INTERNATIONAL STANDARD NORME INTERNATIONALE ME>KAVHAPOAHbIH CTAHAAPT

ISO 8402:1994(E/F/R)

Quality management and quality assuranceVocabulary

Management de la quallte et assurance de la quallte - Vocabulaire

Ynpaaneaae Ka4eCTBOM '" o6ecne4eH",e Ka4eCTBa - Cnoaaps

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Contents

Page

Scope .. , >............... 1

Terms end definitions ,................................................................... 1

;

j Section 1:
I Section 2:
Section 3:
Section 4: General terms :...................................... 2

Terms related to quality G

Terms related to the GJality system 14

Terms related to tools and techniques 23

Annex A Bibliography 31

Alphabetical indexes

English 34

French ~................ 36

Russian 38

9

INTERNATIONAL STANDARD NORME INTERNATIONALE ME)I(IlYHAPOIlHblt1 CT AHIlAPT

ISO 8402:1994(E/F/R)

i\"

Sommaire

Page

Domalna d·appllcatlon ; ;........... 1

Termas et definitions 1

Sactlon 1: Termes genetaux 2

Section 2: Termes relatifs it la qualite 6

Section 3: Termes relatifs au systeme qualite 14

Section 4: Termes relatifs aux outlls et aux techniques 23

Annexe A Bibliographie 31

Index alphabetlques

Anglais 34

Fran~ais . 36

Russe 38

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AnclJa .... THIt.e YKa:saTenM

AHrnMHCKMH ...•.•...•. 34

<I>paHUY3cKMH ;............... 36

PyCCKMH 38

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ISO 8402:1994(E/F/R)

e iso

Introduction

Many ordinary words. in everyday use. are used in the quality field in a specific or restricted manner compared with the full range of dictionary definitions. due to such reasons as:

- the adoption of quality terminology by different sectors of business and industry to suit their specific perceived needs,

- the introduction of a multiplicity of terms by quality professionals in different industrial and economic sectors.

The intant of this International Standard is to clarify and standardize the quality terms as they apply to the field of quality management. These terms and definitions are discussed and grouped together in the text according to logical topics. They are also regrouped in an alphabetical index at the end for convenience. .

The word quality (2.1) in popular usage often means different things to different people. In this International Standard quality is defined as the totality of characteristics of an entity that bear on its abillty to satisfy stated and implied needs.

There are many different usages of the word quality. These different usages create considerable confusion and misunderstanding. Two such usages are "conformance to requirements· and ·degree of excellence". ·Conformance to requirements" leads people to argue that "quality costs less". which in some cases it doe s, Conversely. ·degree of excellence" implies that "qualitv costs more", which in some cases it does. In order to resolve some of the confusion in the usage of the word quality. another term grade (2.2) can be used to describe the degree of excellence. The term grade is used. when needed. to describe the sense of technical excellence. Grade reflects a planned or recognized difference in the requirements for quality. Although the different categories of grade do not necessarily stand in rank order relationship to each other. grade indicators can readily be used in a rank order sense to describe the sense of technical excellence. An example of this usage is that it costs more to provide and run a five-star hotel than a boarding house.

The term product (1.4) is used throughout this International Standard. It is the result of activities or processes and can be tangible or intangible. or a combination thereof. In current ISO quality management standardization. products are classified in four generic product categories:

- hardware (e.g. parts. components. assemblies),

- software (e.g. computer programs, procedures. information, data,

records).

- processed materials (e.g. raw materials. liquids. solids, gases. sheets. wires).

- services (e.g. insurance. banking. transport).

j

It is recognized that products generally involve combinations of these generic product categories. The terms and concepts presented in this International Standard are intended to be applicable to any product.

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ISO 8402:1994(E/F/R)

In this International Standard, the term entity (1.1) includes the term product, but extends further to cover, for example, activity, process (1.2), organization (1.7) or person.

Confusion has arisen in understanding the terms quality control (3.4), quality assurance (3.5), quality management (3.2) and total quality management (3.7). This International Standard Is intended to clarify these concepts.

In simplified terms, quality control concerns the operational means to fulfil the quality requirements, while quality assurance aims at providing confidence in this fulfilment, both within the organization and externally to custom,rs(1.9) and authorities. Within International Standards, the English terms "ensure" and "assure" are used in the following sense: "ensure" means to make sure or certain, "assure" means to give confidence to oneself or to others.

Quality management includes both quality control and quality assurance, as well as the additional concepts of quality policy (3.1), quality planning (3.3) 'and quality Improvement (3.8). Quality management operates throughout the quality system (3.6). These concepts can be extended to all parts of an organization.

Total quality management brings 'to these concepts a long.ferm global management strategy and the participation of all members of the organization for the benefit of the organization itself, its members, its customers and society as a whole.

All concepts addressed in this International Standard have both economic and timeImplications. This should be recognized in the interpretation of all definitions in this International Standard even though it has not been explicitly stated in each definition.

The distinction made in this International Standard between the terms defect (2.11) and nonconformity (2.10) is crucial as it has legal connotations, particularly those associated with product liability (2.12) issues. Consequently, the term defect should be used with extreme care.

The terms defined in this International Standard have direct application to the International Standards on quality given in annex A.

Other pertinent standards are listed in annex A. Special attention should be paid to vocabulary standards in the statistics field: parts 1 to 3 of ISO 3534.

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ISO 8402:19941E/F/R)

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Introduction

Dans Ie domaine deIa qualite. beaucoup de ter":,e~ d'usage ?ourant s'emploient dans un sens specifique ou plus restnctlf.que celul donne par I'ensemble des definitions du dictionnaire. Ceci resulte notam-

ment

_ de "adoption par dlfferents secteurs commerciau~ et ind~~triels d'une terminologie de la qualite satisfaisant leurs besoms speclflques

pereus,

_ de "introduction d'unemultiplicite determes par les prof~ssionnels de la qualite dans differents secte~l'$~i~dustriels et economlques.

La presente Norme internationale a ~o~r' objet,. de ~Iari~er at de normaliser les termes relatifs a la quallte tels qu lis s appllquent au domaine du management de la qualite. Ces termes et definitions sont traites et regroupes dans Ie texte selon Uri ordre logique'des sujets. " sontegalement regroupes dans un index alphabetique a la fin du document par souci d'ordre pratique.

Dans Ie langage courant. Ie terme qualite (2.1) n'a pas Ie meme sens pour' tout Ie monde. Dans la prt!Jsente Norme Internatlonale, Ie terme quante est defini comme etant I'ensemble des caracteristiquel d'une entite qui lui co,nferent I'aptitude a satisfaJre des besoins exprlmes et Implicltes.

II y a de nombreuses acceptions differentes du mot qualite. Ces differentes acceptions creent de nombreuses confusions et malentendus. Deux de ces acceptions sont «la conformite lUX exigencesll et eele degre d'excellence». La conformite aux exigences am~ne 8 argumenter que la «quallte coute moins», ce qui est vra! dans certains cas. Inversement, «Ie degre d'excellenee» implique que «la qualite coute plus», ce qui est vrai dans certains cas. Afin d'eviter une certaine confusion dans I'acception du terme qualite,un autre terme, classe (2.2), peut etre utilise pour decrire Ie' degre d'excellence. Le terme classe est, Ie cas echaant, utilise au sens descriptif de I'excellence technique. La classe reflete une difference planifiee ou reconnue dans les exigences pour Ia qua lite. Bien que les categories detinies par differentes categories de classe ne soient pas necessairement rangees les unespar rapport aux autres dans un certain ordre, des indicateurs peuvent etre facilement utilises au sens d'un ordre decrivant celui de I'excellence technique. Un exemple de cet usage est iIIustre par Ie fait qu'il est plus ceateux de diriger un hotel cinq etoiles qu'une pension.

Le terme prodult (1.4) est utilise tout au long de la presente Norme internationale. C'est Ie resultat d'actlvltes ou de processus et iI peut etre materiel ou immaterlel ou bien une combinaison des deux. Dans la normalisation actuelle ISO du management de la quallte, les produits sont classes en quatre categories generiques de produits:

- materiels (par exemple pieces, composants, montages),

- logiciels (par exemple programmes d'ordinateur, procedures,

informations, donnees, enregistrements),

- produits issus de processus a caractere continu (par exemple rnatieres premieres, liquides, solides, gaz, toles, fils),

services (par exemple assurances, banques, transports).

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ISO 8402:1994(E/F/R)

" est reconnu que les produits sont generalement une combinaison de ces categories generlques de produits. Les termes et concepts presentes dans la presente Norme lnternatlonale sont destines a Atre appliques It tout produit.

Dans la presents Norms internationale, Ie terme entlte (1.1) comprend Ie terme prodult, mais englobe egalement un concept plus large, tel qu'une activite, un process,:,s (1.2), un organlsme (1.7) ou une personne.

" Y 8 eu une certaine confusion concernant 18 comprehension des termes maltrlse de la qua lite (3.4), assurance de la quallt' (3.5), management de la qua lite (3.2) et management total de la qua lite (3.7). L'objectif de la presente Norme internationale est de clarifier ces concepts.

En termes simplifies, la mattrlse de la quallte concerne les moyens operatlonnels utilises pour satisfaire aux exlgences pour la quallte, tandis que I'assurance de la quallte vise II donner confiance en cette satisfaction, a la fois au sein de I'organisme et a l'exterleur vis-a-vis des clients (1.9) et des auto rites. Dans les Normes internationales, les termes anglais «ensure» et «assure» sont employes dans Ie sens sulvant: «ensure» signifie rendre sOr ou certain, «assure" signifie se donner conflance ou donner confiance aux autres.

Le management de la qualite comprend a la fois la maitrise de la qualita et I'assurance de la quallte, ainsi que les concepts supplementalres de pollttque quanta (3.1), planlficatlon de la quallta (3.3.) et am611oratlon de la quallte (3.8). Le management de la quallte opere tout au long du systeme quallte (3.6). Ces concepts peuvent s'etendre a toutes les parties d'un organisme.

Le management total de la quallte apporte It ces concepts une strateqle de management global a long terme ainsi que la participation de tous les membres de I'organisme dans I'interet de I'organisme lul-rnerne, de ses membres, de ses clients et de la societe consideree dans son ensemble.

Tous les concepts traites dans la presente Norme internationale ont a la fois des implications economiques et de temps. " faut I'admettre lors de l'lnterpretatlon de toutes les definitions de la presente Norme internationale, merna si chaque definition ne Ie mentionne pas explicitement .

La distinction faite dans la presente Norme internationale entre les termes defaut (2.11) et non-conformlte (2.10) est essentielle car elle com porte des connotations juridiques, tout partlculierement lorsque la responsabllite du fait du prodult (2.12) est mise en cause. Par consequent, Ie terme defaut doit etre utilise avec une extrllme precaution.

Les termes definis dans 18 presente Norme internationale s'appliquent directement aux Normes internationales relatives a la qualite dont la liste figure dans I'annexe A.

D'autres normes approprlees figurent dans l'annexe A. II est bon d'apporter une attention particullere aux normes de vocabulaire dans Ie domaine des statistiques: ISO 3534, Parties 1 It 3.

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ISO 8402:1994(E/F/R)

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BBelleHl.1e

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- npHHRTlileM pa3nM'fHbIM"" OTpacnRMH 6M3Heca H npOMblwneHHOCTH TepM...,Honor...,1II B 06naCT..., Ka'feCTBa, KOTopaR OTSe'faeT MX KOHKpeTHblM nOTpe6HOCTRM,

- BBeneHMeM MHO)l(eCTBa TepMMHOB cneUHanHCTaMH no Ka'feCTsy B pa3n""'fHbIX orpacnax npOMblwneHHOCTIil H 3KOHOMMKM.

Uenb HaCTOR.wero Me~YHaponHoro Craaaapra - nORCHMTb H CTaH~ napT""3HpOBaTb TepM...,Hbl no Ka'feCTBY, KaK OHM nplilMeHRIOTCR B 06naCTlil ynpaBneH...,R Ka'feCTBOM. 3T..., nOHRT...,R ...,CTonKOBaHbl ..., crpynnlilpOBaHbl BMeCTe B rexcre B COOTBeTCTBIII..., C nOrlll'feCKIIIMM TeMaMIil. OHIII TalOKe neperpynnlllpoBaHbl B ancPaBMTHOM YKa3aTene B KOHue CTaHnapra onR yo06CTBa.

Cnoeo Ka'teCTBO (2.1) B 06weOOCTynHOM ynoTpe6neHMIII 03Ha'faeT paaHble nOHRTIIIR onR pa3nlll'fHblX nlOoeH. B HaCTORweM Me)l(JlYHapoOHoM Craaaapre Ka'feCTBO onpeneneuo KaK coaoKynHoCTIt xapaKTep .. cT ... K o6beKTa, OTHOCRLq"'XCR K ero cnoco6HoCT .. YAoaoneTBopRTIt YCTaHoBneHHIt.e .. npeAnonaraeMble nOTpe6HoCT ....

Cyuiecrayer MHoro npyrax pa3n""'fHbIX nOHRTHH, CBR3aHHbiX co cnoco- 60M npMMeHeH...,R TepMIIIHa Ka'leCTBO. 3TO aener K 3Ha'lMTenbHOH nyraH...,ue ..., Henopa3YMeH...,IO. Ilsa H3 lTHX nOHRT""H - lTO "COOTBeTCTBHe Tpe60BaHHAM" III "CTeneHb npeeocxoacrea". COOTBeTCTBllle Tpe60BaH...,RM 3aCTaBnAeT apryMeHTlilpOBaHHO QOKa3bIBaTb, 'ITO "lCa'leCTBO CTO...,T MeHbwe". nonpa3YMeBaeTCR, 'ITO ynoBoneTBopeHllle Hyq "C nepaoro pasa" nOn)l(HO onpaensrears aarparsr, C npyroH CTOPOHbl, ynoTpe6neHHe "CTeneHIII npeeocxoncrea" npennenoraer nporaaononmKHblH CMblcn - "Ka'leCTBO CTOIilT 60nbwe", 'ITO BepHO B HeKOTopblX cny'l8RX. OnR pa3peweHIIIA nyraHMubl, Bbl3BaHHOH npOTIIIBOnOnO)l(HblM np...,MeHeHMeM 3Ha'leHIIIA cnoaa Ka'leCTBO, aKueHT aenaerca Ha npyroH TepMMH - rpaAa", .. R (Knacc. COpT) (2.2). TepM...,H rpaAa", .. R (KnaCc, COpT) ...,cnonb3yeTCR, '1T06bl onacers CMblcn TeXH""'1eCKOrO npeaocxoncraa. 3TOT TepMIIIH RBnReTCA OTpa)l(eHHeM nnaHlllpOBaHHOH ...,n..., nplll3HaHHOH pa3HMUbi B Tpe60BaH...,RX K Ka'leCTBY. HeCMOTpR Ha TO, -rro KaTeropHIII, onpeneneHHble pa3HblMH CTeneHRMM rpanaUlII1II He 06R3aTenbHO pacnonoxeaei B onpeneneHHOM nopanxe, B03MO)l(HO Mcnonb30BaTb MHnHlCaTopbl rpanauua onR onMcaHMR cMblcna CTeneHM npeBOCXOOCTBa. npMMepOM raxoro np...,MeHeHIIIR - nopo)l(e CTOMT npenocraaneaae III nonsscaauae nRTH3Be3nHOH rOCTIIIHMueH, lleM naHCIilOHOM.

TepMIIIH npoAYK","R (1.4) Mcnonb3yeTCR Ha BceM npOTR)I(eHIIIM HaCTORurero MeqYHaponHoro Craunapra. OH 03Ha'laeT pe3ynitTaT AeRTenlt· HOCT ...... n ... npo .... ccoa. 3TO MO)l(eT 6blTb HellTO MaTepManbHoe Hnlll HeMaTepManbHoe, Mnlll KOM6MHaUMR 1113 HMX. B COBpeMeHHOH CTaHnapTM3aUMIII ynpaBneHIIIR Ka'leCTBOM, npOBonMMoH HCO, nponYKUIilA KnaCCMq,IIIUlllpyeTcR no lleTblpeM 06WMM KaTeroplIIRM nponyKulIIlII:

- 060pYOOBaHllle (~anp.3anaCHble 'IaCTM, neTanlll, Y3nbl),

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0150

ISO 8402:1994(E/F/R)

- npOrpaMMHOe 06eene\feHlile (Hanp. KOMnblOTepHble npOrpaMMbl. MeTollIiIKIiI. IiIHc;pOpMaUIiIA. llaHHble. 3anIilCIiI).

- nepepa6aTbiBaeMbie MaTeplilanbl (uanp. csrpse, JlCliIllKOCTliI, ra3bl. nlilCTbl. npoaonoxa),

- ycnyrlil (aanp. crpaxoaaewe, 6aHI<OBCKlile onepauaa, TpaHCnOpT).

np1il3HaeTCA. '4TO BliIllbl nponyxun«, KaK npaBlilnO. ABnAIOTCJ1 C04eTaHIiIAMIiI 4eTbipeX 06wlilx l<aTerOpliIH npOllYKUIiIIiI. TepMIiIHbl iii nOHATIiIA. npenCTaBneHHble B HaCTOAweM MeJICnYHapOllHOM CTaHnapTe. rrpenHa3Ha'4aIOTCA llnA npliIMeHeHIiIA K nlO60H npollYI<UIiIIiI.

B HaCTOAweM MeJICnYHaponHOM Craunapre TepMIiIH .. 06beKT" (1.1) BKnlO4aeT B ce6A TepMIiIH nponyxua», HO pacnpocrpaaaerca nansure, OXBaTblsaA. HanpliIMep. neATenbHOCTb. npo .... cc (1.2), opraH .. 3a ..... 1O (1.7) IiInlil nauo,

B03HIiIKna nyraHlilua B nOHIiIMaHliI1iI TepMIiIHOB ynp.aneH .. e K.'feaOM (3.4). 06eCne'feH .. e K.'feCTaa (3.5), 06 ... ee PYKOBO"CTBO Ka'feCTBOM (3.2) iii Bce06 ... ee pYKoaORCTao Ka'feCTaOM (3.7). HacToAlUliIH MeJICnYHaponHblH Craunapr nplil3BaH npoAeHIiITb 3T1iI nOHATIiIA.

rOBOpA ynpolUeHtto. ynpaaneH .. e Ka'feCTeOM KaeaeTCA cpencra oneparaeuoro xapaxrepa nnA BbmonHeHIiIA Tpe60eaH"~ K Ka'feCTBY. B TO BpeMA I<al< 06eCne'leH .. e Ka'leCTaa HanpaBneHO Ha 1l0CTIiIJlCeHlile YBepeHHoeTIiI B nOM BbmonHeHliI1iI KaK BHyrPIil opraH .. 3a ........ Tal< iii BHe ee - y nOTpe6"Tene~ (1.9) iii nonHOM04HbiX oprauoe.

B Me)f(JlYHaponHblx Crauneprax IiIcnonb3YIOTcA TepMIiIHbl .. 06ecne41i1- aare H iii .. y6eJICnaTb" B cnellylOweM CMblcne: .. 06eCne4Ii1BaTb" 03Ha4aeT repaxrapoaars IiInlil nenars 1l0CToBepHb1M; .. y6eJICllaTb" 03Ha4aeT y6enlilTbCA caMoMY Hnlil y6elllilTb npyrax.

06 ... ee PYKoeoRCTBo Ka'feCTBOM BKnlO4aeT kal< ynpaaneHHe Ka'leCTeOM, Tal< iii 06eCne'feH .. e Ka'leCTBa, a Tal()l(e I<al< nononHIiITenbHble nOHATIiIA - non .. T .. KY a 06naCTM Ka'leCTaa (3. 1), nnaHMpoBaH .. e Ka'leCTea (3.3) iii ynY'fWeH .. e Ka'fetTaa (3.8). 06 ... ee pYKoeoRCTeo Ka'feCTeOM oCYlUecTBnAeTcA C nOMOWblO C .. CTeMbl Ka'feCTaa (3.6). 3TlilnOHATIiIR MOryr 6blTb paenpoeTpaHeHbl Ha Bce nonpa3neneHIiIA opraHH3aUHIiI.

Bce06 ... ee PYKOBORCTeo Ka'feCTeOM SHOCIiIT B llaHHble nOHATIiIR nonroBpeMeHHYIO crparenoo rnoeansaoro PYI<OBollcTBa iii Y4acTlile acex 4neHOB opraHIiI3aUIiIIiI B IiIHTepecax caMoH opreaauaa, ee 4neHOB. ee nOTpe61i1TeneH iii 06wecTBa B uenow,

Bce ynoMIiIHaeMble B HaeTOAweM MeJICllYHaponHoM CTaHnapTe nOHRTIiIA IiIMelOT l<aK )I<OHOMIiI4eCKlile. TaK iii 3aBIiICAWlile OT BpeMeHIiI 3Ha4eHIiIA. 3TO 1l0nJICHO nOHIiIMaTbCA B TonKoaaHIilIiI acex onpelleneHIiIH B HaCTOAweM Me)f(JlYHapollHoM CTaHllapTe. lla*e eenlil ABHO iii He oroeapaaaerca a l<a)I(,QOM onpeneneHIiIIiI.

Pa3nlil4He, cnenaHHoe B HaCTORl1IeM MeJKllYHapOllHOM CTaHllapTe Me)I(,QYTepMIiIHaMIiI "e4JeKT (2.11) iii HeCOOTeeTCTB .. e (2.10) RBnReTC" pewalOWIiIM. Tal< l<aK IiIMeeT nOllTeKCT IOplillllil4eCKoro xapexrepe, OCO- 6eHHO caR3aHHblH C OTBeTCTBeHHOCTblO 3a Ka'feCTBO BblnYCl<aeMOM nponYI<UIiIIiI. CnenoBaTenbHO. TepMIiIH Reclt.KT Hano IiIcnonb30saTb 4pe3Bbl'faHHO OCTOPOJICHO.

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ISO 8402:1994(E/F/R)

QISO

TepMMHbl. onpeaeneuasre B HaCTORLUeM Me)l(llYHapOIlHOM CraHapTe. HenOCpellCTBeHHO npMMeHRIOTCR B Me)l(llYHapOIlHblX Craunaprax no Ka~eCTBY·

npyrMe OTHOCRLUMeCR oona CTaHnapTbl nepe~McneHbl B nplilnoeHliI1iI A. Oc060e BHMMaHlile nomKHO 6blTb yneneHo TepMMOnOrM~eCKIiIM CTaHnapTaM B 06naCTIiI CTaTIiICTIiIKIiI: ~aCTIiI 1-3 ""CO 3534.

