EN 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

• Status: Not Published
• Publication Date: 14-Dec-2000
• Withdrawal Date: 14-Sep-2005
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• Technical Committee: CEN/SS F20 - Quality assurance
• Drafting Committee: CEN/SS F20 - Quality assurance
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Sep-2005
• Completion Date: 15-Sep-2005
• Ref Project: SIST EN ISO 9000:2004 - Quality management systems - Fundamentals and vocabulary (ISO 9000:2000)

Relations

• Replaces: EN ISO 9000-1:1994 - Quality management and quality assurance standards - Part 1: Guidelines for selection and use (ISO 9000-1:1994)
• Effective Date: 22-Dec-2008
• Replaces: EN ISO 8402:1995 - Quality management and quality assurance - Vocabulary (ISO 8402:1994)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary (ISO 9000:2005)
• Effective Date: 22-Dec-2008

Overview

The EN ISO 9000:2000 standard, titled Quality management systems - Fundamentals and vocabulary, is a key European and international standard developed by CEN and ISO respectively. It acts as the foundational document for understanding quality management systems (QMS), outlining essential principles, terminology, and definitions critical to effective quality assurance and management processes. This standard revision consolidates previous versions, incorporating ISO 8402:1994 and ISO 9000-1 through -4, providing updated vocabulary and fundamental concepts essential for organizations adopting or maintaining quality management systems.

This standard serves as a cornerstone for organizations seeking to establish, maintain, or improve their quality management processes, ensuring a harmonized and professional approach aligned with global best practices.

Key Topics

• Fundamentals of Quality Management Systems
  The standard explains the rationale behind QMS, emphasizing developing systems focused on customer satisfaction and product quality. It defines the relationship between quality system requirements and product requirements, promoting a process approach and continual improvement.

• Quality Management Vocabulary
  EN ISO 9000:2000 provides detailed and precise definitions of terms related to quality, management, organizations, processes, products, conformity, documentation, audit, and measurement. This shared vocabulary ensures consistent understanding across industries and countries.

• Process Approach & Documentation
  The process approach is a central principle outlined, where organizations manage activities as interconnected processes, increasing efficiency and control. The document highlights types of documentation used within QMS and their value in maintaining system integrity.

• Evaluating QMS
  The standard describes methods for evaluating QMS effectiveness including process evaluations, auditing procedures, management reviews, and self-assessments.

• Role of Top Management
  It details leadership responsibilities in establishing quality policies and objectives, underscoring management’s role in the success of quality systems.

• Continual Improvement and Statistical Techniques
  Continuous improvement is a required focus, supported by statistical tools to measure, analyze, and enhance quality performance.

• Alignment with Other Management Systems and Models
  The standard discusses how QMS integrates with other management system focuses and excellence models, promoting compatibility and comprehensive organizational management.

Applications

This standard is invaluable for:

• Quality Management Professionals and Consultants
  Implementing or auditing quality management systems with a common framework and terminology.

• Organizations Seeking Certification
  Aligning their practices with widely recognized concepts and vocabulary to comply with ISO 9001 and related standards.

• Training and Education
  Providing foundational knowledge for training quality management teams and stakeholders.

• Regulatory Bodies and Industry Associations
  Ensuring harmonized use of quality terms for regulatory compliance and industry-standard development.

• Multinational Corporations
  Facilitating consistent quality management practices across diverse geographic locations by using a common language.

Related Standards

• ISO 9001:2000 - Quality management systems - Requirements
  Builds upon the fundamentals defined in ISO 9000, specifying detailed requirements for implementing a QMS.

• ISO 19011 - Guidelines for auditing management systems
  Related to auditing practices within quality management systems, complementing vocabulary and processes described in ISO 9000.

• ISO/IEC 17024 - Conformity assessment - General requirements for bodies operating certification of persons
  Shares terminology related to competence and certification referenced in ISO 9000.

