EN ISO/IEC 17011:2017
(Main)Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2017)
Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2017)
ISO/IEC 17011:2017 specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.
Konformitätsbewertung - Anforderungen an Akkreditierungsstellen, die Konformitätsbewertungsstellen akkreditieren (ISO/IEC 17011:2017)
Diese Internationale Norm legt die Anforderungen an die Kompetenz, den gleichbleibenden Betrieb und die Unparteilichkeit von Akkreditierungsstellen fest, die Konformitätsbewertungsstellen begutachten und akkreditieren.
ANMERKUNG Im Kontext dieser Internationalen Norm werden durch die Akkreditierung unter anderem folgende Tätigkeiten abgedeckt: Prüfung, Kalibrierung, Inspektion, Zertifizierung von Managementsystemen, Personen, Produkten, Prozessen und Dienstleistungen sowie das Anbieten von Eignungsprüfungen, die Herstellung von Referenzmaterialien und Validierung und Verifizierung.
Évaluation de la conformité - Exigences pour les organismes d'accréditation procédant à l'accréditation d'organismes d'évaluation de la conformité (ISO/IEC 17011:2017)
ISO/IEC 17011:2017 spécifie les exigences relatives à la compétence, la cohérence des activités et l'impartialité des organismes d'accréditation procédant à l'évaluation et à l'accréditation des organismes d'évaluation de la conformité.
NOTE Dans le contexte du présent document, les activités couvertes par l'accréditation incluent, sans toutefois s'y limiter, l'essai, l'étalonnage, l'inspection, la certification de systèmes de management, de personnel, de produits, de processus et de services, l'organisation d'essais d'aptitude, la production de matériaux de référence, la validation et la vérification.
Ugotavljanje skladnosti - Zahteve za akreditacijske organe, ki akreditirajo organe za ugotavljanje skladnosti (ISO/IEC 17011:2017)
Ta dokument določa zahteve za usposobljenost, dosledno delovanje in nepristranskost akreditacijskih organov, ki akreditirajo organe za ugotavljanje skladnosti.
OPOMBA: V okviru tega dokumenta dejavnosti, ki jih zajema akreditacija, med drugim vključujejo preskušanje, umerjanje, pregledovanje, certificiranje sistemov za upravljanje, osebe, proizvode, postopke in storitve, preskušanje strokovne usposobljenosti, izdelavo referenčnih materialov, potrjevanje in preverjanje.
General Information
Relations
Overview
EN ISO/IEC 17011:2017 (adopted by CEN) specifies requirements for the competence, consistent operation and impartiality of accreditation bodies that assess and accredit conformity assessment bodies. It is the international second edition (revising ISO/IEC 17011:2004) and applies to accreditation of testing and calibration laboratories, inspection bodies, certification bodies (products, processes, management systems, persons), proficiency testing providers, reference material producers and similar conformity assessment activities.
Key topics and requirements
The standard sets out a comprehensive framework covering organisational, technical and procedural elements an accreditation body must address. Major topics include:
- General requirements: legal entity, accreditation agreements, use of accreditation symbols, impartiality and conflict-of-interest controls.
- Structural and resource requirements: governance, organisational structure, staffing, outsourcing and record keeping.
- Competence: competence criteria and management for assessors and technical personnel, plus an informative annex on knowledge and skills.
- Process requirements: application handling, resource review, assessment planning, on-site and remote assessments, review of documented information, and accreditation decision-making.
- Accreditation cycle and scheme management: establishment of accreditation schemes, flexible scopes, extension, suspension, withdrawal or reduction of accreditation.
- Risk and modern assessment methods: introduction of a risk-based approach and explicit recognition of remote assessment and proficiency testing as accreditation activities.
- Information and confidentiality: handling of confidential information, public information and claims of accreditation.
- Management system: document and records control, internal audits, nonconformity management, corrective action, continual improvement, and management reviews.
- Complaints and appeals: formal requirements for receiving and handling complaints and appeals.
Practical applications and who uses it
ISO/IEC 17011 is used by:
- National and regional accreditation bodies establishing or improving accreditation programs.
- Conformity assessment bodies (labs, inspection and certification bodies) preparing for or maintaining accreditation.
- Regulators, procurement officers and supply‑chain managers who rely on accredited results for decision-making.
- International recognition bodies and stakeholders involved in mutual recognition arrangements and trade facilitation.
Practical uses include designing accreditation schemes, defining assessor competence, implementing impartiality safeguards, conducting risk‑based assessment programs, and supporting consistent accreditation decisions.
