Introduction on ISO 9000 Series Standards(ppt 43页)英文.pptx

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1、来自中国最大的资料库下载Introduction on ISO 9000 Series StandardsWhat is ISO?nInternational Organization for StandardizationnWorldwide federation of national standards bodiesnNon-governmental organizationnEstablished in 1947ISO: Management System StandardsnTwo “Management System” standards: qISO 9000 Quality qI

2、SO 14000 EnvironmentalnProvide model for setting up & operating management systemnBuilt on firm foundation of state-of-the-art practicesISO 9000 Family Standards: 2000nISO 9000:QMS - Fundamentals and VocabularynISO 9001:QMS - Requirements nISO 9004: QMS - Guidelines for Performance ImprovementsnISO

3、19011:Guidelines for QMS & EMS Audit ISO 9000 Registrations Worldwide0100,000200,000300,000400,000500,000600,000Dec. 1995Dec. 1996Dec. 1997Dec. 1998Dec. 1999Dec. 2000Dec. 2001Number of RegistrationsISO 9000 Family Standards: 2000nEight QM principlesnWhat is the most important principle?nAnd why?Proc

4、ess-based QMS modelContinual improvementCustomer(and other interested party)RequirementsCustomer (and other interested party)SatisfactionManagement ResponsibilityResource ManagementProductRealizationMeasurement,Analysis &ImprovementProductOutputInput图释图释V a l u e - a d d e d activities Information f

5、lowMajor contents of ISO 9001: 2000n4 Quality Management System4.1 General Requirements4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual4.2.3 Control of Documents4.2.4 Control of RecordsMajor contents of ISO 9001: 2000n5 Management Responsibility 5.1 Management Commitment 5.2 Custome

6、r Focus5.3 Quality Policy 5.4 Planning 5.4.1 Quality Objectives 5.4.2 Quality management system planningMajor contents of ISO 9001: 2000n5 Management Responsibility 5.5 Responsibility Authority and Communication5.5.1 Responsibility and Authority5.5.2 Management Representative5.5.3 Internal communica

7、tion5.6 Management Review 5.6.1 General 5.6.2 Review inputs 5.6.3 Review outputs Major contents of ISO 9001: 2000n6 Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.2.1 General6.2.2 Competence, awareness and training6.3 Infrastructure6.4 Work Environment Major contents of ISO 900

8、1: 2000n7 Product Realization 7.1 Planning of Product Realization 7.2 Customer Related Processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of product requirements 7.2.3 Customer Communication Major contents of ISO 9001: 2000n7 Product Realization 7.3 Design and Developm

9、ent (D&D)7.3.1 Planning of D&D 7.3.2 Inputs of D&D7.3.3 Outputs of D&D 7.3.4 Review of D&D 7.3.5 Verification of D&D 7.3.6 Confirmation of D&D 7.3.7 Control of changes in D&DMajor contents of ISO 9001: 2000n7 Product Realization 7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.

10、4.3 Verification of purchased product 7.5 Production and Service Provision 7.5.1 Control of processes 7.5.2 Validation of processes 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Monitoring and Measuring DevicesMajor contents of ISO 9001: 2

11、000n8 Measurement, Analysis & Improvement 8.1 General8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring and Measurement of Processes 8.2.4 Monitoring and Measurement of ProductMajor contents of ISO 9001: 2000n8 Measurement, Analysis & Improvement 8.3 Con

12、trol of Non Conforming Product 8.4 Analysis of Data 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive ActionQ u a lity P o lic yQ u a lityO b je c tiv e sQ M SP la n n in gIn te r n a lC o m m u n ic a tio nM a n a g e m e n tR e v ie wA llo c a tio n o fR e s o u

13、r c e sT r a in in gIn fr a s tr u c tu r eW o r kE n v ir o n m e n tC o n tr o l o f N o n -c o n fo r m a n c eC o r r e c tiv eA c tio n sM o n ito r in g a n dM e a s u r e m e n tIn te r n a l A u d itA n a ly s is o fD a taCUSTOMERSATISFACTIONCUSTOMERREQUIREMENTSM e a s u r e m e n t,A n a ly

14、 s is &Im p r o v e m e n tR e s o u r c eM a n a g e m e n tM a n a g e m e n t R e s p o n s ib ilityC o n tin u a lIm p r o v e m e n t P r e v e n tiv eA c tio n sR e s p o n s b illity ,A u th o r ityP r o d u c tR e a lis a tio nC u s to m e r -R e la te dP r o c e s s e sD e s ig n &D e v e l

15、o p m e n tP u r c h a s in gP la n n in g o f P r o d u c tR e a lis a tio nD o c u m e n t a n d R e c o r d sC o n tr o lP r o d u c tio n a n dS e r v ic e P r o v is io n.Interaction of key elements under ISO 9001:2000 Establishing QMSnWhen to establish QMS?n-gain access to the international ma

16、rket n-create or strengthen the brand n-clear/standardize/improve the internal processes n-more emphasis on quality and the culture concernedEstablishing QMSnPDCA-Demings contribution-base of process improvementPLANCHECKDOACTDemingSteps to ISO 9001 RegistrationpIdentify key processespDesign & docume

