(©180 2018 — Allright reserved BAHAMAS BUREAU oF STANDARDS aNPCQUALITY QUALITY Is OUR STANDARD Q ey Py. FINAL DRAFT BAHAMAS NATIONAYRDR iDARD Y Quality management systems — Puna and vocabulary romero & hes devas sgh ar 99 Peerage PEIN Se a ms eas rel a (050 - Alceer o fh pbc se erie Wht ncn SQnomics Standards ae subjected to periodic review. ‘The next amendment will be sent without charge if you return the self-addressed label. If we do not raceve this abel we have no record that you wish to be kept up-todate. Please note amendment ot exclusive of revsionof the document. Ourada: Bahamas Bureau of Standards & Quality (88SQ) Source River Centre 1000 Bacardi Road 2.0, BoxN-4843 Nassau, New Providence toinmae " “ (ata entre ncn 2 Se =BBSQ Foreword entical with the English version 150 9000:2015, @ ement systems — Fundamentals and Commitee responce forthe sentard is Teal Commitee Management Stem: Th ‘contains requirements thatare relevant for The Babamas.180 9000:2018 Foreword 150 (the International Organization for Standardization) Is a workdwide federation of national standards bodies (SO member bodies), The work of preparing International Standards is normally ‘arried out through ISO technical committees Each member body interested in a subject for which & technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in Haison with 180, also take pat in the work. 1S0 collaborates closely with the International Electrotechnical Commission (EC) qa mattersof electrotechnica standardization. sds a i! ae ne Reooran eee ema S ‘tenons ra othe posi tha ome fhe lees of his docu Ny be the sbj of potent right 80 shal a be eld responsible for tenting any oF acpabet right Deals of Thy pent its dented uring the development ofthe document i Werte Introducion and/or on he 0 late ptent decaraton ected fave Any trade name used inthis document is information given for ‘RgShvenience of users and does not constitute an endorsement. For an explanation on the meaning of 150 stg expressions related to conformity {Scesoment, a well 85 nformalon about ISO's ajevence to World Trade Organization (70) Principles inthe Technical Barriers ide (TET) see the folowing URI: ‘vausnone/is foreword him ‘Te committe responsible fortis dacum GUS echnical Commitee 150/TC 176, Quality management ‘and quality assurance, Subcommittee SC ( CQweepts ond terminolegy Mt ce pA (Hn a ma i 102015 eavesIntroduction ‘This International Standard provides the fundamental concepts, principles and vocabulary for quality ‘management systems (QMS) ad provides the foundation for other QUS standard. Ths nernaionl Sanford is fotonde to hep th ase to uagertand the fundamental concepts, princes an orabulary of qualty management In oder to beable to effectively and eficenty implement 3 QMS Sa reaizn valve om otber QMS standards This international standard proposes a welldefined QNS, based on a framework that integrates ‘stablhed findamental concept principles processes and respores related to ql, in oer fo tp organization realize their cljectives Ite applable to all organization, regardless ee omplentyor business mode. ts am i o Increase an organiza awareness of fang, dnd ommionene in falling the neds and expecations of hs customers and intrested ts Seheving stsfacion wit is products and service. ‘This International Standard contains seven quality management principles suppor indamental concepts described in 22. In 23, for each quality management principle, “statement” een rach pl ona epg vi he unten wast te ric “ay benefit” that are atfebuted to the principles, and reaoeee Py that a8 prganization can take Inapplying the principle, ‘This International Standard contains the terms and definitions that: ‘QMS standards developed by IS0/TC176, and other sector-s ‘Standards, at the time of publication. The terms and defini = ae management and S standards based on those anged in conceptual order, with ‘an alphabetical index provided atthe end of the document. AageXA includes a set of diagrams ofthe ‘concept systems that form the concept orderingQuality management systems — Fundamentals and vocabulary 1 Scope ‘Ths International Standard describes th fundamental concepts and principles of quality management ‘which ae universally applicable tothe following — organizations sebking sustained success through the Implementation ofa quality management system: 9 ~ Setar a tt eh = onganiations seeking confidence in their supply chain that product and servi ments will bemet; — organizations and interested parties seeking to improve communicatob\ through a common ‘understanding ofthe vocabulary used in quality management, 5 ~ oun petentycrysnis g SOS osarsm — prriet ang seen ain uy ape — developers of related standards. ‘This international Standard species the terms an chat apply tall quality management and ‘quality management system standards develope 176. 2 Fundamental concepts and qu: S Sisal rad ane Na ire in is i ir dnc Th cg ch on ors oy rca ed See pat cg teen epee eae ab moons iS eae thy eee Sag a ree ean aa eecieatoee Gis li ae pt Sy Se ers inagement principles Principles and their interrelationships should be seen as a whole and not in isolation of er. No individual concept or principe is more important than another. At any one time, nding ht balance in application feria 2.2 Fundamental concepts 2.24 Quality ‘an organization focused on quality promotesa culture that resus inthe behaviour, astudes, ctivties| and processes that deliver value through filling the needs and expectations of customers and other ‘relevant intrested partes,180 9000:2015 “The qualiy ofan organizations products and services is determined by the ability to satisfy customers and the intended and unintended impact on relevant interest parties. ‘The quality of products and services inchudes not only their intended function and performance, but also thei perceived value and benefit the customer. 22.2 Quality management system A.QMS comprises activites by which the organization identifies its objectives and determines the ‘Processes and resources required to achieve desired results “The QMS manages the interacting processes and resources required to provide value and realize rs fareelevant interested parties y “The QMS enables top management to optimize the use of resources considering the long angphadt frm consequences oftheir decision, v 'A.QMS provides the means to identily actions to address intended and uninter yuences in providing products and services 223 Context ofan organization 8 ‘Understanding the context of the organization is a process This Influence the organlzations purpose, objectives and sustainabi values, culture, knowledge and performance of the organization. 