EN ISO 9000:2000
(Main)Quality management systems - Fundamentals and vocabulary (ISO 9000:2000)
Quality management systems - Fundamentals and vocabulary (ISO 9000:2000)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of ISO 8402:1994, incorporating ISO 9000-1, -2, -3 and -4 (CC/981112)
Qualitätsmanagementsysteme - Grundlagen und Begriffe (ISO 9000:2000)
Diese Internationale Norm legt die Terminologie für die in den Normen der ISO-9000-Familie beschriebenen Qualitätsmanagementsysteme fest und beschreibt die zugehörigen Grundlagen. Die Internationale Norm ist anwendbar für: a) Organisationen, die sich von der Einführung eines Qualitätsmanagementsystems Vorteile versprechen; b) Organisationen, die von ihren Lieferanten die Gewißheit haben wollen, daß ihre Produktforderungen erfüllt werden; c) die Benutzer der Produkte; d) all jene, die mit einem gemeinsamen Verständnis der im Qualitätsmanagement verwendeten Begriffe zu tun haben (z.B. Lieferanten, Kunden, usw.).
Systèmes de management de la qualité - Principes essentiels et vocabulaire (ISO 9000:2000)
Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI SIST EN ISO 9000
STANDARD
september 2004
Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2000)
(istoveten EN ISO 9000:2000)
Quality management systems – Fundamentals and vocabulary
(ISO 9000:2000)
Systèmes de management de la qualité – Principes essentiels et vocabulaire
(ISO 9000:2000)
Referenčna številka
ICS 01.040.03; 03.120.10 SIST EN ISO 9000:2004 (sl, en)
Nadaljevanje na strani II in od 2 do 57
© 2004-09. Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 9000 : 2004
NACIONALNI UVOD
Standard SIST EN ISO 9000:2004 (sl,en). Sistemi vodenja kakovosti – Osnove in slovar, ima status
slovenskega standarda in je istoveten evropskemu standardu EN ISO 9000, Quality management
systems – Fundamentals and vocabulary, 2000, ki je brez sprememb prevzet mednarodni standard ISO
9000:2000.
NACIONALNI PREDGOVOR
Mednarodni standard ISO 9000:2000 je pripravil tehnični odbor Mednarodne organizacije za
standardizacijo ISO/TC 176 Vodenje in zagotavljanje kakovosti. Slovenski standard SIST EN ISO
9000:2004 je prevod angleškega besedila evropskega standarda EN ISO 9000:2000, ki je istoveten
mednarodnemu standardu, dodan je evropski predgovor k dokumentu. V primeru spora glede besedila
slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v angleškem jeziku.
Slovensko-angleško izdajo standarda je pripravil tehnični odbor SIST/TC VZK Vodenje in
zagotavljanje kakovosti.
PREDHODNA IZDAJA
– SIST EN ISO 8402:1997
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO 9000:2000.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO 9001:2000 in je objavljen z dovoljenjem
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgija
– This national document is identical with EN ISO 9001:2000 and is published with the permission of
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
II
---------------------- Page: 2 ----------------------
EVROPSKI STANDARD EN ISO 9000:2000
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE december 2000
ICS: 03.120 10 Nadomešča EN ISO 8402:1995
Slovenska izdaja
Sistemi vodenja kakovosti - Osnove in slovar
(ISO 9000:2000)
Quality management systems Systèmes de management de Qualitätsmanagementsysteme –
– Fundamentals and la qualité – Principes Grundlagen und Begriffe
vocabulary essentiels et vocabulaire (ISO 9000:2000)
(ISO 9000:2000) (ISO 9000:2000)
Ta evropski standard je CEN sprejel dne 2000-12-15.
Članice CEN morajo izpolnjevati določila poslovnika CEN/CENELEC, s katerim je predpisano, da
mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Seznami
najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na voljo pri centralnem
sekretariatu ali članicah CEN.
Ta evropski standard obstaja v treh uradnih izdajah (nemški, angleški in francoski). Izdaje v drugih
jezikih, ki jih članice CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri centralnem
sekretariatu CEN, veljajo kot uradne izdaje.
