生物科技公司质量管理手册

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生物科技公司日常管理制度

生物科技公司日常管理制度

第一章总则第一条为加强公司内部管理,提高工作效率,确保公司各项业务有序开展,特制定本制度。

第二条本制度适用于公司全体员工,包括但不限于研发、生产、销售、行政等部门。

第三条本制度遵循依法合规、以人为本、高效便捷的原则。

第二章员工考勤第四条公司实行标准工作时间制,每日工作时间为8小时,每周工作时间为40小时。

第五条员工需按时上下班,不得迟到、早退、旷工。

如有特殊情况需请假,应提前向直属上级申请,并经人力资源部门批准。

第六条请假类型包括事假、病假、产假、婚假、丧假等,具体请假流程和审批权限按照公司相关规定执行。

第七条员工请假期间,应保持通讯畅通,确保工作交接顺畅。

第三章工作纪律第八条员工应遵守国家法律法规,遵守公司各项规章制度,维护公司形象。

第九条员工在工作中应恪守职业道德,保守公司商业秘密,不得泄露公司技术信息。

第十条员工应保持工作场所的整洁,爱护公物,节约资源。

第十一条员工应服从上级领导安排,积极参与公司各项活动,提高团队协作能力。

第四章研发与生产第十二条研发部门应严格按照项目计划进行研发工作,确保研发成果符合公司战略目标。

第十三条生产部门应严格执行生产工艺流程,确保产品质量。

第十四条研发和生产部门应定期进行技术交流,分享经验,提高技术水平。

第五章销售与市场第十五条销售部门应制定合理的销售计划,积极开拓市场,提高市场占有率。

第十六条销售人员应遵守诚信原则,不得进行虚假宣传和欺诈行为。

第十七条销售部门应定期收集市场信息,为产品研发和市场策略提供依据。

第六章行政管理第十八条行政部门负责公司内部行政管理,包括财务管理、人力资源、安全保卫等。

第十九条行政部门应定期组织员工培训和团队建设活动,提高员工综合素质。

第二十条行政部门应确保公司办公环境的安全、卫生和舒适。

第七章考核与奖惩第二十一条公司实行绩效考核制度,对员工的工作表现进行定期考核。

第二十二条对表现优秀、贡献突出的员工给予奖励,对违反公司规定的员工进行处罚。

关于生物科技公司企业管理手册

关于生物科技公司企业管理手册

欢迎加入赣州正康生物科技有限公司。

从今天起,您已成为正康的一员。

请细读本手册,它将给您简而精的资料。

包括公司提供的福利,您的权利和义务。

我们希望您能在这里成功地发展,也能为公司带来更大的成就。

赣州正康生物科技有限公司的规章制度是现代化经营活动的客观需要,是全体员工在各项工作动中共同遵守的规范和准则,具有严肃性、权威性、稳定性和强制性。

本守则的编制是为了明确全体员工的服务职责、权利和义务,希望您对这本手册给予支持。

同时,也我答应你给予本公司及每位员工带来更好、更和谐的工作关系和工作气氛。

让我们把今天作为起点,开拓进取,树立敬业精神,贡献才智,繁荣公司。

我们视员工为最好的财产,没有你们的贡献,公司的发展必将受到限制。

因此,公司决定为所有员工提供事业发展的良好机会,同时也希望员工在公司充分发挥自己的聪明才智,与公司一起迎接未来的竞争与挑战。

本手册只是指南,如果您在阅读或执行中有任何的疑问,请与我们或您的部门主管联系。

我们都很乐意解答您的疑惑,并和您坦诚地讨论和交流。

目 录第一章 总则 (1)第二章 公司简介与企业文化 (1)第三章 公司组织架构 (1)第四章 员工行为规范 (2)第五章 员工招聘 (5)第六章 员工考勤 (8)第七章 薪资与福利 (11)第八章 员工培训 (12)第九章 员工考核 (13)第十章 转调与晋升 .............................................14 第十一章 解除或终止劳动关系................................. 14 第十二章 奖励与处罚 .............................................15 第十三章 保密制度 ................................................22 第十四章 消防与安全 (23)生物科技公司企业管理手册 【最新资料,WORD 文档,可编辑修改】第一章总则为加强及规范本公司的经营管理,切实完善和提高公司的管理水平和经济效益,维护公司与员工的合法权益,以督促全体员工遵纪守法,保证各项工作顺利有序地进行,特制定《赣州正康生物科技有限公司员工手册》第一条《赣州正康生物科技有限公司员工手册》(以下简称《员工手册》)是根据国家相关法规以及结合本公司经营特性与状况之实际情况而制定。

quality manual(生物科技质量手册)

quality manual(生物科技质量手册)

