ISO 9000 provides quality management standards for organizations to implement quality assurance systems. It aims to facilitate international trade by providing commonly understood quality standards. Key aspects of ISO 9000 include establishing quality policies, documentation of processes, management commitment, and continual improvement. Organizations must demonstrate that their quality system meets the requirements of ISO 9001 through an external audit process. Implementing an ISO quality system involves investigating current practices, analyzing processes, designing new documentation, developing the quality system, implementing it, and ongoing maintenance.

1. ISO 9000 – Quality
Management Systems
Elements,Requirements and Interpretation of
ISO 9000:2000

2. What is ISO
 System of standardization
 Certification
 Quality standards
 Commercial standards
 Internationally regulated
 Facilitate trade between countries
 Documentation
 Specifications
 Level of Quality
 Trust factor improves
 Conforming to standard processes.
 Promotion of product
 Image of the co.
 Advertisement
 Brand Value increase

3. What is Process based organization
 All activities are based on a process
 SOP is there for controlling all the activities.
 Different Functions are linked for a specific
activity.
 Feedback and improve the process.
 Continous monitoring
 It is a collective effort
 Small organizations-Function based is good
 Big Organizations-Process based is good
 Implementing ISO requires processes to be
implemented.

4. ISO9000 - An Introduction
• ISO standsforInternationalOrganization
for Standardization.
• ISO 9001:2000isaninternational
standardfortheimplementationand
managementof aqualityassurance
system.
• ISO 9000, can be adopted by all types of
organizations producing and supplying all
kindsof goods,servicesand softwareetc.

5. ISO9000 - General Overview
• ISO 9000seriesconstituteISO 9000, 9001,
9002,9003 and 9004.
ISO 9001,9002,9003arethreequalitysystem
modelsforexternalqualityassurance.
ISO 9001 isfordesign, manufacturing,installation
andservicing system,
ISO 9002 coversmanufacturingand installation
ISO 9003coversonlyfinalproductinspectionand
test.
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6. ISO9000 - General Overview
• Anexampleof theimpactcreatedbythe
initiationof ISO 9000isthatmostgovernment,
military
,European,andmulti-nationalcompany
contractsmakeitmandatorytopossess
registrationtoone(ormore)of thestandards.
• ISO 9004providesguidelinesforinternaluseby
amanufacturerdevelopingitsownquality
systemtomeetthebusinessneeds.

7. ISO9000 - General Overview
• T
oattainISO 9000registration, amanufacturer
must provide evidencethatitsmanagementis
activelyinvolvedinitsqualityprocess,thatits supplier
andcustomerassuredthatthereis consistencyin
supply .
• Italsorequirethecontrolondocumentationof
design, production,inspection, handling
,storageanddeliveryofallmaterialsand product

8. ISO9000 - General Overview
• IntheyearssincetheintroductionofISO 9000,
severalissueshavearisen, includingthe application
ofthestandardstocoverservices, software
development,pharmaceutical, processingindustries,
theconceptofan expandedstakeholder
accountabilitybeyond customers,theneedsofthe
smaller organizations,andtheneedsofother
specializedindustrysectors,suchasmedical devices
(ISO 13485/13488).

9. ISO9000 - TheQuality Loop
Customer/
Consumer
Marketing and
Market Research
Disposal after
Use
Sales and
Distribution
Producer/ Procurement
Supplier
Design/Specification
Engineering and
Product Development
Process Planning
And Development
Production
Inspection, Testing,
And Examination
Packing and
Storage
Installation
and
Operation
Technical
Assistance
and
Maintenance

10. ISO 9000 -Objectives
• Theobjectivesof anygoodquality
managementsystemarethefollowing:
– Assurethatthecustomerreceivestheserviceorproductthatis
expectedandremainssatisfied
– Preventerrorsinall operations
– Preventdelivery delays
– Reducecostsofoperation
– Increaseproductivity
– Increasethereliabilityof serviceor product
– Meetallthequalityrequirementsspecifiedbythe customer

11. ISO9000 - Prerequisites ofa Quality
System
• Whateverthedefinitionof quality,onemustfirst
focusonthreefundamentalelements:Quality
Policy, QualityManagement, andQualitySystem.
• ISO 9000familydistinguishesbetween
requirementsforqualitymanagementsystems
andrequirementfor products.

12. ISO9000 - Prerequisites ofa Quality
System
• QualityPolicy: Overallqualityobjectivesand
directionof anorganizationpertainingtokey
elementsof qualitysuchasfitnessforuse,
performance,safetyandreliability,asformally
expressedbytop management.
• QualitySystem: Theorganizationalstructure,
responsibilities, procedures, processes, and
resourcesusedforimplementingquality

13. ISO9000 - Prerequisites ofa Quality
System
• QualityManagement: Thataspectof theoverall
managementfunctionthatestablishesand
implementsthequality policy
.
• Determiningtheneedsandexpectationof
customersandotherinterested parties.
• Thiscan leadtoincreased satisfaction of
customersthanotherinterestedpartiesantothe
successof theorganization.