• ISO 8402:1994 - Quality management and quality assurance - Vocabulary
  The predecessor standard, revised and integrated into ISO 9000:2000.

• Quality Excellence Models
  Such as EFQM (European Foundation for Quality Management), which align with the principles outlined in ISO 9000 to promote organizational excellence.

Summary

EN ISO 9000:2000 provides a comprehensive framework of fundamental concepts and vocabulary essential for establishing quality management systems across all sectors. It supports organizations in achieving consistent quality practices, facilitating audits, and fostering continuous improvement with a global perspective. Utilizing this standard ensures clarity, enhances communication among stakeholders, and integrates quality management seamlessly into organizational operations. This positions EN ISO 9000:2000 as an essential reference for professionals focused on quality, compliance, and operational excellence worldwide.

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.

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
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

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.
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
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.

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.
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.

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
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;
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 drugih This can lead to increased satisfaction of
zainteresiranih strani ter k uspehu organizacije. customers and other interested parties and to
the success of the organization.
2.4 Procesni pristop 2.4 The process approach
Vsako aktivnost ali skupek aktivnosti, ki Any activity, or set of activities, that uses
uporablja vire za pretvorbo vhodov v izhode, resources to transform inputs to outputs can be
lahko obravnavamo kot proces. considered as a process.
Organizacija mora identificirati in obvladovati For organizations to function effectively, they
številne medsebojno povezane in vzajemno have to identify and manage numerous
vplivajoče procese, da bi delovala učinkovito. interrelated and interacting processes. Often,
Izhod enega procesa pogosto tvori neposredni the output from one process will directly form
vhod v naslednji proces. Sistematično the input into the next process. The systematic
identifikacijo in obvladovanje procesov, identification and management of the processes
uporabljenih znotraj organizacije, in posebej employed within an organization and
medsebojnih vplivov med takimi procesi lahko particularly the interaction between such
imenujemo “procesni pristop”. processes is referred to as the “process
approach”.
Namen tega mednarodnega standarda je The intent of this International Standard is to
spodbujati privzem procesnega pristopa za encourage the adoption of the process
vodenje organizacije. approach to manage an organization.
Slika 1 prikazuje procesno utemeljen sistem Figure 1 illustrates the process-based quality
vodenja kakovosti, opisan v družini standardov management system described in the ISO 9000
ISO 9000. Ta prikaz kaže, da zainteresirane family of standards. This illustration shows that
strani igrajo pomembno vlogo pri opredelitvi interested parties play a significant role in
vhodov za organizacijo. Spremljanje providing inputs to the organization. Monitoring
zadovoljstva zainteresiranih strani terja the satisfaction of interested parties requires
vrednotenje informacij o tem, kako the evaluation of information relating to the
zainteresirane strani dojemajo, v kakšnem perception of interested parties as to the extent
obsegu so bile izpolnjene njihove potrebe in to which their needs and expectations have
pričakovanja. Model na sliki 1 ne prikazuje been met. The model shown in Figure 1 does
procesov na ravni podrobnega prikaza. not show processes at a detailed level.
SIST EN ISO 9000 : 2004
Nenehno izboljševanje Conti nual impr ovem ent of
Nenehno izboljševanje Conti nual impr ovem ent of
sistema vodenja kakovosti
the quality management system
sistema vodenja kakovosti the quality management s ystem
Cust om ers
Odjemalci Cust om ers
Odjemalci
Odgov ornost
Management
(and other
(in druge Odgov ornost (in druge (and other Management
vodstva responsibility
vodstv a
inter est ed responsibility inter est ed
zainteresirane zainteresirane
parti es)
strani) strani) parties)
Merjenje, Measur em ent,
Merjenje,
Res ource Measur em ent,
Vodenje v irov analize in analy sis and
Zadovoljstvo Res ource
analy sis and Satisfaction
Vodenje v irov analize in managem ent
izboljšev anje management impr ov em ent
impr ov em ent
izboljšev anje
Vhod Izhod
Input Product Output
Realizacija
Realizacija Requirements Product
Zahteve Proizvod Product
proizv oda realiz ation
proizv oda realiz ation
Legenda Key
Aktivnosti, ki dodajajo vrednost Value-adding activities