QUALITY MANUALAuthorized By: Date:________________________________________________ __________________________ Thomas Oland, President________________________________________________ __________________________ Gregory Melsen, Chief Financial Officer________________________________________________ __________________________ Richard Krzyzek, VP Research________________________________________________ __________________________ Marcel Veronneau, VP Hematology Operations________________________________________________ __________________________ Shelley Falvey, Asst. Director, Quality and Regulatory AffairsQUALITY MANUAL SECTIONTITLE: CONTENTS Number: 540308 Revision: 11 Supersedes:540308.10 Section: 1.1Page: 1 of 1 Revision Date:4/2/09QUALITY MANUAL CONTENTS Section 11.1Page 1 Quality Manual Contents1.2Page 2 Quality Policy1.3Page 3 Company ProfileSection 2Quality System Requirements:2.1 Page 4, 5, 6 Management Responsibilities2.2 Page 7 Quality Audits2.3 Page 8 Personnel2.4 Page 9 Design Controls2.5 Page 10 Document Controls2.6 Page 11 Purchasing Controls2.7 Page 12 Identification and Traceability2.8 Page 13, 14 Production and Process Control2.9 Page 15 Acceptance Activities2.10 Page 16 Non-Conforming Product2.11 Page 17 Corrective and Preventive Action2.12 Page 18 Statistical Techniques2.13 Page 19 Labeling and Packaging Control2.14 Page 20 Material Handling, Storage and Distribution2.15 Page 21 RecordsPage: 1 of 1Revision Date: 4/2/2009R&D Systems Inc. Quality Policy:R&D Systems is committed to the highest level of quality in the manufacture, sale and support of our products. Product quality, compliance to all applicable regulatory requirements, continuous improvement and customer satisfaction shall underlie all of our efforts in development, manufacturing, advertising, sales, shipping and technical support.Definitions:Quality : the totality of features and characteristics that bear on the ability of a product to satisfy fitness for use, including safety and performance (§ 820.3 (s)).Quality system : the organizational structure, responsibilities, procedures, processes and resources for implementing quality management (§ 820.3 (v)).Assurance of quality and integrity are the responsibility of:1. the President, who has responsibility for creation of an atmosphere of high standards;2. the officers, directors, managers and supervisors, who are charged with development and implementation of quality systems; and3. each employee, who is responsible for the quality of his or her work and for suggesting improvements in quality.This Quality Manual is the top tier of our documentation system. It gives an overview of our Quality System. It is supported by corporate and division standard operating procedures (SOPs) which are the second tier of our Quality System documents and are listed in this Quality Manual. The third tier of the documentation system consists of manufacturing/testing documents, forms and specifications developed by each operating unit.Our policies are in conformance with the applicable requirements of the Code of FederalRegulations (21 CFR) Quality Systems Regulations for Medical Devices; ISO 13485 Standard: 2003, ISO 9001 Standard: 2008, the In Vitro Diagnostic Directive 98/79 EC and the Canadian Medical Device Regulations.Sections of the ISO 13485 Standard which do not apply to R&D Systems are as follows: Section 7.5.1.2.3 - Service activities (Reason: Applicable to equipment) Section 7.5.1.2.2 - Installation activities (Reason: Applicable to equipment) Section 7.5.1.3 -Section 7.5.2.2 - Particular requirements for sterile medical devices (Reason: No sterile products)Section 7.5.3.2.2Section 8.2.4.2 - Particular requirements for active implantable devices (Reason: No implantable devices)Related Procedures:540007 Canadian Medical Device License, Facility License and Quality SystemCertification540120 Required Standards Listing, Maintenance and Review}}Page: 1 of 1Revision Date: 4/2/2009R&D Systems was founded in 1976 in Minneapolis, MN. It is a wholly owned subsidiary of TECHNE Corporation (a holding company with no employees). The stock is traded publicly on NASDAQ’s National Market System under the “TECH” symbol. TECHNE has two operating subsidiaries: Research & Diagnostics Systems, Inc. (R&D Systems) and R&D Systems Europe Ltd. (R&D Europe).R&D Systems has two operating divisions: Biotechnology, which manufactures reagents primarily for the research market, and Hematology, which manufactures controls and calibrators for hematology analyzers. The Minneapolis manufacturing facility is certified to ISO 9001:2008 and ISO 13485:2003. The ISO Certificate numbers are FM547845 and FM547846, respectively. In July, 2005 R&D Systems purchased BiosPacific, which became a wholly owned subsidiary. BiosPacific is located in Emeryville, CA and consists of a sales force which provides raw materials for development of Immunoassay kits.R&D Systems Europe in Abingdon, England distributes biotechnology products and is the European Representative for the Biotech Division. They received ISO 9001: 2000 certification in June, 2007. Their ISO Certificate number is 951074360. EuroCell Diagnostics, Village de la Metairie Batiment B, 35131 Chartes de Bretagne is the European Representative for the Hematology Division.R&D Systems Europe has a sales subsidiary, R&D Systems GmBH, in Germany.R&D Systems established a wholly owned subsidiary in the People's Republic of China in May 2007. R&D Systems China Co. Ltd. opened its Warehouse and Distribution Center in Shanghai, China on October 1, 2007. R&D China provides products, marketing and technical support to our Chinese distributors.R&D Systems’ physical plant includes over 498,460 square feet of laboratory, manufacturing, shipping and office space as of December 1, 2008. Offices are in Minneapolis, MN, Abingdon, UK, Wiesbaden, Germany, Shanghai, China and Emeryville, CA with over 665 employees as of December 1, 2008.Section Title: Management Responsibilities Section: 2.1Page: 1 of 3Revision Date: 4/2/2009 Quality is the responsibility of each employee throughout our organization.Management is responsible for communicating our Quality Policy to all employees and for ensuring full understanding of, and commitment to, quality.∙The President has executive responsibility for the Quality System and is responsible for creating an atmosphere where quality is the highest priority.∙The Vice Presidents are responsible for overseeing the development, implementation and maintenance of the Quality System.∙The Asst. Director, Quality has been appointed as the Management Representative by the company president. The Management Representative has responsibility for ensuring that quality requirements are effectively established and maintained in accordance with theappropriate regulations and for reporting on the quality system to upper Management.∙The Asst. Director, Quality, Vice President of Operations (Hematology), and the Quality Assurance (QA) staff are responsible for ensuring that our quality system is fully maintained and implemented.∙Each director, manager and supervisor is responsible for assuring that Quality Systems are followed in his or her area.∙Each employee is responsible for the quality of his or her work.Two groups are dedicated exclusively to Quality:1. The Quality Assurance Department assists operating departments in the development ofquality systems and conducts periodic audits to assure that those systems are implemented faithfully and effectively. Quality Assurance has the responsibility to:∙identify and evaluate quality-related problems.∙recommend solutions to quality problems and verify that any problems have been resolved (corrective actions).∙initiate action to prevent the occurrence of quality problems (preventive actions).∙control non-conforming products until corrective action has been taken.∙set quality goals and objectives for the company and develop plans to meet those goals and objectives.