EN ISO 19011:2018

Guidelines for auditing management systems (ISO 19011:2018)

This document provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of management systems or manage an audit programme.
The application of this document to other types of audits is possible, provided that special consideration is given to the specific competence needed.

Leitfaden zur Auditierung von Managementsystemen (ISO 19011:2018)

Dieses Dokument bietet eine Anleitung zum Auditieren von Managementsystemen, einschließlich der Auditprinzipien, der Steuerung eines Auditprogramms und der Durchführung von Audits von Management¬systemen sowie zur Beurteilung der Kompetenz derer, die in den Auditprozess einbezogen sind. Diese Tätigkeiten beziehen die Person(en), die das Auditprogramm steuert (steuern), Auditoren und Auditteams mit ein.
Es ist auf alle Organisationen, die interne oder externe Audits von Managementsystemen planen und durchführen oder ein Auditprogramm steuern müssen, anwendbar.
Die Anwendung dieses Dokuments auf andere Arten von Audits ist möglich, vorausgesetzt, besondere Aufmerksamkeit wird der speziellen Kompetenz, die erforderlich ist, beigemessen.

Lignes directrices pour l'audit des systèmes de management (ISO 19011:2018)

Le présent document fournit des lignes directrices sur l'audit de systèmes de management, comprenant les principes de l'audit, le management d'un programme d'audit et la réalisation d'audits de systèmes de management. Elle donne également des lignes directrices sur l'évaluation de la compétence des personnes impliquées dans le processus d'audit. Ces activités concernent le(s) responsable(s) du management du programme d'audit, les auditeurs et les équipes d'audit.
Il est applicable à tous les organismes qui doivent planifier et réaliser des audits internes ou externes de systèmes de management ou manager un programme d'audit.
Le présent document peut, en principe, s'appliquer à d'autres types d'audits, à condition toutefois d'accorder une attention toute particulière aux compétences spécifiques requises.

Smernice za presojanje sistemov vodenja (ISO 19011:2018)

Ta dokument opisuje smernice za presojanje sistemov vodenja, vključno z načeli presojanja, vodenjem programa presoje in izvajanjem presoj sistemov vodenja ter smernicami za oceno usposobljenosti posameznikov, vključenih v postopek presoje. Te dejavnosti zajemajo posameznike, ki vodijo program presoje, presojevalce in skupine za presojo.
Uporablja se za vse organizacije, ki morajo načrtovati in izvajati notranje ali zunanje presoje sistemov vodenja ali voditi program presoje.
Ta dokument se lahko uporablja za druge vrste presoj, če je posebna pozornost namenjena posebni usposobljenosti, ki je potrebna zanje.

General Information

• Status: Published
• Publication Date: 03-Jul-2018
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 03.120.20 - Product and company certification. Conformity assessment
• ICS: 13.020.10 - Environmental management
• Technical Committee: CEN/CLC/TC 1 - Criteria for conformity assessment bodies
• Drafting Committee: CEN/CLC/TC 1 - Criteria for conformity assessment bodies
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 04-Jul-2018
• Completion Date: 04-Jul-2018
• Directive: 765/2008 - REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
• Mandate: M/417 - Standardisation mandate addessed to CEN, CENELEC, and ETSI for the use of Harmonised Standards in support of the new legal framework and sectoral certification schemes
• Ref Project: SIST EN ISO 19011:2018 - Guidelines for auditing management systems (ISO 19011:2018)

Relations

• Replaces: EN ISO 19011:2011 - Guidelines for auditing management systems (ISO 19011:2011)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2018
1DGRPHãþD
SIST EN ISO 19011:2011
Smernice za presojanje sistemov vodenja (ISO 19011:2018)
Guidelines for auditing management systems (ISO 19011:2018)
Leitfaden zur Auditierung von Managementsystemen (ISO 19011:2018)
Lignes directrices pour l'audit des systèmes de management (ISO 19011:2018)
Ta slovenski standard je istoveten z: EN ISO 19011:2018
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
13.020.10 Ravnanje z okoljem Environmental management
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 19011
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2018
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.20 Supersedes EN ISO 19011:2011
English Version
Guidelines for auditing management systems (ISO
19011:2018)
Lignes directrices pour l'audit des systèmes de Leitfaden zur Auditierung von Managementsystemen
management (ISO 19011:2018) (ISO 19011:2018)
This European Standard was approved by CEN on 18 June 2018.

