Guidelines for auditing management systems (ISO 19011:2018) · 2019. 3. 14. · EN ISO 19011:2018 (E) 3 European foreword This document (EN ISO 19011:2018) has been prepared by Technical

Dansk standard DS/EN ISO 19011:2018

Vejledning i auditering af ledelsessystemer

Guidelines for auditing management systems (ISO 19011:2018)

2018-07-09

DANSK STANDARDDanish Standards Association

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Tel: +45 39 96 61 01

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© Dansk Standard - Eftertryk uden tilladelse forbudt

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DS/EN ISO 19011:2018KøbenhavnDS projekt: M317017ICS: 03.100.70; 03.120.20

Første del af denne publikations betegnelse er: DS/EN ISO, hvilket betyder, at det er en international standard, der har status både som europæisk og dansk standard.

Denne publikations overensstemmelse er: IDT med: ISO 19011:2018 IDT med: EN ISO 19011:2018

DS-publikationen er på engelsk.

Denne publikation erstatter: DS/EN ISO 19011:2012



EN ISO 19011

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

DS/EN ISO 19011:2018



EN ISO 19011:2018 (E)

2

Contents Page

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

DS/EN ISO 19011:2018



EN ISO 19011:2018 (E)

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of an identical text or by endorsement, at the latest by January 2019, and conflicting national standards shall be withdrawn at the latest by January 2019.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.

DS/EN ISO 19011:2018



DS/EN ISO 19011:2018



© ISO 2018

Guidelines for auditing management systemsLignes directrices pour l'audit des systèmes de management

INTERNATIONAL STANDARD

ISO19011

Third edition2018-07-03

Reference numberISO 19011:2018(E)

DS/EN ISO 19011:2018



ISO 19011:2018(EN)

Contents Page

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

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

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

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

..................................................................................................................................................................................... 1

4 Principles of auditing ...................................................................................................................................................................................... 5

5 Managing an audit programme ............................................................................................................................................................. 65.1 General ........................................................................................................................................................................................................... 65.2 Establishing audit programme objectives ....................................................................................................................... 95.3 Determining and evaluating audit programme risks and opportunities .............................................. 95.4 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 ...................................................... 115.4.3 Establishing extent of audit programme .................................................................................................. 115.4.4 Determining audit programme resources .............................................................................................. 12

5.5 Implementing audit programme .......................................................................................................................................... 125.5.1 General................................................................................................................................................................................... 12

...................................135.5.3 Selecting and determining audit methods .............................................................................................. 145.5.4 Selecting audit team members ......................................................................................................................... 145.5.5 Assigning responsibility for an individual audit to the audit team leader..................155.5.6 Managing audit programme results ............................................................................................................. 165.5.7 Managing and maintaining audit programme records ................................................................16

5.6 Monitoring audit programme ................................................................................................................................................. 175.7 Reviewing and improving audit programme ............................................................................................................. 17

6 Conducting an audit .......................................................................................................................................................................................186.1 General ........................................................................................................................................................................................................ 186.2 Initiating audit ...................................................................................................................................................................................... 18

6.2.1 General................................................................................................................................................................................... 186.2.2 Establishing contact with auditee .................................................................................................................. 186.2.3 Determining feasibility of audit ....................................................................................................................... 19

6.3 Preparing audit activities ............................................................................................................................................................ 196.3.1 Performing review of documented information................................................................................196.3.2 Audit planning ................................................................................................................................................................. 196.3.3 Assigning work to audit team ............................................................................................................................ 216.3.4 Preparing documented information for audit ..................................................................................... 21

6.4 Conducting audit activities ........................................................................................................................................................ 216.4.1 General................................................................................................................................................................................... 216.4.2 Assigning roles and responsibilities of guides and observers ............................................... 216.4.3 Conducting opening meeting ............................................................................................................................. 226.4.4 Communicating during audit ............................................................................................................................. 236.4.5 Audit information availability and access ............................................................................................... 236.4.6 Reviewing documented information while conducting audit ............................................... 236.4.7 Collecting and verifying information .......................................................................................................... 24

...................................................................................................................................... 256.4.9 Determining audit conclusions ........................................................................................................................ 256.4.10 Conducting closing meeting ................................................................................................................................ 26

6.5 Preparing and distributing audit report ........................................................................................................................ 276.5.1 Preparing audit report .............................................................................................................................................276.5.2 Distributing audit report ....................................................................................................................................... 27