∙report to Management on quality related issues.The Quality Assurance Department is responsible for quality systems, but implementation of these systems and quality per se is the responsibility of each director, manager, supervisor and employee.2. The Quality Control (QC) Departments inspect and test products at all stages of themanufacturing process, from raw materials to finished goods. Quality Control Managers have responsibility for product release against predetermined specifications. Due to the varied and highly technical nature of our products, QC functions are distributed throughout the corporation to ensure that testing and inspection are done expertly.The following charts describe the organizational and functional structure of the Company. While the structure and organization of the Quality function varies between the two divisions of R&D Systems, their goals are identical.Related Procedures:540009 Management Quality Systems Review ProcedureOrganizationAssurance541138 QualityQUALITY MANUALSection Title: Management ResponsibilitiesNumber: 540308Revision: 11Supersedes: 540308.10Section: 2.1Page: 2 of 3Revision Date: 4/2/2009 Quality Systems Flow ChartSection Title: Quality Audits Section: 2.2Page: 1 of 1Revision Date: 4/2/2009 Periodic audits assure adherence to our quality systems.Internal Quality System audits are performed by the Quality Assurance staff and by other trained personnel under the guidance of Quality Assurance. Results of audits are reported to the Assistant Director of Quality, the appropriate Vice President, the Company President, and the operating units involved. It is the responsibility of those units to develop corrective actions, to correct deficiencies and to present evidence of correction.Vendor audits are performed by Quality Assurance staff on an as needed basis.Other Quality System effectiveness checks are made by department managers and senior management, through periodic review of product complaints, non-conforming material tracking/trending and material review board meeting minutes.To ensure that the Quality System is effective and relevant, it is reviewed annually by the Senior Management Team, the Asst. Director of Quality, the Regulatory Affairs Specialist and other managers, as appropriate. The agenda for the meeting will be written by Quality Assurance based upon audit results and other outstanding issues related to Quality Systems and product quality. Minutes from the meetings shall be distributed to those present at the meeting as well as any designated attendees that are absent from the meeting. A copy of the agenda and meeting minutes will be maintained on file in Quality Assurance.Related Procedures:Corporate:540009 Management Quality Systems Review ProcedureMeetings541131 Quality540167 FDA Inspection Procedure540291 Internal Audit Procedure540335 Vendor Audit Procedure540552 Corrective and Preventive ActionBiotechnology:540135 Customer Feedback System, Biotech540259 Material Review Board Responsibility Procedure540550 Quality Assurance Auditing of GLP StudiesHematology:6016 Material Review Board Procedure8034 Technical Service Protocol/ComplaintsPage: 1 of 1Revision Date: 4/2/2009It is our policy to hire only qualified personnel and to assure that they are trained in all aspects of their jobs.Copies of job descriptions, job applications, resumes and annual performance reviews are kept on file in the Human Resources Department.The Company has a QSR/GMP training program (including the applicable regulations), conducted by Quality Assurance, which all employees are required to complete. Upon satisfactory completion of this training by an employee, a certificate of completion is given to the employee’s supervisor. Quality Assurance maintains a master log of all certificates of completion issued. Ongoing training, as necessary, assures personnel are familiar with applicable requirements.The Company has provided ISO 13485/CMDR and risk analysis training to Managers and Directors responsible for the manufacture and testing of our products. It is the responsibility of these trained employees to assure that all of their employees are familiar with the pertinent aspects of these regulations.Regulatory Affairs maintains a file of all pertinent Standards and assures that the latest revisions are available. When revisions are available, this is communicated to Quality Assurance and other pertinent personnel so that we can keep up-to-date on the latest regulations and standards. Each department maintains job-specific training records for its employees. Supervisors are responsible for job-specific training, for training on new or revised documents, for assuring that training is effective and for maintaining training records. Notification of document changes are issued as a trigger for training.Related procedures:540189 Personnel Training Procedure540816 Procedure for Generating Training Reports540120 Required Standards Listing, Maintenance and ReviewPage: 1 of 1Revision Date: 4/2/2009 We have different Design Controls for different types of products. In general, they cover the following points.1. Approval of the design goals (Design Input)2. Review of feasibility studies (Design Review)3. Approval of the product description (Design Output)4. Review of process development and preparation of manufacturing documents (DesignVerification Review)5. Review and approval of product validation (Final Design Review/Data Review)6. Transfer to manufacturingThe specific procedures for the different product lines are referenced below.Related Procedures:Biotechnology540045 Definition of Product Design Goals for Assay DevelopmentControls540325 Design540266 Procedural Elements in a Validation540215 Specific Immunoassay Validation Procedures (i.e., Linearity, Precision, etc.) 540217 through 540221, 540223, 540235 - 540238, 540288, 540337, 540409, 540729, 540804 and 541002Hematology6009 Procedural Elements in a Validation6009A Testing Protocol Request3421 Procedure for Developing Operational Procedures6015 Product Introduction/Product Improvement Procedure6015A Design Control and Transfer Worksheet6039 Product Development Request Form6026 Design Input6027 Design Output6040 Design Review ProcedureCorporate540819 Risk Analysis and ManagementPage: 1 of 1Revision Date: 4/2/2009To assure consistent quality, we use written, approved procedures for all operations. The Document Control and Quality Assurance departments or their designee(s) are responsible for controlling the issue, distribution, revision and archiving of these procedures.The documents that must be controlled include:The Quality Manual and Quality Systems SOPsDevice Master RecordsInternal Audit ReportsStandard Operating ProceduresManufacturing ProceduresTesting/Inspection ProceduresCalibration and Maintenance RecordsDevice History RecordsDesign Control RecordsFormsData from ATS StudiesEssential Requirements and Technical Document IndexesBiotechnology uses a formal Document Change Request (DCR) procedure for creating new documents and revising existing documents. It involves review and approval by multiple departments generally including a technical department, the affected department and the Quality Assurance department. The Hematology Division initiates formal Document Control in each Department. The Departmental Supervisor reviews a draft with assistance from designated individuals.Related Procedures:Corporate540643 Standard Operating Procedure (SOP) Review Procedure540578 Record Keeping GuidelinesDocumenta540146 Creating540748 MasterControl™ Electronic Documentation SystemFunctions540750 MasterControl™Biotechnology540205 Document Change Request ProcedureMaintenanceof Document Master Files&540382 Preparation540411 Master Document Replacement Procedure540532 Data Management: General Procedures & Definitions (ATS Lab) Hematology3007 New and Updated Procedure Protocols3008 Procedure Format6005 Document Organization (Document Control)3421 Procedure for Developing Operational Procedures6006 Updating the Device Master Record (DMR)6030 Format for "Product Description/Device Specifications" Documents6031 Format for "Product Type" DocumentsPage: 1 of 1Revision Date: 4/2/2009 Consistent quality of raw materials and contracted services is a key part of our quality system. Purchasing control covers the following areas:∙Specifications: Requirements for raw materials are stated in written specifications available to all personnel doing purchasing and receiving activities.∙Vendor Control: Qualified vendors are listed on each raw material specification. Document 540000, Vendor Qualification describes how to qualify new vendors in Biotechnology and Hematology including outsourced services and processes. Vendor performance is tracked and Vendors who do not perform well may be disqualified and replaced.∙Purchasing Control: The purchase order includes our part number and a request for a Certificate of Analysis where appropriate. All materials used in the manufacture of products are verified against the purchase order. Purchasing interacts with suppliers regarding non-conforming or damaged materials.