The results of these tests shall be documented .
这些试验的结果将成文。
Incident investigation results shall be documented and maintained.
事件调查的结果应形成文件并保持。
The dates and results of quality system reviews shall be documented.
质量体系回顾的日期和结果应做成文档保存。
The ship security assessment shall be documented, verified and retained by the Company.
公司须将船舶保全评量视为正式资料，检视及保留。
All harnesses inspection shall be documented and a dated inspection sticker shall be attached to the harness.
所有安全带的检查必须存档备查，检查日期可用帖纸标注在安全带上。
The approval, including the date and signature of the individual (s) approving the output, shall be documented.
该批准(其中包括批准输出的人员的签字和日期)应当予以记录。
The approval, including the date and signature of the individual (s) approving the requirements, shall be documented.
该批准(其中包括批准需求的人员的签字和日期)应当予以记录。
Design output shall be documented and expressed in terms that can be verified and validated against design input requirements.
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。
The system verification shall be planned concurrently with the development, for each phase of the lifecycle, and shall be documented.
对系统生命周期中的每一阶段，都应该在开发的同时安排系统验证，并形成文件。
In this logbook shall be documented all sessions of operation of the Supplies as well as any problems encountered during operation of the Supplies.
日志中应记录供应品的每次运行，以及运行期间遇到的任何问题。
The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.
设计验证的结果应当记录在设计历史文档中。这些结果包括设计识别、方法学、日期和实施审核的人员。
The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).
设计审核的结果包括设计识别、日期和实施审核的人员，应当记录在设计历史文档中。
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
若顾客提供的要求没有形成文件，组织在接受顾客要求前应对顾客要求进行确认。
Documented information describing the results of the review, including any new or changed requirements for the products and services, shall be retained.
描述评审结果的记录信息，包括任何新的或变更的产品和服务的要求，应该予以保留。
Where the customer does not provide a documented statement of their requirements, the customer requirements shall be confirmed by the organization before acceptance.
若顾客没有提供形成文件信息的要求，这些顾客的要求应在组织接受前得到确认。
Where the customer provides not documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
当顾客以非书面陈述提出要求时，顾客要求应在组织接受之前加以确认。
The control systems, which shall comprise cost, time and resource management, shall be fully documented in the Project Plans and in the Project Procedures Manual.
项目计划和项目过程手册应将包括成本、时间、资源管理在内的控制体系充分记录在案。
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。
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 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。
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。
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。
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。
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。
Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.
标准手艺，其中的表示方式应记录在案的标准或方法，确定并批准了有代表性的样本。
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？
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？
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