ESK TECHNICK NORMA

ICS 01.040.03; 03.120.10 Bezen 2016

Systmy managementu kvality  Zkladn principy a slovnk

SN
EN ISO 9000

01 0300

idt ISO 9000:2015

Quality management systems  Fundamentals and vocabulary

Systèmes de management de la qualit  Principes essentiels et vocabulaire

Qualittsmanagementsysteme  Grundlagen und Begriffe

Tato norma je eskou verz evropsk normy EN ISO 9000:2015. Peklad byl zajitn adem pro technickou normalizaci, metrologii a sttn zkuebnictv. M stejn status jako oficiln verze.

This standard is the Czech version of the European Standard EN ISO 9000:2015. It was translated by the Czech Office for Standards, Metrology and Testing. It has the same status as the official version.

Nahrazen pedchozch norem

Touto normou se nahrazuje SN EN ISO 9000 (01 0300) z dubna 2006.

 

Nrodn pedmluva

Zmny proti pedchoz norm

Tato norma je proti pedchoz norm revidovna z hlediska aktuln terminologie.

Souvisc SN

SN EN 45020 (01 0101) Normalizace a souvisc innosti  Veobecn slovnk

SN EN ISO/IEC 17000 (01 0106) Posuzovn shody  Slovnk a zkladn principy

TNI 01 0115 (01 0115) Mezinrodn metrologick slovnk  Zkladn a veobecn pojmy a pidruen termny (VIM)

SN ISO 3534-2 (01 0216) Statistika  Slovnk a znaky  st 2: Aplikovan statistika

SN EN ISO 9001 ed. 2 (01 0321) Systmy managementu kvality  Poadavky

SN EN ISO 9004 (01 0324) zen udritelnho spchu organizace  Pstup managementu kvality

SN P ISO/TR 16949 (01 0329) Systmy managementu kvality  Zvltn poadavky na pouvn ISO 9001:2008 v organizacch zajiujcch sriovou vrobu a vrobu nhradnch dl v automobilovm prmyslu

SN EN ISO 19011 (01 0330) Smrnice pro auditovn systm managementu

SN ISO/TR 10013 (01 0331) Smrnice pro dokumentaci systmu managementu jakosti

SN ISO 10005:2006 (01 0332) Systmy managementu kvality  Smrnice pro plny kvality

SN ISO 10006:2003 (01 0333) Systmy managementu jakosti  Smrnice pro management jakosti projekt

SN ISO 10007:2004 (01 0334) Systmy managementu jakosti  Smrnice managementu konfigurace

SN ISO 10014 (01 0335) Management kvality  Smrnice pro dosahovn finannch a ekonomickch pnos

SN ISO/TR 10017 (01 0336) Nvod k aplikaci statistickch metod v ISO 9001:2000

SN ISO 10015 (01 0337) Management jakosti  Smrnice pro vcvik

SN ISO 10019:2005 (01 0338) Smrnice pro vbr poradc v systmu managementu kvality a pro vyuvn jejich slueb

SN ISO 10001:2008 (01 0340) Management kvality  Spokojenost zkaznka  Smrnice pro pravidla chovn organizac

SN ISO 10003:2009 (01 0341) Management kvality  Spokojenost zkaznka  Smrnice pro extern een spor organizace

SN ISO 10004:2013 (01 0342) Management kvality  Spokojenost zkaznka  Smrnice pro monitorovn a men

TNI 01 0350 (01 0350) Management rizik  Slovnk (Pokyn 73)

SN ISO 31000 (01 0351) Management rizik  Principy a smrnice

SN EN ISO 10012:2003 (01 0360) Systmy managementu men  Poadavky na procesy men a mic vybaven

SN ISO 1087-1:2002 (01 0501) Terminologick prce  Slovnk  st 1: Teorie a aplikace

SN EN ISO 14001 (01 0901) Systmy environmentlnho managementu  Poadavky s nvodem pro pouit

SN EN ISO 50001 (01 1501) Systmy managementu hospodaen s energi  Poadavky s nvodem k pouit

SN ISO/IEC 27001 (36 9797) Informan technologie  Bezpenostn techniky  Systmy zen bezpenosti informac  Poadavky

Vypracovn normy

Zpracovatel: CTN pi esk spolenosti pro jakost, o. s., I 00417955, Ing. Ondej Hyk, ve spoluprci s CTN PETRAOV BRNO, Ivana Petraov, dpt.

