INTERNATIONAL CIVIL AVIATION ORGANIZATION

AIM QMS

QMSrequirementsandtheapproachofan
externalauditor.

ICAO NACC Regional Office, May 20141

HOWtoIMPLEMENTaQMS?

1.Planning&Designing

2.Describing
Four
Phases
3.ImplementingtheQMS

4.ImprovingtheQMS

2
THEFIRSTSTEPS

QMS
PROCESSES
PROCEDURES
HOW
QUALITY
ORGANISATION

WHO QUALILTY
PRINCIPLES
WHAT ISO9001
QUALITYPO
LICY FOUNDATION
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APOSSIBLEAPPROACH

8.Refine

2.Assign 5.
Responsibilities Disseminate

CONTINUOUS
IMPROVEMENT

1.Set 4.Define
Policy (SMM)

3.Plan 6.Implement
7.Control
andsurvey

4
 Planning and Designing Phase:
Activities

Quick
Scan

Action Series of
Plan Meetings

5
INITIALSURVEY

Startbyreviewingthecurrentsituation

WhatelementsofaQMSarealreadyinplace?

Organisationcharts
Processdocuments
Formsandrecords
Jobdescriptions

6
IDENTIFYMISSINGELEMENTS

Identifytheitemsrequiredthatarenotin
place,thesemaybeforexample:

someprocessdocuments
somenecessaryrecords
aninternalqualityauditprocess
aformalmanagementreviewprocess
acontinualimprovementprocess

IneffectyouareperformingaGap
analysis

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IMPLEMENTATIONPLANS

Inordertoensureasuccessfulimplementationitmustbe
planned,e.g.asaproject:

Resourcesmustbeidentified

Activitiesplannedandassigned

Timescalesagreedanddocumented

Responsibilitiesallocated

Progressmustberegularlymonitored
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 ACTIVITY 2014 2015
M J J A S O N D J F M A M J J
Initial ISO 9001
Briefing
Assessment of
current systems
Formulate Action
Plans
Appoint Project/
Typical Quality Coordinator
ISO 9001 training
ISO for coordinator
Write procedures/
implement systems
9001 Internal Quality
Auditor training
Action Management review
of ISO 9001 systems
Contact ISO 9001
Plan Assessment Bodies
Quality Awareness
Training (all staff)
Implement systems/
Internal Audits
Formal ISO 9001
Assessment

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Describing Phase: Activities

Interfaces Detailed
Check Description

Process Design of
Improvement New
Processes

10
QMSFRAMEWORK

TheframeworkoftheQualityManagement
SystemstartswithTopManagement:
theysetthebusinessobjectives

theymustthenestablishanorganisation toputthosepoliciesinto
action

theymustensurethatkeyprocessesarecontrolled

theymustidentifyresponsibilitiesandinterfaces

theymustensurethatresourcesareprovided

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SYSTEMDOCUMENTATION

Theframeworkofthesystemdocumentationwill
dependuponthebusinessstructure,e.g.

Thesizeandcomplexity oftheorganisation

Isthereadepartmentorteambasedstructure?

Atypicaldocumentationstructureisshownonthe
nextslide.

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TYPICALQMSSTRUCTURE

STANDARD ISO9001(Annex15)

Policy,objectives,organisation,
QUALITYMANUAL outlineofqualitysystem

Processes,practices,
PROCESSDOCUMENTS responsibilities,
ANDPROCEDURES interfaces

Detailedinstructions
INSTRUCTIONS onhowtocarryout
specifictasks

Quality
FORMS records

DesignITSupportInstallationTraining

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DOCUMENTFORMAT

ISO9001:

Thedocumentationmaybeinanyformortypeof
medium

Thereforeitcouldbeintextformorintheformof
processmaps/flowcharts

Itcouldbeapaperbasedsystemorcouldbeon
computer,e.g.accessedviaanintranetbrowser
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CHOOSINGaFORMAT

Eachorganisation canchooseitsownformat

Themajorityatpresenthavepaperbasedtext
documents

Increasinglyorganisations areusingflowchartsand
computerisedsystems

acomputerbasedsolutionoftenhasadvantageswhenit
comestodocumentandchangecontrol

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Implementation Phase: Activities

Putting
planning
into Action

Communication Internal
Training Audit
Plan

16
PRODUCINGtheQMSDocumentation

THEQUALITYMANUAL
Descriptionoftheorganisation

QualityPolicy,keyobjectives

Structureoftheorganisation
Interfaces,responsibilities

OverviewoftheQualitySystem
showapproachtoStandardrequirements
detailandjustifyanyexclusions
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PRODUCINGtheQMSDocumentation

PROCESSDocuments
Doweneedprocessdocuments?

TheISO9001standardcallsforfewmandatory
procedures

Thequestionisdoweneeddocumentsinorder
toeffectivelycontrolourbusinessprocesses?

