Conformity Assessment - General principles and requirements for validation and verification bodies (ISO/IEC 17029:2019)

This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies
providing validation and verification as conformity assessment.
Bodies operating to this document can be internal (first party), collaborative (second party) as well as independent (third party) bodies
and need not offer both, validation and verification activities.
This document is applicable to validation and verification bodies in any sector, providing assurance through confirmation that claims or
declarations are either plausible with regard to the intended purpose (validation) or correctly stated (verification).
This document shall be applied in conjunction with sector specific programmes that contain requirements for validation and verification
processes and rules.
This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or
other forms of recognition of validation and verification bodies by international or regional organizations, governments, regulatory
authorities, program or scheme owners, industry bodies, companies, customers or consumers.
NOTE This document contains generic requirements and is neutral with regard to the operated validation or verification programme. Requirements of
the applicable programmes are additional to the requirements of this document.

Konformitätsbewertung - Allgemeine Grundsätze und Anforderungen an Validierungs- und Verifizierungsstellen (ISO/IEC 17029:2019)

Dieses Dokument enthält allgemeine Grundsätze und Anforderungen an die Kompetenz, die einheitliche Arbeitsweise und die Unparteilichkeit von Stellen, die Validierung/Verifizierung als Konformitäts-bewertungstätigkeiten durchführen.
Stellen, die in Übereinstimmung mit diesem Dokument arbeiten, können Validierung/Verifizierung als eine Tätigkeit der ersten, zweiten oder dritten Seite leisten. Stellen können entweder nur Validierungsstellen oder Verifizierungsstellen sein oder beide Tätigkeiten leisten.
Dieses Dokument gilt für Validierungs-/Verifizierungsstellen in jedem Sektor, die bestätigen, dass Behauptungen entweder plausibel sind im Hinblick auf den beabsichtigten zukünftigen Gebrauch (Validierung) oder wahrheitsgemäß angegeben sind (Verifizierung). Ergebnisse einer anderen Konformitäts-bewertungstätigkeiten (z. B. Prüfung, Inspektion und Zertifizierung) gelten nach diesem Dokument jedoch nicht als Gegenstand einer Validierung/Verifizierung. Dies gilt ebenfalls für Situationen, in denen Validierungs-/Verifizierungstätigkeiten als Schritte innerhalb des anderen Konformitätsbewertungs-prozesses durchgeführt werden.
Dieses Dokument gilt für jeden Sektor in Verbindung mit sektorspezifischen Programmen, die Anforderungen an die Prozesse und die Verfahren von Validierung/Verifizierung enthalten.
Dieses Dokument kann als Grundlage verwendet werden für Akkreditierungen durch Akkreditierungs-stellen, Begutachtungen unter Gleichrangigen in entsprechenden Gruppen von Gleichrangigen oder andere Formen der Anerkennung von Validierungs-/Verifizierungsstellen durch internationale oder regionale Organisationen, Regierungen, Behörden, Programmeigner, Industrieverbände, Unternehmen, Kunden oder Verbraucher.
ANMERKUNG Dieses Dokument enthält allgemeine Anforderungen und ist neutral gegenüber dem betriebenen Validierungs- oder Verifizierungsprogramm. Anforderungen der anzuwendenden Programme gelten zusätzlich zu den Anforderungen dieses Dokuments.

Évaluation de la conformité - Principes généraux et exigences pour les organismes de validation et de vérification (ISO/IEC 17029:2019)

Ugotavljanje skladnosti - Splošna načela in zahteve za organe, ki izvajajo validacijo in verifikacijo (ISO/IEC 17029:2019)

Ta dokument vsebuje splošna načela in zahteve za usposobljenost, dosledno delovanje ter nepristranskost organov, ki izvajajo validacijo in verifikacijo v okviru ugotavljanja skladnosti. Organi, ki delujejo v skladu s tem dokumentom, so lahko notranji (prva stran), sodelovalni (druga stran) in neodvisni (tretja stran) ter niso zavezani k izvajanju tako validacije kot verifikacije. Ta dokument se uporablja za organe, ki izvajajo validacijo in verifikacijo v katerem koli sektorju ter s potrjevanjem zagotavljajo verjetnost trditev in izjav glede na njihov predvideni namen (validacija) oziroma pravilno navedbo (verifikacija). Ta dokument je treba uporabljati v povezavi s programi specifičnih sektorjev, ki vsebujejo zahteve za postopke ter pravila s področja validacije in verifikacije. Ta dokument je mogoče uporabljati kot osnovo za akreditacijo s strani akreditacijskih organov, medsebojno ocenjevanje znotraj skupin za medsebojno ocenjevanje ali druge oblike priznavanja organov, ki izvajajo validacijo in verifikacijo, s strani mednarodnih ali regionalnih organizacij, lokalnih oblasti, regulativnih organov, lastnikov programov oziroma shem, organov gospodarstva, podjetij, naročnikov ali potrošnikov.
OPOMBA: Ta dokument vsebuje splošne zahteve in je nevtralen glede na program validacije oziroma verifikacije, ki se izvaja. Zahteve veljavnih programov so dodatek k zahtevam tega dokumenta.

