文件化程序是企业质量体系有效运行的基础。
Documentation program is the basis in a company which provides an effective operation to quality system.
组织应保留文件化的，关于环境目标的信息。
The organization shall retain documented information on the environmental objectives.
确定那些过程应当加以文件化，以及如何文件化。
Determine those processes that are to be documented and how they are to be documented.
于运用此工具解决问题相比较，过于强调文件化。
To emphasize documentation at the expense of applying the tool.
组织应保留文件化的信息作为管理评审结果的证据。
The organization shall retain documented information as evidence of the results of management reviews.
我觉得，未来非文件化的CAD系统这个话题很重要。
The topic of future of file-less CAD systems is important, in my view.
工厂是否按认证实施规则的要求建立文件化质量体系？
Has the factory established and maintained a documented quality system according to the requirement of the implementation rules for certification?
针对采购物品中有害物质之检验与识别建立文件化程序。
Establish a documented procedure for the inspection and identification of Hazardous substances included in purchased goods.
应配有满足标准要求文件化的环境(职业健康安全)程序。
Documented Environmental (Occupational Health and Safety) procedures for all elements required by the standard should be in place.
体系的文件化包括编写质量手册、程序文件以及作业指导书等。
The documentation of the quality system includes quality manual, procedure document and operation instruction etc.
不合格品的管制及处理的责任与授权，应被定义于文件化程序中。
The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
组织必须证明在特殊特性的确定、文件化和控制方面符合顾客要求。
The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.
请购单应订明，供应商必须执行经认可的，已经文件化的质量计划。
The PR shall stipulate that the vendor will implement an approved, documented Quality Program.
组织应在与顾客要求相符的特殊特性的规定文件化和控制方面加以说明。
The organization shall demonstrate conFORmity to customer requirements FOR designation, documentation and control of special characteristics.
公司对灭菌过程的确认建立文件化程序，灭菌过程确认应在最初使用前进行。
The company shall establish documented procedure for the validation of sterilization process, which shall be earlier than the initial use.
组织应建立并维持文件化程序，以定期评估其与相关环境法令与规章之符合性。
The organization shall establish and maintain a documented procedure for periodically evaluating compliance with relevant environmental legislation and regulations.
对于纠正和预防措施引起文件化程序的任何更改，组织应遵照实施并予以记录。
The organization shall implement and record any changes in the documented procedures resulting form corrective and preventive action.
编写机器指令，测试、调试及集成程序。文件化整个系统及开发数据控制程序。
Write machine instructions, test, debug, and assemble program. Document overall system and develop data control procedures.
设计输出应予文件化，并以对设计输入要求能被查证及作有效性确认方式予以表达。
Design output shall be documented and expressed in terms that can be verified and validated against design input requirements.
注：组织可确定一个格式将策划过程输出文件化，不是所有的案例都需要具体的策划。
Note: You can determine the format for documenting the output of this planning process, and a specific plan is not necessary in all cases.
供应商在实施设计或流程变更之前，是否文件化，是否由经授权人员进行复审、批核？
Are supplier initiated design or process changes documented, reviewed, and approved by authorized internal personnel before implementation?
产品设计或过程变更在实施之前，是否得到客户的文件化批准或者签署文件化豁免书？
Has written customer approval or waiver been obtained and documented prior to a design or process change being implemented into production?
凡是利益相关方认为必须加以澄清的各项要求，其中包括要求文件化程序的要求有所改进。
Improve existing requirements where stakeholders identified need for clarification, including when a documented procedure is required.
组织应建立，实施和保持程序以便产生，更新和控制与环境管理体系相关联的文件化的信息。
The organization shall establish, implement and maintain a procedure to create, update and control the documented information associated with the environmental management system.
组织应建立，实施和保持程序以便产生，更新和控制与环境管理体系相关联的文件化的信息。
The organization shall establish, implement and maintain a procedure to create, update and control the documented information associated with the environmental management system.
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