Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements (ISO/IEC 17021-1:2015)

This part of ISO/IEC 17021 contains principles and requirements for the competence, consistency and
impartiality of bodies providing audit and certification of all types of management systems.
Certification bodies operating to this part of ISO/IEC 17021 do not need to offer all types of management
system certification.
Certification of management systems is a third-party conformity assessment activity (see
ISO/IEC 17000:2004, 5.5) and bodies performing this activity are therefore third-party conformity
assessment bodies.
NOTE 1 Examples of management systems include environmental management systems, quality management
systems and information security management systems.
NOTE 2 In this part of ISO/IEC 17021, certification of management systems is referred to as “certification” and
third-party conformity assessment bodies are referred to as “certification bodies”.
NOTE 3 A certification body can be non-governmental or governmental, with or without regulatory authority.
NOTE 4 This part of ISO/IEC 17021 can be used as a criteria document for accreditation, peer assessment or
other audit processes.

Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren und zertifizieren - Teil 1: Anforderungen (ISO/IEC 17021-1:2015)

Diese Internationale Norm enthält Grundsätze für und Anforderungen an die Kompetenz, Folgerichtigkeit und Unparteilichkeit von Stellen, die Audits und Zertifizierungen von Managementsystemen jeglicher Art (z. B. Umweltmanagementsystem, Qualitäts¬managementsystem, Informationssicherheitsmanagementsystem) 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   Eine Zertifizierungsstelle kann nichtstaatlich oder staatlich sein mit oder ohne regelsetzender Kompetenz.
ANMERKUNG 2   Diese Internationale Norm kann als Vorgabe für die Akkreditierung, Begutachtung unter Gleichrangigen oder für andere Auditprozesse genutzt werden.

Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management - Partie 1: Exigences (ISO/IEC 17021-1:2015)

L'ISO/IEC 17021-1:2015 spécifie les principes et les exigences relatifs à la compétence, à la cohérence et à l'impartialité des organismes procédant à l'audit et à la certification de tous les types de systèmes de management.
Les organismes de certification conformes à l'ISO/IEC 17021-1:2015 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 et 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 - 1. del: Zahteve (ISO/IEC 17021-1:2015)

Ta del standarda ISO/IEC 17021 določa načela in zahteve za usposobljenost, doslednost in nepristranskost organov, ki presojajo in certificirajo vse vrste sistemov vodenja.
Certifikacijskim organom, ki delujejo v skladu s tem delom ISO/IEC 17021, ni treba ponujati vseh vrst certificiranja sistemov vodenja.
Certificiranje sistemov vodenja je dejavnost ugotavljanja skladnosti, ki jo opravljajo tretje osebe (glej točko 5.5 standarda ISO/IEC 17000:2004); organi, ki izvajajo to aktivnost, so zato zunanji organi za ugotavljanje skladnosti.
OPOMBA 1: Primeri sistemov vodenja zajemajo sisteme ravnanja z okoljem, sisteme vodenja kakovosti in sisteme upravljanja informacijske varnosti.
OPOMBA 2: V tem delu standarda ISO/IEC 17021 se certificiranje sistemov vodenja imenuje »certificiranje«, zunanji organi za ugotavljanje skladnosti pa se imenujejo »certifikacijski organi«.
OPOMBA 3: Certifikacijski organ je lahko nevladni ali vladni organ z regulativno močjo ali brez nje.
OPOMBA 4: Ta del standarda ISO/IEC 17021 je mogoče uporabiti kot dokument z merili za akreditacijo, medsebojno ocenjevanje ali druge procese presojanja.

General Information

Status
Published
Public Enquiry End Date
04-May-2014
Publication Date
03-Sep-2015
Technical Committee
Current Stage
6100 - Translation of adopted SIST standards (Adopted Project)
Start Date
13-Aug-2015
Due Date
11-Aug-2016
Completion Date
21-Sep-2016

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SLOVENSKI STANDARD
SIST EN ISO/IEC 17021-1:2015
01-oktober-2015
1DGRPHãþD
SIST EN ISO/IEC 17021:2011

Ugotavljanje skladnosti - Zahteve za organe, ki presojajo in certificirajo sisteme

vodenja - 1. del: Zahteve (ISO/IEC 17021-1:2015)

Conformity assessment - Requirements for bodies providing audit and certification of

management systems - Part 1: Requirements (ISO/IEC 17021-1:2015)

Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren

und zertifizieren - Teil 1: Anforderungen (ISO/IEC 17021-1:2015)

Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la

certification des systèmes de management - Partie 1: Exigences (ISO/IEC 17021-
1:2015)
Ta slovenski standard je istoveten z: EN ISO/IEC 17021-1:2015
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17021-1:2015 en,fr

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO/IEC 17021-1:2015
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SIST EN ISO/IEC 17021-1:2015
EUROPEAN STANDARD
EN ISO/IEC 17021-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2015
ICS 03.120.20 Supersedes EN ISO/IEC 17021:2011
English Version
Conformity assessment - Requirements for bodies providing
audit and certification of management systems - Part 1:
Requirements (ISO/IEC 17021-1:2015)