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17

INTERNATIONAL STANDARD

NORME INTERNATIONALE <C> ISO

ME)f(JlYHAPOJlHbILil CT AHJlAPT

ISO 8402:1994(E/F/R)

Quality management and quality assurance - Vocabulary

Scope

This International Standard defines the fundamental terms relating to quality concepts, as they apply to all areas, for the preparation and use of quality-related standards and for mutual understanding in international communications.

Terms and definitions

In the following definitions, the terms appearing in the alphabetical index are in semi-bold type. Within each definition, reference is made to the number where they are defined.

The numbered terms and definitions are classified under the following main headings:

- general terms;

- terms related to quality;

- terms related to the quality

system;

- terms related to tools and techniques.

Management de la qualite et assurance de la quallte - Vocabulaire

Domalne d'application

La presente Norme Internationale definit les termes fondamentaux relatlfs aux concepts de la qua lite, applicables a tous les domaines en vue de l'elabcratlon et I'utilisation des normes relatives a la qualite et pour une comprehension mutuelle dans les communications internationales.

T ermes et definitions

Dans les definitions suivantes, les termes appartenant a I'index alphabetique figurent en caracteres demi-gras. Dans chaque definition, il est fait reference au nurnero ou ils sont definis.

Les termes et definitions nurnerotes sont classes dans les rubrlques principales indlquees ciapres:

- termes gen'raux;

- termes relatifs a la qualit6;

-' termes relatifs au svstsrne

qualite;

- termes relatifs aux outils et aux techniques.

18

VnpaBneHL1e Ka~eCTBOM L1 o6eCne~eHL1e Ka~eCTBa - CnoBapb

06naCTb npMMeHeHMR

HaCTOJlUlHH Me)l(JlyHaponHblH eTaHaapr onpeaenaer OCHOBHble repMHHbl, OTHOCAUlHeCJI K nOHJlTHJlM Ka'feCTBa B 'faCTH HX npHMeHeHHJI KO BeeM 06naCTJlM, nnJl paspa- 60TKH H Hcnonb30BaHHJI CTaHnaproa no Ka'feCTBY, a TalOKe ycraHOBneHHJI B3aHMonOHHMaHHJI B Me)l(JlYHapOnHblx eBJl3J1X.

TepMII1Hbl M onpeAeneHMA

B npHB6nHMblx HH)I(e onpeneneHHJlX TepMHHbl, BKIlIO'feHHble 8 an<paBHTHbIH yKa3aTenb, Bb'neneHbl nonYJKHpHblM TeKCTOM. no KaJKnOMY onpeaeneHHIO caenaHa ccunxa Ha nyHKT, rae aaHb. 3TH onpeneneHHJI.

npOHYMepOl8HHble TepMHHbl M onpeneneHMJI pacnpeaeneHbl no cnenylOlUHM rnaBHblM rpynnaM:

-o6lUMe TepMMHbl;

- TepMMHbl, CBJl3aHHble C Ka'fe-

CTBOM;

- TepMHHbl, OTHO(JlUlMeCR K eMCTeMe Ka'feeTBa;

- TepMHHbl, OTHOCRUlHe(JI K (peaCTBaM H MeTonaM.

I

I

I

1

ISO 8402:1994(E/F/R)

Section 1:

General terms

1.1 entity Item

that which can be Individually described and considered

Section 1:

Termes generaux

1.1 entite

ce qui peut 6tre d~crit et consldere individuellement

e rso

lfaCTb 1: 06111L1e TepML1Hbl

TO '4TO MO)l(eT 6blTb HHnHBHnyanbHO OOilicaHO H paCCMOTpeHO

NOTE - An entity may be, for ex' NOTE - Une entite peut 6tre, par npl.1MEI.fAHI.1E - 06"elCToM MO)l(eT

ample: exemple 6blTb, HanplllMep:

- an activity or a process (1.2).

- a product (1.4),

- une activit~ ou un processus (1.2).

- un prodult (1.4),

- lleRTenbHOCTb IIInlll npoueee (1.2).

- npoRYKLt"" (1.4),

or a person, or

- an organization (1.7). a system - un organlsme (1.7), un svsterne - OpraH,,!aLt"" (1.7), CIllCTeMa IIInlll

- any combination thereof.

1.2 process

set of inter-related resources and activities which transform inputs into outputs

NOTE - Resources may include personnel, finance, facilities. equipment, techniques and methods.

1.3 procedure

specified way to perform an activity

!"OTES

1 In many cases, procedures are documented (e.g. quality system (3.6) procedures).

2 When a procedure Is doeumented, the term ·written procedure" or "documented procedure· is frequently used.

2

ou une personne, ou

- une combinaison de I'ensemble ci-dessus.

1.2 processus procede

ensemble de moyens et d'setivites Ii~s qui transforment des elements entrants en elements sortants

NOTE - Ces moyens peuvent inclure Ie personnel, les finances, les installations, les equipements. les techniques et les methodes,

1.3 procedure

manlsre speeifiee d'accomplir

une activite

NOTES

1 Dans de nombreux cas, les proce· dures sont exprimees par des documents (par exemple, procedures d'un syst~me qualitit (3.6)).

2 Lorsqu'un. procedure est exprl· mee par un document, Ie terme -procedure iterlt.. est souvent utilise.

19

- ",06a" KOM6111HaUIIIR 1113 HIIIX.

1.2 npoqecc

coeolCynHoCTb B38HMOCBA3aHHltiX pecypeOB H neRTenbHOCTH, KOTOpaa npe06pa3yeT BxonRUlHe sneMeHTbl B BblxonAUlHe

npl.1MEI.fAHI.1E - K pecypcaM MOryr OTHOCIIITbCA: nepccaan, cpencrea 06- cnY)I(lIIaaHH", 060PYlloB8Hllle, TeXHonorill" H MeTollonorlll";

1.3 MeTOAMK8

YCTaHoBneHHblH cnocoe OCYUl&CTBneHHA neRTenbHOCTH

npl.1MEI.fAHI.1R

1 Bo MHOrlllX cnY'fa"x MeTORH"" 1l0KYMeHTMPYIOTCA [HanpHMep, MeT~ R"KM CMCTeM~1 Ka'4e<:Taa (3.6»).

2 KorRs ulCa"~nH60,' , MeTORM"., '

ROKYMeHTMPyeTCA, nY'fwe ynoTpe- 6n"T" TepMHH ,.nMC~MeHHa" MeTaRMU· Hn.M .ROl(yMeHTan~HaJi MeTaRMtca·.

~ISO

A written or documented proedure usually contains the purloses and scope of an activity; what hall be done and by whom; when, "here and how It shall be done; vhat materials, equipment and locuments shall be used; and how I shall be controlled and recorded.

1.4 ,roduct

esult of activities or processes 1.2)

JOTES

I A product may include service 1.5), hardware, processed manrlals, software or a combination hereof.

, A product can be tangible (e.g. rssemblles or processed materials) or intangible (e.g. knowledge or concepts], or a combination thereof.

3 A product can be either Intended [e.g. offering to customers (1.9)) or unintended (e.g. pollutant or unwanted effectsl.

1.5 service

result generated by activities at the Interface between the supplier (1.10) and the customer (1.9) and by supplier internal activities to meet the customer

needs .

NOTES

1 The supplier or the customer may be represented at the interface by personnel or equipment.

2 Customer activities at the Interface with the supplier may be essential to the service delivery (1.61.

3 Une procedure t\crlte com porte g~neralement I'objet et Ie domaine d'applicatlon d'une actlviM; ce qui doit lUre fait et qui doit Ie faire; quando ou et comment cela doit Atre fait; quels mat~rlels. t\quipements et documents dolvent litre utlllses: et comment cela dolt litre maitris~ et e~reglstrl!.

1.4 produit

resultat d'actlvltes ou de processus (1.21

NOTES

1 Le terme prodult peut inclure les services (1.5). les mat~riels. les produits issus de processus a caractere contlnu, les logiciels. Oll line comblnalson des deux.

2 Un prodult peut litre materiel (par example, assemblages ou produits issus de processus III earactere continul ou Immat'rlel (par exemple. connalssances ou concepts). ou une comblnalson des deux.

3 Un prodult paut litre solt Intentlonnel (par exemple, une offre aux clients (1.9)). soit non Intentionnel (par exemple. un polluant ou des effets Indl!sirab'esl.

1.5 service

resultat genere par des activltes II l'lnterface entre Ie fournisseur (1.10) et Ie client (1.9), et par des actlvltes internes au fournisseur pour repondre aux besoins du client

NOTES

1 Le fournlsseur ou Ie client peut litre reprilsent' 1.1 "Interface par des personnes ou par des 6quipements.

2 Les activit's du client It I'interface avec Ie fournt •• eur peuvent litre essentlelles pour la pre.tation de service (1.6).

20

ISO 8402:1994(E/F/R)

3 nHcbMeHHaA HnH nOKYMeHTan .. HsA MeTORMlCa 06b'-'HO eKl1IO-.seT: uenH H 06naCT" neATenbHOCTH; 4TO nomKHO 6b'T" cnen8HO M KeM; xorna, rne H KaK aro nomKHO 6b'T" cnenaHo; KaKHe MaTepHan .. ,. RoteyMeHT ... M KSKoe 060- pynoeaHHe nomKHb, 6 ... T.. Henonb- 30eaH .. '; H K8ICMM 06pa30M sro nonlKHO 6b'T" npoKoHTponHpoeaHo M aaperHCTpMpoBaHo.

1.4

npoAyK ..... "

pe3ynbTaT QeRTenbHOCTM MnM npo... eccos (1.2)

np"'ME4AH"'''

1 npORYKI.tM" MOlKeT eKl1I04ST .. ycnynl (1.5). 060pynoeaHHe. nepepa6aT"'eaeM .. ,e MaTepHanb'. nporpaMMHoe 06eene4eHHe HnH KOM6HHaUHH H3 IIH)(.

2 npOAYICI.tM" MOlKeT 6 .. 'T.. MaTepHsn .. HoM (HanpHMep. Yln .. , HnH nepepa6aT .. ,eaeM .. ,e . MaTepHan .. ,) HnH HeMsTepHsn .. HoM (HanpHMep. HHcpOPMSUM,. HnH nOHATHA), HnM KOM6HHSUHeli! H3 HHX.

3 npORYlCl.tMII MOlkeT 6"'T .. HaMepeHHoiii (HanpHMep, npennolKeHHe nOTpe- 6MTenAM (1.9) HnH HeHsMepeHHoiii (HsnpHMep, 3arpA3HMTenb HnM HelKennenbH ... e nocneRCTBMA).

1.5 ycnyra

MTorM HenOCpeQCTBeHHOro B3aMMOQeMCTBMJI nOCTaBIQ"Ka (1.10) M nOTpe6"TenJl (1.9) M BHyrpeHHeM QeRTenbHOCTM nOCTaBIQMKa no YQOBneTBopeHMIO nOfpe6HocTei1 nOTpe6MTenR

1 nOCTaeaq"1C HnH nOTpe6MTen.. MOryr 6b.T .. npeQCTaBneHb. "PM B3aHMoneiiicreHM nepcoHanOM Mnlll 060pynoeaHH4!M.

2 HenocpenCTBeHHoe 83alllMoneiiicreHe nOTpe6MTenll C nOCTaBaqMKoM MOlKeT 6 ... T.. CyweCTe4!HH"'M nnA npe-, ROCTa.neHMA ycnyrM (1.6).

3

ISO 8402:1994(E/F/R)

3 Delivery or use of tangible products (1.4) may form part of the service delivery.

4 A service may be linked with the manufacture and supply of tangible product.

1.6

service delivery

those supplier (1.10) activities necessary to provide the service (1.5)

1.7 organization

company, corporation, firm, enterprise or institution, or part thereof, whether incorporated or not, public or private, that has its own functions and administration

NOTE - The above definition is valid for the purposes of quality standards. The term ·organization· is defined differently in ISOIIEC Guide 2.

1.8

organizational structure responsibilities, authorities and relationships, arranged in a pattern, through which an organization (1.7) performs its functions

1.9 customer

recipient of a product (1.4) provided by the supplier (1.10)

NOTES

1 In a contractual situation. the customer (1.9) is called the "purehaser" (1.11).

2 The customer may be, for example. the ultimate consumer. user, beneficiary or purchaser.

3 The customer can be either external or internal to the organization.

4

3 La livraison ou I'utilisation de produits (1.4) materiels peut faire partie de la prestation de service.

4 Un servIce peut iUre lie a la fabrication et a la fourniture d'un prodult materiel.

1.6

prestation de service

celles des aetlvltes du fournlsseur (1.10) qui sont necessaires it la fourniture du service (1.5)

1.7 organism.

compagnie. societe. firma, entreprise ou institution, ou partie de celles-ci, 11 responsabillte limltee ou d'un autre statut, de droit public ou prlve, qui a sa propre structure fonctionnelle et administrative

NOTE - La definition ci-dessus s'applique aux normes qualite. Le terme «orqanlsme» est dfHini differemment dans Ie Guide ISOICEI 2.

1.8 organisation

responsabilites, liaisons hierarchiques et relations agencees selon une structure permettant it un organism. (1.7) d'accomplir ses fonctions

1.9 client

destinataire d'un produit (1.4) fourni par Ie 'ournisseur (1.10)

NOTES

1 Dans une situation contractuelle, Ie client (1.9) est denomme «aeheteur» (1.11).

2 Le client paut etre. parexemple, Ie consommateur final, I'utilisateur, Ie bi!neficiaire ou "acheteur.

3 Le client peut etre interne ou externe a I'organlsme.

21

e iso

3 nOCTaBKa IIIn", ",cnonb30BaH"'e MaTep",anbHblX B"'nOB npoRyK"'.... (1.4) MO)l(eT 6blTb '4aCTblC) npeRoCTa8neH .. A ycnyr .. :

4 Vcnyra MO)l(eT 6blTb CBA3aHa C npo"'3BOnCTBOM '" nOCTaBKoH MaTep",anbHOM npORYK"'MM.

1.6

npeRoaaBneHMe ycnyrM lleRTenbHOCTb nOCTaBIQMKa (1.10), He06xoilMMaR IlnR 06ecne4eHMR ycnyrM (1.S)

1.7 opraHM:saqM ..

KOMnaHMR, xopnopeuas, q,MpMa, npellnpMRTMe MnM Y4pe)l(lleHMe, MnM MX ncnpaaneneaas, 06be1lHHeHHbie MnM HeT, 06~eCTBeHHble MnM 4aCTHble, BbInOnHRIO~Me caMOCTORTenbHble q,YHKUMM H MMelO~Me allMMHMCTpaUHIO

npIIIME~AHtilE - Hacroauiee onpeneneHllle np"'MeHIIIMO K CTaHl1apTaM Ha Ka'4eCTBO. TepM"'H .. opraH"'3aU"'A· onpeneneH 8 PYKOBonCTBe IIICO/M3K 2.

1.8

opraHM3a~MOHHa .. apyKTypa 06R3aTenbcTBa, nonHOM04MR M B3aMMOOTHoweHMR, npencrasneaHble B BMlle cxeMbl, no KOTOpoiil opraHM3a~M" (1.7) BblnonHReT C80M q,yHKUMM

1.9 nOTpe6MTenit

nonY4aTenb npoRyK~MM (1.4), npelloCTaanAMoiil nOCTaSIQMKOM (1.10)

np&llME~AH&IIR

1 B KOHTpaKTHoM cHrya"'H'" nerpe- 6MTenlt (1.9) MO)l(eT 6blTIt Ha3BaH noKynaTeneM (1.11).

2 nOTpe6MTeneM MO)l(eT 6ltlTb, Hanp"'Mep, KOHe'4HltIM nOTpe6"'Tenb, nonb30BaTenb, nltrOTHO o6cnY)l("'Bae· Mltliil nOTpe6MTenlt .. n .. nOKynaTenlt.

3 nOTpe6MTenlt MO)l(eT 6101T1o ",n", BHeWH"'M, "'"'" BHYTpeHH"'M.

e iso

1.10 supplier

organization (1.7) that provides a product (1.4) to the customer (1.9)

NOTES

1 In a contractual situation. the supplier may be called the "eontraeter" (1.12).

2 The supplier may be. for example, the producer. distributor. importer. assembler or service organization.

3 The supplier can be either external or Internal to the organization.

1.11 purcha.er

customer (1.9) in a contractual situation

NOTE - The purchaser is sometimes referred to as the ·buslness second party·.

1.12 contractor

supplier (1.10) in a contractual situation

NOTES

1 The contractor Is sometimes reo ferred to as the ·buslness first party·.

2 - In French. the "tltulalra du contrat" is sometimes called "contractant",

1.13 .ubcontractor

organization (1.7) that provides a product (1.4) to the supplier (1.10)

NOTES

1 In English. the subcontractor may also be called ·subsuppller·.

2 In French. the ·sous-contractant· may also be called. 8S appropriate. ·sous-traitant· or ·sous-commancHer·.

1.10

fourni •• eur

organism. (1.7) qui fournit prodult (1.4) au client (1.9)

NOTES

1 Dans une situation contractuelle. Ie fournlsseur peut ~tre d~nomm~ Ictltulalre du contral» (1.12).

2 Le fourntsseur pout Atre. par exemple. Ie producteur, Ie distributeur, I'importateur. I'ensemblier ou I'organisme de service.

3 Le fournlsseur peut etm externe ou interne a I'organlsme.

1.11 acheteur

client (1.9) dans uno situation contractuelle

NOTE - Dans 18 pratique des affalres, 'I'acheteur est parfois appele eeseconde partie».

1.12

tituleire du contrat

fournlsseur (1.10) dans une situation contractuelle

NOTES

1 Dans la pratique des affalres. Ie tltulalre du contrat est parfols appele ccpremlere partie».

2 En fran~als. Ie tltulalre du contrat est parlois appele Ie «contractanb.

1.13 sous-contractant

organisme (1.7) qui fournit un produit (1.4) au fournisseur (1.10)

NOTES

1 En anglals. Ie «subcontractor» peut egalement Itre appele Itsubsupplier».

2 En fra~ais. Ie sous-con1ractant peut egalement &Ire appele. selon Ie cas. ccsous-traltantn ou IIsous-commandlern.

22

ISO 8402:1994(E/F/R)

un

1.10

nOCTaa ... "" OpraHMJallM" (1.7).

nRIOUl8R npoRYKllMIO 6MTenlO (1.9)

npenocraa(1.4) nerpe-

nPIiIME'iAHIiIR

1 B KOHTpaKTH .. lx C"'''YaUMRxnoCTaa"'14K' MO)KeT 6 .. 1Tt. HaJaaH nOAP"A'4MKOM (1.12).

2 nOCTaaulMKoM MO)KeT 6hlTh. HanpMMep. npOMJaOaMTenh. onToaMK. MMnopTep. MOHTa)KHMK MnM cepaMcHaR OpraHMJaUMA.

3 nOCTaBtqMK MO)KeT 6hlTh MnM RHeWHMM. MnM aHYTpeHHMM.

. -~y

1.11 nOKynaTenlt

nOTpe6MTem. (1.9) B KOHTpaKTHoiit CHT)'8UMM

nPIiIME'iAHIiIE - nOKynaTenlt MHoraa paCCMaTp .... aeTCA K8K .TopaR CTopOHa a kOMMep'4eCKOM aeRTenhHOCTM.

1.12 nOAP"R""K

nOCTaBIQMK (1.10) B KOHTpaKTHoiii CHT)'8UMH

nPIiIME'iAHIiIR

t nOAP"A'4MK MHoraa paCCMaTpMaaeTCR KaK nepaa" CTopoHa a KOMMep'4eCKoiit aellTenbHOCTM.

2 Bo «tJpaHuYJCKOM AJblKe Htltulalre du eentrat" MO)l(eT Taue H8JhlBaTbCA Hcontractant· .

1.13 cy6noRP"A"MK

OpraHMJallM" (1.7), npenocrasnRIOUlaR npoRYKllMIO (1.4) nOCTaBIIlMKY (1.10)

nPIiIME'iAHIiIR

1 B aHrnMMcKoM IIJhlKe Hsubcontractor· (cy6noapAD'4MK) MO)KeT TalOlte HaJblBaTbCA Hsubsuppller· (cy6noCTaaWMKoM).

2 80 «tJpaHUYJcKoM RJhlKe HSOUHOntractant· MO)KeT TelOlCe HaJblaaThCII HS0U5- traltant" Mn", "sous-commancHer·.

r

iI

t

I

5

ISO 8402:1994(E/F/R)

Section 2:

Terms related to quality

2.1 quality

totality of characteristics of an entity (1.1) that bear on its ability to satisfy stated and implied needs

NOTE~

.

1 In a contractual environment, or in a regulated environment, such as the nuclear safety (2.8) field, needs are specified, whereas In other environments, implied needs should be identified and defined.

2 In many instances, needs can change with time; this implies a periodic review of requirements for quality (2.3).

3 Needs are usually translated into characteristics with specified criteria (see requirements for quality (2.3)). Needs may include, for example, aspects of performance, usability, dependability (2.5) (availability, reliability, maintainability), safety, environment (see requirements of society (2.4)], economics and aesthetics.

4 The term ·quallty· should not be used as a single term to express a degree of excellence In a comparative sense, nor should it be used in a quantitative sense for technical evaluations. To express these meanings, a qualifying adjective should be used. For example, use can be made of the following terms:

6

Section 2:

Termes relatifs it la quallte

2.1 qualita

ensemble des caracterlstiques d'une entite (1.1) qui lui conferent I'aptitude a satisfaire des besoins exprlrnes et implicites

NOTES

1 Dans une situation contractuelle, ou dans un envlronnement reglemente, tel que Ie domaine de la securlte (2.8) nucleaire, les besoins sont specifies, tandls que dans d'autres, II convient d'identifier et de definir les besoins Implicltes.

2 Dans de nombreux cas, les besoins peuvent 6voluer avec Ie temps; ceci implique la revue perlodique des exlgences pour I. quallte (2.3).

3 Les besolns sent habituellement traduits en earacterlsttques avec des erltares specifies (voir exlgences pour la qualitit (2.3)). les besoins peuvent inclure, par exemple, des aspects de performance, de facilite d'emploi, de suretit de fonctlonnement (2.5) (disponlbilite, fiabilite, maintenabilite), de s6curlte, des aspects relatlfs a I'environnement (voir exigences de societe (2.4)), des aspects economiques et esthetlques.