Related standards
Relevant standards and frameworks often used with ISO/IEC 17011:
- ISO/IEC 17025 (testing and calibration laboratories)
- ISO/IEC 17020 (inspection bodies)
- ISO/IEC 17021 (management systems certification)
- ISO/IEC CASCO guidance and other ISO conformity assessment documents
EN ISO/IEC 17011 is central to ensuring confidence in conformity assessment results and enabling consistent, impartial accreditation practice across sectors and borders.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2018
1DGRPHãþD
SIST EN ISO/IEC 17011:2004
Ugotavljanje skladnosti - Zahteve za akreditacijske organe, ki akreditirajo organe
za ugotavljanje skladnosti (ISO/IEC 17011:2017)
Conformity assessment - Requirements for accreditation bodies accrediting conformity
assessment bodies (ISO/IEC 17011:2017)
Konformitätsbewertung - Allgemeine Anforderungen an Akkreditierungsstellen, die
Konformitätsbewertungsstellen akkreditieren (ISO/IEC 17011:2017)
Évaluation de la conformité - Exigences générales pour les organismes d'accréditation
procédant à l'accréditation d'organismes d'évaluation de la conformité (ISO/IEC
17011:2017)
Ta slovenski standard je istoveten z: EN ISO/IEC 17011:2017
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 17011
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2017
ICS 03.120.20
Supersedes EN ISO/IEC 17011:2004
English version
Conformity assessment - Requirements for accreditation
bodies accrediting conformity assessment bodies (ISO/IEC
17011:2017)
Évaluation de la conformité - Exigences pour les Konformitätsbewertung - Anforderungen an
organismes d'accréditation procédant à l'accréditation Akkreditierungsstellen, die
d'organismes d'évaluation de la conformité (ISO/IEC Konformitätsbewertungsstellen akkreditieren
17011:2017) (ISO/IEC 17011:2017)
This European Standard was approved by CEN on 10 November 2017.
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,
Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2017 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO/IEC 17011:2017 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO/IEC 17011:2017) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN/CLC/JTC 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 June 2018 and conflicting national standards shall be
withdrawn at the latest by June 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17011:2004.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
the United Kingdom.
Endorsement notice
The text of ISO/IEC 17011:2017 has been approved by CEN as EN ISO/IEC 17011:2017 without any
modification.
INTERNATIONAL ISO/IEC
STANDARD 17011
Second edition
2017-11
Conformity assessment —
Requirements for accreditation
bodies accrediting conformity
assessment bodies
Évaluation de la conformité — Exigences pour les organismes
d'accréditation procédant à l'accréditation d'organismes d'évaluation
de la conformité
Reference number
ISO/IEC 17011:2017(E)
©
ISO/IEC 2017
ISO/IEC 17011:2017(E)
© ISO/IEC 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO/IEC 2017 – All rights reserved
ISO/IEC 17011:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 5
4.1 Legal entity . 5
4.2 Accreditation agreement . 5
4.3 Use of accreditation symbols and other claims of accreditation . 6
4.4 Impartiality requirements . 7
4.5 Financing and liability . 8
4.6 Establishing accreditation schemes. 9
5 Structural requirements . 9
6 Resource requirements .10
6.1 Competence of personnel .10
6.1.1 General.10
6.1.2 Determination of competence criteria .10
6.1.3 Competence management .12
6.2 Personnel involved in the accreditation process .12
6.3 Personnel records.13
6.4 Outsourcing.13
7 Process requirements .13
7.1 Accreditation requirements .13
7.2 Application for accreditation .14
7.3 Resource review.14
7.4 Preparation for assessment .14
7.5 Review of documented information .15
7.6 Assessment .15
7.7 Accreditation decision-making .16
7.8 Accreditation information .17
7.9 Accreditation cycle .19
7.10 Extending accreditation .20
7.11 Suspending, withdrawing or reducing accreditation .20
7.12 Complaints .20
7.13 Appeals .21
7.14 Records on conformity assessment bodies .22
8 Information requirements .22
8.1 Confidential information .22
8.2 Publicly available information .22
9 Management system requirements .23
9.1 General .23
9.2 Management system .24
9.3 Document control .24
9.4 Records control.24
9.5 Nonconformities and corrective actions .25
9.6 Improvement .25
9.7 Internal audits .25
9.8 Management reviews .26
Annex A (informative) Knowledge and skills for performing accreditation activities .27
Bibliography .29
© ISO/IEC 2017 – All rights reserved iii
ISO/IEC 17011:2017(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by the ISO Committee on Conformity Assessment (CASCO) and circulated
for voting to the national bodies of both ISO and IEC, and was approved by both organizations.