Évaluation de la conformité - Exigences pour les Konformitätsbewertung - Anforderungen an Stellen, die

organismes procédant à l'audit et à la certification des Managementsysteme auditieren und zertifizieren - Teil 1:

systèmes de management - Partie 1: Exigences (ISO/IEC Anforderungen (ISO/IEC 17021-1:2015)

17021-1:2015)
This European Standard was approved by CEN on 6 June 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,

Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2015 All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 17021-1:2015 E

CEN/CENELE worldwide for CEN national Members and for CENELEC Members.
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SIST EN ISO/IEC 17021-1:2015
EN ISO/IEC 17021-1:2015 (E)
Contents Page

European foreword .............................................................................................................................................3

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SIST EN ISO/IEC 17021-1:2015
EN ISO/IEC 17021-1:2015 (E)
European foreword

This document (EN ISO/IEC 17021-1:2015) has been prepared by Technical Committee ISO/CASCO

"Committee on conformity assessment" in collaboration with Technical Committee CEN-CENELEC/TC 1

“Criteria for conformity assessment bodies” the secretariat of which is held by BSI.

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 January 2016, and conflicting national standards shall be withdrawn at

the latest by January 2016.

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 responsible for identifying any or all such patent rights.

This document supersedes EN ISO/IEC 17021:2011.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association.

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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO/IEC 17021-1:2015 has been approved by CEN as EN ISO/IEC 17021-1:2015 without any

modification.
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SIST EN ISO/IEC 17021-1:2015
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SIST EN ISO/IEC 17021-1:2015
INTERNATIONAL ISO/IEC
STANDARD 17021-1
First edition
2015-06-15
Conformity assessment —
Requirements for bodies
providing audit and certification of
management systems —
Part 1:
Requirements
Évaluation de la conformité — Exigences pour les organismes
procédant à l’audit et à la certification des systèmes de management —
Partie 1: Exigences
Reference number
ISO/IEC 17021-1:2015(E)
ISO/IEC 2015
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SIST EN ISO/IEC 17021-1:2015
ISO/IEC 17021-1:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2015, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO/IEC 2015 – All rights reserved
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SIST EN ISO/IEC 17021-1:2015
ISO/IEC 17021-1:2015(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Principles ..................................................................................................................................................................................................................... 4

4.1 General ........................................................................................................................................................................................................... 4

4.2 Impartiality ................................................................................................................................................................................................ 4

4.3 Competence ............................................................................................................................................................................................... 5

4.4 Responsibility .......................................................................................................................................................................................... 5

4.5 Openness ...................................................................................................................................................................................................... 5

4.6 Confidentiality ......................................................................................................................................................................................... 6

4.7 Responsiveness to complaints ................................................................................................................................................... 6

4.8 Risk-based approach .......................................................................................................................................................................... 6

5 General requirements ..................................................................................................................................................................................... 6

5.1 Legal and contractual matters ................................................................................................................................................... 6

5.1.1 Legal responsibility ....................................................................................................................................................... 6

5.1.2 Certification agreement ............................................................................................................................................. 7

5.1.3 Responsibility for certification decisions ................................................................................................... 7

5.2 Management of impartiality ........................................................................................................................................................ 7

5.3 Liability and financing ...................................................................................................................................................................... 9

6 Structural requirements .............................................................................................................................................................................. 9

6.1 Organizational structure and top management ......................................................................................................... 9

6.2 Operational control ............................................................................................................................................................................. 9

7 Resource requirements ..............................................................................................................................................................................10

7.1 Competence of personnel ...........................................................................................................................................................10

7.1.1 General considerations ............................................................................................................................................10

7.1.2 Determination of competence criteria .......................................................................................................10

7.1.3 Evaluation processes .................................................................................................................................................10

7.1.4 Other considerations .................................................................................................................................................10

7.2 Personnel involved in the certification activities ...................................................................................................10

7.3 Use of individual external auditors and external technical experts .......................................................11

7.4 Personnel records..............................................................................................................................................................................12

7.5 Outsourcing.............................................................................................................................................................................................12

8 Information requirements ......................................................................................................................................................................12

8.1 Public information ............................................................................................................................................................................12

8.2 Certification documents ...............................................................................................................................................................13

8.3 Reference to certification and use of marks ...............................................................................................................14

8.4 Confidentiality ......................................................................................................................................................................................15

8.5 Information exchange between a certification body and its clients ......................................................15

8.5.1 Information on the certification activity and requirements ...................................................15

8.5.2 Notice of changes by a certification body ................................................................................................16

8.5.3 Notice of changes by a certified client ........................................................................................................16

9 Process requirements ..................................................................................................................................................................................16

9.1 Pre-certification activities ..........................................................................................................................................................16

9.1.1 Application .........................................................................................................................................................................16

