EN ISO/IEC 17021:2011
(Main)Conformity assessment - Requirements for bodies providing audit and certification of management systems (ISO/IEC 17021:2011)
Conformity assessment - Requirements for bodies providing audit and certification of management systems (ISO/IEC 17021:2011)
ISO/IEC 17021:2011 contains principles and requirements for the competence, consistency and impartiality of the audit and certification of management systems of all types (e.g. quality management systems or environmental management systems) and for bodies providing these activities. Certification bodies operating to ISO/IEC 17021:2011 need not offer all types of management system certification.
Certification of management systems is a third-party conformity assessment activity. Bodies performing this activity are therefore third-party conformity assessment bodies.
Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren und zertifizieren (ISO/IEC 17021:2011)
Diese Internationale Norm enthält Grundsätze für und Anforderungen an die Kompetenz, Folgerichtigkeit und
Unparteilichkeit von Audits und Zertifizierungen von Managementsystemen jeglicher Art (z. B. Qualitätsmanagementsystemen
oder Umweltmanagementsystemen) und für Stellen, die diese Tätigkeiten ausführen. Zertifizierungsstellen,
die nach dieser Internationalen Norm arbeiten, müssen nicht alle Arten von Managementsystem-
Zertifizierungen anbieten.
Zertifizierung von Managementsystemen (in dieser Internationalen Norm als „Zertifizierung“ bezeichnet) ist
eine Konformitätsbewertungstätigkeit durch eine dritte Seite (siehe ISO/IEC 17000:2004, 5.5). Stellen, die
diese Tätigkeit anbieten, sind daher Konformitätsbewertungsstellen und werden in dieser Internationalen
Norm verkürzt als „Zertifizierungsstellen“ bezeichnet.
ANMERKUNG 1 Diese Anmerkung gilt nur für den englischen Text.
ANMERKUNG 2 Eine Zertifizierungsstelle kann nichtstaatlich oder staatlich sein (mit oder ohne regelsetzender Kompetenz).
ANMERKUNG 3 Diese Internationale Norm kann als Vorgabe für die Akkreditierung oder Begutachtung unter Gleichrangigen
bzw. für andere Auditprozesse genutzt werden.
Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la certification de systèmes de management (ISO/IEC 17021:2011)
L'ISO 17021:2011 spécifie les principes et les exigences relatifs à la compétence, à la cohérence et à l'impartialité lors des audits et lors de la certification de systèmes de management de tous types (par exemple systèmes de management de la qualité ou systèmes de management environnemental) et relatives aux organismes fournissant cette activité. Les organismes de certification conformes à l'ISO 17021:2011 ne sont pas tenus de proposer tous les types de certification de système de management.
La certification de systèmes de management est une activité d'évaluation de la conformité par tierce partie. Les organismes exerçant cette activité sont par conséquent des organismes d'évaluation de la conformité par tierce partie.
Ugotavljanje skladnosti - Zahteve za organe, ki presojajo in certificirajo sisteme vodenja (ISO/IEC 17021:2011)
Ta mednarodni standard vsebuje principe in zahteve po pristojnosti, konsistenci in nepristranskosti za presojo in certifikacijo vseh vrst sistemov vodenja (npr. sistemi vodenja kakovosti ali sistemi vodenja okolja) in za organe, ki zagotavljajo te dejavnosti. Organom za certifikacijo, ki delujejo po tem mednarodnem standardu, ni treba ponujati vseh vrst certifikacij sistemov vodenja. Certifikacija sistemov vodenja (imenovana v tem mednarodnem standardu »certifikacija«) je dejavnost ugotavljanja skladnosti, ki jo izvaja tretja oseba (glej ISO/IEC 17000:2004, točko 5.5). Organi, ki izvajajo to dejavnost, so potemtakem organi za ugotavljanje skladnosti tretje osebe (v tem mednarodnem standardu imenovani »certifikacijski organi«).
