INTERNATIONAL ISO STANDARD 9000 ‘Second ecition 2000-12-18, Quality management systems — Fundamentals and vocabulary ‘Systemes de management de ta qualité — Principes essentiels et vocabtaire AMS on TEM Goh or Toned THSSTANDARDISSUPPLIEDBY [BSB INFO Cenc Private Limited 10009 aon Reelerence number 180 9000:2000(E) @180 2000180 9000:2000(2) ‘his POF tle may contan embedded typoaces exited untess te typeaces which ae embed Were optiized ier pining. Every care has tee IRata pratiem relating tots ound, peace nor @ 180 2000 180 9000:2000(E) Annex A (informative) Methodology used in the development of the vocabulary A.1_ Introduction ‘The universality o!apatication of the ISO 9000 family af standards requires te use o ~ Slechnical description but without the use of technical language, and ~ ranagent and harmonized vocabulary that is easly understandable by all potential users of quality ‘management systems standards, A2 Content of a vocabulary entry and the substitution rule Ane concent forme the unit of wansfer between languages {including variants within one language, for example Sraatcan English and Briish English) For each language he voce {Ppropriate term forthe universal transparency ofthe concept in that language, ie. nota iteral approach to rancaia chosen, Jectnition i formed by describing only those characteristics that aré esseniiat \o Icentty the concept. information the defnaion,: * MIEN i sportane but which i nol essential tole Gescriniee ut in one or more notes to the definition ere should be no change in the Simple method fur checking the accuracy ofa detiniion, Hower Shere the dentin fs complex in tne sense that it contains & nostbor gy terms, suosttution is best caved out taking Schiove symtoctcene ceintions at a time. Complete substiution of the lolshiy cra {terms will become difficult 19 achieve syntactically and unhelpful in conveying meaning, 43 Concept relationships and thelr graphical representation A341 General Sy tmo10By work the relationships between concepts are based on the bierarchicai formation of the characteristics O13 Sees So that tne most economical deserston al @ concon'c eg by naming its species and describing the Sharaciensics tha distinguish it from its parent or sibling Concer Tate nee erimary ems of concept elatnships inceatedin this annex: genenc (4.3.2), partve (A.3.3) and associative (A.3.4), A.32 Generic relation Suborsnate concepts wihin the hierarehyiaheit all the characterise of the surerorainate concept and contain Goserplons of these characteristics which distinguish thern rons {he Superordinate (zaren!) and coordinate (sibling) Concep's. 9. ne relafon of spring, summer, autumn and winter to genre ations ere depicted by a fan or iee diagram without arrows (cee Figure A 1). 1SO 2000~ Al nants reserves 19180 9000:2000(E) IT sping summer autumn Figure A.1 — Graphical representation af a generic relation 3.3. Partitive relation ‘Subordinate cancepts within the hierarchy form constituent parts of the superoiuinate concept. e.g. spring, summer, autumn and winter may be delined as pars of tho concept year. In comparison, itis inappropriate to deline sunny ‘weather (one possible characteristic of summer) as part of a year. Partlive relations are depicted by Y & rake without arrows (see Figure A.2), Singular parts are depicted by one line. muti pare by double lines, year + spring summer winter Figure A.2— Graphical representation of a partiti A.3.4 Associative relation ‘Associative relations cannot provide the economies in descri ‘but are helptulin identitying the nature of the relationship be! e.g. cause and effect, activity and location, ition that are present in generic and partitive relations ween one concept