9.1.2 Application review ......................................................................................................................................................16

9.1.3 Audit programme .........................................................................................................................................................17

9.1.4 Determining audit time ...........................................................................................................................................18

9.1.5 Multi-site sampling .....................................................................................................................................................18

9.1.6 Multiple management systems standards ..............................................................................................19

© ISO/IEC 2015 – All rights reserved iii
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SIST EN ISO/IEC 17021-1:2015
ISO/IEC 17021-1:2015(E)

9.2 Planning audits ....................................................................................................................................................................................19

9.2.1 Determining audit objectives, scope and criteria .............................................................................19

9.2.2 Audit team selection and assignments ......................................................................................................19

9.2.3 Audit plan ............................................................................................................................................................................21

9.3 Initial certification ............................................................................................................................................................................22

9.3.1 Initial certification audit ........................................................................................................................................22

9.4 Conducting audits ..............................................................................................................................................................................23

9.4.1 General...................................................................................................................................................................................23

9.4.2 Conducting the opening meeting ....................................................................................................................23

9.4.3 Communication during the audit ...................................................................................................................24

9.4.4 Obtaining and verifying information ...........................................................................................................24

9.4.5 Identifying and recording audit findings .................................................................................................25

9.4.6 Preparing audit conclusions ...............................................................................................................................25

9.4.7 Conducting the closing meeting ......................................................................................................................25

9.4.8 Audit report .......................................................................................................................................................................26

9.4.9 Cause analysis of nonconformities ................................................................................................................27

9.4.10 Effectiveness of corrections and corrective actions .......................................................................27

9.5 Certification decision ......................................................................................................................................................................27

9.5.1 General...................................................................................................................................................................................27

9.5.2 Actions prior to making a decision ...............................................................................................................28

9.5.3 Information for granting initial certification ........................................................................................28

9.5.4 Information for granting recertification ...................................................................................................28

9.6 Maintaining certification .............................................................................................................................................................28

9.6.1 General...................................................................................................................................................................................28

9.6.2 Surveillance activities ...............................................................................................................................................29

9.6.3 Recertification .................................................................................................................................................................30

9.6.4 Special audits ...................................................................................................................................................................31

9.6.5 Suspending, withdrawing or reducing the scope of certification .......................................31

9.7 Appeals .......................................................................................................................................................................................................31

9.8 Complaints ...............................................................................................................................................................................................32

9.9 Client records ........................................................................................................................................................................................33

10 Management system requirements for certification bodies ...............................................................................34

10.1 Options ........................................................................................................................................................................................................34

10.2 Option A: General management system requirements .....................................................................................34

10.2.1 General...................................................................................................................................................................................34

10.2.2 Management system manual ..............................................................................................................................34

10.2.3 Control of documents ...............................................................................................................................................34

10.2.4 Control of records ........................................................................................................................................................35

10.2.5 Management review ..................................................................................................................................................35

10.2.6 Internal audits .................................................................................................................................................................36

10.2.7 Corrective actions ........................................................................................................................................................36

10.3 Option B: Management system requirements in accordance with ISO 9001.................................36

10.3.1 General...................................................................................................................................................................................36

10.3.2 Scope .......................................................................................................................................................................................37

10.3.3 Customer focus ...............................................................................................................................................................37

10.3.4 Management review ..................................................................................................................................................37

Annex A (normative) Required knowledge and skills .....................................................................................................................38

Annex B (informative) Possible evaluation methods .......................................................................................................................41

Annex C (informative) Example of a process flow for determining and maintaining competence ..43

Annex D (informative) Desired personal behaviour .........................................................................................................................45

Annex E (informative) Audit and certification process ..................................................................................................................46

Bibliography .............................................................................................................................................................................................................................48

iv © ISO/IEC 2015 – All rights reserved
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SIST EN ISO/IEC 17021-1:2015
ISO/IEC 17021-1:2015(E)
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 technical committees collaborate in fields of mutual interest. Other international

organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the

work. In the field of conformity assessment, ISO and IEC develop joint ISO/IEC documents under the

management of the ISO Committee on Conformity assessment (ISO/CASCO).

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 document 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject

of patent rights. ISO and IEC 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).

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

constitute an endorsement.

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 WTO principles in the Technical Barriers

to Trade (TBT) see the following URL: Foreword - Supplementary information

ISO/IEC 17021-1 was prepared by the ISO Committee on Conformity Assessment (CASCO). It was circulated

for voting to the national bodies of both ISO and IEC, and was approved by both organizations.

This first edition of ISO/IEC 17021-1 cancels and replaces ISO/IEC 17021:2011, which has been

technically revised.

