EN ISO/IEC 17021-1:2015
(Main)Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements (ISO/IEC 17021-1:2015)
Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements (ISO/IEC 17021-1:2015)
ISO/IEC 17021-1:2015 contains principles and requirements for the competence, consistency and impartiality of bodies providing audit and certification of all types of management systems.
Certification bodies operating to ISO/IEC 17021-1:2015 do not need to offer all types of management system certification.
Certification of management systems is a third-party conformity assessment activity and bodies performing this activity are therefore third-party conformity assessment bodies.
Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren und zertifizieren - Teil 1: Anforderungen (ISO/IEC 17021-1:2015)
Diese Internationale Norm enthält Grundsätze für und Anforderungen an die Kompetenz, Folgerichtigkeit und Unparteilichkeit von Stellen, die Audits und Zertifizierungen von Managementsystemen jeglicher Art (z. B. Umweltmanagementsystem, Qualitäts¬managementsystem, Informationssicherheitsmanagementsystem) ausführen. Zertifizierungsstellen, die nach dieser Internationalen Norm arbeiten, müssen nicht alle Arten von Managementsystem-Zertifizierungen anbieten.
Zertifizierung von Managementsystemen, in dieser Internationalen Norm als „Zertifizierung“ bezeichnet, ist eine Konformitätsbewertungstätigkeit durch eine dritte Seite (siehe ISO/IEC 17000:2004, 5.5). Stellen, die diese Tätigkeit anbieten, sind daher Konformitätsbewertungsstellen und werden in dieser Internationalen Norm verkürzt als „Zertifizierungsstellen“ bezeichnet.
ANMERKUNG 1 Eine Zertifizierungsstelle kann nichtstaatlich oder staatlich sein mit oder ohne regelsetzender Kompetenz.
ANMERKUNG 2 Diese Internationale Norm kann als Vorgabe für die Akkreditierung, Begutachtung unter Gleichrangigen oder für andere Auditprozesse genutzt werden.
Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management - Partie 1: Exigences (ISO/IEC 17021-1:2015)
L'ISO/IEC 17021-1:2015 spécifie les principes et les exigences relatifs à la compétence, à la cohérence et à l'impartialité des organismes procédant à l'audit et à la certification de tous les types de systèmes de management.
Les organismes de certification conformes à l'ISO/IEC 17021-1:2015 ne sont pas tenus de proposer tous les types de certification de système de management.
La certification de systèmes de management est une activité d'évaluation de la conformité par tierce partie et les organismes exerçant cette activité sont par conséquent des organismes d'évaluation de la conformité par tierce partie.
Ugotavljanje skladnosti - Zahteve za organe, ki presojajo in certificirajo sisteme vodenja - 1. del: Zahteve (ISO/IEC 17021-1:2015)
Ta del standarda ISO/IEC 17021 določa načela in zahteve za usposobljenost, doslednost in nepristranskost organov, ki presojajo in certificirajo vse vrste sistemov vodenja.
Certifikacijskim organom, ki delujejo v skladu s tem delom ISO/IEC 17021, ni treba ponujati vseh vrst certificiranja sistemov vodenja.
Certificiranje sistemov vodenja je dejavnost ugotavljanja skladnosti, ki jo opravljajo tretje osebe (glej točko 5.5 standarda ISO/IEC 17000:2004); organi, ki izvajajo to aktivnost, so zato zunanji organi za ugotavljanje skladnosti.
OPOMBA 1: Primeri sistemov vodenja zajemajo sisteme ravnanja z okoljem, sisteme vodenja kakovosti in sisteme upravljanja informacijske varnosti.
OPOMBA 2: V tem delu standarda ISO/IEC 17021 se certificiranje sistemov vodenja imenuje »certificiranje«, zunanji organi za ugotavljanje skladnosti pa se imenujejo »certifikacijski organi«.
OPOMBA 3: Certifikacijski organ je lahko nevladni ali vladni organ z regulativno močjo ali brez nje.
OPOMBA 4: Ta del standarda ISO/IEC 17021 je mogoče uporabiti kot dokument z merili za akreditacijo, medsebojno ocenjevanje ali druge procese presojanja.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2015
1DGRPHãþD
SIST EN ISO/IEC 17021:2011
Ugotavljanje skladnosti - Zahteve za organe, ki presojajo in certificirajo sisteme
vodenja - 1. del: Zahteve (ISO/IEC 17021-1:2015)
Conformity assessment - Requirements for bodies providing audit and certification of
management systems - Part 1: Requirements (ISO/IEC 17021-1:2015)
Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren
und zertifizieren - Teil 1: Anforderungen (ISO/IEC 17021-1:2015)
Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la
certification des systèmes de management - Partie 1: Exigences (ISO/IEC 17021-
1:2015)
Ta slovenski standard je istoveten z: EN ISO/IEC 17021-1:2015
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO/IEC 17021-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2015
ICS 03.120.20 Supersedes EN ISO/IEC 17021:2011
English Version
Conformity assessment - Requirements for bodies providing
audit and certification of management systems - Part 1:
Requirements (ISO/IEC 17021-1:2015)
Évaluation de la conformité - Exigences pour les Konformitätsbewertung - Anforderungen an Stellen, die
organismes procédant à l'audit et à la certification des Managementsysteme auditieren und zertifizieren - Teil 1:
systèmes de management - Partie 1: Exigences (ISO/IEC Anforderungen (ISO/IEC 17021-1:2015)
17021-1:2015)
This European Standard was approved by CEN on 6 June 2015.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving
this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning
such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre
has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 17021-1:2015 E
CEN/CENELE worldwide for CEN national Members and for CENELEC Members.
C
Contents Page
European foreword .3
European foreword
This document (EN ISO/IEC 17021-1:2015) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN-CENELEC/TC 1
“Criteria for conformity assessment bodies” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by January 2016, and conflicting national standards shall be withdrawn at
the latest by January 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17021:2011.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEC 17021-1:2015 has been approved by CEN as EN ISO/IEC 17021-1:2015 without any
modification.