4slegal, technological competitive, market, cultural, social and ci rogts@pbtermines factors which internal factors suchas nsiders external factors such environment ‘examples ofthe ways in which an organtzation’s purpose polserand obecivs 2.24 Interested pares ~ ‘The concept of interested paris extends RS us slely on the customer It is important to pressed Include its vision, mission, considerall relevant interested parties. Part ofthe process for understanding hy the organization Is Identify its interested parties. ‘The relevant interest parties ar the rovide sgnificant risk to onganieational sustainability if thelr needs and expectations are aes ganizations define what results are necessary to deliver to hn nro pn SNe te Orpen aac appa te spor of the er eee paren hey depend ever aes rassipon 22584 Genera Top manage tjupor tthe QMS and engagement of pope nls = prowist dequehuman and ther essres — canning processes and results; Stcermining and evaluating of sks and opportunities; — implementing appropriate ations. Responsible acquisition, deployment, maintenance, enhancement and disposal of resources support the ‘organization in achieving ls objectives. 2.2.52 People People are essential resources within the organization. The performance of the organization is ‘dependent upon how people behave within the system n which they work 8jr cere peope brn gad ei ened tog cove desing tthe aly pean arpa feu a 2253 Comper I eis hn uni has cos ica pa sl a soci 4 ae se Vik ns a eS ae oe ‘prea pr cera Goro eer cone tastiiarus Washed wins iD cers alps By ce ce gs emcees coeaon ecm i peerprncetay s Planned and effective jaternl (Le. throughout the organization) and external relevant {terested partes) communication enhances people's engagement and increased nding of, =the context ofthe organization, = the nowds and seine nb ahem — eons <= 2-¢uay management rings we oo & ‘The primary focus of qualty management Is, eastomer requirements and to strive to exceed customer expectations taut S sun sa thre! freate more vale forthe Interested parties contribu 23:1. Key benefits < ene eee a Ines Leeomer satisfaction: = customer loyalty, sustained succes ofthe organization, —Xerhanced repeat business — enhanced reputation ofthe organization — expanded customer bas — increased revenue and marketshare180 9000:2015 2.3.1.4 Possible actions Possible actions include: — recognize direct and indirect customers a those who receive value from the organization; — understand customers’ current and future needs and expectations; — lnkethe organization's objectives to customer needs and expectations; — communicate customer needs and expectations throughout the organization; 9 ie ied ied aiaoe clapree SS A Ca cagtae mone — measure and monitor customer satisfaction and take appropriate actions; Dances eee aero cnarotinatons = actively manage relationships with customers to achieve sustain 23.2 Leadership 3 pea AS weer gag meat ‘engaged in achieving the organization's quality objec 222 Rationale S Creston funy of purge andthe dec Nansen pol esl an orton an ‘Danengts pie pss ant aiken ts sce 2:29 Keybenets oS ‘Some potential Key benefits are: \\~ — increased effectiveness cy in meeting the organization’ quality objectives; newer coordination QOPE ranean processes — improved congmgPtion etweon levels and enctons fhe organization: — evened improvement ofthe capbiliy of he orpnlation ad people to dever desiree 23.240 peieible actions actions include — communicate the organization's mission, vision, strategy, policies and processes throughout the ‘organization; = create and sustaln shared values, fairness and ethical models for behaviour at all levels of the bnganization: = establish a culture of rust and integrity, — encourage an organization-wide commitment to quality; 0= ensure that leadersatall levels are postive examples to people inthe ormaniation, — provide people with the required resources trainingand authority to act with accountability: — inspie, encourage and recognize the contribution of people 23.3 Engagement of people 23.81 Statement cappten cnpome cp pep t el e hat nation ee 2 cite ereaimaniratiy ocemssalante nt xe 2a:82 tateme S ana an tas tepanc Sapeaea Sek wane oestrone eect tnopiicienngtnceacee tie veecire 2.3.3.3 Key benefits: Ps Some potential hy benefits are: Sy — improved understanding of the organization's qualty objet, ope in the or ‘Increased motivation to achieve them: ¥ — sch ntemets pininpronent ai g eS — enhanced personal development, ntiatives and — enhanced people satisfaction: opinion — increased attention o shared ages ce troghon the organiton 23:4 ossibleacins <> Possible actions ince: = eGo st people to determine constraints to performance and to take initiatives without fear; S32 peste pope cetnion eagle — ebro errant pron eves — conduct surveys to assess people's satisfaction, communicate the results and take appropriate "180 9000:2018 234 Process approach 2.3.4.1 Statement Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function 36a cohereat system, 23.42 Rationale ‘The QMS consists of interrelated processes. Understanding how results ae produced by ths system enables an organization to optimize the system and its performance. Saad ag toa ss psacpailay eae 1 Foals ce ot cic ace Sl & = Sn ntti — optimized performance through effective process management, « acm gl reduced cross functional barriers; LE ena uae Laine 234A Peale scious Ee € Possible actions include = define objectives ofthe sytem and pro Fy toachiove the = establish authority, responsibil and ity for managing processes — understand the organization's capatiifrand determine resource constraints prior to action; — determine process interdepehgbades end analyse the effet of modifications to individual processes on the rena = manage processes Interrelatons as a system to achieve the organization's quality objectives effective cently: ensure then information is avallableto operate and improve the processes and to monitor, analyse: se the performance ofthe overall system; B map ttre cirri 2.2: falpPovement QbI semen ‘successful organtzatons have an ongoing foc on improvement. 2.35.2 Rationale Improvement is essential for an organization to maintain current levels of performance, to react to ‘anges nts internal and external conditions and to create new opportunites, 23.8.3 Key benefits Some potential key benefits are: 2= improved process performance, organizational capability and customer satisfaction — enhanced focus on root cause investigation and determination, flowed by prevention and corrective actions; Ce S) Seneca Ss is se calcein dele SO = gla ln rea la Hi py Pn i eg improvement objectives, ologles to achieve 2 felted decrdetere eiemacy previ outro rake aes scree tee = track, review and audit the planning implementadog eompletion and results of improvement role 3S — integrate improvement consideration a geet or modified products and services Sao — rp ntl mpoeG> de raimosbatanasne Shaper Sco cues wg uch oo Te Decision sn be a complex process and it always involves some uncertainty. It often favolves rultiple iberand sources of inputs, as well as thelr interpretation, which can be subjective. Is Impo fnderstand cause and effect relationships and potential unintended consequences, Facts, cevidenctghd