17、nt systempImplement and operate systempInternal auditspRegistrar auditpMaintain registrationSteps to Registration1. Identify key processes “Process map” shows relationship between processes throughout organizationQMS Model for AIOUs External MBA Degree Program Steps to Registration2. Design & docume

18、nt systemDocumentationnQuality Policies & ObjectivesnQuality Manual nProcedure documentsnSupportive documents: Work Instructions, Regulations nQuality Records - demonstrate conformance to system Steps to Registration3. Implement and operate systemnCommunicate throughout organizationnDepartments perf

19、orm work as described in proceduresSteps to Registration4. Internal AuditsnTrained Internal AuditorsnDocumented internal audit plan nAudit results reviewed by managementnMake corrections & improvements to quality systemSteps to Registration5. Registrar Audit nDocumentation reviewed by auditornRegist

20、rar sends audit teamnOn-site audit typically 2-3 daysnAuditors verify that system operates as outlined in procedure manualnRecommend for registrationnCertificate issuedThird Party Registration SystemOthersANSI/RAB(U.S.)ISO / TC176Quality ManagementandQuality AssuranceTechnical CommitteeNationalAccre

21、ditationBodiesQMISGSRegistrarsOtherOtherCFSOOrganizationsSCC(Canada)BSISteps to Registration6. Maintain RegistrationnContinue to operate quality systemnSurveillance audits (annual / semi-annual)n3-year cycleCFSO Registration: Key MilestonesnDecember 31, 2002:Quality Management System Documentation c

22、ompleted (Head Office)nJanuary 31, 2003:Internal Audit team trainedCFSO Registration: Key MilestonesnApril 30, 2003:Internal Audits completed on all Quality System ProceduresnJune 30, 2003: ISO 9001 Registration achieved (Head Office)CFSO Registration: Key MilestonesnDecember 31, 2003:Quality Manage

23、ment System Documentation completed (Regional Centers)nJune 30, 2004: ISO 9001 Registration expanded to Regional Centers (Sample Basis)Argument about the Standards effectivenessnAn issue that has long occupied both the business world and researchers is whether the development and certification of a

24、quality management system according to ISO 9000 standards can finally guarantee real improvement to the certified organizations. Argument about the Standards effectivenessnLiterature review on the standards effectiveness reveals two schools of thought. One school of thought supports that the standar

25、ds offer a good first step towards TQM and business excellence, while the other school of thought is based on the view that organizations are mainly interested in quick and easy certification without real commitment to quality, leading to the development of “static” quality systems that cannot guara

26、ntee customer satisfaction Tsiotras & Gotzamani, 1996 Argument about the Standards effectivenessnThe revised ISO 9000:2000 version is much closer to the business excellence models. The new series is based on a set of quality management principles that have a good deal in common with the principles o

27、f TQM, and there is a remarkable convergence with the quality management principles of the most popular business excellence models. In fact, the Baldrige criteria have had a profound effect on the ISO 9001:2000 revision Hampton, 2000 and as a result, the new ISO 9000:2000 requirements are more custo

28、mer, process and continuous improvement oriented. Argument about the Standards effectivenessnHowever, there are serious doubts and reservations again concerning the degree to which the new standards will really boost companies performance more than the previous ones Bendell, 2000, Biazzo & Bernardi,

29、 2003, Costa & Martinez-Lorente, 2003, Janas & Luczac, 2002, Larsen & Haversjo, 2000, Laszlo, 2000, Wealleans, 2002 What Others Sayn“ISO 9001 has helped management establish a transparent internal organization that is clear to all employees.”Wieslaw Vic Uzieblo, Director of Marketing, Protektor, Pol

30、andWhat Others Sayn”Each dollar invested generates at least a four-fold return if the standard is implemented well.”Robert Dor, Coordinator for Service Quality, Municipality of Saint-Augustin-de-Desmaures, Canada What Others Sayn“At IBM, the ISO 9000 standards have proven to be a template for the cr

31、eation of a sound quality system. By embarking on the ISO 9000 journey, it is reasonable to expect lower costs, improved customer satisfaction, greater brand loyalty, and stronger market performance associated with this quality effort.” Dr. Jack E. Small, Director ISO 9000, IBM, USA Case of the fran

32、chised car dealer-supply chain viewnManagement responsibility-Quality policyCase of the franchised car dealer-supply chain viewnResource management-Supply of resources-Infrastructure and work environmentCase of the franchised car dealer-supply chain viewnProduct realization-Identification of require

33、ments relevant to the product-Communication with customer -Purchase-Sign and traceabilityCase of the franchised car dealer-supply chain viewnMeasurement, analysis and improvement-Customer satisfaction-Supervision and Measurement -Control of the nonconformity-ImprovementAssignment 1#nThere is a quali

34、ty inspection executive (QIE) in the company who is strict with quality inspection. In a recent inspection, he found the non-conforming products. He took the measure of preventing them from being deliver and reported this case to the top management (TM) in time. TM usually gives him great support. B

35、ut this time, TM communicated with him to ask for delivery as that order is very urgent and failure to deliver on time will cause big loss. But QIE refused to do so with the support of quality manual and product quality requirements. Finally, TM commanded deliver of those products and meanwhile promised not to do so next time.Your opinion?