ISO9001：2000全英文

1、ISO 9001:2000 ObjectiveIntroduce the concept of new ISO 9001 StandardHighlight important areas and changes of the new standardBriefly introduce the system requirements of the new standardWhat is ISO 9001: 20002nd revision of Quality Management System Requirement Standard from International Organizat

2、ion for StandardsReplacement for previous ISO 9001 / 9002 and 9003 standards of 1994Introduced considerable conceptual changesApplicable to all types of Organizations with possible permissible omissions of certain requirementsNew ISO 9001QMSResource managementMeasurement, analysis & improvements

3、Product RealizationManagementResponsibilityContinual Improvement cycleGeneral requirementsGeneral requirementsISO 9001:2000 ModelCUSTOMERSCUSTOMERSQuality ManagementSystem5.ManagementResponsibility7. ProductRealization6. ResourceManagement8. MeasurementAnalysis and ImprovementRequirementsSatisfactio

4、nContinual Improvement ofthe Quality Management SystemConsumptionProductPrinciples of new standardBased on eight quality management principlesLeadershipProcess approachInvolvement of peopleSystem approach to ManagementContinual improvementFactual approach to decision makingMutual beneficial supplier

5、 relationship Customer focusPrinciples of new standardCustomer focusOrganization depends customers Understand current & future customer needs.Meet / exceed customer expectations LeadershipLeaders establish purpose & direction of the organizationShould create & maintain environment to ach

6、ieve organizations objectivesInvolvement of PeoplePeople of all levels are essence of an organizationTheir full involvement for organizations benefitProcess approachDesired results are achieved more efficiently when activities and resources are managed as processPrinciples of new standardSystem appr

7、oach to ManagementIdentifying, understanding and managing interrelated process as a system contributes to the organizations effectiveness & efficiencyContinual improvementsContinual improvement of the organizations overall performance should be a permanent objective of the organizationFactual ap

8、proach to decision makingEffective decisions are based on the analysis of data and informationMutually beneficial supplier relationshipsAn organization & its suppliers are interdependentMutually beneficial relationship enhances the ability of both to create valueExpectations of the new StandardA

9、void the application of systems that are separate from the organizations business processEnable the development of a Quality system that is fully integrated into the normal operations of organizations businessEnable Continual improvements of the system for enhanced customer satisfactionEnable compli

10、ance to statutory & regulatory requirementsImportant changes + Why it is to be doneWhat to do, When, Whom & How to doInvolvement of peopleContinual improvements should be achievedMaintain the system requirementsImprovements+ Statutory & regulatory requirementsRequirements specified by cu

11、stomer / organizationProduct requirementsValue adding processes20 quality elementsApproachCustomer satisfactionProductsMain focusNew VersionPrevious versionCriteriaProcess approachProcess definition Set of interrelated or interacting activities which transforms inputs into outputsEnsure continual im

12、provements Identify the processesDo it for all value adding processes Establish measuring criteriaIdentify the Interactions to other processesIdentify the Inputs & outputsProcess approach Continual improvements of ProcessPDCA CycleProcesses in termsOf Added ValueDOContinual improvements of Proce

13、sses based on objective measurementsACTIONMeasure results of processPerformance and effectiveness - Objective MeasurementsCHECKUnderstandings & meeting requirementsPLANE.g. - Purchasing ProcessPerformance MeasurementsDelivery status On-time, On spec, NCP etcSupplier evaluation OutputsReceipt of

14、Material on right conditionRight Quality Right QuantityRight TimePurchasing ProcedureInteractions toStorageInspection and TestingManufacturingFinanceInputsRequired item / quantity / dateApplicable specsSupplier sourceSuppliers capability to meet our requirementsProvision of resourcesHuman resourcesI

15、nfrastructuresWork environment6 Resource ManagementGeneral requirementsDocumentation RequirementsPlanningCustomer related processesDesign & developmentPurchasingProduction & service provisionManagement CommitmentCustomer focusQuality policyPlanningResponsibility, authority & communicatio

16、nManagement Reviews5 Management Responsibility8 Measurement Analysis & improvement System Requirements / Structure of the Standard4 Quality Management System7 Product RealizationGeneralMonitoring & measurementControl of NCPAnalysis of dataImprovements4 - Quality management system4.1 General

17、requirementsIdentificationof processes requiredCriteria and methods to ensure Operation & controlAvailability of information & resources for operation & controlMonitoring and Measuring of processesContinual improvements4 - Quality management systemQuality PolicyQuality ObjectivesQuality

18、ManualProcedures required by the StandardProcedures required for planning, operation & control of Organization activitiesRecords4.2 Document requirements5.6 Responsibility authority & communicate5.4 Planning5 - Management Responsibility 5.1 Management commitment5.2 Customer focus5.7 Manageme