INTERNATIONAL ISO/IEC
STANDARD 17021-1
First edition
2015-06-15
Conformity assessment —
Requirements for bodies
providing audit and certification of
management systems —
Part 1:
Requirements
Évaluation de la conformité — Exigences pour les organismes
procédant à l’audit et à la certification des systèmes de management —
Partie 1: Exigences
Reference number
ISO/IEC 17021-1:2015(E)
©
ISO/IEC 2015
ISO/IEC 17021-1:2015(E)
© ISO/IEC 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO/IEC 2015 – All rights reserved
ISO/IEC 17021-1:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 4
4.1 General . 4
4.2 Impartiality . 4
4.3 Competence . 5
4.4 Responsibility . 5
4.5 Openness . 5
4.6 Confidentiality . 6
4.7 Responsiveness to complaints . 6
4.8 Risk-based approach . 6
5 General requirements . 6
5.1 Legal and contractual matters . 6
5.1.1 Legal responsibility . 6
5.1.2 Certification agreement . 7
5.1.3 Responsibility for certification decisions . 7
5.2 Management of impartiality . 7
5.3 Liability and financing . 9
6 Structural requirements . 9
6.1 Organizational structure and top management . 9
6.2 Operational control . 9
7 Resource requirements .10
7.1 Competence of personnel .10
7.1.1 General considerations .10
7.1.2 Determination of competence criteria .10
7.1.3 Evaluation processes .10
7.1.4 Other considerations .10
7.2 Personnel involved in the certification activities .10
7.3 Use of individual external auditors and external technical experts .11
7.4 Personnel records.12
7.5 Outsourcing.12
8 Information requirements .12
8.1 Public information .12
8.2 Certification documents .13
8.3 Reference to certification and use of marks .14
8.4 Confidentiality .15
8.5 Information exchange between a certification body and its clients .15
8.5.1 Information on the certification activity and requirements .15
8.5.2 Notice of changes by a certification body .16
8.5.3 Notice of changes by a certified client .16
9 Process requirements .16
9.1 Pre-certification activities .16
9.1.1 Application .16
9.1.2 Application review .16
9.1.3 Audit programme .17
9.1.4 Determining audit time .18
9.1.5 Multi-site sampling .18
9.1.6 Multiple management systems standards .19
© ISO/IEC 2015 – All rights reserved iii
ISO/IEC 17021-1:2015(E)
9.2 Planning audits .19
9.2.1 Determining audit objectives, scope and criteria .19
9.2.2 Audit team selection and assignments .19
9.2.3 Audit plan .21
9.3 Initial certification .22
9.3.1 Initial certification audit .22
9.4 Conducting audits .23
9.4.1 General.23
9.4.2 Conducting the opening meeting .23
9.4.3 Communication during the audit .24
9.4.4 Obtaining and verifying information .24
9.4.5 Identifying and recording audit findings .25
9.4.6 Preparing audit conclusions .25
9.4.7 Conducting the closing meeting .25
9.4.8 Audit report .26
9.4.9 Cause analysis of nonconformities .27
9.4.10 Effectiveness of corrections and corrective actions .27
9.5 Certification decision .27
9.5.1 General.27
9.5.2 Actions prior to making a decision .28
9.5.3 Information for granting initial certification .28
9.5.4 Information for granting recertification .28
9.6 Maintaining certification .28
9.6.1 General.28
9.6.2 Surveillance activities .29
9.6.3 Recertification .30
9.6.4 Special audits .31
9.6.5 Suspending, withdrawing or reducing the scope of certification .31
9.7 Appeals .31
9.8 Complaints .32
9.9 Client records .33
10 Management system requirements for certification bodies .34
10.1 Options .34
10.2 Option A: General management system requirements .34
10.2.1 General.34
10.2.2 Management system manual .34
10.2.3 Control of documents .34
10.2.4 Control of records .35
10.2.5 Management review .35
10.2.6 Internal audits .36
10.2.7 Corrective actions .36
10.3 Option B: Management system requirements in accordance with ISO 9001.36
10.3.1 General.36
10.3.2 Scope .37
10.3.3 Customer focus .37
10.3.4 Management review .37
Annex A (normative) Required knowledge and skills .38
Annex B (informative) Possible evaluation methods .41
Annex C (informative) Example of a process flow for determining and maintaining competence .43
Annex D (informative) Desired personal behaviour .45
Annex E (informative) Audit and certification process .46
Bibliography .48
iv © ISO/IEC 2015 – All rights reserved
ISO/IEC 17021-1:2015(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical
activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work. In the field of conformity assessment, ISO and IEC develop joint ISO/IEC documents under the
management of the ISO Committee on Conformity assessment (ISO/CASCO).
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for
the different types of document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights.
Details of any patent rights identified during the development of the document will be in the Introduction
and/or on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
ISO/IEC 17021-1 was prepared by the ISO Committee on Conformity Assessment (CASCO). It was circulated
for voting to the national bodies of both ISO and IEC, and was approved by both organizations.
This first edition of ISO/IEC 17021-1 cancels and replaces ISO/IEC 17021:2011, which has been
technically revised.
ISO/IEC 17021 consists of the following parts, under the general title Conformity assessment —
Requirements for bodies providing audit and certification of management systems:
— Part 1: Requirements
— Part 2: Competence requirements for auditing and certification of environmental management systems
[Technical Specification]
— Part 3: Competence requirements for auditing and certification of quality management systems
[Technical Specification]
— Part 4: Competence requirements for auditing and certification of event sustainability management
systems [Technical Specification]
— Part 5: Competence requirements for auditing and certification of asset management systems [Technical
Specification]
— Part 6: Competence requirements for auditing and certification of business continuity management
systems [Technical Specification]
— Part 7: Competence requirements for auditing and certification of road traffic safety management
systems [Technical Specification]
© ISO/IEC 2015 – All rights reserved v
ISO/IEC 17021-1:2015(E)
Introduction
Certification of a management system, such as the environmental management system, quality
management system or information security management system of an organization, is one means
of providing assurance that the organization has implemented a system for the management of the
relevant aspects of its activities, products and services, in line with the organization’s policy and the
requirements of the respective international management system standard.
This part of ISO/IEC 17021 specifies requirements for bodies providing audit and certification of
management systems. It gives generic requirements for such bodies performing audit and certification in
the field of quality, the environment and other types of management systems. Such bodies are referred to
as certification bodies. Observance of these requirements is intended to ensure that certification bodies
operate management system certification in a competent, consistent and impartial manner, thereby
facilitating the recognition of such bodies and the acceptance of their certifications on a national and
international basis. This part of ISO/IEC 17021 serves as a foundation for facilitating the recognition of
management system certification in the interests of international trade.
Certification of a management system provides independent demonstration that the management
system of the organization:
a) conforms to specified requirements;
b) is capable of consistently achieving its stated policy and objectives;
c) is effectively implemented.
Conformity assessment, such as the certification of a management system, thereby provides value to the
organization, its customers and interested parties.
Clause 4 describes the principles on which credible certification is based. These principles help the user
to understand the essential nature of certification and they are a necessary prelude to Clauses 5 to 10.
These principles underpin the requirements in this part of ISO/IEC 17021, but such principles are not
auditable requirements in their own right. Clause 10 describes two alternative ways of supporting and
demonstrating the consistent achievement of the requirements in this part of ISO/IEC 17021 through
the establishment of a management system by the certification body.
Certification activities are the individual activities that make up the entire certification process, from
application review to termination of certification. Annex E provides an illustration of the way in which
many of these activities can interact.
Certification activities involve the audit of an organization’s management system. The form of attestation
of conformity of an organization’s management system to a specific management system standard or
other normative requirements is usually a certification document or a certificate.
This part of ISO/IEC 17021 is applicable to the auditing and certification of any type of management
system. It is recognized that some of the requirements, in particular those related to auditor competence,
can be supplemented with additional criteria in order to achieve the expectations of the interested parties.
In this part of ISO/IEC 17021, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2.
vi © ISO/IEC 2015 – All rights reserved
INTERNATIONAL STANDARD ISO/IEC 17021-1:2015(E)
Conformity assessment — Requirements for bodies
providing audit and certification of management systems —
Part 1:
Requirements
1 Scope
This part of ISO/IEC 17021 contains principles and requirements for the competence, consistency and
impartiality of bodies providing audit and certification of all types of management systems.
Certification bodies operating to this part of ISO/IEC 17021 do not need to offer all types of management
system certification.
Certification of management systems is a third-party conformity assessment activity (see
ISO/IEC 17000:2004, 5.5) and bodies performing this activity are therefore third-party conformity
assessment bodies.
NOTE 1 Examples of management systems include environmental management systems, quality management
systems and information security management systems.
