Is there a documented procedure in place for changing in product design?
是否有订立文件程序来处理产品设计的更改？
Is there documented procedure about maintaining and testing card access system?
有关于维护和测试门禁系统的文件程序?。
A documented procedure should be followed if uncoded printed materials are returned to stock.
如果将未打印批号的包装材料退库，则应按书面程序规定执行。
CMM required that project effort and cost estimates be developed according to a documented procedure.
CMM要求项目努力和开销评估根据一个被记录的程序进行。
Do you maintain a documented procedure for the identification of inspection and test status of a product?
你保持记录的程序确定检查和试验状态的产品？
A documented procedure shall BE established to define requirements for reviewing preventive action taken.
应编制形成文件的程序以规定评审所采取的预防措施等方面的要求。
Is there a documented procedure for handling of complains, including clearly defined steps and responsibility?
是否有书面的客诉处理程序，包括步骤及职责？
Packaging materials should be issued for use only by authorised personnel following an approved and documented procedure.
只能由专人按照经批准的书面规程发放包装材料。
Establish a documented procedure for the inspection and identification of Hazardous substances included in purchased goods.
针对采购物品中有害物质之检验与识别建立文件化程序。
A documented procedure shall be established to define the controls needed to review and update as necessary and re-approve documents.
编制形成文件的程序控制应规定必要时对文件进行评审与更新并再次批准。
Improve existing requirements where stakeholders identified need for clarification, including when a documented procedure is required.
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。
Does a documented procedure exist indicating control and related responsibilities and authorities for dealing with nonconforming product?
有记录程序表明在处理不合要求产品时的控制，相关责任和相关权威部门吗？
The company shall establish documented procedure for the validation of sterilization process, which shall be earlier than the initial use.
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。
Does the organization have a documented procedure in place to cover all the aspects of RAMS and process in place to manage LCC activities?
组织是否有一个文件化的程序来覆盖RAMS的所有方面，另外，组织是否有过程管理LCC活动？
A documented procedure shall be established to define the controls needed to ensure that documents remain legible and readily identifiable.
是否有文件化的设计确认和控制的体系程序，这些文件是否存档并受控？
The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
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。
Is there a documented procedure for handling of incidents, which do or potentially can negatively affect product quality, safety or legality?
针对影响到产品质量，安全或合法性的事故，是否有书面的事故处理程序？
Server failures will have catastrophic consequences, since no formal and documented procedure exists for automated backups of relevant server systems.
服务器失败将造成灾难性后果，因为没有正式的或记录好的过程用于自动备份相关服务器系统。
The organization shall establish and maintain a documented procedure for periodically evaluating compliance with relevant environmental legislation and regulations.
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 responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure.
策划和实施审核以及报告结果和保持记录的职责和要求，应在形成文件的程序中作出规定。
NOTE 1 Where the term "documented procedure" appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.
注：1、本标准出现“形成文件的程序”之处，即要求建立该程序，形成文件，并加以实施和保持。
NOTE 1 Where the term 'documented procedure "appears within this International Standard, this means that the procedure is established, documented, implemented and maintained."
备注1本国际标准中出现“文件化程序”之处，系要求该程序须被建立、文件化、实施及维持。
The Responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
书面程序应界定为规划和执行稽核之责任与要求，并应记录和报告结果（见4.2.4）
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
策划和实施审核以及报告结果和保持记录(见4.2.4)的职责和要求应在形成文件的程序中作出规定。
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
策划和实施审核以及报告结果和保持记录(见4.2.4)的职责和要求应在形成文件的程序中作出规定。
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