FDAQSR820-ISO13485：2016内审检查表英文版

FDA/ISOQMSAuditChecklistbyGreenlightGuru,,,,,,

Audit#:,,,,"NC=Non-Conformance

OFI=OpportunityforImprovement

PP=PositivePractice

A=Acceptable",,

Dates:,,,,,,

LeadAuditor:,,,,,,

,,,,,,,

Item,Subsystem/AssessmentDetail,FDA/ISOreference,AuditorNotes,AuditorObservation,ObjectiveEvidence,"NC,OFI,PP,orA?"

ManagementControls(mainsubsystem),,,,,,

1,"ensureQualityManualdefinesscopeofQMS,procedures(orreferenceto)withinQMS,anddescriptionoftheinteractionofprocesseswithinQMS","

ISO13485:2016:4.1,4.2.2","reviewqualitymanual;

reviewQMSmetrics;

reviewcriticalprocessesandprocedures",,,

2,verifycriteriaandmethodsareinplacetomonitorandcontrolprocessesforeffectiveness,"

ISO13485:2016:4.1.3(a),4.2.1(d),8.4","reviewQMSmetrics;

reviewmanagementreviews",,,

3,"VerifyfirmhasestablishedandconductsManagementReviews,atleastannually","

ISO13485:2016:5.1(d),5.6;

21CFR820.5,820.20(c)","requestprocedureinadvance;

reviewmanagementreviews",,,

4,"confirmmanagementreviewsexaminesuitabilityandeffectivenessofqualitysystems,improvementsneededbecauseofcustomerrequirements,andresourceneeds","

ISO13485:2016:4.1.3(c),5.6.1,5.6.3,6.1,8.4;

21CFR820.20(c)",reviewprocedure,,,

5,"ensuremanagementreviewaddressesauditresults,customerfeedback,processperformance,CAPAs,previousmanagementreviews,changestoQMS,recommendationsforimprovement,andneworrevisedregulatoryrequirements","

ISO13485:2016:5.6.2",reviewmanagementreviews,,,

6,verifyfirmhasestablishedaQualityManualandQualitySystemProceduresandInstructionsthatareappropriate,"

ISO13485:2016:4.1.2(a),4.2.1(b),(c);

21CFR820.5,820.20(c),(d),(e),820.22","requestqualitymanualandproceduresinadvance;

reviewdocuments",,,

7,VerifyfirmhasestablishedQualityPlan,"

ISO13485:2016:4.2.1(d),5.4;

21CFR820.20(d)",requestqualityplaninadvance,,,

8,confirmthatQualityPlanningaddressesQMSneedsandQualityObjectives,"

ISO13485:2016:5.4.2;

21CFR820.20(a),(d)",reviewqualityplan,,,

9,verifyfirmhasimplementedQualityPolicyandQualityObjectives,"

ISO13485:2016:4.2.1(a),5.1(b),(c),5.3,5.4.1

21CFR820.20(a),(d)","interviewemployeesaboutqualitypolicy;

reviewtrainingrecords",,,

10,VerifyfirmhasestablishedQualityAuditproceduresandconductsaudits,"

ISO13485:2016:4.2,8.2.4;

21CFR820.20(c),820.22","requestprocedureinadvance;

reviewauditscheduleanddocuments;

reviewauditortraining",,,

11,ensurequalityauditsexaminecomplianceandeffectiveness,"

ISO13485:2016:4.1.3(c),4.2.1(d),8.2.4;

21CFR820.22","reviewprocedure;

reviewauditrecords",,,

12,verifythatauditorsaretrained,"

ISO13485:2016:6.2,8.2.4;

21CFR820.22","reviewauditrecords;

reviewtrainingrecords",,,

13,ensurethatauditsareconductedbyobjectiveparties,"

ISO13485:2016:8.2.4;

21CFR820.22","reviewauditrecords;

reviewtrainingrecords",,,

14,confirmqualityauditsarelinkedtoCAPA,"

ISO13485:2016:8.2.4;

21CFR820.22,820.100",reviewprocedures,,,

15,Revieworganizationalstructureoffirm;confirmresourcesareavailabletosupportprocesses,"

