Ebook On How To Implement An ISO 9001 QMS

Implementing an ISO 9001
Quality Management System
ETI Group
ThisguidetoimplementinganISO
9001QualityManagementSystem
(QMS)waspreparedbyETIGroup.
Theguideisbasedonour
experiencesassistingmorethan
650small,mediumandlarge
companiesthroughthecomplete
implementationprocessfromstart
tosuccessfulregistration.
CopyrightETIGroup2014
Page1
ETI Group
ThoughtforToday
Qualitymanagementsucceedswhen
thecostofthesystemislessthan
thecostofdefectsandpoorservice
whichwouldotherwiseresult.
PROFIT = INCOME - EXPENSES
Page2
TABLE OF CONTENTS
SubjectHeading
Page#
Introduction
ManagingChange
WhatisaQualityManagementSystem?
10
WhyImplementaQualityManagementSystem?
16
TheISO9001Standard
18
15StepstoImplementISO9001
28
Page3
Introduction
Formoreandmorecompanies,implementingaQualityManagement
System(QMS)basedonISO9001oroneoftherelatedstandardssuchas
AS9100,ISO13485orISO/TS16949isbecominganecessity!Itcanhelp
winnewcustomersaswellasretainexistingones.Whilethegoalisto
achieveregistrationtooneofthesestandards,itisnottheonlygoal.The
internalbenefitsofimplementinganeffectiveQMSaresignificant.
ThisebookisintendedtobeaguidetoimplementinganISO9001
QualityManagementSysteminanyorganization.Asthesizeandnature
oforganizationsvary,wemaynotcoverallofthecircumstancesunique
toyourcompany.WedohoweverdetailthetypicalprocessthatETI
GroupconsultantsusewhenassistingacompanytoimplementanISO
9001QualityManagementSystem(QMS).
Page4
Introduction
ImplementingaQMSmayseemdaunting,especiallyforthesmaller
business,fortunatelythestandardsareflexible,theymandate
requirementsforanorganizationtofollowbutallowyoutofulfillthe
requirementsinawaythatmakessenseforyourbusiness.Thisallowsa
widerangeofcompanies,bothlargeandsmall,manufacturingand
servicetocreateaQMSthatmeetsthespecificneedsoftheirbusiness
aswellastherequirementsoftheappropriatestandard.
TheISO9001frameworkalsoprovidesanexcellentandpracticalmodel
fromwhichtoimplementtheadditionalrequirementsforanAS9100,
ISO13485orISO/TS16949QualityManagementSystem.
Page5
Introduction
Everyorganizationhasmanagementproceduresandinstructionsfor
creatinganddeliveringtheirproductsandservicestocustomers.Most
haveevolvedovertheyears,andaregenerallyadequate ifthey
werent,organizationswouldquicklygooutofbusiness.
Howeverpoormanagementsystemscanleadtowastefulprocesses,
poorproductsandservices,anddissatisfiedcustomers.Anefficient
organizationcantypicallybecharacterizedby:
Explicitawarenessof,and
concernfor,theneedsof
customersandother
stakeholders(suppliers,
employees,society,etc.),
Seniorandmiddlemanagers
whounderstandandfocuson
businessneeds,
Acommitmenttoimproveproductsandservices,
Employeedevelopmentandtrainingprogramsthatmeettheneedsof
theorganization,
Processesdesignedtoidentifyandreducewastedresources,
Complete,current,clearandrelevantdocumentation.
OrganizationsareincreasinglyintroducingformalQualityManagement
Systems(QMS)togaintheseandotherbenefits.
Page6
Managing Change
Thegreatestresourceacompanyhasisitspeople,inevitablytherewill
beresistancetochangeswhenimplementingandmaintainingyour
QualityManagementSystem(QMS).
Theoldway
TransitionZone
Thenewway
Peoplefeeldoneto
Newwayfeelschaotic
Peopledonthearthings
Oldanimositiesmaysurface
Newopportunitiesareidentified
Productivitymaytemporarilydecline
Resistancehasmanyfacesincludingdenial,lackofmotivationand
questioningofthemotivationbehindthedecisiontoimplementa
QMS.Strategiesformanagingchangeshouldbeaddressedduring
implementationplanning.
Page7
Managing Change
ThejourneyfromapreQMSorganizationtoonethatoperateswiththe
qualityandcontrolsnecessaryforcertificationisnotacasualtaskandis
unlikelytosucceedwithoutthecommitmentanddedicatedsupportof
topmanagement.
ForManagement
Forthepeopleaffected
changeis
changeis
Planned
Outoftheircontrol
Gradual
Sudden
ASolution
Problematic
Logical
Arbitrary
Opportunistic
Disruptive
Intentional
Disruptive
Somecommonformsofresistanceandsuggestedsolutionsare
detailedonthefollowingpage.
Page8
Managing Change
CommonFormsofResistance
CommonComplaint
RootCause
ProvenSolution
Thisisjustanother
flavorofthemonth.
Pastinitiativeshave Demonstrateleadershipbelief
beenlaunchedwith Selectbestpeopleastrainers
