SIST EN ISO/IEC 17029:2019
(Main)Conformity Assessment - General principles and requirements for validation and verification bodies (ISO/IEC 17029:2019)
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 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.
Konformitätsbewertung - Allgemeine Grundsätze und Anforderungen an Stellen, die Validierungs- und Verifizierungstätigkeiten durchführen (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 - Exigences et principes généraux pour les organismes de validation et de vérification (ISO/IEC 17029:2019)
Le présent document contient les principes généraux et les exigences relatifs à la compétence, au fonctionnement cohérent et à l'impartialité des organismes réalisant la validation/vérification en tant qu'activités d'évaluation de la conformité.
Les organismes opérant conformément au présent document peuvent fournir des prestations de validation/vérification comme des activités de première, seconde ou tierce partie. Les organismes peuvent être des organismes de validation uniquement, des organismes de vérification uniquement ou fournir les deux activités.
Le présent document est applicable aux organismes de validation/vérification de tous secteurs, qui fournissent une confirmation que des déclarations sont soit plausibles au regard de l'utilisation future prévue (validation), soit établies en toute véracité (vérification). Cependant, les résultats d'autres activités d'évaluation de la conformité (par exemple essais, inspection et certification) ne sont pas considérés comme étant soumis à une validation/vérification conformément au présent document, ni les situations où les activités de validation/vérification sont réalisées en tant qu'étapes d'un autre processus d'évaluation de la conformité.
Le présent document est applicable à tout secteur, conjointement à des programmes spécifiques à chaque secteur qui contiennent des exigences relatives aux processus et procédures de validation/vérification.
Le présent document peut servir de base pour l'accréditation par des organismes d'accréditation, l'évaluation par les pairs au sein de groupes d'évaluation par les pairs, ou d'autres formes de reconnaissance des organismes de validation/vérification par des organisations internationales ou régionales, des gouvernements, des autorités réglementaires, des propriétaires de programmes, des organismes industriels, des entreprises, des clients ou des consommateurs.
NOTE Le présent document contient des exigences générales et est neutre par rapport au programme de validation/vérification appliqué. Les exigences des programmes applicables s'ajoutent à celles du présent document.
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
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO/IEC 17029:2019(E)
© 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
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Phone: +41 22 749 01 11
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO/IEC 2019 – All rights reserved
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
© ISO/IEC 2019 – All rights reserved iii
ISO/IEC 17029:2019(E)
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
iv © ISO/IEC 2019 – All rights reserved
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
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
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
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 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
claim
information declared by the client (3.13)
Note 1 to entry: The claim is the object of conformity assessment by validation (3.2)/verification (3.3).
© ISO/IEC 2019 – All rights reserved 1
ISO/IEC 17029:2019(E)
Note 2 to entry: The claim can represent a situation at a point in time or could cover a period of time.
Note 3 to entry: The claim should be clearly identifiable and capable of consistent evaluation or measurement
against specified requirements by a validation body (3.4)/verification body (3.5).
Note 4 to entry: The claim can be provided in the form of a report, a statement, a declaration, a project plan, or
consolidated data.
3.2
validation
confirmation of a claim (3.1), through the provision of objective evidence, that the requirements for a
specific intended future use or application have been fulfilled
Note 1 to entry: Objective evidence can come from real or simulated sources.
Note 2 to entry: Validation is considered to be a process to evaluate the reasonableness of the assumptions,
limitations, and methods that support a claim about the outcome of future activities.
Note 3 to entry: Validation is applied to claims regarding an intended future use based on projected information
(confirmation of plausibility).
Note 4 to entry: Figure C.1 illustrates the application of validation.
[SOURCE: ISO 9000:2015, 3.8.13, modified — The words “of a claim” and “future” have been added to
the definition and the Notes to entry have been modified.]
3.3
verification
confirmation of a claim (3.1), through the provision of objective evidence, that specified requirements
have been fulfilled
Note 1 to entry: Verification is considered to be a process for evaluating a claim based on historical data and
information to determine whether the claim is materially correct and conforms with specified requirements.
Note 2 to entry: Verification is applied to claims regarding events that have already occurred or results that have
already been obtained (confirmation of truthfulness).
Note 3 to entry: Figure C.2 illustrates the application of verification.
[SOURCE: ISO 9000:2015, 3.8.12, modified — The words “of a claim” have been added to the definition
and the Notes to entry have been modified.]
3.4
validation body
body that performs validation (3.2)
Note 1 to entry: A validation body can be an organization, or part of an organization.