Technick normalizan komise: TNK 6 Management kvality a prokazovn kvality

Pracovnk adu pro technickou normalizaci, metrologii a sttn zkuebnictv: Ing. Kristna iakov

EVROPSK NORMA EN ISO 9000
EUROPEAN STANDARD
NORME EUROPENNE
EUROPISCHE NORM Z 2015

ICS 01.040.03; 03.120.10 Nahrazuje EN ISO 9000:2005

Systmy managementu kvality  Zkladn principy a slovnk
(ISO 9000:2015)

Quality management systems  Fundamentals and vocabulary
(ISO 9000:2015) 

Systèmes de management de la qualit  Principes essentiels et vocabulaire
(ISO 9000:2015)

Qualittsmanagementsysteme  Grundlagen
und Begriffe
(ISO 9000:2015)

Tato evropsk norma byla schvlena CEN dne 2015-09-14.

lenov CEN jsou povinni splnit vnitn pedpisy CEN/CENELEC, v nich jsou stanoveny podmnky, za kterch se tto evropsk norm bez jakchkoliv modifikac udluje status nrodn normy. Aktualizovan seznamy a biblio-
grafick citace tkajc se tchto nrodnch norem lze obdret na vydn v dicm centru CEN-CENELEC nebo u kterhokoliv lena CEN.

Tato evropsk norma existuje ve tech oficilnch verzch (anglick, francouzsk, nmeck). Verze v kadm jinm jazyce peloen lenem CEN do jeho vlastnho jazyka, za kterou zodpovd a kterou notifikuje dicmu centru CEN-CENELEC, m stejn status jako oficiln verze.

leny CEN jsou nrodn normalizan orgny Belgie, Bulharska, Bval jugoslvsk republiky Makedonie, esk republiky, Dnska, Estonska, Finska, Francie, Chorvatska, Irska, Islandu, Itlie, Kypru, Litvy, Lotyska, Lucemburska, Maarska, Malty, Nmecka, Nizozemska, Norska, Polska, Portugalska, Rakouska, Rumunska, ecka, Slovenska, Slovinska, Spojenho krlovstv, panlska, vdska, vcarska a Turecka.

[image]

Evropsk vbor pro normalizaci

European Committee for Standardization

Comit Europen de Normalisation

Europisches Komitee fr Normung

dic centrum CEN-CENELEC: Avenue Marnix 17, B-1000 Brusel

2015 CEN Veker prva pro vyuit v jakkoli form a jakmikoli prostedky Ref. . EN ISO 9000:2015 E
jsou celosvtov vyhrazena nrodnm lenm CEN.

Evropsk pedmluva

 

European foreword

Tento dokument (EN ISO 9000:2015) vypracovala technick komise ISO/TC 176 Management kvality a prokazovn kvality.

 

This document (EN ISO 9000:2015) has been prepared by Technical Committee ISO/TC 176 Quality manage-
ment and quality assurance
.

Tto evropsk norm je nutno nejpozdji do bezna 2016 udlit status nrodn normy, a to bu vydnm identickho textu, nebo schvlenm k pmmu pouvn, a nrodn normy, kter jsou s n v rozporu, je nutno zruit nejpozdji do bezna 2016.

 

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by March 2016.

 

Upozoruje se na monost, e nkter prvky tohoto dokumentu mohou bt pedmtem patentovch prv. CEN [a/nebo CENELEC] nelze init odpovdnm za identifikaci jakhokoliv nebo vech patentovch prv.

 

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held re-
sponsible for identifying any or all such patent rights.

Tento dokument nahrazuje EN ISO 9000:2005.

 

This document supersedes EN ISO 9000:2005.

Tento dokument byl vypracovn na zklad mandtu udlenho CEN Evropskou komis a Evropskm sdruenm volnho obchodu a podporuje zkladn poadavky smrnice (smrnic) EU.

