Marking Systems, Inc.

MS Die Cut, LLC

T-Shirt Tycoon Solutions, Inc.

Quality Manual

2601 Market St.

Garland TX 75041

Tel. 972-475 0770

Fax. 972-412 0791

Revision

May19,2016

Createdby:

JoeSofinowski

Approvedby:

MihaiBorcoman

Signature:

MarkingSystems,Inc.ISO9001:2015QualityManual

Revisionhistory
Date

Editedby

Descriptionofchange

5/19/2016

JoeSofinowski OriginalDocumentRelease

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MarkingSystems,Inc.ISO9001:2015QualityManual

Tableofcontents
1.

ABOUTTHEORGANIZATION..................................................................................................................4
1.1.
ORGANIZATIONALSTRUCTURE.......................................................................................................................4
2. PURPOSE,SCOPEANDUSERS................................................................................................................4
2.1.
EXCLUSIONS..............................................................................................................................................4
3. TERMSANDDEFINITIONS......................................................................................................................4
4. CONTEXTOFTHEORGANIZATION..........................................................................................................4
4.1.
UNDERSTANDINGTHEORGANIZATIONANDITSCONTEXT.....................................................................................4
4.2.
UNDERSTANDINGTHENEEDSANDEXPECTATIONSOFINTERESTEDPARTIES..............................................................5
4.3.
DETERMININGTHESCOPEOFTHEQUALITYMANAGEMENTSYSTEM......................................................................5
4.4.
QUALITYMANAGEMENTSYSTEMANDITSPROCESSES........................................................................................5
5. LEADERSHIP..........................................................................................................................................6
5.1.
LEADERSHIPANDCOMMITMENT....................................................................................................................6
5.1.1.
General..........................................................................................................................................6
5.1.2.
Customerfocus.............................................................................................................................6
5.2.
QUALITYPOLICY.........................................................................................................................................6
5.3.
ORGANIZATIONALROLESANDRESPONSIBILITIES................................................................................................6
6. PLANNING.............................................................................................................................................7
6.1.
ACTIONSTOADDRESSRISKSANDOPPORTUNITIES..............................................................................................7
6.2.
QUALITYOBJECTIVESANDPLANNINGTOACHIEVETHEM.....................................................................................7
6.3.
PLANNINGCHANGES...................................................................................................................................7
7. RESOURCES...........................................................................................................................................7
7.1.
RESOURCES...............................................................................................................................................7
7.2.
COMPETENCE............................................................................................................................................8
7.3.
AWARENESS..............................................................................................................................................8
7.4.
COMMUNICATION......................................................................................................................................8
7.5.
DOCUMENTEDINFORMATION.......................................................................................................................8
8. OPERATION...........................................................................................................................................9
8.1.
ORGANIZATIONALPLANNINGANDCONTROL.....................................................................................................9
8.2.
REQUIREMENTSFORPRODUCTS.....................................................................................................................9
8.3.
DESIGNANDDEVELOPMENTOFPRODUCTS......................................................................................................9
8.4.
CONTROLOFEXTERNALLYPROVIDEDPROCESSES,PRODUCTSANDSERVICES............................................................9
8.5.
PRODUCTIONPROVISION..............................................................................................................................9
8.6.
RELEASEOFPRODUCTS................................................................................................................................9
8.7.
CONTROLOFNONCONFORMINGOUTPUTS.......................................................................................................9
9. PERFORMANCEEVALUATION..............................................................................................................10
9.1.
MONITORING,MEASUREMENT,ANALYSISANDEVALUATION..............................................................................10
9.1.1.
General........................................................................................................................................10
9.1.2.
Customersatisfaction.................................................................................................................10
9.1.3.
Analysisandevaluation..............................................................................................................10
9.2.
INTERNALAUDIT.......................................................................................................................................10
9.3.
MANAGEMENTREVIEW.............................................................................................................................10
10.
IMPROVEMENT...............................................................................................................................11
10.1. GENERAL................................................................................................................................................11
10.2. NONCONFORMITYANDCORRECTIVEACTION..................................................................................................11
10.3. CONTINUALIMPROVEMENT........................................................................................................................11

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1. Abouttheorganization
1.1.

Organizationalstructure

Ownership
Team

SalesandCS
Departments

Production
Departments

Shipping&
ReceivingDept.

Accounting
Dept.

Figure1:Organizationalchart

2. Purpose,scopeandusers
TheQualityManualdocumentsthemanagementsystemofMarkingSystems,Inc.,TTycoonSolutions,
Inc.andMSDieCut,LLC(referredhereinandinotherdocumentsasMSI)anddemonstratesthe
capabilityofMSItocontinuouslyprovideproductsthataddresscustomerrequirements.