CEN 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
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 member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19011:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 19011:2018) has been prepared by Technical Committee ISO/PC 302
"Guidelines for auditing management systems" in collaboration with CCMC.
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 2019, and conflicting national standards shall
be withdrawn at the latest by January 2019.
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.
This document supersedes EN ISO 19011:2011.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 19011:2018 has been approved by CEN as EN ISO 19011:2018 without any modification.

INTERNATIONAL ISO
STANDARD 19011
Third edition
2018-07
Guidelines for auditing management
systems
Lignes directrices pour l'audit des systèmes de management
Reference number
ISO 19011:2018(E)
©
ISO 2018
ISO 19011:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 19011:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles of auditing . 5
5 Managing an audit programme . 6
5.1 General . 6
5.2 Establishing audit programme objectives . 9
5.3 Determining and evaluating audit programme risks and opportunities . 9
5.4 Establishing the audit programme .10
5.4.1 Roles and responsibilities of the individual(s) managing the audit programme .10
5.4.2 Competence of individual(s) managing audit programme .11
5.4.3 Establishing extent of audit programme .11
5.4.4 Determining audit programme resources .12
5.5 Implementing audit programme .12
5.5.1 General.12
5.5.2 Defining the objectives, scope and criteria for an individual audit .13
5.5.3 Selecting and determining audit methods .14
5.5.4 Selecting audit team members .14
5.5.5 Assigning responsibility for an individual audit to the audit team leader.15
5.5.6 Managing audit programme results .16
5.5.7 Managing and maintaining audit programme records .16
5.6 Monitoring audit programme .17
5.7 Reviewing and improving audit programme .17
6 Conducting an audit .18
6.1 General .18
6.2 Initiating audit .18
6.2.1 General.18
6.2.2 Establishing contact with auditee .18
6.2.3 Determining feasibility of audit .19
6.3 Preparing audit activities .19
6.3.1 Performing review of documented information.19
6.3.2 Audit planning . . .19
6.3.3 Assigning work to audit team .21
6.3.4 Preparing documented information for audit .21
6.4 Conducting audit activities .21
6.4.1 General.21
6.4.2 Assigning roles and responsibilities of guides and observers .21
6.4.3 Conducting opening meeting .22
6.4.4 Communicating during audit .23
6.4.5 Audit information availability and access .23
6.4.6 Reviewing documented information while conducting audit .23
6.4.7 Collecting and verifying information .24
6.4.8 Generating audit findings .25
6.4.9 Determining audit conclusions .25
6.4.10 Conducting closing meeting .26
6.5 Preparing and distributing audit report .27
6.5.1 Preparing audit report .27
6.5.2 Distributing audit report .27
6.6 Completing audit .28
6.7 Conducting audit follow-up.28
ISO 19011:2018(E)
7 Competence and evaluation of auditors .
...

SLOVENSKI SIST EN ISO 19011
STANDARD oktober 2018
Smernice za presojanje sistemov vodenja (ISO 19011:2018)
Guidelines for auditing management systems (ISO 19011:2018)
Lignes directrices pour l'audit des systèmes de management (ISO 19011:2018)
Leitfaden zur Auditierung von Managementsystemen (ISO 19011:2018)
Referenčna oznaka
ICS 03.100.70; 03.120.10; 13.020.10 SIST EN ISO 19011:2018 (sl,en)
Nadaljevanje na straneh II in od 1 do 80
© 2020-04. Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 19011 : 2018
NACIONALNI UVOD
Standard SIST EN ISO 19011 (sl,en), Smernice za presojanje sistemov vodenja (ISO 19011:2018),
2018, ima status slovenskega standarda in je enakovreden evropskemu standardu EN ISO 19011,
Guidelines for auditing management systems (ISO 19011:2018), 2018.
NACIONALNI PREDGOVOR
Besedilo standarda EN ISO 19011:2018 je pripravil Projektni odbor ISO/PC 302, Smernice za presojanje
sistemov vodenja. Slovenski standard SIST EN ISO 19011:2018 je prevod angleškega besedila
evropskega standarda EN ISO 19011:2018. 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 VZK Vodenje in zagotavljanje kakovosti.

Odločitev za privzem tega standarda je dne 28. 8. 2018 sprejel SIST/TC VZK Vodenje in zagotavljanje
kakovosti.
ZVEZA S STANDARDI
Standard se ne sklicuje na druge standarde.
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO 19011:2018.

PREDHODNA IZDAJA
– SIST EN ISO 19011:2011.
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz "mednarodni standard", v SIST EN ISO
19011:2018 to pomeni "slovenski standard".

– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO 19011:2018 in je objavljen z dovoljenjem

Upravni center
CEN-CENELEC
Rue de la Science 23
B-1040 Bruselj
This national document is identical with EN ISO 19011:2018 and is published with the permission
of
CEN-CENELEC
Management Centre
Rue de la Science 23
B-1040 Brussels
II
EVROPSKI STANDARD  EN ISO 19011
EUROPEAN STANDARD
NORME EUROPÉENNE
julij 2018
EUROPÄISCHE NORM
ICS 03.100.70, 03.120.20   Nadomešča EN ISO 19011:2011

Slovenska izdaja
Smernice za presojanje sistemov vodenja
(ISO 19011:2018)
Guidelines for auditing Lignes directrices pour l'audit Leitfaden zur Auditierung von
management systems des systèmes de management Managementsystemen
(ISO 19011:2018) (ISO 19011:2018) (ISO 19011:2018)

Ta evropski standard je CEN sprejel 18. junija 2018.

Člani CEN morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je predpisano,
da mora biti ta evropski standard brez kakršnih koli sprememb sprejet kot nacionalni standard.
Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na zahtevo
na voljo pri Upravnem centru CEN-CENELEC ali kateremkoli članu CEN.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru
CEN-CENELEC, veljajo kot uradne izdaje.

Člani CEN so nacionalni organi za standarde 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, Srbije, Slovaške, Slovenije, Španije,
Švedske, Švice, Turčije in Združenega kraljestva.

CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung

Upravni center CEN-CENELEC: Rue de la Science 23, B-1040 Bruselj

© 2018 CEN Lastnice avtorskih pravic so vse države članice CEN Ref. oznaka EN ISO 19011:2018 E

SIST EN ISO 19011 : 2018
VSEBINA StranCONTENTS Page
Predgovor k evropskemu standardu . 5 European foreword . 5

Predgovor . 6 Foreword . 6
Uvod . 8 Introduction . 8
1 Področje uporabe . 11 1 Scope . 11
2 Zveza s standardi . 11 2 Normative references . 11
3 Izrazi in definicije . 11 3 Terms and definitions . 11
4 Načela presojanja . 17 4 Principles of auditing . 17
5 Vodenje programa presoj . 19 5 Managing an audit programme . 19
5.1 Splošno . 19 5.1 General . 19
5.2 Določitev ciljev programa presoj . 23 5.2 Establishing audit programme
objectives . 23
5.3 Določitev in ovrednotenje tveganj ter 5.3 Determining and evaluating audit
priložnosti programa presoj . 24 programme risks and opportunities . 24
5.4 Določitev programa presoj . 25 5.4 Establishing the audit programme . 25
5.4.1 Vloge in odgovornosti posameznikov, 5.4.1 Roles and responsibilities of the
ki vodijo program presoj. . 25 individual(s) managing the audit
programme . 25
5.4.2 Kompetentnost posameznikov, 5.4.2 Competence of individual(s)
ki vodijo program presoj . 26 managing audit programme . 26
5.4.3 Določitev obsega programa presoj . 26 5.4.3 Establishing extent of audit
programme . 26
5.4.4 Določitev virov za program presoj . 28 5.4.4 Determining audit programme
resources . 28
5.5 Izvedba programa presoj . 28 5.5 Implementing audit programme . 28
5.5.1 Splošno . 28 5.5.1 General . 28
5.5.2 Določitev ciljev, obsega in kriterijev 5.5.2 Defining the objectives, scope and
za posamezno presojo . 29 criteria for an individual audit . 29
5.5.3 Izbira in določitev presojevalnih 5.5.3 Selecting and determining audit
metod . 31 methods . 31
5.5.4 Izbira članov presojevalne skupine . 31 5.5.4 Selecting audit team members . 31
5.5.5 Dodelitev odgovornosti za posamezno 5.5.5 Assigning responsibility for an individual
presojo vodji presojevalne skupine . 32 audit to the audit team leader . 32
5.5.6 Vodenje rezultatov programa 5.5.6 Managing audit programme results . 34
presoj . 34
5.5.7 Vodenje in vzdrževanje zapisov 5.5.7 Managing and maintaining audit
programa presoj . 34 programme records .34
5.6 Nadzorovanje programa presoj . 35 5.6 Monitoring audit programme . 35
5.7 Pregledovanje in izboljševanje programa 5.7 Reviewing and improving audit
presoj . 36 programme . 36
6 Izvajanje presoje . 37 6 Conducting an audit . 37
6.1 Splošno . 37 6.1 General . 37
6.2 Začetek presoje . 37 6.2 Initiating audit . 37
6.2.1 Splošno . 37 6.2.1 General . 37
6.2.2 Vzpostavitev stika s presojancem . 37 6.2.2 Establishing contact with auditee . 37
6.2.3 Ugotavljanje izvedljivosti presoje . 38 6.2.3 Determining feasibility of audit . 38
SIST EN ISO 19011 : 2018
6.3 Priprava aktivnosti presoje . 38 6.3 Preparing audit activities . 38
6.3.1 Pregled dokumentiranih informacij . 38 6.3.1 Performing review of documented
information . 38