4 II convient que Ie terme «qualitit» ne soit utilise isolement ni pour exprimer un degre d'excellence dans un sens comparatif, ni pour des evaluations techniques dans un sens quantitatif. Pour exprimer ces deux sens, II est bon qu'un qualificatif soit utilise. Par exemple, on peut employer les termes suivants:

23

elsa

4aCTb 2:

TepM~Hbl, CBJl3aHHbie C Ka"leCTBOM

2.1

Ka .. eCTBO

cOBoqnHOCTb xapalCTeplIICTIIIK o6'beKTa (1.1), OTHOCALUIIIXCA K ero cnoC06HOCTIII ynoBneTBOplIITb YCTaHoBneHHble III npennonaraewsie noTpe6HoCTIII

npl-1ME~AHl-1"

1 nplil 3alCJ1lO'4eHIIIIII KOHTpaKTa IIInlil .. pernaMeHTlllpOaaHHc»t OKPYlItatOweM cpeae, Hanp. B 06naCTlil 6ellonacHOCTM (2.8) RnepHblx YCTaHoaoK, nOTpe6- HOCTIII '4eTKO YCTaHaBnlll8alOTcR, Torn8 KaK a apyrlllx ycnoalilAx npellno-' naraeM"le nOTpe6HoCTM nOnllt.HItI 6"1n. ablRBneHbI III onpeneneHbl.

2 80 MHOrlllX cny\4aAx nOTpe6HoCTM MOryT MeHRTbCR co BpeMeHeM; 'TO npennonaraeT npOBeneHllle neplilonM'4eCKOrO aHanlll3a Tpe608aHMM K Ka· ..easy (2.3).

3 06bl'4HO no,-pe6HOCTIII nepeaonRTCR a xapaKTeplIICTMKM Ha OCHoae YCTaHoaneHHblx KplilTeplilea [CMOTplil Tpe60BaHM" K Ka'4eCTay (2.3». noTpe6HoCTlil MOryT alCJ1lO'4aTb, HanplIIMep, TaKlile acneKTbl,KaK )KCnnyaTSUIIIOHHble xapaKTeplilCTIIIKlII, q,YHKUIIIOHanbHaR nplilronHOCTb, HaRe.HOCTb (2.5) (roToBHoCTb, 6e30TKa3HOCTb, peMOHTonplilronHoCTb), 6e30nacHoCTb (2.8), oKpYlltalOwaR epena (CMOTplil Tpe60BaHM" 06IQeCTBa (2.4»), )KOHOMIII'4eCKlile III )CTeTlIIlleCKlile Tpe60aaHIilR.

4 tlnR BblpallteHIIIR npeBocxonHoiil CTeneHM B cpaaHIIITenbHoM IIInM B KOnM'4eCT8eHHOM cMblcne nplll npeaeneHlII1II TeXHIII'4eCKIIIX oueHOK TepMIIIH "Ka'4eCT80· He Mcnonb3yeTCR 11130nMpOBaHHo. ~To6bl Bb'pa3l11Tb nlll 3HalleHIIIA, nOnlltHO nplilMeHRTbCA KalleCTaeHHoe npanararensace. HanplIIMep, MOryT IIIcnonb30aarbCR cnenylOwille TepMIIIHbl:

ClISO

a) "relatlve quality· where entities are ranked on a relative basis In the degree of excellence or comparative sense (not to be confused with grade (2.2»);

b) ·quallty level· in a quantitative sense (as used In acceptance sampling) and ·quallty me.sure· where precise technical avaluatlons .re carried out.

5 The achievement of satisfactory quality involves all stages of the quality loop (4.1) as a whole. The contributions to quality of these various stages are sometimes Identified separ.tely for emphasis; for example, quality due to definition of needs, quality due to product (1.4) design, quality due to conformance, qu.llty due to product support throughout Its lifetime.

6 In some references, quality is referred to as ·fitness for use· or ·fitnet>s for purpose· or ·customer (1.9) satisfaction· or "conformance to the requirements·. These represent only certain facets of quality, as defined above,

2.2 grade

category or rank given to entities (1.1) having the same functional use but different requirements for quality (2.3)

NOTES

1 Grade reflects a planned or recognized difference in requirements for quality. The emphasis is on the functional use and cost relationship.

2 A high-grade entity (e.g. 8 luxurious hotel) can be of unsatisfactory quality (2.1) and vice versa.

a] «quallti relative .. lorsque les entltis sont classltes en fonctlon do leur degrl! d'exeeflenee ou d'une manlere comparative (II ne pas confondre avec classe (2.2)1;

b) «niveau de qualltlt .. dans un sens quantltatif (tel qu'employ6 dans Ie contrOle par ltchantillonnage) et «mesure de la qualltlt.. lorsque des evaluations techniques prltcises sont effectu6es,

5 L'obtention d'une quallti satlsf.lsante Impllque I'ensemble des phases de la boucle d. la qualltlt (4.1), Les contributions lila quallt6 de ces dlffltrentes phases sont partols considltrees sltparltment pour les distinguer; par exemple, qualltlt due II la dl!finltlon des besolns, qualltlt due II la conception du prodult (1.4), qualltlt due II la conformltlt (2.9), quallt' due au soutlen du prodult tout au long de son cycle de vie,

6 Dans certains textes existants, on identlfie la qua lit' II "I'aptitude II I'usage .. , ou II ,,"aptitude II I'emploi .. , ou II .. Ia satisfaction du client (1,9)" ou II «Ia conformitl! 8UX exigencesll• Ces notions ne reprl!sentent que certaines facettes de la qua lit', telle que dltfinie cl-dessuI,

2.2 classe

c8tegorie ou rang attribue it des entites (1.1) ayant la merne fonetion d'usage, rnais sournises a des exigences pour la qua lite (2.3) differentes

NOTES

1 La elasse tradult une diffl!rence prltvue ou reconnue dans les exlgences pour 18 quallt6. L'accent est mis sur la relation entre fonction d'usage et couto

2' Une 8ntlt' de classe 61evl!e (par e)(emple un h6tel de luxel peut litre de quallt' (2.1) non satisfaisante et inversement.

24

, ISO 8402:1994(E/F/R)

a) "OTHOCIilTenhHoe Ka'feCTBo·, Korna 061t8KTbl KI1acclII$IIIUIilPYIOTCA 8 3a8111- CIilMOCTIil OT IIIX CTeneHIII npesocxoacraa IIInlil B Cp8BHIIITenbHoM dAblene (He n)'TaTb C rpaRa~lIIeA (KI1aCCOM, COpTOM) (2.2));

6) "ypoaeH.. Ka'feCT8a· B KOnlll'feCTaeHHOM CMb,ene (nplilMeHAeTcA nplil CTaTIilCTIII'feCKOM nplileMO'fHOM KOHrpene) III "Mepa Ka"8CTB8", Korna npoBonATCA TO'fHb,e TeXHIII'feCKlile oueHKIII.

5 QOCTlII)lCeHllle ynoBneTBOplilTen .. Horo Ka'fecT8. BKI1IO'faeT Bce CTanllllll neTnM l(a"eCTB8 (4.1) KaK enlilHoe uenoe, BKI1an B Ka"eCT80 JTIIIX pa3nlll"fHblX CTanlll'" IIIHorna IIIneHTM$IIIUlilpyeTCII OTAenbHO C ~enblo IIIX B"'neneHIIIA, HanplilMep, Ka"feCT80, o6yenoBneHHoe nOTpe6HOCTAMIII, l(a'f8CT80 06yenoBneHHoe npoeKTlllpoa8HllleM npoRyl(~MM (1.4), Ka"8CT.O 06ycnOBneHHoe COOneTa.MeM.

_.:;.._1

6 B HeI(OTOpb'X cnpa.O'fH .. ,X IIICTO"fHIilKax Ka'feCT80 0603Ha'faeTCA KaK "nplilronHoCTh AnA IIIcnonb30BaHIIIA· ",nlll "cooTBeTCTBlile uen",·, IIInlil "YIlOBneTBopeHllle Hy~ nOTpe6MTenA (1.9)·, IIInlil "COOTBeTCTBlile Tpe60BaH"'AM·. Bee )TO npeacraanaer c060'" TonbKO HeKoTop .. ,e CTOpOH .. , Ka"feCTBa, onpeneneHHoro 8 .. ,we.

2.2 rpaAa~ .. " Knacc COpT

xareropaa IIInlil paspan, npaceoeaHble o6 .. eKT8M (1.1), IIIMelOUlIilM TO )l(e caMoe tPYHKUliloHanbHoe npaMeHeHllle, HO pa3nlll'fHble Tpe6oBaHMA K K8'feCTBY (2.3)

np&o1ME4AH&o1"

1 rpaRa~MA (KI1aCC, COpT) OTpa)ICaeT npenYCMoTpeHHoe IIIn", nplil3HaHHoe pa3nlll4111e B Tpe608aHIII"X I( lCa"feCTay. Ynop nenaeTC" Ha B3alllMoCBR3h $YHKUliloHanhHoro IIICnOnh!108aHlilA III !larpar,

2 061oel(T 8h'COKoro KI1acca (Hanp"'Mep, rOCTlIIHlllua "nIOKc·) MO)ICeT 6 .. 'T .. HeynoBneTBoplIITen .. Horo Ka"eaaa.(2.1) III H8060pOT.

7

ISO 8402:1994(E/F/R)

3 Where grade is denoted numerically, the highest grade is usually designated as 1, with the lower grades extending to 2, 3. 4. etc. Where grade is denoted by a point score. such as a number of stars, the lowest grade usually has the least points or stars.

2.3

requirement. for quality· expression of the needs or their translation into a set of quantitatively or qualitatively stated requirements for the characteristics of an entity (1.1' to enable its reaUzation and examination

NOTES

1 It is crucial that the requirements for quality fully reflect the stated and implied needs of the customer (1.9).

2 The term 'requirements' covers market-based and contractual as well as an organization's (1.7) internal requirements. They may be developed, detailed and updated at different planning stages.

3 Quantitatively stated require·ments for the characteristics include, for instance, nominal values, rated values, limiting deviations and tolerances.

4 The requirements for quality should be expressed in functional terms and documented.

2.4

requirements of society obligations resulting from laws, regulations, rules, codes, statutes and other considerations

3 Lorsque la cia sse est indiquee par un chiffre. la cia sse la plus elevee est designee habituellement par 1. les classes inf8rieures etant 2. 3. 4. etc. Lorsque la classe est lndlquae par un nombre de points. tel que par exemple un nombre d'atoiles. la classe la moins 61evee est designee habituellement par Ie plus petit nombre de points ou d'etolles.

2.3

exigence. pour Ie quant' expression des besoins, ou leur traduction en un ensemble d'exigences exprimees en termes quantitatif. ou qualitatifs pour les ceracterlstlques d'une entlte (1.1) afin de permettre sa realisation et son examen

NOTES

1 II est essentiel que les exlg.nces pourla· quallte refletent completemen! les besolns ex primes et lrnpllcites du client (1.9'.

2 Le terme lIexigencesll couvre aussi bien les exlgences du rnarche, celles du contrat, que celles qui sont internes ~ un organlsme (1.7). Elles peuvent ~tre alaborees. detaillees et actualisees a diff6rents stades de la planification.

3 Les exlgences exprimees en termes quantltatlf. et relatives aux caracteristiques comprennent, par exemple, des valeurs nominales. des valeurs assignees, des ecarts limites et des tolerances.

4 " convient d'exprimer les exlgenees pour la qualita en termes de fonctions et par des documents.

2.4

exigence. de societe obligations resultant de lois, de reglements, de regles, de codes, d'actes et d'autres considerations

25

OISO

3 Korna Knaee 0603Ha'-leH '-IIIIeneHHb.M 3Ha'-leHllleM. Bb.eweMY Knaeey 06b''fHO npllleBalilBaeTCR 1, a c nOHIII)I(eHllleM Knaeea - eOOTaeTCTaeHHO 2.3.4 '" T.a. Koraa Knaee 0603Ha'-leH Kon"''-IeCTBOM 3HaKOB, HanptllMep, "'IIIenOM 3Be3JlO'-leK, TO 06b''-IHO HIII3WIIIH KOBee IIIMeeT MeHbwee '-Ilileno 3Be3Jlo",eK.

2.3

Tpe60.aHMIJI K Ka"eCT.Y Bblpa)l(eHllle onpeneneHHblx noTpe6HoCTeM IIInlil IIIX nepeBon B Ha60p KOnlll'"leCTBeHHO IIInlil Ka'"leCTBeHHO YCTaHoBneHHblx Tpe60- BaHIilM K xapalCTeplilCTIilKaM 061teKTa (1.1), '"IT06bl "aTb B03MO)l(HOCTb IIIX peanlll3auIIIIII III npoBepKIII

np~ME4AH~R

1 CyweCTBeHHo, '-IT06b' Tpe60BaHMR K Ka",eCTBY nonHOCTblO OTpa)l(anlll YCTaHoBneHHb.e M npennonaraeMb.e nOTpe6HoCTlil nOTpe6MTenR (1.9)

2 TepMIIIH .. Tpe60BaHMe' OXBaTb'BaeT pb.HO'-lHb.e III KOHTpaKTHb.e Tpe- 60BaHIIIR, a TaK)l(e BHyTpeHHllle rpe- 60BaHIIIR opraHM3a~MM (1.7). OHIII MOryT 6blTb pa3pa60TaHb', neTanIll3111- pOBaHb. III aKTYanlll3l11poBaHb. Ha pasnlll'-lHb'X sranax nnaHlllpOBaHIIIR.

3 3aJlaHH".e KOnlll'-leCTBeHHb.e Tpe60- BaHIIIR K xapaKTepIIICTIIIKaM BKnIO"'aIOT, HanplllMep, HOMIilHanbHb.e 3Ha'-leHIIIR, OTHoelilTenbHb.e 3Ha'-leHIIIR, npeneneHb.e OTKnOHeHMR III JlOnyeKIII.

4 Tpe60aaHMR K Ka'leCTay JlOn)l(Hb' 6b.Tb Bb'pa)l(eHbl Ha Ha'-lanbHOH CTaJlIIIIII BCPYHKUllloHanHb.x TepMIIIHax III JlOKYMeHTanbHo 0cpopMneHb"

2.4

Tpe6o.aHMIJI o6aqeCT.a 06f13aTenbCTSa, SblTeKalOWlile 1113 3aKOHos, IIIHcrPYKUIIIH, "paSllln, KOaexcoe, YCTasoB III npyrlllx co06- pa)l(eHH"

OISO

NOTES

1 "Other considerations· include notably protection of the envIronment, health, safety (2.8), security, conservation of energy and natural resources.

2 All requirements of society should be taken Into account when defining the requirements for qualIty (2.3).

3 Requirements of society Include jurisdictional and regulatory requirements. These m8Y vary from one jurisdiction to another.

2.& dependability

collective term used to describe the . availability performance and its Influencing factors: reliability performance, maintain. ability performance and maintenance-support performance

NOTES

1 Dependability is used onlv for general descriptions In non-quantitative terms.

2 Dependability is one of the timerelated aspects of quality (2.1).

3 The definition of dependability and note 1 given above are taken from IEC 50(191), which also Includes related terms and definitions.

2.6 compatibility

ability of entities (1.1) to be used together under specific conditions to fulfil relevant requirements

NOTE - The above definition Is valid for the purposes of quality standards. The term ·compatiblllty· Is defined differently In ISOIIEC Guide 2.

NOTES

1 L'expression «d'autres conslderatlons» vise notamment la protection de I'environnoment, la sant~. la s6curltlt (2.8), 18 sOretlt, la conservation de I'energle et des ressources naturelles.

2 II convient que toutos les exlgences de soc"t' lolent prises en compte lors de Ie dltflnltlon des exl· genc,!s pour la quant6 (2.3).

3 Les exlgenees de . societe comprennent des exlgences juridiques et r~glement8Ires. Elles peuvent varier selon les juridictlons.

2.5

.Oret' de fonctlonnement ensemble de. proprh§t'. qui decrlvent la disponlblllte et les facteurs qui la conditionnent: fiabllite, malntenabllite et loglstique de maintenance

NOTES

1 La sOret' d. fonctlonnement est une notion g6ner81e sans caract~re quantltatif.

2 La sOret6 d. fonctlonnement est un des aspects de la quallte (2.1) lies au temps.

'3 La definition de la sO rete de fonctlonnement et la note 1 citees eldessus proviennent de la CEI 50(191), qui contient egalement des termes et des definitions qui lui sont assocles.

2.6 compatibilite

aptitude d'entltes (1.1) a etre utillsees conjolntement dans des conditions spsclflques pour satisfaire a des exigehces pertinentes

NOTE - La d6flnltlon cl·dessus s'applique 8UX normes quallte. Le terme «compatlblllte" est definl dlff~remment dans Ie GuldelSOICEI 2.

26

ISO. 8402: 1994(E/F IR)

nPHMEI.fAHHR

1 .. npYrMe Co06p8)lCeHM"· BKI1IO ... aIOT 38UlIIIT)' oKPY)lCalOUlelii cpenb', 3nOpoase, 6eJOnaCHOCTIt (2.8), Hane)ICHOCTIt, .coxpaHeHllle )HeprlllM III ecreCT8eHHblX pecypCOB.

2 nplil onpeneneHMIII rpe608aH .. " k Ka ... eCTBY (2.3) DOn)ICHIt. y'-!MTltlaaTltat ace Tpe60.aH .. " 06 .... CT •••

J Tpe60 ...... " 06 ... eCT.. 8K11IO ... aIOT IOpMnlll ... ecKlile M HopMaTM8HIt.e Tpe60- BaHIII". OHM MOryr MeHATltat OT oaHoM 06naCTM npMMeHeHM" IOpMaM ... ecKMx aKT08 K apyroM.

2.&

Ha" •• HOCT ..

c06MparenbHbli1l TepMMH, Mcnonb!yeMbli1llV1A onMcaHMR xapaKrepMCTMKM rOTOBHOCTM M BnMAIOWMX Ha Hee cPalCToPOB: 6e30TKa3HocTM, peMoHTOnpMrOJlHOCTM M 06ecne'4eHHOCTM TeXHM'4eCKOrO 06cnY*M-' BaHMA M peMoHTa

nPHMEI.fAHHR

, Hane)ICHOCTIt MCnOnlt3yeTat TonbKO an" 06UlIIIX onMcaHMIiI, Korn8 He nplllMeH"IOTC" KonM ... eCTBeHHble TepMMHbl.

2 Hane)ICHOCTIt "8n11eTC" oaHMMM3 3aSIllC"UlMX OT speMeHIII acnexroa Ka'feCTaa (2.1)

3 OnpeaeneHMe Hane)ICHOCT" III npaMe'4aHlile " npMBeneHHble eblwe, a3"Tltl 1013 rnaslt' 191 cnosap" M3K 50, KOTOPIoIM Ta.o.U! SKl1IO ... aer pOllCTseHHble TepMMHbl III onpeneneHIII".

2.6 CORMeCTMMOCT ..

cnoc06HOCTb o61oelCToB (1.1) K

cOBMeCTHOMY Mcnonlo30BaHMIO B

KOHKpeTHblx ycnOBMRX C uenblO BblnonHeHMA cooTBeTCTBYlOl1IMX rpe- 6oBaHMi1I

IlP"'ME~AHHE - BblwenpMleneHHoe onpelleneHllle npMMeHReTcA I CTa",naprax .Ha Ka'4eCTBO. TepMMH .. COIMe" CTMMOCTIt· onpeneneH a PyKoBonCTSE!

HCO/M3K2. .

l'

I L

9

ISO 8402:1994(E/F/R)

2.7 interchangeability

ability of an entity (1.1) to be used in place of another, without modification, to fulfil the same requirements

NOTES

1 A qualifier such as ·functional interchangeability· or "dlmensional Interchangeability· should be used depending on specific circumstances

2 The above definition is valid for the purposes of quality standards. The term "interchangeability· is defined differently in ISO/IEC Guide 2.

2.8 .afety

state in which the risk of harm (to persons) or damage is limited to an acceptable level

NOTES

1 Safety is one of the aspects of quality (2.1).

2 The above definition is valid for the purposes of quality standards. The term ·safety· is defined differently in ISO/IEC Guide 2.

2.9 conformity

fulfilment of specified requirements

NOTE - The above definition is valid for the purposes of quality standards. The term "ccnformltv" is defined differently in ISOIIEC Guide 2.

2.10 nonconformity

nonfulfilment of a specified requirement

10

2.7 interchangeabilite

aptitude d'une entite (1.1) a etre utilisee sans modification a la place d'une autre pour satisfaire aux memes exigences

NOTES

1 En fonctlon de clrconstances particulleres, il convient d'ajouter un quallficatlf tel que "Interchange.blllt' fonctlonnelle» ou "lnterchange.bUlte dlrnenslonnelle».

2 La definition ci-dessus s'applique aux normes quatlte, Le terme .. interchangeabilite" est detini differemment dans Ie Guide ISO/CEI 2.

2.8 .'curlt'

etat dans lequel Ie risque de dommages corporels ou materiels est limite a un niveau acceptable

NOTES

1La securite est I'un des aspects de la qua lite (2.1).

2 La definition cl-dessus s'applique aux normes qualite. Le terme "securite.. est defini differemment dans Ie Guide ISO/CEI 2.

2.9 conformit'

satisfaction aux exigences spec ifiees

NOTE - La dllfinition ci-dessus s'applique aux normes qua lite. Le

terme ftconformitll" - est defini

differemment dans Ie Guide

ISO/CEI2.

2.10 non-conformite

non-satisfaction a une exigence specifil~e

27

e iso

2.7

B3aMM03aMeHJleMOCTit cnoc06HoCTb o61oeKTa (1.1) 6blTb IttCnOnb30BaHHbiM 6e3 MOlllttct:>lttKaUltt" BMeCTO IlpyrorollnA BblnOnHeHlttA Tex )l(e Tpe60BaHItt"

npIf1ME4AHIf1ft

1 B 3a8101CIIIMOCTIo1 OT KOHKpeTHblx ycnOBIo1" cneayer IIIcnonb30BaTb onpellenlo1Tem. .. CPYHKLU10HanbHafl 8]811111040- S8MeH".MOCTb· IIInlil .. p83MepHafl 838- MM038MeH"eMocrb· .

2 BblwenpIo1BelleHHoe

onpelleneHllle

nplo1MeHfleTCfI B CTaHllapTax Ha Ka~eCTBO. TepMIIIH .. B3aIllM03aMeHfleMOCTb· onpelleneH B PyKoBollCTBe If1COIM3K 2.

2.8 6esonacHOCTit

(OCTOAHltte, npltt KOTOPOM plttCK apeaa (nepcoaany) Ittnltt ywep6 orpaHItt'4eH llonYCTlttMblM YPoBHeM

npIf1ME4AHIf1ft

1 6e30nacHOCTb flsnfleTCfI OOHIilM 1013 acneKToB Ka .. eeraa (2.1).

2 Bblwenplo1BeneHHoe onpeneneaae nplilMeHAercA B CTaHuapTax Ha Ka~eCTBO. TepMIo1H .. 6e30nacHoCTb" onpellenel1H B PYKoBollCTBe If1CO/M3K 2.

