文件使用者应爱护文件，保持整洁，当文件破损影响使用时，应到文控专员处办

Document users should take care of the document and keep it tidy. When the document is damaged and affects its use, it should go to the document control specialist to go through the replacement procedures, return the damaged document, reissue the new document, and fill in the "Document Distribution, Recycling, Destruction Record"; <br>document To be easy to identify and retrieve, the document number should be marked in a visible position, and the documents of each department should be kept in categories for retrieval. <br>Medical device documentation <br>Medical device documentation is a document of the quality management system. The company establishes and maintains a document for each medical device. The document refers to the formed document to prove compliance with the medical device quality management system standard requirements and applicable regulatory requirements. <br>The contents of the medical device documentation include, but are not limited to: <br><br><br>an overview of the medical device, its intended use/intended purpose and marking, including all instructions for use. <br>Including technical reports, summary reports, instructions, packaging labels, etc. <br>Product specifications, including drawings, quality standards, BOM, intermediate product quality standards, enterprise standards or product technical requirements, etc. <br>Specifications or procedures for manufacturing, packaging, storage, disposal, and circulation, including process specifications, process operating procedures, confirmation and verification documents, etc. <br>Measurement and monitoring procedures, including inspection procedures for materials, intermediate products, and finished products. <br>Where appropriate, installation requirements. <br>Not suitable for our company's medical device products. <br>Where appropriate, service procedures, including user manuals, product education videos, etc. <br>The medical device documents are prepared by the members of the medical device design and development project team, reviewed by the project team members and the person in charge, and approved by the person in charge of the enterprise. <br>In order to establish and maintain medical device documents and ensure the current validity, the company's medical device documents adopt the form of reference documents, so it is necessary to indicate the reference document name, file number, version number, storage department and other information. When the reference document is updated, the medical device The documentation should also be updated. <br>All controlled documents of the company are controlled by hand signature of paper documents. If it is necessary to record the operation of the equipment, the electronic records should be printed into a paper version and archived together with the corresponding paper records.<br>When working with a computer, personnel must lock the screen immediately after leaving the computer to prevent files in the computer from being deleted by mistake. <br>When the revision of <br>documents and the use of obsolete documents require revision, if only the contents of the document need to be revised without revising the derived records, the application department shall submit an application to the Quality Department and fill out the "Document Approval Form" and submit it to the relevant departments for approval. Obtain review and approval from the original approval department or other designated departments. <br>The document can be revised only after approval, and the revision is reviewed, approved, and effective in accordance with the requirements of 5.2; the "document revision record table" at least reflects the history of this revision. <br>In the "Document Approval Form", mark "N/A" in the "Record Change" column, and only the file version needs to be upgraded at this time. <br>If the document revision involves the revision of the derivative record, the revision of the document content is reflected in the "Document Revision Record Table". <br>The content of the record revision is reflected in the "Record Change" column of the "Document Approval Form", at which time both the file and the record need to be upgraded. <br>If only the content of the record is revised, the revision department will reflect the changes in the "Record Changes" column of the "Document Approval Form", and only the version of the record needs to be upgraded at this time.