Članice CEN so nacionalne ustanove za standardizacijo Avstrije, Belgije, Češke republike, Danske,
Finske, Francije, Grčije, Irske, Islandije, Italije, Luksemburga, Nemčije, Nizozemske, Norveške,
Portugalske, Španije, Švedske, Švice in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Europäisches Komitee für Normung
Comité Européen de Normalisation
Centralni sekretariat: Rue de Stassart 36, B-1050 Bruselj
© 2000. Lastnice avtorskih pravic so vse države članice CEN Ref. št. EN ISO 9000:2000 E
---------------------- Page: 3 ----------------------
SIST EN ISO 9000 : 2004
Predgovor
Besedilo mednarodnega standarda ISO 9000:2000 je pripravil tehnični odbor ISO/TC 176 Vodenje in
zagotavljanje kakovosti, pododbor SC1 Pojmi in izrazi, v sodelovanju Centralnim sekretariatom CEN.
Ta evropski standard nadomešča EN ISO 8402:1995.
Ta evropski standard mora dobiti status nacionalnega standarda z objavo istovetnega besedila ali z
razglasitvijo najpozneje do junija 2001, nacionalne standarde, ki so v nasprotju s tem standardom, pa
je treba umakniti najpozneje do junija 2001.
V skladu z notranjimi predpisi CEN/CENELEC morajo ta evropski standard obvezno uvesti nacionalne
organizacije za standarde naslednjih držav: Avstrije, Belgije, Češke republike, Danske, Finske,
Francije, Grčije, Irske, Islandije, Italije, Luksemburga, Nemčije, Nizozemske, Norveške, Portugalske,
Španije, Švedske, Švice in Združenega kraljestva.
Razglasitvena objava
Besedilo mednarodnega standarda ISO 9000:2000 je CEN odobril kot evropski standard brez
kakršnihkoli sprememb.
Mednarodna organizacija za standardizacijo (ISO) je svetovna zveza nacionalnih organov za
standarde (članov ISO). Mednarodne standarde ponavadi pripravljajo tehnični odbori ISO. Vsak član,
ki želi delovati na določenem področju, za katero je bil ustanovljen tehnični odbor, ima pravico biti
zastopan v tem odboru. Pri delu sodelujejo tudi vladne in nevladne mednarodne organizacije,
povezane z ISO. V vseh zadevah, ki so povezane s standardizacijo na področju elektrotehnike, ISO
tesno sodeluje z Mednarodno elektrotehniško komisijo (IEC).
Osnutki mednarodnih standardov so pripravljeni v skladu s pravili, podanimi v 3. delu Direktiv ISO/IEC.
Osnutki mednarodnih standardov, ki jih sprejmejo tehnični odbori, se pošljejo vsem članom v
glasovanje. Za objavo mednarodnega standarda je treba pridobiti soglasje najmanj 75 odstotkov
članov, ki se udeležijo glasovanja.
Opozoriti je treba na možnost, da so lahko nekateri elementi tega mednarodnega standarda predmet
patentnih pravic. ISO ne prevzema odgovornosti za identifikacijo katerihkoli ali vseh takih patentnih
pravic.
Mednarodni standard ISO 9000 je pripravil tehnični odbor ISO/TC 176 Vodenje in zagotavljanje
kakovosti, pododbor SC1 Pojmi in izrazi.
Ta druga izdaja razveljavlja in nadomešča ISO 8402:1994.
Dodatek A tega mednarodnega standarda je podan le informativno. Vsebuje pojmovne diagrame, ki
grafično prikazujejo razmerja med izrazi na specifičnih pojmovnih področjih, ki se nanašajo na sisteme
vodenja kakovosti.
