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，来开发并改进工厂、设施和设备的计划。mitigation methods for developing and improving plant，facility，and equipment plans. In designing plant 在设计工厂布局时，组织应： a） 优化材料的流动和搬运，以及对空间场地的layouts，the organization shall: 增值利用，包括对不合格品的控制，并且 a）optimize material flow，material handling，b） 在适用时，便于材料的同步流动。 应开发并适时对新产品或新操作的制造可行性进行评价的方法。制造可行性评估应包括产能策划。这些方法还应适用于评价对现有操作的提议更改。 组织应保持过程有效性，包括定期风险复评，以纳入在过程批准、控制计划维护（见第8.5.1.1条）及作业准备的验证（见第8.5.1.3条）期间做出的任何更改。 制造可行性评估和产能策划的评价应为管理评审的输入（见ISO 9001第9.3条）。 注1：这些要求应当包括对精益制造原则的应用。 注2：这些要求应当应用于现场供应商活动，如适用。 7.1.3.1 工厂、设施及设备策划 and value-added use of floor space including control of nonconforming product，and b）facilitate synchronous material flow，as applicable. Methods shall be developed and implemented to evaluate manufacturing feasibility for new product or new operations. Manufacturing feasibility assessments shall include capacity planning. These methods shall also be applicable for evaluating proposed changes to existing operations. The organization shall maintain process effectiveness，including periodic re-evaluation relative to risk，to incorporate any changes made during process approval，control plan maintenance（see Section 8.5.1.1），and verification of job set-ups（see Section 8.5.1.3）. Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to management reviews（see ISO 9001，Section 9.3）. NOTE 1 These requirements should include the application of lean manufacturing principles. NOTE 2 These requirements should apply to on-site supplier activities，as applicable. 7.1.4 Environment for the operation of processes See ISO 9001:2015 requirements. The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. NOTE A suitable environment can be a combination of human and physical factors, such as: a) social (e.g. non-discriminatory, calm, non-confrontational); b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise). These factors can differ substantially depending on the products and services provided. 7.1.4 过程操作的环境 见ISO 9001:2015的要求。 组织应确定、提供并维护过程运行所需的环境，以获得合格的产品和服务。 注：适当的过程运行所需的环境可能是人文因素与物理因素的组合，例如： a) 社会因素（如无歧视的、和谐稳定、无对抗）； b) 心理因素（如舒缓心里压力、预防过度疲劳、 保护个人情感） c) 物理因素（如：温度、热量、湿度、照明、空气流通、卫生、噪音） 由于所提供的产品和服务不同，这些因素可能有显著的差异。 注：在ISO 45001（或等效标准）第三方认证被认可的情况下，该认证可以证明组织符合本要求的人员安全方面。 7.1.4.1 过程操作的环境----补充 组织应保持生产现场处于与产品和制造过程相协调的有序、清洁和整理的状态。 NOTE Where third-party certification to ISO 45001（or equivalent）is recognized，it may be used to demonstrate the organization's conformity to the personnel safety aspects of this requirement. 7.1.4.1 Environment for the operation of processes - supplemental The organization shall maintain its premises in a state of order，cleanliness，and repair that is consistent with the product and manufacturing process needs. 7.1.5 Monitoring and measuring resources 7.1.5.1 General See ISO 9001:2015 requirements. The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided: a) are suitable for the specific type of monitoring and 7.1.5 监视和测量资源 7.1.5.1 总则 见ISO 9001:2015的要求。 7.1.5.1 总则 当利用监视或测量来验证产品和服务符合要求时，组织应确定并提供所需的资源，以确保结果有效和可靠。 组织应确保所提供的资源： a) 适合特定类型的监视和测量活动； b) 得到适当的维护，以确保持续适合其用途。 组织应保留作为监视和测量资源适合其用途的证据的形成文件的信息。 7.1.5.1.1 测量系统分析 应进行统计研究来分析在控制计划所识别的每种检验、测量和试验设备系统的结果中呈现的变异。所采用的分析方法及接受准则，应与测量系统分析的参考手册相一致。如果得到顾客的批准，其他分析方法和接收准则也可以应用。 替代方法的顾客接受记录应与替代测量系统分析的结果一起保留（见第9.1.1.1条）。 注：测量系统分析研究的优先级应当着重于关键或特殊产品或过程特性。 7.1.5.2 测量可追溯性 见ISO 9001:2015的要求。 measurement activities being undertaken; b) are maintained to ensure their continuing fitness for their purpose. The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. 7.1.5.1.1 Measurement systems analysis Statistical studies shall be conducted to analyse the variation present in the results of each type of inspection，measurement，and test equipment system identified in the control plan. The analytical methods and acceptance criteria used shall conform to those in reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer. Records of customer acceptance of alternative methods shall be retained along with results from alternative measurement systems analysis（see Section 9.1.1.1）. NOTE Prioritization of MSA studies should focus on critical or special product or process characteristics. 7.1.5.2 Measurement traceability See ISO 9001:2015 requirements. 7.1.5.2 Measurement traceability 当要求测量溯源时，或组织认为测量溯源是信任测量结果有效的基础时，测量设备应： a) 对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前进行校准和（或）检定（验证），当不存在上述标准时，应保留作为校准或检定（验证）依据的形成文件的信息； b) 予以标识，以确定其状态； c) 予以保护，防止由于调整、损坏或衰减所导致的准状态和随后的测量结果的失效。 当发现测量设备不符合预期用途时，组织应确定以往测量结果的有效性是否受到不利影响，必要时应采取适当的措施。 注：一个可追溯到装置校准记录的编号或其他标识符，满足ISO 9001：2015要求的意图。 When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information; b) identified in order to determine their status; c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.