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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