This second edition cancels and replaces the first edition (ISO/IEC 17011:2004), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— alignment with the CASCO common structure for standards and incorporation of CASCO common
elements in clauses on impartiality, confidentiality, complaints and appeal and management system;
— recognition of proficiency testing as an accreditation activity;
— addition of new definitions for “accreditation scheme” (see 3.8), “flexible scope of accreditation” (see
3.7), “remote assessment” (see 3.26) and “assessment programme” (see 3.27);
— introduction of the concept of risk;
— incorporation of competence criteria in the document, including an informative annex on knowledge
and skills.
iv © ISO/IEC 2017 – All rights reserved
ISO/IEC 17011:2017(E)
Introduction
This document specifies the requirements for accreditation bodies accrediting conformity assessment
bodies. In the context of this document, activities covered by accreditation include but are not limited to
testing, calibration, inspection, certification of management systems, persons, products, processes and
services, provision of proficiency testing, production of reference materials, validation and verification.
It is important for interested parties to know that conformity assessment bodies are competent to
perform their tasks. For that reason, there is an increasing demand for impartial attestation of their
competence. Such attestation is done by accreditation bodies that are impartial and independent
in relation to the conformity assessment bodies and the conformity assessment bodies' clients.
Accreditation bodies normally operate in a non-profit distributing manner and conduct regular
assessments of conformity assessment bodies to ensure that conformity assessment bodies conform to
relevant international standards and other normative documents.
A system to accredit conformity assessment bodies is intended to provide for a consistent application
of conformity assessment to international consensus based standards and conformity assessment
schemes, in order to benefit public health, safety, environment and welfare and support regulators
and end users. It can facilitate national and cross-border trade, as pursued by trade authorities and
organizations.
This document can be used to support peer evaluation mechanisms which have been created at
regional and international levels and through which confidence is provided that accreditation bodies
are operating in accordance with this document.
In this document, 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.
For the purposes of research, users are encouraged to share their views on this document and their
priorities for changes to future editions. Click on the link below to take part in the online survey:
17011_ed2_usersurvey
© ISO/IEC 2017 – All rights reserved v
INTERNATIONAL STANDARD ISO/IEC 17011:2017(E)
Conformity assessment — Requirements for accreditation
bodies accrediting conformity assessment bodies
1 Scope
This document specifies requirements for the competence, consistent operation and impartiality of
accreditation bodies assessing and accrediting conformity assessment bodies.
NOTE In the context of this document, activities covered by accreditation include, but are not limited to,
testing, calibration, inspection, certification of management systems, persons, products, processes and services,
provision of proficiency testing, production of reference materials, validation and verification.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
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/IEC 17000 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
accreditation
third-party attestation related to a conformity assessment body (3.4) conveying formal demonstration
of its competence to carry out specific conformity assessment tasks
[SOURCE: ISO/IEC 17000:2004, 5.6]
3.2
accreditation body
authoritative body that performs accreditation (3.1)
Note 1 to entry: The authority of an accreditation body is generally derived from government.
[SOURCE: ISO/IEC 17000:2004, 2.6]
3.3
accreditation body logo
logo used by an accreditation body (3.2) to identify itself
3.4
conformity assessment body
body that performs conformity assessment activities and that can be the object of accreditation (3.1)
Note 1 to entry: Whenever the term “conformity assessment body” is used in the text, it applies to both the
applicant and accredited conformity assessment bodies, unless otherwise specified.
© ISO/IEC 2017 – All rights reserved 1
ISO/IEC 17011:2017(E)
[SOURCE: ISO/IEC 17000:2004, 2.5, modified — The words “and that can be the object of accreditation”
have been added to the definition and the Note to entry has been added.]
3.5
conformity assessment activity
activity conducted by a conformity assessment body (3.4) when assessing conformity
Note 1 to entry: In the context of this document, activities covered by accreditation (3.1) include, but are not limited
to, testing, calibration, inspection, certification of management systems, persons, products, processes and services,
provision of proficiency testing, production of reference materials, validation and verification. For simplicity, these
are referred to as conformity assessment activities being performed by conformity assessment bodies.
3.6
scope of accreditation
specific conformity assessment activities for which accreditation (3.1) is sought or has been granted
3.7
flexible scope of accreditation
scope of accreditation (3.6) expressed to allow conformity assessment bodies to make changes in
methodology and other parameters which fall within the competence of the conformity assessment body
(3.4) as confirmed by the accreditation body (3.2)
3.8
accreditation scheme
rules and processes relating to the accreditation (3.1) of conformity assessment bodies to which the
same requirements apply
Note 1 to entry: Accreditation scheme requirements include, but are not limited to, ISO/IEC 17020, ISO/IEC 17021,
ISO/IEC 17025, ISO/IEC 17024, ISO 17034, ISO/IEC 17043, ISO/IEC 17065, ISO 15189 and ISO 14065.
3.9
accreditation activity
individual operational tasks of the accreditation process (3.11)
Note 1 to entry: See Clause 7.
3.10
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 accreditation body (3.2).
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”.
[SOURCE: ISO/IEC 17021-1:2015, 3.2, modified — The words “certification body” have been replaced by
“accreditation body” in Note 1 to entry.]