2.9 COOTBeTCTBllle

BblnOnHeHltte YCTaHoBneHHbix rpe- 60BaHItt"

npIf1ME4AHHE - BblwenplilBeoeHHoe onpeoeneHIo1e nplo1MeHAeTCA a CTaHnaprax Ha Ka ... eCTBO. TepMHH "COOTBeTCTBIo1e· eneenene« B PyKoBooCTBe If1CO/M3K 2.

2.10 HeCOOTBeTCTBllle

HeBbinOnHeHltte YCTaHoBneHHoro

Tpe60BaHlttR

e rso

NOTE - The definition covers the departure or absence of one or more quality (2.1) characteristics [including dependabllltv (2.5) characteristics). or quality system (3.6) elements from specified requirements.

2.11 defect

nonfulfilment of an intended usage requirement or reasonable expectation. including one concerned with safety (2.8)

NOTE - la definition s'applique a I'~cart ou I'absence. par rapport aux exlgences speciflees. d'une au plusleurs caracterlsttques constitutives de la qualltit (2.1) tv compris celles relatives a 18 sQretit de fonctlon. nement (2.5)1. ou d'un ou plusleurs el~mentsde svstltme qua lit' (3.6).

2.11 defaut

non-satisfaction it une exigence ou a une attente raisonnable liees it une utilisation prevue. V compris celles qui ont trait a la $8curlte (2.8)

NOTE - The expectation must bo NOTE - l'sttente doll fttrn raison-

reasonable under the existing elr- nable dans les circonstances du

cumstances. moment.

2.12

product liability

generic term used to describe the onus on a producer or others to make restitution for loss related to personal injury,property damage or . other harm caused by a product (1.4)

NOTE - The legal and financial implications of product lIabllltv may vary from one jurisdiction to another.

2.13

qualification process

process of demonstrating whether an entity (1.1) is capable of fulfilling specified requirements

NOTE - The term "qualification" is sometimes used to designate this process (1.2).

2.14 qualified

status given to an entity (1.1) when the capability of fulfilling specified requirements has been demonstrated

2.12

responsablllte du fait du produit

terme gene rique utilise pour decrire I'obligation faite a un producteur. ou It d'autres, de dedommager des pertes relatives It des dommages corporels, materiels ou autres causes par un prodult (1.4)

NOTE - les implications I6gales 8t financieres de la responsablllt' du fait du prodult peuvent varier selon les jurldictions.

2.13

processus de qualification processus demontrant qu'une entlte (1.1) est capable de repondre aux exigences specifiees

NOTE - Le terme «qualification II est patfois utilise pour d~signer ce processus (1.2).

2.14 quallf"

statut accords a une entite (1.1), quand I'aptitude a repondre aux exigences specifiees a ete demontree

28

ISO 8402:1994(E/F/R)

np&o1ME"tAHME - HaCTo"lQee onpe"eneHHe 8KnIO'4aeT oTcyTCT8He OIlHO~ IiIn ... HeeKOnltKMX xaplKTepMCTMK K ... eCTBI (2.1) (a TOM \fMcne HanelKHOCTM (2.S». HnM !neMeHTOa CMCTeM .. ' KB'4eCTBa (3.6), 11M60 Ml( OTKI10HeHHe OT YCTaHoBneHH"'l( Tpe60BaH ... ~.

2.11 ReciJeKT

HeBb.nonHeHHe 3allaHHoro WlH OlKHnaeMoro Tpe60aaHHR, kaealOweroCA 001oekT8 (1.1), a TalOKe Tpe60BIHMR, OTHOCRLQef"OCR k 6e30nacHOCTM (2.8)

np&o1ME"tAHME - OlltMllaeMOe Tpe60- BaH ... e tlon*HO 61t1TIo Lleneeoo6paJHIt'M C TO'fKM 'peHM" CYlQeCTBYIOWMx ycnoBMitt.

2.12

OT.eTCT •• HHOCT .. :sa K .... CT.O npoRyKq ....

06WMM TepMMH, omllcb.BalOWMM 06R38TenbCTBa, B03naraeMbte Ha . M3rOTOBMTenA MnM npYrMx 1lMll, no B03MeweHMIO )'Ulep6a 1013-38 HaHeCeHMR TpaMB, nOBpeqeHMA c06- CTBeHHOCTM MnM npyroro Bpena, Bb13B8HHorO npoRYKLlMeiil (1.4)

np&o1ME"tAH&o1E - IOpMAM",eeKoe 101 «PMHaHeOBoe .Ha'4eHMe OTBeTCTBeHHOCTM . 31 KI",eCTBO npORYkLlMM MOllteT MeH"Tloe" OT ollHoiil 06nlCTM nplilMeHeHM" IOPMIlM\fecKMX aKTOB K Ilpyroiil.

2.13

npoqecc; K •• n"~"KaLl"" npouecc neMoHCTpaUMM B03MOlKHOCTH 0610eKTa (1.1) BblnOnHRTb YCTauonneHHb.e Tpe60BaHHR

nl'&o1ME\fAH&o1E - Itn" 0603HI",eHM" srore npOLleeea (1.2) IiIHor,,1 Mcnom.- 3yeTc" TepMliIH .. kBanM«i»MKBqM" I .

2.14

K •• n"~"",,,pO •• H

craryc, npMCBaMBaeMb.M 061teKTY (1.1), xema 6blnO nponeMoHCTpMpoBaHo, "TO OH MMeeT· B03- MOlKHOCTM Bb.nonHRTb YCTaHoaneHHb.e Tpe60BaHMR

11

f

I

I

ISO 8402:1994IE/F/R)

2.15 inspection

activity such as measuring, examining, testing or gauging one or more characteristics of an entity (1.1) and comparing the results with specified requirements in order to establish whether conformity (2.9) is achieved for each characteristic

NOTES

1 In French, the term "lnspectlon" may designate an activity of quality surveillance (4.7) carried out within the framework of a defined assign· ment.

2 The above definition is valid for the purposes of quality standards. The term "lnspectlon" is defined differently in ISOIIEC Guide 2.

2.16 self-inspection

inspection (2.15) of the work by the performer of that work, according to specified rules

NOTE - The results of self-inspec· tlon may be used for process (1.2) control.

2.17 verification

confirmation by examination and provision of objective evidence (2.19) that specified requirements have been fulfilled

NOTES

, In design and development. verificatlon· concerns the process (1.2) of examining the result of a given activity to determine conformity (2.9) with the stated requirements for that activity.

2 The term ·verified· is used to designate the corresponding status.

12

2.15 controle

actlvites telles que mesurer, examiner, essayerou passer au calibre une ou plusieurs caracteristiques d'une entite (1.1), et comparer les resultats aux exigences specifiees en vue de determiner si la conformlte (2.9) est obtenue pour chacune de ces caracterlstlques

NOTES

1 En franc;ais, Ie terme «inspection" peut designer une activite de surveillance de la quanti (4.7) conduit. dans Ie cadre d'une mission bien de· finie.

2 La definition cl-dessus s'appllque aux normes qualite. Le terme «contrOle» est defini differemment dans Ie Guide ISO/CEI 2.

2.16 autocontrole

controle (2.15) par l'executant luirnerne du travail qu'il a accompli, suivant des ragtes specifiees

NOTE - Les resultats de I'autocontr61e peuvent 6tre utilises pour la maitrisedu processus (1.2).

2.17 verification

confirmation par examen et apport de preuves tangibles (2.19) que les exigences speclfiees ont ete satisfaites

NOTES

1 En conception et developpement, la verification concerne Ie processus (1.2) d'examen du resultat d'une activite en vue de determiner Is conformltlt (2.9) aux exigences fides pour ladite activite.

2 Le terme «v'rIfl6" designe Ie statut correspondant.

29

e iso

2.15 KOHTpon ..

nenrensaccrs, BK11IO"IalOwaA, npoBeneHMe H3MepeHHi:1, 3KcnepTH3bl, HcnblTaHHi:1 HnH oueHKH onHoH HnM HeCKonbKHX xapaKTepHCTMK (c uenblO KanH6poBKH) o61oeKTa (1.1) 1.1 cpaBHeHMe nonY"IeHHblX pe3ynbTaToB c YCTaHoBneHHblMH Tpe60BaHHRMH anA onpeneneHM,., nocTHrHyro nH COOTBeTCTBMe (2.9) no KallCQOH 1.13 3THX xapaKTepHCTHK

npVlME"IAHt.1R

1 Bo q,paHUY3cKOM R3blKe TepM"'H .. inspection· MO)l(eT 060JHaLlaTb neRTenbHOCTb no Ha,.,opy sa KaLlec:T80M (4.7), npoBon"'MYIO B paMKax onpenel1eHHOrO 3anaH"'R.

2 BblweyK83aHHOe onpeael1eH",e nplIIMeHReTCR B eraHnapTax Ha Ka'leerBO. TepM"'H .. KOHTPOl1b· enpeaeneH B PyKoBoaCTBe VlCO/M3K 2.

2.16 caMoKoHTPon ..

KOHTpOnlt (2.15) BblnOnHeHHoH pa- 60Tbl ee McnonHMTeneM B coOTBeTCTBHH C YCTaHoBneHHblMH npaBHnaMH

npVlME4AHJ,1E - Pe3ynbTaTbl caMOKompon" MOfyT IIIcnonb308aTbCR .anR ynpa8neH"'''' npoueceoM (1.2).

2.17 npoBepKoiI

nonTBep*neHHe nyreM sxcnepTH3bl H npenCTaBneHH,. 061oeKTHBHoro nexasarenserea (2.19) roro. "ITO ycraHoBneHHble Tpe6oBaHH,. 6blnH BblnOnHeHbl

1 np'" npoeKT"'poBaH"'''' "'. paapa- 60TKe "pOBepKa 03Ha4aeT "POUeCC (1.2) npoBeneH"'''' JKenepT"'3bl pe3ynbTaTOB aaHHolii neRTel1bHOCT'" e uel1blO onpeneneH"'''' ee COOTBeTCT8 .. " (2.9) Bl(OnHblM Tpe60BaHHRM.

2 TepM",H .. npoBepeHo· ",enOl1b- 3yeTCR all'" 0603Ha'leHIII'" COOTDeTCTBYlOwero eraryca,

e rso

2.18 validation

confirmation by examination and provision of objective evidence (2.19) that the particular requirements for a specific intended use are fulfilled

NOTES

1 In design and development, validation concerns the process (1.2) of examining a product (1.4) to determine conformity (2.9) with user needs.

2 Validation is normally performed on the final product under defined operating conditions. It may be necessary In earUer stage ••

3 The term ·valldated· Is used to designate the corresponding status.

4 Multiple validations may be carried out If there are different Intended uses.

2.19

objective evidence information which can be proved true, based on facts obtained through observation, measurement, test or other means

2.18 validation

confirmation par examcn et apport de preuve. tangibles (2.19) que lesexigences partlculleres pour un usage specifique prevu sont satisfaites

NOTES

1 En conception et d~veloppement, la validation concerne Ie processus (1.2) d'examen d'un prodult(1.4) en vue de d~temlner la conformlte (2.9) aux besolns de I'utlllsateur.

2 La validation s'effectue normalement sur Ie prodult final dans des conditions d'utillsation d~finies. E.Jle p.ut s'av6r.' necesalre II des 6tapes anterleures,

3 Le terme .. v.Ild6,. d~signe Ie statut correspondent.

4 Plusleurs valld.tlons peuvent Atre effectu~es s'U y a diff~rents usages prevus.

2.19

preuve tangible

information dont la veracite peut etre demontree, fondee sur des faits obtenus par observation, mesurage, essai ou autres moyens

30

ISO 8402:1994(E/F/R)

2.18 YTeep*AeHM.

npM,,8HM. 38KOHHOA eMnb. nORTBep)l(JleH...,e nyreM 3KCnepT...,3bl ..., npeRCTaBneH...," 06"eKTM8· Horo ROKaJaTenbCT8a (2.19) roro, '41'0 oc06ble Tpe60a8H...,,., npeRHa3H8'4eHHble RnA KOHKpeTHoro np...,MeHeH...,A, c06nlOReHbl

1 "pM npoeICTMpoe8HMM M pa3pa- 60TKe )'11Iep*"eHM. 03Ha'4aeT npoae"eHHe 3KCnepTH3bl npoRYKqMM (1.4) c uenblO onpe"eneHMR COOT_eTa_MII (2.9) HYQ8M n01'pe6MTen,..

2. VT_epJICA.HMe 06'""'t'l0 ocytUe·

CTBnRe.TCR H8 KOHe'4HOA npoRYkqMM B - ,,_

onpeaeneHHb'X ycnOBM"X 'ttcnny(lT.UMM. OMO MOJICeT 6 .. ,1''' He06xooMMO

.... 60nee paHHMx C1'aaH,.lC.

1 TepMMH HYT8ep*"eHo· Mcnonb- 3yeTCR """ 0603H ... eHM" COOTeeTcT8YlOwero CTaryca.

4 MoryT. ocyweCTII"ATbCR MHoroKpaT· Hb'. YT_.p*"eHM", eClt'" npeonon.raeTCR pa3nH'4HOe MCnon,,'OBaHMe.

2.19

06'beKTM8Hoe AOK83aTenbCT8o MH<p0pMaU...,A, KOTOpa,. MO)f(er 61:11TI:I nOKa3aHa, 'fTO OHa npaanMBa, OCHOBaHa Ha <paKTax ..., nonY'feHa nyreM H86nlOneHMA, M3MepeH...,,., ...,cnI:lITaHMA Mn..., npyrMx CpeRCTl!

13

ISO 8402:1994(E/F/R)

Section 3:

Terms related to the quality system

3.1

quality policy

overall intentions and direction of an organization (1.7) with regard to quality (2.1), as formally expressed by top management

NOTE - The quality policy forms one element of the corporate policy and is authorized by top manage· ment.

3.2

quality management

all activities of the overall management function that determine the quality policy (3.11, objectives and responsibilities, and implement them by means such as quality planning (3.3), quality control (3.4), quality assurance (3.5) and quality improvement (3.8) within the quality system (3.6)

NOTES

1 Quality management Is the responsibility of all levels of management but must be led by top management. Its implementation involves all members of the organization (1.7).

2 In quality management, consid· eration is given to economic aspects.

I

J

14

Section 3:

Termes relatifs au systeme qua lite

3.1

politi qua quallt'

orientations et objectlfs generaux d'un organlsma (1.7) concernant la quallta (2.1), tels qu'ils sont exprlmes formellemant par la direction au plus haut niveau

NOTE - L. polltlqu. quant6 est un element de t. politlque generale et est approuvee par la direction au plus haut niveau.

3.2

management de 'aquanta

ensemble des activites de la fonction genera Ie de management qui determinent la politique qualita (3.1), les objectifs etles responsabilltes, et les mettent en oeuvre par des moyens tels que fa planificatlon de la qualita (3.3), la maitrise de la qualita (3.4), I'assurance de la qualita (3.5) et I'amelioration de la quante (3.8) dans Ie cadre du systeme qualita (3.6)

NOTES

1 Le management de la quallt6 est la responsabillte de tous les niveaux de direction, mals II doit ~tre conduit par 18 direction au plus haut nlveau. Sa mise en oeuvre implique taus les membres de I'organlsme (1.71.

2 Le management de la quant' prend en corn pte les aspects economiques.

31

e iso

.... aers 3:

TepMMHbl OTHocsn,QMecSI K CMCTeMe Ka'leCTBa

3.1

nonlo1TllKa • 06naCTM KallfeCTBa OCH08Hble HanpaeneHIIIA III l(enlll opraHMla....... (1.7) B 06naCTlil Ka· 'feCTa. (2.1), o~lIIulllanbHo c~opMynlllpoBaHHbte BbICWIIIM· PYKOBOQCTBOM

np~ME'4AH~E - non..,...K8 a 06n8CTM ka~CT8a "a""eTa. ,ne,.,eHTOM o6we~ nonMTMklll III yTaepqaeTa. abICW"'M .PYK080IlCT80M.

3.2

o6tqee PYKOBOACTBO Ka'teCTBOM aAMMHMapaTMBHoe ynpaaneHllle Ka'teCTBOM '

re aCneKTbl 06meH ct>YHKU1011o1 ynpaBneH101A, KOTopble onpeaenAIOT nonMTMKY a o6naC1l1 Ka'teCTaa (3.1), lten101 III OTBeTCTBeHHOCTb, a TalOKe ocymeCTBnAIOT 101X C nOMomblO TaKIllX cpencra, KaK

nnaHMpoaaHMe Ka'feCTBa (3.3),

ynpaBneHMe Ka'4eCTBOM (3.4},

o6eCne'4eHMe Ka'4eCTBa (3.S) 101 yny'4WeHMe Ki'I'4eCTBa (3.8), B paMKax CMCTeMbl Ka'4eCTBa (3.6)

np&.1ME4AH~R

1 06"laHHoCTIII no o6weMYPYKOaOIlCTay Ka'4eCTIIOM ne)KaT H8 8cex YP08HAIC ynpaaneHM", HO ynpaanATh 101MIII aOn)KHO .blCwee pYKo80aCTao. B 06wee P)'K080RCTBO Ka'4eCTBOM aoaneKalOTCA ace '4neHbl OpraHMJaLlMl1 (1.7).

2 nplII 061Qe... pYKoaOACTa. K8'4eCTBO'" aKueHT RenaeT<" Ha 'KOHOMIII '4eCKMe aCnekTbl.

OISO

3.3

quality planning

activities that establish the objectives and requirements for quality (2.3) and for the appllcation of quality system (3.6) elements

NOTE - Quality planning covers:

a) product (1.4) planning: Identifying, classifying and weighting the characteristics for quality (2.1) as well as establishing· the objectives, requirements for quality and constraints;

b) managerial and operational planning: preparing the application of the quality system including organizing and scheduling;

c) the preparation of quality plans (3.13) and the making of provisions for quality Improvement (3.8).

3.4

quality control

operational techniques and .. activities that are used to fulfil requirements for quality (2.3)

NOTES

1 Quality control involves operational techniques and activities aimed both at monitoring a process (1.2) and at eliminating causes of unsatisfactory performance at all stages of the qua'lIty loop (4.1) in order to' achieve economic effectiveness.

2 Some quality control and quality assurance (3.5) actions are interrelated.

3.5

quality assurance

all the planned and systematic activities implemented within

3.3

planification de la qua lite actlvttes qui determinent les objoctifs et les exlgences pour 18 quallte (2.3), ainsl que les exigences pour la mise en osuvre d'elements du systeme quallte (3.6)

ISO 8402:1994(E/F/R)

3.3

nnaHMpo •• HM. K.'t.CT •• neRTenbHOCTb, KOTopaR YCT8H8B",!lBaeT uenH H Tpe6oBaHM", K 'Ka'teCT.y(2.3) MnpMMe ... eHMIO )neMeHTOB CMCTeM .. ' KatteCTa. (3.6)

NOTE - La pl.nlfle.tlon de la qua- n~&ilMEI.fAHME - "naHMpoa.HMe "a-

IIti recouvre 'feCTa. oxaaTIo.aaeT:

a) la planlflcation pour un prodult (1.4): Identification, classification et pondaratlon des ceracterlstlques relatives It la quallti (2.1), ainsl qu'etabtlssernent des objectlfs, des exlgenees pour la qu.llti et des contraintes;

b) la planlfication de management et operationn.lle: preparation de la mise en <Buvr. du syst'me quallt' comprenant I'organlsatlon et Ie ealendrier;

c) 1'6Iaboratlon de pl.ns quallte (3.13) et la prise de dispositions pour I·amillor.tlon d. I. quallte (3.8).

3.4

mattri •• d. fa qua lit' techniques et activites it caractsre operetlonnel utlllsees pour satisfaire aux exig.nees pour la qualite (2.3)

NOTES

1 La maitrlse de la quallte comprend des techniques et aclivites a caractere operatlonnel qui ont pour but It la fois de piloter un processus (1.2) et d'ellmlner les causes de fonctlonnement non satlsfaisant a to utes les phases de la boucle de la qualite (4.1) en vue d'atteindre la mellleure efflcaclte economique.

2 Certaines actions de maitrlse de la quallt' et d'assuranee de 'a quallt' (3.5) sont liees entre elles.

3.5

assuranca d. la qua lit' ensemble des actlvltes preetabiles et systematiques mises en

32

a) nmlHMpoaaHHe Ka ... eCTaa nPDAYK~MM (1.4): MlIeHTMctMKaUMA, MaCCHct>IIIkaUIII" M oueHKa xapaKTepMCTIIII< Ka'fI!!CTaa (2.1),· a TalOlCe· YCTaHo8neHMe ueneitl, TPe6oaaHM. " K ...... CT.y M wTpact>HloIx caHKUlllltI;

6) nnaHMpoaaHMI! ynpaaneH'feCl<oitl III ct>YHKullloH.n .. Hoii! aellTen .. HOCTIII: noarOToaKa npHMeHeHIII" CMCTeM'" Ita'feCTaa, 8 TOM 'fMCOe opraHMJaUIII"M coCTa8neHllle KaneHaapHoro rpact>MKa;

a) noaroT081C)' nporpaMM .. 1 "a'f.CT8a (3.13) M a ... pa60TKY nono*eHMA no ynY'fweHMIO Ka'feCT8' (3.8).

3.4

ynp •• neH .. e ".'teCT.OM

MeTonbl M BHQbl neRTenbHOCTH

onepaTM8Horo xapaKTepa, HC-

nonb3yeMbie QnA BblnOnHeHHR

Tpe60aaHMA K KatteCT8Y (2.3)

np&ilMEI.fAH&ilR

1 YnpsaneHMe KS'feCTBOM aMI04seT MeToalo. III 8111al>l ae"TenIoHOCTM onepaTM8Horo xapaKTepa, Hanpa8neHHIo.e KaK Ha ynpaBneHMe npo~eccoM (1.2), TaK M Ha ydpaHeHMe npM4MH HeyaoBneTBoplilTenbHoro 4JVHKU"'OH"'POBaH"''' Ha acex :nanax neTnM Ka'feCT8a (4.1) an" 1I0CTMlKeH&II" JKOHOM"'4ecKoiit Jct>ct>eKTMBHOCT&II.

2 HeKoToplo.e neiitCTBM"no ynpa8neH"tO 1t.'feCT80M M 06ecne'feHMIO Ita'4eCTBa (3.5) 8Ja&llMOC8"JaHIo •.

3.5

o6.cn .... H ... Ka ... CT ••

Bce nnaHMpyeMbte M CMCTeMaTM- 4eCKH ocYllleCTBnAeMble BHQhf QeR-

15

I

ISO 8402:1994(EIF/R)

the quality system (3.6), and demonstrated as needed, to provide adequate confidence that an entity (1.1) will fulfil requirements for quality (2.3)

NOTES

1 There are both Internal and external purposes for quality assurance:

a) Internal quality assurance: within an organization (1.7), quality assurance provides confidence to the management;

b) external quality assurance: in contractual or other situations, quality assurance provides confidence to the customers (1.9) or others.

