SIST EN ISO 19011:2003
(Main)Guidelines for quality and/or environmental management systems auditing (ISO 19011:2002)
Guidelines for quality and/or environmental management systems auditing (ISO 19011:2002)
ISO 19011:2002 provides guidance on the principles of auditing, managing audit programmes, conducting quality management system audits and environmental management system audits, as well as guidance on the competence of quality and environmental management system auditors.
It is applicable to all organizations needing to conduct internal or external audits of quality and/or environmental management systems or to manage an audit programme.
The application of ISO 19011 to other types of audits is possible in principle provided that special consideration is paid to identifying the competence needed by the audit team members in such cases.
Leitfaden für Audits von Qualitätsmanagement- und/oder Umweltmanagementsystemen (ISO 19011:2002)
Diese Internationale Norm gibt Anleitung zur Umsetzung von Auditprinzipien, zum Management von Auditprogrammen, zur Durchführung von Audits von Qualitätsmanagement- und Umweltmanagementsystemen sowie zur Qualifikation von Auditoren von Qualitätsmanagement- und Umweltmanagementsystemen.
Sie ist anwendbar auf alle Organisationen, die interne oder externe Audits von Qualitätsmanagement- oder Umweltmanagementsystemen durchführen müssen oder ein Auditprogramm benötigen.
Die Anwendung dieser Internationalen Norm auf andere Arten von Audits ist im Prinzip möglich, vorausgesetzt, dass der Festlegung der Qualifikation, die für die Mitglieder des Auditteams in solchen Fällen erforderlich ist, besondere Aufmerksamkeit beigemessen wird.
Lignes directrices pour l'audit des systemes de management de la qualité et/ou de management environnemental (ISO 19011:2002)
L'ISO 19011:2002 fournit des conseils sur les principes de l'audit, le management des programmes d'audit, la réalisation d'audits de systèmes de management de la qualité et/ou de management environnemental ainsi que sur la compétence des auditeurs de ces systèmes.
Elle est applicable à tous les organismes qui doivent réaliser des audits internes ou externes de systèmes de management de la qualité et/ou de management environnemental ou manager un programme d'audit.
L'ISO 19011 peut, en principe, s'appliquer à d'autres types d'audits, à condition toutefois d'accorder une attention particulière à l'identification des compétences requises pour les membres de ces équipes d'audit.
Smernice za presojanje sistemov vodenja kakovosti in/ali sistemov ravnanja z okoljem (ISO 19011:2002)
SIST EN ISO 19011:2003 vsebuje napotke za vodenje programov presoj, izvajanje notranjih ali zunanjih presoj sistemov vodenja kakovosti in/ali ravnanja z okoljem in tudi za kompetentnost in ocenjevanje presojevalcev. Skupini mednarodnih standardov ISO 9000 in ISO 14000 namreč poudarjata pomembnost presoj kot orodja vodenja za nadzorovanje in overjanje učinkovitega izvajanja politike kakovosti in/ali okoljske politike organizacije. Presoje so tudi bistveni del aktivnosti ugotavljanja skladnosti, kot je zunanja certifikacija/registracija, in ocenjevanja in nadzorovanja nabavne verige. Standard lahko uporabljajo pri svojem delu številni uporabniki, tako presojevalci, organizacije, ki izvajajo sisteme vodenja kakovosti in/ali ravnanja z okoljem, organizacije, ki morajo izvajati presoje sistemov vodenja kakovosti in/ali ravnanja z okoljem iz pogodbenih razlogov, in tudi organizacije, udeležene pri certificiranju ali usposabljanju presojevalcev, pri certifikaciji/registraciji sistemov vodenja, pri akreditaciji ali pri standardizaciji na področju ocenjevanja skladnosti. Z možnostjo prilagodljivosti smernic, kot je nakazana na več mestih v besedilu, se lahko uporaba teh smernic prilagodi velikosti, naravi in kompleksnosti presojane organizacije in tudi ciljem in predmetom izvajanih presoj. Besedilo standarda pa dopolnjujejo še dodatni napotki ali primeri za specifične teme, ki so namenjeni kot praktična pomoč, v nekaterih primerih je to namenjeno podpori uporabe tega mednarodnega standarda v majhnih organizacijah.
General Information
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Standards Content (Sample)
SLOVENSKI SIST EN ISO 19011:2003
STANDARD
januar 2003
Smernice za presojanje sistemov vodenja kakovosti in/ali sistemov ravnanja z
okoljem (ISO 19011:2002)
(istoveten EN ISO 19011:2002)
Guidelines for quality and/or environmental management systems auditing (ISO
19011:2002)
ICS 03.120.20; 13.020.10 Referenčna številka
SIST EN ISO 19011:2003(en)
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
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EUROPEAN STANDARD
EN ISO 19011
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2002
ICS 03.120.20; 13.020.10 Supersedes EN ISO 14010:1996, EN ISO 14011:1996,
EN ISO 14012:1996, EN 30011-1:1993, EN 30011-2:1993
and EN 30011-3:1993
English version
Guidelines for quality and/or environmental management
systems auditing (ISO 19011:2002)
Lignes directrices pour l'audit des systèmes de Leitfaden für Audits von Qualitätsmanagement- und/oder
management de la qualité et/ou de management Umweltmanagementsystemen (ISO 19011:2002)
environnemental (ISO 19011:2002)
This European Standard was approved by CEN on 9 September 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19011:2002 E
worldwide for CEN national Members.
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EN ISO 19011:2002 (E)
CORRECTED 2003-06-04
Foreword
This document (ISO 19011:2002) has been prepared by Technical Committees ISO/TC 176
"Quality management and quality assurance" and ISO/TC 207 "Environmental management" in
collaboration with CMC.
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 April 2003, and conflicting national
standards shall be withdrawn at the latest by April 2003.