3.5
verification body
body that performs verification (3.3)
Note 1 to entry: A verification body can be an organization, or part of an organization.
3.6
validation statement
declaration by the validation body (3.4) of the outcome of the validation (3.2) process
Note 1 to entry: Validation statements can be referred to using specific programme terminology, such as
“decisions”, “opinions” or “reports”.
Note 2 to entry: The validation statement reflects only the situation at the point in time it is issued.
2 © ISO/IEC 2019 – All rights reserved
ISO/IEC 17029:2019(E)
Note 3 to entry: The validation statement can be confirming or not confirming the claim (3.1), with or without
comments, according to the programme requirements.
3.7
verification statement
declaration by the verification body (3.5) of the outcome of the verification (3.3) process
Note 1 to entry: Verification statements can be referred to using specific programme terminology, such as
“decisions”, “opinions” or “reports”.
Note 2 to entry: The verification statement reflects only the situation at the point in time it is issued.
Note 3 to entry: The verification statement can be confirming or not confirming the claim (3.1), with or without
comments, according to the programme requirements.
3.8
validation programme
rules, procedures and management for carrying out validation (3.2) activities in a specific sector
Note 1 to entry: Validation programmes can be operated at international, regional, national, sub-national or
sector-specific level.
Note 2 to entry: A programme can also be called a “scheme”.
Note 3 to entry: A set of standards able to cover all the requirements of this document can serve as a programme.
3.9
verification programme
rules, procedures and management for carrying out verification (3.3) activities in a specific sector
Note 1 to entry: Verification programmes can be operated at international, regional, national, sub-national or
sector-specific level.
Note 2 to entry: A programme can also be called a “scheme”.
Note 3 to entry: A set of standards able to cover all the requirements of this document can serve as a programme.
3.10
programme owner
person or organization responsible for developing and maintaining a specific validation programme
(3.8) or verification programme (3.9)
Note 1 to entry: The programme owner can be the validation body (3.4)/verification body (3.5) itself, a
governmental authority, a trade association, a group of validation bodies/verification bodies, an external
programme owner or others.
[SOURCE: ISO/IEC 17065:2012, 3.11, modified — The term “scheme owner” has been replaced with
“programme owner” and the words “certification scheme” have been replaced with “validation
programme or verification programme” in the definition.]
3.11
scope of validation/verification
identification of:
— the claim (3.1) to be the object of validation (3.2) or verification (3.3), including the boundaries of
the claim,
— the applicable validation programme (3.8)/verification programme (3.9), and
— the standards and other normative documents, including their date of publication, to which the
claim is validated/verified
© ISO/IEC 2019 – All rights reserved 3
ISO/IEC 17029:2019(E)
3.12
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 activities of the validation body (3.4)/verification body (3.5).
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 “subsequent activities of the certification
body” have been replaced with “activities of the validation body/verification body” in Note 1 to entry.]
3.13
client
organization or person requesting validation (3.2)/verification (3.3)
3.14
consultancy
participation in establishing the claim (3.1) that will be the object of validation (3.2)/verification (3.3)
Note 1 to entry: The term “consultancy” is used in relation to activities of validation bodies (3.4)/verification
bodies (3.5), their personnel and organizations related or linked to the validation bodies/verification bodies.
Note 2 to entry: Participation in establishing the claim also includes involvement in design of the object leading
to the claim or providing object specific expertise that supports the preparation of the claim.
Note 3 to entry: Arranging training and participating as a trainer is not considered as consultancy, provided
that, where the course relates to the claim that will be the object of validation/verification, it is confined to the
provision of generic information; i.e. the trainers should not provide client (3.13) specific solutions.
Note 4 to entry: The provision of generic information, but not client specific solutions for establishing the claim
that will be the object of validation/verification, is not considered to be consultancy. Such information can
include:
— explaining the meaning and intention of validation/verification requirements;
— explaining associated theories, methodologies, techniques, or tools;
— sharing non-confidential information on related best practices.
3.15
level of assurance
degree of confidence in the claim (3.1)
Note 1 to entry: The levels of assurance and the conditions to achieve them can be defined in the programme (e.g.
absolute, reasonable, limited).
3.16
material
significant to intended users
Note 1 to entry: Materiality is the concept that misstatements, individually or aggregated, can influence the
reliability of the claim (3.1) or decisions made by the intended user.
Note 2 to entry: Materiality can be qualitative or quantitative.