ISO13485:2016:4.1.3(b),5.1(e),5.5.1,5.5.2,6.1,6.2;

21CFR820.20(b),820.25",requestorganizationalchart(s)inadvance,,,

16,verifyfirmhasdefinedamanagementrepresentativewithexecutiveresponsibilityforimplementingandreportingqualitymanagementsystem,"

ISO13485:2016:5.1,5.5.1,5.5.2,6.1,6.2;

21CFR820.20(b)(3),820.25","askmanagementrepresentativetoidentifyresponsibilityfor:

-changestoprocedures,devicedesigns,manufacturingprocesses

-reviewofqualityauditresults

-oversightandinteractionwithCAPAactivities",,,

17,"verifyappropriateresponsibilities,authority,andresourcesareinplaceforqualitysystemactivities","

ISO13485:2016:5.1(e),5.5.1,5.5.2,6.1,6.2;

21CFR820.5(b)(1)-(2),820.20(b),820.25",interviewmanagementrepresentativeaboutresourceallocation,,,

18,"verifyfirmhasestablishedproceduresforidentifyingtrainingneeds;

ensurepersonnelaretrainedtoperformassignedresponsibilities","

ISO13485:2016:6.2;

21CFR820.25(b)","reviewprocedures;

reviewtrainingrecords",,,

19,"ATAUDITCONCLUSION...

Determineifexecutivemanagementensuresadequateandeffectivequalitysystemisimplemented.Ensuremanagementiscommittedtoandcommunicatesimportanceofmeetingcustomerrequirements,regulatoryrequirements,andQMS.","

ISO13485:2016:5.1(a),5.2,5.5.3","interviewexecutivemanagement;

provideconfirmationorfailuresofqualitysystem;

reviewothersubsystemsandreturntomanagementcontrols",,,

Design&Development/DesignControls(mainsubsystem),,,,,,

1,verifyproductsaresubjecttodesigncontrols,"

ISO13485:2016:7.1,7.3;

21CFR820.30(a)","reviewprocedure;

reviewproducts",,,

2,verifydesigncontrolandriskmanagementproceduresareestablishedandapplied,"

ISO13485:2016:7.3;

21CFR820.30(a)-(j)",ensureproceduresaddressalldesigncontrolelements,,,

3,"ensuredesignanddevelopmentstagesareidentified;confirmthatreview,verification,validation,anddesigntransferactivitiesateachstageareappropriate;verifyresponsibilitiesfordesignanddevelopmentaredefined","

ISO13485:2016:7.3.2;

21CFR820.30",reviewprocedures,,,

4,selectadesignproject,,"selectioncriteria:

-containssoftware

-singleproductfocus

-riskbased

-resultofcomplaints,problems

-mostrecent

-coverproductrange

-recent510(k),PMA,CEmark",,,

5,"reviewtheprojectdesign&developmentplan,responsibilities,andinterfaces","

ISO13485:2016:7.3.2;

21CFR820.30(b)","reviewprocedure;

assessplan's

-milestones

-phases

-responsibilities

-riskmanagement

-interfaces",,,

6,"verifydesign&developmentplanisupdated,reviewed,andapproved","

ISO13485:2016:7.3.2;

21CFR820.30(b)","reviewplanrevisions;

reviewandapprovalprocedures",,,

7,"confirmdesigninputrequirementswereestablished,reviewed,andapproved;ensurecustomerrequirementsarecaptured;ensureinputsincludefunctional,performance,safety,andstatutoryandregulatoryrequirements","

ISO13485:2016:7.2.1,7.3.3;

21CFR820.30(c)","reviewprocedure;

ensurerequirementsaddress

-intendeduse

-functional,performance,andsafetyrequirements

-applicablestatutoryandregulatoryrequirements

-userandpatientneeds

-otheressentialrequirements",,,

8,"incomplete,ambiguous,and/orconflictingrequirementswereaddressed","

ISO13485:2016:7.3.3;

21CFR820.30(c)","reviewprocedure;

reviewresolutions",,,

9,"confirmdesign&developmentoutputsareestablished,verifiable,reviewed,andapproved","

