Scribd Logo
Upload

Welcome to Scribd!

  • ISO 13485 FDA Package

    Uploaded by

    Nirav Desai
    788 views2 pages
    This document provides an overview of an all-in-one certification package for ISO 13485 and FDA compliance. It includes planning tools like a gap analysis checklist and risk management exercise. Training materials cover an introduction to ISO 13485 through PowerPoint presentations and computer-based training. The package also provides documentation templates like a quality manual, procedures, and forms to establish an quality management system that meets both ISO 13485 and FDA requirements. Customers can use these templates and tools to efficiently implement a compliant quality system.

    Original Description:

    Iso 13485 FDA All in One

    Original Title

    Iso 13485 FDA All in One

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    This document provides an overview of an all-in-one certification package for ISO 13485 and FDA compliance. It includes planning tools like a gap analysis checklist and risk management exercise. Training materials cover an introduction to ISO 13485 through PowerPoint presentations and computer-based training. The package also provides documentation templates like a quality manual, procedures, and forms to establish an quality management system that meets both ISO 13485 and FDA requirements. Customers can use these templates and tools to efficiently implement a compliant quality system.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    788 views2 pages

    ISO 13485 FDA Package

    Uploaded by

    Nirav Desai
    This document provides an overview of an all-in-one certification package for ISO 13485 and FDA compliance. It includes planning tools like a gap analysis checklist and risk management exercise. Training materials cover an introduction to ISO 13485 through PowerPoint presentations and computer-based training. The package also provides documentation templates like a quality manual, procedures, and forms to establish an quality management system that meets both ISO 13485 and FDA requirements. Customers can use these templates and tools to efficiently implement a compliant quality system.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 2

    13485store.

    com

    ISO13485andFDACompliantAllinOneCertificationPackage
    IncludedContents(Linktowebsiteformoredetails)

    Planning

    GapAnalysisChecklist
    Adetailed,72pagechecklist(MSWord)withguidanceonwhattolookfortoevaluateyourcurrentprocessesandtheircompliance
    totheISO13485requirementshighlightingadditionalrequirementstoupgradeanexistingQMStobecomeFDAQSRcompliant..

    RiskManagementExercise
    RiskManagementandriskanalysisarerequiredinISO13485.Ourexercisewilltakeyouthroughtheanalysisofrisksfortheproduct
    realizationstepsrequiredforyourproducts.

    ProjectManagersGuide
    Thiswalksyouthroughtheprocessofplanningandexecutingyourproject.

    Training

    IntroductiontoISO13485PowerPointPresentationMaterials
    Usethesepresentationmaterialstoeducatemanagement,employees,customerorothergroupsonISO13485.Thispackage
    includes61PowerPointslideswithspeakernotes,quizzesandaTrainersGuide

    IntroductiontoISO13485Computerbasedtraining
    UsethistrainingtoeducateemployeesonISO13485.Thisonlinecomputertrainingrunsapproximately1/2hour.Thetraining
    includesslides,audioandquizzes.

    Setof11EmployeeFlyers
    Employeeawarenessisacriticalaspectofasuccessfulproject.KeepyouremployeesinformedandinvolvedintheISO13485
    project.TheseFlyersimproveawarenessandknowledgeofISO13485inyourorganization.Sendthemoutonaregularbasisduring
    theimplementation.

    InternalAuditProgram

    InternalAuditChecklist,Procedure,AuditPlanandForms
    ThiscompleteInternalAuditChecklist&ToolsPackageprovideseverythingyouneedtoestablishyourInternalAuditProcess.
    IncludesChecklist,planning&reportingforms,andaPowerPointonthebasicsofAuditing.Thischecklistcontainsallthe
    requirementstoaudityourQMStobothISO13485andtotheFDAQSR21CFR820.

    InternalAuditorTrainingMaterials
    Conductthoroughtrainingforyourinternalauditors.ThispackageincludesPowerPointpresentations,StudentManual,Trainers
    Guide,Exercisesandasetofdocumentationfortraineestoaudit.

    ISO13485Documentation(QualityManual,Procedures,Forms)

    QualityManual
    AfulldocumentedISO13485ManualfororganizationstouseasanexampleandtemplatefortheirownQualityManual.Writtenin
    MSWordforeasycustomization.

    Procedures&Forms
    Readytocustomize,fullywrittenprocedurestobeusedasafoundationandatemplateforyourqualitysystem.

    Seedetailedlistofcontentsonnextpage

    13485store.com
    ISO13485FDADocumentationContents

    Procedure
    1. DocumentControl
    2. ControlofQualityRecords
    3. ManagementResponsibility
    4. Competence,AwarenessandTraining
    5. Infrastructure
    6. WorkEnvironment
    7. PlanningofProductRealization
    Processes
    8. CustomerRelatedProcesses
    9. RiskManagement
    10. DesignandDevelopment
    11. Purchasing
    12. ControlofProductionandservice
    Provision(forISO13485)
    13. ProductionandProcessControls(for
    QSR21CFR820)
    14. ValidationofProcessesforProduct
    Realization
    15. IdentificationandTraceability
    16. CustomerProperty
    17. PreservationofProperty
    18. ControlOfMonitoringandMeasuring
    Devices
    19. PostProductionFeedback
    20. InternalAudits
    21. MonitoringandMeasuringofProduct
    RealizationProcesses
    22. ControlofNonConformingProduct
    23. StatisticalTechniques
    24. RootCauseAnalysis
    25. CorrectiveAction
    26. PreventiveAction
    27. ProductRecallandAdvisoryNotices
    Form
    1. MasterDocumentList
    2. SoftwareInventorySpreadsheet
    3. DocumentChangeRequestForm
    4. DocumentRevisionChecklist
    5. QualityRecordstable
    6. QMSMeasuring,MonitoringandAnalysisTable
    7. KeyProcessMasterList
    8. ManagementReviewAgenda
    9. ManagementReviewChecklist
    10. QualityPolicy
    11. OrganizationChart
    12. ActionPlanForTrainingForm
    13. GroupTrainingSignIn
    14. JobDescriptionForm
    15. EquipmentProblemReport
    16. EquipmentMaintenanceRecord
    17. QualityPlanningtableForm
    18. Clause7Inclusion,ExclusionWorksheet
    19. ProcessFlowChartexample
    20. ClientAssessmentMemo
    21. RiskManagementPlan
    22. RiskList
    23. DesignPlan
    24. DesignReview
    25. DesignChangeForm
    26. SupplierQualityReport
    27. SupplierCorrectiveActionRequest
    28. ApprovedSubcontractorList
    29. Processroutingsummarysheet
    30. Processroutingdetailsheet
    31. ProcessValidationWorksheet
    32. TraceabilitySerialNumberLog
    33. CustomerPropertyControlLog
    34. StorageInspectionReport
    35. EquipmentList
    36. CustomerSatisfactionSurveyandAnalysis
    37. InternalAuditPlan
    38. InternalAuditReport
    39. ApplicableProceduresbyWorkArea
    40. AuditChecklist
    41. ProductRealizationMeasuring,MonitoringandAnalysis
    Table
    42. RejectedMaterial/DispositionReportNCR
    43. RootCauseAnalysisActionPlan
    44. Corrective/PreventiveActionRequest
    45. ProcedureTemplate
    46. WorkInstructionTemplate
    47. FormTemplate

    You might also like