ISO/IEC 17021 consists of the following parts, under the general title Conformity assessment —

Requirements for bodies providing audit and certification of management systems:
— Part 1: Requirements

— Part 2: Competence requirements for auditing and certification of environmental management systems

[Technical Specification]

— Part 3: Competence requirements for auditing and certification of quality management systems

[Technical Specification]

— Part 4: Competence requirements for auditing and certification of event sustainability management

systems [Technical Specification]

— Part 5: Competence requirements for auditing and certification of asset management systems [Technical

Specification]

— Part 6: Competence requirements for auditing and certification of business continuity management

systems [Technical Specification]

— Part 7: Competence requirements for auditing and certification of road traffic safety management

systems [Technical Specification]
© ISO/IEC 2015 – All rights reserved v
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SIST EN ISO/IEC 17021-1:2015
ISO/IEC 17021-1:2015(E)
Introduction

Certification of a management system, such as the environmental management system, quality

management system or information security management system of an organization, is one means

of providing assurance that the organization has implemented a system for the management of the

relevant aspects of its activities, products and services, in line with the organization’s policy and the

requirements of the respective international management system standard.

This part of ISO/IEC 17021 specifies requirements for bodies providing audit and certification of

management systems. It gives generic requirements for such bodies performing audit and certification in

the field of quality, the environment and other types of management systems. Such bodies are referred to

as certification bodies. Observance of these requirements is intended to
...

SLOVENSKI SIST EN ISO/IEC 17021-1
STANDARD
oktober 2015
Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in certificirajo
sisteme vodenja – 1. del: Zahteve (ISO/IEC 17021-1:2015)

Conformity assessment – Requirements for bodies providing audit and certification

of management systems – Part 1: Requirements (ISO/IEC 17021-1:2015)
Évaluation de la conformité – Exigences pour les organismes procédant à l’audit
et à la certification des systèmes de management – Partie 1: Exigences
(ISO/IEC 17021-1:2015)
Konformitätsbewertung – Anforderungen an Stellen, die Managementsysteme
auditieren und zertifizieren – Teil 1: Anforderungen (ISO/IEC 17021-1:2015)
Referenčna oznaka
ICS 03.120.20 SIST EN ISO/IEC 17021-1:2015 (sl, en)
Nadaljevanje na strani II in od 1 do 87

© 2016-10: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO/IEC 17021-1 : 2015
NACIONALNI UVOD

Standard SIST EN ISO/IEC 17021-1 (sl,en), Ugotavljanje skladnosti – Zahteve za organe, ki presojajo

in certificirajo sisteme vodenja – 1. del: Zahteve (ISO/IEC 17021-1:2015), 2015, ima status slovenskega

standarda in je istoveten evropskemu standardu EN ISO/IEC 17021-1, Conformity assessment –

Requirements for bodies providing audit and certification of management systems – Part 1: Requirements

(ISO/IEC 17021-1:2015), 2015.
NACIONALNI PREDGOVOR

Besedilo standarda EN ISO/IEC 17021-1:2015 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 17021-1:2015

je prevod angleškega besedila evropskega standarda EN ISO/IEC 17021-1:2015. 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.

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 9000:2015 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar (ISO
9000:2015)

SIST EN ISO/IEC 17000:2005 (sl,en,ne,fr) Ugotavljanje skladnosti – Slovar in splošna načela

(enakovreden ISO/IEC 17000:2004)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO/IEC 17021-1:2015.
PREDHODNA IZDAJA
– SIST EN ISO/IEC 17021:2011.
OPOMBE

– Povsod, kjer se v besedilu standarda uporablja izraz “mednarodni standard”, v SIST EN ISO/IEC

17021-1:2015 to pomeni “slovenski standard”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO/IEC 17021-1:2015 in je objavljen z dovoljenjem

CEN
Avenue Marnix 17
1050 Bruselj
Belgija

This national document is identical with EN ISO/IEC 17021-1:2015 and is published with the

permission of
CEN
Avenue Marnix 17
1050 Bruxelles
Belgium
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EVROPSKI STANDARD EN ISO/IEC 17021-1
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE julij 2015
ICS: 03.120.20 Nadomešča EN ISO/IEC 17021:2011
Slovenska izdaja
Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in certificirajo
sisteme vodenja – 1. del: Zahteve
(ISO/IEC 17021-1:2015)

Conformity assessment – Évaluation de la conformité – Exigences Konformitätsbewertung –

Requirements for bodies providing pour les organismes procédant à l’audit Anforderungen an Stellen, die

audit and certification of et à la certification des systèmes de Managementsysteme auditieren und

management systems – Part 1: management – Partie 1: Exigences zertifizieren – Teil 1: Anforderungen

Requirements (ISO/IEC 17021- (ISO/IEC 17021-1:2015) (ISO/IEC 17021-1:2015)
1:2015)
Ta evropski standard je CEN sprejel 6. junija 2015.

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 in njihovi bibliografski podatki se na zahtevo lahko dobijo

pri Upravnem centru CEN-CENELEC ali kateremkoli članu CEN in CENELEC.

