IATF16949 中英文对照版 201710 - 图文(4)

NOTE A number or another identifier traceable to the device calibration record meets the intent of the requirements in ISO 9001:2015. 7.1.5.2.1 Calibration/verification records 7.1.5.2.1 校准/验证记录 The organization shall have a documented process for 组织应有一个形成文件的过程，用于管理校准/验证managing calibration/verification records. 记录。用以提供符合内部要求、法律法规要求及顾Records of the calibration/verification activity for all 客规定要求证明的所有量具、测量和试验设备（包gauges and measuring and test equipment（including 括员工拥有的测量设备、顾客拥有的设备或现场供employee-owned equipment relevant for measuring，应商拥有的设备），其校准/验证活动的记录应予以保customer-owned equipment，or on-site 持。 supplier-owned equipment）needed to provide 组织应确保校准/验证活动和记录应包括以下细节： a） 根据影响测量系统的工程更改进行的修订； b） 校准/验证时获得的任何偏离规范的读数： c）对偏离规范情况导致的产品预期使用风险的评估； d）当在计划验证或校准期间，或在其试用期间，检验、测量和试验设备被查出偏离校准或存在缺陷，应保留有关此检验、测量和试验设备先前测量结果有效性的形成文件的信息，包括校准报告上显示的相关标准的最后一次校准日期和下一次校准到期日； e）如果可疑产品或材料已被发运，对顾客的通知； f）校准/验证后，有关符合规范的声明； g）对用于产品或过程控制的软件版本符合规定的验证； h）所有量具（包括员工拥有的设备、顾客拥有的设备或现场供应商拥有的设备）校准和维护活动的记录； i）对用于产品和过程控制的生产相关软件的验证（包括安装于员工拥有的设备、顾客拥有的设备或现场供应商拥有的设备的软件）。 evidence of conformity to internal requirements，legislative and regulatory requirements，and customer-defined requirements shall be retained. The organization shall ensure that calibration/verification activities and records shall include the following details: a）revisions following engineering changes that impact measurement systems； b）any out-of-specification readings as received for calibration/verification； c）an assessment of the risk of the intended use of the product caused by the out-of-specification condition； d）when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use，documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment shall be retained，including the associated standard's last calibration date and the next due date on the calibration report； e）notification to the customer if suspect product or material has been shipped； f）statements of conformity to specification after calibration/verification； g）verification that the software version used for product and process control is as specified； h）records of the calibration and maintenance 7.1.5.3 实验室要求 7.1.5.3.1 内部实验室 组织的内部实验室设施应有一个确定的范围，包括其从事所要求的检验、试验或校准服务的额能力。该实验室范围应包括在质量管理体系文件中。实验室至少应为以下事项明确规定并实施要求： a） 实验室技术程序的充分性； b） 实验室人员的资格； c） 产品试验； d） 正确执行这些服务的能力，可追溯到相关过程标准（例如：ASTM、EN等）；如果没有可用的国家或国际标准，组织应明确并实施一个验证测量系统能力的方法； e） 顾客要求，如有： f） 对有关记录的评审。 注：通过ISO/IEC 17025（或等效标准）第三方认可可以证明组织内部实验室符合这个要求。 7.1.5.3.2 外部实验室 为组织提供检验、试验或校准服务的外部/商业/独立实验室应有一个确定的范围，包括其从事所要求的检验、试验或校准的能力，并且： -实验室应通过ISO/IEC 17025或等效的国家标准的认可，认可（证书）范围应包括相关检验、试验或校准服务；校准证书或试验报告应包含国家认activities for all gaugin（including employee-owned equipment，customer-owned equipment，or on-site supplier-owned equipment）； i）production-related software verification used for product and process control（including software installed on employee-owned equipment，customer-owned equipment，or on-site supplier-owned equipment）. 7.1.5.3 Laboratory requirements 7.1.5.3.1 Internal laboratory An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection，test，or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement，as a minimum，requirements for: a）adequacy of the laboratory technical procedures； b）competency of the laboratory personnel； c）testing of the product； d）capability to perform these services correctly，traceable to the relevant process standard（such as ASTM，EN，etc.）； when no national or international standard（s）is available，the organization shall define and implement a methodology to verify measurement system capability； e）customer requirements，if any； f）review of the related records. NOTE Third-party accreditation to ISO/IEC 17025（or equivalent）may be used to demonstrate the organization's in-house laboratory conformity to this requirement. 7.1.5.3.2 External laboratory External/commercial/independent laboratory facilities used for inspection，test，or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection，test，or calibration，and either: - the laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include the relevant 可机构的标志；或 -应有证据证明该外部实验室可以被顾客接受。 注：这些证据可以通过顾客评估来证实，或由顾客批准的第二方机构评估，来证明该实验室满足了ISO/IEC 17025或等效国家标准的意图。第二方机构评估可由评估实验室的组织，采用顾客批准的评估方法进行。 当某一设备没有具备资格的实验室时，校准服务可以由设备制造商进行。在这种情况下，组织应确保第7.1.5.3.1条中的要求得到满足。 校准服务的采用，除了由具备资格的（或顾客接受的）实验室提供的以外，需要时，可能需要获得政府监管机构的确认。 7.1.6 组织知识 inspection，test，or calibration service in the scope of the accreditation（certificate）； the certificate of calibration or test report shall include the mark of a national accreditation body； or - there shall be evidence that the external laboratory is acceptable to the customer. NOTE Such evidence may be demonstrated by customer assessment，for example，or by customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment. Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment In such cases，the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met. Use of calibration services，other than by qualified（or customer accepted）laboratories，may be subject to government regulatory confirmation，if required. 7.1.6 Organizational knowledge See ISO 9001:2015 requirements. The organization shall determine the knowledge necessary 见ISO 9001:2015的要求。 