3.11
accreditation process
activities from application through to granting and maintenance of accreditation (3.1) as defined by the
accreditation scheme (3.8)
3.12
accreditation symbol
symbol issued by an accreditation body (3.2) to be used by accredited conformity assessment bodies to
indicate they are accredited
2 © ISO/IEC 2017 – All rights reserved
ISO/IEC 17011:2017(E)
3.13
accreditation decision
decision on granting (3.14), maintaining (3.15), extending (3.16), reducing (3.17), suspending (3.18) and
withdrawing (3.19) accreditation (3.1)
3.14
granting accreditation
awarding accreditation (3.1) for a defined scope of accreditation (3.6)
3.15
maintaining accreditation
confirming the continuance of accreditation (3.1) for a defined scope
3.16
extending accreditation
adding conformity assessment activities to the scope of accreditation (3.6)
3.17
reducing accreditation
cancelling part of the scope of accreditation (3.6)
3.18
suspending accreditation
putting temporary restrictions in place for all or part of the scope of accreditation (3.6)
3.19
withdrawing accreditation
cancelling accreditation (3.1) for the full scope
3.20
complaint
expression of dissatisfaction, other than appeal (3.21), by any person or organization, to an accreditation
body (3.2), relating to the activities of that accreditation body or of an accredited conformity assessment
body (3.4), where a response is expected
[SOURCE: ISO/IEC 17000:2004, 6.5, modified — The words “to a conformity assessment body or
accreditation body, relating to the activities of that body” have been replaced by “to an accreditation body,
relating to the activities of that accreditation body or of an accredited conformity assessment body”.]
3.21
appeal
request by a conformity assessment body (3.4) for reconsideration of any adverse accreditation decision
(3.13) related to its desired accreditation (3.1) status
3.22
assessment
process undertaken by an accreditation body (3.2) to determine the competence of a conformity
assessment body (3.4), based on standard(s) and/or other normative documents and for a defined scope
of accreditation (3.6)
3.23
reassessment
assessment (3.22) performed to renew the accreditation (3.1) cycle
3.24
assessment technique
method used by an accreditation body (3.2) to perform an assessment (3.22)
Note 1 to entry: Assessment techniques, can include, but are not limited to:
— on-site assessment;
© ISO/IEC 2017 – All rights reserved 3
ISO/IEC 17011:2017(E)
— remote assessment (3.26);
— witnessing (3.25);
— document review;
— file review;
— measurement audits;
— review of performance in proficiency testing and other interlaboratory comparisons;
— validation audits;
— unannounced visits;
— interviewing.
3.25
witnessing
observation by the accreditation body (3.2) of a conformity assessment body (3.4) carrying out conformity
assessment activities within its scope of accreditation (3.6)
3.26
remote assessment
assessment (3.22) of the physical location or virtual site of a conformity assessment body (3.4), using
electronic means
Note 1 to entry: A virtual site is an online environment allowing persons to execute processes, e.g. in a cloud
environment.
3.27
assessment programme
set of assessments (3.22) consistent with a specific accreditation scheme (3.8) that the accreditation body
(3.2) performs on a specific conformity assessment body (3.4) during an accreditation (3.1) cycle
3.28
assessment plan
description of the activities and arrangements for an assessment (3.22)
[SOURCE: ISO 19011:2011, 3.15, modified — The word “audit” has been replaced by “assessment”.]
3.29
accreditation body personnel
internal or external individuals carrying out activities on behalf of the accreditation body (3.2)
3.30
assessor
person assigned by an accreditation body (3.2) to perform, alone or as part of an assessment team, an
assessment (3.22) of a conformity assessment body (3.4)
3.31
team leader
assessor (3.30) who is given the overall responsibility for the management of an assessment (3.22)
3.32
technical expert
person assigned by an accreditation body (3.2), working under the responsibility of an assessor (3.30),
who provides specific knowledge or expertise with respect to the scope of accreditation (3.6) to be
assessed and does not assess independently
Note 1 to entry: A technical expert is not expected to have assessor qualifications and training.
4 © ISO/IEC 2017 – All rights reserved
ISO/IEC 17011:2017(E)
3.33
interested party
person or organization with a direct or indirect interest in accreditation (3.1)
Note 1 to entry: Direct interest refers to the interest of those who undergo accreditation; indirect interest refers
to the interests of those who use or rely on accredited conformity assessment bodies.
Note 2 to entry: Interested parties can include the accreditation body (3.2), conformity assessment bodies, their
associations and their clients, industry services, trade associations, scheme owners, governmental regulatory
bodies or other governmental services, or non-governmental organizations, including consumer organizations.
3.34
consultancy
participation in any of the activities of a conformity assessment body (3.4) subject to accreditation (3.1)
EXAMPLE 1 Preparing or producing manuals or procedures for a conformity assessment body.