 

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).

Podle vnitnch pedpis CEN-CENELEC jsou tuto evrop-
skou normu povinny zavst nrodn normalizan orga-
nizace nsledujcch zem: Belgie, Bulharska, Bval jugoslvsk republiky Makedonie, esk republiky, Dnska, Estonska, Finska, Francie, Chorvatska, Irska, Islandu, Itlie, Kypru, Litvy, Lotyska, Lucemburska, Maarska, Malty, Nmecka, Nizozemska, Norska, Polska, Portugalska, Rakouska, Rumunska, ecka, Slovenska, Slovinska, Spojenho krlovstv, panlska, vdska, vcarska a Turecka.

 

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxem-
bourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Oznmen o schvlen

 

Endorsement notice

Text ISO 9000:2015 byl schvlen CEN jako EN ISO 9000:2015 bez jakchkoliv modifikac.

 

The text of ISO 9000:2015 has been approved by CEN as EN ISO 9000:2015 without any modification.

  

Obsah

 

Contents

Strana

 

Page

Pedmluva 6

vod 7

1 Pedmt normy 8

2 Zkladn pojmy a zsady managementu kvality 8

2.1 Obecn 8

2.2 Zkladn pojmy 9

2.2.1 Kvalita 9

2.2.2 Systm managementu kvality 9

2.2.3 Kontext organizace 9

2.2.4 Zainteresovan strany 9

2.2.5 Podpora 10

2.3 Zsady managementu kvality 11

2.3.1 Zamen na zkaznka 11

2.3.2 Veden (leadership) 12

2.3.3 Angaovanost lid 12

2.3.4 Procesn pstup 13

2.3.5 Zlepovn 14

2.3.6 Rozhodovn na zklad dkaz 15

2.3.7 Management vztah 16

2.4 Vvoj systmu managementu kvality s vyuitm zkladnch pojm a zsad 17

2.4.1 Model systmu managementu kvality 17

2.4.2 Vvoj systmu managementu kvality 18

2.4.3 Normy systmu managementu kvality, jin
systmy managementu a modely excelence 19

3 Termny a definice 20

3.1 Termny vztahujc se k osob nebo osobm 20

3.2 Termny vztahujc se k organizaci 21

3.3 Termny vztahujc se k innosti 23

3.4 Termny vztahujc se k procesu 25

3.5 Termny vztahujc se k systmu 27

3.6 Termny vztahujc se k poadavku 29

3.7 Termny vztahujc se k vsledku 32

3.8 Termny vztahujc se k datm, informacm
a k dokumentu 35

3.9 Termny vztahujc se k zkaznkovi 38

3.10 Termny vztahujc se k charakteristice 40

3.11 Termny vztahujc se k urovn 41

3.12 Termny vztahujc se k opaten 43

3.13 Termny vztahujc se k auditu 45

Ploha A (informativn) Pojmov vztahy a jejich
grafick znzornn 49

Bibliografie 79

 

Foreword 6

Introduction 7

1 Scope 8

2 Fundamental concepts and quality management principles 8

2.1 General 8

2.2 Fundamental concepts 9

2.2.1 Quality 9

2.2.2 Quality management system 9

2.2.3 Context of an organization 9

2.2.4 Interested parties 9

2.2.5 Support 10

2.3 Quality management principles 11

2.3.1 Customer focus 11

2.3.2 Leadership 12

2.3.3 Engagement of people 12

2.3.4 Process approach 13

2.3.5 Improvement 14

2.3.6 Evidence-based decision making 15

2.3.7 Relationship management 16

2.4 Developing the QMS using fundamental
concepts and principles 17

2.4.1 QMS model 17

2.4.2 Development of a QMS 18

2.4.3 QMS standards, other management systems
and excellence models 19

3 Terms and definitions 20

3.1 Terms related to person or people 20

3.2 Terms related to organization 21

3.3 Terms related to activity 23

3.4 Terms related to process 25

3.5 Terms related to system 27

3.6 Terms related to requirement 29

3.7 Terms related to result 32

3.8 Terms related to data, information
and document 35

3.9 Terms related to customer 38

3.10 Terms related to characteristic 40

3.11 Terms related to determination 41

3.12 Terms related to action 43

3.13 Terms related to audit 45

Annex A (informative) Concept relationships and their graphical representation 49