highfanfareandlittle Minimizefanfare
results
Idonthave
timecannotfreeup
resources.
Toomanyprojects/
activitiesinprocess
Thiscantworkinmy
areaofthebusiness.
Misconceptionabout ISO9001hasbeensuccessfully
implementedineverybusiness
howaQuality
ManagementSystem sector.
Showexamplesfromother
worksorlackof
similarcompaniesthatareISO
informationabout
howitapplies
9001registered.
Stopotherinitiativesnotrelated
tocurrentprioritiesorthatonly
makeaminorcontribution.
Howisthisdifferent
Fatiguefrommany
frompastimprovement improvement
initiatives?
initiatives
Explain/showkeydifferences.
Isthisincrementalto
myexistingbusiness
plan?
Dontwanttoaddto
existingworkload
AlignISO9001implementation
worktodirectlysupportthe
existingbusinessplan
Doesmanagement
reallybelieve/support
it?
Lackofconfidence
thateveryoneison
board
Genuineleadership
commitmenttoimplementation
isrequired notjusttalk.
Page9
What is a Quality
Management System?
DevelopedbytheInternationalOrganizationforStandardization,ISO9001
comprisesasetofrequirementsthatreflecttimeproven,universally
acceptedgoodbusinesspractices,themajorityofwhicharemandatory.
AS9100,ISO13485andISO/TS16949standardsutilizetheISO9001
frameworkandhaveadditionalindustryspecificrequirements.
Acommonsensewayof
ORGANIZINGTHE
BUSINESSPROCESSES
thataffectthequality
ofyourproductsandservices
TheaimofaQMSisto
assurethatanorganization
consistentlymeetscustomer
needsbycontrollingthecore
processesthataffectthem
suchassalesorders,design,
production,inspection,
delivery,etc.
Therequirementsalsogobeyondthese"core"processestoaddress
supportprocesseslikepurchasing,training,calibration,maintenance,and
performancemetrics.
Page10
What is a Quality
Management System?
AProcessApproach
AnimportantaspectofaQMSisitsprocessorientedapproach.Insteadof
lookingatdepartmentsandindividualprocesses,itrequiresanorganization
tolookathowprocessesinteractandintegratewitheachother.
Bottomline: AQMSismuchmorethanacomprehensivesetofrules.It
willhelpyoumanageyourbusinessmoreeffectivelyandimprovethe
performanceofyourorganizationonanongoingbasis.
Page11
What is a Quality
Management System?
AQMSwillhelpyoumanageyourbusinessmoreeffectivelyand
improvetheperformanceofyourorganizationonanongoingbasis.
Saywhatyoulldo!
Dowhatyousay!
ProveIt!
ImproveIt!
Basically,ISO9001requirementsfall
underfourmajorcategories:
Requirementsthathelpassure
thattheorganizationsproducts
and/orservicesmeetcustomer
specifications.
Requirementsthatassurethe
QMSisconsistentlyimplemented
andverifiable.
Requirementsformeasuringtheeffectivenessofthevarious
componentsofthesystem.
Requirementsthatsupportthecontinualimprovementofthe
companysabilitytomeetcustomerneeds.
Page12
What is a Quality
Management System?
ThegeneralcomponentsofaQualityManagementSystem(QMS),as
definedbyISOTechnicalCommittee,TC176,areasfollows:
CustomerFocus:Customersneedsandexpectationsneedtobe
identifiedandachieved.
Leadership:TopManagementmustshowtheircommitmenttotheQMS
byleading,communicatingandunitingeveryoneintheorganizationto
achievethecompanysdesiredgoalsandbyprovidingtheresources
necessarytoaccomplishthem.
Involvementofpeople:Irrespectiveoftheirpositioninthecompany
everyoneisinvolvedintheQMS.
Process Approach: Allactivitiesinthecompanyaretreatedasaprocess.
Thiswillprovideforasystematicdefinitionofactivitiesinordertomeet
thestatedgoalsandidentifytheresourcesrequiredtomeetthosegoals.
SystemsApproachtoManagement:Requiresidentifyingallofthe
processesinthecompanyandtheirinterdependenceandthen
managingtheseprocessesasacompletesystem.
ContinualImprovement:ContinualImprovementofthecompanyisa
neverendingprocessinvolvingestablishinggoalsandmeasuring
progresstowardsachievingthosegoals.
FactualApproachtoDecisionMaking:Thisisthemethodofcollecting
andanalyzingdataandthenusingittomakesounddecisionsonwhat
pathtotake.
Page13
What is a Quality
Management System?
QualityManagementSystemRequirements
ToachieveISO9001certificationyourcompanymustestablish,
documentandimplementaQMSandmaintainitseffectivenessin
accordancewiththestandard.Controlleddocumentsaretypically
organizedandwrittenaccordingtoahierarchyshownbelow.
Quality
Manual
Procedures
(Business Processes)
Work Instructions
Records
ISO 9001 Documentation Pyramid