Pretok informacij Information flow
OPOMBA: Besedilo v oklepaju se ne nanaša na ISO 9001. NOTE Statements in parentheses do not apply to ISO 9001.
Slika 1: Model, osnovan na procesih sistema vodenja Figure 1 - Model of a process-based quality
kakovosti management system
2.5 Politika kakovosti in cilji kakovosti 2.5 Quality policy and quality objectives
Politika kakovosti in cilji kakovosti se postavljajo Quality policy and quality objectives are
zato, da se ustvari žarišče, ki usmerja established to provide a focus to direct the
organizacijo. Oboje določa želene rezultate in organization. Both determine the desired results
pomaga organizaciji uporabiti njene vire za and assist the organization to apply its
doseganje teh rezultatov. Politika kakovosti resources to achieve these results. The quality
daje okvir za določitev in pregledovanje ciljev policy provides a framework for establishing
kakovosti. Cilji kakovosti morajo biti skladni s and reviewing quality objectives. The quality
politiko kakovosti in zavezanostjo nenehnemu objectives need to be consistent with the quality
izboljševanju. Doseganje ciljev kakovosti mora policy and the commitment to continual
biti merljivo. Doseganje ciljev kakovosti lahko improvement, and their achievement needs to
pozitivno vpliva na kakovost proizvodov, be measurable. The achievement of quality
uspešnost delovanja in finančne učinke ter s objectives can have a positive impact on
tem na zadovoljstvo in zaupanje zainteresiranih product quality, operational effectiveness and
strani. financial performance and thus on the
satisfaction and confidence of interested parties.
2.6 Vloga najvišjega vodstva znotraj  2.6 Role of top management within the
sistema vodenja kakovosti quality management system
Z voditeljstvom in ukrepi lahko najvišje vodstvo Through leadership and actions, top
ustvari okolje, v katerem so zaposleni management can create an environment where
popolnoma vključeni in v katerem lahko sistem people are fully involved and in which a quality
vodenja kakovosti učinkovito deluje. Načela management system can operate effectively.
vodenja kakovosti (glej 0.2) lahko najvišje The quality management principles (see 0.2)
vodstvo uporabi kot podlago za svojo vlogo, ki can be used by top management as the basis
je naslednja: of its role, which is as follows:
a) določiti in vzdrževati politiko kakovosti in a) to establish and maintain the quality policy
cilje kakovosti organizacije; and quality objectives of the organization;
b) propagirati politiko kakovosti in cilje b) to promote the quality policy and quality
kakovosti v celotni organizaciji, da bi se objectives throughout the organization to in-
povečale zavest, motivacija in vključenost; crease awareness, motivation and involvement;
c) v celotni organizaciji zagotoviti osredotočenost c) to ensure focus on customer requirements
na zahteve odjemalcev; throughout the organization;
SIST EN ISO 9000 : 2004
d) zagotoviti, da se izvajajo ustrezni procesi, ki d) to ensure that appropriate processes are
omogočajo izpolnjevanje zahtev odjemalcev implemented to enable requirements of
in drugih zainteresiranih strani ter doseganje customers and other interested parties to be
ciljev kakovosti; fulfilled and quality objectives to be achieved;
e) zagotoviti, da je uspešen in učinkovit sistem e) to ensure that an effective and efficient
vodenja kakovosti vzpostavljen, da se le-ta quality management system is established,
za doseganje teh ciljev kakovosti izvaja in implemented and maintained to achieve
vzdržuje; these quality objectives;
f) zagotoviti, da so na voljo potrebni viri; f) to ensure the availability of necessary
resources;
g) periodično pregledovati sistem vodenja g) to review the quality management system
kakovosti; periodically;
h) odločati o ukrepih glede politike kakovosti in h) to decide on actions regarding the quality
ciljev kakovosti; policy and quality objectives;
i) odločati o ukrepih za izboljševanje sistema i) to decide on actions for improvement of the
vodenja kakovosti. quality management system.
2.7 Dokumentacija 2.7 Documentation
2.7.1 Pomen dokumentacije 2.7.1 Value of documentation
Dokumentacija omogoča sporočanje namena Documentation enables communication of
in konsistentnosti ukrepa. Njena uporaba intent and consistency of action. Its use
prispeva k: contributes to
a) doseganju skladnosti z zahtevami odjemalcev a) achievement of conformity to customer
in izboljševanju kakovosti; requirements and quality improvement,
b) pripravi primernega usposabljanja; b) provision of appropriate training,
c) ponovljivosti in sledljivosti; c) repeatability and traceability,
d) preskrbi objektivnih dokazov in d) provision of objective evidence, and
e) vrednotenju uspešnosti in trajne ustreznosti e) evaluation of the effectiveness and continuing
sistema vodenja kakovosti. suitability of the quality management system.
Izdelava dokumentacije naj ne bo sama sebi Generation of documentation should not be an
namen, temveč naj bo aktivnost, ki dodaja end in itself but should be a value-adding
vrednost. activity.
2.7.2 Vrste dokumentov, ki se uporabljajo v 2.7.2 Types of document used in quality
sistemu vodenja kakovosti management systems
V sistemih vodenja kakovosti se uporabljajo The following types of document are used in
naslednje vrste dokumentov: quality management systems:

a) dokumenti, ki tako navznoter kot tudi a) documents that provide consistent
navzven, podajajo konsistentne informacije information, both internally and externally,
o sistemu vodenja kakovosti organizacije; about the organization's quality management
taki dokumenti se imenujejo poslovniki system; such documents are referred to as
kakovosti; quality manuals;
b) dokumenti, ki opisujejo, kako se sistem b) documents that describe how the quality
vodenja kakovosti uporablja pri specifičnem management system is applied to a specific
SIST EN ISO 9000 : 2004
proizvodu, projektu ali pogodbi; taki product, project or contract; such documents
dokumenti se imenujejo plani kakovosti; are referred to as quality plans;
c) dokumenti, ki vsebujejo zahteve; taki c) documents stating requirements; such
dokumenti se imenujejo specifikacije; documents are referred to as specifications;
d) dokumenti, ki vsebujejo priporočila ali d) documents stating recommendations or
predloge; taki dokumenti se imenujejo suggestions; such documents are referred
smernice; to as guidelines;
e) dokumenti, ki podajajo informacije o tem, e) documents that provide information about
kako konsistentno izvajati aktivnosti in how to perform activities and processes
procese; taki dokumenti lahko vključujejo consistently; such documents can include
dokumentirane postopke, delovna navodila documented procedures, work instructions
in risbe; and drawings;
f) dokumenti, ki podajajo objektivne dokaze o f) documents that provide objective evidence
izvedenih aktivnostih ali doseženih rezultatih; of activities performed or results achieved;
taki dokumenti se imenujejo zapisi. such documents are referred to as records.
Vsaka organizacija določi obseg potrebne Each organization determines the extent of
dokumentacije in medij, ki ga bo uporabljala. To documentation required and the media to be
je odvisno od dejavnikov, kot so vrsta in velikost used. This depends on factors such as the type
organizacije, kompleksnost in medsebojno and size of the organization, the complexity and
vplivanje procesov, kompleksnost proizvodov, interaction of processes, the complexity of
zahteve odjemalcev, zahteve ustrezne products, customer requirements, the applicable
regulative, dokazane sposobnosti osebja in regulatory requirements, the demonstrated ability
obsega, v katerem je treba dokazovati of personnel, and the extent to which it is
izpolnjevanje zahtev sistema vodenja kakovosti. necessary to demonstrate fulfilment of quality
management system requirements.
2.8 Ocenjevanje sistemov vodenja kakovosti 2.8 Evaluating quality management systems
2.8.1 Ocenjevanje procesov znotraj sistema 2.8.1 Evaluating processes within the quality
vodenja kakovosti management system
Pri ocenjevanju sistemov vodenja kakovosti When evaluating quality management systems,
obstajajo štiri osnovna vprašanja o vsakem there are four basic questions that should be
procesu, ki je predmet ocene. asked in relation to every process being
evaluated.
a) Ali je proces prepoznan in primerno a) Is the process identified and appropriately
opredeljen? defined?
b) Ali so odgovornosti določene? b) Are responsibilities assigned?
c) Ali so postopki uvedeni in se vzdržujejo? c) Are the procedures implemented and
maintained?
d) Ali je proces učinkovit pri doseganju d) Is the process effective in achieving the
zahtevanih rezultatov? required results?