EXAMPLE 2 Participating in the operation or management of a conformity assessment body.
EXAMPLE 3 Giving specific advice or specific training towards the development and implementation of the
management system, operational procedures and/or competence of a conformity assessment body.
4 General requirements
4.1 Legal entity
The accreditation body shall be a legal entity, or a defined part of a legal entity such that it is legally
responsible for its accreditation activities.
NOTE 1 Governmental accreditation bodies are deemed to be legal entities on the basis of their status within
their government.
NOTE 2 An accreditation body that is part of a larger body can operate under a different name.
4.2 Accreditation agreement
The accreditation body shall establish a legally enforceable arrangement with each conformity
assessment body that requires the conformity assessment body to conform to at least the following:
a) to commit to fulfil continually the requirements for accreditation for the scope for which
accreditation is sought or granted and to commit to provide evidence of fulfilment. This includes
agreement to adapt to changes in the requirements for accreditation;
b) to cooperate as is necessary to enable the accreditation body to verify fulfilment of requirements
for accreditation;
c) to provide access to conformity assessment body personnel, locations, equipment, information,
documents and records as necessary to verify fulfilment of requirements for accreditation;
d) to arrange the witnessing of conformity assessment activities when requested by the
accreditation body;
e) to have, where applicable, legally enforceable arrangements with their clients that commit the
clients to provide, on request, access to accreditation body assessment teams to assess the
conformity assessment body's performance when carrying out conformity assessment activities at
the client’s site;
f) to claim accreditation only with respect to the scope for which it has been granted;
g) to commit to follow the accreditation body's policy for the use of the accreditation symbol;
h) not to use its accreditation in such a manner as to bring the accreditation body into disrepute;
© ISO/IEC 2017 – All rights reserved 5
ISO/IEC 17011:2017(E)
i) to inform the accreditation body without delay of significant changes relevant to its accreditation;
NOTE Such changes can concern:
— its legal, commercial, ownership or organizational status;
— the organization, top management and key personnel;
— resources and location(s);
— scope of accreditation;
— other matters that can affect the ability of the conformity assessment body to fulfil requirements for
accreditation.
j) to pay fees as determined by the accreditation body;
k) to assist in the investigation and resolution of any accreditation-related complaints about the
conformity assessment body referred to it by the accreditation body.
4.3 Use of accreditation symbols and other claims of accreditation
4.3.1 The accreditation body shall take measures to ensure that the accredited conformity
assessment body:
a) fully conforms to the requirements of the accreditation body for claiming accreditation status,
when making reference to its accreditation in communication media;
b) does not make any misleading or unauthorized statement regarding its accreditation;
c) upon withdrawal of its accreditation, discontinues its use of any reference to that accreditation;
d) does not refer to its accreditation in a way so as to imply that a product, process, service,
management system or person is approved by the accreditation body;
e) informs its affected clients of the suspension, reduction or withdrawal of its accreditation and the
associated consequences without undue delay.
4.3.2 When an accreditation body has an accreditation symbol, the accreditation body shall have the
legal right to use it and the accreditation symbol shall be legally protected.
4.3.3 The accreditation body shall have a documented policy governing the use of the accreditation
symbol and claims of accreditation status. This policy shall specify as a minimum:
a) requirements for the use and monitoring of the accreditation symbol in combination with any
conformity assessment body mark;
b) that the accreditation symbol is not affixed on its own or used to imply that a product, process or
service (or any part of it) has been certified or approved by the accreditation body;
c) requirements for reproduction of the accreditation symbol;
d) requirements for any reference to accreditation;
e) requirements for the use of the accreditation symbol and claims of accreditation status in
communication media;
f) that the conformity assessment body only uses the accreditation symbol and claims of accreditation
status for the specific activities covered by the scope of accreditation.
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ISO/IEC 17011:2017(E)
4.3.4 The accreditation symbol shall have, or be accompanied with, a clear indication as to which
conformity assessment activity the accreditation is related.
4.3.5 The accreditation body shall take suitable action to deal with incorrect or unauthorized claims
of accreditation status, or misleading or unauthorized use of accreditation symbols and the accreditation
body logo.
NOTE Suitable actions can include requests for corrective action, suspension, withdrawal of accreditation,
publication of the transgression and, if necessary, legal action.
4.4 Impartiality requirements
4.4.1 Accreditation shall be undertaken impartially.
4.4.2 The accreditation body shall be responsible for the impartiality of its accreditation activities
and shall not allow commercial, financial or other pressures to compromise impartiality. Where
an accreditation body, including a governmental accreditation body, is part of a larger entity, the
accreditation body shall be organized so that accreditation is provided impartially.
4.4.3 The accreditation body shall have top management commitment to impartiality. It shall document
and make public an impartiality policy which includes the importance of impartiality in carrying out
its accreditation activities, managing conflict of interest and ensuring objectivity of its accreditation
activities.