This document supersedes EN ISO 14010:1996, EN ISO 14011:1996, EN ISO 14012:1996, EN
30011-1:1993, EN 30011-2:1993 and EN 30011-3:1993.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 19011:2002 has been approved by CEN as EN ISO 19011:2002 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2
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EN ISO 19011:2002 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 9000 2000 Quality management systems - EN ISO 9000 2000
Fundamentals and vocabulary
3
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INTERNATIONAL ISO
STANDARD 19011
First edition
2002-10-01
Guidelines for quality and/or environmental
management systems auditing
Lignes directrices pour l'audit des systèmes de management de la qualité
et /ou de management environnemental
Reference number
ISO 19011:2002(E)
©
ISO 2002
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ISO 19011:2002(E)
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ii © ISO 2002 – All rights reserved
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ISO 19011:2002(E)
Contents Page
Foreword . iv
Introduction. v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Principles of auditing. 3
5 Managing an audit programme. 4
5.1 General. 4
5.2 Audit programme objectives and extent. 6
5.4 Audit programme implementation. 8
5.5 Audit programme records . 8
5.6 Audit programme monitoring and reviewing . 9
6 Audit activities. 9
6.1 General. 9
6.2 Initiating the audit . 11
6.3 Conducting document review. 13
6.4 Preparing for the on-site audit activities . 13
6.5 Conducting on-site audit activities . 14
6.6 Preparing, approving and distributing the audit report . 20
6.6.1 Preparing the audit report . 20
6.6.2 Approving and distributing the audit report. 20
6.7 Completing the audit. 21
6.8 Conducting audit follow-up. 21
7 Competence and evaluation of auditors. 21
7.1 General. 21
7.2 Personal attributes. 22
7.3 Knowledge and skills. 22
7.4 Education, work experience, auditor training and audit experience . 25
7.5 Maintenance and improvement of competence. 27
7.6 Auditor evaluation. 28
© ISO 2002 – All rights reserved iii
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ISO 19011:2002(E)
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.
International standards are drafted in accordance with the rules given in the ISO/IEC Directives, part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards
accepted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the members casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 19011 was prepared jointly by Technical Committee ISO/TC 176, Quality management and quality assurance,
Subcommittee SC 3, Supporting technologies, and Technical Committee ISO/TC 207, Environmental management,
Subcommittee SC 2, Environmental auditing and related environmental investigations.
This first edition of ISO 19011 cancels and replaces ISO 10011-1:1990, ISO 10011-2:1991, ISO 10011-3:1991,
ISO 14010:1996, ISO 14011:1996 and ISO 14012:1996.
iv © ISO 2002 – All rights reserved
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ISO 19011:2002(E)
Introduction
The ISO 9000 and ISO 14000 series of International Standards emphasize the importance of audits as a
management tool for monitoring and verifying the effective implementation of an organization's quality and/or
environmental policy. Audits are also an essential part of conformity assessment activities such as external
certification/registration and of supply chain evaluation and surveillance.
This International Standard provides guidance on the management of audit programmes, the conduct of internal or
external audits of quality and/or environmental management systems, as well as on the competence and evaluation
of auditors. It is intended to apply to a broad range of potential users, including auditors, organizations
implementing quality and/or environmental management systems, organizations needing to conduct audits of
quality and/or environmental management systems for contractual reasons, and organizations involved in auditor
certification or training, in certification/registration of management systems, in accreditation or in standardization in
the area of conformity assessment.
The guidance in this International Standard is intended to be flexible. As indicated at various points in the text, the
use of these guidelines can differ according to the size, nature and complexity of the organizations to be audited,
as well as the objectives and scopes of the audits to be conducted. Throughout this International Standard,
supplementary guidance or examples on specific topics are provided in the form of practical help in boxed text. In
some instances, this is intended to support the use of this International Standard in small organizations.
Clause 4 describes the principles of auditing. These principles help the user to appreciate the essential nature of
auditing and they are a necessary prelude to clauses 5, 6 and 7.
Clause 5 provides guidance on managing audit programmes and covers such issues as assigning responsibility for
managing audit programmes, establishing the audit programme objectives, coordinating auditing activities and
providing sufficient audit team resources.
Clause 6 provides guidance on conducting audits of quality and/or environmental management systems, including
the selection of audit teams.
Clause 7 provides guidance on the competence needed by an auditor and describes a process for evaluating
auditors.
Where quality and environmental management systems are implemented together, it is at the discretion of the user
of this International Standard as to whether the quality management system and environmental management
system audits are conducted separately or together.
Although this International Standard is applicable to the auditing of quality and/or environmental management
systems, the user can consider adapting or extending the guidance provided herein to apply to other types of
audits, including other management system audits.
This International Standard provides only guidance, however, users can apply this to develop their own audit-
related requirements.
In addition, any other individual or organization with an interest in monitoring conformance to requirements, such as
product specifications or laws and regulations, may find the guidance in this International Standard useful.
© ISO 2002 – All rights reserved v
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INTERNATIONAL STANDARD ISO 19011:2002(E)
Guidelines for quality and/or environmental management systems
auditing
1 Scope
This International Standard provides guidance on the principles of auditing, managing audit programmes,
conducting quality management system audits and environmental management system audits, as well as guidance
on the competence of quality and environmental management system auditors.
It is applicable to all organizations needing to conduct internal or external audits of quality and/or environmental
management systems or to manage an audit programme.
The application of this International Standard to other types of audit is possible in principle, provided that special
consideration is paid to identifying the competence needed by the audit team members in such cases.
2 Normative references
The following normative documents contain provisions which, through references in this text, constitute provisions
of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent edition of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to apply. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 9000:2000, Quality management systems — Fundamentals and vocabulary
ISO 14050:2002, Environmental management — Vocabulary
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 9000 and ISO 14050 apply,
unless superseded by the terms and definitions given below.
