1、 1 / 35Quality management systems RequirementsISO 9001:2015(E)Introduction.1 Scope.2 Normative references.3 Terms and definitions.4 Context of the organization.4.1 Understanding the organization and its context.4.2 Understanding the needs and expectations of interested parties4.3 Determining the sco
2、pe of the quality management system.4.4 Quality management system and its processes.5 Leadership.5.1 Leadership and commitment.5.1.1 General.5.1.2 Customer focus.5.2 Policy.5.2.1 Establishing the quality policy.5.2.2 Communicating the quality policy.5.3 Organizational roles, responsibilities and aut
3、horities6 Planning.6.1 Actions to address risks and opportunities.6.2 Quality objectives and planning to achieve them.6.3 Planning of changes.7 Support.7.1 Resources.7.1.1 General.7.1.2 People.7.1.3 Infrastructure.7.1.4 Environment for the operation of processes.7.1.5 Monitoring and measuring resour
4、ces.7.1.6 Organizational knowledge.7.2 Competence.7.3 Awareness.7.4 Communication.7.5 Documented information.7.5.1 General.7.5.2 Creating and updating.7.5.3 Control of documented information质量管理体系 要求GB/T 19001201X/ ISO 9001:2015代替 GB/T 190012008(ISO 9001:2015，IDT)引 言1 范围2 规范性引用文件3 术语和定义4 组织环境4.1 理解组
5、织及其环境4.2 理解相关方的需求和期望4.3 确定质量管理体系的范围4.4 质量管理体系及其过程5 领导作用5.1 领导作用和承诺5.1.1 总则5.1.2 以顾客为关注焦点5.2 方针5.2.1 制定质量方针5.2.2 沟通质量方针5.3 组织内的角色、职责和权限6 策划6.1 应对风险和机遇的措施6.2 质量目标及其实现的策划6.3 变更的策划7 支持7.1 资源7.1.1 总则7.1.2 人员7.1.3 基础设施7.1.4 过程运行环境7.1.5 监视和测量资源7.1.6 组织的知识7.2 能力7.3 意识7.4 沟通7.5 成文信息7.5.1 总则7.5.2 创建和更新7.5.3 成
6、文信息的控制2 / 358 Operation.8.1 Operational planning and control.8.2 Requirements for products and services.8.2.1 Customer communication.8.2.2 Determining the requirements for products and services.8.2.3 Review of the requirements for products and services.8.2.4 Changes to requirements for products and
7、services.8.3 Design and development of products and services.8.3.1 General.8.3.2 Design and development planning.8.3.3 Design and development inputs.8.3.4 Design and development controls.8.3.5 Design and development outputs.8.3.6 Design and development changes.8.4 Control of externally provided proc
8、esses, products and services.8.4.1 General.8.4.2 Type and extent of control.8.4.3 Information for external providers.8.5 Production and service provision.8.5.1 Control of production and service provision.8.5.2 Identification and traceability.8.5.3 Property belonging to customers or external provider
9、s8.5.4 Preservation.8.5.5 Post-delivery activities.8.5.6 Control of changes.8.6 Release of products and services.8.7 Control of nonconforming outputs.9 Performance evaluation.9.1 Monitoring, measurement, analysis and evaluation.9.1.1 General.9.1.2 Customer satisfaction.9.1.3 Analysis and evaluation.