4 © ISO/IEC 2019 – All rights reserved
ISO/IEC 17029:2019(E)
4 Principles
4.1 General
4.1.1 The principles described in this clause provide the basis for the requirements specified in this
document. These principles should be applied as guidance for decisions that sometimes need to be made
for unanticipated situations. Principles are not requirements.
4.1.2 The overall aim of validation/verification is to give confidence to all parties that a validated/
verified claim fulfils the specified requirements. The value of validation/verification is the confidence
that is established by an impartial evaluation by a competent validation/verification body.
4.1.3 Parties that have an interest in validation/verification include, but are not limited to:
a) clients of the validation/verification bodies;
b) programme owners;
c) users of the validated/verified claims;
d) regulatory authorities.
4.2 Principles for the validation/verification process
4.2.1 Evidence-based approach to decision making
The process deploys a method for reaching reliable and reproducible validation/verification conclusions
and is based on sufficient and appropriate objective evidence. The validation/verification statement is
based on evidence collected through an objective validation/verification of the claim.
4.2.2 Documentation
The validation/verification process is documented and establishes the basis for the conclusion and
decision regarding conformity of the claim with the specified requirements.
4.2.3 Fair presentation
Validation/verification activities, findings, conclusions and statements, including significant obstacles
encountered during the process, as well as unresolved, diverging views between the validation/
verification body and the client are truthfully and accurately reflected.
4.3 Principles for validation/verification bodies
4.3.1 Impartiality
Decisions are based on objective evidence obtained through the validation/verification process and are
not influenced by other interests or parties.
Threats to impartiality can include but are not limited to the following.
a) Self-interest: threats that arise from a person or body acting in their own interest. A concern
related to validation/verification, as a threat to impartiality, is financial self-interest.
b) Self-review: threats that arise from a person or body reviewing the work done by themselves.
c) Familiarity (or trust): threats that arise from a person or body being too familiar with or trusting
of another person instead of seeking evidence for validation/verification.
© ISO/IEC 2019 – All rights reserved 5
ISO/IEC 17029:2019(E)
d) Intimidation: threats that arise from a person or body having a perception of being coerced openly
or secretively, such as a threat to be replaced or reported to a supervisor.
4.3.2 Competence
Personnel have the necessary knowledge, skills, experience, training, supporting infrastructure and
capacity to effectively perform validation/verification activities.
4.3.3 Confidentiality
Confidential information obtained or created during validation/verification activities is safeguarded
and not inappropriately disclosed.
4.3.4 Openness
A validation/verification body needs to provide public access to, or disclosure of, appropriate
information about its validation/verification process.
4.3.5 Responsibility
The client of the validation/verification body, and not the validation/verification body, has the
responsibility for the claim and its conformity with the applicable specified requirements.
The validation/verification body has the responsibility to base a validation/verification statement
upon sufficient and appropriate objective evidence.
4.3.6 Responsiveness to complaints
Parties that have an interest in validation/verification have the opportunity to make complaints. These
complaints are appropriately managed and resolved. Responsiveness to complaints is necessary in
order to demonstrate integrity and credibility to all users of validation/verification outcomes.
4.3.7 Risk-based approach
Validation/verification bodies need to take into account the risks associated with providing competent,
consistent and impartial validation/verification. Risks can include, but are not limited to, those
associated with:
a) the objectives of the validation/verification and the programme requirements;
b) competence, consistency and real as well as perceived impartiality;
c) legal, regulatory and liability issues;
d) the client organization, where validation/verification is being carried out, and its management
system, operating environment, geographic location, etc.;
e) the susceptibility of any parameter included in the claim to generate a material misstatement, even
if there is a control system implemented;
f) the level of assurance to be achieved and the corresponding evidence-gathering used in the
validation/verification process;
g) perception of interested parties;
h) misleading claims or misuse of marks by the client;
i) risk control and opportunities for improvement.
6 © ISO/IEC 2019 – All rights reserved
ISO/IEC 17029:2019(E)
5 General requirements
5.1 Legal entity
The validation/verification body shall be a legal entity, or a defined part of a legal entity, that can be
held legally responsible for all its validation/verification activities.
NOTE A governmental validation/verification body is a legal entity on the basis of its governmental status.