NOTE 2 In this part of ISO/IEC 17021, certification of management systems is referred to as “certification” and
third-party conformity assessment bodies are referred to as “certification bodies”.
NOTE 3 A certification body can be non-governmental or governmental, with or without regulatory authority.
NOTE 4 This part of ISO/IEC 17021 can be used as a criteria document for accreditation, peer assessment or
other audit processes.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000, ISO/IEC 17000 and the
following apply.
3.1
certified client
organization whose management system has been certified
3.2
impartiality
presence of objectivity
Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely
influence subsequent activities of the certification body.
© ISO/IEC 2015 – All rights reserved 1
ISO/IEC 17021-1:2015(E)
Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “independence”,
“freedom from conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-
mindedness”, “even-handedness”, “detachment”, “balance”.
3.3
management system consultancy
participation in establishing, implementing or maintaining a management system
EXAMPLE 1 Preparing or producing manuals or procedures.
EXAMPLE 2 Giving specific advice, instructions or solutions towards the development and implementation of
a management system.
Note 1 to entry: Arranging training and participating as a trainer is not considered consultancy, provided that,
where the course relates to management systems or auditing, it is confined to the provision of generic information;
i.e. the trainer should not provide client-specific solutions.
Note 2 to entry: The provision of generic information, but not client specific solutions for the improvement of
processes or systems, is not considered to be consultancy. Such information may include:
— explaining the meaning and intention of certification criteria;
— identifying improvement opportunities;
— explaining associated theories, methodologies, techniques or tools;
— sharing non-confidential information on related best practices;
— other management aspects that are not covered by the management system being audited.
3.4
certification audit
audit carried out by an auditing organization independent of the client and the parties that rely on
certification, for the purpose of certifying the client’s management system
Note 1 to entry: In the definitions which follow, the term “audit” has been used for simplicity to refer to third-
party certification audit.
Note 2 to entry: Certification audits include initial, surveillance, re-certification audits, and can also include
special audits.
Note 3 to entry: Certification audits are typically conducted by audit teams of those bodies providing certification
of conformity to the requirements of management system standards.
Note 4 to entry: A joint audit is when two or more auditing organizations cooperate to audit a single client.
Note 5 to entry: A combined audit is when a client is being audited against the requirements of two or more
management systems standards together.
Note 6 to entry: An integrated audit is when a client has integrated the application of requirements of two or more
management systems standards into a single management system and is being audited against more than one standard.
3.5
client
organization whose management system is being audited for certification purposes
3.6
auditor
person who conducts an audit
3.7
competence
ability to apply knowledge and skills to achieve intended results
2 © ISO/IEC 2015 – All rights reserved
ISO/IEC 17021-1:2015(E)
3.8
guide
person appointed by the client to assist the audit team
3.9
observer
person who accompanies the audit team but does not audit
3.10
technical area
area characterized by commonalities of processes relevant to a specific type of management system and
its intended results
Note 1 to entry: See Note to 7.1.2.
3.11
nonconformity
non-fulfilment of a requirement
3.12
major nonconformity
nonconformity (3.11) that affects the capability of the management system to achieve the intended results
Note 1 to entry: Nonconformities could be classified as major in the following circumstances:
— if there is a significant doubt that effective process control is in place, or that products or services will meet
specified requirements;
— a number of minor nonconformities associated with the same requirement or issue could demonstrate a
systemic failure and thus constitute a major nonconformity.
3.13
minor nonconformity
nonconformity (3.11) that does not affect the capability of the management system to achieve the
intended results
3.14
technical expert
person who provides specific knowledge or expertise to the audit team
Note 1 to entry: Specific knowledge or expertise is that which relates to the organization, the process or activity
to be audited.
3.15
certification scheme
conformity assessment system related to management systems to which the same specified requirements,
specific rules and procedures apply
3.16
audit time
time needed to plan and accomplish a complete and effective audit of the client organization’s
management system
3.17
duration of management system certification audits
part of audit time (3.16) spent conducting audit activities from the opening meeting to the closing
meeting, inclusive
Note 1 to entry: Audit activities normally include:
— conducting the opening meeting;
— performing document review while conducting the audit;
© ISO/IEC 2015 – All rights reserved 3
ISO/IEC 17021-1:2015(E)
— communicating during the audit;
— assigning roles and responsibilities of guides and observers;
— collecting and verifying information;
— generating audit findings;
— preparing audit conclusions;
— conducting the closing meeting.
4 Principles
4.1 General
4.1.1 The principles described in this clause provide the basis for the subsequent specific performance
and descriptive requirements in this part of ISO/IEC 17021. This part of ISO/IEC 17021 does not give
specific requirements for all situations that can occur. These principles should be applied as guidance for
the decisions that may need to be made for unanticipated situations. Principles are not requirements.
4.1.2 The overall aim of certification is to give confidence to all parties that a management system
fulfils specified requirements. The value of certification is the degree of public confidence and trust that
is established by an impartial and competent assessment by a third-party. Parties that have an interest in
certification include, but are not limited to
a) the clients of the certification bodies;
b) the customers of the organizations whose management systems are certified;
c) governmental authorities;
d) non-governmental organizations;
e) consumers and other members of the public.
4.1.3 Principles for inspiring confidence include:
— impartiality;
— competence;
— responsibility;
— openness;
— confidentiality;
— responsiveness to complaints;
— risk-based approach.
NOTE This part of ISO/IEC 17021 sets out the principles of certification in Clause 4; the corresponding
principles related to auditing can be found in ISO 19011:2011, Clause 4.
4.2 Impartiality
4.2.1 Being impartial, and being perceived to be impartial, is necessary for a certification body to deliver
certification that provides confidence. It is important that all internal and external personnel are aware of
the need for impartiality.
4 © ISO/IEC 2015 – All rights reserved
ISO/IEC 17021-1:2015(E)
4.2.2 It is recognized that the source of revenue for a certification body is its client paying for certification,
and that this is a potential threat to impartiality.
4.2.3 To obtain and maintain confidence, it is essential that a certification body’s decisions be based
on objective evidence of conformity (or nonconformity) obtained by the certification body, and that its
decisions are not influenced by other interests or by other parties.
4.2.4 Threats to impartiality may include but are not limited to the following.
a) Self-interest: threats that arise from a person or body acting in their own interest. A concern related
to certification, as a threat to impartiality, is financial self-interest.
b) Self-review: threats that arise from a person or body reviewing the work done by themselves.
Auditing the management systems of a client to whom the certification body provided management
systems consultancy would be a self-review threat.
c) Familiarity (or trust): threats that arise from a person or body being too familiar with or trusting of
another person instead of seeking audit evidence.
d) Intimidation: threats that arise from a person or body having a perception of being coerced openly
or secretively, such as a threat to be replaced or reported to a supervisor.
4.3 Competence
4.3.1 Competence of the personnel of the certification body in all functions involved in certification
activities is necessary to deliver certification that provides confidence.
4.3.2 The competence also needs to be supported by the management system of the certification body.
4.3.3 It is a key issue for the management of the certification body to have an implemented process for
the establishment of competence criteria for the personnel involved in the audit and other certification
activities and to perform evaluation against the criteria.
4.4 Responsibility
4.4.1 The certified client, and not the certification body, has the responsibility for consistently achieving
the intended results of implementation of the management system standard and conformity with the
requirements for certification.
