杭州某外资医药项目质量管理手册

杭州某外资医药项目质量管理手册内容摘要：

For the documents related the confidential economy or technique, they should be performed in accordance with the confidential regulation of the pany. 对涉及到经济、技术等方面的机密文件、资料要严格按照公司有关保密规定执行。 杭州 ****制药新生产基地项目 10 Collecting materials for project files: 工程档 案资料收集管理内容 ： Asbuilt drawing 工程 竣 工图。 Random technique materials: equipment qualification certificate, packaging list, unpacking record, instruction, equipment drawing, etc. 随机技术资料 ： 设备的出厂合格证、装箱单、开箱记录、说明书、设备图纸等。 Jian Li and owner: detailed items of Jian Li。 documents, guidance, letter, notice and meeting minutes from Jian Li。 project gauge ticket, project payment list, Jian Li’s monthly report, claiming materials, advice brochure for the final accounting and inspection, special reports for each project construction phase, and relevant materials from owner. 监理及业主 （总包方） 资料 ： 监理实施细则 ； 监理所发文件、指令、信函、通知 、 会议 纪要； 工程计量单和工程款支付证书 ； 监理月报 ； 索赔文件资料 ；竣工结算审核意见书 ； 项目施工阶段 各类 专题报告 ； 业主 （总包方） 发出的相关文件资料。 All technique materials throughout the whole construction 工程建设过程中形成的全部技术文字资料 ： First type materials: meeting minutes of drawing inspection, business contact list, attached drawing except for replacing drawing and newlyadded drawing, change notice, material list, equipment appointing list and other change materials. 一类文字资料 ： 图纸会审纪要 ； 业务联系单及除代替图、新增图以外的附图 ； 变更通知单及代替图、新增图以外的附图 ； 材料代用单 ； 设备处理委托单；其它形式的变更资料。 Second type materials: submitting inspection list, submitting inspection certificate and object transmitting list, random technique material list, construction appointed note and plementary materials, project contract, 杭州 ****制药新生产基地项目 11 technique kickoff, the proved construction design and plan, mencement report, pletion report, quality assessment, construction and installation record, quality, inspection and accident dealing plan and report, certificates, quality assessment, and testing report for various materials and fittings, various records for functional test and check test, budgeting materials. 二类文字材料 ： 交工验收资料清单；交工验收证书、实物交接清单、随机技术资料清单；施工委托书及其补充材料；工程合同（协议书）；技术交底，经审定的施工组织设计或施工方案；开工报告、竣工报告、工程质量评定证书；施工、安装记录及施工大事记、质量检查评定 资料 和 质量 事故处理方案、报告；各种建筑材料及构件等合格证、质量鉴定及试验报告；各种功能测试、校核试验的试验记录；工程的预、决算资料。 Completion materials transmitted to pany from project department: 项目部移交到公司档案科的竣工资料内容 ： Bidding not, project contract, construction anizational design, inspection materials for pletion, quality assessment certificate. 中标通知 、 工程承包合同 、 施工组织设计 、 交工竣工验收资料 、 质量评定等级证书。 Time for transmitting the materials from project department to pany is after the pletion. 项目部向公司档案科移交竣工资料 的 时间 为 工程项目结束后。 Project department should submit a plete material to management pany and owner according to the requirements. 项目部按照公司档案科的 要求 内容装订 成册 后交一套 完整的资料给 LL、业主、监理和公司总部。 Project department should at any time do well about collecting and filing materials, establishing registration account, which was in charge of professional staff. Transmitting, borrowing and copying should be conducted after project manager’s agreement, and record is do must. 项目部 应随时做好资料的收集和归档工作，专人负责，建立登记台帐， 如 杭州 ****制药新生产基地项目 12 需转发、借阅 、 复印 时 ， 应 经项目 经理 同意后方可办理， 并 做好记录。 采购 Purchasing should base on the construction drawing, construction anizational design, change design notice and construction budgeting and should be approved by relevant leaders. 材料采购要依据《施工图》、《施工组织设计》、《设计变更通知单》和《施工图预算》等要求报项目部有关领导审批后实施。 Staff who sign the contract with contractor should have the appointment certificate. 签定购销合同人员必须具有授权或委托证明书。 Big material bidding document procedure 大型材料招标文件程序 Compiling bidding document, bidding invitation includes application, quantity, time and method for getting bid, application location and environment: 编制招标文件，投标邀请函包括标的用途、数量，获取招标文件的方法及时间，使用地点及环境情况等内容： General requirement: bidders’ enterprise business license, legal entity’s code, legal representative’s certificate, production license, quality system certification, afterservice certificate, afterservice mitment letter, quantity and submitting method, location and deadline, the time arrangement for bidding open, bidding evaluation and bidding assurance. a. 一般要求：包括投标人的企业营业执照、法人代码证、法定代表人证书 (或委托代理人证书 )、产品生产许可证、质量体系认证证书、售后服务承诺书、数量及提交方式、地点、截止时问；开标、评标、定标的时间安排。 Content and requirement of bid. They include goods’ name, type, function, quantity, technique index and executing standard. 杭州 ****制药新生产基地项目 13 b. 标的内容及要求。 包括物资名称、规格型号、性能数量、技术参 数、执行标准。 Other instructions c. 其他需要说明的事项。 Check and selecting manufactures and agent 考核并选择厂家及代理商 Be familiar with the manufacture’s operation, price, function, quality, deployment and afterservice. Select bidding unit through marketing research and technique munication. a. 了解生产厂家生产经营情况、价格、性能、质量、配置、售后服务等情况，通过市场调研、技术交流，选择邀请投标单位。 Establishing evaluation standard based on the Proposal. Defining evaluation items such as mercial articles, product functions, product quality, product price, payment and afterservice through prehensive factors. b. 以招标文件为依据，制定评分标准，根据综合评价的各种因素设定商务条款、产品性能、产品质量、产品价格、付款条件、售后服务等评分项目。 Bidding open, bidding evaluation and bidding assurance should be conducted and explained based on the bidding procedures. c. 按招投标程序进行开标、评标， 投标人对投标文件进行陈述解释，并进行答疑。 Recheck the Proposal. Relevant staff should give scores according to the standard, and fill the summary table from highest score to lowest score. d. 对投标文件进行审查。 依评分标准进行评标打分，填写评分汇总表，按得分高低推荐为中标候选单位。 At least 5person’s team should be formed to evaluate the suppliers to ensure 杭州 ****制药新生产基地项目 14 the suppliers’ supplying quality and ability. e. 对提供物资的供方，应成立不少于 5 人的评价小组，对供方满足质量保证要求的能力进行评价。 Feedback and Review of Proposal 回标、开标 Proposal should be。