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1、ISO 9001：2015Quality management systems Requirements质量管理体系-要求Introduction引 言0.1 General 总则The adoption of a quality management system is a strategic decision for an organization that can helpto improve its overall performance and provide a sound basis for sustainable development initiatives.The pote
2、ntial benefits to an organization of implementing a quality management system based on thisInternational 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
3、 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 Internatio
4、nal 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 managemen
5、t 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 organizat
6、ion 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 coul
7、d 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 expe
8、ctations 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
9、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 clar
10、ifying 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
11、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
12、”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 im
13、portant for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organizations performance when applying the principle.The quality management principles are: customer focus; leadership; engagement of people; process approach; improv
14、ement; 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； - 领导力；- 全员参与； - 过程方法； - 改进； - 循证决策； - 关系管理。 0.3 Process approach过程方法0.3.1 General 总则 This International Standard promotes the adopt
15、ion 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 in 4.4.Understandin
16、g and managing interrelated 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 organization ca