2.1.

Exclusions

MSIhasnoexclusionofISO9001:2015.

3. Termsanddefinitions
ForthepurposeofthisQualityManual,MSIreferencesthetermsanddefinitionslistedintheISO
9000:2015QMSFundamentalsandVocabularydocument.
The2015revisionofthisdocumentapplies.

4. Contextoftheorganization
4.1.

Understandingtheorganizationanditscontext

MSIconsidersthecontextoftheorganizationaccordingtoContextoftheOrganizationandInterested
Parties.

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4.2.

Understandingtheneedsandexpectationsofinterestedparties

MSIhasdeterminedtheinterestedparties,theirneedsandexpectationsandlistedtheminInterested
Parties.

4.3.

DeterminingthescopeoftheQualityManagementSystem

MSIhasdeterminedtheboundariesandapplicabilityoftheQualityManagementSystemintheScopeof
QualityManagementSystem.

4.4.

QualityManagementSystemanditsprocesses

MSIhasestablishedandimplementedtheQMS,whichismaintainedandcontinuallyimprovedaccording
totherequirementsoftheISO9001:2015standardincludingprocessesneededandtheirinteractions.
MSIdeterminedtheprocessesneededfortheQMSandtheirapplicationthroughtheorganization.
MSIdeterminedrequiredinputsanddesiredoutputsoftheprocesses,criteriaandmethodsneededfor
effectiveoperationandcontroloftheseprocesses,aswellasresourcesneededandresponsibilitiesand
authoritiesforprocessesintheQMSCrossReference.Sequencesandinteractionsbetweenthe
processesaredescribedinFigure2:ProcessMap.
Duringmanagementreview,topmanagementofMSIevaluatesprocessesandmakeschangesneededin
ordertoensurethattheprocessesachieveintendedresultsandimproveprocessesandtheQMS.
Figure2:ProcessMap

QMS
MANAGINGPROCESSES
Measurement,
analysisand
improvement

Resource
Management

BASICANDSUPPORTINGPROCESSES

Sales/CS

Designand
Development
(ifnecessary)

Purchasing

Production

Shipping

Customersatisfaction

Customerrequirements

Management
Responsibility

OUTSOURCEDPROCESSES
Printing,
embossing

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5. Leadership
5.1.

Leadershipandcommitment

5.1.1. General
TopmanagementofMSIistakingaccountabilityfortheeffectivenessoftheQMSandproviding
resourcestoensurethattheQualityPolicyandQualityObjectivesarecompatiblewiththestrategic
directionandthecontextoftheorganization.
TopmanagementensuresthatQMSrequirementsareintegratedintoMSIsbusinessprocesses,andthat
theQMSisachievingtheintendedresults.
TopmanagementcommunicatestheimportanceofaneffectiveQMS,promotescontinualimprovement,
aprocessapproach,andriskbasedthinking,andsupportsrelevantmanagementrolestodemonstrate
leadershiptotheirareasofresponsibility.
5.1.2. Customerfocus
TopmanagementofMSIdemonstratesleadershipandcommitmentwithrespecttocustomerfocus
throughensuring:

5.2.

thatcustomerandstatutoryandregulatoryrequirementsaredefined,understood,and
consistentlymet
therisksandopportunitiesthatcanaffectconformityofproductsandtheabilitytoenhance
customersatisfactionaredeterminedandaddressed
thefocusonenhancingcustomersatisfactionismaintained

QualityPolicy

MSIhasdefinedtheQualityPolicyandQualityObjectivesasaseparatedocumentandmadeitavailable
toemployeesandthepublic.
ThisPolicyrepresentstheframeworkforplanningandimprovingtheQMS,andsettinggeneraland
specificqualityobjectives.

5.3.

Organizationalrolesandresponsibilities

Responsibilitiesandauthoritiesforrelevantrolesareassignedbytopmanagementandcommunicated
withinMSI.TopmanagementassignsrolesandresponsibilitiesforensuringthattheQMSconformsto
ISO9001:2015andreportingontheperformanceoftheQMS,includingtheQMSperformance,totop
management.

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6. Planning
6.1.

Actionstoaddressrisksandopportunities

WhileplanningtheQMS,MSIconsidersthecontextoftheorganization,needsandexpectationsof
interestedparties,andthescopeoftheQMS.
MSIdeterminesrisksandopportunitiesrelatedtotheabilitytogiveassurancethattheQMScanachieve
intendedresults,enhancedesirableresults,preventorreduceundesiredeffects,iscompatiblewiththe
contextoftheorganization,andcanachievecontinualimprovement.
RisksandopportunitiesrelatedtotheQMSareaddressedaccordingtotheProcedureforAddressing
RisksandOpportunities.