and another within a concepl system, activity and resuit, tool and function, material and product. Associative relations are depicted by a line with arrowheads at each end (see Figure A.3). sunshine >». cummer Figure A.3 — Graphical representation of an associative relation1S0 9000:2000(E) A4 Concept diagrams Ss Sranderd ito 4-13 show the concept eiagrams on which the thematic ‘roupings of clause 3 of this International Standard are based, caeeh he deitions of the terms are repeated, any related rotes are ot. and it is recommended to reler 10 Clause 3 to consult any such notes, requirement (2.12) sede epecaion hat “<———3> grace (31.9) (5 slated, ganeraty category or tank given tome Inptied o¢ Boigatany ‘tteront quality requremants for product, processes or systems ‘ving the same Knctona we quality 2.1.1) gro to which a set of Inherent enavactenstes hte reawtements| - capability 1) ably ofan organization, system o: prcess to ‘ealize procuct tat wil ld tre regurorrene er tat produc customer satisfaction (3.1.) customers pereeston tthe degree townen tie customers requcements have Been tins Figure A.4— Concepts relating to quality (3:1) at1S0 9000:2000(E) system 20 i ail ssl inaretted r ‘corsa activites ineraceng oom ‘Davee Sed conch sn orsanzason management system 22) systemto estabisn ‘nat emove toed abjecives quality management system (323) management system i ‘direct ana coral an cogantaven win ragardto ‘ualty quality planning (029) Gz) part of quality par of quatty managomortiocused management focused anagem focused ‘on settog quaity ‘ontting quatty on prong objectives and reqarements _cenfidence tat qually sect sacessany ‘he rescue 1 ash the quatty obeetves tfectiveness (1 14) ‘extent fo which planed 2ctvies ae realized an planned resus achieved quality management (2a) coordinated acing to rect ‘snd conto an organizaten ‘wih agar tan top management @a2y Tersen or gre poopie wo drects and cones an ‘tganizatan atthe highest Tevel quality policy (22.4) ‘overall iniontors ang cerganitaton related to ualty as tora ‘roressod by top ‘management quality objective 2s) ‘something sougnt of ames ak related Yo cualy continual improvement 213 recurnng acy to werease the abity tran control quality assurance quality improvement rear) par ol qualty management focused on vereasing ‘fa abliyo halt ually equrements efficiency 22.15) Felabonstip between recut achieved and resources used Figure A.5 — Concepts relating to management (2.2) 22organizational structure (932) arangemert ot responsbiltes, atnortes ‘and relationships berreen rosie 'S0 9000:2000(E) organization (32.1) {Youn of people ano actbes mth an, ‘rrargement et responses, authorises ‘end eonsnps interested party 37) Detson or croup narng an increst inne pectormarce oe SUCEOSS can erganizaton customer 2.5 supplier 2.3.6) Sore orpazaton or 7 ‘rgansatono barton nat erstoe intrasteucture eS sere ot or * esucr “organzatone spstomal nett, i euomentancsentes Werk environment - reuded torte operation of G34) ‘snowansaton sett condtens under wich wen pre Figure A.6 — Concepts relating to organization (3.3) L Procedure as) process 4.3) nachapeeaseeees SO ttotinardteder <> product 242) ‘nach ora process design and development erry setof processes that transtonns ‘tequiements ina epeciteg haracteistes ero the specitcaion ola product process orsysiem a ‘eracing aces wnien reaullofa process transis imo outputs project (24.) tunlgue process, contising oo set of coorinated and conroies actives wit stat and frfan Gates, Uunderaken to achieve an objective conforming Specie requremenss, netuding te consvaine ee lime, cost and esoutees Figure A.7 — Concepte relating to process and product (2.4) dependability pees