QualityManualaddresseseachareaofthestandardwithastatement
explaininghowtheorganizationmaintainscompliancetorequirements.
Procedures arehighleveldocumentsthatdetailhowtheorganizations
processesaredesignedandcontrolled.
WorkInstructionsareveryspecificanddetailallnecessaryinstructions
requiredforperformingaspecifictask.
Records mustbemaintainedtoshowcompliancetoqualitysystem
requirements.
Page14
What is a Quality
Management System?
Documents
QualitySystemdocumentsshoulddetailprocessesandproceduresto
ensuretheymeettherequirementsofthestandard.Thiswillensure
that:
Employeesperformthesametask,thesameway,everytime
Informationisrecordedinthesameway,everytime
Newemployeesaretrainedtoaconsistentstandard.
Everyone!
Everywhere!
EveryTime!
ControlledDocuments
Documentsmustbecontrolledtoensureonlythecurrentversionis
availabletoemployeeswhileperformingtheirduties.Aprocedureis
requiredtodetailthemanagementofallcontrolleddocuments.
Page15
Why Implement a Quality

Management System?
InternalBenefits
QualityManagementSystemregistrationwillhelpyouwinnew
customersandretainexistingones.Whilethegoalistoachieve
registration,itisnottheonlygoal.Theinternalbenefitsofaneffective
systemaresignificant:
Anunderstandingthatqualityisnotjusttheresponsibilityofthe
qualitydepartment,itseveryone'sresponsibility.
Documentedproceduresandworkinstructionsformthebasisfor
repetitionandbecomethewaywedobusiness.
Lessdependencyonkeyindividuals,responsibilityand
accountabilityforkeytasksaredistributedacrosstheworkforce.
Monitoringandmeasuringofkeyqualityperformanceindicators
improvesmanagementoversight.
InternalAuditshelpidentifyproblemsthatcouldimpactcustomer
satisfactionand/oroperationalefficiency.
AformalCorrectiveandPreventativeActionsystemensures
permanentsolutionstoproblemsaredevelopedandimplemented.
Operationstransformedfromdetectionmodetoaprevention
mode.Preventiontakesalotlessworkandisfarlessexpensive
thandetection.
Increasedprofitabilityasproductivityimprovesandreworkcosts
arereduced.
Page16
Why Implement a Quality

Management System?
ResultsofasurveyofISO9001RegisteredCompanies,
QualitySystemsUpdateMagazine
CustomerSatisfaction
Ontimedeliveryincreased20%
ImprovedOperations
89%reportgreateroperationalefficiency
48%reportincreasedprofitability
76%reportmarketingbenefits
26%reportimprovedexportsales
ResultsofasurveyofISO9001RegisteredCompaniesinThe
UnitedKingdomconductedbyLloydsRegisterQualityAssurance
90
80
70
60
50
40
30
20
10
0
Greater
Improved Improved
Reduced Improved
Management Efficiency/ Consistency Waste Customer
Control Productivity Across Sites
Service
Reduced
Costs
Reduced
Employee
Turnover
Other
Page17
The ISO 9001 Standard

Goal=DevelopConsistent,ReliableProcesses
Improvement of Quality
4 Continual
Management System
C
U
S
T
O
M
E
R
S
A
T
I
S
F
A
C
T
I
O
N
5 Management
responsibility
R
E
Q
U
I
R
E
M
E
N
T
S
8 Measurement,
analysis,
Resource
6 management
Input
improvement
Product
7 realization
Product
C
U
S
T
O
M
E
R
Output
ModelofaprocessbasedQualityManagementSystem
Areliableprocessproducesaconsistent,predictableoutcome,andis:
Consciouslydeveloped:Factsanddataarecollected,themethodis
thoughtaboutbyparticipants,debated,andagreedto,beforethe
methodisimplemented.
Explicitlyestablished:Themethodiscarefullydocumentedin
sufficientdetailforthepurposesneeded.Everyattemptismadeto
makethemethoderrorproof.
Consistentlyfollowed:Everyonefollowsthemethodasdocumented!
Currentlybelievedtobebestway:Themethodisuseduntil
someonethinksofabetterway.
Page18

4 QualityManagementSystem
4.1GeneralRequirements
DescribeshowyourQMSistobeestablished
ProvidesrulesforallprocessesintheQMS
4.2DocumentationRequirements
DescribesinformationstructureofyourQMS
Shouldthinkintermsofinformation
managementandcontrolrather
thandocumentmanagement
5 ManagementResponsibility
5.1
ManagementCommitment
5.2
CustomerFocus
5.3
QualityPolicy
5.4
Planning
5.5
Responsibility,Authority&
Communication
5.6
ManagementReview
Implication
Thissystembelongsto
management!
Strongemphasison
responsibilities of
management!
Page19

6 ResourceManagement
6.1
ProvisionofResources
Determine&provideresourcesneeded
6.2
Implement&maintain&
ContinuallyimproveQMS
Enhancecustomersatisfaction
HumanResources
Provide&Manage
ResourcesNeededto
MeetCustomers
Requirements
Assignmentofpersonnel
Competence,training,andawareness
6.3
Infrastructure buildings,utilities,equipment,transport,IT
6.4
WorkEnvironment temperature,humidity,lighting,
cleanliness,ESDprotection,etc.
7 ProductRealization
Customer
Policies,Plans,Resources
Customer
Related
Processes
Design
and
Development
7.2
7.3
Purchasing
7.4
Customer
Production
AndService
Provision
7.5
ControlofMonitoring&MeasuringEquipment 7.6
PlanningofProductRealization 7.1
Sequenceofprocesses&subprocessesneededtoproducetheproduct
Strongemphasisonsequenceofprocesses&interactions
Page20

7.1
PlanningofProductRealization
Documentedinasuitableform(QualityPlanoruseofestablishedQMS)
Determine:
Qualityobjectivesforproduct,projectorcontract
Specificresource&processneedsforproduct
Verification,validation,monitoring,measurement,inspectionand
testactivitiesneeded(includingacceptancecriteria)
Recordrequirements
Planningforeachproduct,projectorcontractmustbedone
7.2
CustomerRelatedProcesses
7.2.1
Determinationofrequirementsrelatedtotheproduct
Whatisit?
7.2.2
Reviewofrequirements Canwedoit?Isthereachange?
7.2.3
CustomerCommunication questions,ordersandchanges,
feedback,complaints
Page21

7.3
DesignandDevelopment
7.3.1
Planning projectplanwithdesignstages,tasks,
responsibilities
7.3.2
Inputsthedesignrequirements
7.3.3
Outputs thedocumenteddesign,theproductspecification
7.3.4
Review checkingoutputagainstinputforeachstage
7.3.5
Verification makingsurethedesignwillmeetrequirements
7.3.6
Validation makingsuretheproductwillmeetrequirements
7.3.7
ControlofChanges ensurechangesareidentified,
evaluated,controlledandrecorded
7.4
Purchasing
7.4.1
PurchasingProcess Select&managesuppliers
7.4.2
PurchasingInformation Specifyrequirementsforwhatyou
wanttobuy
7.4.3
VerificationofPurchasedProduct Toinspectornotto
inspect?
Page22