19、nt Review5.3 Quality policyQuality objectivesQMS planningGeneralReview inputsReview outputsInternal communicationManagement representativeResponsibility & authority5 - Management ResponsibilityDevelopment, implementation and continually improvement of QMSCommunication of importance ofRegulatory

20、& statutory requirementsMeeting customer requirementsQuality Policy & Quality objectivesResponsibilities & authorities Appointment of Management RepresentativeConducting Management ReviewsProviding required resourcesEstablishment ofQuality PolicyQuality ObjectivesIdentification of Custom

21、er requirementsTop Managements commitment5 - Management ResponsibilityNew DevelopmentEvidence must be provided to show that the Management is committed to the above requirementsAuditors could speak to and audit Top Management (E.g. MD / Directors) to establish their commitment to the management syst

22、em6.4 Work Environment6.3 Infrastructures6 - Resource Management6.2 Human ResourcesGeneralCompetence, awareness & training6.1 Provision of resources6 - Resource ManagementResources required toImplementing, monitoring & continual improvementsEnhance Customer satisfaction by meeting customer r

23、equirementsHuman ResourcesInfrastructuresInfrastructures needed to achieve product conformityWork environmentWork environment needed to achieve product conformityResource Management6 - Human ResourcesCompetent on the basis of appropriate education, skill and experienceDefine competencies for people

24、performing work affecting product qualityProvide training or actionsEvaluate effectiveness of the training / actionsEmployees should aware importance of the activity being performed6.2 Human Resources7.6Control of monitoring measuring devicesControlPreservation of productValidation of processesIdent

25、ification & traceabilityCustomer property7.5Production & service provisionVerification of purchased productsPurchasing processPurchasing information7.4PurchasingDesign planningDesign inputsDesign outputsDesign reviewDesign ChangesDesign validationDesign verification7.3Design and development7

26、 - Product Realization 7.1Planning of product realizationIdentification of customer requirementReview of customer requirementCustomer communication7.2 Customer related processes7 - Product Realization Quality objectives of Products SpecsProcesses, procedures to realize productVerification, validatio

27、n, monitoring, inspection and testing of productRecord to demonstrate conformance 7.1Planning of Product realization7 - Product Realization Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirementsEffective communication with custome

28、r in relation to Product informationSales order handlingCustomer feedback Customer complaintsIdentification of Customer / Market requirementsSpecified by customerRequirements taken for grantedStatutory / Regulatory requirements 7.2Customer related processes (Sales)7 - Product Realization Design inpu

29、ts and outputsReview and verification, validation and control of changesAccuracyPotential hazards & faultsCorrectionsEvaluations against lessons learnedPlanningEffective & efficientExpectations of interested partiesEHS7.3Design and Development (Product)7 - Product Realization Supplier evalua

30、tionVerification of purchased product Inspection and testingDegree of control depends on effects of subsequent processes and effect on final product7.4PurchasingPurchasing is done in controlled manner to ensure that purchased products conforms to specific requirements7 - Product Realization Product

31、characteristics (Specs)Procedures and work instructionsSuitable equipments to manufacture. Monitoring and inspection & testingProduct release, delivery and post deliveryProcess validationIdentification and traceability Customers propertyMaterial supplied by customers e.g. 3rd party blending7.5Pr

32、oduction and service provisionManufacturing / service provision under controlled condition to ensure conformity of product7 - Product Realization 7.6 Control of monitoring and measuring devicesControl and Calibration of equipments used for monitoring, inspection and testing8 - Measurement, analysis

33、and improvement8.2Monitoring & measurements8.4Analysis of data8.5Improvement8.3 Control of non conforming productMeasurement of productInternal auditsCustomer satisfactionMeasurement of processesCorrective actionPreventive actionContinual improvements8.1General8 - Measurement, analysis and impro

34、vementTo demonstrateConformity of the productConformity to QMS requirementsContinually improvements and the effectiveness of the system8.2 - Monitoring and MeasurementsCustomer satisfaction / perceptionInternal audits - conformity planned arrangements of QMS and ISO9001Monitoring and measurements of

35、 processes to determine / demonstrate ability of processes to achieve required resultsMonitoring and measurements of product Conformity to product requirements8.3 - Control of NCPTo assure that NCP products are identified and controlled to prevent unintended use / delivery8.1 - To demonstrateConform

36、ity of the productConformity to QMS requirementsContinually improvements and the effectiveness of the system8 - Measurement, analysis and improvement8.4 - Analysis of data Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement

37、of the systemAnalysis shall provide information related toCustomer satisfaction / perceptionConformity to specs, requirementsTrends of processes and products Opportunities for preventive actionsSuppliers8 - Measurement, analysis and improvement8.5 - ImprovementsContinual ImprovementsQMS needed to be

38、 continually improvedCorrective actionActions to prevent recurrence of NCP, NCR etcIncludes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant recordsPreventive actionActions against potential non conformities to avoid their occurrenceIncludes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of recordsCriteria for measurementsInternal auditsEffectiveness & efficiency of processesOpportunities for impr