collective tem usea te describe the availabilty perarmance ands infleneng factors relabty erlormanee, maintnabiy Perlonrance, and maintenance ertormance EE: «Pac z0m erst rsonee Suppor raceabllity (3.5.4) ably raze te history, ‘aoalcarrneetccaton ef Mat which under ‘cncideraton ‘quality characteristic (25.2) inherent characterise ofa rode, processor system Figure A.8 — Concepts relating to characteristics (2.5)180 9000:2000(E) . requirement (3.2) x’ nonconformity 0.621 , Steet ieee aS Se" conformity 51) ontulment ola secdhenonrech an (mnt ipettedare release 3639) semis peas Fool Preventive action comectve action concession ve Tete" deviation perm scion ethnte pont ag Seven Scare Siceces™ rameter eat “hens qccmmesa Pema oe ctsrctcatom —"sposl ae, Sree aura re seaonens "ease conectionasy = anoanae er (3610 cane, noneentoming produto precede fongnayintenses rework a6) regrade 6.) sctonena ‘eran he ences ‘govocte povuca mat sorcniomng exis othe productos eae fo ‘eqataments mraxe cota 2 repair 269) pect onn neon rocket tomate Seceptape lore Figure A.9 — Concepts relating to conformity (3.6) 24 (2130 2000 au gis reserved10 s00u:z000(€) information (37.1 ) document (37.2) meanings data —<———> Infomation snd ks ‘Seppoding megum Procedure document (rot defined see mateo ‘ocr SPeceallon 73) quality manual 74) quality plan (a7) record (37.5) ecumert sang acuman spoainng ng Seeumontspociying document staing “sstonsns qaiymanagemen stem seme aptching doar acnieved er “temomganzaton “" Sssoclatedsouces-Ddng snaante Sulboappied by “sctces pores wom and when toa Sones projec, Prout, process or Figure A10— Concepts relating to documentation (37) determination 7 frat a cere evidence 28.1) ceecveness ofthe _subiect mater to aoe, ry =" / ‘De proasion ot sence. that soeciied ojeeeve enderce, tnat ‘equromente nave baen ‘pe teauirements fora pesionass ose eet colt ‘ore charactenstes etsuement teins aecorang oe eve orgaugng Figure A.11 — Concepts relating to examination 3.8) {GP 180 2000 A ighis served 25 2 3 : eet$0 9000:2000(E) audit programme (39.2) audit client (327) isles cen sea auditee a2) 4 sraareaton opera nesta mecticins cramesvon eng ceueeo avout per ‘pectic purpose auait901) A€——>e- aut findings 29) systemabs, independent a sus cl the evauaton of 4 documented process for ve coleceg suo cence obtaining aust encence and Spans! aut enena, evahuanng tebiectvely to whieh a , “ audit criteria 3.9.) audit team (29.19) audit avidenra (va) procecures of fe ox more austors cecores, statements of factor Reranem ede) ‘onaueang an aude ‘ner wntormaton wach are faaunca felevant to tne auaterten s audit conclusion 2.6) outcome ofan ava proved by technical expert (29.11 it eazy petses —@—pe Alor 2.9.9) specie knowedge of of nn On consgeraton ofthe audt cspense nn stiecta eatee loc ‘bjectves and al aust findings Figure A.12 — Concepts relating to audit (3.9) peed ‘ - ae10 9000:2000( measurement process 2.102) metrological confirmation (3.10.2) seta operadons i dotemine fet of operations required to ensure rat ‘ovale ofa quantiy, ‘maatuing eaupment cantons tothe Yoaurament for isinended se ee ‘control ftonsineconnvasy >” Metrological function (3.106) on wth pantera ements neces tachi ‘esponsiiy or detrng on ‘steal sin oa ‘pleengow mearoertat cons conto’ contol sytem ‘measuramont processos: a aaa eaeP ment 404) metrological characteristic missioner sand torercy AC 105) ‘material oe ausiary apparatus or ‘combination herect necessary 10 fealze a measurement proces steguising feature which can invence tha rasuits ot measurement Figure 4.13 — Concepts relating to quality assurance for measurement Processes (3.10) ©150 2000 At nguis reseved 27'S0 9000:2000(E) Bibliography IN] ISONEG Guide 2, Stanaardzation and related activities — General vocabulary 12] 150 704, Terminology work — Principles and methods. rs 180 1087-1, Terminology work — Vocabulary — Part 1: Theory and application. iq 10 3838-2, Statistics — Vocabulary and symbols — Part 2: Statistical quality control [8] 10 9000-1:1994, Quality management and quality assurance standards — Part 1: Guidelines for selection and use. (6) 'S0 9001:2000, Quality management systems — Requirements. 