7.5
ProductionandServiceProvision
7.5.1
ControlofProductionandServiceProvision
Infothatdescribestheproduct
WorkInstructionsasneeded
Suitableequipment
Availabilityanduseofmonitoring&measuringequipment
Inspectionsandtests
Release,deliveryandpostdeliveryactivities
7.5.2
ValidationofProcessesforProductionandServiceProvision
specialprocesses
7.5.3
IdentificationandTraceability ID,pass/failstatus,uniqueIDas
required
7.5.4
CustomerProperty safeguardcustomersuppliedproduct,
equipment,software,intellectualproperty,personaldata
7.5.5
PreservationofProduct protectproductfromstarttofinish
Page23

7.6
ControlofMonitoringandMeasurementEquipment
A.K.A.Calibration
Calibratedorverifiedatspecifiedintervals,orpriortouse,
againsttraceablemeasurementstandards
Identifiedtoenablestatustobedetermined
Recordcalibration/verificationresults
Assess&recordvalidityofpriorresultsifdevicesarefoundto
notconformtorequirements takecorrectiveactionon
equipmentandaffectedproduct
8 Measurement,AnalysisandImprovement
8.1
General Plan&determinemethods(statisticaltechniques)
andextentofuse
10 0
8.2
Monitoring&Measurement
8.3
ControlofNonconformingProduct
8.4
AnalysisofData
8.5
Improvement
80
60
40
20
0
J
10 0
80
60
40
20
0
J
Page24

8.2
Monitoring&Measurement
8.2.1
CustomerSatisfaction monitorperceptionofquality
8.2.2
InternalAudit atool forevaluatinginternalcompliance

Auditsmustbeplannedandrecorded,
objectiveandimpartial,with
timelyCorrectiveActiontakenbyManagementand
followuptoverifyactionstaken.
Resultsmustbereported.
8.2.3
8.2.4
Monitoring&MeasurementofProcesses
Abilitytomeetperformanceobjectives
Maintaincapabilityandimproveifneeded
Monitoring&MeasurementofProduct
Verifyrequirementsaremet
Resultsrecorded
Recordauthorityresponsibleforreleasetocustomer
Page25

8.3
ControlofnonconformingProduct
Identificationandcontrolofanydefective
material/producttopreventitsuse
Determinationofactionstotake
Reverificationafterrework/repair
Evaluationofneedforrecallofshippedproduct
8.4
AnalysisofData
Determine,collectandanalyze appropriatedata,Purpose:
DemonstratesuitabilityandeffectivenessofQMS
Evaluateimprovementopportunities
Includedatageneratedbymonitoring/measuringactivities&other
relevantsources
Analyzedataforinformationon:
Customersatisfaction
Conformitytoproductrequirements
Characteristics&trendsofprocessesandproducts
LookforPreventiveActionopportunities
Supplierperformance
Page26

