EN ISO 9004-1:1994
(Main)Quality management and quality system elements - Part 1: Guidelines (ISO 9004-1:1994)
Quality management and quality system elements - Part 1: Guidelines (ISO 9004-1:1994)
Qualitätsmanagement und Elemente eines Qualitätsmanagementsystems - Teil 1: Leitfaden (ISO 9004-1:1994)
Management de la qualité et éléments de système qualité - Partie 1: Lignes directrices (ISO 9004-1:1994)
Vodenje kakovosti in elementi sistema kakovosti - 1. del: Smernice
General Information
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Standards Content (Sample)
SLOVENSKI SIST EN ISO 9004-1
prva izdaja
STANDARD
december 1997
Vodenje kakovosti in elementi sistema kakovosti - 1. del: Smernice
(istoveten ISO 9004-1:1994; EN ISO 9004-1:1994)
Quality management and quality system elements - Part 1: Guidelines
Gestion de la qualité et éléments de système qualité - Partie 1: Lignes
directrices
Qualitätsmanagement und Elemente eines Qualitätsmanagementsystems -
Teil 1: Leitfaden
Deskriptorji: vodenje kakovosti, program zagotavljanja kakovosti, vodenje, uporaba
Referen~na {tevilka
ICS 03.120.10 SIST EN ISO 9004-1:1997 (sl,en)
Nadaljevanje na straneh od II do III in od 2 do 64
© Standard je zalo`il in izdal Urad Republike Slovenije za standardizacijo in meroslovje pri Ministrstvu za znanost in tehnologijo.
Razmno`evanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9004-1 : 1997
UVOD
Standard SIST EN ISO 9004-1, Vodenje kakovosti in elementi sistema kakovosti - Smernice,
prva izdaja, 1997, ima status slovenskega standarda in je istoveten evropskemu standardu EN
ISO 9004-1, prva izdaja, 1994.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 9004-1:1994 je pripravil tehni~ni odbor Evropske organizacije za
standardizacijo CEN/CS F20 Zagotavljanje kakovosti, katerega sekretariat sodi pod Centralni
sekretariat CEN. Slovenski standard SIST EN ISO 9004-1:1997, prva izdaja, je prevod
evropskega standarda EN ISO 9004-1:1994. V primeru spora glede besedila slovenskega
prevoda v tem standardu je odlo~ilen izvirni evropski standard v angle{~ini. Predlog
slovensko-angle{ke izdaje standarda je pripravil tehni~ni odbor USM/TC QAS Zagotavljanje
kakovosti, njegovo delo je nadaljeval tehni~ni odbor USM/TC VZK Vodenje in zagotavljanje
kakovosti.
Ta slovenski standard je dne 1997-10-27 odobril direktor USM.
ZVEZE S STANDARDI
S prevzemom tega evropskega standarda veljajo naslednje zveze:
SIST EN ISO 8402:1997 (sl,en,de,fr) Vodenje in zagotavljanje kakovosti - Slovar
SIST ISO 9000-1:1996 (en) Standardi za vodenje in zagotavljanje kakovosti -
1. del: Smernice za izbiro in uporabo
SIST ISO 9000-2:1996 (en)Standardi za vodenje in zagotavljanje kakovosti -
2. del: Splo{ne smernice za uporabo standardov
ISO 9001, ISO 9002 in ISO 9003
SIST ISO 9000-3:1996 (en) Standardi za vodenje in zagotavljanje kakovosti -
3. del: Smernice za uporabo standarda ISO 9001 pri
razvoju, nabavi in vzdr`evanju programske opreme
SIST ISO 9000-4:1996 (en) Standardi za vodenje in zagotavljanje kakovosti -
4. del: Vodilo za vodenje programa zagotovljivosti
SIST ISO 9004-2:1997 (sl,en) Vodenje kakovosti in elementi sistema kakovosti -
2. del: Smernice za storitve
SIST ISO 9004-3:1996 (en) Vodenje kakovosti in elementi sistema kakovosti -
3. del: Smernice za predelane materiale
SIST ISO 9004-4:1996 (en) Vodenje kakovosti in elementi sistema kakovosti -
4. del: Smernice za izbolj{evanje kakovosti
SIST ISO 10005:1996 (en) Vodenje kakovosti - Smernice za plane kakovosti
SIST ISO 10007:1996 (en) Vodenje kakovosti - Smernice za vodenje konfiguracije
II
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SIST EN ISO 9004-1 : 1997
OSNOVA ZA IZDAJO STANDARDA
- Prevzem standarda EN ISO 9004-1:1994
OPOMBE
- Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v
SIST EN ISO 9004-1:1997 to pomeni “slovenski standard”.