4.4.2 The certification body has the responsibility to assess sufficient objective evidence upon which to
base a certification decision. Based on audit conclusions, it makes a decision to grant certification if there is
sufficient evidence of conformity, or not to grant certification if there is not sufficient evidence of conformity.
NOTE Any audit is based on sampling within an organization’s management system and therefore is not a
guarantee of 100 % conformity with requirements.
4.5 Openness
4.5.1 A certification body needs to provide public access to, or disclosure of, appropriate and timely
information about its audit process and certification process, and about the certification status (i.e.
the granting, maintaining of certification, expanding or reducing the scope of cert
...
SLOVENSKI SIST EN ISO/IEC 17021-1
STANDARD
oktober 2015
Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in certificirajo
sisteme vodenja – 1. del: Zahteve (ISO/IEC 17021-1:2015)
Conformity assessment – Requirements for bodies providing audit and certification
of management systems – Part 1: Requirements (ISO/IEC 17021-1:2015)
Évaluation de la conformité – Exigences pour les organismes procédant à l’audit
et à la certification des systèmes de management – Partie 1: Exigences
(ISO/IEC 17021-1:2015)
Konformitätsbewertung – Anforderungen an Stellen, die Managementsysteme
auditieren und zertifizieren – Teil 1: Anforderungen (ISO/IEC 17021-1:2015)
Referenčna oznaka
ICS 03.120.20 SIST EN ISO/IEC 17021-1:2015 (sl, en)
Nadaljevanje na strani II in od 1 do 87
© 2016-10: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO/IEC 17021-1 : 2015
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17021-1 (sl,en), Ugotavljanje skladnosti – Zahteve za organe, ki presojajo
in certificirajo sisteme vodenja – 1. del: Zahteve (ISO/IEC 17021-1:2015), 2015, ima status slovenskega
standarda in je istoveten evropskemu standardu EN ISO/IEC 17021-1, Conformity assessment –
Requirements for bodies providing audit and certification of management systems – Part 1: Requirements
(ISO/IEC 17021-1:2015), 2015.
NACIONALNI PREDGOVOR
Besedilo standarda EN ISO/IEC 17021-1:2015 je pripravil tehnični odbor ISO/CASCO "Odbor za
ugotavljanje skladnosti" v sodelovanju s tehničnim odborom CEN/CLC/TC 1 "Merila za organe za
ugotavljanje skladnosti", katerega sekretariat vodi BSI. Slovenski standard SIST EN ISO/IEC 17021-1:2015
je prevod angleškega besedila evropskega standarda EN ISO/IEC 17021-1:2015. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v angleškem jeziku.
Slovensko-angleško izdajo standarda je pripravil SIST/TC UGA Ugotavljanje skladnosti.
ZVEZE S STANDARDI
S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen standardov, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO 9000:2015 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar (ISO
9000:2015)
SIST EN ISO/IEC 17000:2005 (sl,en,ne,fr) Ugotavljanje skladnosti – Slovar in splošna načela
(enakovreden ISO/IEC 17000:2004)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO/IEC 17021-1:2015.
PREDHODNA IZDAJA
– SIST EN ISO/IEC 17021:2011.
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “mednarodni standard”, v SIST EN ISO/IEC
17021-1:2015 to pomeni “slovenski standard”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO/IEC 17021-1:2015 in je objavljen z dovoljenjem
CEN
Avenue Marnix 17
1050 Bruselj
Belgija
This national document is identical with EN ISO/IEC 17021-1:2015 and is published with the
permission of
CEN
Avenue Marnix 17
1050 Bruxelles
Belgium
II
EVROPSKI STANDARD EN ISO/IEC 17021-1
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE julij 2015
ICS: 03.120.20 Nadomešča EN ISO/IEC 17021:2011
Slovenska izdaja
Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in certificirajo
sisteme vodenja – 1. del: Zahteve
(ISO/IEC 17021-1:2015)
Conformity assessment – Évaluation de la conformité – Exigences Konformitätsbewertung –
Requirements for bodies providing pour les organismes procédant à l’audit Anforderungen an Stellen, die
audit and certification of et à la certification des systèmes de Managementsysteme auditieren und
management systems – Part 1: management – Partie 1: Exigences zertifizieren – Teil 1: Anforderungen
Requirements (ISO/IEC 17021- (ISO/IEC 17021-1:2015) (ISO/IEC 17021-1:2015)
1:2015)
Ta evropski standard je CEN sprejel 6. junija 2015.
Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je
predpisano, da mora biti ta standard brez kakršnih koli sprememb sprejet kot nacionalni standard.
Najnovejši seznami teh nacionalnih standardov in njihovi bibliografski podatki se na zahtevo lahko dobijo
pri Upravnem centru CEN-CENELEC ali kateremkoli članu CEN in CENELEC.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem
centru CEN-CENELEC, veljajo kot uradne izdaje.
Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški odbori Avstrije,
Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske,
Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nekdanje jugoslovanske republike
Makedonije, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije,
Španije, Švedske, Švice, Turčije in Združenega kraljestva.
CEN CENELEC
Evropski komite za standardizacijo Evropski komite za standardizacijo v elektrotehniki
European Committee for Standardization European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Normung Europäisches Komitee für Elektrotechnische Normung
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj
© 2015. Lastnice avtorskih pravic so vse države članice CEN in CENELEC Ref. št. EN ISO/IEC 17021-1:2015 E
SIST EN ISO/IEC 17021-1 : 2015
Predgovor k evropskemu standardu European foreword
Ta dokument (EN ISO/IEC 17021-1:2015) je This document (EN ISO/IEC 17021-1:2015) has
pripravil tehnični odbor ISO/CASCO “Odbor za been prepared by Technical Committee
ugotavljanje skladnosti” v sodelovanju s ISO/CASCO "Committee on conformity
tehničnim odborom CEN-CENELEC/TC 1 "Merila assessment" in collaboration with Technical
za organe za ugotavljanje skladnosti", katerega Committee CEN-CENELEC/TC 1 “Criteria for
sekretariat vodi BSI. conformity assessment bodies” the secretariat of
which is held by BSI. N ISO/IEC 17021-1:2015)
Ta evropski standard mora dobiti status This European Standard shall be given the
nacionalnega standarda z objavo istovetnega status of a national standard, either by
besedila ali z razglasitvijo najpozneje do januarja publication of an identical text or by
2016, nacionalne standarde, ki so v nasprotju s endorsement, at the latest by January 2016, and
tem standardom, pa je treba umakniti najpozneje conflicting national standards shall be withdrawn
do januarja 2016. at the latest by January 2016.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. CEN [in/ali CENELEC] ne prevzema subject of patent rights. CEN [and/or CENELEC]
odgovornosti za identifikacijo katerih koli ali vseh shall not be held responsible for identifying any
takih patentnih pravic. or all such patent rights.
Ta dokument nadomešča EN ISO/IEC This document supersedes EN ISO/IEC 17021:
17021:2011. 2011.