5.2 Responsibility for validation/verification statements
The validation/verification body shall be responsible for, and shall retain autho
...
ba
S L O V E N S K I SIST EN ISO/IEC 17029
S T A N D A R D december 2019
Ugotavljanje skladnosti – Splošna načela in zahteve za organe, ki
izvajajo validiranje in preverjanje (ISO/IEC 17029:2019)
Conformity Assessment – General principles and requirements for validation
and verification bodies (ISO/IEC 17029:2019)
Évaluation de la conformité – Exigences et principes généraux pour les
organismes de validation et de vérification (ISO/IEC 17029:2019)
Konformitätsbewertung – Allgemeine Grundsätze und Anforderungen an Stellen,
die Validierungs- und Verifizierungstätigkeiten durchführen (ISO/IEC 17029:2019)
Referenčna oznaka
ICS 03.120.20 SIST EN ISO/IEC 17029:2019 (sl, en)
Nadaljevanje na straneh II in od 1 do 69
© 2023-07. Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
.
SIST EN ISO/IEC 17029 : 2019
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17029 (sl, en), Ugotavljanje skladnosti – Splošna načela in zahteve za
organe, ki izvajajo validacijo in verifikacijo (ISO/IEC 17029:2019), 2019, ima status slovenskega
standarda in je istoveten evropskemu standardu EN ISO/IEC 17029 (en), Conformity Assessment -
General principles and requirements for validation and verification bodies (ISO/IEC 17029:2019), 2019.
NACIONALNI PREDGOVOR
Evropski standard EN ISO/IEC 17029:2019 je pripravil Odbor za ugotavljanje skladnosti ISO/CASCO v
sodelovanju s tehničnim odborom Evropskega komiteja za standardizacijo CEN/CLC TC 1 Merila za
organe za ugotavljanje skladnosti. Slovenski standard SIST EN ISO/IEC 17029:2019 je prevod
evropskega standarda EN ISO/IEC 17029:2019. Ob sporu zaradi besedila slovenskega prevoda v tem
standardu je odločilen izvirni evropski standard v angleškem jeziku.
Odločitev za privzem tega standarda je 13. novembra 2019 sprejel tehnični odbor SIST/TC UGA
Ugotavljanje skladnosti.
ZVEZA S STANDARDI
S prevzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO/IEC 17000:2020 (sl,en) Ugotavljanje skladnosti – Slovar in splošna načela (ISO/IEC
17000:2020, popravljena verzija 2020-12)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda SIST EN ISO/IEC 17029:2019
OPOMBE
̶ Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
̶ Povsod, kjer se v besedilu standarda uporablja izraz "evropski standard" oziroma "mednarodni
standard", v SIST EN ISO/IEC 17029:2019 to pomeni "slovenski standard".
̶ Ta nacionalni dokument je istoveten EN ISO/IEC 17029:2019 in je objavljen z dovoljenjem
CEN-CENELEC
Upravni center
Avenue Marnix 17
1000 Bruselj
Belgija
This national document is identical with EN ISO/IEC 17029:2019 and is published with the
permission of
CEN-CENELEC
Management center
Avenue Marnix 17
1000 Bruxelles
Belgium
II
EVROPSKI STANDARD EN ISO 17029
EUROPEAN STANDARD
EUROPÄISCHE NORM
november 2019
NORME EUROPÉENNE
ICS 03.120.20
Slovenska izdaja
Ugotavljanje skladnosti – Splošna načela in zahteve za organe, ki
izvajajo validiranje in preverjanje (ISO/IEC 17029:2019)
Conformity Assessment – Évaluation de la conformité – Konformitätsbewertung –
General principles and Principes généraux et exigences Allgemeine Grundsätze und
requirements for validation and pour les organismes de validation Anforderungen an Stellen, die
verification bodies (ISO/IEC et de vérification (ISO/IEC Validierungs- und
17029:2019) 17029:2019) Verifizierungstätigkeiten
durchführen (ISO/IEC
17029:2019)
Ta evropski standard je CEN odobril 5. oktobra 2019.
Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je
predpisano, da mora biti ta evropski standard brez kakršnihkoli sprememb sprejet kot nacionalni
standard. Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na
voljo pri Upravnem centru CEN-CENELEC ali članih CEN in CENELEC.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem
centru CEN-CENELEC, veljajo kot uradne izdaje.
Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški odbori Avstrije,
Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske,
Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije, Nizozemske, Norveške,
Poljske, Portugalske, Republike Severna Makedonija, Romunije, Slovaške, Slovenije, Srbije, Španije,
Švedske, Švice, Turčije in Združenega kraljestva.