- Uvod in nacionalni predgovor nista sestavni del standarda.
- Slovenski standard SIST EN ISO 9004-1:1997 je istoveten standardu
EN ISO 9004-1:1994 in je izdan z dovoljenjem
CEN
Rue de Stassart, 36
1050 Bruselj
Belgija
This national document is identical with EN ISO 9004-1:1994 and it is published with
the permission of
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
III
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EVROPSKI STANDARD EN ISO 9004-1:1994
EUROPEAN STANDARD
EUROPÄISCHE NORM Julij 1994
NORME EUROPÉENNE
ICS: 03.120.10
Deskriptorji: vodenje kakovosti, program zagotavljanja kakovosti, vodenje, uporaba
Slovenska izdaja
Vodenje kakovosti in elementi sistema kakovosti -
1. del: Smernice (ISO 9004-1:1994)
Quality management and Gestion de la qualité et Qualitätsmanagement und
quality system elements - éléments de système qualité - Elemente eines
Part 1: Guidelines Partie 1: Lignes directrices Qualitätsmanagementsystems -
(ISO 9004-1:1994) (ISO 9004-1:1994) Teil 1: Leitfaden
(ISO 9004-1:1994)
Ta evropski standard je dne 1994-06-20 sprejel CEN. ^lanice CEN morajo izpolnjevati dolo~ila
poslovnika CEN/CENELEC, s katerim je predpisano, da mora biti ta standard brez
kakr{nihkoli sprememb sprejet kot nacionalni standard.
Seznami najnovej{ih izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na
voljo pri Centralnem sekretariatu ali ~lanicah CEN.
Ta evropski standard obstaja v treh uradnih izdajah (angle{ki, francoski in nem{ki). Izdaje v
drugih jezikih, ki jih ~lanice CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Centralnem sekretariatu CEN, veljajo kot uradne izdaje.
^lanice CEN so nacionalne ustanove za standardizacijo Avstrije, Belgije, Danske, Finske,
Francije, Gr~ije, Irske, Islandije, Italije, Luksemburga, Nem~ije, Nizozemske, Norve{ke,
Portugalske, [panije, [vedske, [vice in Zdru`enega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardisation
Europäisches Komitee für Normung
Comité Européen de Normalisation
Centralni sekretariat: Rue de Stassart 36, B-1050 Bruselj
© 1993 Lastnice avtorskih pravic so vse dr`ave ~lanice CEN
Ref. {t. EN ISO 9004-1:1994 E
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SIST EN ISO 9004-1 : 1997
Predgovor Foreword
Ta evropski standard je pripravil tehni~ni This European Standard has been prepared
odbor ISO/TC 176 Vodenje in zagotavljanje by ISO/TC 176 “Quality management and
kakovosti Mednarodne organizacije za quality assurance” of the International
standardizacijo (ISO) in sta ga z Organization for Standardization (ISO) and
vzporednim postopkom glasovanja prevzela was adopted by ISO and CEN following a
ISO in CEN. parallel voting procedure.
Ta evropski standard zamenjuje This European Standard replaces
EN 29004:1987. EN 29004:1987.
Ta evropski standard dobi status This European Standard shall be given the
nacionalnega standarda z objavo status of a national standard, eighter by
istovetnega besedila ali z razglasitvijo, in publication of an identical text or by
sicer najpozneje do januarja 1995. endorsement, at the latest by January 1995,
Nacionalne standarde, ki so v nasprotju s and conflicting national standards shall be
tem standardom, je treba umakniti withdraw at latest by January 1995.
najpozneje do januarja 1995.
V skladu s poslovnikom CEN/CENELEC In accordance with the CEN/CENELEC
morajo uporabo tega evropskega standarda Internal Regulations, following countries are
obvezno uvesti naslednje dr`ave: Avstrija, bound to implement this European Standard:
Belgija, Danska, Finska, Francija, Gr~ija, Austria, Belgium, Denmark, Finland, France,
Islandija, Irska, Italija, Luksemburg, Nem~ija, Germany, Greece, Iceland, Ireland, Italy,
Nizozemska, Norve{ka, Portugalska, [panija, Luxemburg, Netherlands, Norway, Portugal,
[vedska, [vica in Zdru`eno kraljestvo. Spain, Sweden, Switzerland and United
Kingdom.