2 Some quality control (3.4) and quality assurance actions are interrelated.

3 Unless requirements for quality (2.3) fully reflect the needs of the user, quality assurance may not provide adequate confidence.

3.6

quality system

organizational structure (1.8), procedures (1.3), processes (1.2) and resources needed to implerr ent quality management (3.2)

NOTES

1 The quality system should be as comprehensive as needed to meet the quality (2.1) objectives.

2 The quality system of an organIzation is designed primarily to satisfy the Internal managerial needs of the organization (1.7). It is broader than the requirements of a particular customer (1.9), who evaluates only the relevant part of the quality system.

16

oeuvre dans Ie cadre du syteme qualita (3.6), et dernontrees en tant que de besoin, pour donner la confiance appropriee en ce qu'une entite (1.1) satisfera aux exigences pour la qualita (2.3)

NOTES

1 L'assuranee de la quallti vise II la fois des objectifs internes et externes:

a) assurance de la qu.llt. interne: au sein d'un organlsme (1.7), I'assur.nce de I. quallt, sert a donner confiance a 18 direction;

b) assurance de I. qua lit' externe: dans des situations contractuelles ou autres, I'assurance de la qualit' sert a donner confiance aux cllent~ (1.9) ou a d'autres.

2 Certaines actions de maitrlse de la quallt' (3.4) et d'.ssur.nce de I. quallt' sont li6es entre elles.

3 Si les exigences pour la qu.llte (2.3) ne refletent pas entlsrernent les besoins de I'utillsateur, I'assurance de la qualite peut ne pas donner la confiance approprlee:

3.6

systeme quant.

ensemble de I'organlsatlon (1.8), des procedures (1.3), des processus (1.2) et des moyens necessaires pour mettre en ceuvre Ie management de I. qualita (3.2)

NOTES

1 II convient que Ie systeme quallte ne soit pas plus etendu qu'it n'est besoin pour atteindre les objectifs relatifs a 18 qualit, (2.1).

2 Le systeme quallt, d'un organlsme (1.7) est conc;u essentiellement pour satisfaire les besoins internes de management de I'oraanlsme. II VI au-del II des exlgences d'un client (1.9) particulier qui n'evalue que I. partie du systeme qualite qui Ie concerne.

33

OISO

TenbHOCTIit B paMKax C .. CTeMb' Ka'feCTBa (3.6), a TalOKe nOATSep)l(tlaeMble(ecnllt 3TO TPe6yeTCJI), Heo6xOAlltMbie MJI C03AaHlltJl AOCTaTO'fHOM YBepeHHoCTIit B TOM, 'fTO 061teKT (1.1) 6yAeT BblnOnHRTb Tpe6oaaH .... K Ka'feCTBY (2.3)

np~ME~AHIIIR

1 CyweCTBYIOT KaK 8HewH ... e, TaK ... 8HYTPeHHMe uen... 06eCne'feH"'R Ka.. eCT8.:

a) 8HYTpeHHee o6eCne'feHMe Ka'4eCT8a: 8 paM1<aX opraHM3a~MM (1.7) 06ecne'feHMe Ka'feCT8a C03DaeT y8epeHHoCTb y PYK080DCTBa;

6) BHeWHee 06ecne'feHMe Ka'4eCT8a: 8 KOHTpalCTHblX ... n... DpyntX CMTYaUMRX 06eCne'4eHMe Ka'feCT8a C03DaeT yBepeHHOCTbY nOTpe6MTenR (1.9) Mn", DpyntXnMU.

2 ~eKoToPble neMCTBM" noynpaBneHMIO Ka'feCT80M (3.4) ... 06ecne'4eHMIO Ka'4eCT8a B3aMMOCB"3aHbl.

3 ECIlM Tpe6oBaHM" K Ka'4eCTBY He OTpa)KalOT nonHoCTblO nOTpe6HOCTIo1 nonb30BaTenR, 06eCne'4eHMe Ka'feCT8a MO)KeT He C03naTb nOCTaTO'fHOIiI yBepeHHoCT ....

3.6

CJIICTeMa Ka"eCT.a

cOBoKynHocTb opraH"3a~MoHHOM CTPYKTYPIIo' (1.8), MeTOA .. K (1.3), npeueccea (1.2) lit pecypcos, He06xonlltMbiX MR oCYUleCTBneHIltR o6U1ero PYKoBoACTsa Ka'feCTBOM (3.2)

np~ME~AHIltR

1 MacwTa6bl CMCTeMb' Ka'feCT8a, Don)KHbl cooT8eTCTBoBaTb uen"M B 06naCTM Ka'feCT8a (2.1).

2 CMCTeMa Ka'feCTBa opraHM3a~"M npenHa3H.'feHa, npeJK.Qe acerc, M" ynoBneT80peHM" BHYTpeHHMx nOTpe6- HOCTelil ynpaBneH ... " opraHM3a~MeM (1.7). OHa wlllpe, 'feM Tpe608.HMR onpeneneHHoro nOTpe6MTenR (1.9), KOTOPbl1il oueH ... BaeT TonbKO TY 'faCTb CMCTeMIt' Ka'4eCT8a, KOTopaR OTHOCIIITCR K 3TMM Tpe60BaHM"M.

e iso

3 For contractual or mandatory quality assessment (4.6) purposes. demonstration of the implementation of Identified quality system elements may be required.

3.7

total quality management

management approach of an organization (1.7), ,centred on quality (2.1), based on the participation of all its members and aiming at long-term success through customer (1.9) satisfaction, and benefits to all members of the organization and to society

NOTES

1 The expression "all Its members" designates personnel in all departments and at all levels of the organIzational structure (1.8).

2 The strong and persistent leadership of top management and the education and training of all members of the organization are essential for the success of this approach.

3 In total quality management. the concept of quality relates to the achievement of all managerial obJectives.

4 The concept ·benefits to society· implies. as needed. fulfilment of the requirements of society (2.4).

5 Total quality management (TOM) or parts of it are sometimes called ·total quality·, ·CWOC· (company-wide quality control). ·TOC· (total quality control) and so on.

3 Pour les besoins d'une 'valuatlon quallte (4.6) contractuelle ou obligatolre. la demonstration de la mise en ceuvre d'illements Identlflils du systeme qua lit' peut fttre exigile.

3.7

management total de laqualit'

mode de management d'un organlsme (1.7), centre sur la qualit' i2.1), base sur la participation de tous ses membres et visant au succes ~ long terme par 18 satisfaction du client (1.9), et ~ des avantages pour tous les membres de I'organlsme et pour la soclllt6

NOTES

1 Par «tous ses rnernbres», on entend Ie personnel dans tous les services et II tous les niveaux de I'organlsatlon (1.8).

2 Une implication forte et permanente de la direction au plus haut niveau et la formation genilrale et permanente de taus les membres de I'organlsatlon sont Indispensables au succss de ce mode de management.

3 En management total de la qualite. Ie concept de quallt' se rMere au fait d'attelndre tous les objectifs de management.

4 Le concept "avantages pour la societell lmpllque, sl besoln est. de satlsfalre les exlgences de soc"t' (2.4).

5 Le management total de la quallt6 (TOM) ou certains de ses aspects sont parfols dllsignes par les expressions «quallt6 total811• "CWOCII (en anglels «company-wide quality eentrel»], "TOCII (en anglais «total quality controlll). etc.

34

ISO 8402:1994(E/F/R)

3 B CS,,! .... C Tpe60saH .... "M .... KOHTPaKTa .... n.... 06"3aTen .. H .. IM.... npenn .... caH .... "MIII no npoaeneHlll1O o.._eHKIiI Ka'feCT8a {4.6) MOlKeT 6 .. 'T.. ssrpe- 60BaHo HarnAnHoe nOKa3aTenbCT80 np .... MeHeH .... A onpeneneHH .. ,x 3neMeHTOB CIiICTeMIt' Ka'feCT8a.

3_7

Bceo6111ee PYKOBOACTBO Ka".CT.OM

noaxon K PYKoBonC::TBY opraH"'.LIM eM (1,7), HaLleneHHb',M Ha Ka'4eCT80 (2.1), oCHoBaHHblM Ha Y'4.CTMM ecex ee '4neHOB M Hanpa8- neHHblM Ha nOCTM*eHMe nonroCpO'4HOrO ycnexa nyreM YlloBneTBopeHMR Tpe60BaHM" norpe6MTenJl (1.9) M ablrOllbl IlnR '4neH08 opr.HM,aLlM" M 0611leCT8a

npIo1ME'4AHIo1R

1 • Bce 'fne""'· 03Ha'faeT nepcouan so acex nenpaanene« .... "x .... Ha scex YP08H"X OpraHIiIJa"_liIoHHoA CTpyKT}'plot (1.8).

2 (IIIn .. Hoe.... HaCTO~'f1ll80e pYK080n(T80 co CTOPOHb' Bblcwe~ anM .... HIIICTpaulllliI, o6Y'feHllle .... non rOT08 Ka scex 'fneH08 opraHliI3aL&MIiI "8n"IOTC" cyweCTSeHHblM.... MOMeHTaMIil J1I1" ycnewHo~ pean .... 3aU"' .... nplil8eneHHoro nenxona,

3 np'" eCe06IQeM pYK080nCT8e Ka'feCTeOM KOHuenUIil" Ka'feCTea "'MeeT

oTHoweH e K nOCT .... lKeH .... 1O scex uene~

ynpaBneH ".

4 .. B .. lroaltl anA 06IQeCT8a· noapa3yMeBalOT 8blnonHeH .... e Tpe608aHM" 06- IQeCT8a (2.4).

5 Total quality management (TQM) (8(e06IQee PYKOiJOllCT80 Ka'fe(T8oM) .... n'" ero COCTa8HIole 'faCT .... IIIHorna Ha- 3 .. 18alO't .. total quality- ( .. 8ce06IQee l(8'feCT80·), .. CWQC· (company wide quality control) ( .. ynpa8neHMe Ka'fe(T80M 8 MacUlTa6ax KOMnaHMIiI·), .. TQe· (total quality control) ( .. Bce- 06IQee ynpaaneHMe Ka'feCT80M·) .... TJl.

17

ISO 8402:1994(E/F/R)

3.8

quality improvement

actions taken throughout the organization (1.7) to increase the effectiveness and efficiency of activities and processes (1.2) in order to provide added benefits to both the organization and its customers (1.9)

3.9

management review

formal evaluation by top management of the status and adequacy of the quality system (3.6) in relation to quality policy (3.1) and objectives

NOTES

1 Man.agement review may include review of the quality policy.

2 Quality audit (4.91 results are one of the posssible inputs to management review.

3 The term "top management" refers to the management of the organization (1.71 whose quality system is being reviewed.

3.10

contract review

systematic activities carried out by the supplier before signing the contract to ensure that requirements for quality (2.3) are adequately defined, free from ambiguity, documented and can be realized by the supplier (1.10)

NOTES

1 The contract review is the responsibility of the supplier but can be carried out jointly with the customer (1.9).

2 A contract review may be repeated at different phases of the contract as needed.

18

3.8

amelioration dela qua lite actions entreprises dans tout I'organisme (1.7), en vue d'accroitre l'efflcacite et Ie rendement des activltes et des processus (1.2) pourapporter des avantages accrus a la fois it I'organisme et a ses clients (1,9)

3.9

revue de direction

evaluation forrnallsee, effectuee par la direction au plus haut niveau, de I'etat et de l'adequatlon du systeme quallte (3.6) par rapport a la politique quallte (3.1) et a ses objectifs

NOTES

1 La revue d. direction peut inclure de reconslderer la politlque qualite.

2 Les resultats d'audits quallt' (4.91 constituent une des donnees d'entree possibles de la revue de direction.

3 La «direction au plus haut niveau» designe la direction de I'organisme (1.71 dont Ie systeme qua lite est passe en revue.

3.10

revue de contrat actionssystematiques effectuees par Ie fournisseur avant la signature du contrat pour s'assurer que les exigences pour la qua lite (2.3) sont definies de fac;:on adequate, sans ambigu"ite, exprimees par des documents et realisables par Ie fournisseur (1.10)

NOTES

1 La revue de contrat est de la responsabilite du fournisseur, mais elle peut Atre effectuee conjointe. ment avec Ie client (1.9).

2 Une revue de contrat peut itre repetee It dlfferentes eta pes du contrat, si besoin est.

35

elsa

3.8

ynyltuieHMe KalteCTaa MeponplilATIIIA, npennplllHIIIMaeMble noeoony B opraHM3a",MIII (1.7) C ",enblO nOBblweHIIIA 3q,q,eKTIIIBHOCTIII III pe3ynbTaTIIIBHoCTlil neaTenbHOCTIil III npo",eccoa (1.2) nml nony~eHMA ablronbl KaK MA opraHM3a",MM. TaK H nnA ee norpe- 6MTeneM (1.9)

3.9

aHanMS co CTOPOHIt. pYKoaoACTaa

0q,M"'lIIanbH8A. oueaea BblCWIIIM PYKOBODCTBOM COCTOAHHA CMCTeMbl Ka'teCTBa (3.6) III ee COOTBeTCTBIilA nonMTMKe a o6naCTM Ka'teCTaa (3.1) III ",enAM

np~ME4AH~R

1 AHan .. , co CTOPOHb' PYKoaoACTaa MOlKeT aKl1IO'4aTb aHanM3 non"T14K14 a o6nacnt Ka'feCTBa.

2 Pe3ynbTaTIs' npoaepK" Ka'4eCTaa (aYA .. Ta) (4.9) ABnAIOTCA OJlHIotM" 1ot3 B03MOlKHbiX BXOJlHblX JlaHHIsIX .anA aHa"143a co CTOPOHb' PYKoaORCTaa.

·3 TepMIotH "ab,cwee PYKoaoRCTao· OTHOCIotTCA K PYKOBOJlCTBY opraH .. sa....... (1.7), C"CTeM8Ka'feCTaa KOTOPOtii aHanlot3lotpyeTCA.

3.10

aHanM3 KOHTpaKTa ClilCTeM8TIII4eCK8A De,.TenbHOCTb. npennpMHIIIMaeMaA "OCTaB~IIIKoM DO nODnlllC8HMA KOHTpaKTa, "IT061>1 y6eDIIITbCR, 'tTOTpe6oaaHMJI K Ka'teCTay (2.3) TO'tHO onpeaeneasi, 11136aBneHbl OT DBycMb,cneHHocTIil. DOKYMeHTanbHo oq,opMneHbl III MOryl' 6blTb BblnonHeHbl "OCTaalQMKOM (1.10)

np~ME4AH~R

1 AHan .. , KOHTpaKTa ABnAeTCA 061'1- 3aHHOCTblO nOCTaBIQMKa. HO MOlKeT 6b'Tb Bb'nonHeH coaMeCTHO C nerpe- 6MTeneM (1.9) .

2 AHan .. , KOHTpaKTa MOlKeT 6blTb n08TopeH Ha pa3nlll"lHbiX CTaJlHAX, ecnlot :tTO Heo6xoJlMMO.

10 ISO

3.11

design review

documented, comprehensive and systematic examination of a design to evaluate its capability to fulfil the requirements for quality (2.3), identify problems, if any, and propose the development of solutions

NOTE - A de.lgn r.vlew can be conducted at any stage of the design proce •• (1.2), but should in any case be conducted at the completion of this process.

3.12

quality manual

document stating the quality policy (3.1) and describing the quality system (3.6) of an organization (1.7)

NOTES

1 A quality manuil may relate to the totality of an organization's activities or only to a part of it. The title and scope of the manual reflects the field of application.

2 A quality manual will normally contain or refer to, as a minimum:

a) quality policy;

b) the responsibilities, authorities and inter-relationships of personnel who manage, perform, verify or review work affecting quality (2.1 I;

cl the quality system (3.6) procedures (1.3) and instructions;

d) a statement for reviewing, updating and controlling the manual.

3 A quality manual can vary in depth and format to suit the needs of an organization. It may comprise more than one document. Depending on the scope of the manual, a

3.11

revue de conception

examen d'une conception, mene de fa~on complete et systemstique It "aide de documents, en vue d'evaluer sa capacite It satisfaire aux exlgences pour 18 qualite (2.3), d'identifier les preblemes et, s'iI y en a, de proposer Ie developpernent de solutions

NOTE - Une revue de conception pout (llro condulte .. touts I\tape du processus (1.2) de conception, mals II convient, dans tous les cas, d'en mener une II I'achltvement de ce processus.

3.12

manuel quallta

document enon~ant la polltique quallte (3.1) et decrivant Ie systeme quallte (3.6) d'un organisme (1.7)

NOTES

1 Un manuel quallte peut porter sur la totalile des actlvltes d'un organisme ou seulement sur une partie de celles-ci. Le titre et I'objet du manuel expllcitent Ie champ d'appllcatian.

2 Un manuel qualite contiendra normalement, ou fera reference II, au molns

a) la polltlque quante;

b) les responsabllltes, les pouvoirs et les relations entre les personnes qui dirlgent, effectuent, verifient ou passent en revue les travaux qui ont une incidence sur la qua lite (2.11;

c) les procedures (1.3) et les instructions du syst"me quallt' (3.6);

d) des dispositions pour revoir, meltre II jour et g6rer Ie manuel.

3 Pour s'adapter lUX besolns d'un organlsme, Ie degr6 de d6tall .et la forme d'un manuel qua lit' peuvent varier. Le manuel peut Atre constitu6 de plusieurs volumes. Selon I'objet

36

ISO 8402:1994(EIF/R)

3.11

aHanlll' npoeKTa JlOKYMeHTlilpoBaHHaR, acecropoaHaR III CIilCTeMaTIII-.eCKa" nposepxa npoexra c uenblO oueHKIII ero B03MO)KHOCTIII BblnonHRTb Tpe60~ BaHIil" K Ka-.eCTBY (2.3), Bb.RBnRTb np06neMb. III onpenem'Tb cnoc06b' IIIX peweHIIIA

np&o1ME~AH&o1E -AHanMJ npoeKTa MOlICeT npORoaMT .. eA H8 mo60M :nane npeuecca (1.2) npoeKTMpoBaHMA, HO B m060M cn)"fa. OH aomK.H 6"IT .. ocyweCTBneH no JaBepWeHIiIM npoLleeca.

3.12

PYKOBOACTBO no Ka'feCTBY JlOKYMeHT, 1113naralOI1IIIIH nonlllTMKY B 06naCTM Ka"eCTBa (3.1) III onlllcb.BalOl1IlIIH clilCTeMY Ka"eCTBa (3.6) opraHIII3aLlIIIIII (1.7)

np&o1ME~AH&o1R

1 PYKOBORCTRO no Ka ... eCTRY MOlKeT OXBaTblBaTb BCIO neATenbHOCTb opraHMJaUMM MnM ronseo ee ... aCT... HaMMeHOBaHMe M o6naeT" aeATenbHOCTM onpeneneHHoro pYKoBoaCTBa oTpalKaer cct>epy ero npIo1MeHeHMA.

2 PYKOBORCTBO no Ka ... eCTBy 06bl ... HO coaeplKMT MnM, no KpaiilHeiil Mepe, CCblnaeTC" He:

a) nonMTMKY B 06naCTM Ka ... eCTBa;

6) OTBeTCTBeHHOCTb, nonHOMO ... MA M B3alilMOOTHoweHIiIA nepceuene, KOTOPbliil ocyweCTBnAeT pYKoBonCTBo, IiICnonaaer, nposepaer IiInlil aHanM3li1pye,. pa60ry, Bnlo1AIOWYIO Ha Ka ... eCTBO (2.1);

B) MeTORMKM (1.3)CMCTeM .. , Ka ... eCTaa (3.6)'" IiIHCTPYKUIilIo1;

r) nonOlKeHlile no nepecMoTpy iii KoppeKTlilpoBKe PYKoBoACTBa.

3 PYKOBORCTBO no Ka ... eCTRY MO~.T pasn ...... aTbcA no 06beMY lit ct>opMaTy, C )"feToM nOTpe6HoCTeiil OpraHMJaUMM. OHO MOlKeT COCTOATb M~ HeCKOnltKIiIX AOKYMeHToB. B 3aBIo1cMMoCTM OT Ha-

19

ISO 8402: 1994(E/F IR)

qualifier may be used, for example, H quality assurance manual" , "quality management manual".

3.13

quality plan

document setting out the specific quality (2.1) practices, resources and sequence of activities relevant to a particular product (1.4), project or contract

NOTES

1 A quality plan usually makes reference to the parts of the quality manual (3.12) applicable to the specific case.

2 Depending on the scope of the plan, a qualifier may be used, for example, "quality assurance pian", "quality management pian".

3.14 specification

document stating requirements

NOTES

1 A qualifier should be used to indicate the type of specification, ~ such as "product (1.4) specification", "test specification".

2 A specification should refer to or include drawings, patterns or other relevant documents and indicate the means and the criteria whereby conformity (2.9) can be checked.

3.15 record

document which furnishes objective evidence (2.19) of activities performed or results achieved

20

du manuel, un qualificatif peut etre utilise, par exemple «manuel assurance qualiten, «manuel management de la quallt'".

3.13

plan quallt'

document linonQant les pratiques, les moyens et la sequence· des activMs liees It la quallta (2.1) specifiques It un produit (1.4), projet ou contrat particulier

NOTES

1 Un plan qualite fait generalement reference aux parties du manuel quallte (3.12) appllcables specifiquement.

2 Selon I'objet du plan, un qualificatif peut etre utilis6, par exemple «plan assurance qualltell, «plan management de la quallt.n.

3.14 specification

document enonctant des exi-

gences

NOTES

1 II convient d'utiliser un qualificatif pour preciser Ie type de specification, comme par exemple «specification de prodult» (1.4), Clspecification d'essal».

2 II convient qu'une specification contienne des dessins. des rnodeles ou autres documents appropries ou qU'elie en indique la reference. II convient egalement qu'elle indique les moyens et les erlteres suivant lesquels la conformlte (2.9) peut etre verifiE!e.

3.15 enregistrement

document qui fournit des preuves tangibles (2.19) des actlvltes effectuees ou des resultats obtenus

37

elsa

3Ha~eHlllft PYKOBOQCTBa OHO IIIHOrQa Ha3blBaeTCft "PYKOBORCTBO no 06ecne~eHMIO Ka'4eCTBa" IIInll1 H PYKOBORCTBO no 8RMMHMCTpaTMBHoMY ynpaBneHMIO Ka'feCTBOM " .

3.13

nporpaMM. K .... CTII.

