ESK TECHNICK NORMA

ICS 03.120.10 Duben 2009

Systmy managementu kvality  Poadavky

SN
EN ISO 9001

01 0321

idt ISO 9001:2008

Quality management systems  Requirements

Systmes de management de la qualit  Exigences

Qualittsmanagementsysteme  Forderungen

Tato norma je eskou verz evropsk normy EN ISO 9001:2008. 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 9001:2008. 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 9001 (01 0321) ze srpna 2001 a SN EN ISO 9001 ed. 2 (01 0321) z bezna 2002.

 

Nrodn pedmluva

Zmny proti pedchozm normm

Revize normy ISO 9001 byla provedena s clem vyjasnit text normy. Revize nezavd dn nov poadavky. Zmny v textu normy jsou uvedeny v ploze B.

Informace o citovanch normativnch dokumentech

ISO 9000:2005zavedena v SN EN ISO 9000:2006 (01 0320) Systmy managementu kvality  Zkladn principy a slovnk

Souvisc SN

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

SN ISO 10002:2005 (01 0339) Management kvality  Spokojenost zkaznka  Smrnice pro vyizovn stnost v organizacch

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

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

SN ISO 10006:2004 ed. 2 (01 0333) Systmy managementu jakosti  Smrnice pro management jakosti projekt

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

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

SN ISO/TR 10013:2002 (01 0331) Smrnice pro dokumentaci systmu managementu jakosti

SN ISO 10014:2007 (01 0335) Management kvality  Smrnice pro dosahovn finannch a ekonomickch pnos

SN ISO 10015:2001 (01 0337) Management jakosti  Smrnice pro vcvik

SN ISO/TR 10017:2004 (01 0336) Nvod k aplikaci statistickch metod v ISO 9001:2000

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

SN EN ISO 19011:2003 (01 0330) Smrnice pro auditovn systmu managementu kvality a/nebo systmu environmentlnho managementu

SN EN ISO 14001:2005 (01 0901) Systmy environmentlnho managementu  Poadavky s nvodem pro pouit

Vysvtlivky k textu pevzat normy

esk text normy byl pepracovn s clem zvit jeho srozumitelnost. Nov peklad nkterch termn a slov nesm bt dvodem pro vystaven neshody v rmci certifikanho auditu.

K podpoe sprvnho chpn textu je dle uvedeno vysvtlen pekladu vraz, pro kter nebylo v norm mon nalzt zcela vstin esk ekvivalent a mohly by bt chpny ve zkreslenm, nebo omezenjm vznamu, ne je mnn v anglickm textu normy. Pokud byl vypracovn vklad technickou komis ISO/TC 176, je uveden tento vklad, kter je v ppad poteby doplnn.

  1. performance

V norm je pouit peklad vkonnost, kter vak m v kontextu systm managementu kvality specifick vznam, viz vklad ISO.

Vklad ISO

Rozsah, ve kterm organizace, systm, osoby nebo procesy uskuteuj sv zmry (The extent to which an organization, system, person or process realizes its purpose).

  1. commitment

V norm je pekldn podle kontextu jako aktivita, angaovanost a aktivita nebo zvazek, protoe neexistuje esk ekvivalent odpovdajc vznamu v anglitin. V tto norm je vak nutno chpat jako osobn angao-
vanost a osobn pesvden o elnosti danho opaten.

Vklad ISO

Oddanost vci nebo zmrm (The state of being dedicated to a cause or policy)

  1. training

Tento pojem m v anglitin irok vznam a zahrnuje jak trnink a vcvik, tak kolen, a ppadn i obecnj ppravu, vchovu. V norm byl zvolen peklad vcvik, pestoe z vznamovho hlediska se mohou vyskyt-
nout ob monosti pekladu. Je tedy ppustn v praxi pout i peklad kolen, pokud je to vhodnj, protoe o vhodnosti pekladu lze rozhodnout a na zklad pesnch vznamovch souvislost.