Ta evropski standard obstaja v treh uradnih izdajah (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, Nekdanje jugoslovanske republike

Makedonije, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije,

Španije, Švedske, Švice, Turčije 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-CENELEC: Avenue Marnix 17, B-1000 Bruselj

© 2015. Lastnice avtorskih pravic so vse države članice CEN in CENELEC Ref. št. EN ISO/IEC 17021-1:2015 E

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SIST EN ISO/IEC 17021-1 : 2015
Predgovor k evropskemu standardu European foreword

Ta dokument (EN ISO/IEC 17021-1:2015) je This document (EN ISO/IEC 17021-1:2015) has

pripravil tehnični odbor ISO/CASCO “Odbor za been prepared by Technical Committee

ugotavljanje skladnosti” v sodelovanju s ISO/CASCO "Committee on conformity

tehničnim odborom CEN-CENELEC/TC 1 "Merila assessment" in collaboration with Technical

za organe za ugotavljanje skladnosti", katerega Committee CEN-CENELEC/TC 1 “Criteria for

sekretariat vodi BSI. conformity assessment bodies” the secretariat of
which is held by BSI. N ISO/IEC 17021-1:2015)

Ta evropski standard mora dobiti status This European Standard shall be given the

nacionalnega standarda z objavo istovetnega status of a national standard, either by

besedila ali z razglasitvijo najpozneje do januarja publication of an identical text or by

2016, nacionalne standarde, ki so v nasprotju s endorsement, at the latest by January 2016, and

tem standardom, pa je treba umakniti najpozneje conflicting national standards shall be withdrawn

do januarja 2016. at the latest by January 2016.

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:
17021:2011. 2011.

Ta dokument je bil pripravljen v okviru mandata, This document has been prepared under a

ki sta ga CEN podelila Evropska komisija in mandate given to CEN by the European
Evropsko združenje za prosto trgovino. Commission and the European Free Trade
Association.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN-CENELEC Internal

morajo ta evropski standard obvezno uvesti Regulations, the national standards organizations

nacionalne organizacije za standardizacijo of the following countries are bound to

naslednjih držav: Avstrije, Belgije, Bolgarije, implement this European Standard: Austria,

Cipra, Češke republike, Danske, Estonije, Finske, Belgium, Bulgaria, Croatia, Cyprus, Czech

Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Republic, Denmark, Estonia, Finland, Former

Latvije, Litve, Luksemburga, Madžarske, Malte, Yugoslav Republic of Macedonia, France,

Nekdanje jugoslovanske republike Makedonije, Germany, Greece, Hungary, Iceland, Ireland,

Nemčije, Nizozemske, Norveške, Poljske, Italy, Latvia, Lithuania, Luxembourg, Malta,

Portugalske, Romunije, Slovaške, Slovenije, Netherlands, Norway, Poland, Portugal,

Španije, Švedske, Švice, Turčije in Združenega Romania, Slovakia, Slovenia, Spain, Sweden,

kraljestva. Switzerland, Turkey and the United Kingdom.
Razglasitvena objava Endorsement notice

Besedilo ISO/IEC 17021-1:2015 je CEN odobril The text of ISO/IEC 17021-1:2015 has been

brez sprememb kot EN ISO/IEC 17021-1:2015. approved by CEN as EN ISO/IEC 17021-1:2015

without any modification.
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SIST EN ISO/IEC 17021-1 : 2015
Vsebina Stran Contents Page

Predgovor ......................................................... 7 Foreword.............................................................. 7

Uvod .................................................................. 9 Introduction ......................................................... 9

1 Področje uporabe ....................................... 11 1 Scope ............................................................ 11

2 Zveze s standardi ....................................... 11 2 Normative references ................................... 11

3 Izrazi in definicije......................................... 12 3 Terms and definitions ................................... 12

4 Načela ......................................................... 15 4 Principles ...................................................... 15

4.1 Splošno .................................................... 15 4.1 General ...................................................... 15

4.2 Nepristranskost ........................................ 15 4.2 Impartiality ................................................. 15

4.3 Kompetentnost ......................................... 16 4.3 Competence .............................................. 16

4.4 Odgovornost ............................................ 17 4.4 Responsibility ............................................ 17

4.5 Odprtost ................................................... 17 4.5 Openness .................................................. 17

4.6 Zaupnost .................................................. 17 4.6 Confidentiality 17

4.7 Odzivnost na pritožbe .............................. 17 4.7 Responsiveness to complaints .................. 17

4.8 Pristop na podlagi tveganja ..................... 18 4.8 Risk-based approach ................................. 18

5 Splošne zahteve ......................................... 18 5 General requirements ................................... 18

5.1 Pravne in pogodbene zadeve .................. 18 5.1 Legal and contractual matters ................... 18

5.1.1 Pravna odgovornost .............................. 18 5.1.1 Legal responsibility ................................. 18

5.1.2 Pogodba o certificiranju ........................ 18 5.1.2 Certification agreement .......................... 18

5.1.3 Odgovornost za odločitve 5.1.3 Responsibility for certification

o certifikaciji ............................................... 19 decisions ...................................................... 19