∙Contract and Supply Agreements: Purchasing, Sales or Business Development is responsible to assure customer contracts and supply agreements are in place when required. Intellectual property contracts, customer contracts and supply agreements are managed by the Corporate Legal Department.Related Procedures:SystemsR&DProcedure,540687 PurchasingR&DSystems540192 ReceivingProcedure,Qualification540000 VendorProcedureAudit540335 VendorProcedure540876 QuarantinedProduct540805 Policy Regarding Contracts and Supply AgreementsRawMaterials Specifications (Biotech)640xxx Non-biologicalMaterial Specifications (Biotech)Raw645xxx Biological54xx, 55xx Biological Raw Material Specifications (Hematology)56xx, 57xx Non-biological Raw Materials Specifications (Hematology)Section Title: Identification and Traceability Section: 2.7Page: 1 of 1Revision Date: 4/2/2009The ability to trace a lot of product back to all raw materials used in its manufacture and to trace any lot of raw material to products it became part of is an essential feature of our Quality System.A part number and lot number (or receiving number) control all materials used to manufacture products. This provides complete traceability from receipt of raw materials through final shipment to the customer. In Biotechnology, Document Control is responsible for assigning part numbers. An MRP System (RenCS) is in place in the ELISA kit manufacturing area which is used to track inventory, assign job (lot) numbers and plan the production of the ELISA products. Lot numbers for all other products may be sequentially assigned from the Lot Number Database or are assigned at the time of bottling.The Hematology Director of Operations assigns final product lot numbers for Hematology products.Receiving departments are responsible for assigning receiving numbers to incoming raw materials.Related Procedures:540153 Part Number Assignment (Biotech)540523 Electronic Part Number Requisition Procedure540206 Lot Number Assignment (Biotech)540540 Receiving of Specimens for RDS-ATS Lab540831 RenCS, Add and Maintain Part Records8862 Assigning Final Product Lot Numbers (Hematology)6019 Identification and Traceability (Hematology)Page: 1 of 2Revision Date: 4/2/2009We design quality into our products. Areas of the manufacturing process that require control are identified during the development of a product and the effects of variables and appropriate limits are established.Process Control is accomplished through planning, written procedures, inspection, calibration, training, supervisory oversight and employee awareness. Changes to the manufacturing process, if required, are controlled, qualified and validated.∙Written procedures provide bills of materials, instructions for production, equipment required, working environment, filling and labeling instructions, record sheets, expiration dating, in-process testing, and acceptance criteria.∙Monitoring of product manufacture is accomplished through the use of Batch Records (Device History Records) containing the current revisions of the documents required for the manufacture of a product. Document Control assembles batch records for kit component manufacturing. Other manufacturing and Quality Control departments print official copies of their documents from MasterControl™. Operations, in Hematology, assembles the batch records. Quality Control verifies compliance through review and approval of completed batch records prior to final product release.∙The Specification Deviation Procedure handles deviations from the written procedures.∙All new inspection, measuring and test equipment is inspected and validated, when appropriate, against manufacturer’s specifications and identified with a permanent preventive maintenance number. Equipment is calibrated on a regular schedule. Improperly maintained or calibrated equipment will not be used. Records of calibration and maintenance aremaintained by the Facilities & Equipment Department. Quality Assurance audits equipment periodically, to ensure that calibration is proceeding according to schedule.∙The supervisor or lead personnel contributes to quality through training employees, assisting employees with new or specialized processes, interpreting instructions for andcommunicating process changes to employees.Related Procedures:ProcedureDeviation540126 Specification540142 Procedure for Documentation of Equipment Maintenance and/or Calibration 540310 Software Validation540133 Internal Notification Procedure: Receipt of New EquipmentPage: 2 of 2Revision Date: 4/2/2009 Biotechnology540781 Planning Guidelines, Immunoassay Manufacturing540834 RenCS, Recipe Authorization540833 RenCS, Add, Copy and Maintain a Process Specification540832 RenCS, Adding and Copying a Recipe540207 Product Finishing Label Control540072 Filling Operations Procedure540267 Preparation, Completion and Approval of Batch Records540278 Bottling Procedure for Cytokines and Antibodies Designated for Retail Sale 540256 Labeling Procedure for Cytokines and Antibodies Designated for Retail Sale 540134 Incoming Equipment Validation Procedure540503 Process Deviation Form, Dept 374540657 Process Deviation Form, Dept 375 and 394Hematology9090 Product Finishing Label Control9054 Bottling Procedure8812 Finished Device Inspection Procedure8813 Guideline for Determining Assay Ranges8006 Bottled Product Release8809 Assay Sheet Printing and Release6009A Testing Protocol Request6017 Product Type, Product Type Revision, Product Change NotificationSection Title: Acceptance Activities Section: 2.9Page: 1 of 1Revision Date: 4/2/2009 Acceptance/inspection activities are critical to the manufacture of quality products.∙Incoming materials are received in accordance with documented procedure(s).∙Deliveries are inspected against the purchase order for type, quantity and external transit damage. Additional inspection may include verification against Certificates of Analysis, in-house material specifications or incoming testing procedures.∙In-process testing is specified by the manufacturing and/or Quality Control procedures.Testing may include the recording of physical parameters such as pH and temperature, actual functionality testing and/or visual inspection.∙Final inspection and testing are completed before any product is released for sale. Quality Control signs the product release forms. Proteins and antibodies are released by the Director of Manufacturing. All documentation is reviewed and the product is physically inspected before release stickers are placed on the product and batch record.All inspections and testing must be supported by completed documentation. Release by exception must be documented and approved by the Material Review Board. Such approval must be documented.Related Procedures:540192 Receiving Procedure, R&D Systems540080 Raw Materials Departmental Receiving and Inspection Procedure540124 Inspection of Assembled Kits540143 Literature and Label Approval Procedure550449 Immunoassay Approval/Rejection Criteria540267 Preparation, Completion and Approval of Batch Records540526 Receiving of OEM Products540363 Releasing Retail Product540194 Certificate of Analysis Procedure541138 Quality Assurance Organization8812 Finished Device Inspection Procedure (Hematology)Section Title: Non-Conforming Product Section: 2.10Page: 1 of 1Revision Date: 4/2/2009Our quality system provides for the identification, documentation, evaluation, segregation, and disposition of non-conforming product.Quality Assurance administers the non-conforming materials system with the participation of the Material Review Board (MRB). Within departments producing research use only materials, appropriate technical personnel will review non-conforming material and make decisions concerning disposition of that material. Any employee with knowledge ofnon-conforming material may call for a Material Review Board meeting. Minornon-conformities may be released by Quality Control with adequate documentation. Disposition of major non-conformities lies with the MRB. QA is responsible for documenting the activities of the MRB. The Biotech MRB is composed of representatives from Quality, Manufacturing, and Development. Additional representatives from Product Support, Marketing, Technical Service or Sales may also participate as required. All corrective actions must be fully documented. Minutes from meetings of the MRB are published and maintained in MasterControl™.In Hematology, MRBs are documented using the Material Review Board (MRB) form. Minutes from meetings of the MRB are published and maintained in MasterControl™. A summary of MRBs is distributed quarterly to managers for review.All non-conforming material is clearly marked with Quarantine stickers or labeled appropriately. In addition, it is physically separated from conforming material until final disposition.A Specification Deviation is issued for any deviation in the manufacturing procedure even if it ultimately meets final release specifications. If a product is reworked, it must undergo all required inspections and tests as well as any additional inspection or testing required by the MRB. Reworked material must pass the same release criteria as the original product.Related Procedures:ProcedureDeviation540126 Specification540552 Corrective and Preventive Action540259 Material Review Board Responsibility ProcedureProcedure540265 Reprocessing540330 Procedure for Quarantine/Rejecting Approved Product (Biotech)3009 Adjustment/Replacement of a Finished Product (Hematology)6016 Material Review Board Procedure (Hematology)1012 Rework Procedure (Hematology)541214 Corrections, Removals and Recalls for IVD Products。