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ugotavljanje skladnosti - Zahteve za organe, ki presojajo in certificirajo sisteme vodenja (ISO/IEC 17021:2011)Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren und zertifizieren (ISO/IEC 17021:2011)Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management (ISO/IEC 17021:2011)Conformity assessment - Requirements for bodies providing audit and certification of management systems (ISO/IEC 17021:2011)03.120.20Certificiranje proizvodov in podjetij. Ugotavljanje skladnostiProduct and company certification. Conformity assessmentICS:Ta slovenski standard je istoveten z:EN ISO/IEC 17021:2011SIST EN ISO/IEC 17021:2011en01-april-2011SIST EN ISO/IEC 17021:2011SLOVENSKI
STANDARDSIST EN ISO/IEC 17021:20061DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO/IEC 17021
February 2011 ICS 03.120.20 Supersedes EN ISO/IEC 17021:2006
English version
Conformity assessment - Requirements for bodies providing audit and certification of management systems (ISO/IEC 17021:2011)
Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management (ISO/IEC 17021:2011)
Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren und zertifizieren (ISO/IEC 17021:2011) This European Standard was approved by CEN on 17 January 2011.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels© 2011 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17021:2011 E SIST EN ISO/IEC 17021:2011
Reference numberISO/IEC 17021:2011(E)© ISO 2011
INTERNATIONAL STANDARD ISO/IEC17021Second edition2011-02-01Conformity assessment — Requirements for bodies providing audit and certification of management systems Évaluation de la conformité — Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management
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ii © ISO 2011 — All rights reserved
ISO/IEC 17021:2011(E) © ISO 2011 — All rights reserved iii Contents Page Foreword.v Introduction.vi 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Principles.3 4.1 General.3 4.2 Impartiality.3 4.3 Competence.4 4.4 Responsibility.4 4.5 Openness.4 4.6 Confidentiality.4 4.7 Responsiveness to complaints.4 5 General requirements.5 5.1 Legal and contractual matters.5 5.2 Management of impartiality.5 5.3 Liability and financing.6 6 Structural requirements.7 6.1 Organizational structure and top management.7 6.2 Committee for safeguarding impartiality.7 7 Resource requirements.8 7.1 Competence of management and personnel.8 7.2 Personnel involved in the certification activities.9 7.3 Use of individual external auditors and external technical experts.10 7.4 Personnel records.10 7.5 Outsourcing.10 8 Information requirements.11 8.1 Publicly accessible information.11 8.2 Certification documents.11 8.3 Directory of certified clients.12 8.4 Reference to certification and use of marks.12 8.5 Confidentiality.13 8.6 Information exchange between a certification body and its clients.13 9 Process requirements.14 9.1 General requirements.14 9.2 Initial audit and certification.22 9.3 Surveillance activities.25 9.4 Recertification.26 9.5 Special audits.27 9.6 Suspending, withdrawing or reducing the scope of certification.27 9.7 Appeals.28 9.8 Complaints.28 9.9 Records of applicants and clients.29 10 Management system requirements for certification bodies.30 10.1 Options.30 10.2 Option 1: Management system requirements in accordance with ISO 9001.30 10.3 Option 2: General management system requirements.30 SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) iv © ISO 2011 — All rights reserved Annex A (normative)
Required knowledge and skills.34 Annex B (informative)
Possible evaluation methods.35 Annex C (informative)
Example of a process flow for determining and maintaining competence.37 Annex D (informative)
Desired personal behaviours.39 Annex E (informative)
Third-party audit and certification process.40 Annex F (informative)
Considerations for the audit programme, scope or plan.42 Bibliography.44
ISO/IEC 17021:2011(E) © ISO 2011 — All rights reserved v Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity. ISO and IEC
...
SLOVENSKI SIST EN ISO/IEC 17021
STANDARD
april 2011
Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in certificirajo
sisteme vodenja (ISO/IEC 17021:2011)
Conformity assessment – Requirements for bodies providing audit and
certification of management systems (ISO/IEC 17021:2011)
Évaluation de la conformité – Exigences pour les organismes procédant à l'audit
et à la certification des systèmes de management (ISO/IEC 17021:2011)
Konformitätsbewertung – Anforderungen an Stellen, die Managementsysteme
auditieren und zertifizieren (ISO/IEC 17021:2011)
Referenčna oznaka
ICS 03.120.20 SIST EN ISO/IEC 17021 (sl, en)
Nadaljevanje na strani II in od 1 do 75
© 2014-10: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO/IEC 17021 : 2011
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17021 (sl,en), Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in
certificirajo sisteme vodenja (ISO/IEC 17021:2011), 2011, ima status slovenskega standarda in je
istoveten evropskemu standardu EN ISO/IEC 17021, Conformity assessment – Requirements for
bodies providing audit and certification of management systems (ISO/IEC 17021:2011), 2011.
NACIONALNI PREDGOVOR
Besedilo standarda EN ISO/IEC 17021:2011 je pripravil tehnični odbor ISO/CASCO "Odbor za
ugotavljanje skladnosti" v sodelovanju s tehničnim odborom CEN/CLC/TC 1 "Merila za organe za
ugotavljanje skladnosti", katerega sekretariat vodi BSI. Slovenski standard SIST EN ISO/IEC
17021:2011 je prevod angleškega besedila evropskega standarda EN ISO/IEC 17021:2011. V primeru
spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v
angleškem jeziku. Slovensko-angleško izdajo standarda je pripravil SIST/TC UGA Ugotavljanje
skladnosti.
