IATF16949 中英文对照版 201710 - 图文(5)

术）和外部更改（如：ISO 9001、IATF 16949、核心工具及顾客特定要求）对相关要求的认知。 7.2.4第二方审核员能力 组织应证实从事第二方审核的审核员的能力。第二方审核员应符合顾客对审核员资质的特定要求，并证实最少具备以下核心能力，包括了解： a） 汽车审核过程方法，包括基于风险的思维； b） 适用的顾客特定和组织特定要求； c） ISO 9001和IATF 16949中适用的与审核范围有关的要求； d） 适用的待审核制造过程，包括PFMEA和控制计划； e） 与审核范围有关的适用的核心工具要求； f） 如何计划审核、实施审核、编制审核报告并关闭审核发现。 7.3 Awareness See ISO 9001:2015 requirements. （e.g.，ISO 9001，IATF 16949，core tools，and customer specific requirements）. 7.2.4 Second-party auditor competency The organization shall demonstrate the competence of the auditors undertaking the second-party audits. Second-party auditors shall meet customer specific requirements for auditor qualification and demonstrate the minimum following core competencies，including understanding of: a）the automotive process approach to auditing，including risk based thinking； b）applicable customer and organization specific requirements； c）applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit； d）applicable manufacturing process（es）to be audited，including PFMEA and control plan； e）applicable core tool requirements related to the scope of the audit； f）how to plan，conduct，prepare audit reports，and close out audit findings. 7.3意识 见ISO 9001：2015的要求。 组织应确保在其控制下工作人员知晓： a) 质量方针； b) 相关的质量目标； c) 他们对质量管理体系有效性的贡献，包括改进质量绩效的益处； d) 不符合质量管理体系要求的后果。 The organization shall ensure that persons doing work under the organization’s control are aware of: a) the quality policy; b) relevant quality objectives; c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance; d) the implications of not conforming with the quality management system requirements. 7.3.1 Awareness - supplemental The organization shall maintain documented information that demonstrates that all employees are 7.3.1意识——补充 aware of their impact on product quality and the 组织应保持形成文件的信息，证实所有员工都认识importance of their activities in achieving，到其对产品质量的影响，以及他们所从事的活动在maintaining，and improving quality，including 实现、保持并改进质量中的重要性，还包括顾客要customer requirements and the risks involved for the 求及不合格品带给顾客的风险。 customer with non- conforming product. 7.3.2 员工激励和授权 组织应保持形成文件的信息，激励员工实现质量目标，进行持续改进，并建立一个提倡创新的环境。该过程应包括促进整个组织对质量和技术的认知程度。 7.3.2 Employee motivation and empowerment The organization shall maintain a documented process（es）to motivate employees to achieve quality objectives，to make continual improvements，and to create an environment that promotes innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization. 7.4 Communication See ISO 9001:2015 requirements. The organization shall determine the internal and external communications relevant to the quality management system, including: a) on what it will communicate; b) when to communicate; c) with whom to communicate; d) how to communicate; e) who communicates. 7.4 沟通 见ISO 9001:2015的要求。 组织应确定与质量管理体系相关的内部和外部沟通，包括： a) 沟通什么； b) 何时沟通； c) 与谁沟通； d) 如何沟通； 7.5 Documented information e) 由谁沟通。 7.5.1 General See ISO 9001:2015 requirements. 7.5 形成文件的信息 7.5.1 总则 The organization’s quality management system shall include: a) documented information required by this International Standard; b) documented information determined by the organization as being necessary for the effectiveness of the quality management system. NOTE The extent of documented information for a quality management system can differ from one organization to another due to: — the size of organization and its type of activities, processes, products and services; — the complexity of processes and their interactions; — the competence of persons. 见ISO 9001:2015的要求。 组织的质量管理体系应包括： a) 本标准要求的成文信息； b) 组织确定的为确保质量管理体系有效运行所需的成文信息。 注：对于不同组织，质量管理体系成文信息的多少与详略程度可不同，取决于： --组织的规模，以及活动、过程、产品和服务的类型； --过程及其相互作用的复杂程度； -- 人员的能力。 7.5.1.1 Quality management system documentation The organization’s quality management system shall 7.5.1.1 质量管理体系文件 be documented and include a quality manual，which can be a series of documents（electronic or hard 组织的质量管理体系应形成文件，并包括一份质量手册，可由一系列（电子或硬拷贝形式的）文件构copy）. 成。 质量手册的格式和结构由组织自行决定，将取决于组织的规模、文化和复杂性。如果采用一系列文件，则应保留一份构成组织质量手册文件的清单。 质量手册应至少包含以下内容： a） 质量管理体系的范围，包括任何删减的细节和正当的理由； b） 为管理体系建立的形成文件的过程或对其引用； c） 组织的过程及其顺序和相互作用（输入和输出），包括任何外包过程控制的类型和程度； d） 一个显示组织质量管理体系内哪些地方满足了顾客特定要求的文件（如：一张表格，清单或矩阵）。 注：可采用一个显示组织过程如何满足本汽车QMS标准要求的矩阵来辅助在组织过程与本汽车QMS标准之间建立联系。 The format and structure of the quality manual is at the discretion of the organization and will depend on the organization’s size，culture，and complexity. If a series of documents is used，then a list shall be retained of the documents that comprise the quality manual for the organization. The quality manual shall include，at a minimum，the following: a）the scope of the quality management system，including details of and justification for any exclusions； b）documented processes established for the quality management system，or reference to them； c）the organization’s processes and their sequence and interactions（inputs and outputs），including type and extent of control of any outsourced processes； d）a document（for example, a table, a list, or a matrix）indicating where within the organization's quality management system their customer-specific requirements are addressed. NOTE A matrix of how the requirements of this Automotive QMS standard are addressed by the organization's processes may be used to assist with linkages of the organization's processes and this Automotive QMS， 7.5.2 Creating and updating See ISO 9001:2015 requirements. When creating and updating documented information, the organization shall ensure appropriate: 7.5.2 创建和更新 a) identification and description (e.g. a title, date, author, or 见ISO 9001:2015的要求。 