Skupni odgovori na zgornja vprašanja lahko The collective answers to the above questions
določijo rezultat ocenjevanja. Obseg ocenjevanja can determine the result of the evaluation.
sistema vodenja kakovosti se lahko spreminja in Evaluation of a quality management system can
lahko obsega vrsto aktivnosti, kot so presojanje vary in scope and encompass a range of
in pregledovanje sistema vodenja kakovosti ter activities, such as auditing and reviewing the
samoocenjevanje. quality management system, and self-
assessments.
SIST EN ISO 9000 : 2004
2.8.2 Presojanje sistema vodenja kakovosti 2.8.2 Auditing the quality management system
Presoje se uporabljajo za določanje obsega, v Audits are used to determine the extent to
katerem so zahteve sistema vodenja kakovosti which the quality management system
izpolnjene. Izsledki presoj se uporabljajo za requirements are fulfilled. Audit findings are
ocenjevanje uspešnosti sistema vodenja used to assess the effectiveness of the quality
kakovosti in za identificiranje možnosti za management system and to identify
izboljševanje. opportunities for improvement.
Presoje prve stranke izvaja organizacija sama First-party audits are conducted by, or on behalf
ali nekdo v njenem imenu v interne namene in of, the organization itself for internal purposes
so lahko podlaga za lastno izjavo organizacije o and can form the basis for an organization's
skladnosti. self-declaration of conformity.
Presoje druge stranke izvajajo odjemalci ali Second-party audits are conducted by
druge osebe v imenu odjemalca. customers of the organization or by other
persons on behalf of the customer.
Presoje tretje stranke izvajajo zunanje Third-party audits are conducted by external
neodvisne presojevalske organizacije. Take independent organizations. Such organizations,
organizacije, ki so ponavadi akreditirane, usually accredited, provide certification or
izstavijo certifikat ali registracijo o skladnosti z registration of conformity with requirements
zahtevami, kot so na primer zahteve ISO 9001. such as those of ISO 9001.
ISO 19011 podaja napotke za izvajanje presoj. ISO 19011 provides guidance on auditing.
2.8.3 Pregledovanje sistema vodenja 2.8.3 Reviewing the quality management
kakovosti system
Ena izmed vlog najvišjega vodstva je v tem, da One role of top management is to carry out
izvaja redne sistematične ocenitve p
...

EUROPEAN STANDARD
DRAFT
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.

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
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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.

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.
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© International Organization for Standardization, 2004

ISO 9000:2000/DAmd 1
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ii ISO 2004 – All rights reserved

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 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
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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
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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

ISO 9000:2000/DAM 1
Introduction
No change
DRAFT AMENDMENT ISO 9000:2000/DAM 1

Quality management systems — Fundamentals and
vocabulary — Amendment 1
1 Scope
No change
2 Fundamentals of qualit
...