ISO13485:2016:7.3.4(a),(c);

21CFR820.30(d)","reviewprocedure;

reviewdrawings,specifications,labeling,packaging,workinstructions,IFUs",,,

10,"ensuredesign&developmentoutputsareappropriateforpurchasing,production,andservicing","

ISO13485:2016:7.3.4(b);

21CFR820.30(d)",reviewprocedure;,,,

11,verifyessentialdesign&developmentoutputsareidentified,"

ISO13485:2016:7.3.4(d);

21CFR820.30(d)","reviewprocedure;

reviewdrawings,specifications,labeling,packaging,workinstructions,IFUs",,,

12,confirmacceptancecriteriaisreferencedbydesign&developmentoutputsandwasdefinedpriortodesignverificationanddesignvalidationactivities,"

ISO13485:2016:7.3.4(c),7.3.6;

21CFR820.30(d)&(f)","reviewprocedure;

reviewdrawings,specifications,labeling,packaging,workinstructions,IFUs;

reviewverificationactivities",,,

13,determineifdesignverificationconfirmeddesignoutputsmetdesigninputrequirements,"

ISO13485:2016:7.3.6;

21CFR820.30(f)","reviewprocedure;

reviewverificationactivities",,,

14,confirmdesignvalidationresultsprovedevicemetpredetermineduserneedsandintendeduses,"

ISO13485:2016:7.3.7;

21CFR820.30(g)","reviewprocedure;

reviewvalidationactivities",,,

15,confirmdesignvalidationdidnotleaveunresolveddiscrepancies,"

ISO13485:2016:7.3.7;

21CFR820.30(g)",assessdesignandspecificationchanges,,,

16,"ifrequiredbynationalorregionalregulations,confirmclinicalevaluationsand/orevaluationofdeviceperformancewereperformed","

ISO13485:2016:7.3.7;

21CFR820.30(g)","reviewprocedure;

reviewevaluationdata",,,

17,"ifdevicecontainssoftware,confirmsoftwarewasvalidated","

ISO13485:2016:7.3.2,7.3.7;

21CFR820.30(g),820.75","ensuresoftwarecomponenthavesatisfieddesign,validation,andchangecontrolrequirements",,,

18,determineifinitialproductionunits(orequivalents)wereusedfordesignvalidation,"

ISO13485:2016:7.3.7;

21CFR820.30(g)","reviewprocedure;

evaluateprototype/productionrecords",,,

19,confirmriskmanagementactivitieswereperformed,"

ISO13485:2016:7.1;

ISO14971:2000;

21CFR820.30(g)","reviewprocedure;

reviewriskmanagementfile;

ensureriskanalysis,evaluation,andcontrolstepsareaddressed",,,

20,"confirmdesignchangeswerecontrolledandvalidated(orwhereappropriate,verified)","

ISO13485:2016:7.3.2,7.3.6,7.3.9;

21CFR820.30(i),820.70(b),820.75(c)","reviewprocedure;

reviewdesignchangesanddocumentationdecisions",,,

21,confirmdesignchangeshavebeenreviewedforeffectoncomponentsandproductpreviouslymade,"

ISO13485:2016:7.3.2,7.3.6,7.3.9;

21CFR820.30(i),820.70(b)",reviewdesignchangesanddocumentationdecisions,,,

22,determineifdesignreviewswereconductedatappropriatestagesofdesign&development,"

ISO13485:2016:7.2.2,7.3.2,7.3.5;

21CFR820.30(e)","reviewprocedure;

reviewdesignreviewdocumentation",,,

23,confirmdesignreviewattendeeswereappropriateforstageandincludedindependentreviewer,"

ISO13485:2016:7.3.2,7.3.5;

21CFR820.30(e)",reviewdesignreviewdocumentation,,,

24,determineifdesignwascorrectlytransferredtoproduction,"

ISO13485:2016:7.3.2,7.3.8;

