ISO9001：2015
Quality management systems—
Requirements
质量管理体系-要求
Introduction引言
0.1General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；
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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，以最小化负面影响并在机会出现时将机会利用最大化（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。
0.2Quality management principles质量管理原则
This International Standard is based on the quality management principles described in ISO9000.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ISO9000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；
-领导力；
-全员参与；
-过程方法；
-改进；
-循证决策；
-关系管理。
0.3Process approach过程方法
0.3.1General总则
This International Standard promotes the adoption of a process approach 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 in4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s 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
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the organization 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 strategic 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 overall 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 terms of added value;c)the achievement of effective process performance;d)improvement of processes based on evaluation of data and information.Figure 1gives a schematic representation of any process and shows the interaction of its elements.The monitoring and measuring check points,which are necessary for control,are specific to each process and will vary depending on the related risks 本标准鼓励在建立、实施质量管理体系以及改进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。采用过程方法须考虑的特定要求包含在4.4中。
将相互关联的过程作为体系进行理解和管理，会有助于组织实现其预期结果的有效性和效率。该方法能够是组织控制体系的过程间的相互关系和相互依存，以使组织的整体绩效得到提高。
过程方法运用系统的定义和管理过程及其相互作用，以期实现与组织的质量方针和战略方向一致的预期
结果。将PDCA 循环全面用于旨在利用机会优势和预防不期望的结果的基于风险的思维（见0.3.3），能够实现对过程和整个体系进行管理。
在质量管理体系中应用过程方法能够：
a)对满足要求的理解和一致性；b)从增值的角度考虑过程；c)实现有效的过程绩效；d)在评价数据和信息的基础上改进过程。图1给出了过程示意图并展示了过程要素的相互作用。将必要控制的监视和测量检查具体到每个过程并将根据相
关风险而改变。
图1：单一过程要素图0.3.2Plan-Do-Check-Act cycle 策划-实施-检查-改进循环The PDCA cycle can be applied to all processes and to the quality management system as a whole.Figure 2illustrates how Clauses 4to 10can be grouped in relation to the PDCA cycle.PDCA 循环能够应用于所有过程和整个质量管理体系。图2展示了第4章到第10章分别与PDCA 的关联。
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NOTE Numbers in brackets refer to the clauses in this International Standard.图中数字表示本国际标准中的章节。图2：本标准中的PDCA 循环模式
The PDCA cycle can be briefly described 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 organization’s policies;and identify and address risks and opportunitys;—Do:implement what was planned;—Check:monitor and (where applicable)measure processes and the resulting products and services against policies,objectives and requirements and planned activities,and report the results;—Act:take actions to improve performance,as necessary.PDCA 模式可以简要描述如下：Plan –策划：根据顾客要求和组织方针，为提供结果建立体系目标及其过程，以及所需的资源，识别并提出风险及机会；
Do –实施：实施所策划的（安排）；Check –检查：根据方针、目标和要求及策划的活动，对过程、产品和服务进行监视和测量（适用时），并报告结果；Act –处置：必要时，采取措施，以改进过程绩效。0.3.3Risk-based thinking 基于风险的思维Risk-based thinking (see Clause A.4)is essential for achieving an effective quality management system.The concept of risk-based thinking has been implici
t 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 taking 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 opportunities establishes a basis 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 customers,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 risk can provide an opportunity,but not all positive effects of risk result in opportunities.
为实现有效的质量管理体系，基于风险的思维（见A.4条款）是必要的。基于风险的思维的概念在本标准的以往版本中一直是没有言明的，包括如实施预防措施以消除潜在不合格、分析发生的不合格并采取与不合格的影响相适应的措施防止其再发生。
为符合本标准的要求，组织需要策划和实施应对风险和机会的措施。应对风险和机会是为提高质量管理
体系有效性、实现改进的结果并防止负面影响建立基础。
机会可以形成有益于实现预期结果的状况的结果，例如，让组织吸引顾客、开发新产品和服务、减少浪费或改进生产效率的一系列情况。应对机会的措施还可以包括对相关风险的考虑。风险是不确定的影响，这种不确定可能是正面或负面的影响。来自风险的正面偏离可以提供机会，但不是风险的所有正面影响都能产生机会。
0.4Relationship with other management system standards与其他管理体系标准的关系
This International Standard applies the framework developed by ISO to improve alignment among its International Standards for management systems(see Clause 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 ISO9000and ISO9004as follows:
—ISO9000Quality management systems—Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard;
—ISO9004Managing for the sustained success of an organization—A quality 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/TC176.
This International 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 guidance to the application of
this International Standard within the particular sector.
A matrix showing the correlation between the clauses of this edition of this International Standard and the previous edition(ISO9001:2008)can be found on the ISO/TC176/SC2open access web site at: /tc176/sc02/public.
本标准采用了ISO为改进其管理体系国际标准间的一致性而开发的框架（见A.1条款）。
本标准能够是使组织应用过程方法，再加上PDCA循环和基于风险的思维，使其质量管理体系与与其他管理体系标准的要求保持一致或整合。
本标准与ISO9000和ISO9004相关联：
ISO9000质量管理体系基础和术语为本标准的正确理解和实施提供了必要的背景
ISO9004组织持续成功的管理一种质量管理方法为选择超越本标准要求的发展的组织提供了指南
附录B提供了ISO TC/176开发的与质量管理和质量管理体系有关的其他标准的信息。
本标准不包括针对其他管理体系的特定要求，如环境管理、职业健康安全管理或财务管理。
已开发了一部分基于本标准要求的特定行业的质量管理体系标准，这些标准中的某些标准规定了附加的质量管理体系要求，而其他标准限于为本标准在特定行业内的应用提供指南。
在ISO/TC176/SC2公开获取网站可以到本标准和ISO9001:2008标准条款的对照矩阵表。/tc176/sc02/public
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