant to the
organization's activities,
⎯determining the need for natural resources, and their protection over the long term, and
⎯assessing current organizational and process capabilities (see Annex A).
NOTE For more information about “customer focus”, see the related quality management principle in Annex B.
8.2监测
最高管理者应当建立并保持过程以监测组织的环境、搜集和管理所需的信息以：
识别和理解利益相关方当前和未来的需求和期望
评估优势、弱点、机会和威胁
确定替代、竞争或者新产品的需求
评估当前和未来的市场和技术
预计当前和未来的法律法规要求的改变
理解劳动力市场，及其对组织员工忠诚度的影响
理解社会、经济、生态趋势和本地文化与组织活动的联系
确定对自然资源的要求和对其长期的保护
评估组织当前的过程能力（见附录A）
注：更多关于“顾客为关注焦点”的信息参阅参阅附录B中的质量原则

8.3 Measurement
8.3.1 General
Top management should assess progress in achieving planned results against the mission, vision, policies strategies and objectives, at all levels and in all relevant processes and functions in the organization. A measurement and analysis process should be used to monitor this progress, to gather and provide the information necessary for performance evaluations and effective decision making. The selection of appropriate key performance indicators and monitoring methodology is critical for success of the measurement and analysis process. The methods used for collecting information regarding key performance indicators should be practicable and appropriate to the organization. Typical examples include
⎯risk assessments and risk controls,
⎯interviews, questionnaires and surveys on customer and other interested parties' satisfaction,
⎯benchmarking,
⎯performance reviews, including suppliers and partners, and
⎯monitoring and recording of process variables and product characteristics.
8.3测量
8.3.1总则
最高管理者应当在组织的各个过程和职能的各个层级上评估过程实现策划的结果、使命、愿景、战略方针和目标的能力。应当使用一个测量和分析过程来监测过程、搜集和提供绩效评估和有效决策制订所需的信息。适当的关键业绩指标和监测方法的选择对测量和分析过程的成功非常关键。组织搜集确定关键业绩指标所需信息的方法应当是适当和可行的，典型的例子包括：
风险评估和风险控制
访谈、问卷、对顾客和其他利益相关方的满意度调查
标尺基准
业绩检查，包括供方和伙伴
监测和记录过程变量和产品指标
8.3.2 Key performance indicators
Factors that are within the control of the organization and critical to its sustained success should be subject to performance measurement and identified as key performance indicators (KPIs). The KPIs should be quantifiable and should enable the organization to set measurable objectives, identify, monitor and predict trends and take corrective, preventive and improvement actions when necessary. Top management should select KPIs as a basis for making strategic and tactical decisions. The KPIs should in turn be suitably cascaded as performance indicators at relevant functions and levels within the organization to support the achievement of top level objectives.
KPIs should be appropriate to the nature and size of the organization and to its products, processes and activities.
They need to be consistent with the objectives of the organization, which should, in turn, be consistent with its strategy and policies (see 5.2). Specific information relating to risks and opportunities should be considered when selecting the KPIs. In selecting the KPIs, the organization should ensure that they provide information that is measurable,accurate and reliable, and usable to implement corrective actions when performance is not in conformity with objectives or to improve process efficiency and effectiveness. Such information should take into account
⎯the needs and expectations of customers and other interested parties,
⎯the importance of individual products to the organization, both at the present time and in the future,
⎯the effectiveness and efficiency of processes,
⎯the effective and efficient use of resources,
⎯profitability and financial performance, and
⎯statutory and regulatory requirements, where applicable.
8.3.2关键业绩指标
组织控制中的一些指标对于其持续成功非常关键，被用于业绩的测量，成为关键业绩指标。关键业绩指标应当是可量化和测量的。识别、监测、预测趋势、必要时采取纠正、预防和提升措施。最高管理者应当将关键业绩指标作为制订战略和关键决策的基础。关键业绩指标应在组织的各个层级上适当的分解以支持最高目标的实现。关键业绩指标应当与实际、组织的规模、产品、过程和活动相适应。关键业绩指标应当与组织的目标相一致，目标应于组织的战略和方针相一致。在选择关键业绩指标时应当考虑风险和机会。在选择关键业绩指标时组织应当确保提供的信息是可测量的、准确的可靠的对于采取改进措施或者提升过程充分性和有效性是有用的。应当考虑下列：
顾客和其他利益相关方的需求和期望
当前和未来单个产品对组织的重要性
过程的充分性和有效性
资源的充分和有效使用
利润和财务表现
适用时包括法律法规的要求

8.3.3 Internal audit
Internal audits are an effective tool for determining the levels of compliance of the organization's management system against given criteria, and provide valuable information for understanding, analysing and continually improving the organization's performance. Audits should be conducted by people who are not involved in the activity being examined, in order to give an independent view on what is being performed. Internal audits should assess the implementation and effectiveness of the management system. They can include auditing against more than one management system standard, such as ISO 9001 (quality management) and ISO 14001 (environmental management), as well as addressing specific requirements relating to customers, products, processes or specific issues. To be effective, internal audits should be conducted in a consistent manner, by competent personnel, in accordance with an audit plan. Internal auditing is an effective tool for identifying problems, risks and nonconformities, as well as for monitoring progress in closing previously identified nonconformities (which should have been addressed
through root cause analysis and the development and implementation of corrective and preventive action plans). Verification that the actions taken have been effective can be determined through an assessment of the improved ability of the organization to fulfil its objectives. Internal auditing can also be focused on the identification of good practices (that can be considered for use in other areas of the organization) as well as on improvement opportunities.The outputs of internal audits provide a useful source of information for
⎯addressing problems and nonconformities,
⎯benchmarking,
⎯promoting good practices within the organization, and
⎯increasing understanding of the interactions between processes.
The results of internal audits are usually presented in the form of reports containing information on compliance against the given criteria, nonconformities, and improvement opportunities. Audit reports are also an essential input for management reviews. Top management should establish a process for the review of all internal audit reports, to identify trends that can require organization-wide corrective or preventive actions.The organization should also take the results of other audits, such as second and third party audits, as feedback for corrective and preventive actions.
NOTE See ISO 19011 for further guidance on auditing.
8.3.3内部审核
内部审核可以为组织衡量其管理体系符合指定的标准的水平，并提供组织了解、分析和持续改进业绩表现所需的信息。审核人不能审核自己的工作。内部审核应当评估组织管理体系的运行和有效性。不同的质量管理体系标准可以合并审核，例如iso9001、ISO4001 ，还可以包括来自顾客、产品、过程、特殊问题的特别要求。为保证内审的有效性，内审应当定期、有足够能力的人员从事、按照计划进行。内审是识别问题、风险、不合格和监测关闭上述不合格的过程运行的有效工具。（关闭不合格应当包括根本原因的分析、制订和采取纠正和预防措施计划）。上述行动是否有效实施可以通过组织实现目标能力是否得到提升来验证。内审还可以用来识别好的做法（可以考虑将其移植到组织其他地方）或者改进机会。内审的输出包括：
问题和不合格
基准
组织内好的做法
提升对于过程相互作用的理解
内审的结果通常形成报告，包含与标准的符合性、不合格、改进机会。审核报告是管理评审的重要输入。最高管理者应当建立过程检查所有的内部审核报告，识别那些需要在全组织内纠正或者预防的趋势。组织还应当关注其他的审核的结果，如第二方或第三方审核，并做出纠正和预防措施的反馈
注：参见ISO19011.