7] 180 9004:2000. Qualily management systems — Guidelines for performance improvements. [6] !80 10006:1997, Quatity management — Guidelines to quality in project management, [9] 180 10012:—", qualty assurance requirements for measunng equioment. [10] 180 10013:1995. Guidelines for developing quality manuals, [11] 1SO/TR 10017, Guidance on statistical techniques for ISO 9001:1994. [12] 180 10241, International terminology standards — Preparation and layout. SO/TR 13425, Guide for he selection of statistical methods in standardization and specification, [14] 180 12001:1998, Environmental management ayatema — Specification with guidavice for use. [15] 1SO 19011:~2), Guidetines on quality andlor environmental menagement systems auditing. [16] IEC 60050-191:1990, international Electrotechnical Vocabulary — Chapter 191: Dependability and quality of [17] VIM:1993, Intemational vocabulary of basic and general terms in metrology. BIPMVIECI 1FCCISO/OIMLAUPACAUPAP. (18) Quality Management Principles Brochure, [9] 150 2000 + 180 14000 News (a bimonthly publication which provides comprehensive coverage of international developments relating to ISO's management system standards, including news of their implementation by diverse organizations around the world) *) 1) Tobe published. (Revision of SO 10012-1:1992 and ISO 10012-2:1997) 2) Tobe published. 3) Avaiabia rom wobste: napurwwnvsso.ch 4), Available trom ISO Contral Secretariat (sales @iso.ch),A audit 3.9.1 audit client 39.7 audit conclusion 39.6 audit criteria 39,3 audit evidence 3.9.4 audittingings 3.95 audit programme 39.2 audit team 3.3.10 auditee 398 auditor 3.9.9 ce capability 3.1.5 charaetarietio 2.5.1 concession 3.6.17 conformity 3.6.1 continual Improvement correction ‘366 corrective action criteria 3.93 customer 3.35 customer satisfaction ‘33.4 competence 3.9.12 3213 308 D detect 363 Eependability 3.5.3 design and development 3.4.4 = deviation permit 3612 document 3.72 € eHlectiveness 3.2.14 = alicioney 3.2.43 grade 3.13 “y Intormation a7 Cintesiructure "233 fvtnspection 38.2 zd. Inerested pany 3.3.7 A BCIc0 2000 ~ anngns resend Betas Alphabetical index M management 3.2.6 management system 9.2.2 measurement control system ‘measurement process 310.2 measuring equipment a.ina metrological characteristic 3.10.5 metrological contirmation 9.10.3 metrological function 3.10.6 3.10. N Roncontormity 36.2 ° oblective evidence 2.8.1 organization 3.3.1 tional structure 332 e preventive action 3.6.4 Procedure 3.4.5 Process 3.4.4 Product 3.42 Project 3.4:3 Q Qualification process quality 33.5 Quality assurance 3.2.14 Quality characteristic 3.5.2 auality control 32.10 auality improvement 3.2.12 Quality management 3.2.8 Quality management system 3.2.9 Quality manual 3.7.4 Quality objective 3.256 Quality plan 37.5 quality planning 3.2.9 quality pelley 32.4 dae A tecord 3.7.6 tegrade 3.6.8 relewse ~3.5.13 repair 389 180 9000:z000(6) Foquirement 3.1.2 review 28.7 rework 367 s scrap 36.10 specification 37.3 supplier 3.3.6 system 3.24 T technical expert 3.9.11 test 303 topmanagement 3.2.7 traceability 35.4 . v validation 3.05 verification 34 w Workenvironment 3.34'S0 9000:2000(2) ICS 01.040.03; 03,120.10 Price based on 29 pages (©1S0 2000 At sgh reserved