21CFR820.30(h)","reviewprocedure;

reviewDMR",,,

25,ensureDHFcontainsdesigncontroldocumentation,"ISO13485:2016:7.3.10

21CFR820.30(b)-(j)",reviewDHF,,,

Corrective&PreventiveActions(CAPA)(mainsubsystem),,,,,,

1,verifyCAPAprocedurescomplywithregulatoryrequirements,"

ISO13485:2016:4.1,4.2,8.5;

21CFR820.100(a)",reviewprocedures,,,

2,verifynon-conformingproductandCAPAproceduresdeterminetheneedforinvestigationandnotification,"

ISO13485:2016:8.3,8.5;

21CFR820.90(a),820.100(a)(2)",reviewprocedures,,,

3,verifynon-conformingproductandCAPAproceduresdefineresponsibilitiesforreviewanddisposition,"

ISO13485:2016:8.3,8.5;

21CFR820.90(b)(1)",reviewprocedures,,,

4,"ensurethatproceduresforrework,retesting,andre-evaluationofnonconformingproductexistandarefollowed","

ISO13485:2016:8.3,8.5;

21CFR820.90(b)(2)","reviewprocedures;

reviewDHRs(ofnonconformingproducts)

",,,

5,verifythatappropriaterecordsofqualityproblemshavebeencreatedandused,"

ISO13485:2016:8.3,8.5;

21CFR820.100(a)(1)","reviewrecordsofacceptanceactivities,productiontestfailures,returnedproducts,servicerecords,complaints",,,

6,determineiftrendanalysisdataindicatesqualityproblems;determineifdatausedforCAPAdecisions,"

ISO13485:2016:8.1,8.2.5,8.4,8.5;

21CFR820.100(a)(1),820.250","reviewprocedures;

reviewrecordsofincomingproducts,components,testing,SPCdata",,,

7,"verifyCAPAdataiscomplete,accurate,andtimely;

compareresultsacrossmultipledatasourcestoidentifyqualityproblems","

ISO13485:2016:8.4,8.5;

21CFR820.100(a)(1)","reviewdatasources;

usedatatablestodeterminesamplingplan;

compareresults",,,

8,verifyappropriatestatisticaltechniquesareimplemented,"

ISO13485:2016:8.1,8.2.5,8.4;

21CFR820.100(a)(1),820.250","reviewprocedures;

reviewtechniquesused",,,

9,verifydevicefailureinvestigationsdeterminerootcause,"

ISO13485:2016:8.3,8.5;

21CFR820.100(a)(2)","reviewprocedures;

reviewinvestigations",,,

10,verifyfailureinvestigationsarecommensuratewithrisks,"

ISO13485:2016:8.3,8.5;

21CFR820.100(a)(2),820.90(b)","reviewprocedures;

reviewinvestigations",,,

11,verifycontrolsexisttopreventnon-conformingproductfrombeingreleased,"

ISO13485:2016:8.3;

21CFR820.90(b)","reviewinvestigations;

reviewnon-conformancerecords",,,

12,verifyappropriateactionsweretakenforqualityproblems,"

ISO13485:2016:8.2.5,8.5.2,8.5.3;

21CFR820.100(a)(3),820.100(a)(5);820.100(a)(4),820.100(b)","reviewprocedure;

reviewCAPArecords",,,

13,"determineCAPAactionswereeffective,verified,validated,documented,andimplementedappropriately","

ISO13485:2016:8.5;

21CFR820.100(a)(4),820.100(a)(5),820.100(b)","reviewprocedure;

reviewCAPArecords",,,

14,verifyCAPAsandnonconformitiesweredisseminatedtopersonnelresponsibleforensuringqualityandpreventionofproblems,"

ISO13485:2016:8.3,8.5;

21CFR820.100(a)(6)",reviewCAPAandnon-conformancerecords,,,

15,verifyqualityissuesandCAPAsweredisseminatedforManagementReview,"

ISO13485:2016:5.6.3,8.3,8.5;

21CFR820.100(a)(6),820.100(a)(7)","reviewprocedure;

reviewCAPArecords",,,

16,verifyfirmhasproceduresforhandlingcomplaintsandinvestigationofadvisorynotices/recalls;ensureprovisionsexisttofeedinCAPAsystem,"

