QSR820体系文件（中英文手册+程序）.pdf

Title：Quality ManualOriginator:Approved:D ocument No：Rev：EH istoryVersionIssue dateC hanged contentA2014-11-07A first issueB2014-12-181.U pdate 4.1 General-outsourced process2.U pdate 7.5.1.2.3 service activities3.U pdate appendix-1 D management chartC2015-4-301.U pdate 02 General introduction2.U pdate 5.3 Quality policy3.U pdate 5.5.1 Responsibility and authority4.Add 9 Applicable requirements of C anada medical device regulationsD2015-7-161.U pdate 计em 3 to add some FDA definitions2.Add C MDR and MMD requirement3.Delete 7.5.1.2.34.C hange o-chartE1.Revise grammar and spell2.Add 7.5.3.2.1 traceability mapTable of contents0.Introduction.40.1 Issue order.40.2 G eneral.50.3 Quality commitment.50.4 Process approach.50.5 Relationship with other standards.50.6 Compatibility with Other management systems.51.Scope.51.1 G eneral.51.2 Application.62.Normative references.63.Terms and definitions.64.Quality management system.74.1 G eneral.74.2 D ocumentation requirements.84.2.1 G eneral requirements.84.2.2 Quality manual.94.2.3 Control of documents.94.2.4 Control of records.95.Management responsibility.95.1 Management commitment.95.2 Customer focus.105-3 Quality policy.105.4 Planning.115.4.1 Quality objective.115.4.2 QMS planning.115.5 Responsibility,authority and communication.125.5.1 Responsibility and authority.125.5.2 Management representative.135.5.3 Internal communication.145.6 Management review.145.6.1 G eneral.145.6.2 Review input.145.6.3 Review output.146.Resources management.146.1 Provision of resources.146.2 H uman resources.146.2.1 G eneral.146.2.2 Competence,training and awareness.156.3 Infrastructure.156.4 Work environment.167.Production realization.167.1 Planning of product realization.167.2 Customer-related processes.177.2.1 Identification of the product requirements.177.2.2 Review of requirements related to the product.177.2.3 Customer communication.187.3 D esign and development.187.3.1 D esign and development planning.187.3.2 D esign and development inputs.197.3.3 D esign and development outputs.197.3.4 D esign and development review.197.3.5 D esign and development verification.207.3.6 D esign and development validation.207.3.7 Control of design and development changes.207.4 Purchasing.217.4.1 Purchasing process.217,4.2 Purchasing information.217.4.3 Verification of the purchased product.217.5 Production and service provision.227.5.1 Control of production and service provision.227.5.2 Validation of processes for production and service provision.237.5.3 Identification and traceability.237.5.4 Customer property.257.5.5 Preservation of product.257,6 Control of monitoring and measuring devices.268.Measurement,analysis and Improvement.268.1 G eneral.268.2 Monitoring and measurement.268.2.1 Feedback.268.2.2 Internal audit.278.2.3 Monitoring and measurement of process.278.2.4 Monitoring and measurement of product.288.3 Control of nonconforming product.298.4 Analysis of data.298.5 Improvement.308.5.1 G eneral.308.5.2 Corrective action.308.5.3 Preventive action.319.Applicable requirements of Canada medical device regulations.319.1 SOR/98-282 requirements.319.2 Manufacturer duty.310.Introduction 0.1 Issue order发布令 Issue OrderT his manual is established according to the IS O 13485:2003 Medical device-Quality management system-Requirements for regulatory purposes and QS R 820 Quality system regulation and S OR/98-282 C anada medical device regulations and 93/42 EEC medical device directive and combining with actual situation of company.T his manual is a policy document,a basic regulation of quality management,a rule of quality management system running and a commitment to all customers.All personnel have to perform since the implementation of the manual which is released.本手册是依据IS O 13485医疗器械 质量管理体系 用于法规的要求、21C FR820QS R质量体 系法规和、S OR/98-282加拿大医疗器械法规和93/42 EEC医疗器械指令的有关要求，并结合本公 司具体情况制定的。本手册是公司政策法规性文件，是公司质量管理的基本法规，是质量管理体系 运行的准则，也是对所有顾客的承诺，所有员工自本手册实施之日起，必须遵照执行。本手册自发 布之日起正式实施。General Manager总经理0.2 G eneral公司 founded in 2005 in S uzhou industrial park is a global top-level luxury brand to provide various services of high quality supplier which is mainly engaged in the R&D,production,processing of handheld massager,high quality sex toys,cosmetics,and other related products.According to the different intended use,公司 developed several brands including etc.产品介绍We aim to provide customers with high quality products and service,commit to seek long-term development,experience unprecedented innovation and lead the calligraphy team to achieve customer satisfaction,create a better life for our employees.公司名称公司地址联系电话0.3 Quality commitment公司 is committed to world class quality and superior customer satisfaction.We achieve this through a culture of innovation,continuous improvement,customer responsiveness and operating with an effective QMS that meets all Regulatory Requirements under IS O 9001:2008,IS O 13485:2003,C MDC AS and 21 C FR 820.0.4 Process approachA system based process approach to quality management allows all activities that receive inputs and convert the inputs to outputs be identified as a process.Processes that linked to other processes are also identified and managed accordingly.0.5 Relationship with other standardsAlthough IS O 13485 is a stand-alone standard it is based on IS O 9001:2008.