4.4.4 All accreditation body personnel and committees who could influence the accreditation process
shall act objectively and shall be free from any undue commercial, financial and other pressures that
could compromise impartiality. The accreditation body shall require all personnel and committee
members to disclose any potential conflict of interest whenever it may arise.
4.4.5 The accreditation body shall document and implement a process to provide opportunity for
effective involvement by interested parties for safeguarding impartiality. The accreditation body shall
ensure a balanced representation of interested parties with no single party predominating.
4.4.6 The accreditation body shall have a process to identify, analyse, evaluate, treat, monitor and
document on an ongoing basis the risks to impartiality arising from its activities including any conflicts
arising from its relationships or from the relationships of its personnel. The process shall include
identification of and consultation with appropriate interested parties as described in 4.4.5 to advise on
matters affecting impartiality including openness and public perception.
NOTE 1 Sources of risks to impartiality of the accreditation body can be based on ownership, governance,
management, personnel, shared resources, finances, contracts, outsourcing, training, marketing and payment of
a sales commission or other inducement for the referral of new clients, etc.
NOTE 2 One way of fulfilling the consultation with the interested parties is by the use of a committee.
4.4.7 Where any risks to impartiality are identified, the accreditation body shall document
and demonstrate how it eliminates or minimizes such risks and document any residual risk. The
demonstration shall cover all potential risks that are identified, whether they arise from within the
accreditation body or from the activities of other persons, bodies or organizations.
4.4.8 Top management shall review any residual risk to determine if it is within the level of
acceptable risk.
4.4.9 When an unacceptable risk to impartiality is identified and which cannot be mitigated to an
acceptable level, then accreditation shall not be provided.
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ISO/IEC 17011:2017(E)
4.4.10 The accreditation body’s policies, processes and procedures shall be non-discriminatory and
shall be applied in a non-discriminatory way. The accreditation body shall make its services accessible
to all applicants whose application for accreditation falls within the scope of its accreditation activities
as defined within its policies and rules. Access shall not be conditional upon the size of the applicant
conformity assessment body or membership of any association or group, nor shall accreditation be
conditional upon the number of conformity assessment bodies already accredited.
NOTE It is not considered discriminatory when an accreditation body refuses services to a conformity
assessment body because of proven evidence of fraudulent behaviour, falsification of information or deliberate
violation of accreditation requirements.
4.4.11 The accreditation body and any part of the same legal entity shall not offer or provide any service
that affects its impartiality, such as:
a) conformity assessment activities covered by accreditation which include but are not limited to
testing, calibration, inspection, certification of management systems, persons, products, processes
and services, provision of proficiency testing, production of reference materials, validation and
verification;
b) consultancy.
4.4.12 In case the accreditation body is linked to a body offering consultancy or undertaking those
conformity assessment activities mentioned in 4.4.11 bullet a), the accreditation body shall have:
a) different top management (see 5.7);
b) different personnel performing the accreditation decision-making processes (see Clause 5);
c) distinctly different name, logos and symbols;
d) effective mechanisms to prevent any influence on the outcome of any accreditation activity.
4.4.13 The accreditation body’s activities shall not be presented as linked with consultancy or other
services that pose an unacceptable risk to impartiality. Nothing shall be said or implied that would
suggest that accreditation would be simpler, easier, faster or less expensive if any specified person(s) or
consultancy were used.
NOTE Accreditation bodies can carry out, for example, the following duties that are not considered a risk to
impartiality:
— arranging and participating as a lecturer in training, orientation or educational courses, provided that these
courses confine themselves to the provision of generic information that is freely available in the public domain,
i.e. they cannot provide specific solutions to a conformity assessment body in relation to the activities of that
organization;
— adding value during assessments, e.g. by identifying opportunities for improvement as they become evident
during the assessment without recommending specific solutions;
— advising other accreditation bodies on development of accreditation process;
— advising scheme owners on accreditation requirements, including requirements within relevant conformity
assessment standards.
4.5 Financing and liability
4.5.1 The accreditation body shall have the financial resources, demonstrated by records and/or
documents, required for the operation of its activities. The accreditation body shall have a description of
the source(s) of its income.
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ISO/IEC 17011:2017(E)
4.5.2 The accreditation body shall evaluate the risks arising from its activities and have arrangements
to cover liabilities arising from its activities.
4.6 Establishing accreditation schemes
4.6.1 The accreditation body shall develop or adopt accreditation schemes. The accreditation body shall
document the rules and processes for its accreditation schemes referring to the relevant International
Standards and/or other normative documents.