Opomba o prevzemu Endorsement notice
Besedilo mednarodnega standarda ISO The text of the International Standard ISO
9004-1:1994 je CEN sprejel kot evropski 9004-1:1994 has been approved by CEN as
standard brez kakr{nihkoli sprememb. a European Standard without any
modification.
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SIST EN ISO 9004-1 : 1997
VSEBINA Stran CONTENTS Page
Predgovor.4 Foreword.4
0 Uvod.6 0 Introduction.6
1 Predmet standarda.10 1 Scope.10
2 Zveze z drugimi standardi.11 2 Normative references.11
3 Definicije.11 3 Definitions.11
4 Odgovornost vodstva.13 4 Management responsibility.13
5 Elementi sistema kakovosti.15 5 Quality system elements.15
6 Obravnava sistema kakovosti 6 Financial considerations of quality
s finan~nega vidika.25 systems.25
7 Kakovost v tr`enju.28 7 Quality in marketing.28
8 Kakovost pri izdelavi specifikacij in v 8 Quality in specification and
na~rtovanju.29 design.29
9 Kakovost v nabavi.37 9 Quality in purchasing.37
10 Kakovost procesov.41 10 Quality of processes.41
11 Obvladovanje procesov.43 11 Control of processes.43
12 Overjanje proizvodov.46 12 Product verification.46
13 Obvladovanje kontrolne, merilne in 13 Control of inspection, measuring and
preskusne opreme.48 test equipment.48
14 Obvladovanje neskladnih proizvodov.50 14 Control of nonconforming product.50
15 Korektivni ukrepi.52 15 Corrective action.52
16 Poproizvodne dejavnosti.54 16 Post-production activities.54
17 Zapisi o kakovosti.56 17 Quality records.56
18 Osebje.58 18 Personnel.58
19 Varnost proizvodov .60 19 Product safety.60
20 Uporaba statisti~nih metod.61 20 Use of statistical methods.61
Dodatek Annex
A Bibliografija.63 A Bibliography.63
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SIST EN ISO 9004-1 : 1997
Predgovor Foreword
ISO (Mednarodna organizacija za ISO (the International Organization for
standardizacijo) je svetovna zveza Standardization) is a worldwide federation of
nacionalnih organov za standarde (~lanov national standards bodies (ISO member
ISO). Mednarodne standarde ponavadi bodies). The work of preparing International
pripravljajo tehni~ni odbori ISO. Vsak ~lan, Standards is normally carried out through
ki `eli sodelovati na dolo~enem podro~ju, ISO technical committees. Each member
za katero je ustanovljen tehni~ni odbor, ima body interested in a subject for which a
pravico biti zastopan v tem odboru. Pri technical committee has been established
delu sodelujejo tudi vladne in nevladne has the right to be represented on that
mednarodne organizacije, povezane z ISO. committee. International organizations,
V vseh zadevah, ki so povezane s governmental and non-governmental, in
standardizacijo na podro~ju elektrotehnike, liaison with ISO, also take part in the work.
ISO tesno sodeluje z Mednarodno ISO collaborates closely with the
elektrotehni{ko komisijo (IEC). International Electrotechnical Commission
(IEC) on all matters of electrotechnical
standardization.
Osnutki mednarodnih standardov, ki jih Draft International Standards adopted by the
sprejmejo tehni~ni odbori, se po{ljejo vsem technical committees are circulated for the
~lanicam v glasovanje. Za objavo member bodies for voting. Publication as an
mednarodnega standarda je potrebno International Standard requires approval by
pridobiti soglasje najmanj 75 odstotkov at least 75 % of the member bodies casting
~lanic, ki se udele`ijo glasovanja. a vote.
Mednarodni standard ISO 9004-1 je pripravil International Standard ISO 9004-2 was
tehni~ni odbor ISO/TC 176 Vodenje in prepared by Technical Committee ISO/TC
zagotavljanje kakovosti, pododbor SC 2, 176, Quality management and quality
Sistemi kakovosti. assurance, Subcommittee SC2 Quality
systems.