CEN CENELEC
Evropski komite za standardizacijo Evropski komite za standardizacijo v elektrotehniki
European Committee for Standardization European Committee for Electrotechnical Standardization
Europäisches Komitee für Normung Europäisches Komitee für Elektrotechnische Normung
Comité Européen de Normalisation Comité Européen de Normalisation Electrotechnique
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj
© 2019 CEN Vse pravice do izkoriščanja v kakršnikoli obliki in na kakršenkoli Ref. št. EN ISO/IEC 17029:2019 E
način imajo nacionalni člani CEN in CENELEC.
SIST EN ISO/IEC 17029 : 2019
Evropski predgovor
Ta dokument (EN ISO/IEC 17029:2019) je pripravil tehnični odbor ISO/CASCO "Odbor za ugotavljanje
skladnosti" skupaj s tehničnim odborom CEN/CLC/JTC 1 "Merila za organe za ugotavljanje skladnosti",
katerega tajništvo vodi BSI.
Ta evropski standard mora dobiti status nacionalnega standarda bodisi z objavo istovetnega besedila
ali z razglasitvijo najpozneje do maja 2020, nasprotujoče nacionalne standarde pa je treba razveljaviti
najpozneje do maja 2020.
Opozoriti je treba na možnost, da so nekateri elementi tega dokumenta lahko predmet patentnih pravic.
CEN ne prevzema odgovornosti za identifikacijo nekaterih ali vseh takih patentnih pravic.
V skladu z notranjimi predpisi CEN-CENELEC morajo ta evropski standard obvezno uvesti nacionalne
organizacije za standarde naslednjih držav: Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske,
Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Republike Severna Makedonija, Nemčije, Nizozemske, Norveške, Poljske,
Portugalske, Romunije, Srbije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega
kraljestva.
Razglasitvena objava
Besedilo ISO/IEC 17029:2019 je CEN odobril kot EN ISO/IEC 17029:2019 brez kakršnihkoli sprememb.
SIST EN ISO/IEC 17029 : 2019
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.
SIST EN ISO/IEC 17029 : 2019
VSEBINA Stran
Evropski predgovor . 2
Predgovor k mednarodnemu standardu . 8
Uvod .10
1 Področje uporabe .14
2 Zveze s standardi .14
3 Izrazi in definicije .14
4 Načela .22
4.1 Splošno .22
4.2 Načela za proces validiranja/preverjanja .22
4.2.1 Odločanje na podlagi dokazov .22
4.2.2 Dokumentacija.22
4.2.3 Poštena predstavitev .22
4.3 Načela za organe za validiranje/preverjanje .22
4.3.1 Nepristranskost .22
4.3.2 Kompetentnost .24
4.3.3 Zaupnost .24
4.3.4 Odprtost .24
4.3.5 Odgovornost .24
4.3.6 Odzivnost na pritožbe .24
4.3.7 Pristop na podlagi tveganja .24
5 Splošne zahteve .26
5.1 Pravna oseba .26
5.2 Odgovornost za izjave o validiranju/preverjanju.26
5.3 Obvladovanje nepristranskosti .26
5.4 Obveznosti.28
6 Strukturne zahteve .28
6.1 Organizacijska struktura in najvišje vodstvo .28
6.2 Operativni nadzor .30
7 Zahteve glede virov .30
7.1 Splošno .30
7.2 Osebje .30
7.3 Proces vodenja kompetentnosti osebja .32
7.4 Oddajanje del zunanjim izvajalcem .34
8 Program validiranja/preverjanja .34
9 Zahteve za procese .34
9.1 Splošno .34
9.2 Pred sklenitvijo pogodbe .36
9.3 Sklenitev pogodbe .36
9.4 Planiranje.38
SIST EN ISO/IEC 17029 : 2019
CONTENTS Page
European foreword . 3
Foreword . 9
Introduction .11
1 Scope .15
2 Normative references .15
3 Terms and definitions .15
4 Principles .23
4.1 General .23
4.2 Principles for the validation/verification process .23
4.2.1 Evidence-based approach to decision making .23
4.2.2 Documentation .23
4.2.3 Fair presentation .23
4.3 Principles for validation/verification bodies .23
4.3.1 Impartiality .23
4.3.2 Competence .25
4.3.3 Confidentiality .25
4.3.4 Openness .25
4.3.5 Responsibility .25
4.3.6 Responsiveness to complaints.25
4.3.7 Risk-based approach .25
5 General requirements .27
5.1 Legal entity .27
5.2 Responsibility for validation/verification statements .27
5.3 Management of impartiality .27
5.4 Liability .29
6 Structural requirements .29
6.1 Organizational structure and top management .29