data analysis lead to greater objectivity and confidence in decision making. ey benefits Some potential kay benefits are — improved decision making processes — improved assessment of process performance and alt to achleve objectives; — improved operational effectiveness and efficiency: — increased ability to review, challenge and change opinions and deisions 1180 9000:2015 — Increased ability to demonstrate the effectiveness of past decisions 23.64 Possible actions Possible actions include — determine, measure and monitor key indicators to demonstrate the organization's performance; = make ll data needed avaliable tothe relevant people: Cae eecah aunt minrncea) || te Shear rac et RS Cera t eee oon amen ae sae WO HO asta in on ee td wt inn 2.3.7 Relationship management ~ 2.3.74 Statement wy For sustained success, organizations manage their relationships Ro nt interested partis, such providers: 23.7.2 Rationale < Relevant interested partes influence the performancyr@tay organization. Sustained success is more ily to be achieved when the organization mana fonsips with all ofits interested parties to optimize their impact on ts performance. Re ‘management with Is provider and partner networks is of particular Importance. 23.7.3 Key benefits S Some potential key benefits are: — ennanced performance ofthe fxuatzation and its relevant interested partes through responding to the opportunities and c lated to each interested party; common understand) os values among inerested partis: = crm J ae for interested pares by sharing resources an competence and maradag get td sk wal: “Supply chain that provides a stable flow of products and services ermine relevant Interested parties (suchas providers, partners, customers, investors, employees ‘or society asa whole) and their relationship withthe organization; determine and prioritize interested party relationships that need tobe managed: = establish relationships that balance shor-term gains with long-term considerations; {gather and share information, expertise and resources with relevant interested partes:— measure performance and provide performance feedback to Interested parties, as appropriate, to ‘enhance improvement initiatives — establish colaborative development and improvement activities with providers, partners and other Interested parties; ‘The approaches to QMS described in QMS standards developed by 10/TC176, in other maeevee spt Standards nog ecalence model ae based n comm princi Bey a tenable an organization to identify risks and opportunites and contain guldance for Imppovenabt In the ‘current context, many fsues such as Innovation, ethics, trust and reputation cou sed as parameters within the QMS. Standards related to quality management (eg, 150. fonmental management (eq, 1S0 14001) and eneray management (eg IS0 50001), as ws ‘management ‘standards and organizational excellence models ave addressed this, The US sant deve y 80/776 poe a compe Aco deme prltanes for hs 809001 spate queens fora Qs 60 agro gasanee ons ae fing of objectives of QMS for sustainable sucess and InpeQeperormance Callies Toe Component ofa Qu cue 10100, 130 000 5010008 Raa, 501008, 19 0012 ard {019011 Gudetnes for tech subjects in support ofa OB ince 10 100, 1S0 10008, 18010007, 80 10018 3910015 5010010 and SO sEG Tota! eps inspect of @ NS Tnelao 30/78 0019 and S07 1037 Ragulremen Re Oa proved sector apeie andar uch 190/15 2600, Te various pars ofan rps’ age She anegeent ston The ojos pa ibe ici 98 toned sep cre a et RG) oe rae ee race tee er PR aa oc aaa Se ee ee ra Sees NOTE TheISORandbook ted ue of management system standards can provide useful guidance, 3. Terms and defi aaems ripe orp aaa top man: person: ‘of people who directs and controls an organization (3.2.1 atthe highest eve Age NW iv: Ter manne hs ower et try nd rover win he Note 2 to entry If the scope of te management ontem (353) covers only pat of an organization then top Inatagenent refers to those who directs conta tht pat othe oraniation Note 9 to entry: This constitutes one ofthe common tem and core defiitions fo 180 management system andarde given in AnexSL ofthe Conoidted 50 Supplement the IS0/1Ec Directives, art. 312 ‘quality management system consultantperson who assists the organization (3.2.1) on quality management system realization (3.43), giving advice or formation (38.2) Note 4 to entry: The quality management system consultant can alo assist in relzing pats of = quali management gem (5). Note 2 to entry: 1S010019:2005 prowdes guidance on how to distinguish a competent qualty management ‘3etem consultant rom ane whe is ot competent ies isis ie 9) ae fy ‘taking part in an activity, event or situation vy aus & Seeman et citi anita aadoyacnet ON 345 5 aoe sy Seeeembe same ved xe Eee aetna ory mater ne nena on Gh na tsb alc 6 ca ur cuens tei tre St een 5 [SOURCE:1S0 10007-2003, 3.8, modified} RS ‘customer satsfaction> individual geoph assigned by a DRP provider (32.7) to assist the partes in resovinga disput (39.6) maneLes ——- GRE a4 noe [S0URCE: so 1060: Be ea 52ers zation sa ere) persone drop of people that has es own functions with responsibilities, auchortes and relationships to; objectives (87.1) RN ss pts pel wd ae ind bo Shy Sls. SP! Sovran sat Pate" eeu aah re erection op or tain tre Scere ofp Note 2 to enty: This constitutes ane ofthe common terms and core definitions for ISD management sytem ‘Randarde given In AnnerSL ofthe Consolidated ISO Supplement othe ISO/IEC Directives, Part. The orga Aetntion has been odied by modifying Note 0 ext. 322 ‘context ofthe organization 7180 9000:2018 ‘combination of internal and external sues that can have an effect onan organeations (3.2.1) approach to developing and achieving its objectives (37.1) Note 1 to eng: The organizations objectives cam be related to is product (3.7.6) and series (32.7), {nvestents and behaviour ward is ltred pari (2.23). ote 2 to entry: The concep of cnter of the ogunizaion x equaly applicable to not-for prot or public service ‘organizations ta tist hase seeking pros, Note 3 to ent In Enalith hie concep it ofen refered wo by other terms sucha “business environment “organisational environment” o "ecosystem of an organization Era ear ae yy 323 interested party a & BLE Cir om pn rin evr S9) ac reps men, Frou cnc ope a Ti nl es mo ‘Sees fe at be Cmte Soba Sg HCD, Pn Te od Anon Hae beon moied by ding the Beane < 224 Somer per of ranstion 2.23) hat ol a agAU a product (876) oer (3.77) hati Ronde ore the person or Seige tp eekiei —aane meaner Sie aoe Ineo Asam ete tose 32s Y provider Supplier entation (32-1 6eprovdes a product (37.6) ora serie (37.7) seats leur rete ovendor fs pred ora servi. ae gh reer canbe neal eters th rp, s na contrac station provider someine cle eonracor eee coxemal supplier provider (325) thats not par ofthe onponization (2.2.1) AMPLE Producer sributor eer or vendor of product (2746 or ase (3.727) 327 DRP provider ‘lpcr esltion proces provider *‘person or orpanization (32.1) that supplies and operates an external dispue (3.9.6) resolution process Gan Note 1 to entry: General, a DRP-provder i a legal entity, separate fom the organization or personas 20 Indivdoal ad the complainant. ths way, he tbat of independence and fits are emphases In some ‘Stuotons a sparse unit resabished within the orgainaton to handie unresolved complains (393), Note 2 to entry: The DRP-provder contracts (34:7) with the partes to provige dispute resolution, and i {Szcountable for performance (3.9). The DRP-povider supplies dispute resolver (31.8) The DRP-provder also tiles support eneutve a other ranagertl stall to supply financial resources, clea suppor. scheduling ‘sistance, aiming ecg rooms, supervision and salar fancions sande mr er nant tn tee Sees 28 teria Se este iinksien 12) it gf st (source iso 1o0es2t0. 