ISO13485:2016:7.2.3,8.2.1,8.2.2,8.2.3;

21CFR820.100,820.198",reviewprocedures,,,

MedicalDeviceReporting(MDR),,,,,,

1,VerifyMDRprocedurescomplywithregulatoryrequirements,"

ISO13485:2016:8.5.1;

21CFR803.17",reviewprocedures,,,

2,verifyfirmmaintainsMDReventfilesthatcomplywithregulatoryrequirements,"

ISO13485:2016:8.5.1;

21CFR803.18",reviewMDRfiles,,,

3,"confirmappropriateMDRinformationisidentified,reviewed,reported,documented,andfiled","

ISO13485:2016:8.5.1;

21CFR803,820.198(d)",reviewMDRfiles,,,

4,ensurefirmiseffectiveinidentifyingMDRreportableevents,"

ISO13485:2016:8.5.1;

21CFR803","reviewprocedures;

reviewMDRfiles;

reviewcomplaints&returnedproducts",,,

5,"ensurefirmhasestablishedproceduresforreceiving,reviewing,andevaluatingcomplaints","

ISO13485:2016:7.2.3,8.2.1,8.2.2,8.5.1;

21CFR820.198(a)-(c)",reviewprocedures,,,

6,verifyfirmmaintainscomplaintfilesandthattheyarereasonablyaccessible,"

ISO13485:2016:7.2.3,8.2.1,8.2.2,8.5.1;

21CFR820.198(a),(f),(g)",reviewcomplaintrecords,,,

7,confirmthatcomplaintsareevaluatedtodetermineifaneventshouldbeaMDR,"

ISO13485:2016:7.2.3,8.2.1,8.2.2,8.2.3,8.5.1;

21CFR803,820.198(a)(3)",reviewprocedures,,,

8,"ensurecomplaintinvestigationsincludethedevicename,dateofcomplaint,deviceidentificationnumber,contactinformationofcomplainant,detailsofcomplaint,dateandresultsofinvestigation,anycorrectiveactions,andrepliestocomplainant","

ISO13485:2016:7.2.3,8.2.1,8.2.2,8.5.1;

21CFR820.198(e)",reviewcomplaintrecords,,,

ReportsofCorrections&Removals(C&R),,,,,,

1,verifyC&Rprocedurescomplywithregulatoryrequirements,21CFR806,reviewprocedures,,,

2,examinerecordsofcorrectionsand/orremovalsofproduct,21CFR806,determineifremovalwasinitiatedbyfirm,,,

3,verifyreportingrequirementsareimplemented,21CFR806,reviewprocedures,,,

4,identifyC&Ractionsnotidentifiedorinitiatedbyfirm,21CFR806,identifyeventsnotidentified,,,

5,confirmexistencefileofnon-reportablecorrectionsandremovals,21CFR806.20,reviewnon-reportableC&Rfiles,,,

MedicalDeviceTracking,,,,,,

1,identifyallmanufacturedorimporteddevicesthatrequiretracking,21CFR821.20,reviewproductlistings,,,

2,verifytrackingprocedurescomplywithregulatoryrequirements,21CFR821.25(c),"reviewprocedures;

reviewrecords",,,

3,verifyfirmperformsinternalauditsoftrackingsystempertimeframesspecifiedinregulations,21CFR821.25(c)(3),reviewprocedures,,,

Production&ProcessControls(mainsubsystem)(P&PC),,,,,,

1,verifyproductrealizationprocessesareplanned;confirmthatriskmanagementoccursthroughoutproductrealization,"

ISO13485:2016:7.1;

ISO14971:2000

21CFR820.70",reviewprocedures,,,

2,verifyplanningofproductrealizationisconsistentwithrequirementsofotherprocessesofQMS,"

ISO13485:2016:7.1;

21CFR820.30,820.50,820.80,820.181","reviewprocedures;

reviewproductrealizationdocuments",,,

3,"verifyrequirementshavebeendefinedforsuppliers,contractors,andconsultants;ensuresuppliers,contractors,andconsultantsareselectedonabilitytomeetrequirements","