Vklad ISO

Vuka jednotlivch dovednost nebo vzor chovn/vystupovn pomoc sprvn praxe a instrukc (pokyn) (The act of teaching a particular skill or type of behaviour through regular practice and instruction)

  1. measurement

Tento termn v anglitin zahrnuje men a rovn hodnocen; v norm byl zvolen peklad men, pestoe z vznamovho hlediska se mohou vyskytnout ob monosti pekladu. Je tedy ppustn v praxi pout i pe-
klad hodnocen, pokud je to vhodnj, protoe o vhodnosti pekladu lze rozhodnout a na zklad pesnch vznamovch souvislost.

Vklad ISO

Zjitn velikosti, rozsahu, nebo stupn (neho) srovnnm s normalizovanou jednotkou nebo objektem znm velikosti (Ascertain the size, amount, or degree of (something) by comparison with a standard unit or with an object of known size)

  1. manage, control

Vrazy control a manage nejsou v ISO 9000 definovny, mly by bt pekldny podle kontextu a mly by bt rozlieny. V esk jazyce je to vak na rozdl od anglickho jazyka sloitj.

Vznam vrazu control technick komise ISO/TC 176 vyloila. V pekladu normy bylo pouito zen (kter je vit) a kontrola. zen je teba chpat podle kontextu, ve kterm je pouito. Me to bt tedy pravomoc dvat pkazy, nebo stanovit zpsob, jak dret zleitosti pod kontrolou.

Vklad ISO

Pravomoc dvat pkazy nebo nco dret pod kontrolou (Power to give orders or to restrain something)

Zpsob dren pod kontrolou nebo regulace (Means of restraining or regulating)

Anglick manage nen sice vysvtleno, nicmn z definic managementu kvality a zen kvality (viz ISO 9000) vyplv, e zen kvality je st systmu managementu kvality. Lze tedy odvodit, e manage m ir vznam a nezahrnuje pouze zen, ale tak veden. V tomto vznamu je proto teba manage v norm chpat.

  1. awareness of

Tento vraz znamen vdom neho. Pi pekladu normy bylo zvoleno vdom zvanosti (innosti, systmu managementu, plnn poadavku), protoe vdom zvanosti problematiky je zkladnm pedpokladem sprv-
nho chpn, a tedy nsledn i dodrovn poadavk systmu managementu kvality.

  1. outsourcing

Tento termn zahrnuje v anglitin peveden veden nebo stlho vkonu podnikatelsk innosti organizace na externho poskytovatele sluby. Rozhodne-li se organizace povit vedenm nebo vkonem innosti extern organizaci, uzave s dodavatelem smlouvu, ve kter ur rozsah pevdnch innost. Pi pekladu normy bylo pouito proces zajiovan pomoc externch zdroj.

Vypracovn normy

Zpracovatel: esk normalizan institut, I 48135283, Ing. Ondej Hyk

Technick normalizan komise: TNK 6, Management kvality a prokazovn kvality

Pracovnk adu pro technickou normalizaci, metrologii a sttn zkuebnictv: Ing. Soa Hskov

 

EVROPSK NORMA EN ISO 9001
EUROPEAN STANDARD
NORME EUROPENNE
EUROPISCHE NORM
Listopad 2008

ICS 00.012.10; 03.120.10 Nahrazuje EN ISO 9001:2000

Systmy managementu kvality  Poadavky
(ISO 9001:2008)

Quality management systems  Requirements
(ISO 9001:2008) 

Systmes de management de la qualit  Exigences
(ISO 9001:2008)

Qualittsmanagementsysteme  Anforderungen
(ISO 9001:2008)

Tato evropsk norma byla schvlena CEN 2008-11-08.

lenov CEN jsou povinni splnit Vnitn pedpisy CEN/CENELEC, v nich jsou stanoveny podmnky, za kterch se mus tto evropsk norm bez jakchkoliv modifikac dt status nrodn normy. Aktualizovan seznamy a biblio-
grafick citace tkajc se tchto nrodnch norem lze obdret na vydn v dicm centru 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, m stejn status jako oficiln verze.

CEN

Evropsk vbor pro normalizaci

European Committee for Standardization

Comit Europen de Normalisation

Europisches Komitee fr Normung

dic centrum: rue de Stassart 36, B-1050 Brusel

2008 CEN Veker prva pro vyuit v jakkoli form a jakmikoli prostedky Ref. . EN ISO 9001:2008 E
jsou celosvtov vyhrazena nrodnm lenm CEN.