8.5
Improvement
8.5.1 ContinualImprovement
Continuallyimprove organizationsperformance
Use Policy,objectives,audits,data,CAPAandManagement
Reviewtofacilitateimprovement
8.5.2 CorrectiveAction
Defined,documentedprocess;comprehensive
Eliminatecause(s)topreventrecurrence
Appropriatetotheimpact
8.5.3 PreventiveAction
P
a
s
t
BasicallysameprocessasCorrectiveActionbutusedata
proactively
Detect Analyze Eliminatecausesofpotential problems
CorrectiveActionversusPreventiveAction
Cause
Corrective
Effect
Corrective
action
Adaptive
P
r
e
s
e
n
t
Likely
Cause
Preventive
ActionstoAddress
Current Problems
Possible
Effect
Preventive
action
Contingent
ActionstoAddress
Potential Problems
Page27
F
u
t
u
r
e
15 Steps to Implement
ISO 9001
Designing,documentingandimplementinganISO9000basedQuality
ManagementSystemisasignificantundertaking.Typically,ETIGroup
recommendsandusesafourphaseapproachtoassistclientsin
implementingasystemthatmeetsthespecificneedsoftheirbusiness.
Phase1
Phase2
Planningand
Design
Establish
Measurement
Program
Documentation
Development
Design/Document
Operations
Processes
EstablishQuality
SystemStructure
Phase3
Implementation
Design/Document
Management
Processes
Phase4
Assessmentand
Registration
ThisapproachhasbeenusedsuccessfullybyETIGroupinmorethan650
organizations,bothlargeandsmall.Ataskbytaskoverviewofthis
approachisprovidedonthefollowingpages.
Page28
ISO 9001
PHASE1:PLANNINGANDDESIGN
Step1 DecisionMakingandCommitment
Thefirsttaskisfortopmanagementtodecideifthecompanyshould
pursueISO9001(oroneoftheassociatedstandards ISO13485,
AS9100CorISO/TS16949)registration.
Tomakeaninformeddecision,topmanagementshouldhaveagood
understandingofISO9001fromabusinesspointofview,theconcepts
behindISO9001,thegeneralprocessforimplementationandthe
requirementsofthestandardastheyapplytoyourcompany.
Topmanagementmustalsodemonstrateitscommitmentand
determinationtoimplementanISO9001QualitySysteminthe
organization.Withouttopmanagementcommitment,noquality
initiativecansucceed.
Page29
ISO 9001
1.1TopManagementCommitment
Toprovideevidenceofcommitmenttothedevelopmentand
implementationofaQMSandcontinuallyimproveitseffectiveness,top
managementcanachievethisby:
Communicatingtotheorganizationtheimportanceofmeeting
customer,statutoryandregulatoryrequirements,
Definingtheorganization'squalitypolicyandmakingthisknownto
everyemployee,
Ensuringthatqualityobjectivesareestablishedatalllevelsand
functions,
Ensuringtheavailabilityofresourcesrequiredforthedevelopmentand
implementationofthequalitymanagementsystem,and
Conductingtherequiredmanagementreviewmeetings.
Topmanagementshouldalsoconsider
actionssuchas:
Leadingtheorganizationbyexample,
Participatinginimprovementprojects,
Encouragingtheinvolvementofall
employees.
Page30
ISO 9001
1.2TopManagementCommitment
Topmanagementshouldidentifythegoalstobeachievedthroughthe
QualitySystem.Typicalgoalsmaybe:
Tobecomemoreefficientandprofitable
Toproduceproductsandservicesthatconsistentlymeetcustomers'
needsandexpectations
Improvecustomerssatisfaction
Increasemarketshare
Reducecostsandliabilities
Step2 ImplementationTeam&ManagementRepresentative
ISO9001isimplementedbypeople.Thenextstepistoestablishan
implementationteamandappointaManagementRepresentative(MR)as
itscoordinatortoplanandoverseeimplementation.Implementationteam
membersshouldincluderepresentativesofallorganizationalfunctions
Marketing,Design,Development,Planning,Production,Qualitycontrol,etc.
TheManagementRepresentativeisyour
company'spointpersonandsoontobeexperton
ISO9001.Inthecontextofthestandard,this
personactsastheinterfacebetweenyourtop
managementandtheISO9001registrar. This role
is,infact,muchbroaderthanthat.The
ManagementRepresentativeshouldalsoactas
theorganizationsQualitySystemChampion."
Page31
ISO 9001
2.1ManagementRepresentative(MR)Responsibilities
TheMRmustbeapersonwith:
The totalbackingoftheCEO,
Agenuineandpassionatecommitmentto
qualityingeneralandtheISO9001quality
managementsystemsinparticular,
Therespectresultingfromrankand/or
senioritytoinfluencepeopleatalllevelsand
functionsoftheorganization,and
Agoodknowledgeofqualitymethodsin
generalandISO9001inparticular.
ThestandardmakesitveryclearthattheManagementRepresentative
takesonthethreeresponsibilitiesdescribedbelow.
1.QualitySystemMaintenance. EnsuringthatQualityManagement
Systemprocessesareestablished,implementedandmaintained.
2.ReportingonQualitySystemperformance. Reportingtotop
managementonhowwell,orpoorly,theQMSisperforming,including
identifyinganyneedsforimprovement.
3.Promotingcustomerrequirements. Ensuringallemployeesareaware
ofcustomerrequirements.Itisessentialthatallemployeesunderstand
whatthecustomerneeds,andhowtheycanaffecthowwellthecompany
satisfiestheseneeds.
Page32
Steps to Implementing
ISO 9001
Step3 EmployeeAwarenessTraining
Itisimportanttoinformemployeesasearlyaspossibleofyourplanto
becomeISO9001registered.YouwillneedtoexplaintheconceptofISO
9001andhowitwillaffectemployeesinordertogainbuyinand
support.Don'tdelaythissimplestep,ifnegativerumorsandgossip
develop,yourimplementationeffortswillbecomemuchmoredifficult!
SincetheISO9000QualitySystemaffectsalltheareasandallpersonnel
intheorganization,trainingprogramsshouldbestructuredfordifferent
categoriesofemployees seniormanagers,middlelevelmanagers,
supervisorsandworkers.Thistrainingshouldcover:
Thebasicconceptsofquality
systemsandthestandard,
Theoverallimpactonthe
companysstrategicgoals
Thechangedworkprocesses,
andthelikelyworkculture