5.2 Obvladovanje nepristranskosti ................. 19 5.2 Management of impartiality ....................... 19

5.3 Obveznosti in financiranje ........................ 22 5.3 Liability and financing ................................ 22

6 Strukturne zahteve ...................................... 22 6 Structural requirements ................................ 22

6.1 Organizacijska struktura in 6.1 Organizational structure and top

najvišje vodstvo ......................................... 22 management ................................................ 22

6.2 Operativni nadzor .................................... 23 6.2 Operational control .................................... 23

7 Zahteve glede virov .................................... 23 7 Resource requirements ................................ 23

7.1 Kompetentnost osebja ............................. 23 7.1 Competence of personnel ......................... 23

7.1.1 Splošno ................................................. 23 7.1.1 General considerations .......................... 23

7.1.2 Določanje kriterijev kompetentnosti ...... 24 7.1.2 Determination of competence criteria ..... 24

7.1.3 Procesi vrednotenja .............................. 24 7.1.3 Evaluation processes ............................. 24

7.1.4 Drugi razmisleki .................................... 25 7.1.4 Other considerations .............................. 25

7.2 Osebje, vključeno v aktivnosti 7.2 Personnel involved in the certification

certificiranja ............................................... 25 activities ....................................................... 25

7.3 Vključitev posameznih zunanjih 7.3 Use of individual external auditors

presojevalcev in zunanjih tehničnih and external technical experts ..................... 27

strokovnjakov ............................................. 27

7.4 Zapisi o osebju ......................................... 27 7.4 Personnel records ..................................... 27

7.5 Oddajanje del zunanjim izvajalcem ......... 27 7.5 Outsourcing ............................................... 27

8 Zahteve glede informacij ............................. 28 8 Information requirements .............................. 28

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SIST EN ISO/IEC 17021-1 : 2015

8.1 Javne informacije ..................................... 28 8.1 Public information ...................................... 28

8.2 Certifikacijske listine ................................ 29 8.2 Certification documents ............................. 29

8.3 Sklicevanje na certifikacijo in 8.3 Reference to certification and use

uporaba znakov ......................................... 30 of marks ....................................................... 30

8.4 Zaupnost .................................................. 32 8.4 Confidentiality ............................................ 32

8.5 Izmenjava informacij med certifikacijskim 8.5 Information exchange between a certification

organom in njegovimi strankami ................ 33 body and its clients ...................................... 33

8.5.1 Informacije o aktivnosti in zahtevah 8.5.1 Information on the certification activity and

certificiranja ................................................ 33 requirements ................................................ 33

8.5.2 Obvestilo certifikacijskega organa o 8.5.2 Notice of changes by a certification

spremembah .............................................. 33 body ............................................................. 33

8.5.3 Obvestilo certificirane stranke o 8.5.3 Notice of changes by a certified

spremembah .............................................. 34 client ............................................................ 34

9 Zahteve glede procesov ............................ 34 9 Process requirements ................................... 34

9.1 Aktivnosti pred certificiranjem .................. 34 9.1 Pre-certification activities ........................... 34

9.1.1 Vloga ..................................................... 34 9.1.1 Application .............................................. 34

9.1.2 Pregled vloge ........................................ 35 9.1.2 Application review ................................... 35

9.1.3 Program presoj ..................................... 35 9.1.3 Audit programme .................................... 35

9.1.4 Določanje časa presoje ........................ 37 9.1.4 Determining audit time ........................... 37

9.1.5 Vzorčenje na več lokacijah ................... 38 9.1.5 Multi-site sampling .................................. 38

9.1.6 Standardi za več sistemov 9.1.6 Multiple management systems

vodenja ...................................................... 38 standards ..................................................... 38

9.2 Planiranje presoj ...................................... 38 9.2 Planning audits .......................................... 38

9.2.1 Določanje ciljev, obsega in kriterijev 9.2.1 Determining audit objectives, scope and

presoje ....................................................... 38 criteria .......................................................... 38

9.2.2 Izbira in imenovanje presojevalske 9.2.2 Audit team selection and assignments ... 39

skupine ...................................................... 39

9.2.3 Plan presoje .......................................... 41 9.2.3 Audit plan ................................................ 41

9.3 Začetno certificiranje ................................ 43 9.3 Initial certification ....................................... 43

9.3.1 Začetna certifikacijska presoja.............. 43 9.3.1 Initial certification audit ........................... 43

9.4 Izvajanje presoj ........................................ 45 9.4 Conducting audits ...................................... 45

9.4.1 Splošno ................................................. 45 9.4.1 General ................................................... 45

9.4.2 Izvedba uvodnega sestanka ................. 45 9.4.2 Conducting the opening meeting ............ 45

9.4.3 Komuniciranje med presojo ................. 46 9.4.3 Communication during the audit ............. 46

9.4.4 Pridobivanje in preverjanje informacij ... 47 9.4.4 Obtaining and verifying information ........ 47

9.4.5 Identificiranje in zapisovanje 9.4.5 Identifying and recording audit

ugotovitev presoje ...................................... 47 findings ........................................................ 47