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

Pedmluva

 

Foreword

Tento dokument (EN ISO 9001:2008) byl vypracovn technickou komis ISO/TC 176 Management kvality a prokazovn kvality.

 

This document (EN ISO 9001:2008) has been prepared by Technical Committee ISO/TC 176 Quality mana-
gement and quality assurance.

Tto evropsk norm je nutno nejpozdji do kvtna 2009 dt status nrodn normy, a to bu vydnm identic-
kho textu, nebo schvlenm k pmmu pouvn, a nrodn normy, kter jsou s n v rozporu, je nutno zruit nejpozdji do kvtna 2009.

 

This European Standard shall be given the status of a national standard, either by publication of an iden-
tical text or by endorsement, at the latest by May 2009, and conflicting national standards shall be withdrawn at the latest by May 2009.

 

Upozoruje se na monost, e nkter prvky tohoto dokumentu mohou bt pedmtem patentovch prv. CEN nen odpovdn za identifikovn jakchkoli nebo vech tchto patentovch prv.

 

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

Tento dokument nahrazuje EN ISO 9001:2000.

 

This document supersedes EN ISO 9001:2000.

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

 

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

Oznmen o schvlen

 

Endorsement notice

Text ISO 9001:2008 byl schvlen CEN jako
EN ISO 9001:2008 bez jakchkoli modifikac.

 

The text of ISO 9001:2008 has been approved by CEN as EN ISO 9001:2008 without any modification.

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Adobe je obchodn znaka Adobe Systems Incorporated.

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ISO 2008

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ISO copyright office

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E-mail copyright@iso.org

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Published in Switzerland

Obsah

 

Contents

Strana

 

Page

Pedmluva 10 3

vod 11

0.1 Obecn 11

0.2 Procesn pstup 11

0.3 Vztah k ISO 9004 14

0.4 Kompatibilita s jinmi systmy managementu 14

1 Pedmt 15

1.1 Obecn 15

1.2 Aplikace 15

2 Citovan normativn dokumenty 15

3 Termny a definice 15

4 Systm managementu kvality 16

4.1 Veobecn poadavky 16

4.2 Poadavky na dokumentaci 17

4.2.1 Obecn 17

4.2.2 Pruka kvality 17

4.2.3 zen dokument 17

4.2.4 zen zznam 18

5 Odpovdnost managementu 18

5.1 Angaovanost a aktivita managementu 18

5.2 Zamen na zkaznka 18

5.3 Politika kvality 18

5.4 Plnovn 19

5.4.1 Cle kvality 19

5.4.2 Plnovn systmu managementu kvality 19

5.5 Odpovdnost, provomoc a komunikace 19

5.5.1 Odpovdnost a pravomoc 19

5.5.2 Pedstavitel managementu 19

5.5.3 Intern komunikace 19

5.6 Pezkoumn systmu managementu 19

5.6.1 Obecn 19

5.6.2 Vstup pro pezkoumn 20

5.6.3 Vstup z pezkoumn 20

6 Management zdroj 20

6.1 Poskytovn zdroj 20

6.2 Lidsk zdroje 20

6.2.1 Obecn 20

6.2.2 Kompetence, vcvik a vdom zvanosti 20

6.3 Infrastruktura 21

6.4 Pracovn prosted 21

7 Realizace produktu 21

7.1 Plnovn realizace produktu 21

 

 

Foreword 10

Introduction 11

0.1 General 11

0.2 Process approach 11

0.3 Relationship with ISO 9004 14

0.4 Compatibility with other management systems 14

1 Scope 15

1.1 General 15

1.2 Application 15

2 Normative references 15

3 Terms and definitions 15

4 Quality management system 16

4.1 General requirements 16

4.2 Documentation requirements 17

4.2.1 General 17

4.2.2 Quality manual 17

4.2.3 Control of documents 17

4.2.4 Control of records 18

5 Management responsibility 18

5.1 Management commitment 18

5.2 Customer focus 18

5.3 Quality policy 18

5.4 Planning 19

5.4.1 Quality objectives 19

5.4.2 Quality management system planning 19

5.5 Responsibility, authority and communication 19

5.5.1 Responsibility and authority 19

5.5.2 Management representative 19

5.5.3 Internal communication 19

5.6 Management review 19

5.6.1 General 19

5.6.2 Review input 20

5.6.3 Review output 20

6 Resource management 20

6.1 Provision of resources 20

6.2 Human resources 20

6.2.1 General 20

6.2.2 Competence, training and awareness 20

6.3 Infrastructure 21

6.4 Work environment 21

7 Product realization 21

7.1 Planning of product realization 21

 