Ta dokument je bil pripravljen v okviru mandata, This document has been prepared under a
ki sta ga CEN podelila Evropska komisija in mandate given to CEN by the European
Evropsko združenje za prosto trgovino. Commission and the European Free Trade
Association.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN-CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards organizations
nacionalne organizacije za standardizacijo of the following countries are bound to
naslednjih držav: Avstrije, Belgije, Bolgarije, implement this European Standard: Austria,
Cipra, Češke republike, Danske, Estonije, Finske, Belgium, Bulgaria, Croatia, Cyprus, Czech
Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Republic, Denmark, Estonia, Finland, Former
Latvije, Litve, Luksemburga, Madžarske, Malte, Yugoslav Republic of Macedonia, France,
Nekdanje jugoslovanske republike Makedonije, Germany, Greece, Hungary, Iceland, Ireland,
Nemčije, Nizozemske, Norveške, Poljske, Italy, Latvia, Lithuania, Luxembourg, Malta,
Portugalske, Romunije, Slovaške, Slovenije, Netherlands, Norway, Poland, Portugal,
Španije, Švedske, Švice, Turčije in Združenega Romania, Slovakia, Slovenia, Spain, Sweden,
kraljestva. Switzerland, Turkey and the United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo ISO/IEC 17021-1:2015 je CEN odobril The text of ISO/IEC 17021-1:2015 has been
brez sprememb kot EN ISO/IEC 17021-1:2015. approved by CEN as EN ISO/IEC 17021-1:2015
without any modification.
SIST EN ISO/IEC 17021-1 : 2015
Vsebina Stran Contents Page
Predgovor . 7 Foreword. 7
Uvod . 9 Introduction . 9
1 Področje uporabe . 11 1 Scope . 11
2 Zveze s standardi . 11 2 Normative references . 11
3 Izrazi in definicije. 12 3 Terms and definitions . 12
4 Načela . 15 4 Principles . 15
4.1 Splošno . 15 4.1 General . 15
4.2 Nepristranskost . 15 4.2 Impartiality . 15
4.3 Kompetentnost . 16 4.3 Competence . 16
4.4 Odgovornost . 17 4.4 Responsibility . 17
4.5 Odprtost . 17 4.5 Openness . 17
4.6 Zaupnost . 17 4.6 Confidentiality 17
4.7 Odzivnost na pritožbe . 17 4.7 Responsiveness to complaints . 17
4.8 Pristop na podlagi tveganja . 18 4.8 Risk-based approach . 18
5 Splošne zahteve . 18 5 General requirements . 18
5.1 Pravne in pogodbene zadeve . 18 5.1 Legal and contractual matters . 18
5.1.1 Pravna odgovornost . 18 5.1.1 Legal responsibility . 18
5.1.2 Pogodba o certificiranju . 18 5.1.2 Certification agreement . 18
5.1.3 Odgovornost za odločitve 5.1.3 Responsibility for certification
o certifikaciji . 19 decisions . 19
5.2 Obvladovanje nepristranskosti . 19 5.2 Management of impartiality . 19
5.3 Obveznosti in financiranje . 22 5.3 Liability and financing . 22
6 Strukturne zahteve . 22 6 Structural requirements . 22
6.1 Organizacijska struktura in 6.1 Organizational structure and top
najvišje vodstvo . 22 management . 22
6.2 Operativni nadzor . 23 6.2 Operational control . 23
7 Zahteve glede virov . 23 7 Resource requirements . 23
7.1 Kompetentnost osebja . 23 7.1 Competence of personnel . 23
7.1.1 Splošno . 23 7.1.1 General considerations . 23
7.1.2 Določanje kriterijev kompetentnosti . 24 7.1.2 Determination of competence criteria . 24
7.1.3 Procesi vrednotenja . 24 7.1.3 Evaluation processes . 24
7.1.4 Drugi razmisleki . 25 7.1.4 Other considerations . 25
7.2 Osebje, vključeno v aktivnosti 7.2 Personnel involved in the certification
certificiranja . 25 activities . 25
7.3 Vključitev posameznih zunanjih 7.3 Use of individual external auditors
presojevalcev in zunanjih tehničnih and external technical experts . 27
strokovnjakov . 27
7.4 Zapisi o osebju . 27 7.4 Personnel records . 27
7.5 Oddajanje del zunanjim izvajalcem . 27 7.5 Outsourcing . 27
8 Zahteve glede informacij . 28 8 Information requirements . 28
SIST EN ISO/IEC 17021-1 : 2015
8.1 Javne informacije . 28 8.1 Public information . 28
8.2 Certifikacijske listine . 29 8.2 Certification documents . 29
8.3 Sklicevanje na certifikacijo in 8.3 Reference to certification and use
uporaba znakov . 30 of marks . 30
8.4 Zaupnost . 32 8.4 Confidentiality . 32
8.5 Izmenjava informacij med certifikacijskim 8.5 Information exchange between a certification
organom in njegovimi strankami . 33 body and its clients . 33
8.5.1 Informacije o aktivnosti in zahtevah 8.5.1 Information on the certification activity and
certificiranja . 33 requirements . 33
8.5.2 Obvestilo certifikacijskega organa o 8.5.2 Notice of changes by a certification
spremembah . 33 body . 33
8.5.3 Obvestilo certificirane stranke o 8.5.3 Notice of changes by a certified
spremembah . 34 client . 34
9 Zahteve glede procesov . 34 9 Process requirements . 34
9.1 Aktivnosti pred certificiranjem . 34 9.1 Pre-certification activities . 34
9.1.1 Vloga . 34 9.1.1 Application . 34
9.1.2 Pregled vloge . 35 9.1.2 Application review . 35
9.1.3 Program presoj . 35 9.1.3 Audit programme . 35
9.1.4 Določanje časa presoje . 37 9.1.4 Determining audit time . 37
9.1.5 Vzorčenje na več lokacijah . 38 9.1.5 Multi-site sampling . 38
9.1.6 Standardi za več sistemov 9.1.6 Multiple management systems
vodenja . 38 standards . 38
9.2 Planiranje presoj . 38 9.2 Planning audits . 38
9.2.1 Določanje ciljev, obsega in kriterijev 9.2.1 Determining audit objectives, scope and
presoje . 38 criteria . 38
9.2.2 Izbira in imenovanje presojevalske 9.2.2 Audit team selection and assignments . 39
skupine . 39
9.2.3 Plan presoje . 41 9.2.3 Audit plan . 41
9.3 Začetno certificiranje . 43 9.3 Initial certification . 43
9.3.1 Začetna certifikacijska presoja. 43 9.3.1 Initial certification audit . 43
9.4 Izvajanje presoj . 45 9.4 Conducting audits . 45
9.4.1 Splošno . 45 9.4.1 General . 45
9.4.2 Izvedba uvodnega sestanka . 45 9.4.2 Conducting the opening meeting . 45
9.4.3 Komuniciranje med presojo . 46 9.4.3 Communication during the audit . 46
9.4.4 Pridobivanje in preverjanje informacij . 47 9.4.4 Obtaining and verifying information . 47
9.4.5 Identificiranje in zapisovanje 9.4.5 Identifying and recording audit
ugotovitev presoje . 47 findings . 47
9.4.6 Priprava sklepov presoje . 48 9.4.6 Preparing audit conclusions . 48
9.4.7 Izvedba zaključnega sestanka . 48 9.4.7 Conducting the closing meeting . 48
9.4.8 Poročilo o presoji . 49 9.4.8 Audit report . 49
9.4.9 Analiza vzrokov neskladnosti . 50 9.4.9 Cause analysis of nonconformities . 50
9.4.10 Učinkovitost korekcij in korektivnih 9.4.10 Effectiveness of corrections and
ukrepov . 50 corrective actions . 50
SIST EN ISO/IEC 17021-1 : 2015
9.5 Odločitev o certifikaciji . 51 9.5 Certification decision . 51
9.5.1 Splošno . 51 9.5.1 General . 51
9.5.2 Aktivnosti pred sprejemanjem 9.5.2 Actions prior to making a
odločitve . 52 decision . 52
