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    ISO 9001 - Document Control 4.2.3

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    Arun Kumar
    The document discusses ISO 9001 document control requirements and common issues organizations face in implementing document control systems. It notes that while the ISO 9001 requirements are not difficult to meet, many organizations overcomplicate their systems by adding unnecessary processes and approvals. The key requirements of identifying document revisions, ensuring relevant versions are available, and preventing unintended obsolete document use are fairly straightforward to implement. Organizations should avoid overly complex processes and focus on practical approaches that meet the standard's actual requirements.

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    ISO 9001 - Document Control 4.2.3

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    Arun Kumar
    214 views3 pages
    The document discusses ISO 9001 document control requirements and common issues organizations face in implementing document control systems. It notes that while the ISO 9001 requirements are not difficult to meet, many organizations overcomplicate their systems by adding unnecessary processes and approvals. The key requirements of identifying document revisions, ensuring relevant versions are available, and preventing unintended obsolete document use are fairly straightforward to implement. Organizations should avoid overly complex processes and focus on practical approaches that meet the standard's actual requirements.

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    The document discusses ISO 9001 document control requirements and common issues organizations face in implementing document control systems. It notes that while the ISO 9001 requirements are not difficult to meet, many organizations overcomplicate their systems by adding unnecessary processes and approvals. The key requirements of identifying document revisions, ensuring relevant versions are available, and preventing unintended obsolete document use are fairly straightforward to implement. Organizations should avoid overly complex processes and focus on practical approaches that meet the standard's actual requirements.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    214 views3 pages

    ISO 9001 - Document Control 4.2.3

    Uploaded by

    Arun Kumar
    The document discusses ISO 9001 document control requirements and common issues organizations face in implementing document control systems. It notes that while the ISO 9001 requirements are not difficult to meet, many organizations overcomplicate their systems by adding unnecessary processes and approvals. The key requirements of identifying document revisions, ensuring relevant versions are available, and preventing unintended obsolete document use are fairly straightforward to implement. Organizations should avoid overly complex processes and focus on practical approaches that meet the standard's actual requirements.

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    ISO9001DocumentControl(4.2.3) MarkA.Randig SomethingIruninto,withseeminglyalarmingregularity,aredocumentcontrolsystemsthatareoverly conceived,ridiculouslycomplexandunnecessarilyconstrictive.Thisissomewhatofamysterytome,as withsomuchemphasisplacedonthisarea,itneverthelessseemstoalsobeoneoftheareasthatmost organizationsstrugglewith.ItsnotthattherequirementsoftheISO9001standardaredifficulttomeet itsthefactthatmanyorganizationsseemcompelledtogoaboveandbeyondtherequirementsofthe standard,implementingpracticesthatmakesthemanagementofthisfunctionharderthanitshouldbe. Clause4.2.3oftheISO9001standardrequiresthatdocumentsusedbyanorganizationsQMSbe controlled.ThisisoneofonlysixclauseswithintheISO9001standardwhereawrittenprocedureis required,andit'sprettyclearonwhatcontrolsneedtobeaddressed.Ifwereviewtheactualrequirements ofthestandard,wecanseewhatsreallyneeded Approvedocumentspriortoissue; Letsbepracticalforamoment.Howmanysignaturesdoyouactuallyneed?Manyorganizationsrequire thesignatureofthePresident,ManagementRepresentative,QualityManager,etal.

    etal.Thispracticeisfine, providedtheresareasonforit.Requiringsignaturesforthesakeofhavingsignaturesdoesntaddanyreal value,particularlyifit'sonlyarubberstampor"CYA"typeofexerciseisthePresident,CEO,CFO,etc. ofthecompanyreallygoingtoread(anddotheyreallyneedtoread)allofthesedocuments? Whiletheactualapprovalswillneedtobedefinedbytheorganization,documentapprovalshouldbeleft totheresponsibleparty(e.g.,processowner)andotherappropriatestakeholders.TopManagement doesntneedtosigneverypieceofpaperandjustanotefromexperiencetheytypicallydontwantto.If adocumentcanbeadequatelyreviewedandapprovedbyjustoneortwofunctionswithinanorganization, thatsalltheapprovalsthatadocumentreallyneeds. Reviewandupdateasnecessaryandreapprovedocuments; Therequirementhereisfor"asnecessary".Thiscanbeaperiodic/scheduledreview,oritcanbeareview performedonanasneededbasisinordertoaddressadeficiencyornegativetrendthathasbeen identified.Youalreadyperformamanagementreview,sothismayserveastheperfectopportunityto reviewthedocumentationthatmakesupyoursystemaswell.Youwillneedsomemethodofrecording thisreview,howeverthiscanbeaccomplishedinanymannerthatsuitstheorganization. Updatesandthesubsequentreapprovalofdocumentsshouldonlybeperformedasneededandshould notbeusedmerelytosatisfytherequirementfortheabovereviewit'sanunnecessaryandwasteful practice.Shouldadocumentrequireupdatingandreapproval,thisresponsibilitywouldtypicallyremain withthesameapprovalauthorityastheoriginalversion. Noteherealso,thatmanycodes,standardsand/orspecificationsareonlyupdatedonaperiodicbasis(not annually),sothereisntmuchreasontoreviewand/orupdaterelatedinternaldocumentsmorefrequently, unlesstherewasacausetodoso.
    17117 Westheimer Road Suite #1, Houston TX 77082 Tel: 281-494-4874 / Fax: 413-294-4874 Email: [email protected] / Website: www.masquality.com

    Ensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified; Thestandardrequiresthatdocumentschangesbeidentifiedandtherevisionstatusnoted.Inmostcases, thiscanbeaccomplishedbyarevisionhistorythatsincludedaspartofthedocument,withchangesnoted inthedocument'smargins(blackline),bynotesintherevisionhistory,orbyreferencetoachange record(inmanycases,aChangeRequest).Revisionscanthenbeidentifiedbynumbers(1,2,3...),letters (A,B,C)orsomecombinationthereof.Theorganizationshouldmaintainsomeformofmasterlistor registeridentifyingwhichdocumentsareusedbythesystemandeachdocumentscurrentrevisionstatus. Ensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse; Itsbecomingrarerinthisdayandagetocomeacrosscompaniesthatdontmaintainanetworkserver.By virtueofhavingthesedocumentsinadedicatedfolder(ornetworkdrive)thisrequirementissatisfied, providedaccessisallowedtothosepersonnelthatrequireit.Itshouldbecommunicatedhoweverthatall printedversionofsuchdocumentsareuncontrolledandthattheusershouldrefertotheserverforthe mostrecentversion.Limitingaccesstotheprintingofdocumentscanbehelpful;althoughitisnot essentialtocontrol,providedthatanyprintedcopiesofdocumentsaredestroyedimmediatelyafteruse. Ifpapercopiesofdocumentsareused,thisactivityshouldbelimitedtothosecaseswhereabsolutely necessary.Thecontrolofsuchcopiescanrequireaconsiderableamountofadministration,oftenrequiring resourcesdedicatedtothisactivity.Asthespanofsuchcontrol(e.g.,thenumberofdocumentrecipients) isincreased,considerationshouldalsobegiventothemanagementofrevisionsandthetiming/scheduling oftheirrelease,asperpetualupdatingandreupdatingofpapercopiesnotonlycreatesalotofwork,but canalsocauseconsiderableconfusionincommunicatingnecessaryinformationtoaffectedparties. Inmanycases,functionsutilizingpapercopiescanbenefitfromaplannedrevisionandreleaseschedule (e.g.,monthly,quarterly,annually,etc.)asopposedtoissuingareviseddocumenteachtimethattheneed foraminorcorrectionoreditorialchangeisidentified.ThisapproachwouldnotapplytoMajorissues whichaffectprocessperformanceand/orproductconformancehowever,astheseissueswouldrequirean immediateupdatewhenidentified. Ensurethatdocumentsremainlegibleandreadilyidentifiable; Incaseswheredocumentsmaintainedinanelectronicformat,legibilityreallyisntanissue.Inthecaseof papercopies,ensuringthatdocumentremaininauseableconditionistypicallyaresponsibilityofthe documentrecipient.Asfarasidentificationisconcerned,eachdocumentshouldbeassignedsomeformof identifier(number,lettersorcombinationthereofevenjustatitleisfine)whichallowsthedocumentto bereferencedwithinthesystemandidentifiedaspartofthedocumentationthatmakesupthesystem. Ensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled;and Makealistofthedocumentsthatyouuse.Thiscanincludeapplicablecodes,standardsandspecifications (yesincludingISO9001:2008),aswellasanycustomerspecificationsorinstructions.Customerdesigns arealsoconsidereddocuments,soifyoumaintainthese,thanthisrequirementwouldapplyaswell.In suchcases,youwouldn'tberesponsiblefortheapprovalorupdatingofthesedocuments(theyrenot yours)howeveryouarestillrequiredtoensurethatyouhavethemostrecentversionsandthattheyare madeavailabletoaffectedpersonnelatpointsofuse.
    17117 Westheimer Road Suite #1, Houston TX 77082 Tel: 281-494-4874 / Fax: 413-294-4874 Email: [email protected] / Website: www.masquality.com

    Preventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyare retainedforanypurpose. Thisrequirementprettymuchspeaksforitself.Thesimplestapproachtocomplyingwiththisrequirement istoensurethattherearentdocumentslyingaround.Useofelectronicsystemsmakesthistaskeasier,as thecopymaintainedonthenetworkorserveristhecurrentversionandallothersareconsidered obsolete;howeverifpaperbasedcopiesareused,instructionsshouldbegivenwithanydocument updatesforthedispositionofthedocumentsbeingsuperseded.Supersededand/orobsoletedocuments shouldeitherbedestroyedorifretained,markedasobsolete,supersededorinasimilarmanner. Whileacopyofeachsupersededdocumentshouldberetained,itshouldbemaintainedasafilecopyand controlledinanareawhereitwouldnotbeaccessibleforuse. Idliketomakeafinalnotethatnowherewithinthestandardisthereanyreferencemadetocomplex numberingschemes,theuseofcontrol,uncontrolled,obsoleteorotherstamps,coloredpaper, revisionchecklists,transmittallettersorreceipts.Whilesomeoftheserequirementsmayhelpthe organizationensurecompliancewiththeclauseofthestandard,theyaresupplementalcontrolsthathave beendefinedbytheorganization,notprescribedbythestandard. Ifyouhavingproblemskeepingyourdocumentcontrolfunctioninline,perhapsyouneedtoactuallyre readthestandard.Theproblemsthatyouaresufferingthroughmaybeproblemsthatyouarecreatingfor yourself.Yourcontrolsshouldaddtotheeffectivenessofthefunction,andnotjustcreateadditional bureaucracyandadministration.Aproperlydevelopedandimplementeddocumentcontrolfunction shouldbeaneffective,sustainable,efficientaidinhelpinganorganizationcommunicatednecessary informationtoaffectedparties. Isthishowyourdocumentcontrolsystemworks? MarkRandigisthePresidentandFounderofMASSolutionsLLC.,aHoustonTexasbasedconsultingfirm thatspecializesinhelpingcompaniesachievebreakthroughperformancebyfocusingonQuality EnhancementandProductivityImprovement.TogetyourFREEcopyofMarksnewsletter"TheQuality Specialist",gotohttp://www.masquality.com. 2009MASSolutionsLLC.AllRightsReserved.

    17117 Westheimer Road Suite #1, Houston TX 77082 Tel: 281-494-4874 / Fax: 413-294-4874 Email: [email protected] / Website: www.masquality.com

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