Strana

 

Page

7.2 Procesy tkajc se zkaznka 22

7.2.1 Urovn poadavk tkajcch se produktu 22

7.2.2 Pezkoumn poadavk tkajcch se produktu 22

7.2.3 Komunikace se zkaznkem 22

7.3 Nvrh a vvoj 23

7.3.1 Plnovn nvrhu a vvoje 23

7.3.2 Vstupy pro nvrh a vvoj 23

7.3.3 Vstupy z nvrhu a vvoje 23

7.3.4 Pezkoumn nvrhu a vvoje 24

7.3.5 Ovovn nvrhu a vvoje 24

7.3.6 Validace nvrhu a vvoje 24

7.3.7 zen zmn nvrhu a vvoje 24

7.4 Nkup 24

7.4.1 Proces nkupu 24

7.4.2 Informace pro nkup 25

7.4.3 Ovovn nakupovanho produktu 25

7.5 Vroba a poskytovn slueb 25

7.5.1 zen vroby a poskytovn slueb 25

7.5.2 Validace proces vroby a poskytovn slueb 25

7.5.3 Identifikace a sledovatelnost 26

7.5.4 Majetek zkaznka 26

7.5.5 Uchovvn produktu 26

7.6 zen monitorovacho a micho zazen 26

8 Men, analza a zlepovn 27

8.1 Obecn 27

8.2 Monitorovn a men 27

8.2.1 Spokojenost zkaznka 27

8.2.2 Intern audit 28

8.2.3 Monitorovn a men proces 28

8.2.4 Monitorovn a men produktu 28

8.3 zen neshodnho produktu 29

8.4 Analza dat 29

8.5 Zlepovn 29

8.5.1 Neustl zlepovn 29

8.5.2 Npravn opaten 30

8.5.3 Preventivn opaten 30

Ploha A (informativn) 31

Ploha B (informativn) 41

  

7.2 Customer-related processes 22

7.2.1 Determination of requirements related
to the product 22

7.2.2 Review of requirements related to the product 22

7.2.3 Customer communication 22

7.3 Design and development 23

7.3.1 Design and development planning 23

7.3.2 Design and development inputs 23

7.3.3 Design and development outputs 23

7.3.4 Design and development review 24

7.3.5 Design and development verification 24

7.3.6 Design and development validation 24

7.3.7 Control of design and development changes 24

7.4 Purchasing 24

7.4.1 Purchasing process 24

7.4.2 Purchasing information 25

7.4.3 Verification of purchased product 25

7.5 Production and service provision 25

7.5.1 Control of production and service provision 25

7.5.2 Validation of processes for production
and service provision 25

7.5.3 Identification and traceability 26

7.5.4 Customer property 26

7.5.5 Preservation of product 26

7.6 Control of monitoring and measuring equipment 26

8 Measurement, analysis and improvement 27

8.1 General 27

8.2 Monitoring and measurement 27

8.2.1 Customer satisfaction 27

8.2.2 Internal audit 28

8.2.3 Monitoring and measurement of processes 28

8.2.4 Monitoring and measurement of product 28

8.3 Control of nonconforming product 29

8.4 Analysis of data 29

8.5 Improvement 29

8.5.1 Continual improvement 29

8.5.2 Corrective action 30

8.5.3 Preventive action 30

Annex A (informative) 31

Annex B (informative) 41

 

Pedmluva

 

Foreword

ISO (Mezinrodn organizace pro normalizaci) je celo-
svtovou federac nrodnch normalizanch orgn (len ISO). Mezinrodn normy obvykle pipravuj tech-
nick 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 orga-
nizace, 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 Interna-
tional 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.