Prva izdaja ISO 9004-1 razveljavlja in The first edition of ISO 9004-1 cancels and
zamenjuje ISO 9004:1987, pripravljena pa je replaces ISO 9004:1987, and has been
bila kot rezultat pripomb na ISO 9004:1987. prepared as a result of comments received
ISO zahteva, da so vsi njihovi standardi on ISO 9004:1987. ISO requires that all its
pregledani vsakih pet let. Ko je bil ISO standards be reviewed every five years and,
9004 raz{irjen v serijo standardov, je bilo as ISO 9004 has been expanded into a
odlo~eno, da bo popravljena izdaja series of standards, it was considered that
ISO 9004 iz leta 1987 postala prvi del the revision of the 1987 edition of ISO 9004
serije, to je ISO 9004-1. should become the first part in the series,
i.e. ISO 9004-1.
Pripombe, ki jih je med pregledom sprejela Comments adopted by Working Group 12 of
delovna skupina 12, ki sodi v okvir ISO/TC 176/SC2 during the review were
ISO/TC 176/SC 2, so bile utemeljene z based on the following considerations.
naslednjimi razmi{ljanji.
a) ISO 9004 je dokument za interno a) ISO 9004 is a document for internal
uporabo v organizaciji. Ni namenjen use by an organization. It is not
kot vodilo k standardom ISO 9001, intended as guidance to ISO 9001,
ISO 9002, ISO 9003, za kar je na ISO 9002 or ISO 9003, for which ISO
voljo ISO 9000-2. 9000-2 is available.
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SIST EN ISO 9004-1 : 1997
b) Zaradi oblikovnih razlogov je bila b) For editorial reasons, the 1987
ohranjena struktura dokumenta iz leta document structure was retained in
1987 tudi v izdaji 1994. Strukture the 1994 edition. The structure of all
vseh {tirih standardov, ISO 9001, ISO four standards ISO 9001, ISO 9002,
9002, ISO 9003 in ISO 9004, bodo ISO 9003 and ISO 9004 will be
spremenjene in usklajene med seboj changed and aligned with each other
v naslednjem petletnem velikem in the next five-year major revision.
pregledu.
c) Ta izdaja je pravzaprav oblikovna c) This edition is essentially an editorial
popravljena izdaja, ki usklajuje izrazje revision to align terminology with ISO
z ISO 8402 in osvetljuje potrebo po 8402 and to reflect the need to serve
bolj{em delovanju ne le proizvajalne, better not only manufacturing but also
ampak tudi procesne in storitvene process and service industries.
industrije.
d) Ta izdaja predstavlja nekaj novej{ih d) This edition also introduces some
zamisli o splo{nem vodenju kakovosti, newer general quality management
kot na primer, da so vse aktivnosti concepts, such as that all activities
lahko obravnavane kot procesi, z can be considered as processes, with
vhodi in izhodi. input and output.
e) Ve~ji poudarek je dan planiranju in e) More emphasis has been placed on
preventivnim ukrepom, zato so planning and preventive action. For
aktivnosti, kot so ravnanje, this reason, activities such as
prepoznavanje in pakiranje, dodatno handling, identification and packaging
obravnavane v Kakovosti pri izdelavi processes are now additionally dealt
specifikacij in v na~rtovanju (8. with under Quality in specification and
poglavje), Kakovosti procesov (10. design (clause 8), Quality of
poglavje) in Obvladovanju procesov processes (clause 10) and Control of
(11. poglavje). processes (clause 11).
f) Slika 1 je obnovljena in sedaj odra`a f) Figure 1 has been updated to reflect
aktivnosti, povezane s kakovostjo v quality activities in the life cycle of a
`ivljenjskem krogu proizvoda. product.
g) Predstavljene so nove metode g) New methods for the financial
finan~nih poro~il o u~inkovitosti reporting of quality management
vodenja kakovosti. effectiveness have been introduced.