A term in a definition or note which is defined elsewhere in this clause is indicated by boldface followed by its entry
number in parentheses. Such a boldface term may be replaced in the definition by its complete definition.
3.1
audit
systematic, independent and documented process for obtaining audit evidence (3.3) and evaluating it objectively
to determine the extent to which the audit criteria (3.2) are fulfilled
NOTE 1 Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for
management review and other internal purposes, and may form the basis for an organization's self-declaration of conformity. In
many cases, particularly in smaller organizations, independence can be demonstrated by the freedom from responsibility for the
activity being audited.
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ISO 19011:2002(E)
NOTE 2 External audits include those generally termed second- and third-party audits. Second-party audits are conducted
by parties having an interest in the organization, such as customers, or by other persons on their behalf. Third-party audits are
conducted by external, independent auditing organizations, such as those providing registration or certification of conformity to
the requirements of ISO 9001 or ISO 14001.
NOTE 3 When a quality management system and an environmental management system are audited together, this is termed
a combined audit.
NOTE 4 When two or more auditing organizations cooperate to audit a single auditee (3.7), this is termed a joint audit.
3.2
audit criteria
set of policies, procedures or requirements
NOTE Audit criteria are used as a reference against which audit evidence (3.3) is compared.
3.3
audit evidence
records, statements of fact or other information, which are relevant to the audit criteria (3.2) and verifiable
NOTE Audit evidence may be qualitative or quantitative.
3.4
audit findings
results of the evaluation of the collected audit evidence (3.3) against audit criteria (3.2)
NOTE Audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement.
3.5
audit conclusion
outcome of an audit (3.1), provided by the audit team (3.9) after consideration of the audit objectives and all audit
findings (3.4)
3.6
audit client
organization or person requesting an audit (3.1)
NOTE The audit client may be the auditee (3.7) or any other organization which has the regulatory or contractual right to
request an audit.
3.7
auditee
organization being audited
3.8
auditor
person with the competence (3.14) to conduct an audit (3.1)
3.9
audit team
one or more auditors (3.8) conducting an audit (3.1), supported if needed by technical experts (3.10)
NOTE 1 One auditor of the audit team is appointed as the audit team leader.
NOTE 2 The audit team may include auditors-in-training.
2 © ISO 2002 – All rights reserved
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ISO 19011:2002(E)
3.10
technical expert
person who provides specific knowledge or expertise to the audit team (3.9)
NOTE 1 Specific knowledge or expertise is that which relates to the organization, the process or activity to be audited, or
language or culture.
NOTE 2 A technical expert does not act as an auditor (3.8) in the audit team.
3.11
audit programme
set of one or more audits (3.1) planned for a specific time frame and directed towards a specific purpose
NOTE An audit programme includes all activities necessary for planning, organizing and conducting the audits.
3.12
audit plan
description of the activities and arrangements for an audit (3.1)
3.13
audit scope
extent and boundaries of an audit (3.1)
NOTE The audit scope generally includes a description of the physical locations, organizational units, activities and
processes, as well as the time period covered.
3.14
competence
demonstrated personal attributes and demonstrated ability to apply knowledge and skills
4 Principles of auditing
Auditing is characterized by reliance on a number of principles. These make the audit an effective and reliable tool
in support of management policies and controls, providing information on which an organization can act to improve
its performance. Adherence to these principles is a prerequisite for providing audit conclusions that are relevant
and sufficient and for enabling auditors working independently from one another to reach similar conclusions in
similar circumstances.
The following principles relate to auditors.
a) Ethical conduct: the foundation of professionalism
Trust, integrity, confidentiality and discretion are essential to auditing.
b) Fair presentation: the obligation to report truthfully and accurately
Audit findings, audit conclusions and audit reports reflect truthfully and accurately the audit activities.
Significant obstacles encountered during the audit and unresolved diverging opinions between the audit team
and the auditee are reported.
c) Due professional care: the application of diligence and judgement in auditing
Auditors exercise care in accordance with the importance of the task they perform and the confidence placed
in them by audit clients and other interested parties. Having the necessary competence is an important factor.
Further principles relate to the audit, which is by definition independent and systematic.
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ISO 19011:2002(E)
d) Independence: the basis for the impartiality of the audit and objectivity of the audit conclusions
Auditors are independent of the activity being audited and are free from bias and conflict of interest. Auditors
maintain an objective state of mind throughout the audit process to ensure that the audit findings and
conclusions will be based only on the audit evidence.
e) Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a
systematic audit process
Audit evidence is verifiable. It is based on samples of the information available, since an audit is conducted
during a finite period of time and with finite resources. The appropriate use of sampling is closely related to the
confidence that can be placed in the audit conclusions.
The guidance given in the remaining clauses of this International Standard is based on the principles set out above.
5 Managing an audit programme
5.1 General
An audit programme may include one or more audits, depending upon the size, nature and complexity of the
organization to be audited. These audits may have a variety of objectives and may also include joint or combined
audits (see Notes 3 and 4 to the definition of audit in 3.1).
An audit programme also includes all activities necessary for planning and organizing the types and number of
audits, and for providing resources to conduct them effectively and efficiently within the specified time frames.
An organization may establish more than one audit programme.
The organization’s top management should grant the authority for managing the audit programme.
Those assigned the responsibility for managing the audit programme should
a) establish, implement, monitor, review and improve the audit programme, and
b) identify the necessary resources and ensure they are provided.
Figure 1 illustrates the process flow for the management of an audit programme.
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ISO 19011:2002(E)
Figure 1 — Illustration of the process flow for the management of an audit programme
NOTE 1 Figure 1 also illustrates the application of the Plan-Do-Check-Act methodology in this International Standard.
NOTE 2 The numbers in this and all subsequent figures refer to the relevant clauses of this International Standard.
If an organization to be audited operates both quality management and environmental management systems,
combined audits may be included in the audit programme. In such a case, special attention should be paid to the
competence of the audit team.