Mezinrodn normy se navrhuj v souladu s pravidly uvedenmi v sti 2 smrnic ISO/IEC.

 

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

Hlavnm kolem technickch komis je tvorba mezin-
rodnch norem. Nvrhy mezinrodnch norem pijat technickmi komisemi se rozeslaj lenskm orgnm k hlasovn. Zveejnn mezinrodn normy vyaduje schvlen alespo 75 % hlasujcch len.

 

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 Inter-
national Standard requires approval by at least 75 %
of the member bodies casting a vote.

Upozoruje se na monost, e nkter prvky tohoto dokumentu mohou bt pedmtem patentovch prv. ISO nen odpovdn za identifikovn jakchkoli nebo vech tchto patentovch prv.

 

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.

 

ISO 9001 byla vypracovna technickou komis ISO/TC 176 Management kvality a prokazovn kvality, subkomis SC 2 Systmy kvality.

 

ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems.

Toto tvrt vydn ISO 9001 ru a nahrazuje tet vydn (ISO 9001:2000), kter bylo zmnno s clem vyjasnit nkter body v textu a zvit kompatibilitu s ISO 14001:2004.

 

This fourth edition cancels and replaces the third edition (ISO 9001:2000), which has been amended to clarify points in the text and to enhance compatibility with ISO 14001:2004.

Podrobnosti o zmnch proti tetmu vydn jsou uve-
deny v ploze B.

 

Details of the changes between the third edition and this fourth edition are given in Annex B.

vod

 

Introduction

0.1 Obecn

 

0.1 General

Zaveden systmu managementu kvality by mlo bt strategickm rozhodnutm organizace. Nvrh a imple-
mentace systmu managementu kvality organizace jsou ovlivovny:

 

The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality mana-
gement system is influenced by

  1. prostedm, ve kterm organizace pracuje, jeho zm-
    nami a riziky spojenmi s tmto prostedm,

 
  1. its organizational environment, changes in that envi-
    ronment and the risks associated with that environment,

  1. jejmi mncmi se potebami,

 
  1. its varying needs,

  1. jejmi konkrtnmi cli,

 
  1. its particular objectives,

  1. poskytovanmi produkty,

 
  1. the products it provides,

  1. pouvanmi procesy,

 
  1. the processes it employs,

  1. velikost a strukturou organizace.

 
  1. its size and organizational structure.

Nen zmrem, aby tato mezinrodn norma stanovo-
vala jednotnou strukturu systm managementu kvality ani jednotnou dokumentaci.

 

It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

Poadavky na systm managementu kvality specifi-
kovan v tto mezinrodn norm dopluj poadavky na produkty. Informace s oznaenm POZNMKA slou jako nvod pro pochopen nebo objasnn souvise-
jcho poadavku.

 

The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked NOTE is for guidance in understanding or clarifying the asso-
ciated requirement.

 

Tuto mezinrodn normu mohou pouvat intern a extern strany, vetn certifikanch orgn pi posuzovn schop-
nosti organizace plnit poadavky zkaznka, poadavky zkon a pedpis aplikovanch na produkt a vlastn poadavky organizace.

 

This International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regulatory requirements applicable to the product, and the organizations own requirements.

Pi tvorb tto mezinrodn normy byly vzaty v vahu principy managementu kvality uveden v ISO 9000 a ISO 9004.

 

The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.

0.2 Procesn pstup

 

0.2 Process approach

Tato mezinrodn norma podporuje pouvn proces-
nho pstupu pi vytven, implementaci a zvyovn efektivnosti systmu managementu kvality s clem zv-
it spokojenost zkaznka prostednictvm plnn jeho poadavk.

 

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality manage-
ment system, to enhance customer satisfaction by meeting customer requirements.

Aby organizace fungovala efektivn, mus stanovit a dit mnoho vzjemn propojench innost. innost nebo soubor innost, kter vyuvaj zdroje a jsou zeny za elem pemny vstup na vstupy lze povaovat za proces. Vstup z jednoho procesu asto pmo tvo vstup pro dal proces.

 

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and mana-
ged in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.