2
---------------------- Page: 4 ----------------------
SIST EN ISO 9000 : 2004
Vsebina Stran Contents Page
Predgovor. 4 Foreword .4
0 Uvod . 5 0 Introduction .5
0.1 Splošno. 5 0.1 General .5
0.2 Načela vodenja kakovosti. 5 0.2 Quality management principles.5
1 Predmet standarda. 7 1 Scope .7
2 Osnove sistemov vodenja 2 Fundamentals of quality management
kakovosti . 7 systems .7
2.1 Utemeljitev sistema vodenja 2.1 Rationale for quality management
kakovosti. 7 systems .7
2.2 Zahteve za sisteme vodenja kakovosti in 2.2 Requirements for quality management
zahteve za proizvode . 8 systems and requirements for products.8
2.3 Pristop na podlagi sistemov vodenja 2.3 Quality management systems
kakovosti . 8 approach .8
2.4 Procesni pristop. 9 2.4 The process approach .9
2.5 Politika kakovosti in cilji kakovosti. 10 2.5 Quality policy and quality objectives .10
2.6 Vloga najvišjega vodstva znotraj 2.6 Role of top management within the
sistema vodenja kakovosti. 10 quality management system.10
2.7 Dokumentacija. 11 2.7 Documentation.11
2.8 Ocenjevanje sistemov vodenja 2.8 Evaluating quality management
kakovosti. 12 systems .12
2.9 Nenehno izboljševanje . 14 2.9 Continual improvement .14
2.10 Vloga statističnih metod . 14 2.10 Role of statistical techniques .14
2.11 Osredotočenost sistemov vodenja 2.11 Quality management systems and other
kakovosti in drugih sistemov vodenja. 15 management system focuses .15
2.12 Razmerje med sistemi vodenja kakovosti 2.12 Relationship between quality management
in modeli odličnosti . 15 systems and excellence models .15
3 Izrazi in definicije . 16 3 Terms and definitions.16
3.1 Izrazi v zvezi s kakovostjo. 16 3.1 Terms relating to quality.16
3.2 Izrazi v zvezi z vodenjem . 17 3.2 Terms relating to management.17
3.3 Izrazi v zvezi z organizacijo. 20 3.3 Terms relating to organization .20
3.4 Izrazi v zvezi s procesom in proizvodom. 21 3.4 Terms relating to process and product .21
3.5 Izrazi v zvezi s karakteristikami. 23 3.5 Terms relating to characteristics.23
3.6 Izrazi v zvezi s skladnostjo. 24 3.6 Terms relating to conformity .24
3.7 Izrazi v zvezi z dokumentacijo. 27 3.7 Terms relating to documentation .27
3.8 Izrazi v zvezi s preiskovanjem. 28 3.8 Terms relating to examination.28
3.9 Izrazi v zvezi s presojo . 29 3.9 Terms relating to audit .29
3.10 Izrazi v zvezi z zagotavljanjem 3.10 Terms related to quality assurance for
kakovosti za procese merjenja . 31 measurement processes .31
Dodatek A: Metodologija, uporabljena pri Annex A: Methodology used in the
razvoju slovarja . 34 development of the vocabulary .35
Bibliografija. 54 Bibliography .55
Abecedni seznam. 56 Alphabetical index.57
3
---------------------- Page: 5 ----------------------
SIST EN ISO 9000 : 2004
Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for
(ISO) je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of
standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member
ponavadi pripravljajo tehnični odbori ISO. Vsak bodies). The work of preparing International
član, ki želi delovati na določenem področju, za Standards is normally carried out through ISO
katero je bil ustanovljen tehnični odbor, ima technical committees. Each member body
pravico biti zastopan v tem odboru. Pri delu interested in a subject for which a technical
sodelujejo tudi vladne in nevladne mednarodne committee has been established has the right to
organizacije, povezane z ISO. V vseh zadevah, be represented on that committee. International
ki so povezane s standardizacijo na področju organizations, governmental and non-
elektrotehnike, ISO tesno sodeluje z governmental, in liaison with ISO, also take part
Mednarodno elektrotehniško komisijo (IEC). in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC)
on all matters of electrotechnical
standardization.
Osnutki mednarodnih standardov so pripravljeni International Standards are drafted in
v skladu s pravili, podanimi v 3. delu Direktiv accordance with the rules given in the ISO/IEC
ISO/IEC. Directives, Part 3.
Osnutki mednarodnih standardov, ki jih Draft International Standards adopted by the
sprejmejo tehnični odbori, se pošljejo vsem technical committees are circulated to the
članom v glasovanje. Za objavo mednarodnega member bodies for voting. Publication as an
standarda je treba pridobiti soglasje najmanj 75 International Standard requires approval by at
odstotkov članov, ki se udeležijo glasovanja. least 75 % of the member bodies casting a
vote.