Odločitev za izdajo tega standarda je 3. marca 2011 sprejel SIST/TC UGA Ugotavljanje skladnosti.
ZVEZE S STANDARDI
S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen standardov, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO 9000:2005 Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2005)
SIST EN ISO/IEC 17000:2005 Ugotavljanje skladnosti – Slovar in splošna načela (enakovreden z
ISO/IEC 17000:2004)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO/IEC 17021:2011.
PREDHODNA IZDAJA
– SIST EN ISO/IEC 17021:2006.
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “mednarodni standard”, v SIST EN ISO/IEC
17021:2011 to pomeni “slovenski standard”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO/IEC 17021:2011 in je objavljen z dovoljenjem
CEN
Avenue Marnix 17
1050 Bruselj
Belgija
This national document is identical with EN ISO/IEC 17021:2011 and is published with the
permission of
CEN
Avenue Marnix 17
1050 Bruxelles
Belgium
II
EVROPSKI STANDARD EN ISO/IEC 17021
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE februar 2011
ICS: 03.120.20 Nadomešča EN ISO/IEC 17021:2006
Slovenska izdaja
Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in certificirajo
sisteme vodenja (ISO/IEC 17021:2011)
Conformity assessment – Évaluation de la conformité – Konformitätsbewertung –
Requirements for bodies providing Exigences pour les organismes Anforderungen an Stellen, die
audit and certification of procédant à l'audit et à la Managementsysteme auditieren und
management systems certification des systèmes de zertifizieren (ISO/IEC 17021:2011)
(ISO/IEC 17021:2011) management
(ISO/IEC 17021:2011)
Ta evropski standard je CEN sprejel 17. januarja 2011.
Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je
predpisano, da mora biti ta standard brez kakršnih koli sprememb sprejet kot nacionalni standard.
Najnovejši seznami teh nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko
dobijo pri Upravnem centru CEN-CENELEC ali katerem koli članu CEN in CENELEC.
Ta evropski standard obstaja v treh uradnih različicah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Upravnem centru CEN-CENELEC, veljajo kot uradne izdaje.
Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški odbori
Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Hrvaške,
Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije, Nizozemske,
Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske, Švice in
Združenega kraljestva.
CEN CENELEC
Evropski komite za standardizacijo Evropski komite za standardizacijo v elektrotehniki
European Committee for Standardization European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Normung Europäisches Komitee für Elektrotechnische Normung
Upravni center CEN: Centralni sekretariat CENELEC:
Avenue Marnix 17, B-1000 Bruselj Avenue Marnix 17, B-1000 Bruselj
© 2011. Lastnice avtorskih pravic so vse države članice CEN in CENELEC Ref. št. EN ISO/IEC 17021:2011 E
SIST EN ISO/IEC 17021 : 2011
Predgovor Foreword
Ta dokument (EN ISO/IEC 17021:2011) je This document (EN ISO/IEC 17021:2011) has
pripravil Odbor za ugotavljanje skladnosti v been prepared by the Committee on conformity
sodelovanju s tehničnim odborom assessment in collaboration with Technical
CEN/CENELEC/TC 1 "Merila za organe za Committee CEN/CENELEC/TC 1 “Criteria for
ugotavljanje skladnosti", katerega sekretariat conformity assessment bodies” the secretariat of
vodi BSI. which is held by BSI.
Ta evropski standard mora z objavo istovetnega This European Standard shall be given the
besedila ali z razglasitvijo dobiti status status of a national standard, either by
nacionalnega standarda najpozneje do avgusta publication of an identical text or by
2011, nacionalne standarde, ki so v nasprotju s endorsement, at the latest by August 2011, and
tem standardom, pa je treba umakniti najpozneje conflicting national standards shall be withdrawn
do avgusta 2011. at the latest by August 2011.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. CEN [in/ali CENELEC] ne prevzema subject of patent rights. CEN [and/or CENELEC]
odgovornosti za identifikacijo katerih koli ali vseh shall not be held responsible for identifying any
takih patentnih pravic. or all such patent rights.