Vyuit systmu proces v rmci organizace spolu s identifikac tchto proces, jejich vzjemnm psobe-
nm a jejich managementem tak, aby vytvely zam-
len vstup, lze nazvat procesn pstup.

 

The application of a system of processes within an organization, together with the identification and inter-
actions of these processes, and their management to produce the desired outcome, can be referred to as the process approach.

 

Vhodou procesnho pstupu je to, e umouje neu-
stl zen propojen jednotlivch proces v jejich systmu, stejn jako zen jejich vzjemnch vazeb.

 

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

Je-li takov pstup pouit v systmu managementu kvality, zdrazuje dleitost

 

When used within a quality management system, such an approach emphasizes the importance of

  1. pochopen poadavk a jejich plnn,

 
  1. understanding and meeting requirements,

  1. poteby posuzovat procesy z hlediska pidan hodnoty,

 
  1. the need to consider processes in terms of added value,

  1. dosahovn vsledk tkajcch se vkonnosti a efektiv-
    nosti proces a

 
  1. obtaining results of process performance and effecti-
    veness, and

  1. neustlho zlepovn proces na zklad objektiv-
    nho men.

 
  1. continual improvement of processes based on objec-
    tive measurement.

Model procesn orientovanho systmu managementu kvality, znzornn na obrzku 1, ukazuje propojen pro-
ces uvedench v kapitolch 4 a 8. Z tto ilustrace je zejm, e pi stanovovn poadavk jakoto vstup hraj vznamnou lohu zkaznci. Monitorovn spoko-
jenosti zkaznka vyaduje vyhodnocovn informac tkajcch se toho, jak zkaznci vnmaj, zda organizace splnila jejich poadavky. Model na obrzku 1 pokrv vechny poadavky tto mezinrodn normy, ale nezn-
zoruje procesy na podrobn rovni.

 

The model of a process-based quality management system shown in Figure 1 illustrates the process linkages pre-
sented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1
covers all the requirements of this International Standard, but does not show processes at a detailed level.

 

POZNMKA Navc lze na vechny procesy aplikovat metodu znmou jako Plnuj  Dlej  Kontroluj  Jednej (PDCA). Metodu PDCA lze ve strunosti popsat takto:

Plnuj: stanov cle a procesy nezbytn k dosahovn vsledk v souladu s poadavky zkaznka a s politikami organizace.

Dlej: implementuj procesy.

Kontroluj: monitoruj a m procesy a produkty ve vztahu k poli-
tikm, clm a poadavkm na produkt a podvej zprvy o vsledcch.

Jednej: provdj opaten pro neustl zlepovn vkon-
nosti procesu.

 

NOTEIn addition, the methodology known as Plan-Do-Check-Act (PDCA) can be applied to all processes. PDCA can be briefly described as follows.

Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies.

Do: implement the processes.

Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.

Act: take actions to continually improve process performance.

[image]

Obrzek 1  Model procesn orientovanho systmu managementu kvality

[image]

Figure 1  Model of a process-based quality management system

0.3Vztah k ISO 9004

 

0.3 Relationship with ISO 9004

ISO 9001 a ISO 9004 jsou normy systmu manage-
mentu kvality, kter byly navreny tak, aby se navz-
jem doplovaly. Pesto mohou bt tyto normy pouvny samostatn.

 

ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.

V ISO 9001 jsou specifikovny poadavky na systm managementu kvality, kter me bt organizacemi pouvn pro intern aplikaci nebo certifikaci nebo pro smluvn ely. Tato norma je zamena na efektivnost systmu managementu kvality pi plnn poadavk zkaznka.

 

ISO 9001 specifies requirements for a quality manage-
ment system that can be used for internal application by organizations or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.

 

V dob zveejnn tto normy probh revize ISO 9004. Revize normy ISO 9004 poskytne veden organizace nvod k dosaen trvalho spchu jakkoliv organi-
zace v komplexnm, nronm a trvale promnlivm pro-
sted. ISO 9004 poskytuje ir pohled na management kvality ne ISO 9001. Systematickm a trvalm zlepo-
vnm vkonnosti organizace reaguje na poteby a oe-
kvn vech zainteresovanch stran a bere v vahu jejich spokojenost. Tato norma ovem nen urena pro certifikaci ani jin prvn nebo smluvn ely.