6.6 Completing audit ................................................................................................................................................................................ 28

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Indholdsfortegnelse Side

Forord ..................................................................................................................................................................................................................................... v

Indledning ........................................................................................................................................................................................................................... vi

1 Anvendelsesområde ........................................................................................................................................................................................ 1

2 Normative referencer ..................................................................................................................................................................................... 1

3 Termer og definitioner .................................................................................................................................................................................. 1

4 Auditeringsprincipper ................................................................................................................................................................................... 5

5 Ledelse af et auditprogram ........................................................................................................................................................................ 65.1 Generelt .......................................................................................................................................................................................................... 65.2 Fastlæggelse af auditprogrammets mål ....................................................................................................................................... 95.3 Fastlæggelse og vurdering af risici og muligheder ved auditprogrammet .............................................................. 95.4 Fastlæggelse af auditprogrammet .................................................................................................................................................. 10

5.4.1 Roller og ansvar hos den eller de personer, der leder auditprogrammet ................................................ 105.4.2 Kompetencer hos den eller de personer, der leder auditprogrammet...................................................... 115.4.3 Fastlæggelse af auditprogrammets omfang ............................................................................................................. 115.4.4 Fastlæggelse af ressourcer til auditprogrammet ................................................................................................... 12

5.5 Gennemførelse af auditprogrammet ............................................................................................................................................. 125.5.1 Generelt......................................................................................................................................................................................... 125.5.2 Fastlæggelse af mål, omfang og kriterier for den enkelte audit ..................................................................... 135.5.3 Valg og fastlæggelse af auditmetoder ........................................................................................................................... 145.5.4 Valg af auditteamets deltagere ......................................................................................................................................... 145.5.5 Delegering af ansvar for en bestemt audit til auditteamlederen .................................................................. 155.5.6 Styring af resultaterne af et auditprogram................................................................................................................ 165.5.7 Styring og opretholdelse af registreringer vedrørende et auditprogram ................................................ 16

5.6 Overvågning af auditprogrammet .................................................................................................................................................. 175.7 Gennemgang og forbedring af auditprogrammet .................................................................................................................. 17

6 Gennemførelse af en audit .......................................................................................................................................................................... 186.1 Generelt .......................................................................................................................................................................................................... 186.2 Iværksættelse af audit ............................................................................................................................................................................ 18

6.2.1 Generelt......................................................................................................................................................................................... 186.2.2 Etablering af kontakt med den auditerede ............................................................................................................... 186.2.3 Fastlæggelse af, om audit kan gennemføres ............................................................................................................. 19

6.3 Forberedelse af auditaktiviteter ....................................................................................................................................................... 196.3.1 Gennemgang af dokumenteret information ............................................................................................................ 196.3.2 Planlægning af audit .............................................................................................................................................................. 196.3.3 Tildeling af arbejdsopgaver til auditteamet ............................................................................................................. 216.3.4 Udarbejdelse af dokumenteret information til audit .......................................................................................... 21

6.4 Gennemførelse af auditaktiviteter .................................................................................................................................................. 216.4.1 Generelt......................................................................................................................................................................................... 216.4.2 Tildeling af roller og ansvar til guider og observatører ...................................................................................... 216.4.3 Afholdelse af indledende møde ....................................................................................................................................... 226.4.4 Kommunikation under audit ............................................................................................................................................ 236.4.5 Tilgængelighed af og adgang til auditinformation ................................................................................................ 236.4.6 Gennemgang af dokumenteret information under gennemførelse af audit .......................................... 236.4.7 Indsamling og verifikation af information ................................................................................................................ 246.4.8 Tilvejebringelse af auditresultater ................................................................................................................................ 256.4.9 Udarbejdelse af auditkonklusioner ............................................................................................................................... 256.4.10 Afholdelse af afsluttende møde ....................................................................................................................................... 26

6.5 Udarbejdelse og distribution af auditrapport .......................................................................................................................... 276.5.1 Udarbejdelse af auditrapport ........................................................................................................................................... 276.5.2 Distribution af auditrapporten ........................................................................................................................................ 27

6.6 Afslutning af audit .................................................................................................................................................................................... 28



ISO 19011:2018(EN)

6.7 Conducting audit follow-up....................................................................................................................................................... 28