implicationsofthequality
system.
Inaddition,initialtrainingmayalsobenecessaryonwritingquality
manuals,proceduresandworkinstructions.Whentheinhouseabilityto
providethistrainingisnotavailable,itmaybenecessarytoparticipatein
externaltrainingcoursesrunbyaprofessionaltrainingorganizationsor
anexternaltrainingorganizationcouldprovidethistraininginhouse
Page33
ISO 9001
Step4 PerformaGapAssessment
Thenextstepintheimplementationprocessistocompareyourexisting
qualitysystemwiththerequirementsoftheISO9001standard.Thisis
oftenreferredtoas"gapassessment'withthegoalofdetermining:
Whatexistingcompanyprocesses
andproceduresalreadymeetISO
9001requirements
Whatexistingproceduresand
processesneedtobemodifiedto
meetISO9001requirements
Whatadditionalproceduresand
processesneedtobecreatedto
meetISO9001requirements
Ingeneral,thestepstoperformagapassessmentare:
1. Whatisthepresentoperation/process?Whatalreadyexists?,
2. AnalyzetherelevantsectionsoftheISO9001standardtodetermine
whatisactuallyrequired?
3. Documentthegaps.
Thegapassessmentcanbeperformedinternally,iftherequired
knowledgeexists,oranexperiencedISO9000consultingfirmcanprovide
thisserviceforyou.
Page34
ISO 9001
Step5 ImplementationPlanning
Afterthegapassessment,youshouldhaveaclearpictureofhowyour
existingQualitySystemcompareswiththeISO9001standard.
Adetailedimplementationplanshouldbedeveloped thatidentifiesand
describestaskrequiredtomakeyourQualitySystemfullycompliantwith
thestandard.Thisplanshouldbethoroughandspecific,detailing:
Qualitydocumentationtobedeveloped
TherelevantISO9001standardsection
Personorteamresponsible
Approvalsrequired
Trainingrequired
Resourcesrequired
Estimatedcompletiondate
Theseelementsshouldbeorganizedintoadetailedchart,tobereviewed
andapprovedbytopmanagement.Theplanshoulddefineresponsibilities
ofdifferentdepartmentsandpersonnelandsettargetdatesforthe
completionoftasks.Onceapproved,theManagementRepresentative
shouldcontrol,reviewandupdatetheplanasdocumentationandthe
implementationprocessproceeds.
Atypicalimplementationactionplanisshownonthefollowingpage.
Page35
ISO 9001
Month1
Month3
Month5
Month7
Month9
Month10
Month12
AppointMR&
establishteam
Employee
awarenesstraining
Gapassessment&
planning
Developdocumentation
RegistrarSelection
ImplementQualitySystem
&trainemployees
InternalAudits
ManagementReview
andcorrectiveactions
Stage1
RegistrationAudit
CorrectiveActions
Stage2
RegistrationAudit
Highlevel12monthimplementationplan
Page36
15 Steps to Implementing
ISO 9001
PHASE2:DOCUMENTATIONDEVELOPMENT
Step6 DocumentationDevelopment
ThereisnorightorwrongwaytodocumentyourQMS. Webelievethat
yourcompanyshouldstartwiththeminimumrequirements.Currently
therearesixdocumentedproceduresrequiredtocreateanISO9001
QMS:DocumentControl;ControlofRecords;InternalAudit;
NonConformingProduct;CorrectiveActionandPreventiveAction.
Therewillbesomeadditionaldocumentedproceduresthatwillbe
helpfulforyourstafftofollowwhileworkingonyourcompanysvarious
processes.Thesecanbedeterminedduringtheplanningstageand
shouldbeincludedinyourimplementationprojectplan.
TheRightSizeQualityManagementSystem
MinimumRequirements
6Procedures
18Records
PlusAdditionalKeyProcesses
Overkill
Page37
ISO 9001
6.1OrganizingandDocumentingYourQualitySystem
Documentation istypicallyorganizedandwrittenaccordingtoahierarchy
shownbelow.Alistofthedocumentstobepreparedshouldhavebeen
drawnupandtheresponsibilityforwritingdocumentsassignedtothe
personsresponsibleforeachofthequalitysystemprocessesinyour
companyduringimplementationplanning.
Quality
Manual
Procedures
(BusinessProcesses)
WorkInstructions
Forms&Records
TheQualityManual Ahighleveldocumentthattypicallyincludes:
AstatementexplainingthescopeoftheQualityManagement
System,includingexclusionsanddetailsfortheirjustification
AdescriptionoftheQualitySystemprocessesandtheir
interactions
Thecompanysqualitypolicyandqualityobjectives
Ancompanyprofileshowingtherelationshipsandresponsibilities
ofpersonswhoseworkaffectsquality
Anoverviewofthesystemlevelprocedures
Page38
ISO 9001
QualityManual(Continued)
TheQualityManualisusuallywrittenearlyoninyourQMSimplementation.
Processesandproceduresmaychangeasyourorganizationworksthrough
thedocumentationprocess.Itwillbenecessarytogobackandrevisethe
QualityManualtobringitbackuptodateandensurethatthecorrectprocess
interfacesaredefinedandresponsibilitiesandauthoritiesdocumented.
Procedures arehighleveldocumentsthatdetailhowtheorganizations
processesaredesignedandcontrolledandthechecksthatarecarriedout.
WorkInstructionsareveryspecific,
anddetailallnecessaryinstructions
requiredforperformingaspecifictask.
Listsprovideinformation.Theycan
alsobeincorporatedintothebackofa
procedureasadditionalinformation
(Appendix,Attachments,etc.).
Forms capturerecordsfordata/informationrequiredtosupportorconfirm
processes.Formscanbeseparatelycontrolleddocumentsand/orincluded
withintheappropriateprocedure.
Records mustbemaintainedtoshowcompliancetoqualitysystem
requirements.
Page39
ISO 9001
6.2RecordKeeping Qualityrecordsprovideobjectiveevidenceofyour
compliancetomanyoftheISO9001requirements.Youmustkeepyour
recordsuptodatetoprovecomplianceduringyourregistrationor
subsequentsurveillanceaudits.Minimumrequiredrecordsinclude:
Evidencethatmetricsareusedtomonitorandimprove
processes(QualityObjectives)
ManagementReviewMeetings
EmployeeCompetence,Awareness,andTraining
Productplanningmeetscustomerrequirements
Contractreviewandactionsarisingfromthereview
Designanddevelopmentplanning,inputs,reviews,