 

At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of ISO 9004 will provide guidance to management for achieving sustained success for any organization in a complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction, by the syste-
matic and continual improvement of the organizations performance.
However, it is not intended for certifi-
cation, regulatory or contractual use.

0.4Kompatibilita s jinmi systmy managementu

 

0.4Compatibility with other management systems

Pi vytven tto mezinrodn normy byl peliv zv-
en obsah ISO 14001:2004 za elem zven kom-
patibility tchto dvou norem. Kompatibilita tchto dvou norem je pnosem pro uivatelskou komunitu. Ploha A
ukazuje kompatibilitu ISO 9001:2008 a ISO 14001:2004.

 

During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community. Annex A shows the corres-
pondence between ISO 9001:2008 and ISO 14001:2004.

Tato mezinrodn norma neobsahuje poadavky, kter jsou specifick pro jin systmy managementu, jako jsou napklad poadavky, kter jsou vlastn environmentl-
nmu managementu, managementu bezpenosti a ochrany zdrav pi prci, finannmu managementu nebo mana-
gementu rizik. Nicmn tato mezinrodn norma umo-
uje organizaci sladit svj vlastn systm managementu kvality s dalmi poadavky systm managementu nebo do nj tyto poadavky integrovat. Organizace me pizpsobit svj stvajc systm managementu tak, aby vytvoila systm managementu kvality, kter vyhovuje poadavkm tto mezinrodn normy.

 

This International Standard does not include require-
ments specific to other management systems, such as those particular to environmental management, occupa-
tional health and safety management, financial mana-
gement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related mana-
gement system requirements. It is possible for an organi-
zation to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.

 

Systmy managementu kvality 
Poadavky

 

Quality management systems
Requirements

1 Pedmt

 

1 Scope

1.1Obecn

 

1.1General

Tato mezinrodn norma specifikuje poadavky na systm managementu kvality tam, kde organizace:

 

This International Standard specifies requirements for a quality management system where an organization:

  1. potebuje prokazovat svou schopnost trvale posky-
    tovat produkt, kter spluje poadavky zkaznka a aplikovateln poadavky zkon a pedpis a

 

a) needs to demonstrate its ability to consistently pro-
vide product that meets customer and applicable statutory and regulatory requirements, and

  1. m v myslu zvyovat spokojenost zkaznka pomoc efektivn aplikace tohoto systmu, vetn proces pro jeho neustl zlepovn, a ujiovnm o shod s poadavky zkaznka a s aplikovatelnmi poadavky zkon a pedpis.

 

b) aims to enhance customer satisfaction through the effective application of the system, including pro-
cesses for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

POZNMKA 1 V tto mezinrodn norm se termn pro-
dukt vztahuje pouze k:

a) produktu, kter je pro zkaznka uren nebo zkazn-
kem poadovn,

b) jakmukoli zamlenmu vstupu z proces realizace produktu.

 

NOTE 1 In this International Standard, the term product only applies to

a) product intended for, or required by, a customer,

b) any intended output resulting from the product realization processes.

POZNMKA 2Poadavky zkon a pedpis mohou bt vyjdeny jako prvn poadavky.

 

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

1.2 Aplikace

 

1.2 Application

Vechny poadavky tto mezinrodn normy jsou gene-
rick a jsou aplikovateln ve vech organizacch bez ohledu na jejich typ, velikost a na poskytovan produkty.

 

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

V ppad, e nkter poadavky tto mezinrodn normy nemohou bt, s ohledem na charakter organizace a jej produkt, aplikovny, lze zvit vylouen tchto poa-
davk.

 

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

 

Pokud jsou uinna vylouen, jsou prohlen o shod s touto mezinrodn normou ppustn pouze v ppad, e se tato vylouen omezuj na poadavky kapitoly 7
a nemaj vliv na schopnost nebo odpovdnost organi-
zace poskytovat produkt, kter spluje poadavky zkaz-
nka a aplikovateln poadavky zkon a pedpis.

 

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the orga-
nizations ability, or responsibility, to provide product that meets customer and applicable statutory and regula-
tory requirements.

Konec nhledu text dle pokrauje v placen verzi SN.