7 Competence and evaluation of auditors ....................................................................................................................................287.1 General ........................................................................................................................................................................................................ 287.2 Determining auditor competence ........................................................................................................................................ 29

7.2.1 General................................................................................................................................................................................... 297.2.2 Personal behaviour .....................................................................................................................................................297.2.3 Knowledge and skills ................................................................................................................................................307.2.4 Achieving auditor competence ......................................................................................................................... 327.2.5 Achieving audit team leader competence ............................................................................................... 33

7.3 Establishing auditor evaluation criteria......................................................................................................................... 337.4 Selecting appropriate auditor evaluation method ................................................................................................ 337.5 Conducting auditor evaluation ............................................................................................................................................... 337.6 Maintaining and improving auditor competence................................................................................................... 34

Annex A (informative) Additional guidance for auditors planning and conducting audits .....................35

Bibliography .............................................................................................................................................................................................................................46

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6.7 Opfølgning på audit ................................................................................................................................................................................. 28

7 Auditorers kompetencer og evaluering af auditorer ............................................................................................................ 287.1 Generelt .......................................................................................................................................................................................................... 287.2 Fastlæggelse af auditorkompetencer ............................................................................................................................................ 29

7.2.1 Generelt......................................................................................................................................................................................... 297.2.2 Personlig adfærd ...................................................................................................................................................................... 297.2.3 Viden og færdigheder............................................................................................................................................................ 307.2.4 Opnåelse af auditorkompetencer ................................................................................................................................... 327.2.5 Erhvervelse af auditteamlederkompetencer ........................................................................................................... 33

7.3 Fastlæggelse af kriterier for evaluering af auditorer ............................................................................................................ 337.4 Valg af relevant metode til evaluering af auditorer ................................................................................................................ 337.5 Gennemførelse af auditorevaluering ............................................................................................................................................. 337.6 Vedligeholdelse og forbedring af auditorkompetencer ...................................................................................................... 34

(informativt) ........... 35

Bibliografi ............................................................................................................................................................................................................................ 46



ISO 19011:2018(EN)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

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

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

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.

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

This document was prepared by Project Committee ISO/PC 302, Guidelines for auditing management systems.

This third edition cancels and replaces the second edition (ISO 19011:2011), which has been technically revised.

The main differences compared to the second edition are as follows:

— addition of the risk-based approach to the principles of auditing;

— expansion of the guidance on managing an audit programme, including audit programme risk;

— expansion of the guidance on conducting an audit, particularly the section on audit planning;

— expansion of the generic competence requirements for auditors;

system disciplines (due to the large number of individual management system standards, it would not be practical to include competence requirements for all disciplines);

— expansion of Annex A to provide guidance on auditing (new) concepts such as organization context, leadership and commitment, virtual audits, compliance and supply chain.

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ForordISO (International Organization for Standardization) er en verdensomspændende sammenslutning af nationale stan-dardiseringsorganisationer (ISO's medlemsorganisationer). Internationale standarder udarbejdes normalt af ISO's tekniske komiteer. Medlemsorganisationer, som er interesseret i et emne, inden for hvilket der er oprettet en teknisk komite, har ret til at være repræsenteret i den pågældende komite. Internationale organisationer, både statslige og ikke-statslige, der har en samarbejdsaftale med ISO, deltager ligeledes i arbejdet. ISO samarbejder tæt med IEC (In-ternational Electrotechnical Commission) i alle forhold vedrørende elektroteknisk standardisering.

De procedurer, der er anvendt ved udarbejdelsen af dette dokument, og de procedurer, der er beregnet til vedligehol-delse af dokumentet, er beskrevet i ISO/IEC Directives, Part 1. Især bør de forskellige godkendelseskriterier, der er nødvendige for de forskellige typer ISO-dokumenter, bemærkes. Dette dokument er udarbejdet i overensstemmelse med de redaktionelle regler opstillet i ISO/IEC Directives, Part 2 (se www.iso.org/directives).

Der gøres opmærksom på, at indhold i dette dokument kan være underlagt patentrettigheder. ISO kan ikke drages til ansvar for at identificere sådanne patentrettigheder. Detaljerede oplysninger om eventuelle patentrettigheder, der konstateres under udarbejdelsen af dette dokument, findes i indledningen og/eller på ISO's liste over modtagne pa-tenterklæringer (se www.iso.org/patents).