生物科技公司规章管理制度

生物科技公司规章管理制度

第一章总则第一条为加强公司内部管理,规范员工行为,提高工作效率,保障公司合法权益,根据国家有关法律法规,结合公司实际情况,特制定本制度。

第二条本制度适用于公司全体员工,包括但不限于管理人员、技术人员、生产人员、销售人员和行政人员。

第三条公司规章管理制度应遵循以下原则:1. 法规遵守原则:严格遵守国家法律法规,确保公司经营活动合法合规。

2. 安全生产原则:确保生产安全,防止事故发生。

3. 诚信经营原则:诚实守信,公平竞争,维护公司声誉。

4. 效率优先原则:提高工作效率,优化工作流程。

5. 人才培养原则:注重人才培养,提升员工综合素质。

第二章员工行为规范第四条员工应遵守国家法律法规,维护公司利益,保守公司商业秘密。

第五条员工应按时上下班,遵守劳动纪律,不得迟到、早退、旷工。

第六条员工应保持工作场所整洁,爱护公司财产,节约资源。

第七条员工应团结协作,相互尊重,共同维护公司和谐稳定。

第八条员工应积极参加公司组织的培训和学习,提高自身业务能力和综合素质。

第九条员工应服从领导安排,执行工作任务,不得擅自离岗。

第十条员工应保守公司商业秘密,不得泄露公司技术、产品、市场等信息。

第三章安全生产第十一条公司应建立健全安全生产责任制,确保生产安全。

第十二条员工应遵守安全生产操作规程,不得违章操作。

第十三条公司应定期对生产设备进行维护保养,确保设备安全运行。

第十四条员工应佩戴必要的防护用品,确保自身安全。

第十五条公司应定期组织安全生产培训,提高员工安全意识。

第四章工作纪律第十六条员工应遵守公司工作纪律,不得在工作时间从事与工作无关的活动。

第十七条员工应保持工作场所秩序,不得大声喧哗、打架斗殴。

第十八条员工应妥善保管公司文件、资料,不得随意丢弃、泄露。

第十九条员工应遵守保密制度,不得泄露公司机密。

第五章考勤与休假第二十条公司实行标准工时制,员工应按时上下班。

第二十一条员工享有国家规定的法定节假日、年假、婚假、产假等休假待遇。

生物科技公司质量管理手册

生物科技公司质量管理手册

生物科技公司质量管理手册【最新资料,WORD文档,可编辑修改】目录一、颁布令二、企业概况三、任命书四、质量安全方针及安全目标五、组织机构及质量管理小组六、质量安全管理职责七、质量管理质量奖惩制度八、进货查验记录制度九、生产设备管理制度十、工艺管理制度十一、档案管理制度十二、从业人员培训制度十三、检测设备、计量器具管理制度十四、储存管理制度十五、人员卫生管理制度十六、化验室管理制度十七、产品防护控制制度十八、生产过程控制制度十九、产品出厂检验记录制度二十、不合品处理制度二十一、不符合情况管理办法二十二、从业人员健康检查制度二十三、食品安全事故处置制度二十四、不安全食品召回制度二十五、食品安全风险监测和信息收集制度二十六、食品生产安全自查管理制度一、颁布令本手册是根据《食品安全法》、《食品安全法实施条例》及《食品质量安全市场准入制度》《食品质量安全市场准入审查通则2010版》及《蔬菜制品生产许可证审查细则》、《糖果生产许可证审查细则》、《固体饮料生产许可证审查细则》、《配制酒生产许可证审查细则》对食品生产加工必备条件所作的有关规定及本公司的实际情况编制而成。

本手册适用于公司的玛咖深加工的生产加工过程。

本手册自2016年04月08日开始实施。

本汇编为本公司的质量管理基本制度,全公司各部门及全体员工要认真学习,所有人员都必须遵照执行,严格执行《质量管理手册》,保证产品质量安全。

不得有违反本手册的行为。

经理:和家权云南三迤兴生物科技有限公司2016年4月10日二、企业概况我工公司是专业的玛咖加工企业,创建于2016年,占地面积1500m2,建筑面积1200m2,年设计能力100吨。

固定资产投资为200万元,现有职工10人,专业技术人员3人,管理人员3人。

我公司将本着求实创新的精神,继续努力,为社会作出更大的贡献。

三、任命书一、质量负责人任命高政为公司质量负责人,全面负责质量安全工作, 具有以下质量职责和权限:A、在最高质量负责人领导下,具体负责本公司质量管理的日常领导工作。

