ISO 9001：2015
Quality management systems —Requirements
质量管理体系-要求
审核目的
过程质量审核是对影响过程质量的各因素是否按质量控制计划所规定的要求进行控制、控制是否有效、能否适应等进行审查与评价。
过程质量审核的目的，就是通过审核，检查在生产现场是否按质量控制计划规定的措施执行、是否符合标准，评价其有效性，同时发现问题进行改进，以保证过程质量的稳定。
过程质量审核的内容：
① 操作者是否具备规定的能力或资格；
② 是否按图样、工艺规程和作业指导书进行加工；
③ 设备、工装、刀具等是否符合要求，并且使用正确；
④ 原材料、毛坯、协作件是否符合要求；
⑤ 图样、工艺文件、检验文件等是否完整、统一、正确、有效；
⑥ 是否按规定正确的开展质量检验工作；
⑦ 制造、装配现场环境是否良好；
⑧ 过程质量控制点的设置是否合理，控制的文件等是否齐全，能否真正起到控制的作用。
过程质量审核应根据管理部门的安排有计划的定期进行，审核的重点应是建立质量控制点的过程，以评定其质量控制活动。
开展过程质量审核，可有效改进过程质量控制方法，完善质量控制点的预防控制的作用，为改善过程质量控制、保证产品质量起到积极的作用。
4.3 Determining the scope of the quality management system确定质量管理体系的范围
The organization shall determine the boundaries and applicability of the quality management system
to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
组织应确定质量管理体系的边界和适用性来建立其范围。
在确定质量管理体系范围时，组织应考虑：
a) 在4.1中涉及的外部和内部情况；
b) 在4.2中涉及的有关相关方要求；
c) 组织的产品与服务。
如本标准的要求在确定的范围内适用，组织应应用本标准的所有要求。 组织的质量管理体系范围应可获取并保持形成文件的信息。范围应说明质量管理体系所覆盖的产品和服务，并对组织确定不适用于管理体系范围的本标准的要求说明正当理由。
当被确定为不适用的要求不影响组织确保产品和服务的符合性以及增强顾客满意的能力或责任时，才能声称符合本标准的要求。
4.4 Quality management system and its processes质量管理体系及其过程
4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
4.4.1 组织应按本标准的要求建立、实施、保持和持续改进质量管理体系，包括质量管理体系所需的过程及其相互作用。
组织应确定质量管理体系所需的过程及其在整个组织中的应用，组织应：
a) 确定这些过程所需的输入和期望的输出；
b) 确定这些过程的顺序和相互作用；
c) 确定和应用所需的准则和方法（包括监视、测量和相关的绩效指标），以确保这些过程的有效运行和控制；
d) 确定这些过程所需的资源并确保其可用性；
e) 规定这些过程的职责和权限；
f) 应对按照6.1的要求确定的风险和机会；
g) 评价这些过程并实施所需的变更，以确保这些过程实现预期的结果；
h) 改进过程和质量管理体系。
4.4.2 To the extent necessary, the organization shall:
a) maintain documented information to support the operation of its processes;
b) retain documented information to have confidence that the processes are being carried out as planned.
4.4.2 组织应保持必要程度的：
a) 保持形成文件的信息，为过程运行提供支持；
b) 保留形成文件的信息，以证实过程是按策划执行的。
5 Leadership **力
5.1 Leadership and commitment **力和承诺
5.1.1 General 总则
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements into the organization’s business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the quality management system requirements;
g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality
management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.
较高管理者应通过以下方面证实其**力和对质量管理体系承诺：
a) 对质量管理体系的有效性承担责任；
b) 确保质量方针和质量目标得到建立，并与组织的战略方向和组织环境保持一致；
0.1 General 总则
The adoption of a quality management system is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on this
International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are complementary to requirements for products and services.