Two or more auditing organizations may cooperate, as part of their audit programmes, to conduct a joint audit. In
such a case, special attention should be paid to the division of responsibilities, the provision of any additional
resources, the competence of the audit team and the appropriate procedures. Agreement on these should be
reached before the audit commences.
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ISO 19011:2002(E)
Practical help — Examples of audit programmes
Examples of audit programmes include the following:
a) a series of internal audits covering an organization-wide quality management system for the current year;
b) second-party management system audits of potential suppliers of critical products to be conducted within
6 months;
c) certification/registration and surveillance audits conducted by a third-party certification/registration body on an
environmental management system within a time period agreed contractually between the certification body
and the client.
An audit programme also includes appropriate planning, the provision of resources and the establishment of
procedures to conduct audits within the programme.
5.2 Audit programme objectives and extent
5.2.1 Objectives of an audit programme
Objectives should be established for an audit programme, to direct the planning and conduct of audits.
These objectives can be based on consideration of
a) management priorities,
b) commercial intentions,
c) management system requirements,
d) statutory, regulatory and contractual requirements,
e) need for supplier evaluation,
f) customer requirements,
g) needs of other interested parties, and
h) risks to the organization.
Practical help — Examples of audit programme objectives
Examples of audit programme objectives include the following:
a) to meet requirements for certification to a management system standard;
b) to verify conformance with contractual requirements;
c) to obtain and maintain confidence in the capability of a supplier;
d) to contribute to the improvement of the management system.
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ISO 19011:2002(E)
5.2.2 Extent of an audit programme
The extent of an audit programme can vary and will be influenced by the size, nature and complexity of the
organization to be audited, as well as by the following:
a) the scope, objective and duration of each audit to be conducted;
b) the frequency of audits to be conducted;
c) the number, importance, complexity, similarity and locations of the activities to be audited;
d) standards, statutory, regulatory and contractual requirements and other audit criteria;
e) the need for accreditation or registration/certification;
f) conclusions of previous audits or results of a previous audit programme review;
g) any language, cultural and social issues;
h) the concerns of interested parties;
i) significant changes to an organization or its operations.
5.3 Audit programme responsibilities, resources and procedures
5.3.1 Audit programme responsibilities
The responsibility for managing an audit programme should be assigned to one or more individuals with a general
understanding of audit principles, of the competence of auditors and the ap
...
SLOVENSKI SIST EN ISO 19011
STANDARD
januar 2003
Smernice za presojanje sistemov vodenja kakovosti in/ali ravnanja z
okoljem (enakovreden ISO 19011:2002)
Guidelines for quality and/or environmental management systems auditing
Lignes directrices pour l’audit des systèmes de management de la qualité et/ou
de management environnemental
Deskriptorji:
Referenčna številka
ICS 03.120.20; 13.020.10 SIST EN ISO 19011:2003 (sl, en)
Nadaljevanje na straneh od 2 do 46
© 2004-02. Slovenski prevod standarda je izdal in založil Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov ni dovoljeno.
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SIST EN ISO 19011 : 2003
NACIONALNI UVOD
Standard SIST EN ISO 19011 (sl,en), Smernice za presojanje sistemov vodenja kakovosti in/ali ravnanja
z okoljem, 2003 ima status slovenskega standarda in je enakovreden evropskemu standardu
EN ISO 19011, Guidelines for quality and/or environmental management systems auditing, prva izdaja,
2002.
NACIONALNI PREDGOVOR
Besedilo mednarodnega standarda ISO 19011:2002 sta pripravila mednarodna tehnična odbora
ISO/TC 176 Vodenje in zagotavljanje kakovosti, pododbor SC3 Podporne tehnologije, in ISO/TC 207
Ravnanje z okoljem, pododbor SC2 Okoljsko presojanje in sorodne okoljske preiskave. Prenos tega
standarda v evropski standard je potrdil Centralni sekretariat CEN brez sprememb vsebine
mednarodnega standarda ISO 19011.
Slovenski tehnični odbor SIST/TC VZK Vodenje in zagotavljanje kakovosti je dne 2003-01-00 privzel
evropski standard EN ISO 19011:2002 po metodi ponatisa. Standard v slovenskem jeziku je le njegova
jezikovna različica.
ZVEZA S STANDARDI
S privzemom tega mednarodnega standarda veljajo naslednje zveze:
SIST ISO 9000:2002 (sl,en) Vodenje sistemov kakovosti – Osnove in slovar
SIST ISO 14050:2000 (en) Ravnanje z okoljem - Slovar
PREDHODNE IZDAJE
– SIST EN ISO 14010:1997
– SIST EN ISO 14011:1997
– SIST EN ISO 14012:1997
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO 19011:2002.