reference number); 在创建和更新成文信息时，组织应确保适当的： b) format (e.g. language, software version, graphics) and a) 标识和说明（如：标题、日期、作者、索引编号）； media (e.g. paper, electronic); b) 形式（如语言、软件版本、图表）和载体（如纸c) review and approval for suitability and adequacy. 质的、电子的）； c) 评审和批准，以确保适宜性和充分性。 7.5.3 Control of documented information 7.5.3 成文信息的控制 7.5.3.1 and 7.5.3.2 See ISO 9001:2015 requirements. 7.5.3.1 Documented information required by the quality 7.5.3.1和7.5.3.2 见ISO 9001:2015的要求。 7.5.3.1 应控制质量管理体系和本标准所要求的成文信息，以确保： a) 在需求的场合和时机，均可获得并适用； b) 予以妥善保护（如防止泄密、不当使用或缺失）。 7.5.3.2 为控制成文信息，适用时，组织应进行下列活动： a) 分发、访问、检索和使用； b) 存储和防护，包括保持可读性； c) 变更控制（如版本控制）； d) 保留和处置。 management system and by this International Standard shall be controlled to ensure: a) it is available and suitable for use, where and when it is needed; b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). 7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable: a) distribution, access, retrieval and use; b) storage and preservation, including preservation of legibility; c) control of changes (e.g. version control); d) retention and disposition. 对于组织确定的策划和运行质量管理体系所需的来Documented information of external origin determined by 自外部的成文信息，组织应进行适当识别，并予以the organization to be necessary for the planning and 控制。 operation of the quality management system shall be 对所保留的、作为符合性证据的成文信息应予以保identified as appropriate, and be controlled. 护，防止非预期的更改。 Documented information retained as evidence of 注：对成文信息的“访问”可能意味着仅允许查阅，conformity shall be protected from unintended alterations. NOTE Access can imply a decision regarding the permission to 或意味着允许查阅并授权修改。 view the documented information only, or the permission and authority to view and change the documented information. 7.5.3.2.1 Record retention 7.5.3.2.1 记录保存 组织应有一个确定的、形成文件的并且被执行的记录保存政策。对记录的控制应满足法律法规、组织及顾客要求。 应保存生产件批准文件、工装记录（包括维护和所有权）、产品和过程设计记录、采购订单（如适用）或者合同和修正，保存时间为产品在现行生产和服务中要求的有效期，再加一个日历年，除非顾客和监管机构另有特殊要求。 注：生产件批准形成文件的信息可包括已批准产品、适用的试验设备记录或已批准试验数据。 The organization shall define，document，and implement a record retention policy. The control of records shall satisfy statutory，regulatory，organizational，and customer requirements. Production part approvals，tooling records（including maintenance and ownership），product and process design records，purchase orders（if applicable），or contracts and amendments shall be retained for the length of time that the product is active for production and service requirements，plus one calendar year，unless otherwise specified by the customer or regulatory agency. NOTE Production part approval documented information may include approved product，applicable test equipment records，or approved test data. 7.5.3.2.2 Engineering specifications The organization shall have a documented process 7.5.3.2.2 工程规范 组织应有形成文件的过程，描述基于顾客要求的进度进行的所有顾客工程标准/规范及相关修订的评审、分发和实施。 当工程标准/规范更改导致产品设计更改时，请参见ISO 9001第8.3.6条的要求。当工程标准/规范更改导致产品实现过程更改时，请参见ISO 9001第8.5.6.1条的要求.组织应保留每项更改在生产中实施日期的记录。实施应包括更新过的文件。 应当在收到工程标准/规范更改通知后10个工作日内完成评审。 注：当设计记录引用了这些规范，或这些规范影响了生产件批准过程的文件，例如：控制计划、风险分析（如FMEA）等时，这些标准/规范的更改需要对顾客的生产件批准记录进行更新。 describing the review，distribution，and implementation of all customer engineering standards/specifications and related revisions based on customer schedules，as required. When an engineering standard/specification change results in a product design change，refer to the requirements in ISO 9001，Section 8.3.6. When an engineering standard/specification change results in a product realization process change，refer to the requirements in Section 8.5.6.1. The organization shall retain a record of the date on which each change is implemented in production. Implementation shall include updated documents. Review should be completed within 10 working days of receipt of notification of engineering standards/specifications changes. NOTE A change in these standards/specifications may require an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of the production part approval process，such as control plan，risk analysis（such as FMEAs），etc. 8 Operation 8.1 Operational planning and control See ISO 9001:2015 requirements. The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for 8 运行 the provision of products and services, and to implement the actions determined in Clause 6, by: 8.1 运行策划和控制 a) determining the requirements for the products and services; 见ISO 9001:2015的要求。 b) establishing criteria for: 为满足产品和服务提供的要求，并实施第6章确定的1) the processes; 措施，组织应通过以下措施对所需的过程（见4.4）2) the acceptance of products and services; 进行策划、实施和控制： c) determining the resources needed to achieve conformity a) 确定产品和服务的要求； to the product and service requirements; b) 建立下列内容的准则： d) implementing control of the processes in accordance 1) 过程； with the criteria; 2) 产品和服务的接收。 e) determining, maintaining and retaining documented c) 确定所需的资源以使产品和服务符合要求； information to the extent necessary: d) 按照准则实施过程控制； 1) to have confidence that the processes have been e)在必要的范围和程度上， 确定并保持、保留成文carried out as planned;