Quality Management SystemsIntroductionWhy develop quality standard?Most prevalent standardsMost prevalent standards (cont’d)History of ISOBenefits of ISO regulationISO 9000 series of StandardsISO 2001 RequirementsImplementing ISOImplementing ISO (cont’d)Documentation (why is it needed?)Cascading documentationDocument developmentDocumentationCreating ManualsAuditingObjectives of AuditingAuditing techniquesAuditing procedureRegistrationRegistration processQuestionsQuality Management Quality Management SystemsSystemsAnurag SharmaAnurag SharmaAlfred Borget AnoyeAlfred Borget AnoyeIntroductionIntroductionWhy develop quality Why develop quality standard?standard?To increase quality oriented To increase quality oriented customerscustomersTo generalize norms of qualityTo generalize norms of qualityTo prepare credible benchmarkingTo prepare credible benchmarkingMost prevalent standardsMost prevalent standards ISO 9000: specifies necessary ISO 9000: specifies necessary components of a quality management components of a quality management system system ISO 14001: manages environment ISO 14001: manages environment processes and impacts processes and impacts QS 9000: supplement of IS0 9000:1994 QS 9000: supplement of IS0 9000:1994 for continuous improvement, for continuous improvement, prevention of nonconformance, and prevention of nonconformance, and scrap and rework reductionscrap and rework reduction ISO/TS 16949: specific to the ISO/TS 16949: specific to the Automotive industry Automotive industryMost prevalent standards Most prevalent standards (cont’d)(cont’d)AS 9100: specific to aerospace industry AS 9100: specific to aerospace industry TL 9000: specific to TL 9000: specific to telecommunications industry telecommunications industry ISO 13485 & 88: specific to medical ISO 13485 & 88: specific to medical devices devices TE Supplement: specific to US TE Supplement: specific to US automotive suppliersautomotive suppliersHistory of ISOHistory of ISO Found in 1946Found in 1946International standards for quality International standards for quality systems published in 1987systems published in 1987Republished and updated version in Republished and updated version in 19941994Benefits of ISO regulationBenefits of ISO regulation Significant improvement on:Significant improvement on:Internal qualityInternal qualityProduction reliabilityProduction reliabilityExternal qualityExternal qualityTime performanceTime performanceCost of poor qualityCost of poor qualityISO 9000 series of ISO 9000 series of StandardsStandards ISO 9000: 2000 –focus on ISO 9000: 2000 –focus on fundamentals and vocabularyfundamentals and vocabulary ISO 9001: 2000—focus on ISO 9001: 2000—focus on requirementsrequirements ISO 9004: 2000—focus on guidelines ISO 9004: 2000—focus on guidelines for performance improvementfor performance improvementISO 2001 RequirementsISO 2001 RequirementsIt is the standard used for It is the standard used for registration by acquiring conformity registration by acquiring conformity of the quality management systemof the quality management systemMore details of IS0 9001 found in More details of IS0 9001 found in www.praxiom.comwww.praxiom.comImplementing ISOImplementing ISOManagement InterestManagement InterestManagement representationManagement representationAwareness and communicationAwareness and communicationAssigning a teamAssigning a teamTraining and practicesTraining and practicesTime FrameTime FrameElement ownershipElement ownershipImplementing ISO (cont’d)Implementing ISO (cont’d)Revision of the current systemRevision of the current systemDocumentationDocumentationIdentifying flawsIdentifying flawsInstalling new systemInstalling new systemAuditingAuditingManagement assessmentManagement assessmentRegistrationRegistrationDocumentation Documentation (why is it needed?)(why is it needed?)Records or proofsRecords or proofsFuture referencesFuture referencesPlanning and updatingPlanning and updatingTraceabilityTraceabilityCascading documentationCascading documentationPolicyPolicyProcedureProcedureWork InstructionsWork InstructionsDocument Document DevelopmentDevelopmentDocument developmentDocument developmentPolicies, procedures and work Policies, procedures and work instruction brought togetherinstruction brought togetherRevisionRevisionDiscarding irrelevant documentsDiscarding irrelevant documentsChanges and amendmentsChanges and amendmentsUpdatingUpdatingReader friendly formatReader friendly formatDocumentationDocumentationSimplicitySimplicityBrevity and ConcisenessBrevity and ConcisenessAttractive formatAttractive formatGood fonts and designsGood fonts and designsRelevant informationRelevant informationTraceabilityTraceabilityUnderscoring important issuesUnderscoring important issuesCreating ManualsCreating ManualsStatement of purposeStatement of purposeCompany’s policyCompany’s policyMaking controlled copiesMaking controlled copiesInclusion of ISO 9001Inclusion of ISO 9001Flow diagrams and figures instead of Flow diagrams and figures instead of verbiageverbiageProcedure manuals (refer to flow Procedure manuals (refer to flow diagram in text)diagram in text)AuditingAuditing One of the key elements of ISO One of the key elements of ISO standard, audit is performed in order standard, audit is performed in order to make sure if the system is being to make sure if the system is being followed and the expected results are followed and the expected results are obtained. obtained. It is done by the qualified individuals It is done by the qualified individuals who are trained in auditing principles who are trained in auditing principles and procedures.and procedures.Objectives of AuditingObjectives of AuditingConformance of actual performanceConformance of actual performanceIdentifying deficiencies and Identifying deficiencies and implementing corrective actionsimplementing corrective actionsImprovising the systemImprovising the systemInculcating flawless process to Inculcating flawless process to employeesemployeesAuditing techniquesAuditing techniquesExamining documentationExamining documentationObserving activitiesObserving activitiesListening to employeesListening to employeesIdentifying significant issues from Identifying significant issues from
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