General Information

Status
Published
Publication Date
19-Nov-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
20-Nov-2019
Completion Date
20-Nov-2019

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SLOVENSKI STANDARD
SIST EN ISO/IEC 17029:2019
01-december-2019
Ugotavljanje skladnosti - Splošna načela in zahteve za organe, ki izvajajo
validacijo in verifikacijo (ISO/IEC 17029:2019)
Conformity Assessment - General principles and requirements for validation and
verification bodies (ISO/IEC 17029:2019)
Konformitätsbewertung - Allgemeine Grundsätze und Anforderungen an Stellen, die
Validierungs- und Verifizierungstätigkeiten durchführen (ISO/IEC 17029:2019)

Évaluation de la conformité - Exigences et principes généraux pour les organismes de

validation et de vérification (ISO/IEC 17029:2019)
Ta slovenski standard je istoveten z: EN ISO/IEC 17029:2019
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17029:2019 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 17029:2019
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SIST EN ISO/IEC 17029:2019
EUROPEAN STANDARD
EN ISO/IEC 17029
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2019
ICS 03.120.20
English version
Conformity Assessment - General principles and
requirements for validation and verification bodies
(ISO/IEC 17029:2019)

Évaluation de la conformité - Principes généraux et Konformitätsbewertung - Allgemeine Grundsätze und

exigences pour les organismes de validation et de Anforderungen an Stellen, die Validierungs- und

vérification (ISO/IEC 17029:2019) Verifizierungstätigkeiten durchführen (ISO/IEC
17029:2019)
This European Standard was approved by CEN on 5 October 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,

Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels

© 2019 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO/IEC 17029:2019 E

reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO/IEC 17029:2019
EN ISO/IEC 17029:2019 (E)
Contents Page

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

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SIST EN ISO/IEC 17029:2019
EN ISO/IEC 17029:2019 (E)
European foreword

This document (EN ISO/IEC 17029:2019) 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 May 2020, and conflicting national standards shall be

withdrawn at the latest by May 2020.

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.

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, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO/IEC 17029:2019 has been approved by CEN as EN ISO/IEC 17029:2019 without any

modification.
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SIST EN ISO/IEC 17029:2019
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SIST EN ISO/IEC 17029:2019
INTERNATIONAL ISO/IEC
STANDARD 17029
First edition
2019-10
Conformity assessment — General
principles and requirements for
validation and verification bodies
Évaluation de la conformité — Principes généraux et exigences pour
les organismes de validation et de vérification
Reference number
ISO/IEC 17029:2019(E)
ISO/IEC 2019
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SIST EN ISO/IEC 17029:2019
ISO/IEC 17029:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO/IEC 2019 – All rights reserved
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SIST EN ISO/IEC 17029:2019
ISO/IEC 17029:2019(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Principles ..................................................................................................................................................................................................................... 5

4.1 General ........................................................................................................................................................................................................... 5

4.2 Principles for the validation/verification process ................................................................................................... 5

4.2.1 Evidence-based approach to decision making ....................................................................................... 5

4.2.2 Documentation .................................................................................................................................................................. 5

4.2.3 Fair presentation ............................................................................................................................................................. 5

4.3 Principles for validation/verification bodies ................................................................................................................ 5

4.3.1 Impartiality ........................................................................................................................................................................... 5

4.3.2 Competence .......................................................................................................................................................................... 6

4.3.3 Confidentiality ................................................................................................................................................................... 6

4.3.4 Openness ................................................................................................................................................................................ 6

4.3.5 Responsibility ..................................................................................................................................................................... 6

4.3.6 Responsiveness to complaints ............................................................................................................................. 6

4.3.7 Risk-based approach .................................................................................................................................................... 6

5 General requirements ..................................................................................................................................................................................... 7

5.1 Legal entity ................................................................................................................................................................................................. 7

5.2 Responsibility for validation/verification statements.......................................................................................... 7

5.3 Management of impartiality ........................................................................................................................................................ 7

5.4 Liability .......................................................................................................................................................................................................... 8