311 8 329 S hy foe defining and implamanting the inelastic S MS nna ut iS Imearemen: management tem (37) [SOURCE: 150 10012:2003, 3.6, modified) NS 3:3Terms related t activity aaa Improvement activity to — oe to entry: The activ fQade recurring or singular. 32 tential im eros canane erfrmare (378) ini proces 24) eabhing ies (27) ad Sing oporunes or mproenet Gs seen inal proces trou) the use of ut fongs (2139) and oud concn: (1310), aaa of Eo ea 3388 oar ss ty crs ton 83) Note 2 to entry: This constitutes one ofthe common terms and cote definitions for ISO management sytem Standards given in Annex of the Consolidate 150 Supplement to the I90/TBC Directives, Part. The original eftion has been modified Wy adding Noe tt entry aaa ‘management ‘coordinated activities to direct and contol an organization (32.1) Note to entry: Management ca clade establishing policies (3.5.8) and objectives (171), and process (34.1), twachievethese objectives, ®Note 2 to entry: The word “management” somtimes refers to peopl, Lea person or group of people with futhority and fesponsibiy forthe conduct and contol of an organi When "uanogerent™ i Wed In tis Sense, it should aways be used with some form of qualifier o avid confusion withthe concep of “management” ‘Sst of aves defined above, For example, management sl" Is doprecatd srhereas Yop management {8:13} shal.” acceptable, Othorite ferent words sould be adopted o convey the concept when elated to people anger 9 managers fiat mage cae tka ty 42) ses i ety soci uo 9) dy og nd processes (41) achieve these quallyebjectives trough queiy planing (3:33) gull) a4 8. ‘ually contro (93.7) and quay mprovenene (3385). tas & ‘quality planning part of quality management (3.3.4) focused on setting quality objectives (8.7.2) audapeciving necessary ‘operational processes (3-41), and rated resourees 1 achieve the ie a Far of quay management (22.4) focused on providing < that quality requirements (865) vie we aay Po ‘quality contral Parvo qualty management (3:34) focused on, aualty requirements (3.65) 338 ‘quality improvement & Zn increasing the ability to Fl quality requirements (3.65) (0.710) or raceabiy (3.6.15) 339 ‘configuration. = ‘coordinated ati irect and control configuration (3.108) ot 1 on Al management generally concentrates on technica nd organizational eivites that ee sin contol of Product (31.6) Or sere (3.7) ands product cnfgwution information partof quality management SSO Note 1 to entry: The aes an be related to any aspect suchas efectioness (3.7.1, eftenay Gea) thle eye of te product ih 150 10007:2003, 3.6, modined — Note 1 to entry hasbeen modifi ano ‘change control “configuration management» activities for control of the output (3.75) ater formal approval ofits roduc configuration information (26) ISOURCE: 1s0 10007:2008, 3.1, modified) saat activity “project management> smallest identified objec of workin project (34.2) 2[SOURCE: 180 10006:2003, 3:1, modified) 3342 ‘project management Planning, organilng, monitoring (3:11), controling and reporting of all aspects ofa project (342), ind the motivation ofal those involved in itt achieve the project objectives (sone 0 10062008.26 aA Se ican era tain ict tes ila Ne [SOURCE: ISO 10007:2003, 3.5, modified) ~~ Saisie ead B pees & ‘ed © a P re iis tase ee aaa mahgtro ty Wt etl lo proces cle neg) Pret (76) rere 427) Aependson te conta o te reference. Note 2 to entry: Inputs toa proces ae generally the ouput of tyr Frocesses and outputs ofa process are enealy he nputs to other processes, ‘Ne wo entry: Two or more iterrelaed sn ntareting Se prs nutes ca ale be refered ta procea Note 4to entry: Processes in a erzenzaon (22% )9) generally planned and carid ovt under controlled ‘Condions oad value Wistar Fpl hens aa a toi tha sate acy ‘aaa Ree Bed ecru tae i era anes aml ae sens rh fa. mye peer eS eee ee — a g a Ce Rat eng Sau las al Soc ol ak Gates undecteeg to achieve an objective (37.1) conforming to specific requirements (3.64), including the cer ima, costand resources o rn indi project can form part of ager projet structure and generally has defined start at, Note 2to entry In some projects the objectives and spe are updated andthe product (3.7.5) or struc (3.2.7) ‘hareteries (401 defined progressively asthe projet proceeds. "ote to entry The output (3.75) af projet can be one or several units of product or servic, Note 4 to ent: The project’ orponzotin (32.1 normally temporary and established forthe fete ofthe ren. ote § to enty:The complexity of he interaction among projec activites not neessarly related tothe project 2180 8000:2018 ISOURCE:150 10006:2003,35, modified — Notes 1to3 have been meaiied] 343. ‘quality management system realization process (34.1) of establishing, documenting, implementing, maintaining and continually improving @ ‘quality management system (3.5.4) ISOURCE: 180 10019:2005, 3.1, modified — Notes have been deleted} 344 competence aegusition 9) uit we process (3.4.1) of attaining competence (3.10.4) 34s {soURCE: go 100162012 32, modes) ov a S < Specified way to carry outan activity ora process (3.4.1) rea eae sae, a“ Be cash & take an arangement where an eter organization (2 botorms part of a orannations fnctoner posse aay 8 ee se ete ts ceed tbh eel he fore eapenst goa (153) shoud ote ten: Ths cnsutes ane ofthe ee and ae denon fr 10 manent te ‘Sandards give in Aner Sto the Consolidate reat the 30/18 Directives, Par re Ss contract & Hang agreemen sy 348 design and developmes set of proceses (341) Mgt transform requirements (364) for an object (3.6:1) into more detalled requirements for eeghject Net wo enty- Ge eurements forming nut o dese and development are fen th rea of ener nd he boner more general beta he eurements omg he outa (.73) of dese and rome ar general dood i tr of characte (2303) inaproje (242) tee ots: n Ench the words “design” and “development” and the term “design and development” are 5 used sJnorjmously and sometimes used eo define diferent stages of the overal design and lopment. In French the words “conception” and “devloppement” and the term “conception et ‘dveloppment” are somatic wed synonymeily and