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

Status
Published
Publication Date
12-Dec-2017
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
13-Dec-2017
Completion Date
13-Dec-2017

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SLOVENSKI STANDARD
SIST EN ISO/IEC 17011:2018
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
SIST EN ISO/IEC 17011:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO/IEC 17011:2018
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SIST EN ISO/IEC 17011:2018
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.
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SIST EN ISO/IEC 17011:2018
EN ISO/IEC 17011:2017 (E)
Contents Page

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

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SIST EN ISO/IEC 17011:2018
EN ISO/IEC 17011:2017 (E)
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.
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SIST EN ISO/IEC 17011:2018
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SIST EN ISO/IEC 17011:2018
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
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SIST EN ISO/IEC 17011:2018
ISO/IEC 17011:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO/IEC 17011:2018
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
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SIST EN ISO/IEC 17011:2018
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
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SIST EN ISO/IEC 17011:2018
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
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SIST EN ISO/IEC 17011:2018
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SIST EN ISO/IEC 17011:2018
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
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SIST EN ISO/IEC 17011:2018
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
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SIST EN ISO/IEC 17011:2018
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
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SIST EN ISO/IEC 17011:2018
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 o
...

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