verification,validation(includingchangestodesigns)
Supplierevaluationandreevaluation
Resultsofmonitoringandmeasuring
InternalAudits
Approvaltoreleaseproductfordelivery
Actiontakenonnonconformingproduct
CorrectiveAction
PreventiveAction
Page40
ISO 9001
6.3Documentation GettingStarted
Yourcompanyprobablyalreadyhassomedocumentedpoliciesand/or
procedures.Althoughtheymaybeincomplete,lackingspecificdetail,be
outofdate,orarenotintegratedwithotherbusinessprocessesasrequired
bytheISO9001standard.
Makealistofallthesedocuments,includingprocedures,workinstructions,
formsandlistsandincludetheircurrentstatusincomplete,lackingdetail,
outofdate,inaccurate,notintegratedwithotherbusinessprocesses,etc.
Theremayalsobesomeareasofthebusinesswhichyouchoosenotto
includewithinthescopeofyourQMS,suchasfinanceorbusinessstrategy
documents.
Areasdeemedoutofscopemustnothaveanimpactonproductquality
andshouldnotbeincludedinyourQMDdocumentation,althoughthese
areasshouldbelistedintheexclusionsdocumentedinyourQuality
Manual.
Considertheprimaryaudienceforthedocumentanduselanguageand
vocabularythatisappropriateforthecompanyandfortheusers.
Page41
ISO 9001
6.4Documentation MapCurrentProcesses
Maptheprocessesusedtomanagethequalityframework,including
theirsequenceandinteractionwitheachother.Ensurethatall
stakeholdersareincludedinthemappingprocessandgapsarenoted
wheredocumentsaremissingorwhereaprocessneedstobeupdated
tomeetarequirementoftheISO9001standard.
Start
Purchasing
Verify Price &
Availability with
Supplier
Requestor
Purchase Request
Form
FORM # 7.4 - 2
Identify Product
Service to Purchase
Requestors Mgr
.
Requestors Mgr
.
Return with
Explanation
Review / Approve
Purchase Request
Purchasing
Create Purchase
Order
Purchasing Mgr
Review and
Approve PO
No
Purchase Order
Approved ?
Purchasing
Yes
Approved Vendor
List
Supplier on
Approved
List ?
Forward to
Supplier
Yes
Purchasing
No
Supplier
Evaluation &
Selection Process
Monitor Supplier
Performance
Done
TypicalProcessMap
Page42
ISO 9001
6.5TemplatesforControlledDocuments
Templatesshouldbedevelopedforallofthecontrolleddocumenttypes
youintendtouse.Templatesshouldhaveconsistentstylesandformatsso
thatdocumentsareeasytoreadandnavigate.
Eachtemplatemustmeetcontrolled
documentrequirements.Procedures
andWorkInstructionsshouldhave
Purpose,ScopeandResponsibilities
sections.Acompanylogocanalsobe
includedwiththedocumentheader.
DocumentingyourQualitySystemischallengingandtimeconsumingbut
canbesimplifiedwithgoodpredesignedtemplatesorthehelpofan
experiencedconsultingfirm.Ifyouchoosetopurchasetemplatesthey
shouldbechosencarefullyastheywillhaveasignificantimpactonthe
effortyouspendonimplementation,andevenmoreimportantly,onhow
efficientandbusinessfriendlyyourcompany'sQualitySystemwillbe.
6.6CreateaCompanyQualityPolicy
WehaveallreadanorganizationspostedMissionStatementwhen
enteringtheirestablishment.AQualityPolicyissimilarbutaddressesthe
specificrequirementsofISO9001.ThisisthefoundationofyourQMSand
establishestopmanagementscommitmenttoQuality.Itshouldalsobe
communicatedthroughoutyourorganization.
Page43
ISO 9001
6.7TopLevelQualityObjectives
TheframeworkfordeterminingyourQualityObjectivesis
establishedinyourorganizationsQualityPolicy,these
objectivesarepresentatalllevelsoftheorganization,they
establishmeasureableprocessestoassureyourproductor
servicemeetsstatedrequirements.
6.8DeterminingInteractions
Oneofthemanybenefitsincreating
yourQMSisimprovedcommunications
betweendepartmentalfunctions.
ISO9001
AFoundation
Accomplishingthisrequiresthatyou
forExcellence
clearlydefinethesedepartmental
functionsandidentifytheirinteractions.
YoucanusetheQualityManual,
DocumentedProcedures,oraProcessFlowCharttodothis.
6.9DetermineAuthorities
AnotherbenefitofyourQMSistherequirementtoclearlydefineand
documentauthorities.Itisnotuncommoninmanyorganizationsto
makestaffresponsibleforsomethingwithoutgivingthemaclearly
definedauthoritytoseethetaskthrough.Thisoftenleadstostressand
lowmorale.
Page44
ISO 9001
6.10DocumentControl
A DocumentationControlSystemmustbecreatedtomanagethe
creation,approval,distribution,revision,storage,anddisposalofthe
varioustypesofdocumentationthatyourcompanydevelops.Your
documentcontrolsystemsshouldbeassimpleandaseasytooperateas
possiblebutsufficienttomeetISO9001requirements.Itshouldinclude:
Auniqueidentification,usuallya
lettercodeforthetypeof
document(e.g.SOP,WI,LST)and
asequentialnumber.
Revisioncontrolwhereeach
updatetothedocumentmust
resultinanincrementalincrease
intherevisionnumber.
Achangehistorysummarizingchangesmadetoadocument
Signaturesofthepersonpreparingandthepersonapprovingthe
document.Averificationsignatureisalsousuallyrequiredto
confirmthatthecontentsofthedocumentareaccurate.
Thedateoftheversionorrevision
TheprincipleofISO9001documentcontrolisthatemployeesshouldhave
accesstothedocumentationandrecordsneededtofulfiltheir
responsibilities.
Page45
ISO 9001
Step 7 Review and Release Documents
Managementshouldreviewallof
thedocumentationtoensureit
meetstheoperationalneedsofthe
businessaswellasISO9001
requirements.Followingthe
reviews,subsequentrevisions,and
finalmanagementapproval,
documentationisreleasedforuse
PHASE3:IMPLEMENTATION
Step8 ImplementationandEmployeeTraining
ThenewlydocumentedQuality
Systemisputintopractice
throughoutthecompany.
Managementandemployees
aretrainedonthenewor
revisedworkprocesses,
proceduresandwork
instructionsasformalizedin
yourdocumentation.
Page46
ISO 9001
Step9 QualitySystemRegistrarSelection