Opozoriti je treba na možnost, da so lahko Attention is drawn to the possibility that some of
nekateri elementi tega mednarodnega standarda the elements of this International Standard may
predmet patentnih pravic. ISO ne prevzema be the subject of patent rights. ISO shall not be
odgovornosti za identifikacijo katerihkoli ali vseh held responsible for identifying any or all such
takih patentnih pravic. patent rights.
Mednarodni standard ISO 9000 je pripravil International Standard ISO 9000 was prepared
tehnični odbor ISO/TC 176 Vodenje in by Technical Committee ISO/TC 176, Quality
zagotavljanje kakovosti, pododbor SC1 Pojmi in management and quality assurance,
izrazi. Subcommittee SC 1, Concepts and terminology.
Ta druga izdaja ISO 9000 razveljavlja in This second edition cancels and replaces ISO
nadomešča ISO 8402:1994. 8402:1994.
Dodatek A tega mednarodnega standarda je Annex A of this International Standard is for
podan samo informartivno. Vsebuje pojmovne information only. It includes concept diagrams
diagrame, ki grafično prikazujejo razmerja med that provide a graphical representation of the
izrazi na specifičnih pojmovnih področjih, ki se relationships between terms in specific concept
nanašajo na sisteme vodenja kakovosti. fields relative to quality management systems.
4
---------------------- Page: 6 ----------------------
SIST EN ISO 9000 : 2004
Uvod Introduction
0.1 Splošno 0.1 General
V nadaljevanju našteta družina standardov ISO The ISO 9000 family of standards listed below
9000 je bila razvita z namenom, da pomaga has been developed to assist organizations, of
organizacijam vseh vrst in velikosti pri vzpostavitvi all types and sizes, to implement and operate
in izvajanju uspešnih sistemov vodenja kakovosti. effective quality management systems.
— ISO 9000 opisuje osnove sistemov vodenja — ISO 9000 describes fundamentals of quality
kakovosti in specificira izraze za sisteme management systems and specifies the
vodenja kakovosti. terminology for quality management systems.
— ISO 9001 specificira zahteve za sisteme — ISO 9001 specifies requirements for a
vodenja kakovosti v primerih, ko mora quality management system where an
organizacija dokazati svojo sposobnost, da organization needs to demonstrate its
dobavlja proizvode, ki izpolnjujejo zahteve ability to provide products that fulfil
odjemalcev in zahteve ustrezne regulative, customer and applicable regulatory
in ko si organizacija prizadeva za večje requirements and aims to enhance
zadovoljstvo odjemalcev. customer satisfaction.
— ISO 9004 podaja smernice, ki se nanašajo — ISO 9004 provides guidelines that consider
tako na uspešnost kot učinkovitost sistema both the effectiveness and efficiency of the
vodenja kakovosti. Namen tega standarda quality management system. The aim of this
je izboljševanje delovanja organizacije ter standard is improvement of the performance
zadovoljstva odjemalcev in drugih of the organization and satisfaction of
zainteresiranih strani. customers and other interested parties.
— ISO 19011 provides guidance on auditing
— ISO 19011 podaja napotke za presojanje
quality and environmental management
sistemov vodenja kakovosti in sistemov
systems.
ravnanja z okoljem.
Skupno tvorijo skladno celoto standardov za Together they form a coherent set of quality
sistem vodenja kakovosti, ki omogoča in management system standards facilitating
podpira medsebojno razumevanje v nacionalni mutual understanding in national and
in mednarodni trgovini. international trade.
0.2 Načela vodenja kakovosti 0.2 Quality management principles
Za uspešno vodenje in delovanje je treba To lead and operate an organization successfully,
organizacijo usmerjati in obvladovati na it is necessary to direct and control it in a
sistematičen in pregleden način. Uspeh je lahko systematic and transparent manner. Success can
rezultat uvedbe in vzdrževanja sistema result from implementing and maintaining a
vodenja, zasnovanega tako, da nenehno management system that is designed to conti-
izboljšuje delovanje ob upoštevanju potreb vseh nually improve performance while addressing the
zainteresiranih strani. Vodenje organizacije needs of all interested parties. Managing an
obsega med drugimi področji vodenja tudi organization encompasses quality management
vodenje kakovosti. amongst other management disciplines.