公司s IS O 13485 Quality Management S ystems Manual is established for the purposes of continuity between 21 C FR 820 and IS O 13485:2003.And the relationship of C FR820 and IS O 13485 is shown in Appendex-3.0.6 Compatibility with Other management systemsT his Quality Manual is applicable to other agency requirements while ensuring a basic foundation for Quality Management S ystem.T he Quality S ystems also complies with the U nited S tates Food and Drug Administration-Quality S ystem Regulations U.S.QS R(21 C FR 820)1.Scope1.1 G eneralT he Quality Management S ystem described in this manual is intended to meet the requirements of the quality management systems standard IS O 13485:2003.It also addresses FDAs Quality S ystem Regulations U.S.QS R(21 C FR 820)for the design,development and production of medical devices.Our policies provide a framework to ensure conformity of the companys quality management system to IS O 13485 requirements and maintain the effectiveness of the quality system.T he requirements of this manual will be communicated to all employees,depending on scope of employee responsibilities and impact on the quality system and/or product.1.2 ApplicationT he Quality Management S ystems described in this manual is specific to non-sterile and non-implantable medical devices.T he products include Therapeutic massager,Perineometer,Menstrual cup etc.公司 has neither sterile products nor active implantable medical devices and no particular requirements for such types of products.Additionally,公司 neither installs a product nor requires to providing further services for the manufactured products.T herefore the following clauses of C AN/C AS IS O 13485 and QS R 820 do not apply to 公司s quality management system for medical devices:7.5.1.2.2,installation S ervices7.5.1.2.3 S ervicing Activities”7.5.1.3,T articular requirements for sterile medical devices7.5.2.2,Particular requirements for sterile medical devices7.5.3.2.2,Particular requirements for active implantable medical devices and implantable medical devices”，and8.2.4.2,T articular requirement for active implantable medical devices and implantable medical devicesQS R 820.170 Installation”2.Normative referencesMedical Devices.Quality Management S ystem.Guidance on the Application of IS O 13485:2003 C ode of Federal Regulations title 21,Part 820,Quality S ystem Regulation(QS R)S OR/98-282-2015 Medical devices regulations93/42 EEC medical device directive3.Terms and definitionsAbbreviations:QMS:Quality management systemGM:General managerDFMEA:Design failure mode effect analysisMR:Management representativeBase on:IS O 9000:2005.QMS s.Fundamentals and VocabularyS ome terms and definitions related to medical device listed below:3.1 advisory notice:notice issued by the organization subsequent to delivery of the medical device,to provide supplemental information and/or to advise what action should be taken inthe use of a medical devicethe modification of a medical devicethe return to the organization that supplied the medical device,or the destruction of a medical deviceAdvisory notice might be issued in order to comply with national and regional regulatory requirements.3.2 customer complaint:written,electronic,or oral communication that alleges deficiencies related to the identity,quality,durability,safety,or performance of a medical device that has been placed on the market.3.3 medical device,any instrument,apparatus,implement,machine,appliance,in vitro reagent or calibrator,software,material or other article,intended by the manufacturer to be used,alone or in combination for human beings for one or more of the specific purpose(s)of:diagnosis,prevention,monitoring,treatment or alleviation of disease,diagnosis,monitoring,treatment,alleviation of,or compensation for,injury or handicap investigation,replacement or modification of the anatomy or of a physical process,control of conception,disinfections of medical devices,providing information for medical purposes by means of in Vitro examination of specimens derived from the human body and,which does not achieve its primary intended action in or on the human body by pharmacological immunological or metabolic means,but which may be assisted in its function by such a means.3.4 Active medical device:Any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human Body or gravity.3.5 labeling-.Written,printing or graphic-S tuck or printed on medical device or packing box or other packing material or-Attached to the medical deviceLabel,technical specification or using guidance related to medical device,not includes shipping documents3.6 Quality policy means the overall intentions