4.6.2 The accreditation body shall ensure that any guidance, application or normative documents it
uses have been developed by
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Frequently Asked Questions
EN ISO/IEC 17011:2017 is a standard published by the European Committee for Standardization (CEN). Its full title is "Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2017)". This standard covers: ISO/IEC 17011:2017 specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.
ISO/IEC 17011:2017 specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.
EN ISO/IEC 17011:2017 is classified under the following ICS (International Classification for Standards) categories: 03.120.20 - Product and company certification. Conformity assessment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO/IEC 17011:2017 has the following relationships with other standards: It is inter standard links to EN ISO/IEC 17011:2004. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO/IEC 17011:2017 is associated with the following European legislation: EU Directives/Regulations: 765/2008; Standardization Mandates: M/417. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO/IEC 17011:2017 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
EN ISO/IEC 17011:2017は、認証評価機関を認定する認定機関に対する要件を具体的に定めた重要な文書であり、特にそのスコープは、認定機関の能力、一貫した運営、及び公正性に焦点を当てています。この標準は、国際的な認定フレームワークの確立に必須な要素を提供しており、コンプライアンス及び品質の確保を目的としています。 EN ISO/IEC 17011:2017の強みとして、まず第一に、認定機関がその評価プロセスにおいて求められる透明性を確保し、信頼性の高い結果を提供できるように設計されている点が挙げられます。また、各国の認定機関が国際的に受け入れられるレベルの一貫性をもって認証評価機関を認定できるよう、厳密な基準が設定されていることも大きな強みです。 さらに、この標準は、認定プロセスにおける公正性を保証するために、不正行為の防止や利益相反の管理に関する具体的なガイドラインを提供しています。これにより、認定機関及びその評価対象機関が市場において正当な評価を受けることが促進されます。 EN ISO/IEC 17011:2017は、認定機関が信頼性を欠く業務運営を行ってしまうリスクを低減させる重要な枠組みでもあり、それによって、顧客や他のステークホルダーとの関係構築が容易になります。したがって、この標準は、品質管理やコンプライアンスを重視するすべての組織にとって、非常に関連性の高いものです。
La norme EN ISO/IEC 17011:2017, intitulée "Évaluation de la conformité - Exigences pour les organismes d'accréditation évaluant les organismes d'évaluation de la conformité", présente un cadre essentiel pour garantir la compétence et l'impartialité des organismes d'accréditation. Son portée couvre les exigences nécessaires pour assurer que les organismes d'accréditation fonctionnent de manière cohérente et efficace tout en maintenant des standards élevés de qualité. L'un des points forts de cette norme est son accent sur la transparence et l'impartialité des processus d'accréditation. Cela assure aux parties prenantes, y compris les clients et les organismes de réglementation, que les évaluations réalisées par les organismes de conformité sont dignes de confiance et conformes aux exigences pertinentes. En établissant des critères clairs pour la compétence des organismes d'accréditation, la norme contribue à renforcer la confiance dans le système d'évaluation de la conformité. Un autre aspect marquant de l'ISO/IEC 17011:2017 est sa capacité à s'adapter à divers secteurs et contextes, ce qui le rend pertinent pour une large gamme d'organismes d'évaluation de la conformité. Quelle que soit la spécialisation sectorielle, les exigences établies par cette norme fournissent un fil directeur qui facilite l'uniformité des pratiques d'accréditation à l'échelle internationale. De plus, la norme favorise une approche axée sur le risque, permettant aux organismes d’accréditation d'identifier et de gérer les risques potentiels associés à leur processus d’évaluation. Cela renforce non seulement l'intégrité de l'accréditation, mais aide également à promouvoir une culture de l'amélioration continue au sein des organismes concernés. En synthèse, la norme EN ISO/IEC 17011:2017 est une référence incontournable pour les organismes d'accréditation, offrant des exigences claires et précises qui garantissent la compétence, l'opération cohérente et l'impartialité dans l'évaluation et l'accréditation des organismes d'évaluation de la conformité. Sa pertinence dans le paysage international des normes renforce sa position comme un outil essentiel pour les professionnels du secteur.