Identificiranih je bilo osem načel vodenja Eight quality management principles have been
kakovosti, ki jih lahko uporablja najvišje vodstvo identified that can be used by top management
zato, da vodi organizacijo k izboljšanemu in order to lead the organization towards
delovanju. improved performance.
a) Osredotočenost na odjemalce a) Customer focus
Organizacije so odvisne od svojih odjemalcev, Organizations depend on their customers and
zato naj razumejo njihove trenutne in prihodnje therefore should understand current and future
potrebe, izpolnjujejo njihove zahteve in si customer needs, should meet customer require-
prizadevajo preseči njihova pričakovanja. ments and strive to exceed customer expectations.
5
---------------------- Page: 7 ----------------------
SIST EN ISO 9000 : 2004
b) Voditeljstvo b) Leadership
Vodje vzpostavijo enotnost namena in usmeritve Leaders establish unity of purpose and direction
organizacije. Ustvarijo in vzdržujejo naj notranje of the organization. They should create and
okolje, v katerem se lahko zaposleni popolnoma maintain the internal environment in which
vključijo v doseganje ciljev organizacije. people can become fully involved in achieving
the organization's objectives.
c) Vključenost zaposlenih c) Involvement of people
Zaposleni na vseh ravneh so jedro organizacije People at all levels are the essence of an
in njihova popolna vključenost omogoča, da se organization and their full involvement enables
njihove sposobnosti uporabijo v korist their abilities to be used for the organization's
organizacije. benefit.
d) Procesni pristop d) Process approach
Želeni rezultat se doseže uspešneje, kadar se A desired result is achieved more efficiently
aktivnosti in z njimi povezani viri vodijo kot when activities and related resources are
proces. managed as a process.
e) Sistemski pristop k vodenju e) System approach to management
Identificiranje, razumevanje in vodenje Identifying, understanding and managing
medsebojno povezanih procesov kot sistem interrelated processes as a system contributes
prispevajo k uspešnosti in učinkovitosti to the organization's effectiveness and
organizacije pri doseganju njenih ciljev. efficiency in achieving its objectives.
f) Nenehno izboljševanje f) Continual improvement
Nenehno izboljševanje vsesplošnega delovanja Continual improvement of the organization's
organizacije naj bo stalen cilj organizacije. overall performance should be a permanent
objective of the organization.
g) Odločanje na podlagi dejstev g) Factual approach to decision making
Učinkovite odločitve temeljijo na analizi Effective decisions are based on the analysis of
podatkov in informacij. data and information.
h) Vzajemno koristni odnosi z dobavitelji h) Mutually beneficial supplier relationships
Organizacija in njeni dobavitelji so medsebojno An organization and its suppliers are
odvisni in vzajemno koristen odnos povečuje interdependent and a mutually beneficial
sposobnost obeh strani za ustvarjanje relationship enhances the ability of both to
vrednosti. create value.
Teh osem načel vodenja kakovosti tvori These eight quality management principles
podlago za standarde sistemov vodenja form the basis for the quality management
kakovosti znotraj družine standardov ISO 9000. system standards within the ISO 9000 family.
6
---------------------- Page: 8 ----------------------
SIST EN ISO 9000 : 2004
Sistemi vodenja kakovosti – Quality management systems –
Osnove in slovar Fundamentals and vocabulary
1 Predmet standarda 1 Scope
Mednarodni standard ISO 9000 opisuje temelje This International Standard describes
sistemov vodenja kakovosti, ki so predmet fundamentals of quality management systems,
družine ISO 9000, in opredeljuje izraze v zvezi which form the subject of the ISO 9000 family,
s tem. and defines related terms.