ISO13485:2016:7.1,7.4.2

21CFR820.50(a)","reviewprocedures;

reviewsupplierrecords",,,

4,"ensurefirmmaintainsrecordsofacceptablesuppliers,contractors,andconsultants","

ISO13485:2016:7.4.1;

21CFR820.50(a)(3)",reviewsupplierrecords,,,

5,"verifythatdatasupportingsupplierrequirementsismaintained;verifythatsuppliers,contractors,andconsultantsagreetonotifyfirmofchangesinproductsand/orservices","

ISO13485:2016:7.4;

21CFR820.40,820.50(a)(3),(b)",reviewrecords,,,

6,"verifyproceduresforidentifyingproductduringallstagesofreceipt,production,distribution,andinstallationareinplace","

ISO13485:2016:7.5.8,7.5.9;

21CFR820.60",reviewprocedures,,,

7,"ensurefirmmaintainsproceduresandrecordsfortraceabilityofeachunit,lot,orbatchoffinisheddevicesandcomponents

NOTE:maynotberequiredforalldevices","

ISO13485:2016:7.5.9;

21CFR820.65","reviewprocedures;

reviewDHRs

",,,

8,selectaprocesstoreview,,"selectioncriteria:

-CAPAindicatorsofprocessissues

-processforhigherriskdevice

-degreeofriskforprocesstocausedevicefailures

-lackoffamiliarityandexperiencewithprocess

-processusedformultipledevices

-varietyinprocesstechnologies

-processesnotcoveredduringpreviousinspections",,,

9,verifyprocessiscontrolledandmonitored,"

ISO13485:2016:7.5,7.6,8.2.5,8.2.6,8.4;

21CFR820.50,820.70(a),802.70(e),820.70(f)-(h),820.72,820.75(b),820.80","reviewspecificprocedures,instructions,drawings,etc.;

mayincludein-processand/orfinisheddeviceacceptanceactivities",,,

10,"verifytheequipmentusedhasbeenadjusted,calibrated,andmaintained","

ISO13485:2016:7.5;

21CFR820.70(g)(3),820.72(a),820.70(g)(1)","reviewequipmentrecords;

reviewprocedures",,,

11,"identifycontrolandoversightactivities;

ensurecontrolofinspection,measuring,testequipment,andcalibration","

ISO13485:2016:7.6,8.4;

21CFR820.50(a)(2),820.72","reviewproduction,equipment,maintenance,&calibrationrecordsrelatedto:

-in-processacceptancecriteria&acceptance

-finisheddeviceacceptancecriteria&acceptance

-environmentalcontrolsystems

-contaminationcontrolsystems",,,

12,"verifyfirmhasestablishedproceduresforproductionandprocesschanges;ensurechangesareverifiedorvalidated,asneeded","

ISO13485:2016:7.3.9,7.5.6;

21CFR820.70(b),820.75(c)",reviewprocedures,,,

13,reviewdevicehistoryrecord(DHR)toidentifyrejectsand/ornon-conformances,"

ISO13485:2016:8.3;

21CFR820.70",reviewDHRs,,,

14,"verifythatdefects,rejects,non-conformances,andremovalofmaterialswerehandledproperly","

ISO13485:2016:8.3;

21CFR820.50,820.70(h),820.90,820.100","reviewmaterialrecords;

reviewDHRs;

determineif

-properlyhandled

-resultofequipmentcalibrationfailures

-resultofequipmentmaintenancefailures

-resultofvalidationfailures",,,

15,ensureprocessesthatcannotbefullyverifiedarevalidated,"

ISO13485:2016:7.5.6;

21CFR820.75(a)","reviewprocedures;

identifyprocessesthatcannotbeverified;

reviewvalidationrecordstoensure:

-alloperatorshavedocumentedqualification

-fullchangecontrolofallprocesses

-calibrationandmaintenanceofallinstruments

-equipmentisproperlyinstalled,adjusted,&maintained

-predeterminedproductspecificationsareestablished

-testsamplingandplansareperformedaccordingtostatisticallyvalidrationale

-processtolerancelimitsarechallenged",,,

16,ensureautomatedorsoftwaredrivenprocessesarevalidatedforintendeduses,"