ROKYMeHT, pernaMeHTIIIPYIOLUII'IM KOHKpeTH~le Mep~1 B 06nacrll'l xa.. eCTBa (2.1), pecypc~1 111 nocneROBaTen~Hocr~ neRTen~Hocrlll, oTHoCRLUeMCR K cneUIllq,III~ecKoM npoRYKUMM (1.4), npoexry IIInlil KOHTpaKl)'.

npII'IME4AHII'IR

1 nporpaMMa Ka'4eCTBa 06bl'4HO COQeplKlilT CCblnKIil Ha 'faCTIil PYKoBoRCTBa no Ka'feCTBY (3.12), nplIIMeHfteMble K OTtlenbHblM cny~aftM.

2 B 3aBIIIClilMOCTill OT Ha3Ha'feHlllft nporpaMMbl OHa II1Hoftla Ha3blBaeTCft .. nporpaMMa 06eCne'4eHlllft Ka'4eCTBa· IIInlil HnporpaMMa 8RMMHMCTpaTIIIBHoro ynpasneHM" Ka'CeCTBOM"

3.14

TexH .... ecK .. e ycnOB .. R

ROKYMeHT, YCTaHaBnlllBalOLUIiIH rpe- 60BaHIIIR

npII'IME4AHII'IR

1 nnft 0603Ha'4eHlllft Tillna TeXHM~eCKMX yenoBMM enenyer IIIcnonb30~ BaTb onpenenarens, TaKoIiI, KaK TexHM~eCKMe yenoBMft Ha npoRYKIIMIO (1.4), TeXHM'4eCKMe ycnoBIIIA Ha ",cnblTaH"'ft.

2 TexHM'CecKMe yenoBM.. QonlKHbl "'MeTb eeblnKIil ",nll1 BK11IO'4aTb exeMbl 111 npyrylO cooTBeTCTBYlOwylO QOKYMeHTaUlll10 '" YKa3blBaTb cnoc06bl '" Kpll1- Tepll1"'. nOCpeQCTBOM KOTOPblX MOlKeT 6blTb ocyweCTBneHa npoeepxa COOTBeTCTBM .. (2.9).

3.15 npoToKon

nOKYMeHT, npeRCTaBnRIOLUIiIH 06,.eKTIIIBHoe nOKa3aTenbCT8Q (2.19) 0 npOQenaHHOM pa60Te IIInlil nocTlllrHyrblx pe3yn~TaTax

e tso

NOTES

1 A quality (2.1) record provides objective evidence (2.191 of the extent of the fulfilment of the requirements for quality (2.3) (e.g. product (1.4) quality record I or the effectiveness of the operation of a quality system (3.6) element (e.g. quality system record).

2 Some of the purposes of quality records are demonstration, traceability (3.16) and preventive (4.13) and corrective actIons (4.14).

3 A record can be written or stored on any data medium.

3.16 traceability

ability to trace the history, application or location of an entity (1.11 by means of recorded identifications

NOTES

1 The term ·traceabillty· may have one of three main meanings:

al in a product (1.4) sense, It may relate to

- the origin of materials and parts,

- the product processing history,

- the distribution and location of the product after delivery;

b) In a calibration sense, it relates measuring equipment to national or International standards, primary standards, basic physical constants or properties, or reference materials;

NOTES

1 Un enreglstrem.nt quallt6 (2.1) fournlt des preuves tangibles (2.19) de l'l\tendue de la satisfaction des exlgences pour la quallti 12.3) (par exemple, enregistrement qua lit' d'un prodult (1.4)) ou de l'efficaclt6 du fonctlonnement d'un '16ment du syst.me quallti (3.6) (par exemple, enregistrement relatlf au syst.me quallt6).

2 Parmi les objecUfs des enreglstrements quallt6 figurent la dl\monstratlon, la tra9ablllt6 (3.16) et les actions prbentlves (4.13) et correctives (4.14).

3 Un enregistrement peut Atre 6crlt ou conserv' sur un support de donn6es quelconque.

3.16 tra~abilit'

aptitude it retrouver I'historique, I'utilisation ou la localisation d'une entite (1.11 au moyen d'identifications enregistn!es

NOTES

1 Le terme ICtra9abllltlt" peut iHre utilis6 dans trois accept ions principalas:

al lorsqu'i! se rapporte b un prodult (1.4), Ie terme peut se rMerer b

ISO·.8402: 1994(E/F fR)

nPiliMEYAHHR

1 npOToKon K8'4eCT8a (2.1) npeaoeraanaer 061oeKTM8Hoe nOK8UTena.· CT80 (2.19) CTeneHH .blnonHeHHR TPe6oa8HMH K U'4eCT8Y (2.3) [HanpHMep, npOTOKon Ka"eCT8a npoAYKllMM (1.4» MnM caMaeTenbCTao 'ctlrJ>eKTHBHOCTH pa60Tb' OTaenbHoro ,neMeHTa CMCTeMbl u"eCT8a (3.6) (HanpMMep, npoToKon CMCTeMb' Ka"eCT8a).

2 UenRMM npoToKono8 K8"eCT88, B "aCTHOCTH, RBnAIOTCA nOJlTBepQeHMe, npocne)KM8aeMOCTIt (3.16), npeRynpeQalO",Me (4.13) H KOppeICTMPYIO",Me aeHCT8MR (4.14).

3 npOTOKO" MOllteT 6brrb a nHCb.MeHHOM aMJle MnH 8 rJ>opMe MHrJ>OPMaU~H, xpaHAllIeUlcA B 6nOKe n.MATH ::tOM.

"/ I

. /,' .

3.16 npocne)IClIIBaeMOCTIo

cnocoeaccrs npocnenars npeQblCTOPllllO, IIIcnonb30saHllle IIInlll MeCTOHaXo)KQeHllle o61oeKT8 (1.1) C nOMoutblO IIIneHTIIIQlIIIKaUIIIIII, KOTOpaR peracrpapyercs

nPHMEYAHHR

, TepMHH ·npoCne)KMBaeMoCTb· MOlIteT 6blTb ~cnonb30BaH a oaHoM "'3 Tpex OCHOBHblX !lHa"eHMUI:

a) no oTHoweHMIO K npoRYKllMM (1.4) OH MOllteT onpenenars:

,

- I'orlgine des materlaux et des - npOMCXOlltaeHMe MaTepHanoB M

pil!ces, KOMnneKTyIOIlIHx,

- I'hlstorlque des processus (1.2) appliques au prodult,

- la distribution et I'emplacement du prodult apres Iivralson;

b) lorsqu'Il se rapporte It 1'6talonnage, II s'appllque au raccordement des equipements de mesure aux iltalons natlonaux ou internationaux, aux I\talons prlmalres, aux constantes et proprilltes physiques de base ou mat6rlaux de reference;

38

- npeablCTopHIO npOH3BoaCTaa npoayKll .... ,

- pacnpeaeneHMe H MeCTOHaxOqeHille npoRYKll~M nocne nOCTaBKH;

6) npH KanH6poBKe - YCTaHoBneHHe CB"J~ MelltDY MJMep~TenbHbiM o60pyaoaaHHeM M HaUMOHanbHblMH ~nM MellCllYHapoJ1Hbl.MH CTaHJ1apTaMH, nepBH"HbIMM CTaHaapTaMM, OCHOBHblMH rJ>H3~"ecKMM KOHCTaHTaMH HnH CBoliICTaaMM, ",nH !lTanOHHbIMH MaTep",a-, .:> naMH;

21

ISO 8402:1994(E/F/R)

c) in a data-collection sense, it relates calculations and data generated throughout the quality loop (4.1) sometimes back to the requirements for quality (2.3) for an entity.

2 All aspects of traceability requirements, if any, should be clearly specified, for example, In terms of periods of time, point of origin or identification.

1

22

c)lorsqu'iI se rapporte a la collecte de donnees, II relie les calculs et les donnees generas tout au long de la boucle de I. qualit' (4.1), en remontant partois aux exlgences pour I. quallta (2.3) pour une entite.

2 II convient que tous les aspects concernant les 'ventuelles exigences de tra9abillt' solent clairement specifies, par exemple en termes de periode couverte, point d'origine ou identification.

39

OISO

B) npH e60pe llaHHb'X - YCTaHoBneHHe eB"3e~ Me>KllY B"'~HcneHH"MH H llaHHb'MH no Bee~ nerne Ka'4eCTBa (4.1), _ a HHorlla H MellCllY nepscHa~an"Hb'MH Tpe6oBaHM"MM K Ka'4eCTBY (2.3) OC5loeKTa.

2 Bee aeneKTb' Tpe60BaHH~ K npocne.MBaeMOCTM 1l0mKHb' 6bITb ~eTKO YCTaHOBl1eHb', HanpHMep, no nepaollaM BpeMeHH, MeCTY npOHCXO>KlleHH" HI1 ... "'lleHTM~"'Kau .......

e iso

Section 4:

Terms related to tools and techniques

4.1

quality loop

conceptual model of interacting activities that influence quality (2.1) at the various stages ranging from the Identification of needs to the assessment of whether these needs have been satisfied

NOTE - The quality spiral Is a similar concept.

4.2

quality-related costs

those costs incurred in ensuring and assuring satisfactory quality (2.1), as well as the losses incurred when satisfactory quality is not achieved

NOTES

1 Quality-related costs are classified within an organization (1.7) according to its own criteria.

2 Some losses might be difficult to quantify but can be very significant, such as loss of goodwUI.

4.3

quality losses

losses caused by not realizing the potential of resources in processes (1.2) and activities

Section 4:

Termes relatifs aux outlls et aux techniques

4.1

boucle de la qualita

modele conceptuel des activites tnterdependantes qui influent sur la quallta (2.1 I lors des differentes phases s'echelonnant de I'identification des besolns 8 I'evaluation de leur satisfaction

NOTE - La splrale de la qua lit' est un concept slmilalre.

4.2

cout relatifs it la qualita

couts occasionnes pour rendre sure une qua lite (2.1) satisfaisante et en donner la confiance, ainsi que pertes subies lorsque la qua lite satisfaisante n'est pas obtenue

NOTES

1 Les coOts relatlfs • la quallta sont dMinis au seln d'un organlsme (1.7) selon des crltbres qui lui sont propres.

2 Certaines pertes sont difficilement quantifiables, mals peuvent ~tre d'une grande Importance, teiles que la perte de clientele.

4.3

pertes relatives it la quallta pertes occasionnees par la non mise en oeuvre du potentiel des movens dans des processus (1.2) et des activites

40

ISO 8402:1994(E/F/R)

.... acrs 4:

TepMMHbl, OTHOCS11J4MeCR K cpeACTBaM M MeTOAaM

4.1

neTnR Ka'teCTBa

KOHuenTYanbHaA MOllenb 83aMMO- 3aBMCMMbiX BMIlOB lleATenbHocTM, 8nMAIOlllMX Ha Ka'feCTBO (2.1) Ha pa3nM'fHblX CTallMAX OT on peneneHMA nOTpe6HocTei:1 110 oueHKM MX YlloBneTBopeHMA

np~ME4AHI.1E - CnMpan~ Ka'feCTBa '"~nfteTC" aHanOrM'fHblM nOHftmeM.

4.2

3aTpaTbl. CBR3aHHbie C Ka'teCTBOM

3aTpaTbl, B03HMKalOUU1e npM 06e(ne'feHMM H rapaHTHpoBaHHH YIlOBneTBopHTenbHoro Ka'feCTBct (2.1), a TalOKe CBA3aHHbie C nOTepAMH, xorna He 1l0CTMrHYTO YIlOBneTBopHTenbHoe K8'feCTBO

np~MElJAH~R

1 3aTpaT~I, CB"3aHHble C Ka'feCTBOM, K11aCCM~It1ult1pyIOTCR BH}'TPlt1 opraHM,aUMM (1.7) cornaCHO ee co6CTBeHHbiM KpMTepMftM.

2 HeKoTopble norepa MOlKHO C TPYnOM onpenenMTb Kon"''feCTSeHHO, HO OHM MOryT 6~IT" O'feHb CYl1leCTBeH' HbIMM, H8npMMep. TaKMe, K8K nOTep" npeCTMlKa c:t>MPMbl.

4.3

nOTepM Ka'teCTBa

nore PH, Bbl3BaHHbie He peanasaUHeM nOTeHUHanbHblX B03MO)l(HOCTeM peCYPCOB B npoueccax (1.2) MB xone lleRTenbHOCTM

23

t

J

I

J

ISO 8402:1994(E/F/R)

NOTE - Some examples of quality losses are the loss of customer (1.9) satisfaction, loss of opportunity to add more value to the customer, the organization (1.7) or society, as well as waste of resources and materials.

4.4

model for quality assurance

standardized or selected set of quality system (3.6) requirements combined to satisfy the quality assurance (3.5) needs of a given situation

4.5

degree of demonstration extent to which evidence is produced to provide confidence that specified requirements are fulfilled

NOTES

1 The degree of demonstration may range from an affirmation of existence to furnishing detailed documents and objective evidence (2.19) of fulfilment.

2 The extent depends on criteria such as economics, complexity, innovation, safety (2.8) and environ-mental considerations.

4.6

quality evaluation

systematic examination of the extent to wh ich an entity (1.1) is capable of fulfilling specified requirements

NOTES

1 A quality evaluation may be used to determine supplier (1.10) quality (2.1) capability. In this case, depending on specific circumstances, the result of quality evaluation may be used for quall-

24

NOTE - Comme exemples de pertes relatives a la qualita figurent la perte de la satisfaction du client (1.9), la perte de I'occasion d'accroitre la valeur ajouMe au benefice du client, de I'organlsme (1.7) ou de la societe. ainsi que Ie gaspillage de moyens et de biens.

4.4

modele pour I'assurance de la qualite

ensemble normalise ou selectlonne d'elements de systeme qualite (3.6) associes pour satisfaire les besoins d'assurance de la qualita (3.6) dans une situation donnee

4.5

degre de demonstration etendue de la preuve fournie pour donner confiance en ce que les exigences specifitles sont satisfaites

NOTES

1 Le degre de demonstration peut aller d'une affirmation d'.existence. a la fourniture de documents detailles et de preuves tangibles (2.19) de cette satisfaction.

2 L'etendue depend de criteres tels qu'aspect economlque. cornplexite, innovation. sacurlte (2.8) et considerations relatives a I'environnement.

4.6

evaluation qualita

examen systematique en vue de determiner dans quelle mesure une entita (1.1) est capable de satisfaire aux exigences specifiees

NOTES

1 Une evaluation qualltit peut servlr a determiner la capaclte d'un fournlsseur (1.10) en matiere de quante (2.1). Dans ce cas. en fonction des conditions particulieres. Ie resultat d'une evaluation qualitit

41

elsa

npVlMEYAHVlE - np"'MepaM'" nereps Ka'feCTBa "BnAIOTCA yrpara ynosneTBopeHHoCT1ll nOTpe6l11Tem, (1.9). noTepA B03MO)KHOCT'" $1onOnH"'TentoHO yaen"''f'''Tto CTO"'MOCTb nOTpe6111TenlO, opraHIII3a" .. M (1.7) IIInlll o6l1leCTay. a TalOlCe pacrO'fIllTenbHoe IIIcnonb30aaH",e pecypcoa '" MaTep",an08.

4.4

MOAen .. AnJl o6eCne"leHMJI Ka"leCTBa

cTaHtlapTM30aaHHblH Mmll M36paHHblH Ha60p Tpe60saHII'IH C ... CTeMbl Ka'feCTBa (3.6), 06benll'lHeHHbix C uenblO ynosneTsopeHIIIR norpee-

HOCTeH o6ecne ... eH A Ka ... ecrsa

(3.5) s naHHoH clI'ITYau 1I'I

4.5

CTeneH .. nOATBep*AeHMJI

sen ......... Ha noxaaarenscraa, 06ecne ... liIsalOLUaR ysepeHHocTb s TOM, 4TO YCTaHosneHHble Tpe60saHII'IA SblnOnHl'llOTCA

npVlMEYAHVlR

1 CTeneHto nORTBep>KAeHM" MO)KeT lCone6aTto'" a npeaenax OT 3aAaneH"''' o Hanlll'f"'" $10 npe$10CTaaneH"''' aeTanbHOH .QoICYMeHTau",,,, III 06"eKTMBHoro AOK83aTentoCTaa (2.19) BbinOnHeH"'A.

2 Ben"''''''Ha nOJlTaep>K.QeH"''' 3aa"'CIilT OT TaKIII)( Kp"'Tep"'ea. KaK lKOHOM"'Ka, cnO)KHOCTb. Hoa"'3Ha. 6e30nacHoCTb (2.8) '" co06pa)KeH"'A lKonor",,,,.

4.6

OlCeHKa Ka"leCTBa

c ... CTeMaT ...... eCKal'l npoeepxa, HaCKonbKO o61oeKT (1.1) cnocoeea SbanOnHI'ITb YCTaHoBneHHble rpe- 60saHIIIR

npVlMEYAHVlR

1 O"eHKa Ka'fecr8a MO)KeT npowaaO$1"'TbCII c uenblO onpeJleneH"'A a03- MO)KHOCT'" nOCTa8 ..... Ka (1.10) a 06naaM Ka'fecraa (2.1). B )TOM cny<4ae, a 3aB",c"'MOCT1ll OT KOHKpeTHblX ycn08",1ii. pe3ynbTaT o"eHKM Ka'feCTB3 MO-

e rso

flcatlon (2.13), approval, registration, certification or accreditation purposes.

2 An additional qualifier may be used with the term "quality evaluation" depending on the scope (e.g. process (1.2), p,ersonnel, system), and timing (e.g. precontract) of the quality evaluation such as "precontract procesS quality evaluation".

3 An overall supplier (1.10) quality evaluation also may include an appraisal of financial and technical resources.

4 In English, quality evaluation Is sometimes called "quality assessment", "quality appraisal" or "qualIty survey" In specific circumstances.

4.7

quality surveillance

continual monitoring and verification (2.17) of the status of an entity (1.1) and analysis of records (3.15) to ensure that specified requirements are being fulfilled

NOTES

1 Quality surveillance may be carried out by, or on behalf of, the customer (1.9).

2 Quality surveillance may include observing and monitoring controls which can prevent the deterioration or degradation of an entity (e.g. a process (1.2)) with time.

3 "Continual" may mean either constant or frequent.

4 In French, a quality surveillance activity carried out within the framework of a defined assignment may be called "Inspection".

peut Atre utilise dans un but de qualification (2.13), d'homologatlon, d'enreglstrement, de certification ou d'accr6dltatlon.

2 Un qualificatlf supplementalre peut litre employe avec Ie terme ..ivaluatlon quallt'" sulvant Ie domaine d'appilcatlon lpar exemple, processus (1.2', personnes, sysUtme) et Ie moment oc.. elle se deroule (par exemple avant Ie contrat), tel que .. evaluation quallti precontractuelle

de processus». ~

3 Un" evaluation quallt' globale d'un fournlsseur (1.10, peut egalement com prendre une estimation des ressources financleres et des moyens techniques.

4 En anglals, I"valuatlon quallt' est parfois appeJee "quality assessment .. , «quality appralsah. ou .. quality survey .. , sulvant les elr-

constances.

4.7

surveillance de la qualita supervision et verification (2.17) continues de I'etat d'une entite (1.1) et analyse des enreglstrements (3.15) afin de s'assurer que les exigences specifiees sont satisfaites

NOTES

1 La surveillance de la qua lite peut litre exercee par ou pour Ie client (1.9).

2 La surveillance de la quallti peut comprendrel'observation et la supervision des actions permettant d'eviter la deterioration ou la dl!gradation d'une entlti (par exemplo, un processus (1.2)) avec Ie temps.

3 «Contlnues» peut signifier permanentes ou frequentes.

4 En fran~als, une activite de surveillance de 18 quallti conduite dans Ie cadre d'une mission bien dennle peut Atre appel6e «Inspection".

42

ISO 8402:1994(E/F/R)

lKeT 61t1Tb Mcnonb30BaH B uenax KBanMcjJMKauMM (2.13), on06peHMA, peraCTpauMM MnM aKKpenMTaUMM.

2 C TepMMHoM "olteHKa Ka'4eCTlla" MOlKeT Mcnonb30BaTioCA nononHMTenbHblM onpenenMTenlo B .3aBMCMMOCTM OT 06naCTM neATenbHOCTM (HanpMMep, npouece (1.2), nepcoHan, cMCTeMa] 14 BpeMeHM (HanpMMep, no KOHTpaKTa) olteHKM Ka"eCTBa, TaKoM, KaK "npenKOHTpaKTH811 Ol{eHK8· Ka"eCTB8 npoueeeaw•

3 06waA OlteHKa K8'4eCTlla neeraaWMKa (1.10) MOlKeT TaKlKe BKnlO4aTb oueHKY cjlMHaHcoBblX 14 TeXHM4eCKMX peeypeoB.

4 8 aHrnMMcKoM A3blKe .. quality evaluatlon" (OlteHKa Ka4eCTBa) MHorna Ha3blBalOT "quality assessment· , .. quality appraisal- MnM .. quality survey" B KOHtcpeTHblX ycnOBMAX.

4.7

HaR30p :sa Ka'teCTBOM HenpepblBHoe Ha6moneHHe H npoBepK8 (2.17) COCTORHHR 061teKTa (1.1), a TalOKe aHanH3 npoToKonoB (3.15) C uensio ynoCToBepeHHR roro, 'fTO YCTaHoBneHHble rpefioBaHHR BblOonHRIOTCR

npl1ME4AHl1R

1 Han30p la Ka"eCTBOM MOlKeT oeyweCTBnATbCR nOTpe6MTeneM (1.9) MnH OT ero IIIMeHM.

2 Han30p 3a Ka'4eeTBOM MOlKeT BKnlO4aTb ynpaBneHMe Ha6nlOQeHMeM 14 npoBepKoM, xoropoe MOlKeT npenOTBpaTMTbM3Hoe MnM yxynweHMe Ka4eCTBa 061>eKTa (HanpMMep, npoueeea (1.2» eo BpeMeHeM.

3 CnOBO .. continuous" ( .. HenpepblBHblM -) MOlKeT 0603Ha4aTb nOCTOAHHblM MnM .. aCTO nOBTopAeMbIM.

4 80 cjJpaHUY3eKoM III biKe neATenbHOCTb no HaR30py 3a Ka'4eCTBOM, oeyweCT8nAeMaA B paMKax enpeneneu- ., Horo 3anaHMA, MOlKeT 61olTio HalBaHa "Inspection" ("KOHTponeM").

25

ISO 8402:1994(E/F/R)·

4.8

hold point

point, defined in an appropriate document, beyond which an activity must not proceed without the approval of a designated organization (1.7) or authority

NOTE - The approval to proceed beyond a hold point is given usually in written form, but it may be given by any other agreed system of authorization.

