Designation:D8398−22StandardPracticeforManagementResponsibilitiesinManagingaQualityManagementSystem(QMS)1ThisstandardisissuedunderthefixeddesignationD8398;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticeprovidesthemanagementresponsibilitiesfortheimplementationandoversightofaqualitymanagementsystem(QMS).Itcanbeappliedtoallcannabisoperations,includingcultivation,manufacturing,labeling,dispensing,anddistribution.Thispracticedoesnotaddressthequalityman-agementsystemdetails,butratherfocusesonthemaincon-siderationsformanagement’sroleinsettingupaQMS.GuideD8222providesanoverviewandsomedetailsaboutthecomponentsofaQMS.OtherstandardsprovidedetailsonspecificQMScomponents.1.2ThetermGxPasusedinthispracticeismeanttoincludethosegoodpracticesintheactivitiesincludedin1.1;namelycultivation,manufacturing,distribution,andalltherelevantfunctionsassociatedwiththeseactivities(forexample,purchasing,testing,storing,andsoforth).1.3Althoughthispracticementionstheimportanceofhealthandsafety,itisdonesointhecontextofoverallmanagementresponsibility.Thispracticedoesnotaddressdetailsofahealthandsafetysystem,butitidentifiestheimportanceofthisasamanagementresponsibility.1.4ThispracticeencompassesasinglecomponentoftheQMS(managementresponsibilities)that,whencombinedwiththeotherelements,satisfiestherequirementsofacompleteQMS.1.5Thepracticesdescribedinthisstandardareintendedtoapplytoallproductsofacannabisplantincludingthosethatcanbeclassifiedashempandwhichcontaincannabinoidsandcanbeconsumed/ingestedviamouth,nose,skin(whetherdescribedasmedicine,supplements,food,cosmetics,andsoforth.).1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpractices...
