IATF16949 中英文对照版 201710 - 图文(2)

5.1 领导作用与承诺 See ISO 9001:2015 requirements. 5.1.1 General 总则 5.1.1 总则 Top management shall demonstrate leadership and commitment with respect to the quality management 见ISO 9001:2015的要求。 system by: 最高管理者应证实其对质量管理体系的领导作用和a) taking accountability for the effectiveness of the quality 承诺，通过： management system; a) 对质量管理体系的有效性承担责任； b) ensuring that the quality policy and quality objectives b) 确保制定质量管理体系的质量方针和质量目标，are established for the quality management system and are 并与组织环境和战略方向保持一致； compatible with the context and strategic direction of the c) 确保将质量管理体系要求融入组织的业务过程； organization; d) 促进使用过程方法和基于风险的思维； c) ensuring the integration of the quality management e) 确保获得质量管理体系所需的资源； system requirements into the organization’s business f) 沟通有效的质量管理体系和符合质量管理体系要processes; 求的重要性； d) promoting the use of the process approach and g) 确保实现质量管理体系的预期结果； risk-based thinking; h) 促使、指导和支持员工努力提高质量管理体系的e) ensuring that the resources needed for the quality 有效性； management system are available; i) 推动改进； f) communicating the importance of effective quality j) 支持其他管理者履行其相关领域的职责。 management and of conforming to the quality management 注：本标准中的“业务”一词可大致理解为涉及组织存system requirements; 在目的的核心价值活动，组织可以是公有的、私有g) ensuring that the quality management system achieves 的、盈利或非盈利的。 its intended results; h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system; i) promoting improvement; j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit. 5.1.1.1 公司责任 5.1.1.1 Corporate responsibility The organization shall define and implement corporate responsibility policies，including at a 组织应明确并实施公司责任方针，至少包括反贿赂minimum an anti-bribery policy，an employee code of 方针、员工行为准则以及道德准则升级政策（“举报conduct，and an ethics escalation policy政策”）。 （“whistle-blowing policy”）. 5.1.1.2 Process effectiveness and efficiency Top management shall review the product realization 5.1.1.2 过程有效性和效率 processes and support processes to evaluate and 最高管理者应评审产品实现过程和支持过程，以评improve their effectiveness and efficiency. The results of the process review activities shall be included as 价并改进过程有效性和效率。过程评审活动的结果应作为管理评审的输入（见第9.3.2.1条）。 input to the management review（see Section 9.3.2.1.）. 5.1.1.3 Process owners Top management shall identify process owners who 5.1.1.3 过程拥有者 are responsible for managing the organization's processes and related outputs. Process owners shall 最高管理者应确定过程拥有者，由其负责组织的各understand their roles and be competent to perform 过程和相关输出的管理。过程拥有者应了解他们的those roles（see ISO 9001，Section 7.2）. 角色，并且具备胜任其角色的能力（见ISO 9001 第 7.2条）. 5.1.2 Customer focus See ISO 9001:2015 requirements. 5.1.2以顾客为关注焦点 Top management shall demonstrate leadership and 见ISO 9001:2015的要求。 最高管理者应通过以下方面，证实其对以顾客为关注焦点的领导作用和承诺： a) 确定、理解和持续满足顾客要求以及适用的法律和法规要求； b) 确定和应对能够影响产品和服务符合性以及增强顾客满意能力的风险与机遇； c) 始终致力于增强顾客满意。 commitment with respect to customer focus by ensuring that: a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met; b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; c) the focus on enhancing customer satisfaction is maintained. 5.2 方针 5.2.1 建立质量方针 5.2 Policy 5.2.1 Establishing the qualify policy See ISO 9001:2015 requirements. Top management shall establish, implement and maintain a quality policy that: 见ISO 9001:2015的要求。 