sometnes wed to dsfine ferent tage af he over ‘design and development Note 3 to entry A quaifer can be apple to indicate the nature of whats being designed and developed (eg product (378) deren and devsopment, service (87.7) design and development of process design and Acvlopment3.5Terms related to system 35a system Set of interrelated or interacting elements asz infrastructure sytem (35.1) of facies, equipment and services (3.7.7) needed forthe ne ofan ‘organization (32.1) asa anagement system Berean eras eet me at aa oe, ‘byes (37.1 and process (41) w achieve tone ects Note 1 to ext A management system can adress 2 sgl dle or ~& es, eelty ‘manager (4) ancl management orentonnent management Nowe 2p oni The manigenest san semets ebih he sate sxe, res and c ‘esponsies, planing, operation, plies, pace, rales, bel, reas to achieve hove objectives. ‘Monod fanclons of the organizaton, specie and dente (Of the orgntaton or one or mare Now 3 to enty: The scope of a management system can inclade thn SQ ofthe organtation, specific and ‘uncuons across group of organizations “< 3 ‘iid re ne fh Coed S03 he EcDwets Pon Teo efntion has book modied by modfing Notes 384 ‘uality management system coo Saris ‘work environment Ry eae — Note 1 to entry co Jude physial, toca, payclopal and environmental fcurs (auch as temperate Taser ton schemes, occupational ses, rgonamis and atmosphere compton) 356 metro imation set of s required to ensure that measuring equipment (3.116) conforms to the requlrements & ded use ae ‘ory: Metrologic confirmation goneraly includes cllration or verfecion (3.812) any necessary djttment ot repair (1125), and subsequent recalibration comparison withthe metrlogalresulerents fr ‘ho tended use o tho equipment, as wells an required sealing ad laling Note? to enty: Metrologia confirmation ent achieved unl and wlesthe es ofthe measuring equipment forthe intended use ar been demonstrated and documented. ow 3 ery. Te egurements or tended ute ce ach cones rng, reshton and ‘marimum permis errors Note 4 to entry: Metrlopclrequrements are wus deine from, and are not speed in, product (2.76) requirement. 2180 9000:2015 [SOURCE: 150 10012:2003, 3.5, modifi — Note 10 entry has been modified] asa ‘measurement management system Set of interrelated or interacting elements necessary to achieve metrological confirmation (3.56) and ‘control of measurement processes (3.115) [SOURCE: 180 10012:2003, 31, modified] ase policy oo panna» intentions and diretion of an orgniatin (2.1 a formally expressed x Yep management 2.1), tx 1 ey hs ane eof consonance defo 10 a Sel guint’ the Couchdeed GO Saponet te 07 Decne 3.89 ~~ suai potiey 3 Poy (258) rated to qual (262) SS tox en Gener te ay penn wih overt PSATonorgnisen 21) canbe ‘gned with the organantons ion (3510) ual objec (372. nisin (253) 3 {framework for the setng of ia uash pastures Naat Gero Saar tech ee eo ‘ion “Congantzation> aspiration of what an ong (2.1) would lke to become as expressed by top ‘management (31) 3S tsion G “Sa omni Por rte pms) asa S sate anteihieve slonQagYor oe objective (273) Terms requirement aoa © on Sipe prctabe or conctvable EXAMPLE Product (8:76), sevice (27.7, proces (3A), peron, arganzaton (321), stem (251), Note to entry: Object can be materia (eg an engine, a show of paper a amond). non-material (eg conversion ‘840, projet pln} oF imapned (ep he future stat of he gonzon). [SOURCE: 50 1087-1:2000, 2:12, modified) 362 2auality agree to which ase of inherent characteristics (310.1) of an object (36:1) full requirements (36.4) eT em one th ae po dit sn yr gn 263 ot he orn gen een qo (64) rt) me on EXAMPLE Classofaitinetiketand category of hotel in ahotel roche Sy nn anemia maar iano”, moans existing in the object (346.1). ea requirement S tnd expectation hati aed generally implied oolong »s Note 1 to entry: "Ganealy implied!” means tht it is astm or common py 1 orponitotion (121) ae Interested pares (223) thatthe need or expecation under conlderaton| "Note 2 ony A specified requirement one that i tte, for earl gBcumented informacion (3.8.6) Note 3 to entry: A qualifier can be used te denote a speci rement eg product (3.76) requlrement, ‘ually management (334) requirement astamer (324) equal requirement (3.65). Note #teney Requirements con be generated by die pares orby the organization sl te 5 ent an be mney fr acento (382) tf an expect of sss ni esate nor gece oF ogy Note 6 to entry: This constitutes one ofthhgaumon terms and core definitions for ISO management syste Standards giver In Annex SL of te Copblated 10 Supplement the ISO/IEC Directives, Part. The org Aofintion hasbeen modi by eddiqg Nef 305 terry ass D iy requement, SAD ee Goo (63 fey = remy ly requirement ry requirement (3.64) specified by an authority mandated by algistative body 368 ‘product configuration information requirement (36.4) or othor Information for product (37.6) design, realization, verification (38.12), ‘operation and support [SOURCE: 180 10007-2003, 39, modified] 369 ‘nonconformity 25180 9000:2015 ‘nonfulllment ofa requirement (3.64) Note 1 to enty: This constttes ono ofthe common terms and core defiaitions for 180 management system ‘Sandards given in Anne SU ol the Consolidated 180 Supplement the 10/16 Drees, Pare 3.610 defect ‘nonconformity (3.9) rolated to an intended or specified use Note 1 to entry: The ditincon between the concepts defect and nonconformiy is important as thas gal fonnottons, particulary those ssscatd with produc (37.6 and sec (3.7.7 habit sues Note 2 wo eny: The iendd ws intended by the ction (224) can be alin by he QS he Tay i es ts ee Oo oe eae A Stray = fullment ofa requirement (3.6.4) Note 1 to enty: In Eogich the wort “conarmanc” is synonymous bat defeefied In French the word “compliance” ts synonymous but deprecated, 2 Note 2 to entry: This constittes one ofthe common terms and ex for 150 management sytem andards pve in Annex SL ofthe Consolidated 180 Sapplement SPIE Drees, Part. The orginal ‘etinton has boen mode by ading Note 19 entry. o soa S ‘capabil ‘Sbllty ofan object (35.2) to realize an output wl ui ehe requlremencs (36-4) for hat output Note 1 to enry: Process (34.1) capability termaG@WHel of stats are defined in 18035242. 