This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.采用质量管理体系应该是组织的一项战略性决策，可以帮助组织改进其整体绩效，并为可持续发展计划提供良好的基础。
对于根据本标准实施质量管理体系的组织来说，潜在的收益是：
a) 稳定提供满足顾客要求和法律法规要求的产品和服务的能力；
b) 获取增强顾客满意的机会；
c) 应对与组织环境和目标相关的风险；
d) 证实符合质量管理体系特定要求的能力。
本标准可用于内部和外部。
以下方面不是本标准的目的：
- 统一不同质量管理体系的结构；
- 统一本标准条款结构的文件；
- 在组织中使用本标准的特定术语。
本标准所规定的质量管理体系要求是对产品要求的补充。
本标准采用过程方法，该方法结合了策划-实施-检查-改进（PDCA）循环和基于风险的思维。
过程方法使组织能够策划组织的过程及其相互作用。
PDCA循环使组织能够确保其过程得到充分的资源和管理，并确定和实施改进机会。
基于风险的思维能够使组织确定可能导致其过程和质量管理体系偏离所策划的结果的因素，采取预防性控制，以较小化负面影响并在机会出现时将机会利用较大化（见A.4条款）。
在日益变化和复杂的环境中，持续满足要求和应对未来的需求和期望是组织面临的挑战。要实现这个目标，组织可能发现除了纠正和持续改进以外，变革、创新和重组也是必要的。
本标准中采用了以下动词形式：
“shall”表示要求；
“should”表示建议；
“may”表示允许；
“can”表示可能性或能力
标注为“注”的信息是理解或说明相关要求的指南。
0.2 Quality management principles质量管理原则
This International Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization’s performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
本标准基于ISO 9000中阐述的质量管理原则，该阐述包括每项原则的说明、对组织的重要性、与该原则相关的益处的示例，以及应用该原则时改进组织绩效所采取的典型措施的示例。
质量管理原则是：
- 以顾客为关注焦点；
- **力；
4.3 Determining the scope of the quality management system确定质量管理体系的范围
The organization shall determine the boundaries and applicability of the quality management system
to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
组织应确定质量管理体系的边界和适用性来建立其范围。
在确定质量管理体系范围时，组织应考虑：
a) 在4.1中涉及的外部和内部情况；
b) 在4.2中涉及的有关相关方要求；
c) 组织的产品与服务。
如本标准的要求在确定的范围内适用，组织应应用本标准的所有要求。 组织的质量管理体系范围应可获取并保持形成文件的信息。范围应说明质量管理体系所覆盖的产品和服务，并对组织确定不适用于管理体系范围的本标准的要求说明正当理由。
当被确定为不适用的要求不影响组织确保产品和服务的符合性以及增强顾客满意的能力或责任时，才能声称符合本标准的要求。
4.4 Quality management system and its processes质量管理体系及其过程
4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
4.4.1 组织应按本标准的要求建立、实施、保持和持续改进质量管理体系，包括质量管理体系所需的过程及其相互作用。
组织应确定质量管理体系所需的过程及其在整个组织中的应用，组织应：
management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.
较高管理者应通过以下方面证实其**力和对质量管理体系承诺：
a) 对质量管理体系的有效性承担责任；
b) 确保质量方针和质量目标得到建立，并与组织的战略方向和组织环境保持一致；
c) 确保将质量管理体系要求融入组织的业务过程；
d) 促进过程方法和基于风险的思维的应用；
e) 确保获得质量管理体系所需的资源；
f) 传达有效的质量管理以及满足质量管理体系要求的重要性；
g) 确保质量管理体系实现其预期的结果；
h) 鼓励、指导和支持员工为质量管理体系的有效性做出贡献；
i) 增强改进；
j) 支持其他相关管理者在其负责的区域证实其**力。
注：本标准中的“业务”从广义上解释为对于组织的存在而言具有核心价值的活动，组织可以是公有的、私有的、盈利或非盈利的。
5.1.2 Customer focus以顾客为关注焦点
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained.
较高管理者应通过以下方面，证实其对以顾客为关注焦点的**力和承诺：
a) 确定、理解和持续满足顾客要求和适用的法律法规要求；
b) 确定和应对影响产品和服务符合性以及增强顾客满意能力的风险与机会；
c) 维护以增强顾客满意为关注焦点。
5.2 Policy方针
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