6.2 Operational control .31
7 Resource requirements .31
7.1 General .31
7.2 Personnel .31
7.3 Management process for the competence of personnel .33
7.4 Outsourcing .35
8 Validation/verification programme .35
9 Process requirements .35
9.1 General .35
9.2 Pre-engagement .37
9.3 Engagement .37
9.4 Planning.39
SIST EN ISO/IEC 17029 : 2019
9.5 Izvedba validiranja/preverjanja .40
9.6 Pregled .40
9.7 Odločitev in izdaja izjave o validiranju/preverjanju .42
9.7.1 Odločitev .42
9.7.2 Izdaja izjave o validiranju/preverjanju .42
9.8 Dejstva, odkrita po izdaji izjave o validiranju/preverjanju .44
9.9 Obravnavanje prizivov .44
9.10 Obravnavanje pritožb .44
9.11 Zapisi .46
10 Zahteve za informacije .46
10.1 Javno dostopne informacije.46
10.2 Druge razpoložljive informacije .48
10.3 Sklicevanje na validiranje/preverjanje in uporaba znakov .48
10.4 Zaupnost.48
11 Zahteve za sistem vodenja .50
11.1 Splošno.50
11.2 Vodstveni pregled .50
11.3 Notranje presoje .52
11.4 Korektivni ukrepi .52
11.5 Ukrepi za obravnavanje tveganj in priložnosti .54
11.6 Dokumentirane informacije.54
Dodatek A (informativni): Elementi programov validiranja/preverjanja .58
Dodatek B (informativni): Izrazi in pojmi, opredeljeni v ISO/IEC 17029 .62
Dodatek C (informativni): Ponazoritev uporabe validiranja/preverjanja .66
Literatura .68
SIST EN ISO/IEC 17029 : 2019
9.5 Validation/verification execution .41
9.6 Review .41
9.7 Decision and issue of the validation/verification statement .43
9.7.1 Decision .43
9.7.2 Issue of the validation/verification statement .43
9.8 Facts discovered after the issue of the validation/verification statement .45
9.9 Handling of appeals .45
9.10 Handling of complaints .45
9.11 Records .47
10 Information requirements .47
10.1 Publicly available information .47
10.2 Other information to be available .49
10.3 Reference to validation/verification and use of marks .49
10.4 Confidentiality .49
11 Management system requirements .51
11.1 General .51
11.2 Management review .51
11.3 Internal audits .53
11.4 Corrective action .53
11.5 Actions to address risks and opportunities .55
11.6 Documented information .55
Annex A (informative): Elements of validation/verification programmes .59
Annex B (informative): Terms and concepts defined by ISO/IEC 17029 .63
Annex C (informative): Illustration of validation/verification application .67
Bibliography .69
SIST EN ISO/IEC 17029 : 2019
Predgovor k mednarodnemu standardu
Mednarodna organizacija za standardizacijo (ISO) in Mednarodna elektrotehniška komisija (IEC) tvorita
specializiran sistem svetovne standardizacije. Nacionalni organi, ki so člani ISO ali IEC, sodelujejo pri
pripravi mednarodnih standardov prek tehničnih odborov, ki jih za obravnavanje določenih strokovnih
področij ustanovi ustrezna organizacija. Tehnični odbori ISO in IEC sodelujejo med seboj na področjih,
ki so v njihovem skupnem interesu Pri delu sodelujejo tudi druge mednarodne, vladne in nevladne
organizacije, povezane z ISO in IEC.
Postopki, uporabljeni pri razvoju tega dokumenta, in postopki, predvideni za njegovo nadaljnje
vzdrževanje, so opisani v Direktivah ISO/IEC, 1. del. Posebna pozornost naj se nameni različnim
kriterijem za odobritev, potrebnim za različne vrste dokumentov. Ta dokument je bil pripravljen v skladu
z uredniškimi pravili Direktiv ISO/IEC, 2. del (glej www.iso.org/directives).
Opozoriti je treba na možnost, da je nekaj elementov tega dokumenta lahko predmet patentnih pravic.
ISO in IEC ne prevzemata odgovornosti za prepoznavanje katerihkoli ali vseh takih patentnih pravic.
Podrobnosti o morebitnih patentnih pravicah, identificiranih med pripravo tega dokumenta, bodo
navedene v uvodu in/ali na seznamu patentnih izjav, ki jih je prejela organizacija ISO (glej
www.iso.org/patents), ali na seznamu patentnih izjav, ki jih je prejela organizacija IEC (glej
http://patents.iec.ch).