10、9.2 Internal audit.9.3 Management review.9.3.1 General.9.3.2 Management review inputs.9.3.3 Management review outputs.10 Improvement.10.1 General.10.2 Nonconformity and corrective action.10.3 Continual improvement.Annex A (informative) Clarification of new structure, terminology and concepts.Annex B
11、 (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176.Bibliography.8 运行8.1 运行策划和控制8.2 产品和服务的要求8.2.1 顾客沟通8.2.2 产品和服务要求的确定8.2.3 产品和服务要求的评审8.2.4 产品和服务要求的更改8.3 产品和服务的设计和开发8.3.1 总则8.3.2 设计和开发策划8.3.3 设计和开发输入8.3.4 设计和开发控制8.3.5 设计和开发输出8.3.6
12、 设计和开发更改8.4 外部提供的过程、产品和服务的控制8.4.1 总则8.4.2 控制类型和程度8.4.3 提供给外部供方的信息8.5 生产和服务提供8.5.1 生产和服务提供的控制8.5.2 标识和可追溯性8.5.3 顾客或外部供方的财产8.5.4 防护8.5.5 交付后的活动8.5.6 更改控制8.6 产品和服务的放行8.7 不合格输出的控制9 绩效评价9.1 监视、测量、分析和评价9.1.1 总则9.1.2 顾客满意9.1.3 分析与评价9.2 内部审核9.3 管理评审9.3.1 总则9.3.2 管理评审输入9.3.3 管理评审输出10 改进10.1 总则10.2 不合格和纠正措施10
13、.3 持续改进附录 A（资料性附录）新结构、术语和概念说明附录 B（资料性附录）SAC/TC151 制定的其他质量管理和质量管理体系标准参 考 文 献3 / 35Introduction0.1 GeneralThe 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 initi
14、atives.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
15、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
16、 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 q
17、uality 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 enab
18、les 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 f
19、actors 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 引 言0.1 总则采用质量管理体系是组织的一项战略决策，能够帮助其提高整体绩效，为推动可持续发展奠定良好基础。组织根据本标准实施质量管理体系的潜在益处是：a） 稳定提供满足顾客要求以及适用的法律法规要求的产品和服务的能力；b）
20、促成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和机遇；d） 证实符合规定的质量管理体系要求的能力。本标准可用于内部和外部各方。实施本标准并非需要：统一不同质量管理体系的架构；形成与本标准条款结构相一致的文件；在组织内使用本标准的特定术语。本标准规定的质量管理体系要求是对产品和服务要求的补充。本标准采用过程方法，该方法结合了“策划实施检查处置” （PDCA）循环和基于风险的思维。过程方法使组织能够策划过程及其相互作用。PDCA 循环使组织能够确保其过程得到充分的资源和管理，确定改进机会并采取行动。基于风险的思维使组织能够确定可能导致其过程和质量管理体系偏离策划结果的各种因素，采取预
21、防控制，最大限度地降低不利影响，并最大限度地利用出现的机遇（见附录A.4） 。4 / 35maximum 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, t
22、he 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
23、” 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.0.2 Quality management principlesThis International Standard is based on the quality manage
24、ment 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 organizations performance when app
25、lying the principle.The quality management principles are: customer focus; leadership; engagement of people; process approach; improvement; evidence-based decision making; relationship management.0.3 Process approach0.3.1 GeneralThis International Standard promotes the adoption of a process approach
26、 when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4.Understanding and managing interrelat
27、ed processes as a system contributes to the organizations effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organizat
28、ion can be enhanced.The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and 在日益复杂的动态环境中持续满足要求，并针对未来需求和期望采取适当行动，这无疑是组织面临的一项挑战。为了实现这一目标，组织可能会发现，除了纠正和持续改进，还有必要采取各种形式的改进，如
29、突破性变革、创新和重组。在本标准中使用如下助动词：“应”表示要求；“宜”表示建议；“可”表示允许；“能”表示可能或能够。“注”的内容是理解和说明有关要求的指南。0.2 质量管理原则本标准是在 GB/T 19000 所阐述的质量管理原则基础上制定的。每项原则的介绍均包含概述、该原则对组织的重要性的依据、应用该原则的主要益处示例以及应用该原则提高组织绩效的典型措施示例。质量管理原则是：以顾客为关注焦点；领导作用；全员积极参与；过程方法；改进；循证决策；关系管理。0.3 过程方法0.3.1 总则本标准倡导在建立、实施质量管理体系以及提高其有效性时采用过程方法，通过满足顾客要求增强顾客满意。采用过程方
30、法所需考虑的具体要求见 4.4。将相互关联的过程作为一个体系加以理解和管理，有助于组织有效和高效地实现其预期结果。这种方法使组织能够对其体系的过程之间相互关联和相互依赖的关系进行有效控制，以提高组织整体绩效。过程方法包括按照组织的质量方针和战略方向，对各过程及其相互作用进行系统的5 / 35strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an ov
31、erall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.The application of the process approach in a quality management system enables:a) understanding and consistency in meeting requirements;b) the consideration of processes in te
