Implementation of ISO 9001 Standards for Quality a

1CERTNO.:2006-2-1577SSISO9001:2000ImplementationofISO9001StandardsforQualityattheSingaporeTissueNetworkTheresaP.ChowDeputyDirectorSingaporeTissueNetworkISBER20072CERTNO.:2006-2-1577SSISO9001:2000STNOverviewSTNisthenational,non-profittissueandDNAbankforSingapore.STNwasfoundedinMarch2002fullyfundedbytheBiomedicalResearchCouncil(BMRC)oftheAgencyforScienceTechnologyandResearch(A*STAR)inSingapore.STN’smainbusiness:thecollection,processing,archivinganddistributionofbiospecimensandassociatedclinicaldatatosupportbiomedicalresearch.STN’sbiospecimensareavailabletoresearchersinSingapore,collaboratorsandindustrieswithresearchinterestsinSingapore.3CERTNO.:2006-2-1577SSISO9001:2000STNCurrentStatus•Totaldonors:14,524•27ongoingandpendingprojects•20collaboratinginstitutes•15collectionsites,16processes•Estimatedsamples:540,000byyear20114CERTNO.:2006-2-1577SSISO9001:2000NationalPoolCancerSingaporeConsortiumofCohortStudies(SCCS)DiseaseSpecificTwinPublicHospitalsPrivateHospitalsCancerConsortialGroupsSingaporeProspectiveStudySingaporeMalayEyeStudyMyocardialInfractionGeneticsStudyPsoriasisTardiveDyskinesiaSchizophreniaDengueHepatitisB•Tissues•Bloodandbloodcomponents•DNA/RNA•Urine•Buccalsamples/saliva•ImmortalizedCelllinesStrokeAtrialFibrillationDiabetesCohortMultiEthnicCohortSTNProjects11CERTNO.:2006-2-1577SSISO9001:2000SampleCollection,ProcessingandStorageatSTNPairedcancer&normaltissueBloodSamplecollection(projectbased)Frozentissue(LiquidN2)Histology/Cytology(Roomtemperature)Sampleprocessing(storagecondition)DNAProtein(-80°C)RNA(LiquidN2)Samplealiquot(storagecondition)Viableortransformedlymphocyte(LiquidN2)Plasma/serum(-80°C)Wholeblood,Redbloodcells(-80°C)OthersUrine(-80°C)Saliva(-80°C)Buffycoat(-20°C)DNAProtein(-80°C)RNA(LiquidN2)Protein(-80°C)DNAProtein(-80°C)RNA(LiquidN2)PrincipleInvestigatorsendProjectProposaltoSTNApprovalfromSTNSteeringCommittee&externalreviewersObtainpatient’sconsentSamplescollectionathospitals/clinicsSamplestransportedtoSTNSamplesprocessing&storageatSTNDNA(-80°C)ProteinMetabolites(-80°C)Qualitycontrol/QualityAssurancePre-STNacquisitionPost-STNacquisition126CERTNO.:2006-2-1577SSISO9001:2000ChallengesforBiobankManagementIncreasingnumberofprojectsandcomplexities7CERTNO.:2006-2-1577SSISO9001:2000QualityManagementSystem(QMS)WhyimplementQualityManagementSystem(QMS)?•Toimplementasetofpolicies,processesandproceduresrequiredforplanningandexecution(Production/Development/Service)inthecorebusinessareaofanorganization.•Integratesvariousinternalprocesseswithintheorganization,provideprocessapproachforexecution.•Enablesorganizationtoidentify,measure,controlandimprovecorebusinessprocessesleadingtoimprovedbusinessperformance=customersatisfactionWikipedia8CERTNO.:2006-2-1577SSISO9001:2000WhatisISO?InternationalOrganizationofStandardization()•Voluntaryinternationalstandardsforbusiness,governmentandsociety•Economicbenefit•DiversifiedorganizationsimplementingISO•Certification:Independentauditandcertificationbythirdparty•Certification:Notarequirementforstandard,whichcanbeimplementedwithoutcertification,however,independentconfirmationofconformityaddsvalue.9CERTNO.:2006-2-1577SSISO9001:2000MostwidespreadISOstandards•ISO9000/9001–QualityManagementSystem(QMS)776,608issuedin161countries•ISO14000/14001-EnvironmentalManagementSystems(EMS)111,162issuedin138countries•ISO13485–QMSforMedicalDeviceIndustry5,065in67countries•ISO17025–QMSforTestingLaboratories•ISO16949–QMSforAutomotiveIndustry•ISO17799–InformationSecurityManagementSystemsStatisticsfromISOSurvey(2005)10CERTNO.:2006-2-1577SSISO9001:2000ISO9000:QualityManagementSystemsAfamilyofaboutadozenstandardsforthedevelopmentandimplementationofaQMS•ISO9000–Fundamentalsandvocabulary•ISO9001–QualityManagementSystems•ISO9004–Guidelinesforperformanceimprovements•ISO19011–Guidelinesforauditingquality11CERTNO.:2006-2-1577SSISO9001:2000TheProcessApproach•Identifylinkedactivities•Input……Output….Input…..Output•ManageResourcestotransformInputtoOutputsISO9001:2000–a“process”approachforQMS12CERTNO.:2006-2-1577SSISO9001:2000ModelofaProcess-basedQMSManagementResponsibilityResourceManagementMeasurementAnalysisandImprovementProductRealizationCustomersRequirementsCustomersSatisfactionOutputInputContinualImprovementoftheQualityManagementSystemNeedsPolicies,ObjectivesIdentifykeyprocessesDetermineandprovideresourceApplyprocessforcontinualimprovementsAdaptedfromSSISO9001:2000QualityManagementSystems–RequirementsSPRINGSingapore2000MethodstomeasureeffectivenessCorrective/PreventiveActions13CERTNO.:2006-2-1577SSISO9001:2000KeyProcessesoftheSingaporeTissueNetworkKeyprocessesthataffectthelevelofsatisfactionofbothinternalandexternalcustomersthatwereidentifiedandcontrolled(asdefinedinSTNQualityManual):Customers=Memberofthepublic,hospitals,researchinstitutes,BioethicsAdvisoryCommittee(BAC),InstitutionalReviewBoard(IRB),GovernmentalandStatutoryBodiesSTN’sKeyProcesses•Projectapplication&administration•Collectionofbiospecimensforbothscheduled&unscheduledprojectsincludingallrelatedethicalprocesses•Withdrawalof