生物技术开发有限公司质量管理手册

生物技术开发有限公司质量管理手册

生物技术开发有限公司质量管理手册12020年4月19日质量管理手册(第一版)二○一二年三月一日批准二○一二年三月一日实施乌鲁木齐康福源生物技术开发有限公司发布目录目录............................................ 错误!未定义书签。

0.1<质量管理手册>批准公告........................ 错误!未定义书签。

0.2简介......................................... 错误!未定义书签。

0.3术语......................................... 错误!未定义书签。

1.0质量管理手册的管理 ........................... 错误!未定义书签。

1.1质量方针和质量目标 ........................... 错误!未定义书签。

1.2质量管理体系组织机构图 ....................... 错误!未定义书签。

2.0组织领导及职责权限分配 ....................... 错误!未定义书签。

3.0质量方针和质量目标的确定...................... 错误!未定义书签。

4.0质量管理体系文件和要素 ....................... 错误!未定义书签。

5.0 不合格管理办法.............................. 错误!未定义书签。

6.0环境卫生及废弃物处理管理...................... 错误!未定义书签。

6.1生产操作人员卫生管理制度...................... 错误!未定义书签。

7.0 生产厂区质量卫生管理制度..................... 错误!未定义书签。

8.0厂区要求..................................... 错误!未定义书签。

生物公司质量安全管理制度

生物公司质量安全管理制度

生物公司质量安全管理制度一、目的与适用范围本制度旨在确立生物公司产品质量安全管理的基本要求,适用于本公司所有涉及产品研发、生产、检验、销售及服务全过程的质量管理活动。

二、组织结构与职责1. 成立质量管理委员会,由公司高层领导担任主席,负责制定和审批质量安全政策。

2. 设立质量管理部门,负责日常的质量监督、检查和管理工作。

3. 各部门负责人需确保部门内的质量安全管理工作符合公司制度要求。

三、文件管理1. 建立完善的文件管理体系,确保所有质量安全相关的文件得到妥善保存、更新和管理。

2. 文件应包括质量管理手册、操作规程、记录表格等,并定期进行审核和修订。

四、质量控制1. 制定严格的原料采购标准和供应商评审机制,确保原料的质量安全。

2. 生产过程中实施过程控制,包括关键生产环节的监控和记录。

3. 成品检验应严格按照国家和行业标准执行,不合格产品不得出厂。

五、安全与环境保护1. 严格遵守安全生产法律法规,确保生产过程的安全性。

2. 定期对员工进行安全教育和培训,提高安全意识。

3. 实施环境保护措施,减少生产过程中的环境污染。

六、风险管理1. 建立风险评估机制,定期对产品生产和管理过程中可能出现的风险进行评估。

2. 制定应急预案,对可能发生的事故进行预防和应对。

七、员工培训与发展1. 定期对员工进行质量管理和安全生产方面的培训。

2. 鼓励员工参与质量管理体系的改进和创新。

八、内部审计与持续改进1. 定期进行内部审计,检查质量管理体系的执行情况。

2. 根据审计结果,及时调整和完善管理制度,实现持续改进。

九、客户反馈与满意度1. 建立客户反馈机制,及时收集和处理客户的意见和建议。

2. 定期对客户满意度进行调查,作为改进产品和服务的重要依据。

十、法规遵从性1. 遵守所有适用的国家法律、法规和行业标准。

2. 定期对相关法律法规的变化进行跟踪,确保公司运营的合规性。

阿敏生物企业管理手册QS

阿敏生物企业管理手册QS

AC-01 上海阿敏生物技术有限公司质量管理手册版本:2010. 第二次修订编制:质量小组全体成员审核:苏有录王永强批准:苏翰起草:唐甜沙龙华发布日期:2010-3-15 实施日期:2010-3-15上海阿敏生物技术有限公司1手册内容和范围本手册系依据QS的相关要求和本公司的实际相结合编制而成。

适用于上海阿敏生物技术有限公司质量管理。

2术语和定义2.1本手册采用ISO9000:2000《质量管理体系——基础和术语》的术语和定义;2.2公司——若无特指时,是指上海阿敏生物技术有限公司。

3本手册为公司的受控文件,由总经理批准颁布执行。

手册管理的所有相关事宜均由办公室统一负责,未经管理者代表批准,任何人不得将手册提供给公司以外人员。

手册持有者调离工作岗位时,需将手册交还办公室,办理核收登记。

4手册持有者应使其妥善保管,不得损坏、丢失、随意涂抹。

5在手册使用期间,如有修改建议,各部门负责人应汇总意见,及时反馈到办公室;办公室应定期对手册的适用性、有效性进行评审;必要时应对手册予以修改,执行《文件控制程序》的有关规定。

任命书 ............................................... 5 组织机构图 ............................................ 6 职责、权限 ........................................... 7 文件控制程序 ......................................... 记录控制程序 ......................................... 15 生产过程控制程序 ..................................... 17 检验控制程序 ......................................... 19 检测设备控制程序 ..................................... 22 采购控制程序 ......................................... 23 设备控制程序 ......................................... 25 不合格品控制程序 ..................................... 26 纠正和预防控制程序 .................................. 28 包装、仓储、运输控制程序 . (31)、八 前 公司简介质量方针、目标 ......................................4公司简介上海阿敏生物技术有限公司质量方针、目标质量与安全方针传承、产品质量第一;创新、领引消费时尚。

关于生物科技药业公司质量手册

关于生物科技药业公司质量手册

目 录标题 目录质量手册说明 质量手册修改控制 企业概况 公司组织机构图 公司质量管理体系结构图 质量管理体系过程职责分配表质量管理体系 文件控制程序 质量记录控制程序 管理职责 质量方针 管理策划控制程序 职责和权限 管理评审控制程序 资源管理 人力资源控制程序 设施和工作环境控制程序 产品实现实现过程的策划程序 与客户有关的过程控制程序 设计和开发控制程序 采购控制程序 生产和服务运作控制程序 监控装置的控制程序 测量、分析和改进 客户满意程序测量程序 内部审核程序 过程和产品的测量和监控程序 不合格控制程序 数据分析控制程序 改进控制程序 SMP 、SOP 文件目录生物科技药业有限公司质量手册【最新资料,WORD 文档,可编辑修改】质量手册说明1、手册内容本手册系依据ISO9001:2000《质量管理体系—要求》和本公司的实际相结合编制而成,包括:⑴公司质量管理体系的范围,它包括了ISO9001:2000标准的全部要求;⑵质量管理标准和公司质量管理体系要求的所有程序文件;⑶对质量管理体系所包括的过程顺序和相互作用的表述。