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PRODUCINGtheQMSDocumentation

Benefitsofprocessdocuments
Provideconsistency/repeatability

Defineresponsibility/authority

Continuitywhenstaffchange

Assistinstafftraining

Helpidentifycauseoferrors

Benchmarkforimprovement

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PROCESS

Definition:

Setofinterrelatedorinteractingactivitieswhich
transformsinputsintooutputs

ISO9000

20
PROCESS Constraints

INPUT OUTPUT
PROCESS

Resources

21
PROCEDURE

Definition:

Specifiedwaytocarryoutanactivityorprocess
ISO9000

i.e.describeshowaprocessisperformed

22
PROCEDUREDEVELOPMENT

Establishcurrentpractice

Documentcurrentpractice

Reviewcurrentpractice

Prepareprocedure

Reviewandapprove

Issueprocedure
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PRODUCINGPROCEDURES

Establishstandardformat/template

Indicateapproval/revisionstatus

Considerusingflowchartsorprocessmaps

Traintheprocedurewriters

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FLOWCHART

Usingaflowchartisaveryeffectivewaytodescribeaprocess

apictureisworthathousandwords

SYMBOLS

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 FLOWCHARTSYMBOLS

Anyprocesscanberepresentedintheform
ofasimpleflowchartusingjusttwosymbols:

Activity or process

Decision

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FLOWCHARTRULES

Thereisonerouteintothebox
andonlyonerouteoutforthe
PROCESS
processactivityboxes

Thereisonerouteinandtwo
possibleroutesoutforthedecision Decision
boxes
No
(e.g.yes/noorpass/fail)
Yes
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Example RECEIVE
INFORMATION

VERIFY
ACCURACY

INSERT Yes No
INTO IS IT MAKE
MANUAL CORRECT? CORRECTIONS

END
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Improvement Phase: Activities

Quality
assurance

Management Internal
Review Audit

29
INTERNATIONAL CIVIL AVIATION ORGANIZATION

Quality
SystemsAudits

Produceaprocessflowchartbased
upontheinformationprovided.

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AUDITOBJECTIVES

(1)Toensurethatproceduresarebeingfollowed
ie.Wearedoingwhatwesaywedo

(2)Todeterminetheeffectivenessofthesystems
andproceduresinmeetingthequality
objectives

(3)Toaffordanopportunitytoimprovethequality
system

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AUDITINGSTANDARDS

ISO10011Guidelinesforauditingqualitysystems

Part1:Auditing

Part2:Qualificationcriteriaforquality
systemsauditors

Part3:Managementofauditprogrammes
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AUDIT

WHATDOESTHEABOVESTANDARDSAYABOUT
QUALITYSYSTEMSAUDITING?

Verifycompliance,effectiveness
Plannedauditprogramme
Independentauditors
Documentedprocedure
Timelycorrectiveaction
Followupactivities
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AUDITPROGRAMME

Auditsplannedinadvance
Auditsarenotrandomspotchecks
Scheduledusuallybydepartment,
function,orprocess
Considerthestatusandimportanceof
process,andpreviousresults

34
AUDITTECHNIQUES

INTERVIEW

EXAMINE
VERIFY
VERIFY QUESTION

OBSERVE

35
AUDITREPORT

Summaryofresults,including:

Scope,dates,auditors
Satisfactoryareas
Nonconformities
Observations,recommendations

36
FOLLOWUP

Auditeeresponsiblefor
correctivepreventiveactions

Auditorfollowsupactionto
ensureitistakenandeffective

Auditactionsareclosed records

37
SUMMARYOFAUDITPROCESS

PLANNING
Schedule,
Preparation,
Checklist

AUDITING
OpeningMeeting,
Audit,Closing
Meeting

COMPLETION
Report,Corrective
action,Followup
BENEFITSOFAUDITING

Verifiesthatproceduresarefollowed

Reviewseffectivenessofsystem

Helpstoidentifyproblemareas

Assiststransferofbestpractice

Effectivemechanismforcontinuous
improvement

39
 PreparingforCertification

ISO9001 StepsinImplementation

Managementdecision/commitment
Decidescopeofsystem
Reviewcurrentsituation reportgaps
Formulateactionplan
Document&implementprocesses
Formalassessment
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KEYQUESTIONS

Beforeinvitinganexternalassessment
checkthefollowing:

Arethemandatorydocumentsinplace quality
manualandprocedures?
Arekeyprocessesidentifiedandcontrolled?
Haveinternalauditsandmanagementreviews
beenconducted?
Areresultsfromthesesatisfactory?
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FINALPREPARATION

Considerapreassessment
internal
independentconsultant
yourassessmentbody
Informallofyourstaff
explaintheprocess
clarifytheirresponsibilities
seektheirfeedbackregardinganyconcerns

42
TheCertification
NationalGovernment
Process (e.g.UKDTI)

RegulatingAuthority
(e.g.UKAS,DAR)

Regulation of
the ISO 9001 CertificationBodies
Certification
Process

Companies/Organisations
43
INTERNATIONAL CIVIL AVIATION ORGANIZATION

SUMMARY

44
QUALITYMANAGEMENTPRINCIPLES

Customerfocusedorganization
Leadership
Involvementofpeople
Processapproach
Systemapproachtomanagement
Factualapproachtodecisionmaking
Mutuallybeneficialsupplierrelationships
Continualimprovement

45
KeyPrinciplesofISO9000

1GETORGANISED
defineroles,responsibilities,interfaces
2PROVIDERESOURCES
humanresources,training,facilities
3DOCUMENTMANAGEMENTSYSTEMS
establishprocedures,controldocuments
4CONTROLPROCESSES
planprocesses,controloperations
5KEEPRECORDSOFACTIVITIES
evidenceofeffectiveoperation
6CARRYOUTREGULARCHECKS
inspections,tests,surveys,audits
7IMPROVETHESYSTEMS
proactivecontinualimprovementprocess

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MAINASUMPTION!!!

IftheISO9001:2008implementation
projectistobesuccessful,thenthereMUST
besupportandcommitmentfromTop
Management.

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THANKYOU!

RaulMartinez
ICAONACC
AIMRegionalOfficer
rmartinez@icao.int

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