6 Structural requirements .............................................................................................................................................................................. 8

6.1 Organizational structure and top management ......................................................................................................... 8

6.2 Operational control ............................................................................................................................................................................. 9

7 Resource requirements ................................................................................................................................................................................. 9

7.1 General ........................................................................................................................................................................................................... 9

7.2 Personnel ..................................................................................................................................................................................................... 9

7.3 Management process for the competence of personnel ..................................................................................10

7.4 Outsourcing.............................................................................................................................................................................................11

8 Validation/verification programme ..............................................................................................................................................11

9 Process requirements ..................................................................................................................................................................................11

9.1 General ........................................................................................................................................................................................................11

9.2 Pre-engagement ..................................................................................................................................................................................12

9.3 Engagement ............................................................................................................................................................................................13

9.4 Planning .....................................................................................................................................................................................................13

9.5 Validation/verification execution ........................................................................................................................................14

9.6 Review .........................................................................................................................................................................................................15

9.7 Decision and issue of the validation/verification statement .......................................................................15

9.7.1 Decision ................................................................................................................................................................................15

9.7.2 Issue of the validation/verification statement....................................................................................15

9.8 Facts discovered after the issue of the validation/verification statement .......................................16

9.9 Handling of appeals .........................................................................................................................................................................16

9.10 Handling of complaints .................................................................................................................................................................17

9.11 Records .......................................................................................................................................................................................................17

10 Information requirements ......................................................................................................................................................................18

10.1 Publicly available information ................................................................................................................................................18

10.2 Other information to be available ........................................................................................................................................18

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10.3 Reference to validation/verification and use of marks .....................................................................................19

10.4 Confidentiality ......................................................................................................................................................................................19

11 Management system requirements ...............................................................................................................................................19

11.1 General ........................................................................................................................................................................................................19

11.2 Management review ........................................................................................................................................................................20

11.3 Internal audits ......................................................................................................................................................................................21

11.4 Corrective action ................................................................................................................................................................................21

11.5 Actions to address risks and opportunities ................................................................................................................21

11.6 Documented information ............................................................................................................................................................22

Annex A (informative) Elements of validation/verification programmes .................................................................24

Annex B (informative) Terms and concepts defined by ISO/IEC 17029........................................................................26

Annex C (informative) Illustration of validation/verification application ................................................................28

Bibliography .............................................................................................................................................................................................................................29

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SIST EN ISO/IEC 17029:2019
ISO/IEC 17029:2019(E)
Foreword

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical

Commission) form the specialized system for worldwide standardization. National bodies that

are members of ISO or IEC participate in the development of International Standards through

technical committees established by the respective organization to deal with particular fields of

technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other

international organizations, governmental and non-governmental, in liaison with ISO and IEC, also

take part in the work.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for

the different types of document should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject

of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent

rights. Details of any patent rights identified during the development of the document will be in the

Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents) or the IEC

list of patent declarations received (see http:// patents .iec .ch).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of 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 www .iso .org/

iso/ foreword .html.

This document was prepared by the ISO Committee on Conformity Assessment (CASCO).

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO/IEC 2019 – All rights reserved v
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SIST EN ISO/IEC 17029:2019
ISO/IEC 17029:2019(E)
Introduction

Validation and verification as conformity assessment are understood to be a confirmation of reliability

of information declared in claims. Other terms in use for the object of assessment by validation and

verification are “statement”, “declaration”, “assertion”, “prediction” or “report”.

Both activities are distinguished according to the timeline of the assessed claim. Validation is applied

to claims regarding an intended future use or projected outcome (confirmation of plausibility), while

verification is applied to claims regarding events that have already occurred or results that have

already been obtained (confirmation of truthfulness).

Since the requirements in this document are generic in nature, a programme for the particular

validation/verification needs to be operated. Such a programme further specifies definitions,

principles, rules, processes and requirements for validation/verification process steps, as well as for

the competence of validators/verifiers for a specific sector. Programmes can be legal frameworks,

international, regional or national standards, global initiatives, sector applications as well as individual

agreements with clients of the validation/verification body.

Assurance is provided by validation/verification and gives confidence to stakeholders and parties

interested in the claim. The programme can define levels of assurance, e.g. a reasonable or limited level

of assurance.

According to ISO/IEC 17000, the functional approach to the demonstration that specified requirements

are fulfilled describes conformity assessment as a series of the three functions:

— selection;
— determination;
— review and attestation.

The relationship between the generic terms and concepts defined by ISO/IEC 17000 and the terms and

concepts defined by this document is given in Table B.1.