ISO 9004 sestavljajo naslednji deli pod ISO 9004 consists of the following parts,
splo{nim naslovom Vodenje kakovosti in under the general title Quality management
elementi sistema kakovosti: and quality system elements:
1. del: Smernice Part 1: Guidelines
2. del: Smernice za storitve Part 2: Guidelines for services
3. del: Smernice za predelane Part 3: Guidelines for processed
materiale materials
4. del: Smernice za izbolj{evanje Part 4: Guidelines for quality
kakovosti improvement
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SIST EN ISO 9004-1 : 1997
5. del: Smernice za plane kakovosti Part 5: Guidelines for quality plans
6. del: Smernice o zagotavljanju Part 6: Guide to quality assurance for
kakovosti za vodenje project management
projektov
7. del: Smernice za vodenje Part 7: Guidelines for configuration
konfiguracij management
8. del: Smernice za na~ela Part 8: Guidelines on quality
kakovosti in njihovo principles and their
uporabnost pri vodenju application to management
practices
Dodatek A tega dela standarda ISO 9004 je Annex A of this part of ISO 9004 is for
namenjen samo informiranju. information only.
0 Uvod 0 Introduction
0.1 Splo{no 0.1 General
Ta del standarda ISO 9004 in vsi drugi This part of ISO 9004 and all other
mednarodni standardi v skupini ISO 9000 International Standars in the ISO 9000 family
so splo{ni standardi in neodvisni od are generic and independent of any specific
kateregakoli industrijskega ali gospodarskega industry or economic sector. Collectively
sektorja. Skupaj so vodilo za vodenje they provide guidance for quality
kakovosti in modele zagotavljanja kakovosti. management and models for quality
assurance.
Mednarodni standardi skupine ISO 9000 The International Standards in the ISO 9000
opisujejo, katere elemente naj vklju~ujejo family describe what elements quality
sistemi kakovosti, ne pa, kako naj systems should encompass, but not how a
posamezna organizacija uvaja te elemente. specific organization should implement these
Zaradi razli~nih potreb organizacij ni namen element. Because the needs of organizations
teh mednarodnih standardov vsiljevati vary, it is not the purpose of these
poenotenje sistemov kakovosti. Na International Standards to enforce uniformity
na~rtovanje in uvajanje sistema kakovosti of quality systems. The design and
vplivajo posamezni cilji, proizvodi, procesi in implementation of a quality system will be
lastna praksa organizacije. influenced by the particular objectives,
products, processes and individual practices
of the organization.
Kakovost proizvodov naj bo glavna skrb A primary concern of any organization
vsake organizacije. (Glej 3.5 za definicijo should be the quality of its products. (See
“proizvoda”, ki vklju~uje tudi storitev.) 3.5 for the definition of “product” which
includes service.)
Organizacija naj, ~e ho~e biti uspe{na, In order to be successful, an organization
ponuja proizvode, ki: should offer products that:
a) izpolnjujejo dobro opredeljene potrebe, a) meet a well-defined need, use or
uporabo ali namen purpose;
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SIST EN ISO 9004-1 : 1997
b) zadovoljujejo odjemal~eva pri~akovanja b) satisfy customers’ expectations;
c) so skladni z uporabljenimi standardi c) comply with applicable standards and
in specifikacijami specifications;
d) izpolnjujejo zahteve dru`be (glej 3.3) d) comply with requirements of society
(see 3.3);
e) odra`ajo potrebe okolja e) reflect environmental needs;
f) so dostopni po konkuren~nih cenah f) are made available at competitive
prices;
g) so priskrbljeni ekonomi~no g) are provided economically.
0.2 Organizacijski cilji 0.2 Organizational goals
Organizacija, ki ho~e dose~i svoje cilje, naj In order to meet its objectives, an
zagotovi, da bodo obvladovani tehni~ni, organization should ensure that the
administrativni in ~love{ki dejavniki, ki technical, administrative and human factors
vplivajo na kakovost njenih proizvodov, pa affecting the quality of its products will be
naj bo to strojna oprema, programska under control, whether hardware, software,
oprema, predelani materiali ali storitve. Vse processed materials or services. All such
to obvladovanje naj bo usmerjeno v control should be oriented towards the
zmanj{evanje, izlo~anje in, kar je reduction, elimination and, most importantly,
najpomembnej{e, v prepre~evanje prevention of nonconformities.
neskladnosti.
Da bi dosegli cilje, zastavljene v politiki A quality system should be developed and
kakovosti organizacije, je treba razviti in implemented for the purpose of
uvesti sistem kakovosti. accomplishing the objectives set out in the
organization’s quality policy.