OPOMBE
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
2
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SIST EN ISO 19011 : 2003
VSEBINA Stran Contents Page
Predgovor . 4 Foreword .4
Uvod . 4 Introduction.4
1 Predmet . 7 1 Scope .7
2 Zveza z drugimi standardi . 7 2 Normative references.7
3 Izrazi in definicije . 7 3 Terms and definitions .7
4 Načela presojanja. 10 4 Principles of auditing.10
5 Vodenje programa presoje . 11 5 Managing an audit programme .11
5.1 Splošno.11 5.1 General .11
5.2 Cilji in obseg programa presoj. 13 5.2 Audit programme objectives and extent.13
5.3 Odgovornosti, viri in postopki za program 5.3 Audit programme responsibilities,
presoj . 14 resources and procedures .14
5.4 Izvedba programa presoj. 16 5.4 Audit programme implementation.16
5.5 Zapisi o programu presoj. 16 5.5 Audit programme records .16
5.6 Nadzorovanje in pregledovanje 5.6 Audit programme monitoring and
programa za presoje . 17 reviewing .17
6 Aktivnosti presoje . 17 6 Audit activities .17
6.1 Splošno.17 6.1 General .17
6.2 Pričetek presoje. 19 6.2 Initiating the audit .19
6.3 Izvedba pregleda dokumentov . 22 6.3 Conducting document review.22
6.4 Priprava na aktivnosti presoje na kraju 6.4 Preparing for the on-site audit
samem. 22 activities .22
6.5 Izvedba aktivnosti presoje na kraju 6.5 Conducting on-site audit activities .24
samem. 24
6.6 Priprava, odobritev in razdelitev poročila o 6.6 Preparing, approving and distributing
presoji . 30 the audit report.30
6.7 Zaključitev presoje . 32 6.7 Completing the audit .32
6.8 Izvajanje aktivnosti po presoji .32 6.8 Conducting audit follow-up.32
7 Kompetentnost in ocenjevanje 7 Competence and evaluation of auditors .32
presojevalcev. 32
7.1 Splošno.32 7.1 General .32
7.2 Osebnostne lastnosti. 33 7.2 Personal attributes .33
7.3 Znanje in veščine. 34 7.3 Knowledge and skills.34
7.4 Izobrazba, delovne izkušnje, usposabljanje 7.4 Education, work experience, auditor
za presojevalca in presojevalske training and audit experience.38
izkušnje. 38
7.5 Vzdrževanje in izboljševanje 7.5 Maintenance and improvement of
kompetentnosti . 41 competence .41
7.6 Ocenjevanje presojevalcev .41 7.6 Auditor evaluation .41
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SIST EN ISO 19011 : 2003
Predgovor Foreword
ISO (Mednarodna organizacija za standardizacijo) ISO (the International Organization for
je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of
standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member
ponavadi pripravljajo tehnični odbori ISO. Vsak bodies). The work of preparing International
član, ki želi delovati na določenem področju, za Standards is normally carried out through ISO
katero je bil ustanovljen tehnični odbor, ima technical committees. Each member body
pravico biti zastopan v tem odboru. Pri delu interested in a subject for which a technical
sodelujejo mednarodne vladne in nevladne committee has been established has the right to
organizacije, povezane z ISO. V vseh zadevah, be represented on that committee. International
ki so povezane s standardizacijo na področju organizations, governmental and non-
elektrotehnike, ISO tesno sodeluje z Mednarodno governmental, in liaison with ISO, also take part
elektrotehniško komisijo (IEC). in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC)
on all matters of electrotechnical standardization.
Mednarodni standardi so pripravljeni v skladu s International standards are drafted in
pravili, podanimi v Direktivah ISO/IEC, 3. del. accordance with the rules given in the ISO/IEC
Directives, part 3.
Glavna naloga tehničnih odborov je priprava The main task of technical committees is to
mednarodnih standardov. Osnutki mednarodnih prepare International Standards. Draft International
standardov, ki jih sprejmejo tehnični odbori, se Standards accepted by the technical committees
pošljejo vsem članom v glasovanje. Za objavo are circulated to the member bodies for voting.
mednarodnega standarda je treba pridobiti Publication as an International Standard requires
soglasje najmanj 75 odstotkov članov, ki so approval by at least 75 % of the members casting
glasovali. a vote.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega mednarodnega standarda the elements of this International Standard may
predmet patentnih pravic. ISO ne prevzema be the subject of patent rights. ISO shall not be
odgovornosti za identifikacijo katerihkoli ali vseh held responsible for identifying any or all such
takih patentnih pravic. patent rights.
ISO 19011 sta skupaj pripravila tehnična odbora ISO 19011 was prepared jointly by Technical
ISO/TC 176 Vodenje in zagotavljanje kakovosti, Committee ISO/TC 176, Quality management
pododbor SC3 Podporne tehnologije, in ISO/TC and quality assurance, Subcommittee SC 3,
207, Ravnanje z okoljem, pododbor SC2 Supporting technologies, and Technical Committee
Okoljsko presojanje in sorodne okoljske ISO/TC 207, Environmental management,
preiskave.
Subcommittee SC 2, Environmental auditing and
related environmental investigations.
Ta prva izdaja ISO 19011 razveljavlja in This first edition of ISO 19011 cancels and
nadomešča ISO 10011-1:1990, ISO 10011- replaces ISO 10011-1:1990, ISO 10011-
2:1991, ISO 10011-3:1991, ISO 14010:1996, 2:1991, ISO 10011-3:1991, ISO 14010:1996,
ISO 14011:1996 in ISO 14012:1996. ISO 14011:1996 and ISO 14012:1996.
Uvod Introduction
Skupini mednarodnih standardov ISO 9000 in The ISO 9000 and ISO 14000 series of
ISO 14000 poudarjata pomembnost presoj kot International Standards emphasize the importance
orodja vodenja za nadzorovanje in overjanje of audits as a management tool for monitoring and
učinkovitega izvajanja politike kakovosti in/ali verifying the effective implementation of an organi-
okoljske politike organizacije. Presoje so tudi zation's quality and/or environmental policy. Audits
bistveni del aktivnosti ugotavljanja skladnosti, kot are also an essential part of conformity assessment
je zunanja certifikacija/registracija, in ocenjevanja activities such as external certification/registration
in nadzorovanja nabavne verige. and of supply chain evaluation and surveillance.