9.5.3 Informacije za podelitev začetne 9.5.3 Information for granting initial
certifikacije . 52 certification . 52
9.5.4 Informacije za obnovitev certifikacije . 53 9.5.4 Information for granting recertification . 53
9.6 Vzdrževanje certifikacije . 53 9.6 Maintaining certification . 53
9.6.1 Splošno . 53 9.6.1 General . 53
9.6.2 Nadzorne aktivnosti . 53 9.6.2 Surveillance activities . 53
9.6.3 Obnovitev certifikacije . 54 9.6.3 Recertification . 54
9.6.4 Posebne presoje . 56 9.6.4 Special audits . 56
9.6.5 Začasni odvzem, preklic ali krčenje 9.6.5 Suspending, withdrawing or reducing the
obsega certifikacije . 56 scope of certification . 56
9.7 Prizivi . 57 9.7 Appeals . 57
9.8 Pritožbe . 58 9.8 Complaints . 58
9.9 Zapisi o strankah . 59 9.9 Client records . 59
10 Zahteve za sistem vodenja 10 Management system requirements for
certifikacijskih organov . 60 certification bodies . 60
10.1 Možnosti . 60 10.1 Options . 60
10.2 Možnost A: Splošne zahteve 10.2 Option A: General management system
za sistem vodenja . 61 requirements . 61
10.2.1 Splošno . 61 10.2.1 General . 61
10.2.2 Poslovnik sistema vodenja . 61 10.2.2 Management system manual . 61
10.2.3 Obvladovanje dokumentov . 61 10.2.3 Control of documents . 61
10.2.4 Obvladovanje zapisov . 62 10.2.4 Control of records . 62
10.2.5 Vodstveni pregled . 62 10.2.5 Management review . 62
10.2.6 Notranje presoje . 63 10.2.6 Internal audits . 63
10.2.7 Korektivni ukrepi . 64 10.2.7 Corrective actions . 64
10.3 Možnost B: Zahteve za sistem 10.3 Option B: Management system
vodenja v skladu z ISO 9001 . 64 requirements in accordance with
ISO 9001 . 64
10.3.1 Splošno . 64 10.3.1 General . 64
10.3.2 Obseg . 64 10.3.2 Scope . 64
10.3.3 Osredotočenost na odjemalce . 65 10.3.3 Customer focus . 65
10.3.4 Vodstveni pregled . 65 10.3.4 Management review . 65
Dodatek A (normativni): Potrebno znanje Annex A (normative) Required knowledge and
in veščine . 66 skills . 67
Dodatek B (informativni): Možne metode Annex B (informative) Possible evaluation
vrednotenja . 72 methods . 73
Dodatek C (informativni): Primer poteka Annex C (informative) Example of a process flow
procesa za ugotavljanje in vzdrževanje for determining and maintaining
kompetentnosti . 76 competence . 77
SIST EN ISO/IEC 17021-1 : 2015
Dodatek D (informativni): Zaželeno osebno Annex D (informative) Desired personal
vedenje . 80 behaviour . 81
Dodatek E (informativni): Proces Annex E (informative) Audit and certification
presoje in certificiranja . 82 process . 83
Literatura . 86 Bibliography . 87
SIST EN ISO/IEC 17021-1 : 2015
Predgovor Foreword
ISO (Mednarodna organizacija za standardizacijo) ISO (the International Organization for
in IEC (Mednarodna elektrotehniška komisija) Standardization) and IEC (the International
tvorita specializiran sistem za svetovno Electrotechnical Commission) form the specialized
standardizacijo. Nacionalni organi, ki so člani system for worldwide standardization. National
ISO ali IEC, sodelujejo pri pripravi mednarodnih bodies that are members of ISO or IEC participate
standardov prek tehničnih odborov, ki jih za in the development of International Standards
obravnavanje določenih strokovnih področij through technical committees established by the
ustanovi ustrezna organizacija. Tehnični odbori respective organization to deal with particular fields
ISO in IEC sodelujejo na področjih skupnega of technical activity. ISO and IEC technical
interesa. Pri delu sodelujejo tudi druge committees collaborate in fields of mutual interest.
mednarodne, vladne in nevladne organizacije, ki Other international organizations, governmental
so povezane z ISO in IEC. Na področju and non-governmental, in liaison with ISO and
ugotavljanja skladnosti ISO in IEC pripravljata IEC, also take part in the work. In the field of
skupne dokumente pod vodstvom Odbora conformity assessment, ISO and IEC develop joint
ISO/IEC za ugotavljanje skladnosti ISO/IEC documents under the management of the
(ISO/CASCO). ISO Committee on Conformity assessment
(ISO/CASCO).
Postopki, uporabljeni pri razvoju tega The procedures used to develop this
dokumenta, in postopki, predvideni za njegovo document and those intended for its further
nadaljnje vzdrževanje, so opisani v Direktivah maintenance are described in the ISO/IEC
ISO/IEC, 1. del. Posebna pozornost naj se Directives, Part 1. In particular the different
nameni različnim kriterijem odobritve, potrebnim approval criteria needed for the different types
za različne vrste dokumentov. Ta dokument je bil of document should be noted. This document
pripravljen skladno z uredniškimi pravili Direktiv was drafted in accordance with the editorial
ISO/IEC, 2. del (glej www.iso.org/directives). rules of the ISO/IEC Directives, Part 2 (see
w w w.iso.org/directives).
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some
elementov tega dokumenta predmet patentnih of the elements of this document may be the
pravic. ISO in IEC ne prevzemata odgovornosti subject of patent rights. ISO and IEC shall not
za prepoznavanje katerihkoli ali vseh takih be held responsible for identifying any or all
patentnih pravic. Podrobnosti o morebitnih such patent rights. Details of any patent rights
patentnih pravicah, prepoznanih med pripravo identified during the development of the
tega dokumenta, bodo navedene v uvodu in/ali document will be in the Introduction and/or on the
na seznamu patentnih izjav, ki jih je prejela ISO list of patent declarations received (see
organizacija ISO (glej www.iso.org/patents). w w w.iso.org/patents).
Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is
dokumentu, so informacije za uporabnike in ne information given for the convenience of users
pomenijo podpore blagovni znamki. and does not constitute an endorsement.
Za razlago pomena specifičnih izrazov in For an explanation on the meaning of ISO
terminov ISO, povezanih z ugotavljanjem specific terms and expressions related to
skladnosti, ter informacije o tem, kako ISO conformity assessment, as well as information
spoštuje načela Mednarodne trgovinske about ISO’s adherence to the WTO principles in
organizacije (WTO) v Tehničnih ovirah pri the Technical Barriers to Trade (TBT) see the
trgovanju (TBT), glej naslednji naslov URL: following URL: Foreword – Supplementary
Foreword – Supplementary information. information
ISO/IEC 17021-1 je pripravil Odbor ISO za ISO/IEC 17021-1 was prepared by the ISO
ugotavljanje skladnosti (CASCO). Poslan je bil v Committee on Conformity Assessment
glasovanje nacionalnim organom ISO in IEC in (CASCO). It was circulated for voting to the
obe organizaciji sta ga odobrili. national bodies of both ISO and IEC, and was
approved by both organizations.