According to this functional approach, validation and verification as conformity assessment include a

decision on the confirmation of the claim. The decision as to whether (or not) the claim conforms with

the initially specified requirements is then issued by the validation/verification body as the validation/

verification statement. The specified requirements can be general or detailed, e.g. the claim being

free from material misstatements. The applicable programme can define additional steps within the

validation/verification process.

When determining whether the claim by a client can be confirmed, validation/verification bodies need

to gather information and develop a complete understanding regarding fulfilment of the specified

requirements. This can include an appropriate evaluation of data and plans, reviewing documentation,

performing alternative calculations, visiting sites or interviewing people.

The requirements specified by this document are common to both activities, validation as well as

verification. Wherever a requirement applies only to one activity it is identified.

Validation/verification bodies can be internal bodies of the organization that provides the claim (first

party), bodies that have a user interest in the claim (second party) or bodies that are independent of the

person or organization that provides the claim and have no user interests in that claim (third party).

By defining validation/verification as confirmation, these activities are differentiated from other

conformity assessment tools as neither resulting in a characterization (testing) nor providing

examination (inspection) or an attestation of conformity for a defined period (certification). However,

validation/verification is intended to match applications of the conformity assessment system. Just

as test reports from a laboratory can be included for inspection purposes, or auditing the producer’s

management system can be used as an input for product certification, validation/verification

statements can be used as an input for another conformity assessment activity. Likewise, results of

vi © ISO/IEC 2019 – All rights reserved
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SIST EN ISO/IEC 17029:2019
ISO/IEC 17029:2019(E)

other conformity assessment activities can be used as an input when performing validation/verification

activities.

Statements of conformity themselves, issued as a result of another conformity assessment activity,

are not considered to be objects of validation/verification according to this document. This includes,

for example, a supplier’s declaration of conformity regarding product specifications according to

ISO/IEC 17050, certificates according to ISO/IEC 17021-1 or design examination and verification in the

context of inspection according to ISO/IEC 17020.

Furthermore, this document does not apply to situations where validation/verification activities

are undertaken as steps within the process of testing (ISO/IEC 17025, ISO 15189), inspection

(ISO/IEC 17020) or certification (ISO/IEC 17021-1, ISO/IEC 17065) and where specific requirements

need to be applied for structuring and performing these processes. Examples are method validation as

a step of a testing performed in accordance with ISO/IEC 17025 and design validation/verification in

the context of implementing a management system according to ISO 9001.

Current examples for validation/verification as conformity assessment activities include claims

related to greenhouse gas emissions (e.g. according to ISO 14064-3), environmental labelling, product

declarations and footprints (e.g. according to ISO 14020 and ISO 14040, such as the environmental

product declaration), sustainability or environmental reporting (e.g. according to ISO 14016). Potential

new applications can include claims relating to construction technology, energy management, financial

management, industrial automation systems, software and systems engineering, artificial intelligence,

information technology, healthcare products and medical devices, machine safety, safety and design

engineering, and social responsibility. However, in sector applications where validation/verification

are not performed as conformity assessment activities as defined by this document, these activities are

not within the scope of 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:

https:// fr .surveymonkey .com/ r/ NG3LYKD
© ISO/IEC 2019 – All rights reserved vii
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SIST EN ISO/IEC 17029:2019
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SIST EN ISO/IEC 17029:2019
INTERNATIONAL STANDARD ISO/IEC 17029:2019(E)
Conformity assessment — General principles and
requirements for validation and verification bodies
1 Scope

This document contains general principles and requirements for the competence, consistent operation

and impartiality of bodies performing validation/verification as conformity assessment activities.

Bodies operating according to this document can provide validation/verification as a first-party,

second-party or third-party activity. Bodies can be validation bodies only, verification bodies only, or

provide both activities.

This document is applicable to validation/verification bodies in any sector, providing confirmation

that claims are either plausible with regards to the intended future use (validation) or truthfully stated

(verification). However, results of other conformity assessment activities (e.g. testing, inspection and

certification) are not considered to be subject to validation/verification according to this document.

Neither are situations where validation/verification activities are performed as steps within another

conformity assessment process.

This document is applicable to any sector, in conjunction with sector specific programmes that contain

requirements for validation/verification processes and procedures.

This document can be used as a basis for accreditation by accreditation bodies, peer assessment within

peer assessment groups, or other forms of recognition of validation/verification bodies by international

or regional organizations, governments, regulatory authorities, programme owners, industry bodies,

companies, clients or consumers.

NOTE This document contains generic requirements and is neutral with regard to the validation/verification

programme in operation. Requirements of the applicable programmes are additional to the requirements of this

document.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their conten

...

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