ISO13485:2016:7.5.6;

21CFR820.70(i)",reviewvalidationrecords,,,

17,verifythatvalidationsaredocumentedandconductedbyqualifiedpersonnel,"ISO13485:2016:7.5.6;

21CFR820.75(b)(1)","reviewprocedures;

reviewvalidationrecords",,,

18,reviewpersonnelrecordstodocumentpersonnelaretrainedpermanufacturingprocessesandawareofpotentialdefects,"

ISO13485:2016:6.2;

21CFR820.20(b)(2),820.25,820.70,820.70(d),820.75(b)(1)",reviewpersonnelrecords,,,

19,"ensurethatmonitoringandcontrolmethods,data,dateperformed,individualsperformingtheprocess,andthemajorequipmentusedisdocumented","

ISO13485:2016:7.1,8.4;

21CFR820.75(b)(2)",reviewvalidationrecords,,,

20,determinelinkagestootherprocesses,"

ISO13485:2016:4.1,4.2;

21CFR820.20,820.25,820.30,820.40,820.72,820.90,820.100,820.180","reviewprocedures;

reviewkeyprocesses",,,

21,ensuretheinfrastructureandworkenvironmentareappropriateandcontrolled,"

ISO13485:2016:6.3,6.4;

21CFR820.70(c),(f),(g)","reviewprocedures;

reviewrecords",,,

22,"confirmthatmaintenanceschedules,routineinspections,andadjustmentstoequipmentoccur","

ISO13485:2016:6.3,7.5.1,7.5.6,7.6;

21CFR820.70(g)","reviewprocedures;

reviewrecords",,,

23,verifyproceduresareinplaceforcontaminationcontrolandcleanliness,"

ISO13485:2016:6.4.2,7.5.2;

21CFR820.70(e)",reviewprocedures,,,

24,determineifverificationofpurchasedproductsisadequate,"

ISO13485:2016:7.4.3,8.4;

21CFR820.50(a)(2),820.80(b)","reviewprocedures;

reviewrecords",,,

25,"ensureproceduresdefinereceiving,in-process,andfinalacceptanceactivities.","

ISO13485:2016:7.5.11,8.4;

21CFR820.80(a)-(d)",reviewprocedures,,,

26,"confirmreceiving,in-process,andfinalacceptanceactivityrecordsexist","

ISO13485:2016:8.4;

21CFR820.80(e)",reviewrecords,,,

27,verifythatproceduresexistandthatacceptancestatusofproductisindicated,"

ISO13485:2016:7.1,8.2.6;

21CFR820.86","reviewacceptancecriteria;

reviewprocedures;

reviewproductidentification",,,

28,"ensureproceduresdefinelabelingactivities,includingintegrity,inspection,storage,operations,andcontrolnumbers","

ISO13485:2016:7.5.11;

21CFR820.120",reviewprocedures,,,

29,"confirmthatproductpackagingandshippingcontainersadequatelyprotectdeviceduringprocessing,storage,handling,shipping,anddistribution","

ISO13485:2016:7.5.11;

21CFR820.130","reviewprocedures;

reviewpackagingandshippingcontainers",,,

30,"verifyproceduresexisttopreventmix-ups,damage,deterioration,contamination,orotheradverseeffectstoproductduringhandling","

ISO13485:2016:7.5.11;

21CFR820.140,820.150",reviewprocedures,,,

31,"verifyproceduresexistforproductdistribution;confirmdistributionrecordsincludenameandaddressofconsignee,identificationandquantityshipped,dateofshipment,andidentificationnumbers","ISO13485:2016:4.2.3,7.1,7.5.8,7.5.9.2,7.5.11;

21CFR820.160","reviewprocedures;

reviewdistributionrecords",,,

32,ensureinstallationandinspectionproceduresexist(ifapplicable);verifyinstallationrecordsaremaintained,"

ISO13485:2016:7.5.3;

21CFR820.170","reviewprocedures;

reviewinstallationrecords",,,

33,ensureservicingproceduresexist(ifapplicable);verifyservicingrecordsaremaintained,"

