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
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ISO/IEC 17011:2017
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Reference number
ISO/IEC 17011:2017(E)

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ISO/IEC 17011:2017(E)


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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
6.3
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Personnel involved in the accreditation process..................................................................................................... 12
Personnel records.............................................................................................................................................................................. 13
6.4 (standards.iteh.ai)
Outsourcing............................................................................................................................................................................................. 13
7 Process requirements...................................................................................................................................................................................13
7.1 Accreditation requirements ISO/IEC 17011:2017
....................................................................................................................................................... 13
7.2 Application for accreditation.................................................................................................................................................... 14
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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

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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
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World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.(standards.iteh.ai)
This document was prepared by the ISO Committee on Conformity Assessment (CASCO) and circulated
for voting to the national bodies of both ISO and ISO/IEC 17011:2017
IEC, and was approved by both organizations.
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This second edition cancels and replaces the first edition (ISO/IEC 17011:2004), which has been
9069ea48760a/iso-iec-17011-2017
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.

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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.
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In this document, the following verbal forms are used:
—
(standards.iteh.ai)
“shall” indicates a requirement;
— “should” indicates a recommendation; ISO/IEC 17011:2017
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— “may” indicates a permission;9069ea48760a/iso-iec-17011-2017
— “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

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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
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3 Terms and definitions
(standards.iteh.ai)
For the purposes of this document, the terms and definitions given in ISO/IEC 17000 and the
following apply. ISO/IEC 17011:2017
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ISO and IEC maintain terminological databases for use in standardization at the following addresses:
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— 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.

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[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
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Note 1 to entry: Accreditation scheme requirements include, but are not limited to, ISO/IEC 17020, ISO/IEC 17021,
(standards.iteh.ai)
ISO/IEC 17025, ISO/IEC 17024, ISO 17034, ISO/IEC 17043, ISO/IEC 17065, ISO 15189 and ISO 14065.

3.9 ISO/IEC 17011:2017

accreditation activity https://standards.iteh.ai/catalog/standards/sist/f8826ec5-dfae-4777-a8fb-
individual operational tasks of the accreditation process (3.11)
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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

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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 iTeh STANDARD PREVIEW
cancelling accreditation (3.1) for the full scope
(standards.iteh.ai)
3.20
complaint ISO/IEC 17011:2017
expression of dissatisfaction, other than appeal (3.21), by any person or organization, to an accreditation
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body (3.2), relating to the activities of that accreditation body or of an accredited conformity assessment
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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;

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—   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
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Note 1 to entry: A virtual site is an online environment allowing persons to execute processes, e.g. in a cloud
environment. (standards.iteh.ai)
3.27 ISO/IEC 17011:2017
assessment programme https://standards.iteh.ai/catalog/standards/sist/f8826ec5-dfae-4777-a8fb-
set of assessments (3.22) consistent with a9069ea48760a/iso-iec-17011-2017
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.

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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

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The accreditation body shall be a legal entity, or a defined part of a legal entity such that it is legally
(standards.iteh.ai)
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. ISO/IEC 17011:2017
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NOTE 2 An accreditation body that9069ea48760a/iso-iec-17011-2017
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;

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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,
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when making reference to its accreditation in communication media;
b) (standards.iteh.ai)
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;
ISO/IEC 17011:2017
d) does not refer to its https://standards.iteh.ai/catalog/standards/sist/f8826ec5-dfae-4777-a8fb-
accreditation in a way so as to imply that a product, process, service,
management system or person is approved 9069ea48760a/iso-iec-17011-2017
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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