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SIST EN ISO 19011 : 2003
Ta mednarodni standard podaja napotke za This International Standard provides guidance on
vodenje programov presoj, izvajanje notranjih the management of audit programmes, the
ali zunanjih presoj sistemov vodenja kakovosti conduct of internal or external audits of quality
in/ali ravnanja z okoljem in tudi za and/or environmental management systems, as
kompetentnost in ocenjevanje presojevalcev. well as on the competence and evaluation of
Uporabljali naj bi ga številni možni uporabniki, auditors. It is intended to apply to a broad range
vključno presojevalci, organizacije, ki izvajajo of potential users, including auditors,
sisteme vodenja kakovosti in/ali ravnanja z organizations implementing quality and/or
okoljem, organizacije, ki morajo izvajati presoje environmental management systems,
sistemov vodenja kakovosti in/ali ravnanja z organizations needing to conduct audits of quality
okoljem iz pogodbenih razlogov, in organizacije, and/or environmental management systems for
udeležene pri certificiranju ali usposabljanju contractual reasons, and organizations involved
presojevalcev, pri certifikaciji/registraciji in auditor certification or training, in
sistemov vodenja, pri akreditaciji ali pri certification/registration of management systems,
standardizaciji na področju ocenjevanja in accreditation or in standardization in the area of
skladnosti. conformity assessment.
Smernice v tem mednarodnem standardu naj bi The guidance in this International Standard is
bile prilagodljive. Kot je nakazano na več mestih intended to be flexible. As indicated at various
v besedilu, se lahko uporaba teh smernic points in the text, the use of these guidelines can
razlikuje glede na velikost, naravo in differ according to the size, nature and complexity
kompleksnost presojane organizacije in tudi ciljev of the organizations to be audited, as well as the
in predmetov izvajanih presoj. V tem celotnem objectives and scopes of the audits to be
mednarodnem standardu so podani dodatni conducted. Throughout this International
napotki ali primeri za specifične teme kot Standard, supplementary guidance or examples
praktična pomoč v okvirjenem besedilu. V on specific topics are provided in the form of
nekaterih primerih je to namenjeno podpori practical help in boxed text. In some instances,
uporabe tega mednarodnega standarda v this is intended to support the use of this
majhnih organizacijah. International Standard in small organizations.
V točki 4 so opisana načela presojanja. Ta Clause 4 describes the principles of auditing.
načela pomagajo uporabniku razumeti bistvene These principles help the user to appreciate the
značilnosti presojanja in so nujen uvod k točkam essential nature of auditing and they are a
5, 6 in 7. necessary prelude to clauses 5, 6 and 7.
V točki 5 so podani napotki za vodenje Clause 5 provides guidance on managing audit
programov presoj in obravnavane teme, kot so programmes and covers such issues as
določitev odgovornosti za vodenje programov assigning responsibility for managing audit
presoj, vzpostavitev ciljev programa presoj, programmes, establishing the audit programme
koordiniranje aktivnosti presoj in priskrba objectives, coordinating auditing activities and
zadostnih virov za presojevalne skupine. providing sufficient audit team resources.
V točki 6 so podani napotki za vodenje presoj Clause 6 provides guidance on conducting audits
sistemov vodenja kakovosti in/ali ravnanja z of quality and/or environmental management
okoljem, vključno z izbiro presojevalnih skupin. systems, including the selection of audit teams.
V točki 7 so podani napotki glede potrebne Clause 7 provides guidance on the competence
kompetentnosti presojevalca in opisan proces needed by an auditor and describes a process
ocenjevanja presojevalcev. for evaluating auditors.
Kjer se sistema vodenja kakovosti in ravnanja z Where quality and environmental management
okoljem izvajata hkrati, se uporabnik tega systems are implemented together, it is at the
mednarodnega standarda po lastnem preudarku discretion of the user of this International
odloči, ali bo izvajal presoje sistemov vodenja Standard as to whether the quality management
kakovosti in ravnanja z okoljem ločeno ali hkrati. system and environmental management system
audits are conducted separately or together.
Čeprav je ta mednarodni standard namenjen Although this International Standard is applicable
uporabi za presojanje sistemov vodenja to the auditing of quality and/or environmental
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SIST EN ISO 19011 : 2003
kakovosti in/ali ravnanja z okoljem, lahko management systems, the user can consider
uporabnik razmisli o prilagoditvi ali razširitvi adapting or extending the guidance provided
uporabe podanih napotkov na druge vrste presoj, herein to apply to other types of audits, including
vključno z drugimi presojami sistema vodenja. other management system audits.
V tem mednarodnem standardu so sicer podani This International Standard provides only
samo napotki, vendar jih lahko uporabniki guidance, however, users can apply this to
uporabijo za pripravo njihovih lastnih zahtev v develop their own auditrelated requirements.
zvezi s presojami.
Poleg tega lahko napotki tega mednarodnega In addition, any other individual or organization
standarda koristijo posameznikom ali with an interest in monitoring conformance to
organizacijam, ki želijo nadzorovati skladnost z requirements, such as product specifications or
zahtevami, kot so specifikacije proizvodov ali laws and regulations, may find the guidance in
zakoni in predpisi. this International Standard useful.
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SIST EN ISO 19011 : 2003
Smernice za presojanje sistemov Guidelines for quality and / or
vodenja kakovosti in / ali ravnanja z environmental management systems
okoljem auditing
1 Predmet 1 Scope
Ta mednarodni standard podaja napotke o This International Standard provides guidance
načelih presojanja, vodenju programov presoj, on the principles of auditing, managing audit
izvajanju presoj sistemov vodenja kakovosti in/ali programmes, conducting quality management
ravnanja z okoljem in tudi napotke glede system audits and environmental management
kompetentnosti presojevalcev sistemov vodenja system audits, as well as guidance on the
kakovosti in ravnanja z okoljem. competence of quality and environmental
management system auditors.
Uporaben je v vseh organizacijah, ki morajo It is applicable to all organizations needing to
izvajati notranje ali zunanje presoje sistemov conduct internal or external audits of quality
vodenja kakovosti in/ali ravnanja z okoljem ali and/or environmental management systems or
voditi program presoj. to manage an audit programme.
Ta mednarodni standard je načeloma mogoče The application of this International Standard to
uporabiti pri drugih vrstah presoj, če se pri tem other types of audit is possible in principle,
posebna pozornost posveti potrebni provided that special consideration is paid to
kompetentnosti članov presojevalne skupine. identifying the competence needed by the audit
team members in such cases.