4.9

quality audit

systematic and independent

examination to determine

whether quality (2.1) activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives

NOTES

1 The quality audit typically applies to, but is not limited to, a quality system (3.6) or elements thereof, to processes (1.2), to products (1.4) or to services (1.5). Such audits are often caned ·quality. system audit·, ·process quality audit", 'product quality audit' or ·servlce quality audit·.

2 Quality audits are carried out by

- staff not having direct responsibility in the areas being audited but, preferably, working in cooperation with the relevant personnel.

--,

3 One purposes of a quality audit is to evaluate the need for improvement or corrective action (4.14). An audit should not be confused with quality surveillance (4.7) or

26

4.8 pointd'arrit

point detini dans un document approprle, au-dell! duquel une activite ne doit pas se poursuivre sans I'accord d'un organlsme (1.7) ou d'une autorite designes

NOTE - L'accord pour poursuivre une activite apres un point d'arrit est donne generalement par ecrit, mals II peut egalement Aue donne par tout autre systeme d'autorisation agree.

4.9

audit qua lit'

exam en methodique et independant en vue de determiner si les activites et resultats relatifs a la qualite (2.1) satisfont aux dispositions preetablles et si ces dispositions sont mises en oeuvre de tacon effective et sont aptes a atteindre les objectifs

NOTES

1 L'audit quallt' s'applique essentiellement, mais n'est pas restreint, it un systeme quallt' (3.6) ou it des elements de celui-ci, a des processus (1.2), a des prodults (1.4) ou ill des services (1.5). De tels audits sont couramment appel8s «audit de systeme qualit'», «audit quallte de processus», "audit quallt' de prodult», "audit qua lit' de service".

2 Les audits qua lit' sont conduits par une equipe n'ayant pas de responsabillte directe dans les secteurs a auditer et de preference en cooperation avec Ie personnel de ces secteurs.

3 L'un des buts d'un audit qua lit' est d'evaluer Ie besoin d'ametioration ou d'actlon corrective (4.14). II convient de ne pas confondre I'audit avec des activites de surveillance

43

OISO·

4.8

TO .. Ka 3aAepJKKM

nYHKT, onpeneneHHblH B COOTBeTCTBYlOlQeM nOKyMeHTe, sa npenenaMH KOToporo neRTenbHoCTb He nomKHa npOnOn)l(aTbCR 6e3 caHKUHH Ha TO onpeneneHHoH epraHM3aUMM (1.7) HnH nOnHOMO'4HOrO opraHa (nHua)

npII1ME'4AHII1E - CaHKUIIIR Ha npoJlOn*eHllle JleRTenbHOCTIII 3a npeaenaMill TO'tKM J8JleP*KM 06b1'tHO JlaeTCR B nlllCbMeHHo~ q,opMe, HO TalOKe Mo*eT 6b.Tb nonytteHa III 'tepe3 ynonHOMo'teHHYIO KOMnblOTepHYIO CIIICTeMy.

4.9

npoBepKa Ka .. eCTBa cIIICTeMaTH'4eCKHH H He3aBHCHMblH aHanH3, n03BOnRIOlQHH onpenenHTb COOTBeTCTBHe neRTenbHOCTH H peaynsreroe B o6naCTH K8'teCTBa (2.1) 3annaHHpoBaHHbiM MeponpHRTHRM, a TalOKe 3<p<peKTHBHOCTb BHenpeHHR MeponpHRTHH H HX nparonaocre nOCTaBneHHblM uenfiM

npII1ME~AHII1I1

1 npOBepK8 K8'teCTBa (aYRMT) npnMeHlIeTCR B oeHOBHOM (HO He rensxo) K eMCTeMe Ka'teCTBa (3.6) IIInlll ee sneMeHTaM, TaKIIIM, KaK npoLleecbl (1.2), npOJlYKLlMII <1.4) IIInlll ycnyrM (1.5). noJl06Hb.e aYJlIIITb' 'taCTO Ha3blBalOT

HnpoBepKoM (aYRMToM) CMCTeMb.

Ka'4eCTaa·, "npoBepKoM (aYJlMToM)

Ka'4eCTBa npoLleeca', "npoBepKoM

(aYRMToM) ".'teCTa. npOJlYKLlMM',

"npoBepKoM (aYRMToM) Ka'4eCTBa ycnyrM·.

2 npoBepKM Ka'teCTBa npOBOJlRTCJI nllluaMlII, KOTopb.e He HecyT HenoCpeJlCTBeHHO~ OTBeTCTBeHHOCTIII sa npoBep"eMb.e y>4aCT.KIII. nplII )TOM *enaTenbHO B3alllMOJleiilCTBllle C nepCOHanoM npoBepReMb.X yttaCTKoB.

3 OJlHO~ M3 ueneM npoBepKM lCa'feCTBa RBnReTeR oueHKa Heo6xoJlIIIMOCTM npOBeJleH1II1I ynyttwalOWlllx IIInlll KOppelCTMpYlOwMX AeMCT.MM (4.14). CIIeJlyeT npOBOJlIIITb pa3rpaHIII'teHllle

e iso

Insp.ctlon (2.15) activities perfor· med for the purposes of process control or product acceptance.

4 Quality audits can be conducted for Internal or external purposes.

4.10

quality audit observation

statement of fact made during a quality audit (4.9), and substantiated by objective evidence (2.19)

4.11

quality auditor

person qualified (2.14) to perform quality audits (4.9)

NOTE - A quality auditor designated to manage a quality audit is called a ·Iead quality auditor·.

4.12 auditee

organization (1.7) being audited

4.13

preventive action

action taken to eliminate the causes of a potential noneenformlty (2.10), defect (2.111 or other undesirable situation in order to prevent occurrence

NOTE - The preventive actions may Involve changes. such as in procedures (1.3) and systems, to achieve quality Improvement (3.8) at any stage of the quality loop (4.11.

d. la quallt' 4.7' ou de contr61. (2.15' condultes dans Ie but de maTtrise d'un processus ou d'aceeptatlon d'un prodult.

4 Les audits qualltll peuvent Ittre conduits pour des besolns internes ou externes.

4.10

observation d'audit qualite

constat fait au cours d'un audit quante (4.9) et etaye par des preuves tangibles (2.19)

4.11

audltaur quallt6

personne quann'e (2.14) pour ef· fectuer des audits quallte (4.9'

NOTE - Un .udlteur qualitll designe pour diriger un audit quallta est appele un .responsable d'audlt quaIItll".

4.12 audite

organisme (1.7) soumis a audit

4.13

action preventive

action entre prise pour eliminer les causes d'une non-conformite (2.10), d'un defaut (2.11) et de tout autre evenement lndeslrable potentiels pour ernpecher qu'ils ne se produisent

NOTE - Les actions prllventlves peuvent nllcesslter per exemple des changements dans les procltdures (1.3' et les syst~mes. afin d'obtenlr une amlllloration de la quallti (3.8) II chacun des stades de la boucle de la quallti (4.1'.

44

ISO 8402:1994(E/F/R)

Me>KtlY aYAMToM M AeATenbHoCTb,1O no H.RJOPY J. IC .... CT.OM (4.7) MnM ICOH' TponlO (2.15), oCYlUeCT8nAeMo~ c uen .. 10 ynpaBneHMA npoueccoM MnM

npMeMKM npoRyKu..... '

4 npO.eplCM Ka .. eCT8a (aYR .. Tbl) MOryT npOBOAMTbCA AnA YAo.neT80peHMII 8HyrpeHHMX MnM .HeWHMX noTpe6HOCTe~.

4.10

HB6nlOAeHMe II XOAe npoBepKM KB'teCTBa

KOHCTaTaUMA ct>aKTa, cnenaHHaA B xone npo8epKM Ka'teCT8a (4.9) M OCHOBaHHaA Ha 06heKTMBHoM aoK838TenloCT8e (2.19)

4.11

3KcnepT-.YAMTOP no K.'teCTBY cneu",anMCT. "'MeIOUlMjis K88nMctJMK8UMIO (2.14) n"A npoBeneHMA npoBepKM Ka'teCTa8 (4.9)

nPHME'tAHHE - 3lCcnepT·aYRMTop no Ka'4eCTBY, Ha3Ha'4eHH"I~ nnA pYKoBonCTBa np08epKO" lCa'4eCT.a, Ha3blBaeTCII H rna8H .. IM 3KcnepToM·aYRMTopOM no Ka'4eCT.Y·.

4.12

npoBep"eMa" opraH .. 3a ..... " opraHM3aUMA (1.7), rne npoasao-:"> n"'TCA npoaepxa

4.13

npeAynpeJI(AalOaqee AeiflCTBMe neHCTBMe, npennpMHAToe nnA YCTpaHeH"'A np"''4MH noreauaansHoro HeCOOTBeTCTBM" (2.10), RectJeKT8 (2.1 1) "'"'" npyroM He)J(enaTenbHoM c"'lYau",,,, C TeM, '4T06bl npenoreparars ",x B03HMKHOBeH",e

nPHME'tAHHE - 3TM npeRynpe)I(Ra· IOIQMe Re"CT8M" MOryT n08ne'4" 3a c060~ M3MeHeHMA KaK 8 MeToRMKax (1.3). TaK M 8 CMCTeMax C uenlolO nOCTMlI(eHMA ynY'4lUeHM" Ka'4eCT88"' (3.8) Ha scex !TanaX neTnM K8'4eCT8a (4.1).

27

. ",.

I

1

ISO 8402:1994(E/F/R)

y-

4.14

corrective action

action taken to eliminate the causes of an existing nonconformity (2.10), defect (2.11) or other undesirable situation in order to prevent recurrence

NOTES

1 The corrective actions may involve changes, such as in procedures (1.3) and systems, to achieve quality Improvement (3.8) at any stage of the quality loop (4.1).

2 There is a distinction between "correetlen" and ·corrective action":

- "eorrectlon" refers to repair (4.18), rework (4.19) or adjustment and relates to the disposition of an existing nonconformity (4.15);

- "eerreetlve action· relates to the elimination of the causes of a nonconformity.

4.15

disposition of nonconformity

action to be taken to deal with an existing nonconforming entity (1.1) in order to resolve the nonconformity (2.10)

NOTE - The action may take the form of, for example, correction such as repair (4.18) or rework (4.19), regrade, scrap, concession (4.17) and amendment of a document or a requirement.

4.16

production permit deviation permit

written authorization to depart from the originally specified

28

4.14

action corrective

action entreprise pour eliminer les causes d'une non-eonformlte (2,10), d'un d"aut (2.11) ou de tout autre evenement indesirable existants, pour ernpscher leur renouvellement

NOTES

1 Les actions correctives peuvent necessiter par e~emple des changements dans les procedures (1.3) et les svstemes, afin d'obtenir une amelioration de la qualite (3.8) it chacun des stades de la boucle de la quallte (4.1) •

2 II y a une difference entre «correction" et «action corrective":

- «eerrreetlen» s'applique a une reparation (4.18), une reprise (4.19) ou une mise II niveau et concerne Ie traltement d'une non·conformite (4.15) existante;

- «action eerreetlve» concerne I'elimination de la cause d'une nonconformite.

4.15

traitement d'une non-con-

formite

action a entreprendre vis-a-vis d'une entite (1.1) presentant une non-eontormlte (2.10) en vue de resoudre cette derniere

NOTE - Cene action peut rev6tir la forme, par exemple, d'une correction telle que reparation (4.18) ou reprise (4.19), d'un reclassement, d'une mise au rebut, d'une derogation (4.17), de la modification d'un document "ou d'une exigence.

4.16 derogation

(avant production)

autorisation ecrite de s'ecarter des exigences speclflees a l'ori-

45

e iso

4.14

KoppeKTlllpytotqee ReMCTBllle neHCTBl-1e, npeanpaaaroe nnR YCTpaHeHHR nplllL4l-1H cyuteCTBYIOutero HeCOOTBeTCTBlII1I (2.10), ,ae*eKTa (2.11) Hnl-1 .apyroH He}l(enaTenbHoH cl-1TYaUl-1l-1 C TeM, L4T06bl npencreparars l-1X noaropaoe B03Hl-1KHOBeHl-1e

npVlMEI.IAHL1R

1 3m KoppelCTMpylOlQMe Rel'icTBMA MOryl' nOBne'lb sa c060.:1 lo13MeHeHMR KaK B MeTORMKax (1.3), TaK M B CIilCTeMax C uenblO nOCTM)I(eHIIIR yny'lweHMR Ka'leCTBa (3.8) Ha scex sranax neTnM Ka'leCTBa (4.1).

2 CYlQeCTByeT pa3nlll'llile Me)l(l1Y "KOppeKltMeM· H .. KoppelCTMPYlOlQMM ReMCTBMeM·:

- TepMlo1H "KOppeKltlll"· IIIMeeT OTHoweHllle K peMoHTY (4.18), nepeRenKe (4.19) lo1nlo1 perynlo1poBKe III OTHOCIilTCR K YCTpaHeHlll10 IIIMelOlQeroCR HeCOOTBeTCTBIIIA (4.15);

- TepMlo1H .. KoppelCTlllpYlOutee AeMCTBMe· OTHOCIilTCR K YCTpaHeHlll10 npa- 4111H HeCOOTBeTCTBM".

4.15

YCTpaHeHllle HeCOOTBeTCTBIIIR

1

neHCTBHe, npe.anpHHHMaeMoe B OTHOWeHHl-1 HMelOUieroCR HecooT" BeTCTBYlOuterO o6heKTa (1.1> C uensio YCTpaHeHl-1R HeCOOTBeTCTBHR (2.10)

npVlMEI.IAHL1E - 3TO ne.:1CTBlile MO)l(eT 6blTb npeanplllHRTO B c:popMe, HanplilMep, TaKoliI KOppeKltllllll, KalC peMoHT (4.18) IIInlo1 nepeRenK8 (4.19), nepeaona B 60nee HIII3KYlO xareropsuo, npeBpaweHlo1R B nOM, pa3peweHMA Ha OTCTynneHMe OT Tpe60BaHMM (4.17) III BHeceHlo1A nonpasKIll B ROKYMeHT IIInM Tpe60BaHHe.

4.16

pa3peweHllle Ha npoM3BoACTBO

C oTaynneHIIIJlMM

pa3peweHllle Ha oTCTynneHllle nl-1CbMeHHoe pa3peWeHl-1e Ha Heco6nlOneHl-1e l-1CXOnHbtx YCTaHoB-

~ISO

requirements for a product (1.4) prior to its production

NOTE - A production permit is for a limited quantity or period and for a specified use.

4.17 waiver concession

written authorization to use or release a product (1.4) which does not conform to the specified requirements

NOTE - A waiver is limited to the shipment of a product that has specific nonconforming characteristics within specific deviations. for a limited time or quantity.

4.18 repair

action taken on a nonconforming product (1.4) so that it will fulfil the intended usage requirements although it may not conform to the originally specified requirements

NOTES

1 Repair is one type of disposition of a nonconforming product.

2 Repair includes remedial action taken to restore, for usage, a once conforming but now nonconforming product, for example, as part of maintenance.

gine pour un prodult (1.4) avant sa realisation

NOTE - Une telle dltrogatlon est aecordite pour une quantitlt ou une pltriode limltlte et pour une utilisation pritclse.

4.17 derogation

(apras production'

autorisation acrite d'utiliser ou de livrer un produit (1.4) non conforme aux exigences specifiees

NOTE - Une telle dltrogation est limltlte II la livraison d'un prodult qui possMe certaines caractltrlstiques non conformes comprises dans des limites prltcises, pour une quantitlt ou une periode de temps limitees.

4.18 reparation

action entreprise sur un produit (1.4) non conforme de Iaeon qu'iI satisfasse aux exigences de I'utilisation prevue, bien qu'il ne soit pas necessairernent conforme a~JX exigences specifiees a I'origine

NOTES

1 La reparation est un des modes de traitement d'un prodult non conforme.

2 La rltparatlon comprend les dispositions curatives prises pour rendre utilisable un prodult devenu non conforme aprlts avoir ete conforme antltrleurement, par exemple, au titre d'une opltration de maintenance.

46

ISO 8402:1994(E/F/R)

neHHbiX Tpe60BaHMH IlnR npoAYK~MM (1.4) AO ee M3rOTOBneHMR

npl-1MEYAHl-1E - Pa3peweHMe Ha npOMJBORCTBO C oTCTynneHMJlMM npMMeHlleTCli Mil orpaHIII ... eHHoro KonM"eCTBa npoaYKlWIM MnM nepMoaa apeMeHIII, a TalOlCe orpaHIII"IIIBaeTc" c~epo .. IIIC"OnbIOBaHlilli.

4.17

pa:JpeweHMe Ha OTKnOHeHMe

nMCbMeHHoe paspeureuae Ha MCnonb30BaHMe MnM BblnycK npoAyK~M" (1.4), KOTopaR He cooraercTByeT YCTaHOBneHHbiM Tpe60BaHMRM

npl-1MEYAHl-1E - PalpeweHMe Ha OTKnoHeHMe pacnpoCTpaHAeTCR Ha napTMIO npoRyK~MM, KOTopaR MMeeT KOHKpeTHbie HecooTBeTCTBYIOWMe xapaKTepMCTIIIKIII B npeaenax enpeneneHHbiX OTKnOHeHlllliI, Ha orpaHIII"eHHbliit nepllloa BpeMeHIII IIInlll Ha orpaHIII"eHHoe Konlll"eCTBo.

4.18

peMoHT

lleHCTBMe, npennpaaaroe B OTHOweHMH HeCOOTBeTCTBYlOllleH npoIlYK~MH (1.4) C TeM, 'fT06bl OHa

ynoaneraopana 3anaHHbiM 3KC-

nnyaTaUMoHHbiM Tpe60BaHMRM,

XOTR MO>KeT He COOTBeTCTBOBaTb McxonUbiM YCTaUOBneHHbiM rpe- 60BaHMRM

npII'IMElfAHl-1R

1 PeMoHT ABltAeTCA OaHIIIM 1113 BlllaoB YCTpaHeHHA HecoOTBeTCTBYlOweiit "POAYK,,-MM.

2 PeMOHT BKnIO ... aer aelilCTBllle no HcnpaBneHMIO, npeanpMHRToe anA BOCCTaHOBneHIIIA C ,,-enblO IIIC"OnbIOBaHM" OaHa>Kabl COOTBeTCTBoB8Bweiit, HO ce ..... ac He COOTBeTCTBYlOwe" npoRYK~MM, T.e. RBnAeTCR "aCTblO TeXHIII,,'eCKoro 06cnY>KIIIB8HIII" III peMOHT8.

29

ISO 8402:1994(E/F/R)

4.19 rework

action taken on a nonconforming product (1.4) so that it will fulfil the specified requirements

NOTE - Rework is one type of disposition of a nonconforming product.

j

I

I

I

j

30

4.19 reprise

action entreprise sur un produit ('.41 non conforme de. fatyon qu'it satisfasse aux exigences speciflees

NOTE - La reprise est un des modes de traltement d'un produit non conforme.

47

else

4.19 nepeRenKa

neHCTBHe, npennpaaaroe B OTHOweHHH HecooTBeTCTBYlOl1IeH npoRyKUMM (1.4) C TeM, 'fTo6bl OHa ynoBneTBopRna MCXORHblM ycraHOBneHHblMTpe6oBaHHRM.

nPIIIME\fAHIilE - nepeRenKa "B""eT'" onHMM M3 BMnOB YCTpaHeHMII HecoOTBeTCTBYlOwelil npORYK",MM.

OISO

Annex A (informative)

Bibliography

ISO 3534-1:1993, Statistics - Vocabulary and symbols - Part 1:

Probability and general statistical terms.

ISO 3534-2:1993, Statistics - Vocabulary and general symbols ...;_ Part 2: Statistical quality control.

ISO 3534-3:1985, Statistics - Vocabulary and general symbols - Part 3: Design of experiments.

ISO/IEC Guide 2:1991, General terms and definitions concerning standardization and related activities.

IEC 50(191):1990, International Electro tech n ica I Vocabulary - Chapter 191: Dependability and quality of service.

ISO 9000:1987, Quality management and quality assurance standards - Guidelines for selection and use.

ISO 9000-1:19941" Quality management and quality assurance standards - Part 1: Guidelines fOI selection and use.

11 To be published. (Revision of ISO 9000:1987)

Annex A (informative)

Bibliographie

ISO 3534-1-:1993: Statistique - Vocabulaire et symboles - Partie 1: Probabi/ite et termes stetistiques gentjraux.

ISO 3534-2:1993, Statistique - Vocabulaire et symboles - Partie 2: Maitrise statistique de la qua lite.

ISO 3534-3:1985, Statistique - Vocabulaire et symboles - Partie 3: Plans d'experience.

Guide ISO/CEI 2:1991, Termes genereux et leurs definitions concernant la normalisation et les ectivite« connexes.

CEI50(191):1990, Vocabulaire electrotechnique international - Chapitre 191: Surete de tonetionnement et qualire de service.

ISO 9000:1987, Normes pour la gestion de la qualire et I'assurance de la qualite - Lignes directrices pour la selection et t'utilisetion.

ISO 9000-1:199411, Normes POUI Ie management de la qua lite et I'assurance de la qua lite - Partie 1: Lignes directrices pour leur selection et I'utllisation.

1) A publler.

(Revision de 1'150 9000:1987)

48

ISO.8402:1994(E/F/R)

npMnO>KeHMe A (L4HcfJopMan1BHoe)

ISO 3534-1:1993, Statistics - Vocabulary and symbols - Part 1:

Probability and general statistical terms.

ISO 3534-2:1993, Statistics - Vocabulary and general symbols - Part 2: Statistical quality control.

-'.1

ISO 3534-3:1985, Statistics - Vocabulary and general symbols - Part 3: Design of experiments.

PyKOBOQCTBO &t1COIM3K 2:1991, 06- w"'e TepM"'Hbl '" ",x onpeneneH"'1f B o6nsCT'" cTsHnspT"'3sLI"''''. '" CMe)l(HblX B"'nOB nelfTenbHOCT"'.

M3K 50(191):1990, Me)l(JlYHaponHblH JneKTpOTeXH"''1eCK'''" cnoBSPb - "'acTb 191: HSne)l(HOCTb '" Ka'leCTBO ycnyr"'.

ISO 9000:1987, Quality management and quality assurance standards - Guidelines for selection and use.

ISO 9000-1:199411, Quality man'agement and quality assurance standards - Part 1: Guidelines fOI selection and use.

1) 6yneT ony6nMKoBaH. (nepecMoTp &t1CO 9000:1987)

31

ISO 8402:1994(E/F/R)

ISO 9000-2:1993, Quality management and quality assurance standards - Part 2: Generic guidelines for the application of ISO 9007, ISO 9002 and ISO 9003.

ISO 9000-3:1991, Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software.

ISO 9000-4:1993, Quality management and quality assurance standards - Part 4: Guide to dependability programme management.

