15记录控制程序.docVIP

文件名称 File name 记录控制程序 Record Controlling Procedure 文件编号 File No. LAB/CX-15 编制/日期 Compiled by/Date 版号/修订次 Version/Revise No. B/2 审核/日期 Reviewed by/Date 分发至 Issued to 质管部、实验室 QA, Lab. 批准/日期 Approved by/Date 生效日期 EFF. from 编制依据Compilation Basis ISO/IEC 17025 检验与校准实验室认可准则Inspection and calibration laboratory accreditation criteria. 1 目的Purpose 对记录保持识别、收集、索引、存档、存放、维护和清理。 Keep record identification, collection, index, archive, storage, maintenance and clean. 2 适用范围Scope 所有质量/技术记录。 The whole quality/technical records. 3 职责Duties 质量/技术负责人组织对质量/技术记录进行编制。 Quality/ Technical Leader is responsible for compiling quality/technical records. 实验室主任批准质量/技术记录。 Laboratory Director is responsible for approving quality/technical records. 4 工作程序Working procedure 4.1 质量/技术记录的reproducibility. The compilation, review, approval and change refer to File Controlling Procedure. 4.2记录的识别Record Identification 采用记录的文件名称、记录编号来进行识别。规定如下： Identify the records with file name and record number. The provisions are as the following: 序号No. 文件类别 File Type 编号 Serial Number 编号说明 Instruction 1 质量记录 Quality records LAB/RECZL-NN(or或NN.N) LAB-实验室代号质量手册DDDD-发布年份-程序文件NN(或NN.N)-文件号 -文件号ZL-质量记录2 技术记录 Technical records LAB/RECJS-NN(or或NN.N) RECJS-技术记录4.3记录的填写Records Filling in 各种质量/技术记录应实时如实记录，认真填写、内容完整； All the quality/technical records shall be timely and faithfully recorded and carefully filled in with intact contents. 记录采用黑水钢笔或签字笔规范填写、字迹清晰，不得潦草。不得使用圆珠笔或者铅笔填写； Records shall be standardly filled in with black pen or roller pen and the writing shall be clear without scrawl. Do not use ball pen or pensil. 记录表格不允许出现空项，数据项不需要填写时，应用斜线“/”； Any column in the form shall not appears empty. If the data item need not filling in, write a slash /. 检验工作完成后，由熟悉该项目的检验人员对记录进行复核，复核是否完整、正确。 After inspections are finished, inspectors who are familiar with that project shall review the integrity and correctness of the records. 4.4记录的更改 Record Changes 记录形成后发现错误时,不允许涂改，应划改，并签上姓名、日期。并能清楚辨识更改前的记录； If mistakes are fo