a) is appropriate to the purpose and context of the 最高管理者应制定、实施和保持质量方针，方针应： organization and supports its strategic direction; a) 与组织的宗旨和环境相适应，并支持其战略方向； b) provides a framework for setting quality objectives; b) 提供制定质量目标的框架 c) includes a commitment to satisfy applicable c) 包括对满足适用要求的承诺； requirements; d) 包括对持续改进质量管理体系的承诺。 d) includes a commitment to continual improvement of the quality management system. 5.2.2 Communicating the quality policy See ISO 9001:2015 requirements. 5.2.2 沟通质量方针 见ISO 9001:2015的要求。 质量方针应： a) 作为形成文件的信息，可获得并保持； b) 在组织内得到沟通、理解和应用 c) 适宜时，可向有关相关方提供。 The quality policy shall: a) be available and be maintained as documented information; b) be communicated, understood and applied within the organization; c) be available to relevant interested parties, as appropriate. 5.3 组织的作用、职责和权限 见ISO 9001:2015的要求。 5.3 Organizational roles，responsibilities and authorities See ISO 9001:2015 requirements. Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization. Top management shall assign the responsibility and authority for: a) ensuring that the quality management system conforms to the requirements of this International Standard; b) ensuring that the processes are delivering their intended outputs; c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management; d) ensuring the promotion of customer focus throughout the organization; e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 最高管理者应确保相关角色的职责和权限在整个组织内得到分派、沟通和理解。 最高管理者应分派职责和权限，以： a) 确保质量管理体系符合本标准的要求； b) 确保各过程获得其预期的输出； c) 报告质量管理体系的绩效和改进机会，特别向最高管理者； d) 确保在整个组织推动以顾客为关注焦点； e) 确保在策划和实施质量管理体系的更改时保持其完整性。 Top management shall assign personnel with the 最高管理者应向人员指派职责和权限，以确保顾客responsibility and authority to ensure that customer 要求得到满足。这些指派应形成文件。这包括但不requirements are met. These assignments shall be 限于：特殊特性的选择，质量目标和相关培训的设documented. This includes but is not limited to the 置，纠正和预防措施，产品设计和开发，产能分析，selection of special characteristics，setting quality 物流信息，顾客计分卡以及顾客门户。 objectives and related training，corrective and Preventive actions，product design and development， capacity analysis，logistics information，customer scorecards，and customer portals. 5.3.1 组织的作用、职责和权限----补充 5.3.1 Organizational roles，responsibilities，and authorities - supplemental 5.3.2 Responsibility and authority for product requirements and corrective actions 5.3.2 产品要求和纠正措施的职责和权限 Top management shall ensure that: 最高管理者应确保： a）personnel responsible for conformity to a） 负责产品要求符合性的人员有权停止发运product requirements have the authority to stop 或生产以纠正质量问题； shipment and stop production to correct quality 注：由于一些行业中的过程设计，并非总是能立即停止生产。在这种情况下，必须对受problems； 影响批次进行控制，以防将其发运给顾客。 NOTE Due to the process design in some industries，it b） 拥有纠正措施权限和职责的人员能够及时获知与要求不符的产品或过程，以确保避免might not always be possible to stop production immediately. In this case，the affected batch must be 将不合格品发运给顾客，并确保所有潜在不contained and shipment to the customer prevented. 合格品得到识别与控制； b）personnel with authority and responsibility for c） 所有班次的生产作业都安排有负责确保产corrective action are promptly informed of products 品要求符合性的负责人员或代理职责人员。 6 策划 6.1 风险和机遇的应对措施 6.1.1和6.1.2 见ISO 9001:2015的要求。 6.1.1 策划质量管理体系时，组织应考虑 4.1所描述的因素和 4.2所提及的要求，并确定需要应对的风险和机遇以： a) 确保质量管理体系能够实现其预期的结果； b) 增强有利影响； c) 避免或减少不利影响； d) 实现改进。 6.1.2 组织应策划： a) 应对这些风险和机遇的措施； b) 如何： 1) 在质量管理体系过程中融入整合和实施这些措施（见 4.4）； 2) 评价这些措施的有效性。 