Pomembnost vsakega elementa (ali zahteve) Each element (or requirement) in a quality
sistema kakovosti se spreminja od enega system varies in importance from one type
tipa dejavnosti do drugega in od enega of activity to another and from one product
proizvoda do drugega. to another.
Da bi se dosegla najve~ja u~inkovitost in In order to achieve maximum effectiveness
zadovoljila pri~akovanja odjemalcev, je and to satisfy customer expectations, it is
bistveno, da je sistem kakovosti primeren essential that the quality system be
vrsti dejavnosti in proizvoda, ki ga appropriate to the type of activity and to
organizacija ponuja. the product being offered.
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SIST EN ISO 9004-1 : 1997
0.3 Izpolnjevanje potreb in pri~akovanj 0.3 Meeting customer/organization needs
odjemalca/organizacije and expectations
Sistem kakovosti ima dva med seboj A quality system has two interrelated
povezana vidika: aspects, as follows.
a) potrebe in pri~akovanja odjemalca a) The customer’s needs and
expectations
Potreba odjemalca je zaupanje v For the customer, there is a need for
sposobnost organizacije, da dobavlja confidence in the ability of the
`eleno kakovost in da jo tudi ves ~as organization to deliver the desired
vzdr`uje. quality as well as the consistent
maintenance of that quality.
b) potrebe in interesi organizacije b) The organization’s needs and interests
Poslovna potreba organizacije je, da For the organization, there is a
dose`e in vzdr`uje `eleno kakovost business need to attain and to
ob optimalnih stro{kih; izpolnjevanje maintain the desired quality at an
tega vidika je povezano s planirano optimum cost; the fulfilment of this
in u~inkovito uporabo tehnolo{kih, aspect is related to the planned and
~love{kih in materialnih virov, efficient utilization of the technological,
dostopnih organizaciji. human and material resources
available to the organization.
Oba vidika sistema kakovosti zahtevata Each of the above aspects of a quality
stvarne dokaze v obliki informacij in system requires objective evidence in the
podatkov o kakovosti sistema in kakovosti form of information and data concerning the
proizvodov organizacije. quality of the system and the quality of the
organization’s products.
0.4 Koristi, stro{ki in tveganje 0.4 Benefits, costs and risks
Upo{tevanje koristi, stro{kov in tveganja je Benefit, cost and risk considerations have
zelo pomembno tako za organizacijo kot za great importance for both the organization
odjemalca in nelo~ljivo spremlja najve~je and customer. These considerations are
{tevilo proizvodov. Mo`ni u~inki in inherent aspects of most products. The
razvejenost teh obravnav so dani v to~kah possible effects and ramifications of these
od a) do c): considerations are given in a) to c).
a) upo{tevanje koristi a) Benefit considerations
Za odjemalca je treba upo{tevati For the customer, consideration has to
zmanj{evanje stro{kov, izbolj{anje be given to reduced costs, improved
primernosti za uporabo, pove~anje fitness to use, increased satisfaction
zadovoljstva in zaupanja. and growth in confidence.
Za organizacijo je treba upo{tevati For the organization, consideration has
pove~anje donosnosti in tr`nega to be given to increased profitability
dele`a. and market share.
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SIST EN ISO 9004-1 : 1997
b) upo{tevanje stro{kov b) Cost considerations
Za odjemalca je treba upo{tevati For the customer, consideration has to
varnost, stro{ke nabave, delovanja, be given to safety, acquisition cost,
vzdr`evanja, zastojev in popravil ter operating, maintenance, downtime and
morebitne stro{ke odstranitve. repair costs, and possible disposal
costs.
Za organizacijo je treba upo{tevati For the organization, consideration has
stro{ke, ki izvirajo iz pomanjkljivosti to be given to costs due to marketing
pri tr`enju in na~rtovanju, vklju~no s and design deficiencies, including
stro{ki zaradi neustreznih proizvodov, unsatisfactory product, rework, repair,
predelav, popravil, zamenjav, ponovnih replacement, reprocessing, loss of
obdelav, izgube proizvodnje, jamstva production, warranties and field repair.
in popravil na terenu.
c) upo{tevanje tveganja c) Risk considerations
Za odjemalca je treba upo{tevati For the customer, consideration has to
tveganja glede zdravja in varnosti be given to risks such as those
ljudi, nezadovoljstva s proizvodi, pertaining to the health and safety of
razpolo`ljivosti, reklamacij in izgube people, dissatisfaction with product,
zaupanja. availability, marketing claims and loss
of confidence.