Ta mednarodni standard lahko uporabljajo: This International Standard is applicable to the
following:
a) organizacije, ki si z uvedbo sistema vodenja a) organizations seeking advantage through the
kakovosti prizadevajo za napredek; implementation of a quality management
system;
b) organizacije, ki želijo zaupati svojim b) organizations seeking confidence from their
dobaviteljem, da bodo njihove zahteve za suppliers that their product requirements will
proizvode izpolnjene; be satisfied;
c) uporabniki proizvodov; c) users of the products;
d) tisti, ki se morajo med seboj sporazumeti o d) those concerned with a mutual
izrazih, ki se uporabljajo pri vodenju understanding of the terminology used in
kakovosti (npr. dobavitelji, odjemalci, quality management (e.g. suppliers,
zakonodajalci); customers, regulators);
e) tisti znotraj ali izven organizacije, ki e) those internal or external to the organization
ocenjujejo sistem vodenja kakovosti ali who assess the quality management system
presojajo njegovo skladnost z zahtevami or audit it for conformity with the requirements
ISO 9001 (npr. presojevalci, zakonodajalci, of ISO 9001 (e.g. auditors, regulators,
certifikacijski oziroma registracijski organi); certification/registration bodies);
f) tisti znotraj ali zunaj organizacije, ki f) those internal or external to the organization
svetujejo ali usposabljajo za sistem vodenja who give advice or training on the quality
kakovosti, primernega za organizacijo; management system appropriate to that
organization;
g) razvijalci sorodnih standardov. g) developers of related standards.
2 Temelji sistemov vodenja kakovosti 2 Fundamentals of quality management
systems
2.1 Utemeljitev sistemov vodenja kakovosti 2.1 Rationale for quality management systems
Sistemi vodenja kakovosti lahko pomagajo Quality management systems can assist
organizacijam pri povečevanju zadovoljstva organizations in enhancing customer
odjemalcev. satisfaction.
Odjemalci zahtevajo proizvode s Customers require products with characteristics
karakteristikami, ki zadovoljujejo njihove that satisfy their needs and expectations. These
potrebe in pričakovanja. Te potrebe in needs and expectations are expressed in
pričakovanja so izraženi v specifikacijah product specifications and collectively referred
proizvodov in jih skupno imenujemo zahteve to as customer requirements. Customer
odjemalcev. Zahteve odjemalcev lahko določi requirements may be specified contractually by
odjemalec v pogodbi, lahko pa jih določi the customer or may be determined by the
organizacija sama. V vsakem primeru je organization itself. In either case, the customer
odjemalec tisti, ki dokončno odloči o ultimately determines the acceptability of the
sprejemljivosti proizvoda. Zaradi spreminjanja product. Because customer needs and
potreb in pričakovanj odjemalcev ter zaradi expectations are changing, and because of
7
---------------------- Page: 9 ----------------------
SIST EN ISO 9000 : 2004
pritiska konkurence in tehničnega napredka so competitive pressures and technical advances,
organizacije prisiljene, da nenehno izboljšujejo organizations are driven to improve continually
svoje proizvode in procese. their products and processes.
Sistem vodenja kakovosti spodbuja organizacije, The quality management system approach
da analizirajo zahteve odjemalcev, določijo encourages organizations to analyse customer
procese, ki prispevajo k realizaciji za odjemalca requirements, define the processes that
sprejemljivega proizvoda, in da procese contribute to the achievement of a product,
obvladujejo. Sistem vodenja kakovosti lahko which is acceptable to the customer, and keep
daje okvir za nenehno izboljševanje, s čimer se these processes under control. A quality
povečuje verjetnost večanja zadovoljstva management system can provide the framework
odjemalcev in zadovoljstva drugih zainteresiranih for continual improvement to increase the
strani. Organizaciji in njenim odjemalcem probability of enhancing customer satisfaction
omogoča zaupanje, da je organizacija sposobna and the satisfaction of other interested parties. It
zagotoviti proizvode, ki dosledno izpolnjujejo provides confidence to the organization and its
zahteve. customers that it is able to provide products that
consistently fulfil requirements.
2.2 Zahteve za sisteme vodenja kakovosti in 2.2 Requirements for quality management
zahteve za proizvode systems and requirements for products
Družina ISO 9000 razlikuje med zahtevami za The ISO 9000 family distinguishes between
sisteme vodenja kakovosti in zahtevami za requirements for quality management systems
proizvode. and requirements for products.