9.4.6 Priprava sklepov presoje ..................... 48 9.4.6 Preparing audit conclusions ................... 48

9.4.7 Izvedba zaključnega sestanka .............. 48 9.4.7 Conducting the closing meeting ............. 48

9.4.8 Poročilo o presoji .................................. 49 9.4.8 Audit report ............................................. 49

9.4.9 Analiza vzrokov neskladnosti ................ 50 9.4.9 Cause analysis of nonconformities ......... 50

9.4.10 Učinkovitost korekcij in korektivnih 9.4.10 Effectiveness of corrections and

ukrepov ...................................................... 50 corrective actions ........................................ 50

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SIST EN ISO/IEC 17021-1 : 2015

9.5 Odločitev o certifikaciji ............................. 51 9.5 Certification decision ................................. 51

9.5.1 Splošno ................................................. 51 9.5.1 General ................................................... 51

9.5.2 Aktivnosti pred sprejemanjem 9.5.2 Actions prior to making a

odločitve ..................................................... 52 decision ....................................................... 52

9.5.3 Informacije za podelitev začetne 9.5.3 Information for granting initial

certifikacije ................................................. 52 certification .................................................. 52

9.5.4 Informacije za obnovitev certifikacije .... 53 9.5.4 Information for granting recertification .... 53

9.6 Vzdrževanje certifikacije .......................... 53 9.6 Maintaining certification ............................. 53

9.6.1 Splošno ................................................. 53 9.6.1 General ................................................... 53

9.6.2 Nadzorne aktivnosti .............................. 53 9.6.2 Surveillance activities ............................. 53

9.6.3 Obnovitev certifikacije ........................... 54 9.6.3 Recertification ......................................... 54

9.6.4 Posebne presoje ................................... 56 9.6.4 Special audits ......................................... 56

9.6.5 Začasni odvzem, preklic ali krčenje 9.6.5 Suspending, withdrawing or reducing the

obsega certifikacije .................................... 56 scope of certification .................................... 56

9.7 Prizivi ....................................................... 57 9.7 Appeals ...................................................... 57

9.8 Pritožbe .................................................... 58 9.8 Complaints ................................................. 58

9.9 Zapisi o strankah ..................................... 59 9.9 Client records ............................................ 59

10 Zahteve za sistem vodenja 10 Management system requirements for

certifikacijskih organov ............................... 60 certification bodies ....................................... 60

10.1 Možnosti ................................................. 60 10.1 Options .................................................... 60

10.2 Možnost A: Splošne zahteve 10.2 Option A: General management system

za sistem vodenja ...................................... 61 requirements ................................................ 61

10.2.1 Splošno ............................................... 61 10.2.1 General ................................................. 61

10.2.2 Poslovnik sistema vodenja ................. 61 10.2.2 Management system manual ............... 61

10.2.3 Obvladovanje dokumentov ................ 61 10.2.3 Control of documents ........................... 61

10.2.4 Obvladovanje zapisov ........................ 62 10.2.4 Control of records ................................. 62

10.2.5 Vodstveni pregled .............................. 62 10.2.5 Management review ............................. 62

10.2.6 Notranje presoje ................................. 63 10.2.6 Internal audits ....................................... 63

10.2.7 Korektivni ukrepi ................................ 64 10.2.7 Corrective actions ................................. 64

10.3 Možnost B: Zahteve za sistem 10.3 Option B: Management system

vodenja v skladu z ISO 9001 ..................... 64 requirements in accordance with

ISO 9001 ..................................................... 64

10.3.1 Splošno ............................................... 64 10.3.1 General ................................................. 64

10.3.2 Obseg ................................................. 64 10.3.2 Scope ................................................... 64

10.3.3 Osredotočenost na odjemalce ............ 65 10.3.3 Customer focus .................................... 65

10.3.4 Vodstveni pregled .............................. 65 10.3.4 Management review ............................. 65

Dodatek A (normativni): Potrebno znanje Annex A (normative) Required knowledge and

in veščine ................................................... 66 skills ............................................................. 67

Dodatek B (informativni): Možne metode Annex B (informative) Possible evaluation

vrednotenja ................................................ 72 methods ....................................................... 73

Dodatek C (informativni): Primer poteka Annex C (informative) Example of a process flow

procesa za ugotavljanje in vzdrževanje for determining and maintaining

kompetentnosti .......................................... 76 competence .................................................. 77

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SIST EN ISO/IEC 17021-1 : 2015
Dodatek D (informativni): Zaželeno osebno Annex D (informative) Desired personal

vedenje ...................................................... 80 behaviour ..................................................... 81

Dodatek E (informativni): Proces Annex E (informative) Audit and certification

presoje in certificiranja ............................... 82 process ........................................................ 83