and direction of an organization with respect to quality,as established by management with executive responsibility.3.7 Quality system means the organizational structure,responsibilities,procedures,processes,and resources for implementing quality management.3.8 Design history file(DHF)means a compilation of records which describes the design history of a finished device.3.9 Device history record(DHR)means a compilation of records containing the production history of a finished device.3.10 Device master record(DMR)means a compilation of records containing the procedures and specifications for a finished device.3.11 MDR means medical device report.3.12 QS R means Quality system records.4.Quality management system4.1 G eneral公司 has established,documented,implemented and maintained a QMS(QMS)in accordance with the requirements of C AN/C AS IS O 13485:2003 and U.S.QS R(21 C FR 820).T he effectiveness of the QMS is maintained and the system continually improved through the quality policy,quality objectives,audit results,analysis of data,corrective and preventive action and management review.T he interactions of all the processes taking place within 公司 are defined in the Quality manual in order to be able to effectively apply to the QMS.T he process management comprises the processes needed for the Quality system.T hese are management activities,assurance of resources,product realization and measuring processes.While defining the processes,the customer requirements,legal provisions,nature of product and meeting of the organization requirements,providing an added-value,obtaining of the results on process performance and its effectiveness and importance of the continual improvement have been taken into consideration.Our Process management and improvement system defined in the Process Introduction cards forms a model for controlling of the inputs/outputs of the process,its limits,the processes it interacts with,performance criteria and measuring systems,providing its competition and for its continual improvement.Outsourced processesT he outsourced process should be compliant to 7.4 IS O13485 and 820.50 requirements.4.2 D ocumentation requirements4.2.1 G eneral requirements公司 documentation S ystem is built on the following hierarchical structure:I.Quality Policy and Objectives:Defined in quality manualT he Quality Policy is the statement of our commitment to our customers and is a driving force of our QMS.Quality Objectives are statements of measurable goals to support our Quality Policy.II.Quality manual:provides reference to the procedures established for the QMS also shows the relationship between the procedures and the requirements of the Quality Management S tandards.III.Procedure:Documents used to define in further detail the principles and strategies used to support the elements of the QMS.Procedures are used for groups of people allowing a clear definition of responsibility and interfaces.IV.Work instruction:Documents that provide the detailed instructions for a single operation.It defines what tasks are involved,how they are to be performed,and what reference documentation is needed to perform the task.V.External Documents:Documents for technical standard,system standard or regulations etc.T hese documents are for reference or internal training purposeVI.Form:Blank forms should be controlled as document,forms already filled in should be controlled as record.VII.Record:Provides evidence of meeting quality requirements and the effectiveness of the QMS.4.2.2 Quality manualProcedures documented for the QMS are given in this manual.Interactions between all processes and procedure map are explained in Apendix-1.4.2.3 Control of documentsAccording to the requirements and standards of files distribution management,公司 has enacted a document control procedure to define the management method of documents.T his procedure defines the control responsibility and main point of standard related documents and data,(including applicable legal documents)to ensure the documents can be effectively collected and displayed.Document C ontrol ensures that current revisions(including external documents)are readily available and accessible for public use.Reference to-S OP-04-0002 Document control procedure4.2.4 Control of recordsT o ensure all records are controlled and managed efficiently,公司 implements Record C ontrol Procedure.T his procedure defines the responsibilities involved in collecting,identification,archiving and preservation of records.Reference to-S OP-04-0003 Record control procedure-S OP-10-0015 Good Documentation Practice5.Management responsibility5.1 Management commitmentT op management has been actively involved in implementing the quality management system(QMS)C AN/C AS IS O 13485:2003 and U.S.QS R(21 C FR 820).Vision and mission is formulated for the growth of the QMS,and established quality objectives and the quality policy.T op Management member in 公司 is GM.GM is responsible for fulfilling t