IATF16949 中英文对照版 201710 - 图文(3)

何情况的程度和持续时间； e） 定期测试应急计划的有效性（如：模拟，视情况而定）； f） 利用包括最高管理者在内的跨部门小组对应急计划进行评审（至少每年一次），并在需要时进行更新； g） 对应急计划形成文件，并保留描述修订以及更改授权人员的形成文件的信息。 应急计划应包含相关规定，用以在发生生产停止的紧急情况后重新开始生产之后，以及在常规停机过程未得到遵循的情况下，确认制造的产品持续符合顾客规范。 6.2 质量目标及其实施的策划 6.2.1和6.2.2 见ISO 9001:2015的要求。 6.2.1 组织应在质量管理体系所需的相关职能、层次和过程上设定质量目标。 质量目标应： a) 与质量方针保持一致； b) 可测量； c) 考虑到适用的要求； d) 与提供合格产品和服务以及增强顾客满意有关； e) 予以监视； f) 予以沟通； g) 适时更新。 组织应保持质量目标的形成文件的信息。 6.2.2 策划如何实现其质量目标时，组织应确定： a) 采取的措施； b) 需要的资源； c) 由谁负责； or infrastructure disruptions； d）include，as a supplement to the contingency plans，a notification process to the customer and other interested parties for the extent and duration of any situation impacting customer operations； e）periodically test the contingency plans for effectiveness（e.g.，simulations，as appropriate）； f）conduct contingency plan reviews（at a minimum annually）using a multidisciplinary team including top management，and update as required； g）document the contingency plans and retain documented information describing any revision（s），including the person（s）who authorized the change（s）. The contingency plans shall include provisions to validate that the manufactured product continues to meet customer specifications after the re-start of production following an emergency in which production was stopped and if the regular shutdown processes were not followed. 6.2 Quality objectives and planning to achieve them 6.2.1 and 6.2.2 See ISO 9001:2015 requirements. 6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system. The quality objectives shall: a) be consistent with the quality policy; b) be measurable; c) take into account applicable requirements; d) be relevant to conformity of products and services and to enhancement of customer satisfaction; e) be monitored; f) be communicated; g) be updated as appropriate. The organization shall maintain documented information on the quality objectives. 6.2.2 When planning how to achieve its quality objectives, the organization shall determine: a) what will be done; b) what resources will be required; c) who will be responsible; d) 什么时候完成； e) 如何评价结果。 6.2.2.1 质量目标及其实施的策划 最高管理者应确保为整个组织内的相关职能、过程和级别，明确、建立并保持符合顾客要求的质量目标。 组织在建立其年度（至少每年一次）质量目标和相关性能指标（内部和外部）时，应考虑组织对相关方及其有关要求的评审结果。 d) when it will be completed; e) how the results will be evaluated. 6.3 更改的策划 见ISO 9001:2015的要求。 6.2.2.1 Quality objectives and planning to achieve them - supplemental Top management shall ensure that quality objectives to meet customer requirements are defined，established，and maintained for relevant functions，processes，and levels throughout the organization. The results of the organization’s review regarding interested parties and their relevant requirements shall be considered when the organization establishes its annual（at a minimum）quality objectives and related performance targets（internal and external）. 6.3 Planning of changes See ISO 9001:2015 requirements. When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4). The organization shall consider: a) the purpose of the changes and their potential consequences; b) the integrity of the quality management system; c) the availability of resources; d) the allocation or reallocation of responsibilities and authorities. 当组织确定需要对质量管理体系进行更改时（见4.4），此种更改应经策划并系统的实施。 组织应考虑： a) 更改的目的及其潜在后果； b) 质量管理体系的完整性； c) 资源的可获得性； d) 职责和权限的分配或再分配。 7 支持 7.1资源 7.1.1 总则 见ISO 9001:2015的要求。 7 Support 7.1 Resources 7.1.1 General See ISO 9001:2015 requirements. 7.1.1 General 总则 The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. The organization shall consider: a) the capabilities of, and constraints on, existing internal resources; b) what needs to be obtained from external providers. 组织应确定并提供建立、实施、保持和持续改进质量管理体系所需的资源。 组织应考虑： a) 现有内部资源的能力和约束； b) 需要从外部供方获取的资源。 7.1.2 人员 7.1.2 People See ISO 9001:2015 requirements. 见ISO 9001:2015的要求。 组织应确定并提供所需的人员，以有效实施质量管理体系并运行和控制其过程。 The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. 7.1.3 基础设施 见ISO 9001:2015的要求。 7.1.3 Infrastructure See ISO 9001:2015 requirements. The organization shall determine, provide and maintain 组织应确定、提供并维护过程运行所需的基础设施，the infrastructure necessary for the operation of its processes and to achieve conformity of products and 以获得合格的产品和服务。 services. 注：基础设施可包括： NOTE Infrastructure can include: a) 建筑物和相关的设施； a) buildings and associated utilities; b) 设备，包括硬件和软件； b) equipment, including hardware and software; c) 运输资源； c) transportation resources; d) 信息和通讯技术。 d) information and communication technology. 7.1.3.1 Plant，facility，and equipment planning The organization shall use a multidisciplinary approach including risk identification and risk 组织应使用多方论证的方法，包括风险识别和风险缓解方法，来开发并改 …… 此处隐藏：9274字，全部文档内容请下载后查看。喜欢就下载吧 ……