for the operation of its processes and to achieve conformity 组织应确定必要的知识，以运行过程，并获得合格of products and services. 产品和服务。 This knowledge shall be maintained and be made available 这些知识应予以保持，并能在所需的范围内得到。 to the extent necessary. 为应对不断变化的需求和发展趋势，组织应审视现When addressing changing needs and trends, the 有的知识，确定如何获取或接触更多必要的知识和organization shall consider its current knowledge and 知识更新。 determine how to acquire or access any necessary 注1：组织的知识是组织特有的知识，通常从其经验additional knowledge and required updates. 中获得，是以实现组织目标所使用和共享的信息。 NOTE 1 Organizational knowledge is knowledge specific to the organization; it is gained by experience. It is information 注2：组织的知识可以基于： a) 内部资源（例知识产权；从经验获得的知识；从that is used and shared to achieve the organization’s 失败和成功项目吸取的经验教训；获取和分享未成objectives. 文的知识和经验；过程、产品和服务的改进结果）； NOTE 2 Organizational knowledge can be based on: b) 外部资源（例如标准；学术交流；专业会议，从a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and 顾客或外部供方收集的知识）。 successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services); b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers). 7.2 能力 见ISO 9001:2015的要求。 组织应： a) 确定其控制下工作的人员所需具备的能力，这些人员从事的工作影响质量管理体系绩效和有效性； b) 基于适当的教育、培训或经验，确保这些人员是胜任的； c) 适用时，采取措施以获取所需的能力，并评价措施的有效性； d) 保留适当的成文信息，作为人员能力的证据。 7.2 Competence See ISO 9001:2015 requirements. The organization shall: a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;. b) ensure that these persons are competent on the basis of appropriate education, training, or experience; c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken; d) retain appropriate documented information as evidence of competence. NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons. 注：适当措施可以包括对在职人员进行培训、辅导或重新分配工作，或者招聘、外包胜任的人员。 7.2.1 能力----补充 组织应建立并保持形成文件的过程，识别包括意识（见第7.3.1条）在内的培训需求，并使所有从事影响产品要求和过程要求符合性的活动的人员具备能力。从事特定指派任务的人员应按要求认可，尤其关注对顾客要求的满足。 7.2.2 能力----在职培训 对于承担影响质量要求、内部要求、法规或法律要求符合性的新的或调整职责的人员，组织应对其进行在职培训（其中还应包括顾客要求培训），包括合同工或代理工。在职培训的详细程度应与人员的教育程度及其要在日常工作中执行的任务的复杂程度相称。从事影响质量的工作人员应被告知不符合顾客要求的后果。 7.2.1 Competence - supplemental The organization shall establish and maintain a documented process（es）for identifying training needs including awareness（see Section 7.3.1）and achieving competence of all personnel performing activities affecting conformity to product and process requirements. Personnel performing specific assigned tasks shall be qualified，as required，with particular attention to the satisfaction of customer requirements. 7.2.2 Competence - on-the-joh training The organization shall provide on-the-job training（which shall include customer requirements training）for personnel in any new or modified responsibilities affecting conformity to quality requirements，internal requirements，regulatory or legislative requirements； this shall include contract or agency personnel. The level of detail required for on-the-job training shall be commensurate with the level of education the personnel possess and the complexity of the task（s）they are required to perform for their daily work. Persons whose work can affect quality shall be informed about the consequences of nonconformity to customer requirements. 7.2.3 内部审核员能力 组织应有形成文件的过程，用于验证内部审核员的能力，要考虑到组织规定的要求和/或顾客特定要求。关于审核员能力的更多参考，参见ISO 19011。组织应保持一份合格内部审核员名单。 质量管理体系审核员应能够证实最少具备以下能力： a） 了解汽车审核过程方法，包括基于风险的思维； b） 了解适用的顾客特定要求； c） 了解ISO 9001和IATF 16949中适用的与审核范围有关的要求； d） 了解与审核范围有关的适用的核心工具要求； e） 了解如何计划审核、实施审核、报告审核以及关闭审核发现。 至少，制造过程审核员还应证实对于待审核的相关制造过程，其具有技术知识，包括过程风险分析（例如PFMEA）和控制计划。 至少，产品审核员还应证实其了解产品要求，并能够使用相关测量和试验设备验证产品符合性。 如果由组织的人员提供培训来取得人员能力的情况下，应保留形成文件的信息，证实培训师的能力符合上述要求。 内部审核员能力的维持与改进应通过以下方法进行证实： a） 每年执行组织规定的最小数量的审核，并且 b） 保持基于内部更改（如：过程技术、产品技 7.2.3 Internal auditor competency The organization shall have a documented process（es）to verify that internal auditors are competent，taking into account any requirements defined by the organization and/or customer-specific requirements. For additional guidance on auditor competencies，refer to ISO 19011. The organization shall maintain a list of qualified internal auditors. Quality management system auditors shall be able to demonstrate the following minimum competencies: a）understanding of the automotive process approach for auditing，including risk-based thinking； b）understanding of applicable customer-specific requirements； c）understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit； d）understanding of applicable core tool requirements related to the scope of the audit； e）understanding how to plan，conduct，report，and close out audit findings. At a minimum,manufacturing process auditors shall demonstrate technical understanding of the relevant manufacturing process（es）to be audited，including process risk analysis（such as PFMEA）and control plan. At a minimum, product auditors shall demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity. If the organization’s personnel provide the training to achieve competency，documented information shall be retained to demonstrate the trainer’s competency with the above requirements. Maintenance of and improvement in internal auditor competence shall be demonstrated through: f）executing a minimum number of audits per year，as defined by the organization；and g）maintaining knowledge of relevant requirements based on internal changes（e.g.，process technology，product technology）and external changes