14. ISO9000 - The Philosophy
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Basically,therearetwomindsetapproachestoISO 9000 registration.
First,toviewtheISO 9000seriesasasetof standardswhichneeds to
beaddressedsooneror later.
– Thisfirstapproachisinvariablyandprimarilymotivatedbya
commercial/marketing/businesssetofconvictions.]
TheotherapproachseestheISO 9000standardsassomethingmore
than justa model for quality assurance.
– ThisphilosophywillmoreoftenthannotseeinISO 9000an
opportunitytoimprovemanagerial style.
– Mostexpertsspeakof waysinwhichthevariousISO 9000models
canhelpacompanyreduceinternalcostand/orincreaseefficiency
.
•

15. ISO9000 - Documentation
• Policies, Procedures, and the Manual: Basically,
thequalitymanualconsistsof varyingstagesor
tiers.Therearetypically3or4tierscomprisedof
differentlevelsof information.
Level 1
Level 2
Level 3
Level 4
Quality manual
Operational (procedure,SOPs Protocols
Instruction to operations
Formats, records

16. ISO9000 - Documentation
• Tier 1 consistsof theQualityPolicy,businessunit
policiesand objectives.
Tier 2 consistsof thedepartmentalproceduresand
responsibilitiesforeachof thepertinentISO elements.
Tier 3 consistsof theproceduresreflectingthe
individuals’day-to-day businessactivities(Work
Instructions,PlantEquipmentInstructions,etc.).
Tier 4 (sometimesnotapplicable)consistsof any
businesssupportingdocumentation(Accountingdata,
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17. ISO9000- Execution
• Whenpeoplerealizethatasignificant portionof the
executingeffortsrequiredtoachieveregistrationconsist
of documentingwha t you sayyou do, someindividuals
developanallergicreactionto ISO.
Tothem,therealissueistotalqualitymanagement.To
achievethatobjective,everyonemustbeinvolvedto
solveamultitudeof problemswhichmayhave
accumulatedoverseveralyears.
Suchcriticismsarenotwellfoundedforseveralreasons.
Firstof all,theISO seriesof standardsisamode
l forthe
managementof aqualityassurancesystemdesignedto
insurethatataminimum,aseriesof stepsaretakento
ensurethatyoudoindeedsatisfyyourcustomer
requirements.
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18. ISO9000–Managementcommitment
• Role of Employees: Initssimplestform,bysaying
wha t they do and doing wha t theysay, the
employeeseffectivelyensurethecontinued
successof anyqualitysystem.Thisholdstrue
forISO 9000aswell.Infact,itisthefoundation
uponwhichregistrationlies.
• Role of Employers: hereproprietor,ownershould
responsibleforbusinessgrowth,provide
commitment,withconvictiontodevelopQMS
system .

19. ISO9000–Managementcommitment
• Roleof theInternalQualityAssurance
Individual(s):
Theconductof internalauditsisclearlyspecifiedby
ISO. Toensurecompliance,mostcompaniesenroll
theirdesignatedqualityassuranceindividual(s)into
oneof themanyQualityAuditorcoursescurrently
offeredbythefew“officiallyapproved”agenciesor
registrars.Theindividual(s)shallalsoberesponsible
fortheupkeepandmaintenanceof allthe

20. ISO9000–Managementcommitment
• Role of the Registrar: Oncethequality
assurancesystemhasbeendocumentedand
implemented,anaccreditedregistrarmustbe
consultedtoconductareviewof thequality
manualandtoperformathirdpartyaudit.
AccreditationinCanadaisgrantedbytheSCC
(StandardsCouncilof Canada). Atpresentthere
arearound16accreditedregistrarsin Canada

21. ISO9000–Managementcommitment
• Asmostbusinessesbegintoimplementa
qualityassurancesystem,theyquicklynotice
thatavastnetworkof internalcustomer/supplier
relationshipsbegintodevelop.Whendone
properlyandinaspiritof cooperation,the
setting-upof anISO 9000qualityassurance
systemcanleadtoasharingandexchangeof
informationacrosspreviously impermeable

22. ISO9001:2000-TheStandard
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TheISO 9001:2000standardconsistsof5mainsections
addressing some 23 different elementsof compliance.
Section 1 identifies the ‘Scope’ of the standard,
Section 2 deals with the ‘Normative Reference’ of the
standard,
• Section 3 ad resses the ‘Terms and Definitions’ of the
standard.
The Main Sections:
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Section 4 - Quality Management System
Section 5 - Management Responsibility
Section 6 - Resource Management
Section 7 - Product Realization

23. ISO9001:2000-TheStandard
Section 4 - Quality Management System:
• This Sectiondeals with the establishment, implementation, and
maintenance of the QMS with regards to the control of
documentation andrecords
Section 5 - Management Responsibility:
• This Section serves to provide evidence of management’s
commitment to the development and implementation of the
QMS and to continua ly improve its effectiveness
Section 6–Resource Management:
• This Section covers the organization’s provision of
requirements such asHuman Resources, Infrastructure, and
Work Environment

24. ISO9001:2000-TheStandard
Section 7 - Product Realization:
• This Section serves to confirm how the organization
plans and develops the processes needed for product
realization
Section 8- Measurement, Analysis and Improvement:
• This Section deals with the planning and
implementation of the monitoring,measurement,
analysis and improvement processes needed to
– (a) demonstrate conformity of the product,
– (b) ensure conformity of the QMS, and
– (c) continual y improve the effectiveness of the QMS

25. ISO9000-TheStrategy
• Basicallythereare6workingphasesto
successfullymapoutanyworthwhile
qualitymanagement system:
–SystemInvestigation
–SystemAnalysis
–SystemDesign
–SystemDevelopment
–SystemImplementation
–SystemMaintenance

26. ISO9000- Summary
• Study cur ent
documentation
Conduct interviews
and/or performsurveys
Observe individuals
actual y performing the
activities
Create new
documentation
Meet with executive
management of
responsibility to critique
& approve the new
documentation
Finalize and control new
documentation
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• Performinternal audits
of the ISO 9001:2000
Standards’ elements
Identify al major and/or
minornon-conformances
Recommend cor ective
actions
Perform ‘fol ow-up’
internal audits to confirm
the effectiveness of the
cor ective actions
Have the Quality Manual
reviewed and approved
by an accredited ISO
Registrar
Have the QMS audited by