3.613 Sey Co Shot the histor. ppg ntonan oe (263) egies aa os Set = eon fag oar — teres — tne tn te produto server delve noe in the ald of metrology, the definition in SO/IEC Gulde99 isthe accepted defnon . ity to perform asand when required [SOURCE: 18¢ 60050-192, maiied — Notes have been deleted] 3635 Fnnovation new or changed abject (36:1) realizing or redistributing value "Note 1 to entry Activites resuking in anovation sre generally managed, 2%headset aoe is 3:7Terms ltd wrest Sens Was eps ic co retih a ela SANA a Tefen ae aN ey no ro ee a sure pratmmeen aes e ‘personal erin, 283 qual abject (372) oF by the use of other words wth smal mann Ce am soaker treed. tn i om ty gre 280) oS hoe ein Si poe wr ame or Bi eo oe ses yh ont te om ets 0 mr She Se ce rae ee et snoe neatig emerson NS ‘ance SE ako 863 peli gr esac pd tN ae is rb se try uty cn es tr cine pres) we a ait: iret eh Nee 873) Note 1 tenty: The suc neato (321 emphasies the ne fora balance between its economic o fnancn iceests needs of ts Interested. pares (323) such a6 customers (324) Users Invertors/sharehl 3), people fs the organization. provers (25), partners Interest groups and hae Sosa meemmat & Yoty: Sustained sce eriphasies the nad fora balance between economic financial Interests of Ps a tery terete Note 2 to entry: Sustained succes relates to the ineested paris (3.23) ofan organization, such a customers (2.24) owner people nan organization, providers (3.2.5), tankers unions, partner or society. ans output rest ofa process (34:1) Note to entry: Whether an output ofthe organization (3.21) Is a product (3.7.8) ora src (3.7.7) depen on {he preponderance ofthe chracarsis (3.1041) involved eg, a painting fr salen alley ta product whereas 2180 90002018, supply of commissoned paintings a service a hamburger bought na real store isa produc whereas recsving Snordor nd servings hamburger ordered in fstarant sparta service. 376 product ‘utput (375) of an organization (3.2.1) that ean be produced without any transaction taking place between the organization and the customer (3.24) Note 4 to entry: Production of» produc is achieved without any transaction necessary taking place between Pr jo ces tren oer ae eT aR Note? toent: The dominant element ofa product stat itis enerally tangible Ny Noe 3 to entry Hadoare i tangible and ts amount Isa countable characterise (8.10.1) (6 = ‘materials are tangible snd their amount le» continuous characte (eg, fl and sot ware and Se a acuan are yous ero bean aby Sew ey ce re ees meno Seco a 307 Ny ‘Sepa apie rer ser service SY Site (275) of norgancato (2.2: wt test on ae pecornd bam the ‘organization andthe customer (32.4) Note to entry: The dominantelements ofa service are generally Note 2 to entry: Service often involves ates at the "wth the customer t establish customer fequiromens (34) a well ar upon delivery ofthe 5 ean involve 8 eopnung relationship sich a: atk, scountancieror publi organtaions, schools pas. Note 2 entry Provision ofa service can involve aap the lowing sn acy pefrmed ons cstmersupehlg ree produ (3.76) (eg aca to be repre) ~ an my ptt cg oe nt 6 Be he ne el sence eer © ES acne ta eG oe eto Wom 9) om en sana = ecreston fa the cntomer 4 oe ander): ote ty EB ements 3 perfo sult Noy Performance can reste etherto quantitative or qualtve fing Note 2 entry: Perrmance can relate to the management (3.3.3) of acute: (3.3.1), processes (3.43) products (G.78) series (22.7)gntoms (351) or orgonztions (3.21). Note 3 t entry: This constutes one ofthe common terms and coe definions for IS0 management system ‘Sandards gies in Anner St of the Consoliated 80 Supplement tothe ISO/IEC Directives, Part. The rial denon hasbeen mii by nding Note 2 ext 379 risk 28fect of uncertainty Note 1 ents An eect a deviation from the expeced — postive or negate Note 2 entry Uncertainty isthe state, eve partial of dfceny of information (38.2) related understanding orknowledge ofan even consequence cr Malhood. Note 3 to entry: Risk soften characterized by reference to potential events (as defined in 1S0 Guide 73:2008, 3513) and consequences (os defined in 90 Culde 732009, 3.613) combination o these Note 4 to entry: Risk soften expresed in terms of combination ofthe consequences of an event (in ‘ange a ceeumstances) and the assole ellood (as define n 80 Guide 7.2008, 3611) of oe Note Sto entre The word ries sometimes used then ther is the possibilty eign espe Note 6 to ent This constitutes one ofthe common tems and core defintos for ISO ent sytert ‘Ranarde gion in Annex Sof the Consallsted 10 Supplement tothe ISO/IEC Direct "The oda ‘efntion as eon modified by adding Net Sto entry es s ae ‘asionship between the rsuk achieved and theresures used <> br & tet tow planned avr ara and gla QQ raha Note, to entry: This constiuce one of the common ts andards given i Annex of to ConsliatdIS0 ¢etnton as been moe by adding” ar” before 3.8Terms related to data, informati ore definitions for 190 managertent system. 3 othe ISO/IEC Direcuves, Part. The erga Pa $ aeameneon AY wo mata 9 303 objective ‘daca (38.2) Suppo¥ting the existence or verity of something Note 1 ‘Objective evidence canbe obtained through observation, meosuement (3.114) test (311.8). by a, Nof.2't entry: Objective evidence for the purpose of aul (3.134) gnerally consis of records (3.840), atements of factor other ijormaton (382) which are relevant to the audit eters (3137) and verifiable 3a Information system “quality management system> network of communication channels used within an organization (82:1) 385 document Information (38.2) and the medium on which itis contained180 9000-2015 [BRAMPLE —_ Récord (38:0), speciation (3.8.7, procedure document, dawing report standard ‘oto 10 entry: The medium canbe paper, magnet leceone or opal computer ds photograph oF master spl or combination therel "Note 2 tent A set of documents fr example specications and records roquey calle documentation’ Note 3 to enry: Some requirments (3.6.4) (eg the requirement tobe readable) relate coal types of documents However there can be Afferent requremests for speciieatins (eg the requtement be revision controlled) and for records (eg. the requirement tobe retievabe). i © $e a os information (3.8.2) required to be controlled and maintained by an organization (3.2.1) anethey tium tote wey: Decent etn tie tna RS Detect acim cele x See remem nites Nae bead oul ad ph eer pas — sects (con (80) A Note 3 to entry: This constitutes one ofthe common terms 0 we defiitons for 180 management system sete ete ni cessor ec 387 specifiation S teen) sa mga SON xAMniz Quay mal (89, gaGg>Dlon (89) eal dean, proctire dcumen, wok {and est (3.11.0) speteation), "0.7.8 (ew Productspectication performance (3.78) specication and Note 1 to entry A specifition ghana (eg procedure document proces (34.2) speciation Soi sign and develop znd hu nome cases cn be ind as reord (S810), tied er epee etc tsi ny wen i 7) forthe quality management system (35-4) of an organtzaion (32.1) ey: Quay manuals can vary in detail a format osu the sie and complexity of an individual ion (223). 389 ‘quality plan ‘Specicaion (3.8.7) ofthe procedures (345) and associated resources to be applied when and by whom toa specific abject (3.6.1) Note 1 to entry: These procedures gunerlly inca those referceg t» qulty management (23.4) proceses {Get} and to produc (2.78) and sorte (3.77) reaiation processes 0Note 2 to entry: A quality pln often makes reference to parts ofthe quality manuel (288) orto procedure Aocuments (385) Note 3 tent: A quality plan isgenerally one of the ess of gully planning (335). 