ISO 9001:19942', Quality systems - Model for quality assurance in design, development, production, instal/ation and servicing.

ISO 9002:19943', Quality systems - Model for quality assurance in production, installation and servicing.

ISO 9003:19944', Quality systems - Model for quality assurance in final inspection and test.

ISO 9004:1981, Quality management and quality system elements - Guidelines.

ISO 9004-1:199451, Quality management and quality system elements - Part 1: Guidelines.

2) To be published. (Revision of ISO 9001:1987)

3) To be published. (Revision of ISO 9002:1987)

4) To be published. (Revision of ISO 9003:1987)

5, To be published. (Revision of ISO 9004:1987)

32

ISO 9000-2:1993, Normes pour Ie management de la qua lite et I'assurance de la qua lite - Partie 2: Lignes directrices pour I'application de 1'1509001, 1'1509002 et 1'150 9003.

ISO 9000-3:1991, Normes pour la gestion de la qua lite et I'assurance de la qua lite - Partie 3: Lignes directrices pour I'application de "ISO 9001 au developpement, a la mise a disposition et a la maintenance du logiciel.

ISO 9000-4:1993, Normes pour le management de la qua lite et I'assurance de la qualite - Partie 4: Guide de gestion du programme de surete de Ionctionnement.

ISO 9001:199421, Systemes qualite - Modele pour I'assurance de la qua lite en conception, developpement, production, installation et services associes.

ISO 9002:199431, Systemes qua lite - Modele pour I'assurance de la qua lite en production, installation et services associes.

ISO 9003:1994"', Systemes qua lite - Modele pour I'assurance de la qualite en controt« et essais finals.

ISO 9004:1981, Gestion de la qualite et eJements de systeme qualite - Lignes directrices.

ISO 9004-1:199451, de la qualite et svstem« qua lite Lignes directrices.

Management elements de Partie 1:

2) A publler.

(R~vision de 1'150 9001:1987)

3) A publler.

(Revision de 1'150 9002:1987)

4) A publier.

(R~vlsion de 1'150 9003:1987)

5) A publler.

(R6vislon de 1'150 9004:1987)

49

e iso

ISO 9000-2:1993, Quality management and quality assurance standards - Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003.

ISO 9000-3:1991, Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001 to the development,. supply and mein-: tenance of software.

ISO 9000-4:1993, Quality management and quality assurance standards - Part 4: Guide to dependability programme management.

ISO 9001:199421, Quality systems - Model for quality assurance in design, development, production, installation and servicing.

ISO 9002:199431, Quality systems - Model for quality assurance in production, instal/ation and servicing.

ISO 9003:199441, Quality systems - Model for quality assurance in final inspection and test.

ISO 9004:1981, Quality management and quality system elements - Guidelines.

ISO 9004-1:199451, Quality management and quality system elements - Part 1: Guidelines.

2) 6YAeT ony6nMKoB8H. (nepecMoTp Ii1CO 9001:1987)

3) 6YAeT ony6nMKo •• H. (nepecMoTP Ii1CO 9002:1987)

4) 6YAeT ony6nMK08aH. (nepecMoTp Ii1CO 9003:1987,

5) 6YAeT ony6nMKoB8H. (nepecMOTP Ii1CO 9004:1987)

e rso

ISO 9004-2:1991, Quality management and quality system elements - Part 2: Guidelines for services.

ISO 9004-3:1993, Quality management and quality system elements - Part 3: Guidelines for processed materials.

ISO 9004-4:1993, Quality management and quality system elements - Part 4: Guidelines for quality improvement.

ISO 10011-1:1990, Guidelines for auditing quality systems ~ Part 1:

Auditing.

ISO 10011-2:1991, Guidelines for auditing quality systems - Part 2:

Qualification criteria for quality systems auditors.

ISO 10011-3:1991, Guidelines for auditing quality systems

Part 3: Management of audit programmes.

ISO 10012-1:1992, Qualityassurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment.

ISO 9004-2:1991, Gestion de la qualite et elements de systeme qualite - Partie 2: Lignes directrices pour les services.

ISO 9004-3:1993, Management de la qua lite et elements de systeme qua lite - Partie 3: Lignes directrices pour les produ;ts iss us de processus IJ caractere continuo

ISO 9004-4:1993, Management de. la qual/te et elements de systeme qualite - Partie~: Lignes directrices pour t'emetioretion de la quaUte.

ISO 10011-1:1990, Lignes directrices pour I'audit des svstemes qualite - Partie 1: Audit.

ISO 10011-2:1991, Lignes directrices pour I'audit des svstemes qualite - Partie 2.: Criteres de qualification pour les auditeurs de systemes qualite.

ISO 10011-3:1991, Lignes directrices pour l'eudlt des systemes qualite - Partie 3: Gestion des programmes d'audit.

ISO 10012-1:1992, Exigences d'assurance de la qualite des equipements de mesure - Partie 1:

Confirmation metrologique de I'equipement de mesure.

50

ISO ,8402:1994(E/F/R)·

ISO 9004-2:1991, Quality management and quality system elements - Part 2: Guidelines for services.

ISO 9004-3:1993, Quality management and quality system elements - Part 3: Guidelines for processed materials.

ISO 9004-4:1993, Quality manage'ment and quality system elements -'- Part 4: Guidelines for quality improvement.

ISO 10011-1:1990, Guidelines for auditing quality systems - Part 1:

Auditing.

ISO 10011-2:1991, Guidelines for auditing quality systems - Part 2:

Qualification criteria for quality systems auditors.

ISO 10011-3:1991, Guidelines for auditing quality systems

~art 3: Management of audit programmes.

ISO 10012-1:1992, Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment.

33

ISO 8402:1994(E/F/R)

A

action, corrective 4.14

action, preventive 4.13 appraisal, quality 4.6 assessment, quality 4.6 assurance, model for quality 4.4 assurance, quality 3.5

audit, process quality 4.9

audit, product quality 4.9

audit, quality 4.9

audit, quality system 4.9 audit, service quality 4.9 auditee 4.12

auditor, lead quality 4.11 auditor, quality 4.11

B

business first party 1.12 business second party 1.11

c

company-wide quality control 3.7 compatibility 2.6

concession 4.17

conformity 2.9

contract review 3.10

contractor 1.12

control, company-wide quality 3.7 control, quality 3.4

control, total quality 3.7 correction 4.14

corrective action 4.14

costs, quality-related 4.2 customer 1.9

cwac 3.7

o

defect 2.11

degree of demonstration 4.5 delivery, service 1.6 demonstration, degree of 4.5 dependability 2.5

design review 3.11

deviation permit 4.16

disposition of nonconformity 4.15

34

Alphabetical index

E

entity 1.1

evaluation, quality 4.6 evidence, objective 2.19

G

grade 2.2

H

hold point 4.8

improvement, quality 3.8 Inspection 2.15 inspection, self- 2.16 interchangeability 2.7 item 1.1

l

lead quality auditor 4.11 liability. product 2.12 loop, quality 4.1

losses, quality 4.3

M

management, quality 3.2 management, total quality 3.7 management review. 3.9 manual, quality 3.12

model for quality assurance 4.4

N

nonconformity 2.10 nonconformity, disposition of 4.15

51

10 ISO

o

objective evidence 2.19 observation, quality audit 4.10 organization 1.7 organizational structure 1.8

p

party, business first 1.12 party, business second 1.11 permit, deviation 4.16 permit, production 4.16 plan, quality 3.13

plan, quality assurance 3.13 planning. quality 3.3

point, hold 4.8

policy, quality 3.1 preventive action 4.13 procedure 1.3

process 1.2

process, qualification 2.13 process quality audit 4.9 process quality evaluation 4.6 product 1.4

product liability 2.12 product quality audit 4.9 production permit 4.16 purchaser 1.11

a

qualification 2.13 qualification process 2.13 qualified 2.14

quality 2.1

quality appraisal 4.6 quality assessment 4.6 quality assurance 3.5

quality assurance manual 3.12 quality assurance, model for 4.4 quality assurance plan 3.13 quality audit 4.9

quality audit, process 4.9 quality audit, product 4.9 quality audit, service 4.9

elsa

quality audit observation 4.10 quality auditor 4.11

quality auditor, lead 4.11 quality control 3.4

quality control, company-wide 3.7 quality control, total 3.7

quality evaluation 4.6

quality Improvement 3.8

quality loop 4.1

quality losses 4.3

quality management 3.2

quality management manual 3.12 quality management plan 3.13 quality management, total 3.7 quality manual 3.12

quality plan 3.13

quality planning 3.3

quality policy 3.1

quality record 3.15 quality-related costs 4.2

quality, requirements for 2.3 quality surveillance 4.7

quality survey 4.6

quality spiral 4.1

quality system 3.6

quality system record 3.15 quality, total 3.7

ISO 8402:1994(E/F/R)

R

survey, quality 4.6 system, quality 3.6

record 3.15 repair 4.18

requirements for quality 2.3 requirements of society 2.4 review, contract 3.10 review, design 3.11

review. management 3.9 rework 4.19

T

total quality 3.7

total quality control 3.7

total quality management 3.7 Toe 3.7

TOM 3.7

traceability 3.16

5

self-inspection 2.16 service 1.5

service delivery 1.6

service quality audit 4.9 society, requirements of 2.4 specification 3.14

spiral, quality 4.1

structure, organizational 1.8 subcontractor 1.13 subsuppller 1.13

supplier 1.10

surveillance, quality 4.7

v

validated 2.18 validation 2.18 verification 2.17 verified 2.17

w

waiver 4.17

52

35

ISO 8402:1994(E/F/R)

A

acheteur 1.11

action corrective 4.14

action preventive 4.13 amelioration de la qualite 3.8 arret, pointd' 4.8

assurance de la qualite 3.5 assurance de la quallte,

modele pour I' 4.4

assurance qua lite, manuel 3.12 audit qualite, plan 3.13

audit qualite de processus 4.9 audit qualite de produit 4.9 audit quallte de service 4.9 audit de svsterne qualite 4.9 audlte 4.12

auditeur quallte 4.11 audit qualite 4.9 audit quellte,

observation d' 4.10 audit qualite, responsable d' 4.11 autocontrOle 2.16

B

boucle de la qualite 4.1

C

classe 2.2 client 1.9

conception, revue de 3.11 conformite 2.9 contormlte, non- 2.10 contractant 1.12 contractant, sous- 1.13 contrat, revue de 3.10 contrat, titulaire du 1.12 contrOle 2.15 commandier, sous- 1.13 compatibilite 2.6 correction 4.14

coOts relatifs a la qualite 4.2 CWQC 3.7

o

defaut 2.11

degre de demonstration 4.5 demonstration, degre de 4.5 derogation

(apres production) 4.17

I

36

Index alphabetique

derogation (avant production) 4.16 direction, revue de 3.9

E

entite 1.1

enregistrement 3.15 evaluation qualite 4.6 exigences de societe 2.4 exigences pour la qualite 2.3

F

fonctionnement, sO rete de 2.5 fournisseur 1.10

inspection 4.7 interchangeabilite 2.7

M

maitrisede la qualite 3.4 management de la qua lite 3.2 management total

de la quallte 3.7

manuel assurance quallte 3.12 manuel management

de la qualite 3.12

manuel qualite 3.12

modele pour I'assurance

de la qualite 4.4

N

non-conformitl! 2.10 non-conformlte, traitement d'une 4.15

o

observation d'audit qualite 4.10 organisation 1.8

organisme 1.7

53

else

p

partie, premiere 1.12 partie, seconde 1.11

pertes relatives a la qualM 4.3 plan assurance quante 3.13 plan management de la

quallte 3.13

plan qualite 3.13 planification de la qualite 3.3 point d'arrl!t 4.8

politique quallte 3.1 premiere partie 1.12 prestation de service 1.6 preuve tangible 2.19 procede 1.2

procedure 1.3

processus 1.2

processus, audit qualite de 4.9 processus de qualification 2.13 produit 1.4

produit, audit qualite de 4.9 produit, responsabilite

du fait du 2.12

Q

qualification 2.13 qualification,

processus de 2.13 qualifie 2.14

qualite 2.1 .

quallte, amelioration de la 3.8 quallte, assurance de la 3.5 qualtte, audit .4.9

qualite, audit de svsterne 4.9 qualite, auditeur 4.11 qualitl!, boucle de la 4.1

qua lite, coOts relatifs a la 4.2 quallte, evaluation 4.6 qualite, exlgences pour la 2.3 qualitl!, maitrise de la 3.4 qua lite, management

dela 3.2

quallte, management total de la 3.7

qualite, manuel 3.12 quallte, manuel management de la 3.12

qua lite, manuel

assurance 3.12

qualite, modele pour I'assurance de la 4.4

qualite, observation

d'audlt 4.10

OISO

qualite, pertes relative 1I la 4.3 quallte, plan 3.13

qualite, plan assurance 3.13 quallte, plan management

de la 3.13

quallte, planificatlon de la 3.3 qua lite, politlque 3.1

quallt6, responsable

d'audlt 4.11

quallt', spirale de la 4.1 quallte, surveillance de la 4.7 qua lite, systllme 3.6

quallte totale 3.7

R

reparation 4.18 reprise 4.19 responsabilite du fait

du prodult 2.12 responsable audit quallt'6 4.11

revue de conception 3.11 revue de contrat 3.10 revue de direction 3.9

s

seconde partie 1.11 securlte 2.8

service 1.5

service, audit quallte de 4.9 service, prestatlon de 1.6 societe, exlgences de 2.4 sous-contractant 1.13 sous-commandler 1.13 sous-treltent 1.13 specification 3.14

splrale de la quallte 4.1

sO rete de fonctionnement 2.5 surveillance de la quallt6 4.7 svsterne quallt6 3.6

systeme qua lit', audit de 4.9

54

ISO 8402:1994(E/F/R)

T

tangible, preuve 2.19 titulalre du contral 1.12 TOe 3.7

TOM 3.7

trac;abllite 3.16 traltement d'une non-

conformite 4.15

v

validation 2.18 validite 2.18 verification 2.17 verifie 2.17

37

ISO 8402:1994(E/F/R)

A

~""Z

anMIIIHIIICTpan1SHoe ynpaBneHllle

Ka'leCTBOM 3.2 aHanlll3 KOHTpaKTa 3.10 aHan .. 3 npoeKTa 3.11 aHan .. 3 co CTOpOHb.

pYKoBonCTsa 3.9 ayn"T Ka'leCTSa 4.9

.ynlllT Ka'leCTBa ycny.... 4.9 aynlllT Ka'leCTBa nponYKuIII.. 4.9 aYDIIIT Ka'leCTSa npouecca 4.9 aYDIIIT CIIICTeMb. Ka'leCTSa 4.9

6

6e30naCHOCTb 2.8

B

r

B3a .. M03aMeHAeMOCTb 2.7 Bce06wee Ka'leCTBO 3.7 sce06wee PYKoSonCTso

Ka'leCTSOM 3.7 sceo6wee ynpasneHllle Ka'leCT80M 3.7 sTopaA erepcaa 1.11

r

rnaSHb.H 3KcnepT-aynlllTop no Ka'leCTsy 4.11 rpaaaUIIIII 2.2

II

aeHCTSllle, KoppeKTlllpYlOwee 4.14 aeHCTs .. e, npenynpelKllalOwee 4.13 neq,eKT 2.11 aOKa3aTenbCTBo,06beKTlIIsHoe 2.19

3

3aTpaTbI, call1aHHb.e c Ka'leCTaOM 4.2

38

An~aBMTHbIM YKa3aTenb

K

Ka'leCTaO 2.1 Ka'leCT80, ayalilT 4.9

Ka'leCT80 B MacwTa6ax KOMnaH .... , ynpa8neH .. e 3.7

Ka'leCTBO, Bce06wee 3.7 Ka'leCT80, ace06wee

pyKosoaCTao 3.7

Ka'leCT80, rnaBHb." 3kcnepT-aya .. Top 4.11 Ka'leCT80, Monenb anll

06eCne'leH"" 4.4

Ka'leCTBO, Han30p 3a 4.7 Ka'leCT80,06ecne'leHllle 3.5 Ka4eCTBO, o6wee PYKOBODCTBO 3.2 Ka'leCTSO, oueHKa 4.6

Ka4eCTBO, nerna 4.1

Ka4eCTBO, nnaHlilposaHllle 3.3 Ka'leCTBO, nOnlllTlilKa S o6naCTIII 3.1 Ka4eCTBO, nore pili 4.3

Ka4eCTBO, nposepea 4.9

Ka4eCTBO, nporpaMMa 3.13 Ka4eCT80 nponyKulIIlII,

OT8eTCTBeHHOCTb aa 2.12 Ka4eCTBO nponYKulIIlII, npoaepxa (aya .. T) 4.9 Ka4eCTBO npouecca, npoeepea (aya .. T) 4.9 Ka4eCTSO, pYKoBoaCTso 3.12 Ka4eCT80, pYKoBoaCTBo

no 06eCn4!'4eH"1O 3.12 Ka'leCTBO, CIIICTeMa 3.6 Ka4eCTBO, cnlllpanb 4.1 Ka'leCTBO, Tpe60BaHlilli K 2.3 Ka'leCTBO, yn)l'tweH .. e 3.8 Ka'leCTBO, ynpaBneHllle 3.4 Ka4eCTBO ycny .... , npoaepxa

(aYDIIIT) 4.9

Ka'leCTBO, 3KcnepT-aynlllTop 4.11 KBanlllq,IIIKaulilli 2.13 KBanlll«pIIIKau .. II. npouecc 2.13 KBanlll«pIIIUlilposaH 2.14

xnacc 2.2

KOHTpaKT, aHanlll) 3.10 KOHTponb 2.15

KoppeKTlllpYlOwee neHCTalile 4.14 KoppeKulilli 4.14

M

MeTonlilKa 1.3

Monen .. anll o6eCne'leHIIIII Ka4ecraa 4.4

55

elsa

H

Ha6nlOaeHllle s xoae nposepKIII

Ka4ecraa 4.10 Hane)l(HOCTb 2.5

Haa30p 3. Ka4eCT80M 4.7 HeCOOTBeTCTSlile 2.10 HeCOOTseTCTSllle, yCTpaHeHllle 4.15

o

06ecne4eHllle Ka'leCTSa 3.5 06eCne'leHllle Ka'leCTSa, Monenb anA 4.4 o6eCne'leHllle Ka'leCTBa,

PYKoBonCTBo 3.12 o6weePYKoBoDCTBO Ka4eCTBOM 3.2 oeurecree, Tpe60BaHlilA 2.4

06beKT 1.1

06beKTIIISHOe nOKa3aTenbCTBO 2.19 opraHIII3aUI/Ili 1.7 opraHIII3aullloHHaA CTpYKTYpa 1.8 OTseTCTSeHHOCTI> sa Ka'leCTBO

nponYKulII... 2.12

OTKnOHeH ... e, pa3peweHllle Ha 4.17 oTCTYnneHllle, pa3peweHllle Ha 4.16 oueHKa Ka'leCTsa 4.6

n

nepBali CTOpoHa 1.12 nepenenKa 4.19

nerna Ka'leCTSa 4.1 nnaHlllpoBaHMe Ka4eCTBa 3.3 nOnp"a'lIilK 1.12 nonTseplKlleHMe, CTeneHI> 4.5 nOKynaTenb 1.11

nonlllTMKa s 06naCTM Ka'leCTSa 3.1 nOCTaBWMK 1.10

nOTeplil Ka'leCTBa 4.3

nOTpe6111Tenl> 1.9

npenoCTasneHllle ycnYrM 1.6 npenynpe)l(JlalOwee ae~CTslile 4.13 nplilnaHMe )aKORHOH Clllnl>. 2.18 npoBepeHo 2.17

npoaepKa 2.17

npoBepKa Ka'leCTSa 4.9

npoBepKa Ka'leCTBa npoaYKulII1II 4.9 npoBepKa Ka'leCTaa npouecca 4.9 npoaepKa Ka'leCTaa ycny.... 4.9 npoaepKa CIIICTeMb. Ka'leCTSa 4.9 nposepKaKa'leCTaa,

Ha6nlOneHllle s xone 4.10 npoaeplieMali opraHlillauMli 4.12

e iso

nporpaMMa Ka'leCTBa 3.13 npollYKUHA 1.4

npoexr, aHanH3 3.11 npoH3BollCTBO C oTcrynneHIiIAMIiI,

pa3peweHlile Ha 4.16 npOene)KHBaeMOCTIt 3.16 npOTOKO" 3.15

npouecc 1.2

npouecc KBanHq,HKaUHH 2.13

p

pa3peweHHe Ha OTKnOHeHHe 4.17 pa3peweHHe Ha oTcrynneHlile 4.16 p83peweHHe Ha npoH3BollCTBO

C oTcrynneHHAMH 4.16 peMoHT 4.18

PYKOBOllCTBO Ka'leCTBOM, Bceo6wee 3.7

PYKOBOIlCTBO Ka'leCTBOM,

o6wee 3.2

PYKOBOIlCTBO no allMIiIHHCTpaTMaHoMY ynpaBneHMIO Ka'leCTBOM 3.12

PYKOBOIlCTao no Ka'leCTBY 3.12 PYKOBOIlCTBO no 06eCne'leHIilIO Ka'leCTaa 3.12

c

caMOKOHTpOnlt 2.16 CMCTeMa Ka'leCTaa 3.6 COBMeCTMMOCTIt 2.6 COOTBeTCTaMe 2.9 COpT 2.2

CnMpanlt Ka'leCTaa 4.1

CTeneHIt nOllTBepQe}4MA 4.5 CTopOHa, aTopaA 1.11

erepeue, nepaaA 1.12 CTpYKTYpa, opraHM3aUMoHHa" 1.8 cy6nollp"Il'lMK 1.13 cy6noCTaaWMK 1.13

T

TeXHM'IecK .... e yenoalilA 3.14 TO'lKa 3aJlep)KKM 4.8

56

ISO 8402:1994(E/F/R)

Tpe6oBaH " K Ka'leCTay 2.3

Tpe60aaH " o6weCTaa 2.4

v

YnY'4WeH .... e Ka'leCTBa 3.8 ynpaaneHMe Ka'leCT80M 3.4 ynpa8neHMe Ka'feCTaOM 8 MaCWTa6ax

KOMnaHMM 3.7 ynpa8neHMe Ka'feCTBOM,

Bceo6mee 3.7 yenyra 1.5

yenyra, npellOCTaBneHMe 1.6 yCTpaHeH .... e HeCOOTBeTCTBM" 4.15 yt'BepQeHMe' 2.18

yt'aep"'lleHO 2.18

3KcnepT-BYJlMTOP no KB'IeCTBY 4.11 3KcnepT-aYllMTop no Ka'leCTay, rna8Hltliit 4.11

39

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