6.2.

Qualityobjectivesandplanningtoachievethem

TheOperationsManagercontinuouslydefinesmeasurableandtimedqualityobjectivesfortherelevant
functionsandlevelswithintheorganization.TheobjectivesaremonitoredbytheQualityManagerinthe
contextofmonitoringandmeasurementandmanagementreview.
QualityobjectivesareconsistentwiththeQualityPolicyandprescribedtoalllevelsandfunctionsinMSI,
takingintoaccountapplicablerequirements,relevancetoconformityofproducts,andenhancementof
customersatisfaction.
RealizationoftheobjectiveresultsisregularlyreviewedbytheQualityManagerinordertomonitor
realizationandtoincludenewormodifiedsituationsduringregularproductionmanagerand
managementreviewmeetingsataminimum.

6.3.

Planningchanges

WhentheorganizationdeterminesaneedforchangestotheQualityManagementSystem,theQuality
Managertakesresponsibilitytocarrythemoutinaplannedmanner.
TheQualityManagerplanschangestotheQMSconsideringthepurposeofthechanges&potential
consequences,integrityoftheQMSandallocationorrelocationofresponsibilities&authorities.

7. Resources
7.1.

Resources

MSIdeterminesandprovidesresourcesneededforestablishment,implementation,maintenance,and
continualimprovementoftheQualityManagementSystem.

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7.2.

Competence

MSIprovidesthenecessarystaffwiththeneededknowledgeandskills,organizationalinfrastructure,and
financialresourcesforestablishing,implementation,maintenance,andimprovementoftheQMS.
Incaseswhereitisdeemednecessaryandjustified,MSIwillhirecompetentexternalpersonneland
organizationsfromrelevantfieldsforrealizationofactivitiesforwhichtheorganizationdoesnothave
adequateresources.
Managersareresponsibleforidentifyingtheneedsandconductingprofessionaltrainingofemployees
whocarryoutactivitiesthatmayhaveasignificantimpactonthequalityofproductandcustomer
satisfaction.
Eachdepartmentmanager/processownerisresponsibleforthesuitablecompetencyofhisworkers,on
thebasisofeducation,training,and/orworkexperience,inaccordancewiththerequirementsoftheir
work.
Themethodofensuringthenecessarycompetenciesforroles,responsibilities,andauthoritiesfor
implementationandcontrolactivitieswithintheQMSwasestablishedinaccordancewiththe
Competence,TrainingandAwarenessprocedure.Recordsofcompletedtrainingandtraining
effectivenessarekeptbytheofficemanager.

7.3.

Awareness

MSIensuresthatpersonsdoingworkunderitscontrolareawareoftheQualityPolicy,relevantQuality
Objectives,theircontributiontotheeffectivenessoftheQMS,andimplicationsofnonconformancewith
theQMSrequirements.

7.4.

Communication

TopManagementisresponsiblefordetermininginternalandexternalcommunicationsrelevanttothe
QMS,includingsubject,timing,methodofcommunication,aswellaswhoandwithwhomwill
communicate.

7.5.

Documentedinformation

DocumentedinformationoftheQualityManagementSystemiscarriedoutthroughthefollowing
documents:

QualityPolicyandQualityObjectives
QualityManual
ControlofDocuments
Documents,includingrecords,requiredbyISO9001,arelistedintheControlledDocuments
QualityRecordsLog.

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Documents,includingrecords,whichMSIhasdeterminedtobenecessary,arealsolistedinthe
ControlledDocumentsQualityRecordsLog.

8. Operation
8.1.

Organizationalplanningandcontrol

TheOperationsManagersareresponsibleforplanninganddevelopingprocessesneededforproduct
realizationaccordingtotheMSI/MSDCustomerRequirementsandProductionPlanningProcess
FlowchartandTTycoonCustomerRequirementsandProductionPlanningProcessFlowChart

8.2.

Requirementsforproductsandservices

Communicationwithcustomers,theprocessofdeterminingandreviewingtherequirementsrelatedto
productsandchangestorequirementsforproductsaredefinedintheMSIMSDCustomerRequirements
andProductionPlanningProcessFlowchartandtheTTycoonCustomerRequirementsandProduction
PlanningProcessFlowChart.

8.3.