Ta dokument nadomešča EN ISO/IEC This document supersedes EN ISO/IEC
17021:2006. 17021:2006.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN/CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards
nacionalne organizacije za standardizacijo organizations of the following countries are
naslednjih držav: Avstrije, Belgije, Bolgarije, bound to implement this European Standard:
Cipra, Češke republike, Danske, Estonije, Austria, Belgium, Bulgaria, Croatia, Cyprus,
Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Czech Republic, Denmark, Estonia, Finland,
Italije, Latvije, Litve, Luksemburga, Madžarske, France, Germany, Greece, Hungary, Iceland,
Malte, Nemčije, Nizozemske, Norveške, Poljske, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Portugalske, Romunije, Slovaške, Slovenije, Malta, Netherlands, Norway, Poland, Portugal,
Španije, Švedske, Švice in Združenega Romania, Slovakia, Slovenia, Spain, Sweden,
kraljestva. Switzerland and the United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo ISO/IEC 17021:2011 je CEN odobril The text of ISO/IEC 17021:2011 has been
brez sprememb kot EN ISO/IEC 17021:2011. approved by CEN as a EN ISO/IEC 17021:2011
without any modification.
SIST EN ISO/IEC 17021 : 2011
VSEBINA Stran CONTENTS Page
Predgovor.5 Foreword . 5
Uvod.6 Introduction. 6
1 Področje uporabe . 8 1 Scope . 8
2 Zveza s standardi . 8 2 Normative references. 8
3 Izrazi in definicije . 8 3 Terms and definitions. 8
4 Načela. 10 4 Principles.10
4.1 Splošno. 10 4.1 General. 10
4.2 Nepristranskost. 11 4.2 Impartiality. 11
4.3 Kompetentnost . 12 4.3 Competence. 12
4.4 Odgovornost. 12 4.4 Responsibility . 12
4.5 Odprtost. 12 4.5 Openness.12
4.6 Zaupnost. 13 4.6 Confidentiality.13
4.7 Odzivnost na pritožbe. 13 4.7 Responsiveness to complaints. 13
5 Splošne zahteve . 13 5 General requirements . 13
5.1 Pravne in pogodbene zadeve. 13 5.1 Legal and contractual matters. 13
5.2 Obvladovanje nepristranskosti . 14 5.2 Management of impartiality. 14
5.3 Obveznosti in financiranje.16 5.3 Liability and financing. 16
6 Strukturne zahteve . 16 6 Structural requirements. 16
6.1 Organizacijska struktura in najvišje 6.1 Organizational structure and top
vodstvo 16 management . 16
6.2 Odbor za varovanje nepristranskosti. 17 6.2 Committee for safeguarding impartiality 17
7 Zahteve glede virov . 18 7 Resource requirements . 18
7.1 Kompetentnost vodstva 7.1 Competence of management and
in osebja. 18 personnel. 18
7.2 Osebje, vključeno v aktivnosti 7.2 Personnel involved in the certification
certificiranja. 20 activities . 20
7.3 Uporaba posameznih zunanjih 7.3 Use of individual external
presojevalcev in zunanjih tehničnih auditors and external technical
strokovnjakov. 22 experts. 22
7.4 Zapisi o osebju . 22 7.4 Personnel records . 22
7.5 Oddajanje del zunanjim izvajalcem.23 7.5 Outsourcing . 23
8 Zahteve glede informacij . 24 8 Information requirements . 24
8.1 Javno dostopne informacije. 24 8.1 Publicly accessible information . 24
8.2 Certifikacijski dokumenti. 24 8.2 Certification documents . 24
8.3 Register certificiranih strank . 25 8.3 Directory of certified clients. 25
8.4 Sklicevanje na certifikacijo in uporaba 8.4 Reference to certification and use
znakov. 25 of marks. 25
8.5 Zaupnost. 26 8.5 Confidentiality.26
8.6 Izmenjava informacij med certifikacijskim 8.6 Information exchange between a
organom in njegovimi strankami . 27 certification body and its clients. 27
9 Zahteve glede procesov . 29 9 Process requirements . 29
SIST EN ISO/IEC 17021 : 2011
9.1 Splošne zahteve. 29 9.1 General requirements .29
9.2 Začetna presoja in certifikacija . 41 9.2 Initial audit and certification. 41
9.3 Nadzorne aktivnosti . 45 9.3 Surveillance activities . 45
9.4 Obnovitev certifikacije.46 9.4 Recertification. 46
9.5 Posebne presoje. 47 9.5 Special audits . 47
9.6 Začasni odvzem, preklic ali krčenje 9.6 Suspending, withdrawing or reducing
obsega certifikata. 48 the scope of certification . 48
9.7 Prizivi . 49 9.7 Appeals . 49
9.8 Pritožbe . 50 9.8 Complaints .50
9.9 Zapisi o vložnikih in strankah . 51 9.9 Records of applicants and clients . 51
10 Zahteve za sistem vodenja 10 Management system requirements for
certifikacijskih organov. 52 certification bodies. 52
10.1 Možnosti . 52 10.1 Options.52
10.2 Možnost št. 1: Zahteve za sistem 10.2 Option 1: Management system
vodenja v skladu requirements in accorda
...
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