32、rms of added value;c) the achievement of effective process performance;d) improvement of processes based on evaluation of data and information.Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are nece
33、ssary for control, are specific to each process and will vary depending on the related risks.Figure 1 Schematic representation of the elements of a single process0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illu
34、strates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International 规定和管理，从而实现预期结果。可通过采用 PDCA 循环（见 0.3.2）以及始终基于风险的思维（见 0.3.3）对过程和整个体系进行管理，旨在有效利用机遇并防止发生不良结果。在质量管理体系中应用过程方法能够：a） 理解并持续满足要求；b） 从增值的角度考虑过程；c） 获得有效的过程绩效；d） 在评价数据和信息的基础
35、上改进过程。单一过程的各要素及其相互作用如图 1 所示。每一过程均有特定的监视和测量检查点，以用于控制，这些检查点根据相关的风险有所不同。图 1 单一过程要素示意图0.3.2 PDCA 循环PDCA 循环能够应用于所有过程以及整个质量管理体系。图 2 表明了本标准第 4 章至第 10章是如何构成 PDCA 循环的。6 / 35Standard.Figure 2 Representation of the structure of this International Standard in the PDCA cycleThe PDCA cycle can be briefly describe
36、d as follows: Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers requirements and the organizations policies, and identify and address risks and opportunities; Do: implement what was planned; Check: monitor and (wh
37、ere applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results; Act: take actions to improve performance, as necessary.0.3.3 Risk-based thinkingRisk-based thinking (see Clause A.4) is essential for a
38、chieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analyzing any nonconformities that do occur, and ta
39、king action to prevent recurrence that is appropriate for the effects of the nonconformity.To conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunitiesestablishes a basis
40、 for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects.Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract cus
41、tomers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a
42、risk can provide an opportunity, but notall positive effects of risk result in opportunities.0.4 Relationship with other management system standardsThis International Standard applies the framework developed by ISO to improve alignment among its International Standards for management systems (see Cl
43、ause A.1).This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards.This International Standard relates to ISO 90
44、00 and ISO 9004 as follows:注：括号中的数字表示本标准的相应章节。图 2 本标准的结构在 PDCA 循环中的展示PDCA 循环可以简要描述如下：策划（Plan）：根据顾客的要求和组织的方针，建立体系的目标及其过程，确定实现结果所需的资源，并识别和应对风险和机遇。实施（Do）：执行所做的策划；检查（Check）：根据方针、目标、要求和所策划的活动，对过程以及形成的产品和服务进行监视和测量（适用时） ，并报告结果；处置（Act）：必要时，采取措施提高绩效。0.3.3 基于风险的思维基于风险的思维（见附录 A.4）是实现质量管理体系有效性的基础。本标准以前的版本已经隐含基于
45、风险思维的概念，例如：采取预防措施消除潜在的不合格，对发生的不合格进行分析，并采取与不合格的影响相适应的措施，防止其再发生。为了满足本标准的要求，组织需策划和实施应对风险和机遇的措施。应对风险和机遇，为提高质量管理体系有效性、获得改进结果以及防止不利影响奠定了基础。某些有利于实现预期结果的情况可能导致机遇的出现，例如：有利于组织吸引顾客、开发新产品和服务、减少浪费或提高生产率的一系列情形。利用机遇所采取的措施也可能包括考虑相关风险。风险是不确定性的影响，不确定性可能有正面的影响，也可能有负面的影响。风险的正面影响可能提供机遇，但并非所有的正面影响均可提供机遇。0.4 与其他管理体系标准的关系本
46、标准采用 ISO 制定的管理体系标准框架，以提高与其他管理体系标准的协调一致性（见附录 A.1） 。7 / 35 ISO 9000 Quality management systems Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard; ISO 9004 Managing for the sustained success of an organization A qual
47、ity management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard.Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC 176.This Intern
48、ational Standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management. Sector-specific quality management system standards based on the requirements of this International Standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing
