2avrzanre LRA - Improving performance, ceducing isk -ISOIDIS 800.2014 Draft Iternatonal Standard Analysis ‘Tris ste uree cookies, By continuing to browse the ste you a ur Prvaey oly. 920g to cur use of cookies. To Fn ot mero about the coskls We use and howto doe tha, 68 tose Improving performance, ra Register reducing risk ISO Standards Revi ns |ISOIDIS 9001:2014 Draft Intemational Standard Analysis “ho pbleaion ofthe Draft Intematona Standard (018) of th Iremationl Qualty Manogemect System (GMS) Standard (ISOIDIS 8001:2014) ses ho fit tins all Clara ane fue uoers ean accoes an review ts proposed changes Yo ISO S001, ‘As aresut,ongncatns wile dl to stat lari fer hel rast othe now standard when ts pubshed (comet forecast by 150 to be Septenber 2095, ‘The DIS cortans bane elements ans eng eomen thar ching ans doesn els to provde terete pis with sigh nthe pleniaimpact ofthe charges on emarieators ‘The loons thal ar new to ISOIDIS 90072014 ean be separates ino two types, 1) hot nsw a pt of he war Annex SL intodton to al ISO Manageme ‘System Standards (VSS) and 2) hese sposeally introduces as pa ofthe roision process for ISO 8001 Common Terminology & Structure 1s atipated and a previ Nahlighted by LROA, ISOIDIS 990-2018 corporates the Nigh level suture an cone teminlogy frm ISO Drctve Amex SL “ho icorperain of Amex SL means a Pew suc ae layout ot er ISO 8001 a one which all hanagerert system staearts a asing as (ey ae viedo induced inthe fle, This DIS versin cntains many deftons; they have been Ice to hap the rear understand athe tems used. An understanding ofthe ditions is vital nor {oly rap the now stad oqtemens, A desion wile taken fat: o which dlintion rman sn 80 800% and whieh are elu in {SO 960, (One tom hat is used extnsivaly treughout ISC/DIS 900-2014 is ‘Detrmin’ Deternnation is defined in SOVDIS 8001-2014 a: \Witin ths managemor systems envireemert, rgaislors wilhave fo consid how thy can provis evidence thet a process of determination has akon place an thet ‘an ouput rom that proceas exists ‘Anno A hss bean intadiced andi ifortive in nsture, Tis Annex proves clio er the naw Stuer, Temiology and Concepts contained within ISODIS soot te, ist he eet and temincogy has enange, there sno raquamet fran erpanisatian to use thes tars oto fallow the numbering or strewn thie ‘management syston: Context Contant ofthe Organization ie naw and requires an organisation to daterine the intemal rd extemal sues an requirements het can impact on the planning of he ‘ualty system. Contant secomgs an important censcerion and helps o ensue Pat he managernct system s des¢nad and sutely scape tar a specie ‘iganaation, Ths eb provide the ght focus, approach and balance to th afer laments he rahagementsysten rahe han foe ame ganerle approach cross sergersation Rlsk Based Approach ‘ha norpoation of Annex SL ino ISOIDIS 9002014 now ves ask base apeoach to hrkng and acting. Tha equremenis under a sk based apprcach affect ‘uaty panning and ron ineoporte much of what ws previoul ted Prevetive Action, Now avons wil ned to det the ks ae opera hat Fwd lobe adeazed io gve dsswance tat he QMS can achieve ts ended fess, “ris may appos a anew ara to 1SO $001, howover mary garisatorsatsady have rsk basod thinking nd pling in many pats of thr erganisation which may or ‘may ot have ean connzceato the QMS the past. Ths eer ocun on rik wil mean that an crgaroacn Wil aed to Gemératate how ths equrement em. TRE ‘er and fomaly othe approach nooded 0» paricarcrwsalen wil of couse = be ahiced by cote. ‘Scope and Applicability {Tha way incon and exchalon of requramarts for ISO/DIS 01:20 is aderassad ia ifernt rom prevaus versions, Now eraneatns wil ave te dete the ‘cope of tee managomrt system (mia To lhe management sysem slandads) and man the seope as docanesiedntmaton. The scope wil ee. Be Sstormine rom ha boundaries o Ine ogaeation its coro, interested parton ands product and sence, Wher equrenonts ean bo aped, ts expected that thoy ibe tele theo ler rasan that ty ae nok api Documented Information “he lems ‘documertedprocedu’ and vec and have hen replaced with ‘docu infermatio. In ue, tis means the ‘documented procedre’ ae replaced by the reaurement to mareain Gocumerted formation an recor are raced bythe requerer to retain docuneriednfermation. The ature ad ype of docurrertes information thet an orereston ness o maintain o retain is dopender on the cortex! ans Hs operating ervsormect. The way documerted infomation efed ISOIDIS B001:214 provides more scope fran organisation to determine whats epproprise forts ungue se of ecumstances, rather tan jst allowing 8 prescilve ‘An egarsaion wl now ned fo corse what krowlage noe to achive conomnity of products ant sevice along wth how t wl velo, maitan and retin such kowledge, Wists snow reqemet inthe standard it may not mean wilbe new rien or any ceed orpeaton ae any wellmanaped orersation ‘wil osualy nave mods to manage the ntomation and wrowTeage ft neecs nora petom success. Control of exerally provided products and services Purenating hes boo eid as Cont of extemally provided pris an sevice to mae clear that the eairemens apy fo both physical posit and consimes emoes related to the end proct of the orantesto het ht epecealya new equremor here as alveys been some Corusion around cananestenoree tvteralyprondeepructs ana services whether ts hasbeen tvaugy an ésegelate conan, jant vertu or clsourced acty. Naw ft clear tat however provid, an oganislon wilnood to apply a rakchased approach and delerne th type a extort of cons neces. ‘Whats changing? ‘Aang wi he above ers which may appar naw to many users of ISO S001:208, thas are many eter changes tothe text of exiting green, Thase changee stn ly the tat a porta elae or ake ipl rquramants mate ext. Thase may na egure an otganisaion to change la magorort syst ay ‘ay, Howover wou be worl or an xpaistion to revow whether he rew wating tha stand afgre wh tbl currart oer practices, 2 nando: of wei ae ight boon hipihwwwIrqa.comistanderds-scnemes-dirsctvestse-updatesiso-9001-revisions aspx 122avrzanre LRA - Improving performance, ceducing isk -ISOIDIS 800.2014 Draft Iternatonal Standard Analysis Quatty Manus The requreer fora specie document called a Qalty Manval has boon replaced wih clause tiled Quality Managerent System and is Processes. Organisations are now rege to datenmne tv processes noodles forthe quality managoment system thar Inputs, ouput, secuonea er section = then main documentos Infornaton othe exert necessary to supper tha understanng and apuraion & tooe processes, ithe cure quay manual Tule tase equrerens hen kan tay Leadership ‘Tha equremors clang to the elationship bewesn tho role Top Management playin cresting and supprting an stective quslty management systom have been vanced. There are now mote ses where Top Management nee fo demon reverent and engagement with the ualty Management sytem, sath 88 + Ensuring negation of OMS equrements to the oganations’ hanes processes + Prometng awaroness oft process apsoach * ASsuing te GMS achioves fs terdod ruts + Supporting eer leva manegament rls fo cemonstiate thor leadership FSOIDIS oovts20"4 na longer raqores a specifi rola fs management resesetstive bt defines roles whare Tap Management needs to asign appropriate respons ara auton. 1 bis ean be achoved tough ascgrmar Toone porson, thes maybe that ra change sracaseay. 1, however, the ange ls Is oad” Pan tal of ‘ne paren, thn an eganetin wi ied fo show how thee hate bech eign to abet persome lanning of Changos ‘Another requreet that has been expanded and clad is that f Planning of Charges. Wher he ead for change i idnified here is row s much clare requirement {arsah cures cara op an aystomae ae: Agan ov gna il resto reve Boh pracy fo mara rae 00 ay revlon of te QMS le naceasay. Analysis and Evaluation ‘ne ISOVDIS S001:201 tox hes expanded and enhanced he previous requifements to clay whats expected. The Peformance, Manton and Review defintons sre ‘ocnss performance, extemal provider perfomance ard so on, ae all areas whese an organsatan wll a] raed to review is current apprsach and b daterine i ay "Change is necessary The pt of fe Analyse and Evakntn snow a dened mpc ino the Managemert Review paces Management Review Because oh incorporation of Annex SL athe roison tooth: aaa within the DIS such a the aaas highligtted above, the scope ot nomation tobe conser at Manageme Review may also rood 69 exandad to inci tose areas. Thee rlw an exe eeuramant fer Maragement Review to corider Pow changes Ts cortot affect tho GMS ands sbatoge dracon and 2} tho efectvaness of action akan fo adress ke ard opportune, “hore a mary changes carey includedn th revision t ISO1DIS 900-2074 whaher hese trl ino a nod for an organisation to change ls management Syston les mor feu quosto to answer. The doe of range necessary wl pend on how an argrisaton has dovslope a uses ts ousting managomant Syston. Coteldeation nese to be gen toa whethr fs SO 900" 2008s Imited fo tretly mating te reqUremees as spelen tn standard or] wher Pas Suh econ pc at we et spt ay oq 80 0 08, eve ranger Bs ic day aad he NS, An erarsations cures evaluation ard management of isk wills heal uence tha degree of change alan oxgansation wl ned to undatke nee o mest thase fre requirements of 180 80012016, Agarns his backcrop, ther are fur man slps tat erganisatons shouldbe cons ering 1) Sta withthe O1S and fous onthe areas tat re completely now or have boon revised, Those se the seas tht ae Hkaly tobe nclutedn your ranaton san, Ao, ‘ako sure that quality mansgors and intra autos undartan te dflerances thal Arex St wil o Your QMS ard ary other maragoment Systm serdar In You ergariston 2) Ensure ht your ciation body nt enly understands th DIS, but more imporanty. understands what the DIS means io your QMS and wider rprisaton. 3) rae You Staton tay ot hw gu ana au ang on seers of 20 201Scan coat a puso, wa You Osan. Given tat hae 8 tvee-yearranatn ped rm the date the new standards publohad, Ns Umelrame wil alow oganiators to change a pace suited Lo them, whieh wil ypc ivclve are coifeaton cycle, Ear adopts ard, dood, ary organisation can Pave thor systtrs assessed aginst ISOVDIS S001 2% at ary Stage, npr, on whe towards awarding ceriates a the eaes opprity agains he ral pushed standard. At tis alatvly eat stage into process tat il Teoe usa ind and puslshod [SO 90072015, ema unclear Row those featenors wil eect at dursions, auctor compaterce ard aut mabods, a: wall ss what lle proposed as th Wansten pale oy the aezedtatonauortes. The ongang neested pares engagement pocess, including dseussios and debates Sean new a ey mn OTS saa wh carl aE wich wl one re attract aw aos How can LRQA help? ROA e sma cartroutorto the development and inprovament of standards and aesocistd guidance in tn liso management systems ard cnfaniy asassmnt \wnlde. As fecogisd vies inthe indy = von trough br mombersip athe HOC (Independent Iterator Organisation or Cate), the abs "tenon re body «ur experts are atv invevos the inioraiona oc commits eral reso he words hadng Management System Stancts, paca ISO 8001160 1400" and1SO 4500%/OHSAS 1801 ormupational heath and safe), (ue range of ransiion services inca gap analysis, tring ad euaiona lols (eluding webinars) which have been designed o ensure thet organisation understand ‘hot 60 800-2095 means to tom. Combining chica expr, indus eating aesess0" ran, 2 fel ore of sector specie assessors and me unaue Buran Iescrance asseseman methodslogy LRA abet lp or chore ens ra hoy ae propre fhe ansiion fo 1SO 800% 2018 Fermere nfomaten ploase oral surest co oF vst wr lea cor sostonsresundsta Next steps... "ry, ei ay acre ne ON ant Aas neoprene 7 Ut Rehr shy Ameen Lins, hipihwwwIrqa.comistanderds-scnemes-dirsctvestse-updatesiso-9001-revisions aspx 22