Eventuelle handelsnavne i dette dokument er givet af hensyn til brugerne og indebærer ikke en godkendelse.

Websitet www.iso.org/iso/foreword.html giver en redegørelse for standardernes karakter af frivillighed, betydnin-gen af ISO-specifikke termer og udtryk vedrørende overensstemmelseserklæring samt oplysninger om ISO's overhol-delse af WTO-principperne for tekniske handelshindringer (TBT).

Dette dokument er udarbejdet af projektkomite ISO/PC 302, Guidelines for auditing management systems.

Denne 3. udgave ophæver og erstatter 2. udgave (ISO 19011:2011), hvis indhold er blevet teknisk revideret.

De væsentligste forskelle i forhold til 2. udgave er følgende:

– tilføjelse af en risikobaseret tilgang til principperne for auditering

– udvidelse af vejledningen vedrørende ledelse af et auditprogram, herunder risici forbundet med auditprogram-met

– udvidelse af vejledningen vedrørende gennemførelsen af et auditprogram, særligt afsnittet om planlægning af en audit

– udvidelse af de generiske kompetencekrav til auditorer

– tilpasning af terminologi for at afspejle procesorienteringen

– fjernelse af annekset med kompetencekravene til auditering af kravspecifikke områder inden for et ledelsessy-stem (som følge af det store antal individuelle ledelsessystemstandarder ville det ikke være hensigtsmæssigt at inkludere kompetencekrav til alle områder)

– udvidelse af anneks A med henblik på vejledning i auditering af (nye) koncepter som fx organisationens rammer og vilkår, lederskab og forpligtelse, virtuelle audit, overensstemmelse med lov- og myndighedskrav og eksterne leverandører.



ISO 19011:2018(EN)

Introduction

Since the second edition of this document was published in 2011, a number of new management system standards have been published, many of which have a common structure, identical core requirements

to management system auditing, as well as providing guidance that is more generic. Audit results can

improvement needs and activities.

An audit can be conducted against a range of audit criteria, separately or in combination, including but not limited to:

— statutory and regulatory requirements;

(e.g. quality plan, project plan).

This document provides guidance for all sizes and types of organizations and audits of varying scopes and scales, including those conducted by large audit teams, typically of larger organizations, and those by single auditors, whether in large or small organizations. This guidance should be adapted as appropriate to the scope, complexity and scale of the audit programme.

on their external providers and other external interested parties (second party). This document can also be useful for external audits conducted for purposes other than third party management system

ISO/IEC 17021-1 provides requirements for auditing management systems for third party Table 1).

Table 1 — Different types of audits

1st party audit 2nd party audit 3rd party audit

Internal audit External provider auditaudit

Other external interested party audit

Statutory, regulatory and similar audit

but the reader can adapt the implementation of the guidance to their own situation. This also applies to

This document is intended to apply to a broad range of potential users, including auditors, organizations implementing management systems and organizations needing to conduct management system audits for contractual or regulatory reasons. Users of this document can, however, apply this guidance in developing their own audit-related requirements.

The guidance in this document can also be used for the purpose of self-declaration and can be useful to

the use of this guidance can differ depending on the size and level of maturity of an organization’s management system. The nature and complexity of the organization to be audited, as well as the objectives and scope of the audits to be conducted, should also be considered.

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IndledningSiden udgivelsen af 2. udgave af dette dokument i 2011 er et antal nye ledelsessystemstandarder blevet udgivet, hvoraf mange har en fælles struktur, helt ens grundlæggende krav og fælles termer og definitioner. Som følge deraf er der behov for at overveje en bredere tilgang til auditering af ledelsessystemer og at give vejledning, der er mere gene-risk. Auditresultater kan give input til analysedelen af forretningsplanlægning og kan bidrage til identificeringen af behov for forbedringer og aktiviteter.

En audit kan foretages op mod en række auditkriterier, hver for sig eller som en kombination af flere, herunder men ikke begrænset til

– krav defineret i én eller flere ledelsessystemstandarder

– politikker og krav specificeret af relevante interessenter

– lov- og myndighedskrav

– én eller flere ledelsessystemprocesser defineret af organisationen eller andre parter

– ledelsessystemplan eller -planer vedrørende specifikke output fra ledelsessystemet (fx kvalitetsplan, projekt-plan).