ISO13485:2016:7.5.4;

21CFR820.200","reviewprocedures;

reviewservicingrecords",,,

34,"verifyfirmidentifies,verifies,protects,andsafeguardscustomerpropertyunderitscare","

ISO13485:2016:7.5.10","reviewprocedures;

identifycustomerproperty",,,

SterilizationProcessControls,,,,,,

1,reviewsterilizationprocessprocedures;verifysterilizationprocessisvalidated,"

ISO13485:2016:7.5.7;

21CFR820.75(a),(c)","reviewprocedures;

reviewvalidationrecordstoensureprocessesareeffectivein:

-obtainingSAL

-productperformancenotadverselyaffected

-packagingnotadverselyaffected",,,

2,"reviewsterilizationcontrolandmonitoringactivities;ensureprocesses,equipment,andcalibrationarecurrent","

ISO13485:2016:7.5.5;

21CFR820.50,820.70(a),(c),(e),(f),(g),(h),820.72,820.75(b),820.80",reviewsterilizationrecords,,,

4,reviewDHRforsterilizationfailures;ensureintegrationwithCAPAsystem,21CFR820.75(b),reviewsterilizationrecords,,,

5,ensuresterilizationfailureswerehandledproperly,"21CFR820.70(g)(3),820.72(a),820.70(g)(1)","reviewsterilizationrecords;

reviewequipmentadjustment,calibration,andmaintenance",,,

6,reviewpersonnelrecordstodocumentpersonnelarequalifiedandtrainedwithimplementedsterilizationactivities,"21CFR820.25,820.70(d),820.75(b)",reviewpersonnelrecords,,,

7,ensureautomatedorsoftwaredrivensterilizationprocessesarecontrolledandvalidated,21CFR820.70(i),reviewvalidationrecords,,,

PurchasingControls(mainsubsystemforvirtualmanufacturers),,,,,,

1,reviewsupplierevaluationprocedures,"

ISO13485:2016:7.4.1;

21CFR820.50",reviewprocedures,,,

2,ensuresuppliersareevaluatedforabilitytomeetspecifiedrequirements,"

ISO13485:2016:7.4.1;

21CFR820.50(a)(1)",reviewprocedures,,,

3,ensureadequacyofspecificationsofmaterialsand/orservicesprovidedbysupplierisconfirmed,"

ISO13485:2016:7.4.2;

21CFR820.50(b)",reviewprocedures,,,

4,"confirmpurchasinginformationidentifiesrequirementsforapprovalofproduct,procedures,processes,andequipment,requirementsforpersonnelqualification,andQMSrequirements","

ISO13485:2016:7.4.2;

21CFR820.50","reviewpurchasingrecords;

reviewprocedures",,,

5,verifysupplierevaluationrecordsaremaintained,"

ISO13485:2016:7.4.1;

21CFR820.50(a)(3)","reviewprocedures;

reviewsupplierevaluationrecords",,,

6,determinethatverificationandacceptanceofpurchasedmaterialsand/orservicesisadequate,"

ISO13485:2016:7.4.3;

21CFR820.50(a)(2),820.80(a),820.80(b)","reviewprocedures;

reviewacceptancerecords",,,

Documentation&Records,,,,,,

1,"reviewproceduresforidentification,storage,protection,retrieval,retentiontime,control,approval,distribution,disposition,andchangesofdocumentsandrecords","

ISO13485:2016:4.2.4,4.2.5;

21CFR820.40,820.180",reviewprocedures,,,

2,ensuredocumentsandchangesareapprovedpriortouse,"

ISO13485:2016:4.2.4;

21CFR820.40","reviewprocedures;

reviewdocumentsandrecords;

reviewchangemanagementrecords",,,

3,verifydocumentsandrecordsarelegibleandidentifiable,"

ISO13485:2016:4.2.4(e),4.2.5",reviewdocumentsandrecords,,,

4,ensuredocumentsofexternaloriginareidentifiedwithcontrolleddistribution,"

ISO13485:2016:4.2.4(f)",reviewexternaldocumentsandrecords,,,

5,verifyfirmmaintainsaqualitysy