6.3.2 Načrtovanje presoje . 39 6.3.2 Audit planning . 39
6.3.3 Dodelitev dela presojevalni skupini . 41 6.3.3 Assigning work to audit team . 41
6.3.4 Priprava dokumentiranih informacij 6.3.4 Preparing documented information for
za presojo . 42 audit .42
6.4 Izvajanje aktivnosti presoje . 42 6.4 Conducting audit activities . 42
6.4.1 Splošno . 42 6.4.1 General . 42
6.4.2 Dodelitev vlog in odgovornosti 6.4.2 Assigning roles and responsibilities of
spremljevalcem in opazovalcem . 42 guides and observers . 42
6.4.3 Izvedba uvodnega sestanka . 43 6.4.3 Conducting opening meeting . 43
6.4.4 Komuniciranje med presojo . 45 6.4.4 Communicating during audit . 45
6.4.5 Razpoložljivost in dostop do 6.4.5 Audit information availability and
informacij o presoji . 45 access . 45
6.4.6 Pregledovanje dokumentiranih 6.4.6 Reviewing documented information
informacij med izvedbo presoje . 46 while conducting audit . 46
6.4.7 Zbiranje in preverjanje informacij . 46 6.4.7 Collecting and verifying information . 46
6.4.8 Oblikovanje ugotovitev presoje . 48 6.4.8 Generating audit findings . 48
6.4.9 Določanje sklepov presoje . 48 6.4.9 Determining audit conclusions . 48
6.4.10 Izvedba zaključnega sestanka . 49 6.4.10 Conducting closing meeting . 49
6.5 Priprava in razdelitev poročila o presoji . 50 6.5 Preparing and distributing audit report . 50
6.5.1 Priprava poročila o presoji . 50 6.5.1 Preparing audit report . 50
6.5.2 Razdelitev poročila o presoji . 52 6.5.2 Distributing audit report . 52
6.6 Dokončanje presoje . 52 6.6 Completing audit . 52
6.7 Izvajanje aktivnosti po presoji . 52 6.7 Conducting audit follow-up . 52
7 Kompetentnost in vrednotenje 7 Competence and evaluation of auditors . 53
presojevalcev . 53
7.1 Splošno . 53 7.1 General .53
7.2 Ugotavljanje kompetentnosti 7.2 Determining auditor competence. . 54
presojevalcev . 54
7.2.1 Splošno . 54 7.2.1 General . 54
7.2.2 Osebno vedenje . 54 7.2.2 Personal behaviour . 54
7.2.3 Znanje in veščine . 55 7.2.3 Knowledge and skills . 55
7.2.4 Doseganje kompetentnosti 7.2.4 Achieving auditor competence . 59
presojevalcev . 59
7.2.5 Doseganje kompetentnosti vodje 7.2.5 Achieving audit team leader
presojevalne skupine . 60 competence . 60
7.3 Določitev kriterijev za vrednotenje 7.3 Establishing auditor evaluation criteria . 60
presojevalcev . 60
7.4 Izbira ustrezne metode za vrednotenje 7.4 Selecting appropriate auditor evaluation
presojevalcev . 60 method . 60
7.5 Izvedba vrednotenja presojevalcev . 62 7.5 Conducting auditor evaluation . 62
7.6 Vzdrževanje in izboljševanje 7.6 Maintaining and improving auditor
kompetentnosti presojevalcev . 62 competence . 62
SIST EN ISO 19011 : 2018
Dodatek A (informativni): Dodatni napotki Annex A (informative) Additional guidance
presojevalcem za načrtovanje in izvajanje for auditors planning and conducting
presoj . 63 audits . 63

Bibliography . 80
Literatura . 80

SIST EN ISO 19011 : 2018
Predgovor k evropskemu standardu European foreword
Ta dokument (EN ISO 19011:2018) je pripravil This document (EN ISO 19011:2018) has been
tehnični odbor ISO/PC 302 "Smernice za prepared by Technical Committee ISO/PC 302
presojanje sistemov vodenja" v sodelovanju s "Guidelines for auditing management systems" in
CCMC. collaboration with CCMC.
Ta evropski standard mora z objavo i
...