Dette dokument indeholder vejledning til alle størrelser og typer organisationer samt audit af varierende omfang og størrelse, herunder audit gennemført af store auditteam, typisk i større organisationer, og audit udført af enkelte auditorer, enten i store eller små organisationer. Vejledningen bør anvendes efter auditprogrammets omfang, kom-pleksitet og størrelse.

Dette dokument handler om interne audit (førstepartsaudit) og organisationers audit af deres eksterne leverandører og andre eksterne interessenter (andenpartsaudit). Dette dokument kan også bruges til eksterne audit til andre for-mål end certificering af tredjeparts ledelsessystem. ISO/IEC 17021-1 indeholder krav til auditering af ledelsessyste-mer til tredjepartscertificering og kan bruges som yderligere vejledning (se tabel 1).

Tabel 1 – Forskellige typer audit

Førstepartsaudit Andenpartsaudit

Intern audit Auditering af eksterne leverandører Certificerings- og/eller akkrediteringsaudit

Auditering af andre eksterne interessenter

Audit, der foretages af myndigheder, og lignende audit

For at gøre dette dokument lettere at læse foretrækkes entalsformen "ledelsessystem", men læseren kan tilpasse im-plementeringen af vejledningen til sin egen situation. Dette gælder også brugen af "person" og "personer", "auditor" og "auditorer".

Det er hensigten, at dokumentet skal gælde for en bred gruppe af potentielle brugere, bl.a. auditorer, organisationer, der indfører ledelsessystemer, og organisationer, der udfører ledelsessystemaudit af kontrakt- eller myndigheds-mæssige årsager. Brugere af dette dokument kan imidlertid anvende denne vejledning til at udarbejde deres egne auditrelaterede krav.

Vejledningen i dette dokument kan også anvendes til egenerklæring af overensstemmelse og kan være nyttig for or-ganisationer, der beskæftiger sig med auditoruddannelse og -træning og certificering af personale.

Det har været hensigten at gøre vejledningen i dette dokument fleksibel. Som anført forskellige steder i teksten kan anvendelsen af denne vejledning variere alt efter størrelse og modenhed af en organisations ledelsessystem. Der bør også tages hensyn til typen og kompleksiteten af den organisation, der skal auditeres, samt formålet og omfanget af de audit, der skal udføres.



ISO 19011:2018(EN)

This document adopts the combined audit approach when two or more management systems of different disciplines are audited together. Where these systems are integrated into a single management system, the principles and processes of auditing are the same as for a combined audit (sometimes known as an integrated audit).

This document provides guidance on the management of an audit programme, on the planning and conducting of management system audits, as well as on the competence and evaluation of an auditor and an audit team.

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Dette dokument benytter den kombinerede audittilgang, som omfatter to eller flere ledelsessystemer inden for for-skellige kravspecifikke områder, der auditeres sammen. Når disse systemer kombineres til et enkelt ledelsessystem, er auditeringsprincipperne og -processerne de samme som ved en kombineret audit (også kaldet integreret audit).

Dette dokument vejleder om ledelse af et auditprogram, om planlægning og gennemførelse af ledelsessystemaudit samt om kompetencer hos og evaluering af en auditor og et auditteam.



Guidelines for auditing management systems

1 Scope

This document provides guidance on auditing management systems, including t he 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

2 Normative references

There are no normative references in this document.

INTERNATIONAL STANDARD ISO 19011:2018(EN)

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1 AnvendelsesområdeDette dokument vejleder om auditering af ledelsessystemer, herunder principperne for auditering, ledelse af et audit-program og gennemførelse af ledelsessystemaudit, samt vejledning om vurdering af kompetencer hos de personer, der er involveret i auditprocessen. Disse aktiviteter omfatter den eller de personer, der leder auditprogrammet, audi-torerne og auditteamene.

Det kan anvendes af alle organisationer, der har behov for at planlægge og udføre interne eller eksterne audit af ledel-sessystemer eller lede et auditprogram.

Dette dokument kan anvendes til andre typer audit, forudsat at der tages særligt hensyn til de specifikke kompeten-cer, der er behov for.

2 Normative referencerDer er ingen normative referencer i dette dokument.


Documents

Guidelines for auditing management systems (ISO 19011:2018) · 2019. 3. 14. · EN ISO 19011:2018 (E) 3 European foreword This document (EN ISO 19011:2018) has been prepared by Technical