Za organizacijo je treba upo{tevati For the organization, consideration has
tveganja zaradi pomanjkljivih proizvo- to be given to risks related to
dov, ki vodijo k izgubi dobrega imena deficient products which lead to loss
ali slovesa, k izgubi trga, k of image or reputation, loss of market,
prito`bam, reklamacijam, odgovornosti complaints, claims, liability and waste
za posledice in zapravljanju ~love{kih of human and financial resources.
in finan~nih virov.
0.5 Sklepi 0.5 Conclusions
U~inkovit sistem kakovosti naj bo na~rtovan An effective quality system should be
tako, da izpolni potrebe in pri~akovanja designed to satisfy customer needs and
odjemalca in hkrati varuje interese expectations while serving to protect the
organizacije. Dobro strukturiran sistem organization’s interests. A well-structured
kakovosti je koristno sredstvo vodenja pri quality system is a valuable management
optimiranju in obvladovanju kakovosti v resource in the optimization and control of
povezavi z upo{tevanjem koristi, stro{kov in quality in relation to benefit, cost and risk
tveganja. considerations.
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SIST EN ISO 9004-1 : 1997
Vodenje kakovosti in Quality management and
elementi sistema kakovosti - quality system elements -
1. del: Smernice Part 2: Guidelines
1 Predmet standarda 1 Scope
Ta del mednarodnega standarda ISO 9004 This part of ISO 9004 provides guidance on
podaja smernice za vodenje kakovosti in za quality management and quality system
elemente sistema kakovosti. elements.
Elementi sistema kakovosti so uporabni pri The quality system elements are suitable for
razvoju in izvajanju celovitega in use in the development and implementation
u~inkovitega sistema kakovosti v organizaciji, of a comprehensive and effective in-house
cilj pa je zadovoljiti odjemalca. quality system, with a view to ensuring
customer satisfaction.
Ta del mednarodnega standarda se ne This part of ISO 9004 is not intended for
uporablja v pogodbene in zakonodajne contractual, regulatory or certification use.
namene ali za certificiranje. Prav tako to ni Consequently, it is not a guideline for the
smernica za izvajanje ISO 9001, ISO 9002 implementing of ISO 9001, ISO 9002 and
in ISO 9003. V ta namen se uporablja ISO 9003. ISO 9000-2 should be used for
ISO 9000-2. that purpose.
Izbira primernih elementov standarda The selection of appropriate elements
ISO 9004 in obseg, do katerega jih contained in this part of ISO 9004 and the
organizacija prevzame in izvaja, sta odvisna extent to which these elements are adopted
od dejavnikov, kot so trg, narava proizvoda, and applied by an organization depends
proizvodni procesi in potrebe odjemalca in upon factors such as the market being
uporabnika. served, nature of the product, production
processes, and customer and consumer
needs.
Izraz “proizvod” naj se v tem delu References in this part of ISO 9004 to a
standarda ISO 9004 razlaga, kot je “product” should be interpreted as applicable
uporabljen v splo{nih kategorijah proizvodov, to the generic product categories of
kot so strojna oprema, programska oprema, hardware, software, processed materials or
predelani materiali ali storitve (v skladu z service (in accordance with the definition of
definicijo “proizvoda” v ISO 8402). “product” in ISO 8402).
Opombi: NOTES
1. Za nadaljnja navodila glej ISO 9004-2 in 1 For further guidance, see ISO 9004-2 and
ISO 9004-3. ISO 9004-3.
2. Za informacije o drugih standardih glej 2 For informative references, see annex A.
dodatek A.
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SIST EN ISO 9004-1 : 1997
2 Zveze z drugimi standardi 2 Normative references
V standardih, navedenih v nadaljevanju, so The following standards contain provisions
dana dolo~ila, ki z zvezami v tem besedilu which, through reference in this text,
tvorijo dolo~ila tega dela standarda constitute provisions of this part of
ISO 9004. V ~asu objave sta bili veljavni ISO 9004. At the time of publication, the
navedeni izdaji standardov. Vsi standardi so editions indicated were valid. All standards
predmet revizij, zato se vsem strankam, are subject to revision, and parties to
katerih dogovor temelji na tem delu agreements based on this part of ISO 9004
standarda ISO 9004, priporo~a, d
...
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