Bibliography 78

  

Pedmluva

 

Foreword

ISO (Mezinrodn organizace pro normalizaci) je celo-
svtov federace nrodnch normalizanch orgn
(len ISO). Mezinrodn normy obvykle vypracovvaj technick komise ISO. Kad len ISO, kter se
zajm o pedmt, pro kter byla vytvoena technick
komise, m prvo bt v tto technick komisi zastoupen. Prce se zastuj tak vldn i nevldn mezinrodn organizace, s nimi ISO navzala pracovn styk. ISO zce spolupracuje s Mezinrodn elektrotechnickou komis (IEC) ve vech zleitostech normalizace v elektrotechnice.

 

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.

Postupy pouit pi tvorb tohoto dokumentu a postupy uren pro jeho dal udrovn jsou popsny ve smrnicch ISO/IEC, st 1. Zejmna se m vnovat pozornost rozdlnm schvalovacm kritrim potebnm pro rzn druhy dokument ISO. Tento dokument byl vypracovn v souladu s redaknmi pravidly uvedenmi ve smrnicch ISO/IEC, st 2 (viz www.iso.org/directives).

 

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Upozoruje se na monost, e nkter prvky tohoto dokumentu mohou bt pedmtem patentovch prv. ISO nelze init odpovdnou za identifikaci jakhokoliv nebo vech patentovch prv. Podrobnosti o jakchkoliv patentovch prvech identifikovanch bhem ppravy tohoto dokumentu budou uvedeny v vodu a/nebo v seznamu patentovch prohlen obdrench ISO (viz www.iso.org/patents).

 

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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

 

Jakkoliv obchodn nzev pouit v tomto dokumentu se uvd jako informace pro usnadnn prce uivatel a neznamen schvlen.

 

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

Vysvtlen vznamu specifickch termn a vraz ISO, kter se vztahuj k posuzovn shody, jako i informace o tom, jak ISO dodruje principy Svtov obchodn
organizace (WTO) tkajc se technickch pekek obchodu (TBT), jsou uvedeny na tomto odkazu URL: www.iso.org/iso/foreword.html.

 

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.

Za tento dokument je odpovdn komise ISO/TC 176 Management kvality a prokazovn kvality, subkomise SC 1 Pojmy a terminologie.

 

The committee responsible for this document is Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 1, Concepts and terminology.

Toto tvrt vydn zruuje a nahrazuje tet vydn (ISO 9000:2005), kter bylo technicky zrevidovno.

 

This fourth edition cancels and replaces the third edition (ISO 9000:2005), which has been technically revised.

 

vod

 

Introduction

Tato mezinrodn norma uvd zkladn pojmy, zsady a slovnk pro systmy managementu kvality a je tak podkladem pro jin normy systmu managementu kvality. Tato mezinrodn norma m pomoci uivatelm pochopit zkladn pojmy, zsady a slovnk managementu kvality, aby byli schopni efektivn a inn zavdt systm managementu kvality a zskat hodnotu z jinch norem systmu managementu kvality.

 

This International Standard provides the fundamental concepts, principles and vocabulary for quality manage-
ment systems (QMS) and provides the foundation for other QMS standards. This International Standard is
intended to help the user to understand the fundamental concepts, principles and vocabulary of quality management, in order to be able to effectively and efficiently implement a QMS and realize value from other QMS standards.

 

Tato mezinrodn norma pedkld nleit definovan systm managementu kvality na zklad rmce, kter spojuje zaveden zkladn pojmy, zsady, procesy a zdroje tkajc se kvality, s clem pomoci organizacm realizovat jejich cle. Norma je urena pro vechny
organizace bez ohledu na jejich velikost, sloitost nebo podnikatelsk model. Jejm clem je zvit povdom organizace o jejch povinnostech a zvazcch pi plnn poteb a oekvn zkaznk a zainteresovanch stran a tak pi dosahovn spokojenosti s jejmi produkty a slubami.