2 Zveza z drugimi standardi 2 Normative references
Spodaj navedena standarda vsebujeta določila, The following normative documents contain
ki s sklicevanjem v tem besedilu tvorijo določila provisions which, through references in this text,
tega mednarodnega standarda. Pri datiranem constitute provisions of this International Standard.
sklicevanju se ne upoštevajo poznejši dodatki ali For dated references, subsequent amendments to,
popravki teh dokumentov. Vendar se strankam, or revisions of, any of these publications do not
ki sklenejo dogovore, zasnovane na tem apply. However, parties to agreements based on
mednarodnem standardu, priporoča, naj this International Standard are encouraged to
raziščejo možnost uporabe najnovejše izdaje investigate the possibility of applying the most
spodaj navedenih standardov. Pri nedatiranem recent edition of the normative documents
sklicevanju se upošteva zadnja izdaja standarda. indicated below. For undated references, the latest
Člani ISO in IEC vzdržujejo register veljavnih edition of the normative document referred to
mednarodnih standardov. apply. Members of ISO and IEC maintain registers
of currently valid International Standards.
ISO 9000:2000, Sistemi vodenja kakovosti ISO 9000:2000, Quality management systems
– Osnove in slovar – Fundamentals and vocabulary
ISO 14050:2002, Ravnanje z okoljem – Slovar ISO 14050:2002, Environmental management
– Vocabulary
3 Izrazi in definicije 3 Terms and definitions
V tem mednarodnem standardu se uporabljajo For the purposes of this International Standard,
izrazi in definicije, ki so podani v standardih the terms and definitions given in ISO 9000 and
ISO 9000 in ISO 14050, razen tistih, ki jih ISO 14050 apply, unless superseded by the
zamenjujejo spodnji izrazi in definicije. terms and definitions given below.
Izrazi v definicijah ali opombah, ki so A term in a definition or note which is defined
opredeljeni drugje v tej točki, so označeni s elsewhere in this clause is indicated by boldface
poudarjenimi črkami, v oklepaju pa je navedena followed by its entry number in parentheses.
točka. Tako označen izraz se lahko v definiciji Such a boldface term may be replaced in the
nadomesti z njegovo celotno definicijo. definition by its complete definition.
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3.1 Presoja 3.1 audit
Sistematičen, neodvisen in dokumentiran proces systematic, independent and documented
pridobivanja dokazov presoje (3.3) in njihovega process for obtaining audit evidence (3.3) and
objektivnega vrednotenja, da bi se določil obseg, evaluating it objectively to determine the extent to
v katerem so izpolnjeni dogovorjeni kriteriji which the audit criteria (3.2) are fulfilled
presoje (3.2).
OPOMBA 1: Notranje presoje, ki se včasih imenujejo NOTE 1 Internal audits, sometimes called first-party
presoje prve stranke, izvajajo organizacije audits, are conducted by, or on behalf of, the
same ali se izvajajo v imenu organizacije organization itself for management review and
za notranje namene in lahko tvorijo podlago other internal purposes, and may form the
za lastno izjavo organizacije o skladnosti. V basis for an organization's self-declaration of
mnogih primerih, posebej v manjših conformity. In many cases, particularly in
organizacijah, se lahko neodvisnost smaller organizations, independence can be
dokazuje s tem, da oseba ni odgovorna za demonstrated by the freedom from
presojane aktivnosti. responsibility for the activity being audited.
OPOMBA 2: Zunanje presoje vključujejo to, kar se NOTE 2 External audits include those generally termed
ponavadi imenuje presoje druge ali tretje second- and third-party audits. Second-party
stranke. Presoje druge stranke izvajajo audits are conducted by parties having an
stranke, ki so zainteresirane za organizacijo, interest in the organization, such as
npr. odjemalci, ali pa druge osebe v njihovem customers, or by other persons on their
imenu. Presoje tretje stranke izvajajo behalf. Third-party audits are conducted by
zunanje neodvisne organizacije, kot so external, independent auditing organizations,
organizacije, ki izvajajo certifikacijo ali such as those providing registration or
registracijo skladnosti z zahtevami certification of conformity to the requirements
standardov ISO 9001 in ISO 14001. of ISO 9001 or ISO 14001.
OPOMBA 3: Kadar se sistema vodenja kakovosti in NOTE 3 When a quality management system and an
ravnanja z okoljem presojata hkrati, se to environmental management system are audited
imenuje kombinirana presoja. together, this is termed a combined audit.
OPOMBA 4: Kadar pri presoji enega presojanca (3.7) NOTE 4 When two or more auditing organizations
sodelujeta dve ali več presojevalskih cooperate to audit a single auditee (3.7), this
organizacij, se to imenuje skupna presoja. is termed a joint audit.
3.2 Kriteriji presoje 3.2 audit criteria
Skupek splošnih usmeritev, postopkov ali zahtev set of policies, procedures or requirements
OPOMBA: Kriteriji presoje se uporabljajo kot referenčna NOTE Audit criteria are used as a reference against
podlaga, s katero se primerja dokaz presoje (3.3). which audit evidence (3.3) is compared.
3.3 audit evidence
3.3 Dokaz presoje
Zapisi, ugotovitve o dejstvih ali druge informacije records, statements of fact or other information,
v zvezi s kriteriji presoje (3.2) in se lahko tudi which are relevant to the audit criteria (3.2) and
preverijo. verifiable
OPOMBA: Dokaz presoje je lahko kvalitativen ali NOTE Audit evidence may be qualitative or quantitative.
kvantitativen.
3.4 Ugotovitve presoje 3.4 audit findings
Rezultati vrednotenja zbranih dokazov presoje results of the evaluation of the collected audit
(3.3) glede na kriterije presoje (3.2). evidence (3.3) against audit criteria (3.2)
OPOMBA: Ugotovitve presoje lahko pokažejo bodisi NOTE Audit findings can indicate either conformity or
skladnost ali neskladnost s kriteriji presoje nonconformity with audit criteria or
ali priložnosti za izboljšave. opportunities for improvement.