文件使用者应爱护文件，保持整洁，当文件破损影响使用时，应到文控专员处办理更换手续，交回破损文件，补发新文件，并填写《文件分发、回收、销毁记录》；<br>文件要易于识别和检索，文件编号应标注在显见位置，各部门文件分类保存，以便检索。<br>医疗器械文档<br>医疗器械文档属于质量管理体系的文件，本公司为每个医疗器械建立并保持一个文档，文档引用形成的文件以证明符合医疗器械质量管理体系标准要求和适用的法规要求。<br>医疗器械文档的内容包括但不限于：<br><br><br>医疗器械的概述、预期用途/预期目的和标记，包括所有使用说明。<br>包括技术报告、综述报告、说明书、包装标识等。<br>产品规范，包括图纸、质量标准、BOM、中间产品质量标准、企业标准或产品技术要求等。<br>制造、包装、贮存、处置和流通的规范或程序，包括工艺规程、工序操作规程、确认和验证文档等。<br>测量和监视程序，包括物料、中间产品、成品的检验规程等。<br>适当时，安装要求。<br>不适合本公司医疗器械产品。<br>适当时，服务程序，包括使用手册、产品宣教片等。<br>医疗器械文档由该医疗器械设计开发项目组成员编写，项目组成员和负责人审核，企业负责人批准。<br>为建立和保持医疗器械文档，保证现行有效，本公司医疗器械文档采用引用文件的形式，因此需要注明引用文件名称、文件编号、版本号、保管部门等信息，当引用文档更新时，医疗器械文档也要进行更新。<br>公司所有受控文件均以纸质文件手签名方式受控，需要对设备的运行情况进行记录的，电子记录要打印成纸质版与相应的纸质记录一并归档保存。<br>使用计算机办公的，人员离开电脑后要立即锁屏，防止电脑里的文件被误删。<br>文件的修订和作废<br>文件使用过程中需要修订时，如仅需修订文件内容而不修订派生记录使用部门向质量部提出申请并填写《文件审批表》，提交各相关部门审批，其中修改的内容应得到原审批部门或指定的其他部门的评审和批准。<br>经批准后方可进行文件修订，修订后按照5.2要求审核、批准及生效；“文件修订记录表”中至少体现本次修订的历史。<br>《文件审批表》中“记录更改”一栏打N/A，此时仅需升版文件版本。<br>如文件修订涉及派生记录修订，文件内容修订体现在“文件修订记录表”中。<br>记录修订的内容体现在《文件审批表》中“记录更改”一栏，此时文件和记录均需升版。<br>如仅修订记录内容，修订部门将更改内容体现在《文件审批表》中“记录更改”一栏，此时仅需升版记录的版本。

Document users shall take good care of the documents and keep them clean. When the documents are damaged and affect the use, they shall go through the replacement procedures with the document control specialist, return the damaged documents, reissue new documents, and fill in the document distribution, recovery and destruction records;<br>The documents shall be easy to identify and retrieve, the document number shall be marked in the obvious position, and the documents of each department shall be classified and saved for retrieval.<br>Medical device documentation<br>The medical device documents belong to the documents of quality management system. The company establishes and maintains a document for each medical device. The documents are quoted to prove that they meet the requirements of the medical device quality management system standards and applicable regulatory requirements.<br>The contents of medical device documents include but are not limited to:<br>Overview, intended use / intended purpose and marking of the medical device, including all instructions for use.<br>Including technical report, overview report, instruction manual, packaging identification, etc.<br>Product specifications, including drawings, quality standards, BOM, intermediate product quality standards, enterprise standards or product technical requirements.<br>Specifications or procedures for manufacturing, packaging, storage, disposal and circulation, including process procedures, process operation procedures, confirmation and verification documents, etc.<br>Measurement and monitoring procedures, including inspection procedures for materials, intermediate products and finished products.<br>Where appropriate, installation requirements.<br>Not suitable for the company's medical device products.<br>When appropriate, service procedures, including user manual, product education film, etc.<br>The medical device documents shall be prepared by the members of the medical device design and development project team, reviewed by the members of the project team and the person in charge, and approved by the person in charge of the enterprise.<br>In order to establish and maintain the medical device documents and ensure the current effectiveness, the company's medical device documents are in the form of reference documents, so it is necessary to indicate the reference document name, document number, version number, safekeeping department and other information. When the reference documents are updated, the medical device documents shall also be updated.<br>All controlled documents of the company are controlled by manual signature of paper documents. If it is necessary to record the operation of the equipment, the electronic records shall be printed into paper version and filed together with the corresponding paper records.<br>When using computer for office work, the personnel shall lock the screen immediately after leaving the computer to prevent the documents in the computer from being deleted by mistake.<br>Revision and cancellation of documents<br>When the document needs to be revised in the process of using, if only the content of the document needs to be revised but not the derivative record using department, the user department shall apply to the quality department and fill in the document approval form, and submit it to each relevant department for approval, and the revised content shall be reviewed and approved by the original approval department or other designated departments.<br>The document can be revised only after approval. After revision, it shall be reviewed, approved and come into effect in accordance with the requirements of 5.2; "document revision record form" shall at least reflect the history of this revision.<br>In the document approval form, type N / A in the column of "record change", at this time, only the version of the document needs to be upgraded.<br>If the document revision involves the derivative record revision, the document content revision is reflected in the document revision record table.<br>The content of record revision is reflected in the column of "record change" in the document approval form. At this time, both documents and records need to be upgraded.<br>If only the recorded content is revised, the revision department will reflect the changed content in the column of "record change" in the document approval form, at this time, only the version of the record needs to be upgraded.<br>