30.10 record ‘document (3.85) stating results achieved or providing evidence of activites performed Note 1 to entry: Records can be used, for example to formalize racabilty (3.6.18) and to provide evidence of verti (2812) preventive ction (3.121) and corrective ation (2.122), sent Vv project management plan document (3.85) specifying what is necessary to meet the objectives) (3.7.1) ofthat (3.42) "Note w ent A project management plan should acude or fer othe projects qualtnlon (3.89). Note 2 to entry The project managemant plan alto ices or references 3 plane ae those rating to ‘organizational structures, resoutes, schedule, budget ri (C79). nt (S83), environmental Imarageren heath and safety management and security management, appropri. {S0URCE: 150 10006:2008, 3.7) Sy sea & verification {onllemation, through the provision of objecting MRE (3:83), tha specified requirements (364) ‘Serrsfuranon i hci seme cise ener O65) Not 0 nn The werd wre Qt deste caren aaa validation ‘confirmation, th provision of objective evidence (3.8.3), that the reguirements (8.64) for Specific intende plication have been fullled Note 1 10 exGingh¥ objective evidence needed fora validation Is the result of tet (3.119) oF other form of secrmingtga 111 sucha performing ternative clealatons or reviewing documents (385) 7 The word "valde used to designate the corresponding tats Yo entry: The use condons for validation can he ea or simulated. sea configuration status accounting formalized recording and reporting of product configuration information (8.68) the status of proposed changes and the status of the implementation of approved changes [souRcE: 180 10007:2003,3.7] aeas o180 9000:2015 specific case ‘quality plan> subject ofthe quality plan (3.89) Note 1 to enty:This erm is se to avoid repetion of proces (24.1) product (3.7.6, projet (342) or contact (3.479 wisi 10 20005. 2 9term rested comer has 2 ‘ret eat on comms an erent tans pe 74 oe Sor a ae ee {URC nna nee —Th wen en ae Sr ated Ph lstomers (324) perception ofthe degree to which the costomer epectaapehave been fle Sees acini SUR maa yrs dee pe masta oa som = Note 2 tency Complains (3.93) are a common indicator ee stsfcion bu thet absence dos not secesany ily high customer ststaction. Nore to ony re when etoner panes o een agreed wth theca tied eis Aves not necessary ensure high customer stil Minibar sees 393 & ‘complaint ‘customer satisfaction» ex of dissatisfaction made to an organization (32:1), related to Is roduc (37.6) or service the complaint-handling process (24.1) sel where a response or resolution is explicitly opty expected tsouRcE1s0 segs smd — The term servic" has ben ncudd In the defiatn] 398 ‘customer satisfaction code of conduct promises, made to customers (3.2.4) by an organization (3.2.4) concerning its behaviour, that are aimed ftenhanced customer satisfaction (39.2) and related provisions Note 1 to entry: Relted provisions can indude objectives (271), condons, mations contact information (382) and complains (393) handling procdures(345). Note 2 entry In 150 10001:2007 therm “ods se instead of "customer satisfaction code of conduc. 2{SOURCE: Iso 10001:2007, 31, modified — The term “code has heen removed as an admitted term, and Note 2to entry bas ben modified} 396 Aispute customer satsfetion> disagreement, arising from a complaint (3.93), submited to a DRP-provider ez) Note 1 to entry: Some organiaton (222) allow their customers (22) ta express her desatistacton to a DRP- provider inte fs instance. In ths steaton the expresion of dsatsfacion becomes compel when sen to the oganzation for a response, and becomes dxpute in resolved by the orgnteton without DR Intervention. Many organteaions pofer her customers to st oxpest any dso to of jc Teor ling dispute resoation eternal tthe oegantation 3.10 Terms related to characteristic 3104 > cea ee as weal ca rudecwiataetised daa a ssh ankdcncrtanies eevee gus m= neerpmmms omnes ee Bee etna eae ee » mento li tn i ® ae 9 teen ena 9 el 25 ae Inherent cha (10.1 of an objec (3.6.1 related toa requirement (3.6.4) aan strat), ‘ Noted to ste erent means existing in something, especially as a permanent characteristic. re A cbracoritic assigned tan eject (og the price ofan object) not qual character oF 3.163 ‘human factor ‘characteristic (310.1) ofa prson having an impact onan objet (3.6.1) under consideration Note tency Characteristics can be physical cogtve or social. Note2 wo enry Human factors can have a significant impact on a monegemenc stom (35:3). 2104 ‘competence Fy180 9000:2015 aby to apply knowledge and skis to achieve intondod results "Note 1 terry Demonstrated competences sometines referred to as qualification Note 2 to entry: This contiztes ane of the common tems and core defn for 1S0 management system ‘Sundards given in Annex Sof the Coneoiaed IS0 Supplement tthe ISO/IEC Directives, Parc. The original ‘etinkion hs been modified by adding Note 1 ten. 308 metrological characteristic ‘Sree 105) wih cine hres of mearoment (3114) no tortocteniyonontiseniintmeneeis, oS te ene Mela ancien te ctarain & a0 a centurion Interreated functional and physical characteristics (3.10.1) ofa product (376) 9 yrvice (3.7.7 dened inproduct configuration information (35.8) Sime 8 aa ream ee ange te Ee eGo es ar sats an aga os ated ad we produc (37.6) or service (3.7.7) ata pot in tne reference for activities throughout the {ite eyele ofthe product or sorice (sce 50 strat 34 note te tcl the deo 24 Trmreaed en dtermine gaia ‘determination aatvtyt find out oe oF mo rstics (3.10.1) and thele characteristic values sana Ss rvew 3 Terni hwy neg oe 720 nebo te cathe oe.) Shp A sie be on Pronghorn Gt} od por ow tietermining (311.1) the status of ayer (35.1), process (3.4.1), aproduct (8.7.6) a service (3.7.7), 0F an activigy Revie ca aleo ncide the determination ofecony (3.710) Note Lo enry: Fr the determination fhe status there canbe a need to eheck supervise o rity observe. Note 2t entry: Monitoring is generally a determination ofthe status ofa objet (2.6), arid ue ferent ‘Sages oa diferent tines, PaNote 3 to entry: This constnutes one ofthe common terms and cove defiakions for 180 management system ‘Sandards given in AnnexSL. ofthe Consokiated 150 Supplement tothe 180/1EC Directives Parc The oFigial ‘etntion and Note teary have been modified, and ote 2t entry hasbeen added. 