3.5 Sklep presoje 3.5 audit conclusion
Izid presoje (3.1), ki ga poda presojevalna outcome of an audit (3.1), provided by the audit
skupina (3.9) po premisleku o ciljih in vseh team (3.9) after consideration of the audit
ugotovitvah presoje (3.4). objectives and all audit findings (3.4)
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3.6 Naročnik presoje 3.6 audit client
Organizacija ali oseba, ki zahteva presojo (3.1). organization or person requesting an audit (3.1)
OPOMBA: Naročnik presoje je lahko presojanec (3.7) NOTE The audit client may be the auditee (3.7) or any
ali katerakoli druga organizacija, ki ima other organization which has the regulatory or
zakonsko ali pogodbeno pravico zahtevati contractual right to request an audit.
presojo.
3.7 Presojanec 3.7 auditee
Presojana organizacija. organization being audited
3.8 Presojevalec 3.8 auditor
Oseba, kompetentna (3.14) za izvedbo presoje person with the competence (3.14) to conduct
(3.1). an audit (3.1)
3.9 Presojevalna skupina 3.9 audit team
Eden ali več presojevalcev (3.8), ki izvajajo one or more auditors (3.8) conducting an audit (3.1),
presojo (3.1) in so jim po potrebi v pomoč supported if needed by technical experts (3.10)
tehnični izvedenci (3.10).
OPOMBA 1: En presojevalec v presojevalni skupini je v NOTE 1 One auditor of the audit team is appointed as
splošnem določen za vodjo presojevalne the audit team leader.
skupine.
NOTE 2 The audit team may include auditors-in-
OPOMBA 2: V presojevalni skupini so lahko presojevalci training.
pripravniki.
3.10 Tehnični izvedenec 3.10 technical expert
Oseba, ki priskrbi presojevalni skupini (3.9) person who provides specific knowledge or
specifično znanje ali izvedensko mnenje. expertise to the audit team (3.9)
OPOMBA 1: Specifično znanje ali izkušnje vključujejo NOTE 1 1 Specific knowledge or expertise is that
znanje ali izkušnje v zvezi z organizacijo, which relates to the organization, the process
procesom ali presojanimi aktivnostmi ali or activity to be audited, or language or
jezikom ali kulturo. culture.
OPOMBA 2: Tehnični izvedenec v presojevalni skupini NOTE 2 A technical expert does not act as an auditor
ne deluje kot presojevalec (3.8). (3.8) in the audit team.
3.11 Program presoj 3.11 audit programme
Skupek ene ali več presoj (3.1), planiranih v set of one or more audits (3.1) planned for a
specifičnem časovnem okviru in usmerjenih v specific time frame and directed towards a
specifičen namen. specific purpose
OPOMBA: Program presoj vključuje vse aktivnosti, NOTE An audit programme includes all activities
potrebne za planiranje, organiziranje in necessary for planning, organizing and
izvedbo presoj. conducting the audits.
3.12 Plan presoje 3.12 audit plan
Opis aktivnosti in dogovorov za presojo (3.1). description of the activities and arrangements for
an audit (3.1)
3.13 Predmet presoje 3.13 audit scope
Obseg in meje presoje (3.1). extent and boundaries of an audit (3.1)
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OPOMBA: Predmet presoje navadno vključuje opis NOTE The audit scope generally includes a
fizičnih lokacij, organizacijskih enot, description of the physical locations,
aktivnosti in procesov ter tudi časovni okvir. organizational units, activities and processes,
as well as the time period covered.
3.14 Kompetentnost 3.14 competence
Izkazane osebnostne lastnosti in izkazana demonstrated personal attributes and
sposobnost za uporabo znanja in veščin. demonstrated ability to apply knowledge and skills
4 Načela presojanja 4 Principles of auditing
Za presojanje je značilno zanašanje na številna Auditing is characterized by reliance on a
načela. Ta naredijo presojo za učinkovito in number of principles. These make the audit an
zanesljivo orodje za podporo politikam vodenja in effective and reliable tool in support of
obvladovanja, s tem da priskrbi informacije, na management policies and controls, providing
podlagi katerih lahko organizacija ukrepa z information on which an organization can act to
namenom izboljšanja svojega delovanja. improve its performance. Adherence to these
Upoštevanje teh načel je prvi pogoj za zagotovitev principles is a prerequisite for providing audit
ustreznih in zadostnih sklepov presoj in možnosti conclusions that are relevant and sufficient and
presojevalcem, ki delujejo medsebojno neodvisno, for enabling auditors working independently from
da bi prišli do podobnih sklepov v podobnih one another to reach similar conclusions in
okoliščinah. similar circumstances.
Naslednja načela se nanašajo na presojevalce. The following principles relate to auditors.
a) Etično obnašanje: temelj strokovno a) Ethical conduct: the foundation of
opravljenega dela professionalism
Odgovornost, neoporečnost, zaupnost in Trust, integrity, confidentiality and discretion
preudarnost so bistvene za presojanje. are essential to auditing.
b) Korektnost predstavitve: dolžnost b) Fair presentation: the obligation to report
poročati resnično in točno truthfully and accurately
Ugotovitve presoj, sklepi presoj in poročila o Audit findings, audit conclusions and audit
presojah odgovorno in natančno odsevajo reports reflect truthfully and accurately the
aktivnosti presoje. Poroča se o pomembnih audit activities. Significant obstacles
ovirah, na katere se je naletelo med presojo, encountered during the audit and
in o nerešenih razlikah v mnenjih med unresolved diverging opinions between the
presojevalno skupino in presojancem. audit team and the auditee are reported.
c) Skrb za strokovnost: uporaba c) Due professional care: the application of
prizadevnosti
...
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