Morebitna trgovska imena, uporabljena v tem dokumentu, so informacije za uporabnike in ne pomenijo
podpore blagovni znamki.
Za razlago prostovoljne narave standardov, pomena specifičnih pojmov in izrazov ISO, povezanih z
ugotavljanjem skladnosti, ter informacij o tem, kako ISO spoštuje načela Svetovne trgovinske
organizacije (WTO) v tehničnih ovirah pri trgovanju (TBT), glej spletno mesto
www.iso.org/iso/foreword.html.
Ta dokument je pripravil Odbor ISO za ugotavljanje skladnosti (CASCO).
Uporabnik naj vse povratne informacije ali vprašanja o tem dokumentu posreduje nacionalnemu organu
za standarde v svoji državi. Celoten seznam teh organov je na voljo na spletnem mestu
www.iso.org/members.html.
SIST EN ISO/IEC 17029 : 2019
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.
SIST EN ISO/IEC 17029 : 2019
Uvod
Validiranje in preverjanje se v okviru ugotavljanja skladnosti razumeta kot potrditev zanesljivosti
informacij, izraženih v trditvah. Za predmet ugotavljanja skladnosti z validiranjem in preverjanjem se
uporabljajo tudi izrazi, kot so "izjava", "deklaracija", "trditev", "napoved" ali "poročilo".
Aktivnosti se razlikujeta glede na časovnico ocenjevane trditve. Validiranje se uporablja pri trditvah, ki
se nanašajo na predvideno prihodnjo uporabo ali na načrtovani izid (potrditev verodostojnosti), medtem
ko se preverjanje uporablja pri trditvah o dogodkih, ki so se že zgodili, ali rezultatih, ki so že pridobljeni
(potrditev resničnosti).
Ker so zahteve v tem dokumentu splošne narave, je treba za določeno validiranje/preverjanje upoštevati
poseben program. V takem programu so nadalje določeni definicije, načela, pravila, procesi in zahteve
za posamezne korake postopka validiranja/preverjanja ter za kompetentnost izvajalcev
validiranja/preverjanja za posamezni sektor. Programi so lahko pravni okviri, mednarodni, regionalni ali
nacionalni standardi, globalne pobude, sektorske aplikacije ter posamezni sporazumi s strankami
organov za validiranje/preverjanje.
Z validiranjem/preverjanjem sta deležnikom in zainteresiranim stranem podana zagotovitev in zaupanje
v trditev. V programu so lahko določene stopnje zagotavljanja, npr. razumna ali omejena stopnja
zagotavljanja.
V skladu z ISO/IEC 17000 funkcionalni pristop k dokazovanju, da so izpolnjene specificirane zahteve,
opisuje ugotavljanje skladnosti kot niz treh funkcij:
̶ izbiranje,
̶ ugotavljanje,
̶ pregled in potrditev.
Povezava med splošnimi izrazi in pojmi, opredeljenimi v ISO/IEC 17000, ter izrazi in pojmi, opredeljenimi
v tem dokumentu, je podana v preglednici B.1.
V skladu s tem funkcionalnim pristopom validiranje in preverjanje kot aktivnosti ugotavljanja skladnosti
vključujeta odločitev o potrditvi trditve. Organ za validiranje/preverjanje nato izda odločitev v obliki izjave
o validiranju/preverjanju glede tega, ali trditev je (ali ni) skladna s prvotno specificiranimi zahtevami.
Specificirane zahteve so lahko splošne ali podrobne, npr. da je trditev brez bistvenih napačnih navedb.
Veljavni program lahko določa dodatne korake znotraj procesa validiranja/preverjanja.
Pri ugotavljanju, ali se trditev stranke lahko potrdi, morajo organi za validiranje/preverjanje zbrati
informacije in razviti popolno razumevanje glede izpolnjevanja specificiranih zahtev. To lahko vključuje
ustrezno ovrednotenje podatkov in planov, pregledovanje dokumentacije, izvajanje alternativnih
izračunov, obiske lokacij ali razgovore z ljudmi.
V tem dokumentu navedene zahteve so skupne za obe aktivnosti, tako za validiranje kot za preverjanje.
Če se katera zahteva nanaša samo na eno aktivnost, je to označeno.