Literatura ......................................................... 86 Bibliography ...................................................... 87

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SIST EN ISO/IEC 17021-1 : 2015
Predgovor Foreword

ISO (Mednarodna organizacija za standardizacijo) ISO (the International Organization for

in IEC (Mednarodna elektrotehniška komisija) Standardization) and IEC (the International

tvorita specializiran sistem za svetovno Electrotechnical Commission) form the specialized

standardizacijo. Nacionalni organi, ki so člani system for worldwide standardization. National

ISO ali IEC, sodelujejo pri pripravi mednarodnih bodies that are members of ISO or IEC participate

standardov prek tehničnih odborov, ki jih za in the development of International Standards

obravnavanje določenih strokovnih področij through technical committees established by the

ustanovi ustrezna organizacija. Tehnični odbori respective organization to deal with particular fields

ISO in IEC sodelujejo na področjih skupnega of technical activity. ISO and IEC technical

interesa. Pri delu sodelujejo tudi druge committees collaborate in fields of mutual interest.

mednarodne, vladne in nevladne organizacije, ki Other international organizations, governmental

so povezane z ISO in IEC. Na področju and non-governmental, in liaison with ISO and

ugotavljanja skladnosti ISO in IEC pripravljata IEC, also take part in the work. In the field of

skupne dokumente pod vodstvom Odbora conformity assessment, ISO and IEC develop joint

ISO/IEC za ugotavljanje skladnosti ISO/IEC documents under the management of the
(ISO/CASCO). ISO Committee on Conformity assessment
(ISO/CASCO).
Postopki, uporabljeni pri razvoju tega The procedures used to develop this

dokumenta, in postopki, predvideni za njegovo document and those intended for its further

nadaljnje vzdrževanje, so opisani v Direktivah maintenance are described in the ISO/IEC

ISO/IEC, 1. del. Posebna pozornost naj se Directives, Part 1. In particular the different

nameni različnim kriterijem odobritve, potrebnim approval criteria needed for the different types

za različne vrste dokumentov. Ta dokument je bil of document should be noted. This document

pripravljen skladno z uredniškimi pravili Direktiv was drafted in accordance with the editorial

ISO/IEC, 2. del (glej www.iso.org/directives). rules of the ISO/IEC Directives, Part 2 (see

w w w.iso.org/directives).

Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some

elementov tega dokumenta predmet patentnih of the elements of this document may be the

pravic. ISO in IEC ne prevzemata odgovornosti subject of patent rights. ISO and IEC shall not

za prepoznavanje katerihkoli ali vseh takih be held responsible for identifying any or all

patentnih pravic. Podrobnosti o morebitnih such patent rights. Details of any patent rights

patentnih pravicah, prepoznanih med pripravo identified during the development of the

tega dokumenta, bodo navedene v uvodu in/ali document will be in the Introduction and/or on the

na seznamu patentnih izjav, ki jih je prejela ISO list of patent declarations received (see

organizacija ISO (glej www.iso.org/patents). w w w.iso.org/patents).

Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is

dokumentu, so informacije za uporabnike in ne information given for the convenience of users

pomenijo podpore blagovni znamki. and does not constitute an endorsement.

Za razlago pomena specifičnih izrazov in For an explanation on the meaning of ISO

terminov ISO, povezanih z ugotavljanjem specific terms and expressions related to

skladnosti, ter informacije o tem, kako ISO conformity assessment, as well as information

spoštuje načela Mednarodne trgovinske about ISO’s adherence to the WTO principles in

organizacije (WTO) v Tehničnih ovirah pri the Technical Barriers to Trade (TBT) see the

trgovanju (TBT), glej naslednji naslov URL: following URL: Foreword – Supplementary

Foreword – Supplementary information. information

ISO/IEC 17021-1 je pripravil Odbor ISO za ISO/IEC 17021-1 was prepared by the ISO

ugotavljanje skladnosti (CASCO). Poslan je bil v Committee on Conformity Assessment

glasovanje nacionalnim organom ISO in IEC in (CASCO). It was circulated for voting to the

obe organizaciji sta ga odobrili. national bodies of both ISO and IEC, and was
approved by both organizations.
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SIST EN ISO/IEC 17021-1 : 2015

Ta prva izdaja ISO/IEC 17021-1 razveljavlja in This first edition of ISO/IEC 17021-1 cancels and

nadomešča ISO/IEC 17021:2011, ki je bil replaces ISO/IEC 17021:2011, which has been

strokovno revidiran. technically revised.

Standard ISO/IEC 17021 s splošnim naslovom ISO/IEC 17021 consists of the following parts,

Ugotavljanje skladnosti – Zahteve za organe, ki under the general title Conformity assessment

presojajo in certificirajo sisteme vodenja, je – Requirements for bodies providing audit and

sestavljen iz naslednjih delov: certification of management systems:
– 1. del: Zahteve – Part 1: Requirements
– 2. del: Zahteve glede kompetentnosti za – P
...

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