ISO AWARENESS PROGRAMME

8/7/2019 ISO AWARENESS PROGRAMME

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AWARENESS PROGRAMMEAWARENESS PROGRAMME


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What is ISO 9001 : 2001 ?What is ISO 9001 : 2001 ?

Released in Jan,2000

Require 3rd partycertification

Suitable for differentindustries & culture

Emphasize onprocess approachrather than elementapproach

Serve as basicfoundation forcontinual improvement

Aim at achievingcustomer satisfaction

Additional confidencefor global sourcing

Globally recognized QMS

ISO 9001


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The Goals of ISO 9001 : 2000The Goals of ISO 9001 : 2000

Continual improvement

Emphasize oncustomersatisfaction

Emphasize ondefect prevention

Enhanceprocesseffectivenessand efficiency


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Negative Perception of ISO9001Negative Perception of ISO9001

Because ofCorporateDirective

Just for the sake ofcertification

Business still go oneven w/o ISO9000

Treat it as 2nd priorityas it is only QMRbusiness

Satisfy auditor insteadof customer

Aim at achievingcustomer satisfaction

Because customersrequire it

Paper work exercise

NegativePerception


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ISO 9000 : 2000 STANDARD SERIESISO 9000 : 2000 STANDARD SERIES

ISO 9000 : Quality Management System:

Fundamentals and Vocabulary

ISO 9001 :

Quality ManagementSystems:Requirements

Emphasize ondefect prevention

ISO 19011 :Guidelines on Qualityand EnvironmentalAuditing


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ISO9001 : 2000 QMS STRUCTUREISO9001 : 2000 QMS STRUCTURE

LEVEL 4Quality System Records

LEVEL 1QualityManual

LEVEL 2Quality System Procedure

LEVEL 3Support Documents

(Work Instruction, Standards, Drawings)Reference Manual


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THE EIGHT MANAGEMENTTHE EIGHT MANAGEMENT

PRINCIPLESPRINCIPLESTHE BASIC OF ISO 9001 : 2000THE BASIC OF ISO 9001 : 2000

SERIES OF STANDARDSERIES OF STANDARD


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Principle 1Principle 1 Customer focusCustomer focus

Principle 2Principle 2 LeadershipLeadership

Principle 3Principle 3 Involvement of peopleInvolvement of people

Principle 4Principle 4 Process approachProcess approach


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Principle 5Principle 5 System approach toSystem approach tomanagementmanagement

Principle 6Principle 6 Continual improvementContinual improvement

Principle 7Principle 7 Factual approach toFactual approach todecision makingdecision making

Principle 8Principle 8 Mutually beneficialMutually beneficialsupplier relationshipsupplier relationship


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ISO 9001 QMS MODELISO 9001 QMS MODEL

QUALITY MANAGEMENT SYSTEMCONTINUAL IMPROVEMENT

Managementresponsibility

Measurement,Analysis,

Improvement

Resourcemanagement

Product

realization

ProductOutputInput

Based onprocess

approach


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Quality Management SystemQuality Management System

General RequirementsGeneral Requirements

Documentation RequirementsDocumentation Requirements

Management ResponsibilityManagement Responsibility

Management CommitmentManagement Commitment Customer FocusCustomer Focus

Quality PolicyQuality Policy

PlanningPlanning Responsibility, Authority andResponsibility, Authority andCommunicationCommunication

Management ReviewManagement Review


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Resource ManagementResource Management

Provision Of ResourcesProvision Of Resources

Human ResourcesHuman Resources InfrastructureInfrastructure

Work EnvironmentWork Environment


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Product RealizationProduct Realization Planning Of Product RealizationPlanning Of Product Realization

CustomerCustomer related Processesrelated Processes

Design and DevelopmentDesign and Development PurchasingPurchasing

Production and Service ProvisionProduction and Service Provision

Control Of Monitoring and MeasuringControl Of Monitoring and Measuring

DevicesDevices


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Measurement, Analysis andMeasurement, Analysis andImprovementImprovement

GeneralGeneral

Monitoring and MeasurementMonitoring and Measurement Control of Nonconforming ProductControl of Nonconforming Product

Analysis of DataAnalysis of Data

ImprovementImprovement


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Overview Of ISO 9001Quality Management

System


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00 IntroductionIntroduction11 ScopeScope22 Normative referenceNormative reference33 Terms and definitionsTerms and definitions

44 Quality ManagementQuality ManagementSystemSystem4.14.1 General requirementsGeneral requirements4.24.2 DocumentationDocumentation

RequirementsRequirements55 Management ResponsibilityManagement Responsibility

5.15.1 ManagementManagementCommitmentCommitment

5.25.2 Customer focusCustomer focus5.35.3 Quality PolicyQuality Policy5.45.4 PlanningPlanning

5.55.5 Responsibility &Responsibility &Authority andAuthority andCommunicationCommunication

5.65.6 Management ReviewManagement Review66 Resource ManagementResource Management

6.16.1 Provisions of resourceProvisions of resource

6.26.2 Human ResourceHuman Resource

6.36.3 InfrastructureInfrastructure6.46.4 Work EnvironmentWork Environment

77 Product RealizationProduct Realization7.17.1 Planning of productPlanning of product

realizationrealization7.27.2 Customer relatedCustomer related

processesprocesses7.37.3 Design & DevelopmentDesign & Development7.47.4 PurchasingPurchasing7.57.5 Production & ServiceProduction & Service

provisionprovision7.67.6 Control of MonitoringControl of Monitoring

& measuring devices& measuring devices88 Measurement, Analysis andMeasurement, Analysis and

ImprovementImprovement8.18.1 GeneralGeneral

8.28.2 Monitoring &Monitoring &MeasurementMeasurement

8.38.3 Control ofControl ofNonconformingNonconformingProductProduct

8.48.4 Analysis of DataAnalysis of Data

8.58.5 ImprovementImprovement


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Introduction To Audit


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What is AuditWhat is Audit

Systematic, independent andSystematic, independent anddocumented process for obtainingdocumented process for obtainingaudit evidenceaudit evidence and evaluating itand evaluating itobjectively to determine the extentobjectively to determine the extentto whichto which audit criteriaaudit criteria are fulfilledare fulfilled

ISO 19011 Def. 3.1


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Summary of Internal Audit RequirementsSummary of Internal Audit Requirements

(clause 8.2.2)(clause 8.2.2)

Internal Audit

Clause 8.2.2

Conduct atplannedinterval

Consider status& importanceof processes

Qualifiedauditor shall be

independent

Actions takenwithout undue

delay

Verification ofactions taken

Ensure it iseffective andvalue added


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To ensureTo ensure compliance to ISO9001compliance to ISO9001

requirementsrequirements

To ensure the system isTo ensure the system is

implementedimplemented effectivelyeffectively

To identify areas forTo identify areas for continualcontinual

improvementimprovement especially defectespecially defectprevention, reduction of variation &prevention, reduction of variation &waste in the supply chainwaste in the supply chain


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To improveTo improve customer satisfactioncustomer satisfaction

To giveTo give management a picturemanagement a picture ofof

what is happening in the companywhat is happening in the company

To cultivateTo cultivate quality awarenessquality awareness

among employeesamong employees


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