SIST EN ISO/IEC 17021-1 : 2015
Ta prva izdaja ISO/IEC 17021-1 razveljavlja in This first edition of ISO/IEC 17021-1 cancels and
nadomešča ISO/IEC 17021:2011, ki je bil replaces ISO/IEC 17021:2011, which has been
strokovno revidiran. technically revised.
Standard ISO/IEC 17021 s splošnim naslovom ISO/IEC 17021 consists of the following parts,
Ugotavljanje skladnosti – Zahteve za organe, ki under the general title Conformity assessment
presojajo in certificirajo sisteme vodenja, je – Requirements for bodies providing audit and
sestavljen iz naslednjih delov: certification of management systems:
– 1. del: Zahteve – Part 1: Requirements
– 2. del: Zahteve glede kompetentnosti za – Part 2: Competence requirements for auditing
presojanje in certificiranje sistemov and certification of environmental manage-
ravnanja z okoljem [tehnična specifikacija] ment systems [Technical Specification]
– 3. del: Zahteve glede kompetentnosti za – Part 3: Competence requirements for auditing
presojanje in certificiranje sistemov vodenja and certification of quality management
kakovosti [tehnična specifikacija] systems [Technical Specification]
– 4. del: Zahteve glede kompetentnosti za – Part 4: Competence requirements for
presojanje in certificiranje sistemov auditing and certification of event
upravljanja trajnostnih dogodkov [tehnična sustainability management systems
specifikacija] [Technical Specification]
– 5. del: Zahteve glede kompetentnosti za – Part 5: Competence requirements for
presojanje in certificiranje sistemov auditing and certification of asset manage-
upravljanja sredstev [tehnična specifikacija] ment systems [Technical Specification]
– 6. del: Zahteve glede kompetentnosti za – Part 6: Competence requirements for
presojanje in certificiranje sistemov auditing and certification of business
upravljanja neprekinjenega poslovanja continuity management systems [Technical
[tehnična specifikacija] Specification]
– 7. del: Zahteve glede kompetentnosti za – Part 7: Competence requirements for
presojanje in certificiranje sistemov auditing and certification of road traffic
upravljanja varnosti cestnega prometa safety management systems [Technical
[tehnična specifikacija] Specification]
SIST EN ISO/IEC 17021-1 : 2015
Uvod Introduction
Certificiranje sistemov vodenja, kakršni so npr. Certification of a management system, such as the
sistem ravnanja z okoljem, sistem vodenja environmental management system, quality
kakovosti ali sistem upravljanja informacijske management system or information security
varnosti organizacije, je eden od načinov management system of an organization, is one
zagotavljanja, da ima organizacija uveden means of providing assurance that the organization
sistem za vodenje pomembnih vidikov svojih has implemented a system for the management of
aktivnosti, proizvodov in storitev v skladu s svojo the relevant aspects of its activities, products and
politiko in z ustreznim mednarodnim standardom services, in line with the organization’s policy and
sistema vodenja. the requirements of the respective international
management system standard.
Ta del standarda ISO/IEC 17021 opredeljuje This part of ISO/IEC 17021 specifies requirements
zahteve za organe, ki presojajo in certificirajo for bodies providing audit and certification of
sisteme vodenja. Podaja splošne zahteve za management systems. It gives generic require-
organe, ki presojajo in certificirajo sisteme ments for such bodies performing audit and
vodenja na področju kakovosti, okolja ter druge certification in the field of quality, the environment
vrste sistemov vodenja. Taki organi se imenujejo and other types of management systems. Such
certifikacijski organi. Z upoštevanjem teh zahtev bodies are referred to as certification bodies.
se zagotavlja, da certifikacijski organi Observance of these requirements is intended to
kompetentno, dosledno in nepristransko izvajajo ensure that certification bodies operate manage-
certificiranje sistemov vodenja, s čimer se ment system certification in a competent, consistent
omogoči priznavanje takih organov in and impartial manner, thereby facilitating the
sprejemanje njihovih certifikatov na nacionalni in recognition of such bodies and the acceptance of
mednarodni ravni. Ta del ISO/IEC 17021 je their certifications on a national and international
temelj za omogočanje priznavanja certifikatov za basis. This part of ISO/IEC 17021 serves as a
sisteme vodenja v interesu mednarodne foundation for facilitating the recognition of
trgovine. management system certification in the interests of
international trade.
Certifikacija sistema vodenja je neodvisen Certification of a management system provides
dokaz, da je sistem vodenja organizacije: independent demonstration that the manage-
ment system of the organization:
a) skladen s specificiranimi zahtevami; a) conforms to specified requirements;
b) sposoben dosledno dosegati navedeno b) is capable of consistently achieving its
politiko in cilje organizacije; stated policy and objectives;
c) učinkovito izvajan. c) is effectively implemented.
Ugotavljanje skladnosti, kamor sodi certifikacija Conformity assessment, such as the certification
sistema vodenja, s tem zagotavlja vrednost za of a management system, thereby provides value
organizacijo, njene odjemalce in zainteresirane to the organization, its customers and interested
strani. parties.
V točki 4 so opisana načela, na katerih temelji Clause 4 describes the principles on which credible
verodostojna certifikacija. Ta načela uporabniku certification is based. These principles help the
pomagajo razumeti bistvo certifikacije in so user to understand the essential nature of
potreben uvod v točke od 5 do 10. Ta načela so certification and they are a necessary prelude to
podlaga za zahteve iz tega dela ISO/IEC 17021, Clauses 5 to 10. These principles underpin the
vendar pa taka načela sama po sebi niso requirements in this part of ISO/IEC 17021, but
zahteve, ki bi jih bilo mogoče presojati. V točki such principles are not auditable requirements in
10 sta opisana dva alternativna načina, ki their own right. Clause 10 describes two alternative
pomagata in prikazujeta, kako stalno dosegati ways of supporting and demonstrating the
zahteve iz tega dela ISO/IEC 17021 s tem, ko consistent achievement of the requirements in this
certifikacijski organ vzpostavi sistem vodenja. part of ISO/IEC 17021 through the establishment
of a management system by the certification body.
SIST EN ISO/IEC 17021-1 : 2015
Aktivnosti certificiranja so posamezne aktivnosti, Certification activities are the individual
ki sestavljajo celoten proces certificiranja, od activities that make up the entire certification
pregleda vloge do prenehanja veljavnosti process, from application review to termination
certifikacije. V dodatku E je ponazorjeno, na of certification. Annex E provides an illustration
kakšen način lahko te aktivnosti vplivajo ena na of the way in which many of these activities can
drugo. interact.
Aktivnosti certificiranja vključujejo presojo Certification activities involve the audit of an
sistema vodenja organizacije. Oblika potrditve organization’s management system. The form of
skladnosti sistema vodenja organizacije s attestation of conformity of an organization’s
specifičnim standardom za sisteme vodenja ali z management system to a specific management
drugimi normativnimi zahtevami je praviloma system standard or other normative
certifikacijska listina ali certifikat. requirements is usually a certification document
or a certificate.
Ta del ISO/IEC 17021 se lahko uporablja za This part of ISO/IEC 17021 is applicable to the
presojanje in certificiranje vseh vrst sistemov auditing and certification of any type of
vodenja. Nekatere od zahtev, zlasti tiste, ki se management system. It is recognized that some
nanašajo na kompetentnost presojevalcev, se of the requirements, in particular those related to
lahko dopolnijo z dodatnimi kriteriji, da bi se tako auditor competence, can be supplemented with
izpolnila pričakovanja zainteresiranih strani. additional criteria in order to achieve the
expectations of the interested parties.
