ts1694920xx(中英文对照版本)内容摘要:
ement systemRequirements ISO9001: 2020,质量管理体系 — 要求 3 Terms and definitions 3 术语和定义 For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. 为了本国际标准的目的, ISO9000 中给出了术语和定义适用。 The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: 本版 ISO9001标准描述供应链使用的术语,已经被更改以及反映当前使用的术语: supplier→ anization→ customer 供方 → 组织 → 顾客 The term ”anization” replace the “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies, Also, the term ”supplier” now replaces the term “subcontractor” . 本国际标准所使用的术语“组织”取代了 ISO9001: 1994中使用的术语“供方”,并指代本标准所适用的单位,现在使用的“供方”取代以前使用的术语“分承包方”。 Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. 在本国际标准中,当出现术语“产品”时,也能表示“服务”。 Terms and definitions for automotive industry 汽车行业的术语和定义 For the purposes of this Technical Specification, the terms and definitions 针对本技术规范的目的,适用 ISO9000:2020 和以下给出的术语和定义。 11 11 given in ISO 9000:2020 and the following apply. Control plan 控制计划 Documented description of the systems and processes required for controlling product(see annex A) 对控制产品所要 求的体系和过程的文件化的描述(见附录 A)。 Design responsible anization 具有设计职责的组织 Organization with authority to establish a new, or change an existing, product specification 组织有权限建立新的、或更改现有的产品规范。 NOTE This responsibility includes testing and verification of design performance within the customer’s specified application. 注 本职责包括按顾客指定方法进行设计性能的试验和验证。 Error proofing 防错 Product and manufacturing process design and development to prevent manufacture of nonconforming products. 产品和制造过程设计和开发以防止制造不合格产品。 Laboratory 实验室 Facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical or reliability testing. 进行包括但不限于化学、冶金、尺寸、物理、电性能或可靠性试验在内的检验、试验和校准的设施。 Laboratory scope 实验室范围 Controlled document containing 受控文件包括: — specific tests, evaluations and calibrations that a laboratory is qualified to perform, — 实验室有资格进行的特定试验、评价和校准, 12 12 — list of the equipment which it uses to perform the above, and — 用来进行上述活动的设备清单 ,和 — list of methods and standards to which it performs the above — 进行上述活动的方法和标准的清单。 Manufacturing 制造 Process of making of fabricating 制造或装配以下事项的过程: — production materials, — 生产材料, — production or service parts, — 生产件或服务件, — assemblies, or — 装配, 或 — heat treating, welding, paining, plating or other finishing services — 热处理、焊接、喷漆、电镀或其它最终服务。 Predictive maintenance 预知性维护 Activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes. 基于过程数据,通过预知可能的失效模式而避免维护问题的活动。 Preventive maintenance 预防性维护 Planned action to eliminate cause of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design. 为消除设备失效和非计划的生产中断而策划的活动,是制造过程设计 的输出。 Premium freight 超额运费 Extra costs or charges incurred additional to contracted delivery. 由于产生额外交付而导致的额外的成本或费用。 NOTE This can be caused by method, quality, unscheduled or late deliveries, etc. 注 这可能会因方法、数量、非计划或延迟交付等而导致。 Remote location 外部场所 13 13 Location that supports sites and at which nonproduction processes occur 支持现场及非生产过程发生的场所。 Site 现场 Location at which valueadded manufacturing processes occur 增值制造过程发生的场所。 Special characteristic 特殊特性 Product characteristic or manufacturing process parameter which can affect safety or pliance with regulations, fit, function, performance or subsequent processing of product. 可能影响安全性或法规的符合性、产品的配合、功能、性能,或产品后续生产过程的产品特性或制造过程参数。 4 Quality management system 4 质量管理体系 General requirements 总要求 ISO 9001:2020, Quality management systemRequirements ISO9001: 2020,质量管理体系 — 要求 4 Quality management system 4 质量管理体系 General requirements 总要求 The anization shall establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The anization shall: 组织必须按本标准的要求建立质量管理体系,形成文件,加以实施和保持,并持续改进其有效性。 组织必须: a)identify the process needed for the quality management system and their application through the anization(), a)识别质量管理体系所需的过程,及其在组织中的应用(见 ), b)determine the sequence and interaction of these process, b)确定这些过程的顺序和相互作用, c)determine criteria and methods needed to ensure that both the operation and c)确定为确保这些过程的有效运作和控制所需的准则和方法, 14 14 control of these processes are effective, d)ensure the availability of resources and information necessary to support the operation and monitoring of these processes, d)确保可以获得必要的资源和信息,以支持这些过程的运作和监测, e)monitor, measure and analyse these processes, and e)监测、测量和分析这些过程,和 f)implement actions necessary to achieve planned results and continual improvement of these processes, f)实施必要的措施,以实现这些过程策划的结果和对这些过程的持续改进。 These processes shall be managed by the anization in accordance with the requirements of this International Standard. 组织必须按本标准的要求管理这些过程。 Where an anization choose to outsource any process that affects product conformity with requirements, the anization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. 针对组织所选择的任何影响产品符合要求的外包过程,组织必须确保对其实施控制。 对此类外包过程的控制必须在质量管理体系中加以识别。 NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 注 上述质量管理体系所需的过。ts1694920xx(中英文对照版本)
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性时,公司各项制程管制指导书及类似的文件( FMEA、管制计划、操作说明),应使用顾客指定的管制特性符号(或者公司内部与之对等的符号、标记)来标明那些会影响管制特性的制程步骤。 设计和开发输出 — 补充 产品设计输出应以能被验证和确认的形式来表达,并符合产品设计输入的要求, 制造过程设计输出 制程设计输出应以能被验证和确认的形式来表达,并符合制程设计输入的要求 TS16949: 2020 部分
( 4)使产品从设计、开发、接 单.制造、出货一系列动作均有据可依; ( 5)项目策划使产品开发成本处可预测、可控制状态(生产调控图); ( 6)更多考虑产品在生产及使用中的安全问题,在满足客户需求的前提下,更多保护公司的利益 ( 7)过程的改进使特殊性具有最高优先权限。 由咨询顾问小组组织现状及按 ISO/ TS16949 要求进行各职能部门的诊断与全面了解。 2.预期目标: (
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