2、术语和定义本手册采用ISO9000:2000《质量管理体系——基本原理和术语》的术语和定义3、本手册为公司的受控文件,由总经理批准颁布执行。

手册管理的所有相关事宜均由质量监督部统一负责,未经管理者代表批准,任何人不得将手册提供给公司以外人员。

手册持有者调离工作岗位时,应将手册交还质量监督部,办理核收登记。

4、手册持有者应使其妥善保管,不得损坏、丢失、随意涂抹。

5、在手册使用期间,如有修改建议,各部门负责人应汇总意见,及时反馈到质量监督部;质量监督部应定期对手册的适用性、有效性进行评审;必要时应对手册予以修改,执行文件控制程序的有关规定。

公司概况上海玉瑞生物科技(安阳)药业有限公司属股份制企业,投资亿元,2005年兴建,是一家现代化制药企业。

公司位于河南安阳韩陵工业园,西临107国道、京珠高速和京广铁路,交通便利,环境优美,布局合理。

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生物科技公司质量管理手册文件排版存档编号:[UYTR-OUPT28-KBNTL98-UYNN208]目 录一、 颁 布 令二、企业概况三、 任 命 书四、质量安全方针及安全目标五、组织机构及质量管理小组六、质量安全管理职责七、质量管理质量奖惩制度八、进货查验记录制度九、生产设备管理制度十、工艺管理制度十一、档案管理制度十二、从业人员培训制度十三、检测设备、计量器具管理制度十四、储存管理制度十五、人员卫生管理制度十六、化验室管理制度十七、产品防护控制制度生物科技公司质量管理手册【最新资料,WORD 文档,可编辑修改】十八、生产过程控制制度十九、产品出厂检验记录制度二十、不合品处理制度二十一、不符合情况管理办法二十二、从业人员健康检查制度二十三、食品安全事故处置制度二十四、不安全食品召回制度二十五、食品安全风险监测和信息收集制度二十六、食品生产安全自查管理制度一、颁布令本手册是根据《食品安全法》、《食品安全法实施条例》及《食品质量安全市场准入制度》《食品质量安全市场准入审查通则2010版》及《蔬菜制品生产许可证审查细则》、《糖果生产许可证审查细则》、《固体饮料生产许可证审查细则》、《配制酒生产许可证审查细则》对食品生产加工必备条件所作的有关规定及本公司的实际情况编制而成。

本手册适用于公司的玛咖深加工的生产加工过程。

本手册自2016年04月08日开始实施。

本汇编为本公司的质量管理基本制度,全公司各部门及全体员工要认真学习,所有人员都必须遵照执行,严格执行《质量管理手册》,保证产品质量安全。

不得有违反本手册的行为。

经理:和家权云南三迤兴生物科技有限公司2016年4月10日二、企业概况我工公司是专业的玛咖加工企业,创建于2016年,占地面积1500m2,建筑面积1200m2,年设计能力100吨。

固定资产投资为200万元,现有职工10人,专业技术人员3人,管理人员3人。

我公司将本着求实创新的精神,继续努力,为社会作出更大的贡献。

三、任命书一、质量负责人任命高政为公司质量负责人,全面负责质量安全工作, 具有以下质量职责和权限:A、在最高质量负责人领导下,具体负责本公司质量管理的日常领导工作。

负责本公司的质量管理体系各部分、各过程的建立、实施、保持和完善。

B、具体领导质量部门工作C、向最高负责人报告本公司实施质量体系所取得的业绩,以及质量管理体系所需作的改进。

D、组织内部检查和考核,确保形成自我完善机制,保证体系的有效运行。

E、组织质量管理文件、制度的制定和审核。

F、负责与质量管理有关事宜和外部沟通与联络。

G、组织评审重要的不合格(包括不合格工作及不合格品)二、质检部化验员任命质检部章郭飞为公司专职化验员,独立行使质量检验工作,并负责化验室和一切计量器具和检测仪器的管理工作。

经理:和家权2016年4月8日四、质量安全方针及安全目标为了持续稳定安全生产,把好质量关,在满足国家法律法规基础上以“以顾客为关注焦点”来占领、拓展市场。

(一)根据本公司实际现状质量方针为:安全生产,质量为本科学管理,服务大众(二)质量安全目标:按照食品生产的要求,建立质量管理制度,对本公司员工和生产操作人员进行培训,严格执行本公司的管理规定。

遵照玛咖深加工的特点,确定了生产工序的质量控制点,严格把关,力求做到以下几点。

1、市场抽查合格率:100%2、产品投诉率控制在%以下,客户投诉处理率为100%,不合格产品召回率达到100%。

3、食品安全质量事故0。

4、卫生条件达标率:100%五、组织机构及质量管理小组(一)组织结构:经理负责全面工作,是本公司的安全和质量第一责任人,并负责产品的销售和填报原材料的采购计划。

生产车间主任负责下属各个车间的生产及设备管理和维修的管理工作。

检验室负责产品及原辅料质量检验。

组织结构准的产品。

公司决定成立质量管理小组,质量管理小组组长为 徐稳祥 ,小组成员: 质量管理小组对采购、生产、销售全过程实行标准化质量管理。

各部门要认真组织学习《质量管理手册》和其他工艺文件,持续、稳定的生产出符合国家标准的合格产品。

经理:和家权云南三迤兴生物科技有限公司2016年4月10日六、质量安全管理职责为了明确在质量安全管理活动中的关键部门、人员应负的责任及享受的权利,使质量安全管理工作和有章可循,特制定本质量管理职责。

一人员岗位职责(一)经理质量安全职责和权限:1、认真贯彻国家政策、法令和饮用纯净水的相关产品标准,生产规范,全面负责公司生产、技术、质量、设备、卫生、销售、保卫、劳动等项管理工作和规章制度实施。

负责指导制定质量安全目标并督促组织实施。

2、负责组织制定本公司生产、销售计划、质量安全保证措施计划、机电设备大、中修理计划、技术改造计划、劳动力需要计划、物资采购计划及实施。

3、负责组织职工的思想政治教育、法制教育、安全卫生教育、素质教育和技术培训、练兵考核工作,牢固树立质量第一,卫生保证,文明生产,争创名牌的思想和艰苦奋4、负责组织建立质量体系并使其有效运行。