Zahteve za sisteme vodenja kakovosti so Requirements for quality management systems
specificirane v ISO 9001. Zahteve za sisteme are specified in ISO 9001. Requirements for
vodenja kakovosti so splošne in uporabne za quality management systems are generic and
organizacije v katerikoli industrijski ali applicable to organizations in any industry or
gospodarski panogi ne glede na kategorijo economic sector regardless of the offered
ponujenega proizvoda. ISO 9001 ne postavlja product category. ISO 9001 itself does not
zahtev za proizvode. establish requirements for products.
Zahteve za proizvode lahko določijo odjemalci ali Requirements for products can be specified by
organizacija sama ob predvidevanju zahtev customers or by the organization in anticipation of
odjemalcev ali pa regulativa. Zahteve za customer requirements, or by regulation. The
proizvode in v nekaterih primerih za pripadajoče requirements for products and in some cases
procese so lahko vsebovane na primer v associated processes can be contained in, for
tehničnih specifikacijah, standardih za proizvode, example, technical specifications, product
standardih za procese, pogodbenih dogovorih in v standards, process standards, contractual
zahtevah regulative. agreements and regulatory requirements.
2.3 Pristop na podlagi sistemov vodenja 2.3 Quality management systems approach
kakovosti
Pristop k razvoju in izvajanju sistema vodenja An approach to developing and implementing a
kakovosti sestavlja več korakov, vključno z quality management system consists of several
naslednjimi: steps including the following:
a) določitev potreb in pričakovanj odjemalcev a) determining the needs and expectations of
in drugih zainteresiranih strani; customers and other interested parties;
b) določitev politike kakovosti in ciljev b) establishing the quality policy and quality
kakovosti organizacije; objectives of the organization;
c) določitev procesov in odgovornosti, c) determining the processes and responsibili-
potrebnih za doseganje ciljev kakovosti; ties necessary to attain the quality objectives;
d) določitev in zagotovitev virov, potrebnih za d) determining and providing the resources
doseganje ciljev kakovosti; necessary to attain the quality objectives;
8
---------------------- Page: 10 ----------------------
SIST EN ISO 9000 : 2004
e) vzpostavitev metod za merjenje uspešnosti e) establishing methods to measure the
in učinkovitosti vsakega procesa; effectiveness and efficiency of each
process;
f) uporaba teh merjenj za določanje uspešnosti f) applying these measures to determine the
in učinkovitosti vsakega procesa; effectiveness and efficiency of each process;
g) določitev načinov preprečevanja neskladnosti g) determining means of preventing
in odpravljanja njihovih vzrokov; nonconformities and eliminating their causes;
h) vzpostavitev in uporaba procesa za h) establishing and applying a process for
nenehno izboljševanje sistema vodenja continual improvement of the quality
kakovosti. management system.
Podoben pristop je možno uporabiti pri Such an approach is also applicable to
vzdrževanju in izboljševanju obstoječega maintaining and improving an existing quality
sistema vodenja kakovosti. management system.
Organizacija, ki prevzame gornji pristop, ustvari An organization that adopts the above
zaupanje v sposobnost svojih procesov in approach creates confidence in the capability of
kakovost svojih proizvodov ter zagotovi temelje its processes and the quality of its products,
za nenehno izboljševanje. To lahko vodi k and provides a basis for continual improvement.
povečanemu zadovoljstvu odjemalcev in drug
...
EUROPEAN STANDARD
DRAFT
EN ISO 9000:2000
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
June 2004
ICS
English version
Quality management systems - Fundamentals and vocabulary -
Amendment 1 (ISO 9000:2000/DAmd 1:2004)
Systèmes de management de la qualité - Principes Qualitätsmanagementsysteme - Grundlagen und Begriffe -
essentiels et vocabulaire - Amendement 1 (ISO Änderung 1 (ISO 9000:2000/DAmd 1:2004)
9000:2000/DAmd 1:2004)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/SS F20.
This draft amendment A1, if approved, will modify the European Standard EN ISO 9000:2000. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other language made
by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status
as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9000:2000/prA1:2004: E
worldwide for CEN national Members.
