Designation:D8222−21aStandardGuideforEstablishingaQualityManagementSystem(QMS)forConsumerUseofCannabis/HempProducts1ThisstandardisissuedunderthefixeddesignationD8222;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidefocusesonthecoreelementsofaneffectivequalitymanagementsystem(QMS)necessarytooptimizeconsumerandproductsafety,productquality,andconformancewithrequirementsfromindustry,governmentalagencies,andotherauthoritieshavingjurisdiction.Thisguideincorporatesbasicqualityprinciples,guidelines,andindustrybestpracticesnecessarytoestablishaQMSadaptabletoallorganizations.1.2Lawsandregulationsfromauthoritieshavingjurisdic-tionsupersederecommendationswithinthisguide.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpracticesanddeter-minetheapplicabilityofregulatorylimitationspriortouse.1.4Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecom-mendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.2.ReferencedDocuments2.1ASTMStandards:2D8220GuideforConductingRecall/RemovalProceduresforProductsintheCannabisIndustryD8229GuideforCorrectiveActionandPreventiveAction(CAPA)fortheCannabisIndustryD8244GuideforAnalyticalLaboratoryOperationsSupport-ingtheCannabis/HempIndustryD8250PracticeforApplyingaHazardAnalysisCriticalControlPoints(HACCP)SystemforCannabisConsum-ableProductsD8282PracticeforLaboratoryTestMethodValidationandMethodDevelopmentD8286GuideforProcessingCannabisProductComplaints2.2ASQDocument:3FailureModeandEffectsAnalysis(FMEA)BriefSummary3.Termin...