直接领导质量安全管理和质量安全检验部门,对生产质量安全全面负责。

5、组织贯彻执行国家有关产品质量安全管理工作的法规、政策和方针。

6、负责质量安全体系的提出及审批。

7、重视职工质量安全意识教育,树立全员抓质量安全的观点。

8、定期委托他人或亲自对质量安全体系进行评审。

9、委托他人负责检查和了解和外部质量保证的活动,并记录整理归档。

(二)办公室主任职责1、在经理的领导下,负责公司办公室的组织管理工作,做好相关部门的协调工作和后勤保障工作。

2、组织财务人员做好企业财务管理工作,保障企业生产经营的经济往来正常顺利,提高资金周转率,促进企业发展。

3、组织做好人事劳动管理工作,员工来访接待及处理工作。

4、组织做好公司内后勤服务工作,协调公司内外关系。

5、做好企业会议记录,起草企业有关文件材料,当好经理管理企业的助手。

6、完成领导临时交办的任务。

(三)生产车间主任岗位责任:一、在经理领导下,认真贯彻执行国家关于饮用纯净水的生产规范和标准,以及公司各项规章制度。

二、负责日常组织生产、监督检查产品质量安全、劳动纪律、生产卫生工作以及机电设备的维修和安全操作规程的执行,制止违章作业,保证设备完好,生产正常。

三、合理组织调配劳动力,做到安排合理,提高效率,发挥全体员工的积极性,避免窝工或忙闲不均。

四、负责组织车间员工,完成公司下达的生产任务、技术改造、设备维修等项目。

五、负责车间员工的思想教育、质量安全教育、安全卫生教育,不断提高员工思想素质和技术素质。

六.负责统计上报生产产品的生产数量、规格以及成品数量,生产过程中出现的故障及其原因,责任和排除情况。

(四)质检部长职责1、全面负责本公司的生产技术工作和质量管理工作,确保生产的正常进行和产品质量的稳定。

2、根据纯净水产品生产原理和本公司生产设备性能,提出本公司产品生产工艺规程、设备操作规程、质量管理制度等,经经理批准后贯彻实施。

3、负责本公司生产技术、生产工艺、生产设备的改进工作和新产品的研制开发工作,应用新技术,提高产品质量,降低生产成本。

4、抓好质量管理工作,组织、协调质量体系中的各种质量活动,推动、督促各部门开展质量管理工作。

5、掌握本公司质量体系动作的动态,搞好质量管理体系的建立、改进、实施,提高质量体系的工作效能,提高产品质量。

6、负责统一管理本公司质量信息的传递,充分发挥质量信息的作用,根据企业发展变化,修订、起草本公司质量目标及质量文件、制度等。

7、负责对本公司生产的全过程进行生产技术、质量工作的指导和监督(五)财务部长职责1作好公司财务管理工作,保证手续完备、数据推确、内容真实,账证相符、账账相符、账实相符。

2按时编制财务报表。

3与生产、经营各部门密切配合,做好销售收入的管理工作。

4及时向经理反应公司的财务状况及财务信息,以便公司做出正确决策。

5 做好成本核算,降低成本,节约费用,提高经济效益,并监督生产费用支出。

6 认真做好各会计档案的归档与保管工作。

7 承办经理交给的其它工作。

(六)供销部长岗位责任:1、在经理领导下,负责日常采购计划和日常销售业务,全面贯彻落实公司下达的销售指标。

2、负责组织开展产品宣传活动,认真调查收集客户信息,适时提供调整生产计划方案3、经常深入用户,收集用户意见和建议,并将用户意见建议分类整理及时通报经理,以便扩大销售改进工作。

4、负责本部门的员工思想政治教育,素质教育和业务教育,不断提高业务能力。

5、按时,按要求做好销售业务报表和销售款的回收上缴工作,杜绝销售长期拖欠现象,严禁未经经理批准将销售款拉作他用。

6、以身作则,办事公正,树立公司的良好形象,对员工进行文明卫生,仪表,仪容,交谈技巧和态度以及业务洽谈策略,技巧的指导。

7、贯彻落实上级的指示精神和本公司的各项规章制(七)销售人员质量安全职责,权限:1、认真贯彻执行上级有关质量方针和政策。

2、深入开展质量品牌的广告宣传,不断扩大用户,以质取胜。

3、坚持质量第一方针,贯彻企业宗旨,搞好用户服务。

4、坚持文明规范用语,礼貌待客。

5、收集市场信息,经过整理后,向公司反馈,以求发展和提高。

6、认真对待客户,对于产品质量、服务质量的意见,并吸收有用信息,改进工作,提高服务质量。

7、遵守职业道德,不合格产品、过期产品不销售。

销售运输调度员质量安全职责,权限:1、认真贯彻执行上级有关质量方针政策规定,负责制订各种运输管理制度,并在实施中进行监督和检查。

2、每天合理做好计划调度工作,使各车都能保质保量完成运输任务。

3、负责监督和检查运输员工的“文明搬运、礼貌待人”的服务质量,使顾客喝得满意,用得开心。

4、要监督员工小心搬运,减少破桶,保证送到用户处的产品完好无损。

(八)生产设备管理员岗位责:一、严格遵守公司的各项规章制度。

二、认真负责搞好生产设备管理工作,保证生产设备正常运转,保证水、电等能源充裕稳定供应。

三、负责制定企业设备各项管理制度,并督促检查有关人员贯彻执行,编制企业设备完好率考核办法和实施设备完好率考核工作。

四、编制设备大、中修理工作计划,并负责实施设备大、中修理,生产班组设备的日常维护保养工作格操作使用,保持生产设备较高的完好水平。

五、加强对操作人员的设备机构操作知识,技能的教育指导,提高操作工人技术水平,协助技术部门和质检部门对职工进行安全生产教育。

六、组织落实对外设备选购、验收工作,自制设备的设计、制造、试车、运转等工作。

七、组织、监督对设备档案资料的管理工作。

八、协调公司主管生产副经理管理好班组生产。

(九)机电管理员岗位责任:一.在经理的领导下,负责本公司机电设备、电气仪表、工具、工艺管道、通风设备、净化消毒实施管理,使其处于完好状态。

二.提出有关设备、设施的维修、改造、技术革新方案,经批准后负责组织实施。

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