3414 process (34.1) to determine avalue Note 3 to entry: According to 80 3534-2 the value determined i general the value ofa any, Yor 2 nr Ti conutoe of he conn urs te dons or 0 manuemen en ies at che fe eater ere a ee ae ea nee > suns av Seated Ais ~S as ‘nearing insiamen, software measurement standard, =a sul apparatus or combinatlon thereot necessary to realize measurement process (3. i ¥ determination (3.11.1 of conformity (3.6.11) to specified Vea asi speach Cl et Ala 2 Th ret on gS) try ry 9) oe sane S fe S {rmination (1:3 acon SN ubeet (1.64) pected sor apt Note to entry the result Na re conformity (36.11), can be use for purposes validation (2.833), 3g rusia & crag sent of ropes ale on werent he pak At ees ob Note 3 to exten asessment shouldbe creed out t appropriate pins inthe project if cycle atoes project 0 Raced on tera or project processes and product (27.6) or serves 07.7) ‘@ ty: The results of progress evahiations can lead to revision ofthe project management plan (3.11. [SDRC 10 10006:2005,34, modfed — Notes to entryhave een mode] 3:12 Terms related to action aaza Preventive action eion to siminate the cause of potential nonconformiyy (269) or other potential undesirable "Note to entry: There canbe more than one cause for a potential nnconformiy80 9000:2018 Note 2 to entry: Preventive action Is taken to preven currence whereas corrective action (3:42:2) i taken to proven recurrence 3422 corrective action action toeiminate the cause ofa nonconformity (3.69) and to prevent recurrence Note 1 meni There can be more than one cause fora woseonfrmty. Ber ere ate etn a irate Hs Sah proventoccurrenc. Note 3 to entry: This constitutes ane ofthe common tens and core definions for 180 man dards given in Anner SL of te Consoldated 130 Supplement tothe 1S/Ec Dretvs, = Tiyan etntion has been mode by adding Notes 1 an 2 entry. = & ‘correction ‘ction to elminate adateced nonconformity (388) tte w nt: Acorrstion canbe mde nadvane of in concn wh iat tee 210 ney Aceon canbe for ral evr (128 or erg KONE) ae ae S. En one rode (53) o «meng (666 6c (78 or ee (7.7 oder o Sra Mrcedcneee kt aan gid oaks aaa Saee se wae or mle (127) 9 PW (878) or re (87.7) ht dwt nt anor etaegaremens not ey Acne perhaps athe eae fay amar crest a act ps sad ay ped eta etiee a gegen auze Eton pera oS pean palm he ernaly sce mguamens (264) opr (78 oF er rprorta ped Ean Se apace ireeenthndees crest oire S Bam Note 1 to entry In Eoglish nthe contexof sofware and documents (3.8.5), the word “release frequently used torelec toa version ofthe sofware othe document tall 1 tothe next stage of process (34:1) or the next process aa28 rework ‘ction on a nonconforming (3.69) product (37.6) or service (3.77) to make it conform to the requirements (364) 38Note 1 tent Rework can affect or change parts ofthe nonconforming producto service, 3429 repair action on a nonconforming (3.59) product (37.6) or service (377) to make it acceptable for the intended use Note 3 to etry: A sucessful epic of nonconforming prod or service doesnot necessary make the product te servce conform tothe requirements (244) Tecan be that in conjunction witha repair a cncesion (24125) Is equred Note etry Rep nce eed aon an ona prev onfoming product or service ope Grn Weeeeu persone _ S Note to entry: Reps cn alt or dang parts of the nonconforming product or service. 3 aaauo S&S = s Acton on a nonconforming (368) produc (276) or service (8.7.7) t precudDNY orignal intended iid? "Gendt ass we sas tai O ‘otenac Independent nd documented prog) or obtaining object evden (283) and ‘valuatingfeobjectively to determine the ich the aud ertaria (3.13.7) are fulled Note 1 te entry: The fundamental lems CB fn ee (1) mr em Seno x Note 2 ont An aut an ae sete (a par ems (toed pty orth para tnd neon bea combined aude MAW) ora jin cud (233). ‘ua include the determination (3:11) of the conormigy S45) eared out by personel not being responsibe fr the Note 3 to entry: Intepaaits, sometimes called frstparty aud, are conducted by. or on behalf of, the Drgnization (321) Jef management (33) review (S112) and other Internal purposes, and ean fre the tal for 30 orga ‘ocaraton of conformity. Independence canbe demonstrated by the fFeadom from respon hy being auto Note 40 teal audits nlade those general called second and shindpary audits, Second party audits ares having an interest nthe organization such ar eastomers (2.24), or hy ater persons 08 “Tirdpary audits ae conductd by exeraal, tndopendent auditing orgoiatons suchas tose Eeriction/eeistaton of confrmiy or governmental agencies Notts to entry: This constites oa ofthe common terms and core definitions for IO tsanagement system Standards given In Annex SL ofthe Consaliated 180 Supplement to the 1S0/TECDrectives, Part. The orginal ‘etnkion and Note entry have been modified to remove effect of crularty beoween audi eters sod audit evidence term entre, ad Notes 3 and to entry have been ade aa32 ‘combined avait ‘nude 0.13.2) carried out together a a single audtee (3:13.12) on two or more management systems G53) a180 9000:2015 Note to entry: The parts of a management system that can be involved ina combined aut canbe ented by the relevant management system stndards product andar, service standards or process standards beng applied by the organtadon (3.21). ae Ne aca ct aa i Rp dr perish aii os, a rere apn Ba Ah ad aca pare SOE purpose OY {SOURCE: 10 19011-2011, 3.13, modited] ay aaas x ee Ss ‘extent and boundaries of an audit (3.13.1) =~ Note 1 ta entry: The suit scope senealyIndudes a description of hep ons, organiatons units, ast nd processes (34.1. \ {s0URCEf0 190112011314 modified — Note entry es sean aaa S auditptan & terion ofthe actives and sores 2 [SOURCE: 10 19011-2013, 315] es 3s Budi erteria Set of pices 35.8), procedures (438-97 reauremens (3.64) used as a reference spans which abject evidence (3.83) compa [SouRCe: 10 190112011, 334M — The term “a evidence” has been replaced by “ojeive biden) SS aaa y audi erdence records a ct other infrmatio, which ae elvan to the aud ertara (3:13) and vera toc Ge 29 nto arn ed 2. Note 1 toenry Ai ining inate canformi (3.611) or nonconformity (2.69). Note 2to entry: Aut ndings ca ead tothe doneeaton af pporcniis for improvement (2.1 a recording good pratces. Note 3 to entry: tn English, if the aut erri (323.7) ae selected from statutory requirements (368) or ‘eplatory requrements(2.87) the aud ading can be alld compliance ce non-complance. [SOURCE; 150 19011:2011, 34, modified — Note’ to entry has been modified] 38343.0 ‘audit conclusion ‘outcome of an audit (3.13.1), after consideration ofthe auit objectives and all auat findings (3.13.9) [souRcE: iso 19011:2033, 35] 343.41 ‘audit client ‘rganiation (3.2.1) oF person requesting an audi (3.13.1) [SOURCE: 150 19011:2011, 3.6, mocified — Note to entry has been deleted] 343.42 wy soaice s nation (921) bing ried & (souecs 0 39031:2033, 27 Ss 34343 4 guide SY ‘audit> person appointed by the audtce (3.13, saponin 314) (sure 901201, 2331 3 a e re Er cia ale can veil [soURCE: 150 1901: aorsananagah aaaas s rem wh coe 26S 0 person vo conduc nanfhQRD Be Note 1 @Qap Spec knowledge or expertise eats tothe organization (3.21), th proce (SA) or sev be language or clure Nolb2 oon A technical expert does not acta an autor (3.1315) in he eu team (3.13:14), [SOURCE: Iso 19011:2011, 3.10, modified — Note 1 to entry has been modified) 343.47 observer - person who accompanies the audit team (2.13.14) but does nat act as an auditor (2.13.15) Note 1 tenty An observe can bea member of the aude (3.132) regulator or ther neresed par (323) rho witnesses the ue 2482). 280 9000:2015, [S0URCE: 1s0 19012:2011, 311, modified — The verb “audit” has boon removed from the definition; Note to entry has been modified}