Organi za validiranje/preverjanje so lahko notranji organi organizacije, ki poda trditev (prva stranka),
organi, ki se za trditev zanimajo kot uporabniki (druga stranka), ali organi, ki so neodvisni od osebe ali
organizacije, ki poda trditev, in se za to trditev ne zanimajo kot uporabniki (tretja stranka).
SIST EN ISO/IEC 17029 : 2019
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).
SIST EN ISO/IEC 17029 : 2019
Po definiciji sta aktivnosti validiranje in preverjanje opredeljeni kot potrditev, vendar se razlikujeta od
drugega ugotavljanja skladnosti, saj ne zajemata niti opredeljevanja (preskušanja) niti pregledovanja
(kontrole) ali potrjevanja skladnosti za določeno obdobje (certificiranja). Sta pa validiranje in preverjanje
prav tako namenjena ugotavljanju skladnosti. Tako kot so lahko poročila o preskusu iz laboratorija
vključena v kontrolne namene ali kot se presojanje sistema vodenja proizvajalca lahko uporabi kot
vhodni podatek za certifikacijo proizvoda, se lahko izjave o validiranju/preverjanju uporabijo kot vhodni
podatek v drugo aktivnost ugotavljanja skladnosti. Prav tako se lahko rezultati drugih aktivnosti
ugotavljanja skladnosti uporabijo kot vhodni podatek pri izvajanju aktivnosti validiranja/preverjanja.
V skladu s tem dokumentom se same izjave o skladnosti, izdane na podlagi rezultata druge aktivnosti
ugotavljanja skladnosti, ne štejejo za predmete validiranja/preverjanja. To na primer vključuje izjavo
dobavitelja o skladnosti glede na specifikacije izdelkov v skladu z ISO/IEC 17050, certifikate v skladu z
ISO/IEC 17021-1 ali pregled in overitev snovanja v okviru kontrole v skladu z ISO/IEC 17020.
Nadalje se ta dokument ne nanaša na situacije, ko se aktivnosti validiranja/preverjanja izvajajo kot koraki
v okviru procesa preskušanja (ISO/IEC 17025, ISO 15189), kontrole (ISO/IEC 17020) ali certificiranja
(ISO/IEC 17021-1, ISO/IEC 17065) in ko morajo biti za strukturiranje in izvajanje teh procesov
uporabljene posebne zahteve. Primeri so validiranje metode kot korak preskušanja, izvedenega v skladu
z ISO/IEC 17025, in validiranje/preverjanje snovanja v okviru izvajanja sistema vodenja po ISO 9001.
Aktualni primeri validiranja/preverjanja kot aktivnosti ugotavljanja skladnosti vključujejo trditve v zvezi z
izpusti toplogrednih plinov (npr. v skladu z ISO 14064-3), okoljsko označevanje, izjave o izdelkih in
odtisih (npr. v skladu z ISO 14020 in ISO 14040, kot je okoljska izjava o izdelkih), trajnostno ali okoljsko
poročanje (npr. v skladu z ISO 14016). Morebitne nove aplikacije lahko vključujejo trditve v zvezi z
gradbeno tehnologijo, z upravljanjem z energijo, s finančnim upravljanjem, s sistemi industrijske
avtomatizacije, s programskim in sistemskim inženiringom, z umetno inteligenco, z informacijsko
tehnologijo, z izdelki za zdravstveno nego in medicinskimi pripomočki, z varnostjo strojev, z varnostnim
in oblikovalskim inženiringom ter z družbeno odgovornostjo. Pri sektorskih aplikacijah, kjer se validiranje
in preverjanje ne izvajata kot aktivnosti ugotavljanja skladnosti, opredeljeni v tem dokumentu, pa ti dve
aktivnosti nista znotraj področja uporabe tega dokumenta.
V tem dokumentu so uporabljene naslednje glagolske oblike:
̶ "je treba" ali "mora" označuje zahtevo;
̶ "naj" označuje priporočilo;
̶ "je mogoče" ali "lahko" označuje dovoljenje;
̶ "lahko" označuje možnost ali sposobnost.
Več podrobnosti je v Direktivah ISO/IEC, 2. del.
Za namene raziskave uporabnike spodbujamo, da izmenjujejo svoje poglede na ta dokument in
prednostne naloge glede sprememb prihodnjih izdaj. Za sodelovanje pri spletni raziskavi kliknite na
spodnjo povezavo:
https://fr.surveymonkey.com/r/NG3LYKD
SIST EN ISO/IEC 17029 : 2019
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 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 sha
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