or processes that do not conform to requirements to ensure that nonconforming product is not shipped to the customer and that all potential nonconforming product is identified and contained； c）production operations across all shifts are staffed with personnel in charge of，or delegated responsibility for，ensuring conformity to product requirements. 6 Planning 6.1 Actions to address risks and opportunities 6.1.1 and 6.1.2 See ISO 9001:2015 requirements. 6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: a) give assurance that the quality management system can achieve its intended result(s); b) enhance desirable effects; c) prevent, or reduce, undesired effects; d) achieve improvement. 6.1.2 The organization shall plan: a) actions to address these risks and opportunities; b) how to: 1) integrate and implement the actions into its quality management system processes (see 4.4); 2) evaluate the effectiveness of these actions. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision. NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs. 所采取的应对风险和机遇的措施应与其对产品和服products and services. 务符合性的潜在影响相适应。 注1：应对风险的选择可以包括：避免风险、为获取机遇而接受风险、消除风险源、改变风险的可能性和结果、分担风险或经过决策而延缓风险。 注2：机遇可以带来新实践的采用、推出新产品、打开新市场、获得新客户、建立合作关系、使用新技术以及能够解决组织或其他顾客需求的其他有利可能性。 6.1.2.1 Risk analysis 6.1.2.1 风险分析 组织应在风险分析中至少包含从产品召回、产品审核、使用现场的退货和修理、投诉、报废及返工的经验教训。 组织应保留形成文件的信息，作为风险分析结果的证据。 The organization shall include in its risk analysis，at a minimum，lessons learned from product recalls，product audits，field returns and repairs，complaints，scrap，and rework. The organization shall retain documented information as evidence of the results of risk analysis. 6.1.2.2 Preventive action The organization shall determine and implement 6.1.2.2 预防措施 action（s）to eliminate the causes of potential 组织应确定并实施措施，以消除潜在不合格的原因，nonconformities in order to prevent their occurrence. 防止不合格发生。预防措施应与潜在问题的严重程Preventive actions shall be appropriate to the severity 度相适应。 of the potential issues. 组织应建立一个用于减轻风险负面影响的过程，过程包括以下方面： a） 确定潜在不合格及其原因； b） 评价防止不合格发生的措施的需求； c） 确定并实施所需的措施； d） 所采取措施的成文信息； e） 评审所采取的预防措施的有效性； f） 利用取得的经验教训预防类似过程中的再次发生（见ISO 9001 第7.1.6条）。 6.1.2.3 应急计划 组织应： a） 对保持生产输出并确保顾客要求得以满足而言必不可少的所有制造过程和基础设施设备，识别并评价相关的内部和外部风险。 b） 根据风险和对顾客的影响制定应急计划； c） 准备应急计划，以在下列任一情况下保证供应的持续性：关键设备故障（另见第8.5.6.1.1条）；外部提供的产品、过程和服务中断；常见自然灾害；火灾；公共事业中断；信息技术系统受到网络攻击；劳动力短缺；或者基础设施破坏； d） 作为应急计划的补充，包含一个通知顾客和其他相关方的过程，告知影响顾客作业的任 The organization shall establish a process to lessen the impact of negative effects of risk including the following: a）determining potential nonconformities and their causes； b）evaluating the need for action to prevent occurrence of nonconformities； c）determining and implementing action needed； d）documented information of action taken； e）reviewing the effectiveness of the preventive action taken； f）utilizing lessons learned to prevent recurrence in similar processes（see ISO 9001，Section 7.1.6）. 6.1.2.3 Contingency plans The organization shall: a）identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain production output and to ensure that customer requirements are met； b）define contingency plans according to risk and impact to the customer； c）prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures（also see Section 8.5.6.1.1）； interruption from externally provided products，processes，and services； recurring natural disasters； fire； utility interruptions；cyber-attacks on information technology systems; labour shortages；