Der Standard EN ISO/IEC 17011:2017 ist von zentraler Bedeutung für die Akkreditierungsstellen, die Konformitätsbewertungsstellen akkreditieren. Der Scope des Dokuments legt klar die Anforderungen an die Kompetenz, den konsistenten Betrieb und die Unparteilichkeit der Akkreditierungsstellen fest. Dies ist entscheidend, um die Glaubwürdigkeit der Konformitätsbewertung im Markt zu gewährleisten. Ein herausragendes Merkmal des Standards ist seine umfassende und strukturierte Herangehensweise, die sicherstellt, dass Akkreditierungsstellen die erforderlichen Kompetenzen aufweisen, um die fachliche Integrität ihrer Bewertungen zu gewährleisten. Die im Standard festgelegten Anforderungen fördern die Transparenz und Konsistenz in den Prozessen der Akkreditierung, was zu einer höheren Akzeptanz der Ergebnisse auf internationaler Ebene führt. Darüber hinaus betont die EN ISO/IEC 17011:2017 die Notwendigkeit der Unparteilichkeit, was bedeutet, dass Akkreditierungsstellen unabhängig von externen Einflüssen operieren müssen. Dies fördert das Vertrauen in die Akkreditierung und die damit verbundenen Bewertungen, was sowohl für die akkreditierten Stellen als auch für die Verbraucher von großem Vorteil ist. Die Relevanz dieses Standards erstreckt sich über verschiedene Branchen, in denen Konformitätsbewertungen eine wesentliche Rolle spielen. Seine weitreichenden Anwendungsmöglichkeiten unterstützen Organisationen dabei, die Anforderungen an Qualitätsmanagementsysteme und gesetzliche Vorgaben zu erfüllen. Insgesamt bietet der Standard EN ISO/IEC 17011:2017 einen klaren Rahmen, der die hohen Erwartungen an die Qualität und Zuverlässigkeit von Akkreditierungsstellen erfüllt und sicherstellt, dass diese normativen Anforderungen von Konformitätsbewertungsstellen konsequent eingehalten werden.
The SIST EN ISO/IEC 17011:2018 standard provides comprehensive requirements for the accreditation bodies responsible for assessing and accrediting conformity assessment bodies. One of the primary strengths of this standard is its emphasis on the competence of accreditation bodies, ensuring that they possess the necessary skills and understanding of the specific requirements related to the conformity assessment process. This attention to competence is crucial for maintaining the integrity of the accreditation landscape. Additionally, the standard delineates the importance of consistent operation, which fosters trust and reliability among stakeholders. By establishing a framework for uniform practices, the ISO/IEC 17011:2017 facilitates a level of assurance that accreditation bodies can effectively perform their roles in evaluating conformity assessment bodies, thereby contributing to the overall quality of products and services in various industries. Another significant aspect of the standard is its focus on impartiality. Understanding that the credibility of accreditation hinges on unbiased evaluations, the standard lays down requirements that accreditation bodies must adhere to, thus preventing conflicts of interest. This impartiality is essential for maintaining the confidence of consumers and other entities relying on accredited conformity assessment bodies. In terms of relevance, the ISO/IEC 17011:2017 standard addresses the evolving needs of the global market for conformity assessment. As businesses increasingly seek to demonstrate compliance with international standards, having a robust framework for accreditation becomes vital. The standard's comprehensive approach ensures that accreditation bodies are equipped to handle these demands while upholding the principles of objectivity and fairness. Overall, the SIST EN ISO/IEC 17011:2018 standard serves as an essential guideline for accreditation bodies, reinforcing the fundamental aspects of competence, consistent operation, and impartiality, which are crucial for the effective accreditation of conformity assessment bodies.
SIST EN ISO/IEC 17011:2018 표준은 인증 평가 기관을 인증하는 인증 기관의 요구 사항을 명확히 규정하고 있습니다. 이 표준은 주로 인증 기관의 역량, 일관된 운영 및 공정성을 보장하기 위한 필수 조건을 다루고 있으며, 이는 인증 평가 프로세스의 신뢰성을 높이는 데 중요한 역할을 합니다. 이 표준의 주요 강점 중 하나는 국제적 합의를 기반으로 한다는 점입니다. EN ISO/IEC 17011:2017은 다양한 국가와 문화에 걸쳐 적용 가능한 기준을 제시하여, 전 세계적으로 인정받는 인증 평가 체계를 구축하는 데 기여합니다. 또한, 이 표준이 규정하는 요구 사항들은 인증 기관이 인증 평가 기관을 공정하고 효과적으로 평가할 수 있도록 돕습니다. 결과적으로, 이는 소비자와 산업계 모두에게 명확하고 신뢰할 수 있는 인증을 제공합니다. EN ISO/IEC 17011:2017의 범위는 인증 기관의 운영 방식을 개선하고 개선 사항을 발견할 수 있는 프레임워크를 제시하며, 이는 인증 평가의 질을 높이는 데 기여합니다. 특히, 인증 기관들이 공정하게 평가되고 평가 프로세스에서 일관성을 유지할 수 있도록 지원함으로써, 인증 과정에 대한 신뢰를 구축합니다. 이 표준은 인증 평가의 세계적 요구를 반영하고 있으며, 인증 기관이 국제 기준에 맞게 운영될 수 있도록 하는 매우 중요한 도구입니다. 전체적으로 SIST EN ISO/IEC 17011:2018은 인증 평가 기관의 역량을 강화하고, 신뢰할 수 있는 인증 평가를 가능하게 함으로써, 관련 산업 전반에 걸쳐 긍정적인 영향을 미칩니다.
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