 

This International Standard proposes a well-defined QMS, based on a framework that integrates established fundamental concepts, principles, processes and resources related to quality, in order to help organizations realize their objectives. It is applicable to all organizations,
regardless of size, complexity or business model. Its aim is to increase an organizations awareness of its duties and commitment in fulfilling the needs and expectations of its customers and interested parties, and in achieving satisfaction with its products and services.

Tato mezinrodn norma obsahuje sedm zsad mana-
gementu kvality podporujcch zkladn pojmy popsan v 2.2. Pro kadou zsadu managementu kvality se v 2.3 uvd zsada a popis kad zsady, odvodnn vysvtlujc, pro by se organizace mla danou zsadou zabvat, hlavn pnosy, kter jsou pisuzovny jednotlivm zsadm, a mon opaten, kter me organizace pijmout pi uplatovn dan zsady.

 

This International Standard contains seven quality management principles supporting the fundamental concepts described in 2.2. In 2.3, for each quality manage-
ment principle, there is a statement describing each principle, a rationale explaining why the organization would address the principle, key benefits that are
attributed to the principles, and possible actions that an organization can take in applying the principle.

Tato mezinrodn norma obsahuje termny a definice, kter plat pro vechny normy managementu kvality a systmu managementu kvality, kter vypracovala ISO/TC 176, a pro jin normy systmu managementu kvality specifick pro urit odvtv v dob jejich zveejnn. Termny a definice jsou uspodny v pojmovm azen s abecednm rejstkem na konci dokumentu. Ploha A obsahuje soubor diagram pojmovch systm, kter tvo pojmov uspodn.

 

This International Standard contains the terms and
definitions that apply to all quality management and QMS standards developed by ISO/TC 176, and other sector-specific QMS standards based on those standards, at the time of publication. The terms and definitions are arranged in conceptual order, with an alphabetical
index provided at the end of the document. Annex A 
includes a set of diagrams of the concept systems that form the concept ordering.

 

POZNMKA Nvod k nkterm dalm, asto pouvanm slovm v normch systmu managementu kvality, kter vypracovala ISO/TC 176 a kter maj slovnkov vznam, je uveden ve slovnku na adrese: http://www.iso.org/iso/ 03_
terminology_used_in_iso_9000_family.pdf

 

NOTE Guidance on some additional frequently-used words in the QMS standards developed by ISO/TC 176, and which have an identified dictionary meaning, is provided in a glossary available at: http://www.iso.org/iso/ 03_terminology_used_
in_iso_9000_family.pdf

1 Pedmt normy

 

1 Scope

Tato mezinrodn norma popisuje zkladn pojmy a zsady managementu kvality, kter jsou veobecn po-
uiteln pro

 

This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following:

  • organizace, kter usiluj o udriteln spch prosted-
    nictvm zaveden systmu managementu kvality;

 

    organizations seeking sustained success through the implementation of a quality management system;

    zkaznky, kte usiluj o zskn dvry ve schopnost organizace trvale poskytovat produkty a sluby vyho-
    vujc jejich poadavkm;

 

    customers seeking confidence in an organizations ability to consistently provide products and services conforming to their requirements;

    organizace, kter usiluj o zskn dvry v jejich dodavatelskm etzci, e poadavky na produkt a slubu budou splnny;

 

    organizations seeking confidence in their supply chain that product and service requirements will be met;

    organizace a zainteresovan strany, kter usiluj o zlepen komunikace prostednictvm spolenho porozumn slovn zsob pouvan v manage-
    mentu kvality;

 

    organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management;

    organizace provdjc posuzovn shody podle
    poadavk ISO 9001;

 

    organizations performing conformity assessments against the requirements of ISO 9001;

    poskytovatele vcviku/kolen, posuzovn nebo pora-
    denstv v managementu kvality;

 

    providers of training, assessment or advice in quality management;

 
  • zpracovatele pslunch norem.

 

    developers of related standards.

Tato mezinrodn norma specifikuje termny a definice, kter plat pro vechny normy managementu kvality a systmu managementu kvality, kter vypracovala ISO/TC 176.

 

This International Standard specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176.

Konec nhledu - text dle pokrauje v placen verzi SN.