Chapter 10: Quality Management SystemsWhat’s ISO?What We Need to KnowGetting to Know ISOBenefits of ISO RegistrationRequirements1st Three RequirementsRequirements ActivityThe Other 5 Requirements4 – Quality Management System (QMS)5 – Management Responsibility6 – Resource Management7 – Product Realization8 – Measure, Analyze and ImproveDocumentation ActivityDocumentationBREAK!ImplementationImplementation ActivityInternal AuditsHow To Do An Internal AuditAudit ActivityTwo Ways to be ISO CertifiedRegistrationRegistration ProcessWhat We Now KnowResourcesChapter 10:Quality Management SystemsJennifer SadorusHeather HellerWhat’s ISO?International Organization for StandardizationProvide international standards for products and servicesFacilitates worldwide exchange of goods and servicesWhat We Need to Know1. Basics of ISO2. Benefits3. Requirements4. Documentation Procedures5. How to Implement ISO6. How to do an Internal Audit7. How to RegisterGetting to Know ISOFound in 1946 – Geneva, Switzerland90 Member CountriesANSI – USA RepresentativeISO Technical Committee (TC) 176Developed the International Standards for Quality in 1987ISO 9000, 9001 & 9004Benefits of ISO RegistrationGlobal competitivenessMaintain or increase market sharesSecondary benefits for the supplierDecrease in scrap, rework and nonconformities at final inspectionIncrease in product reliabilityImproved time to market, on-time delivery and throughputDecrease in the cost of poor quality measured but external forcesRequirementsScopeNormative ReferencesTerms and DefinitionsQuality Management System (QMS)Management ResponsibilitiesResource ManagementProduct or Service RealizationMeasurement, Analysis and Improvement1st Three RequirementsScopeNormative ReferenceTerms and DefinitionsINFORMATION ONLYRequirements ActivityThe Other 5 Requirements5 - MANAGEMENT 4 - QMS COUNTINUAL7 - PRODUCT 6 - RESOURCE8 - MEASUREMENT, ANALYSISINPUTOUTPUTCUSTOMER RESPONSIBILITY IMPROVEMENT REALIZATION MANAGEMENT AND IMPROVEMENTREQUIREMENTSPRODUCTSATISFACTIONMODEL OF A PROCESS-BASED QUALITY MANAGEMENT SYSTEM4 – Quality Management System (QMS)Identify the processDetermine the process sequenceSet methods for effective operation and control of processEnsure availability of resources and information for the processMonitor, measure and analyze the processContinually improve the processDocumentQuality policies, manuals, procedures…Set controls for documents and maintain records of conformance5 – Management ResponsibilityCommitmentCustomer FocusQuality PolicyPlanning – Quality Objectives and QMSDefine Responsibilities, Authorities and CommunicationReview6 – Resource ManagementProvision of ResourcesHuman ResourcesInfrastructureWork Environment7 – Product RealizationPlanCustomer RelatedDesign and DevelopPurchasingProduction and Service ProvisionControl of Monitoring and Measuring Devices8 – Measure, Analyze and ImproveMonitor and MeasureControl of Nonconforming ProductAnalysis of DataImprovementDocumentation ActivityForm 4 Groups of 3DocumentationPOLICYPROCEDUREWORK INSTRUCTIONSRECORDS OR PROOFOR PRACTICESBREAK!ImplementationTop Management CommitmentAppoint the Management RepresentativeAwarenessAppoint an Implementation TeamTrainingTime ScheduleSelect Element OwnersReview the Present SystemWrite the DocumentationInstall the New SystemInternal AuditManagement ReviewPre-AssessmentRegistrationImplementation ActivityInternal AuditsObjectivesDoes actual performance conform to documented QMS?Initiate corrective action to deficienciesFollow up on noncompliance items from previous auditsProvide continued improvement through feedbackEncourage possible improvements by thinking about the systemHow To Do An Internal AuditAuditorTrained in auditing principles and proceduresObjective, honest and impartialGood communicator, listener and observerTechniquesExamination of documentsObservation of activitiesInterviewsProcedurePre-Audit MeetingTimetables, what is being audited, review requirementsAuditDetermine how well the system has been implemented and maintainedClosing MeetingPresent a summary including nonconformities, corrective action and decide on follow-upAudit ActivityForm 2 GroupsTwo Ways to be ISO Certified2-Party SystemCustomer audits the supplier’s quality system3-Party SystemRegistrar audits and certifies a supplier’s quality systemRegistrationSelect a RegistrarQualifications and experienceCertificate recognitionRegistration processTime and cost constraintsAuditor qualificationsRegistration ProcessApplication for RegistrationDocument ReviewPre-AssessmentAssessmentRegistrationFollow-up SurveillanceWhat We Now Know1. Basics of ISO2. Benefits3. Requirements4. Documentation Procedures5. How to Implement ISO6. How to do an Internal Audit7. How to
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