V tem delu ISO/IEC 17021 so uporabljene In this part of ISO/IEC 17021, the following
naslednje glagolske oblike: verbal forms are used:
– "treba je" ali "mora" ("shall") označuje – “shall” indicates a requirement;
zahtevo;
– "naj" ("should") označuje priporočilo; – “should” indicates a recommendation;
– "sme" ("may") označuje dovoljenje; – “may” indicates a permission;
– "lahko" ("can") označuje možnost ali – “can” indicates a possibility or a capability.
sposobnost.
Nadaljnje podrobnosti so v Direktivah ISO/IEC, Further details can be found in the ISO/IEC
2. del. Directives, Part 2.
SIST EN ISO/IEC 17021-1 : 2015
Ugotavljanje skladnosti – Conformity assessment –
Zahteve za organe, ki presojajo in Requirements for bodies providing
certificirajo sisteme vodenja – audit and certification of management
1. del: Zahteve systems – Part 1: Requirements
1 Področje uporabe 1 Scope
Ta del standarda ISO/IEC 17021 vsebuje načela This part of ISO/IEC 17021 contains principles
in zahteve za kompetentnost, doslednost in and requirements for the competence,
nepristranskost organov, ki presojajo in consistency and impartiality of bodies providing
certificirajo vse vrste sistemov vodenja. audit and certification of all types of
management systems.
Certifikacijskim organom, ki delujejo v skladu s Certification bodies operating to this part of
tem delom ISO/IEC 17021, ni treba nuditi ISO/IEC 17021 do not need to offer all types of
certifikacije vseh vrst sistemov vodenja. management system certification.
Certificiranje sistemov vodenja je aktivnost Certification of management systems is a
ugotavljanja skladnosti, ki jo izvajajo tretje third-party conformity assessment activity (see
stranke (glej ISO/IEC 17000:2004, točka 5.5); ISO/IEC 17000:2004, 5.5) and bodies
organi, ki to aktivnost izvajajo, so torej organi za performing this activity are therefore third-
ugotavljanje skladnosti kot tretja stranka. party conformity assessment bodies.
OPOMBA 1: Primeri sistemov vodenja vključujejo NOTE 1 Examples of management systems include
sisteme ravnanja z okoljem, sisteme environmental management systems,
vodenja kakovosti in sisteme za upravljanje quality management systems and
informacijske varnosti. information security management systems.
OPOMBA 2: V tem delu ISO/IEC 17021 se certificiranje NOTE 2 In this part of ISO/IEC 17021, certification of
sistemov vodenja imenuje "certifikacija", management systems is referred to as
organe ugotavljanja skladnosti kot tretjo “certification” and third-party conformity
stranko pa "certifikacijski organi". assessment bodies are referred to as
“certification bodies”.
OPOMBA 3: Certifikacijski organ je lahko nevladni ali NOTE 3 A certification body can be non-
vladni, z regulativnimi pooblastili ali brez governmental or governmental, with or
njih. without regulatory authority.
OPOMBA 4: Ta del ISO/IEC 17021 se lahko uporabi kot NOTE 4 This part of ISO/IEC 17021 can be used as
dokument s kriteriji za akreditacijo ali a criteria document for accreditation, peer
medsebojno ocenjevanje ali za druge assessment or other audit processes.
procese presoje.
2 Zveze s standardi 2 Normative references
Ta dokument se v celoti ali delno sklicuje na The following documents, in whole or in part,
naslednje normativne dokumente, ki so nujno are normatively referenced in this document
potrebni za njegovo uporabo. Pri datiranem and are indispensable for its application. For
sklicevanju velja samo navedena izdaja. Pri dated references, only the edition cited
nedatiranem sklicevanju se uporablja najnovejša applies. For undated references, the latest
izdaja dokumenta (vključno z morebitnimi dopolnili). edition of the referenced document (including
any amendments) applies.
ISO 9000, Sistemi vodenja kakovosti – Osnove ISO 9000, Quality management systems –
in slovar Fundamentals and vocabulary
ISO/IEC 17000, Ugotavljanje skladnosti – Slovar ISO/IEC 17000, Conformity assessment –
in splošna načela Vocabulary and general principles
SIST EN ISO/IEC 17021-1 : 2015
3 Izrazi in definicije 3 Terms and definitions
V tem dokumentu se uporabljajo izrazi in definicije For the purposes of this document, the terms and
iz standardov ISO 9000, ISO/IEC 17000 ter definitions given in ISO 9000, ISO/IEC 17000 and
naslednji izrazi in definicije: the following apply.
3.1 3.1
certificirana stranka certified client
organizacija, katere sistem vodenja je certificiran organization whose management system has
been certified
3.2 3.2
nepristranskost impartiality
prisotnost objektivnosti presence of objectivity
Opomba 1 k izrazu: Objektivnost pomeni, da nasprotja Note 1 to entry: Objectivity means that conflicts of
interesov ne obstajajo ali so rešena tako, da ne vplivajo interest do not exist, or are resolved so as not to adversely
negativno na poznejše aktivnosti certifikacijskega organa. influence subsequent activities of the certification body.
Opomba 2 k izrazu: Drugi uporabni izrazi pri podajanju Note 2 to entry: Other terms that are useful in conveying
elementa nepristranskosti so: "neodvisnost", "odsotnost the element of impartiality include “independence”, “freedom
nasprotja interesov", "odsotnost pristranskosti", "odsotnost from conflict of interests”, “freedom from bias”, “lack of
predsodkov", "nevtralnost", "poštenost", "odprtost duha", prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-
"enakopravno obravnavanje", "neopredeljenost", "uravnoteženost". handedness”, “detachment”, “balance”.
3.3 3.3
svetovanje za sistem vodenja management system consultancy
sodelovanje pri vzpostavljanju, izvajanju ali participation in establishing, implementing or
vzdrževanju sistema vodenja maintaining a management system
1. PRIMER: Priprava ali izdelava poslovnikov ali postopkov. EXAMPLE 1: Preparing or producing manuals or procedures.
2. PRIMER: Dajanje specifičnih nasvetov, navodil ali rešitev EXAMPLE 2: Giving specific advice, instructions or solutions
za razvoj in izvajanje sistema vodenja. towards the development and implementation of a
management system.
Opomba 1 k izrazu: Organiziranje usposabljanja in Note 1 to entry: Arranging training and participating as
sodelovanje v vlogi predavatelja se ne šteje za svetovanje, a trainer is not considered consultancy, provided that,
če je v primeru, ko se tečaj nanaša na sisteme vodenja ali where the course relates to management systems or
presojanje, svetovanje omejeno na dajanje splošnih auditing, it is confined to the provision of generic information;
informacij, tj. predavatelj naj ne daje specifičnih rešitev za i.e. the trainer should not provide client-specific solutions.
stranko.
Opomba 2 k izrazu: Dajanje splošnih informacij, ne pa Note 2 to entry: The provision of generic information, but
tudi specifičnih rešitev za izboljšanje procesov ali sistemov not client specific solutions for the improvement of
stranke, se ne šteje za svetovanje. Take informacije lahko processes or systems, is not considered to be consultancy.
vključujejo: Such information may include:
– razlaganje pomena in namena kriterijev certificiranja;
– ex
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