Designanddevelopmentofproducts

TheCreativeDirectorappointspersonsresponsibleforplanning,realization,andmanagementof
productdesignanddevelopmentandprojectmanagementaccordingtotheTTYDesignand
DevelopmentWorkInstructions.

8.4.

Controlofexternallyprovidedprocesses,productsandservices

Bydocumentinganadequatemethodforevaluationandselectionofsuppliers,MSIensuresthat
deliveredproductiscompliantwithspecifiedpurchasingrequestsaccordingtotheProcedurefor
PurchasingandEvaluationofSuppliers.

8.5.

Productionandserviceprovision

MSIdefinesactivitiesofplanningandexecutingtheproductandservicerealizationprocessunder
controlledconditions,inordertoensurefullcapabilityoftheprocessandtopreventnonconformity
occurrence.Atthesametime,allnecessaryresourcesforexecutionoftheseprocessesareprovided
accordingtotheproductiondepartmentflowcharts.

8.6.

Releaseofproductsandservices

Theorganizationhasimplementedplannedarrangements,atappropriatestages,toverifythatthe
productandservicerequirementsaremet,accordingtotheProcedureforReleaseofProductsand
ProcedureforVMI.

8.7.

Controlofnonconformingoutputs

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Theorganizationensuresthatoutputsthatdonotconformtotheirrequirementsareidentifiedand
controlledtopreventtheirunintendeduseordelivery,accordingtotheProcedureforevaluatingnon
conformingproductmaterialanddocumentingCARs.

9. Performanceevaluation
9.1.

Monitoring,measurement,analysisandevaluation

9.1.1. General
Theownershipteams,OperationsManagersandprocessownersinMSIdefinewhatwillbemonitored
andmeasured,aswellasthemethodsandtimingformonitoringandmeasuring.Resultsofthe
monitoringandmeasuringwillbeevaluatedatappropriatelevelsandfunctionsintheorganizationand
thetoplevelmanagementwillevaluatetheperformanceoftheQMSduringthemanagementreview.
9.1.2. Customersatisfaction
MSImonitorscustomersperceptionsofthedegreetowhichtheirneedsandexpectationshavebeen
fulfilledaccordingtotheProcedureforMeasuringCustomerSatisfaction.
9.1.3. Analysisandevaluation
MSIanalyzesandevaluatesappropriatedataandinformationarisingfrommonitoringand
measurement.
Theresultsoftheanalysisareusedtoevaluate:

9.2.

conformityofproducts;
thedegreeofcustomersatisfaction;
theperformanceandeffectivenessoftheQualityManagementSystem;
ifplanninghasbeenimplementedeffectively;
theeffectivenessofactionstakentoaddressrisksandopportunities;
theperformanceofexternalproviders;
theneedforimprovementstotheQualityManagementSystem.

Internalaudit

MSIconductsinternalauditsatplannedintervalstodemonstrateconformanceandeffectivenessofthe
QualityManagementSystemaccordingtotheInternalAuditProcedure.

9.3.

Managementreview

TopManagementofMSIconductsregularreviewsoftheQMS,approximatelyeverythreemonths,
accordingtotheProcedureforManagementReview.

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10.Improvement
10.1. General
MSIdeterminesandselectsopportunitiesforimprovementandimplementsanynecessaryactionsto
meetcustomerrequirementsandenhancecustomersatisfaction.
Theseinclude:

improvingproductstomeetrequirements,aswellastoaddressfutureneedsandexpectations;
correcting,preventing,orreducingundesiredeffects;
improvingtheperformanceandeffectivenessoftheQualityManagementSystem.

10.2. Nonconformityandcorrectiveaction
MSIhandlesnonconformitiesinordertocontrolandcorrectthemanddealwiththeconsequences,
accordingtotheProcedureforevaluatingnonconformingproductmaterialanddocumentingCARs.
MSIhasestablishedacorrectiveactionsystemtoinvestigateanddocumenttherootcauseandactions
tocorrectsupplier,internal,andcustomerreportednonconformities.Correctiveactionsareassignedto
aresponsibleindividualandtrackedbynumberandcompletiondateaccordingtotheProcedurefor
evaluatingnonconformingproductmaterialanddocumentingCARs.

10.3. Continualimprovement
MSIcontinuallyimprovesthesuitability,adequacy,andeffectivenessoftheQualityManagement
System.
Theorganizationconsiderstheresultsofanalysisandevaluation,andtheoutputsfrommanagement
review,todetermineifthereareneedsoropportunitiestobeaddressedaspartofcontinual
improvement.Projects,projectstatusandresponsibilitiesarerecordedintheContinualImprovement
ProjectLog.

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