---------------------- Page: 1 ----------------------
EN ISO 9000:2000/prA1:2004 (E)
Foreword
This document (ISO 9000:2000/DAmd 1:2004) has been prepared by Technical Committee
ISO/TC 176 "Quality management and quality assurance", Subcommittee 1, “Concepts and
terminology”, in collaboration with the CEN Management Centre (CMC).
This document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO 9000:2000/DAmd 1:2004 has been approved by CEN as an Amendment to the
European Standard (EN ISO 9000:2000/prA1:2004) without any modifications.
(ISO) (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is
normally carried out through ISO technical committees. Each member body interested in a
subject for which a technical committee has been established has the right to be represented
on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electronical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC
Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft
International Standards adopted by the technical committees are circulated to the member
bodies for voting. Publication as an International Standard requires approval by at least 75 %
of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the
subject of patent rights. ISO shall not be held responsible for identifying any or all such patent
rights.
Amendment 1 to ISO 9000:2000 was prepared by Technical Committee ISO/TC 176, Quality
management and quality assurance, Subcommittee SC 1, Concepts and terminology.
Annex A of this International Standard is for information only. It includes concept diagrams
that provide a graphical representation of the relationships between terms in specific fields
relative to quality management systems.
2
---------------------- Page: 2 ----------------------
DRAFT AMENDMENT ISO 9000:2000/DAmd 1
ISO/TC 176/SC 1 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2004-06-24 2004-11-24
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Quality management systems — Fundamentals and vocabulary
AMENDMENT 1
Systèmes de management de la qualité — Principes essentiels et vocabulaire
AMENDEMENT 1
ICS 01.040.03; 03.120.10
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2004
---------------------- Page: 3 ----------------------
ISO 9000:2000/DAmd 1
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's
member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
©
ii ISO 2004 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 9000:2000/DAM 1
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Fundamentals of quality management systems. 1
2.1 Rationale for quality management systems . 1
2.2 Requirements for quality management systems and requirements for products. 1
2.3 Quality management systems approach. 1
2.4 The process approach. 1
2.5 Quality policy and quality objectives. 1
2.6 Role of top management within the quality management system . 1
2.7 Documentation. 1
2.7.1 Value of the documentation. 1
2.7.2 Types of document used in quality management systems. 1
2.8 Evaluating quality management systems . 2
2.8.1 Evaluating processes within the quality management system . 2
2.8.2 Auditing the quality management system . 2
2.8.3 Reviewing the quality management system . 2
2.8.4 Self-assessment. 2
2.9 Continual improvement. 2
2.10 Role of the statistical techniques. 2
2.11 Quality management systems and other management system focuses. 2
2.12 Relationship between quality management systems and excellence models. 2
3 Terms and definitions. 2
3.1 Terms relating to quality . 2
3.2 Term relating to management . 3
3.3 Terms relating to organization . 3
3.4 Terms relating to process and product. 3
3.5 Terms relating to characteristics . 3
3.6 Terms relating to conformity . 3
3.7 Terms relating to documentation. 4
3.8 Term relating to examination. 4
3.9 Terms relating to audit . 4
3.10 Terms relating to quality assurance for measurement processes. 6
Annex A (informative) Methodology used in the development of the vocabulary . 7
A.1 Introduction. 7
A.2 Content of a vocabulary entry and the substitution rule. 7
A.3 Concept relationships and their graphical representation . 7
A.3.1 General. 7
A.3.2 Generic relation. 7
A.3.3 Partitive relation. 7
A.3.4 Associative relation. 7
A.4 Concepts diagrams. 7
Bibliography . 15
Alphabetical index . 17
© ISO 2004 – All rights reserved iii
---------------------- Page: 5 ----------------------
ISO 9000:2000/DAM 1
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to ISO 9000:2000 was prepared by Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 1, Concepts and terminology.
Annexe A of this International standard is for information only. It includes concept diagrams that provide a
graphical representation of the relationships between terms in specific fields relative to quality management
systems.
iv © ISO 2004 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 9000:2000/DAM 1
Introduction
No change
© ISO 2004 – All rights reserved v
---------------------- Page: 7 ----------------------
DRAFT AMENDMENT ISO 9000:2000/DAM 1
Quality management systems — Fundamentals and
vocabulary — Amendment 1
1 Scope
No change
2 Fundamentals of qualit
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.