ItisadvisabletoselectaRegistrationBodythatissuitedtoyour
organizationearlyinyourimplementationproject.Theregistrationbody
isanindependentorganizationthatisofficiallyaccreditedtoissueQuality
Systemcertifications.Theregistrarwillaudityour
company'sQualitySystemandiftheauditis
successful issuetheQualitySystemcertificate.
Whenchoosingacertificationbodytocarryout
yourISO9001registrationaudit,someselection
criteriashouldbetakenintoaccount:
Isthecertificationbodyaccreditedand,ifso,
bywhom?Accreditationmeansthatthe
certificationbodyhasbeenofficially
approvedascompetenttocarryout
certificationbyanationalaccreditationbody.
Isthecertificationbodyrecognizedbyyourcompanyscustomers?
Doesthecertificationbodyauditor(s)haveexperienceinyour
organizationsbusinesssector?
Isyouorganizationcomfortableworkingwithyourauditor(s)asboth
sideshavetoworktogetherforalongperiodoftime?
Lastbutnotleast,weconsideritimportantthatyouractualauditoris
basedgeographicallyclosetoyou,otherwisetravelexpensesforyour
auditorsvisittoyourfacilitycouldbeveryhigh?
Page47
ISO 9001
Step10 InternalAuditorTraining&CommenceInternalAudits
ISO9001andrelatedstandardsrequirethatyourcompanyperiodically
performaninternalaudittoevaluatetheeffectivenessofyourQuality
SystemandcheckthatitcomplieswithISO9001requirementsaswell
asyourorganizationsowndocumentedworkpractices.
Aqualityauditisa:Systematic,independentanddocumentedprocess
forobtainingauditevidenceandevaluatingitobjectivelytodetermine
theextenttowhichauditcriteriaarefulfilled.
ISO9000:2005
InternalauditsarealsoagreathelpimplementingyourQuality
SystemandacompleteinternalauditofyourQualitySystemis
requiredbeforeyoucanpassyourregistrationaudit.
Yourinternalauditprogramshouldbe
planned,takingintoconsideration
thestatusandimportanceofthe
differentprocessesthatarerunning
inyourorganization.
Atleasttwoofyouremployees
willneedtobetrainedas
internalauditors.
Thecriteriafortheaudit,scopes,frequenciesandmethodsshouldalsobe
defined.Theperson(s)responsiblefortheaudit,shouldbeobjectiveand
impartial,theonlyrestrictionisthattheycannotaudittheirownwork.
Page48
ISO 9001
Step11.ManagementReview
WhenyourQualitySystemhasbeenoperatingforthreetosixmonths
andaninternalauditofyourQualitySystemhasbeencompleteda
ManagementReviewshouldbeconductedandcorrectiveactions
implementedasnecessary.
Managementreviewsareconductedtoensurethecontinuingsuitability,
adequacyandeffectivenessofyourQualitySystem.Thereviewshould
includeassessingopportunitiesforimprovementandtheneedfor
changestotheQualitySystem,includingthequalitypolicyandquality
objectives.Theinputtomanagementreviewshouldinclude:
Resultsofaudits,
Customerfeedback
Processperformanceand
productconformity
Statusofpreventiveand
correctiveactions
Followupactionsfromprevious
managementreviews
ChangesthatcouldaffecttheQualitySystem,and
recommendationsforimprovements
ManagementReviewsshouldalsoaddresspitfallstoeffective
QualitySystemimplementation
Page49
ISO 9001
PHASE4:ASSESSMENTANDREGISTRATION
Step12 Stage1RegistrationAudit
WhenyouQualitySystemhas
beeninoperationforafew
monthsandhasstabilized,itis
normallytimetoscheduleyour
stage1registrationaudit.
Yourselectedregistrationbody
willfirstcarryoutanauditof
yourdocumentationandthen,if
yourdocumentsmeetthe
requirementsofthestandard,
theregistrarwillvisityourfacility
andperformastage1AudittoensureallapplicableISO9001orrelated
standardrequirementshavebeenmet.
Step13 CorrectiveActions
Followingyourstage1audit,managementwillreviewtheresultsand
makecorrectiveactionstofixanynonconformances(activitiesthatare
notincompliancewiththerequirementsofthestandardand/oryour
owndocumentedworkpractices)foundduringthestage1registration
audit
Page50
ISO 9001
Task14 Stage2RegistrationAudit
YourselectedRegistrarwillperformastage2RegistrationAudittoensure
allapplicableISO9001orrelatedstandardrequirementshavebeenmet
andthatyouhavecorrectedanynonconformancesfoundduringthe
stage1audit.
Followingthesuccessfulcompletionofthestage2audityourcompany
willbeawardedanISO9001certificate,generally
foraperiodofthreeyears.Duringthisthreeyearperiod,your
registrationbodywillcarryoutperiodicsurveillanceauditstoensurethat
thesystemiscontinuingtooperatesatisfactorily.
Task15 ContinualImprovement
CertificationtoISO9000shouldnotbeanend.
Youshouldcontinuallyseektoimprovethe
effectivenessandsuitabilityofyourQuality
Systemthroughtheuseofyour:
Qualitypolicy
Qualityobjectives
Auditresults
Analysisofdata
Correctiveandpreventiveactions
Managementreview
Page51
ETIGroup:
Todate,ETIGrouphasassistedmore650companiestoachieveQuality
ManagementSystem(QMS)Certificationallpassedtheirregistration
auditsatthefirstattempt.Ourservicesinclude.OurQualityManagement
SystemservicescoverthefullrangeofISO9001andrelatedstandards:
ISO9001 AS9100 ISO/TS16949 ISO13485

Implementing a QMS can be expensive, challenging and time consuming. It
can also distract key people from their regular daytoday tasks. To
minimize disruptions to your business, ETI Group offers a broad range of
practical solutions to assist you in implementing a QMS that meets the
specific needs of your business as well as the requirements of the
appropriate standard(s).
For more information on how we can help you implement an effective
Quality Management System please contact ETI Group at:
Tel: 360-681-2188 or 503-484-5979
Email: info@etigroupusa.com
or
visit our website at www.etigroupusa.com
Page52

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