SIST-TS ISO/IEC TS 17035:2024
(Main)Conformity assessment - Guidelines for validation and verification programmes
Conformity assessment - Guidelines for validation and verification programmes
1.1 This document provides guidance to validation and verification programme owners and validation and verification bodies on the development, content and operation of validation and verification programmes.
1.2 This document is intended to be used in conjunction with ISO/IEC 17029 and any sector application of ISO/IEC 17029 as well as in conjunction with other conformity assessment programmes, e.g. as part of the evaluation activities in a scheme for the certification of products according to ISO/IEC 17065.
Évaluation de la conformité — Lignes directrices pour les programmes de validation et de vérification
Ugotavljanje skladnosti - Smernice za programe validacije in verifikacije
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2024
Ugotavljanje skladnosti - Smernice za programe validacije in verifikacije
Conformity assessment - Guidelines for validation and verification programmes
Évaluation de la conformité — Lignes directrices pour les programmes de validation et
de vérification
Ta slovenski standard je istoveten z: ISO/IEC TS 17035:2024
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.
Technical
Specification
ISO/IEC TS 17035
First edition
Conformity assessment —
2024-09
Guidelines for validation and
verification programmes
Évaluation de la conformité — Lignes directrices pour les
programmes de validation et de vérification
Reference number
© ISO/IEC 2024
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO/IEC 2024 – All rights reserved
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Validation/Verification programmes . 4
4.1 General .4
4.2 Programme content .5
4.2.1 Scope of validation/verification .5
4.2.2 Competence, impartiality and operation of validation/verification bodies .5
4.2.3 Steps for the validation/verification process .6
4.2.4 Evidence gathering activities .6
4.2.5 Reporting .7
4.3 Programme development . .7
4.4 Programme maintenance, review and improvement .8
5 Programme owner . 9
Annex A (informative) Clarification of logo/symbol/mark . 10
Annex B (informative) Recognition of validation/verification programmes .12
Annex C (informative) Questions to help recognize a validation/verification programme . 14
Bibliography . 17
© ISO/IEC 2024 – All rights reserved
iii
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 or www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any
claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC had not
received notice of (a) patent(s) which may be required to implement this document. However, implementers
are cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall not be held
responsible for identifying any or all such patent rights.
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.
In the IEC, see www.iec.ch/understanding-standards.
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 and
www.iec.ch/national-committees.
© ISO/IEC 2024 – All rights reserved
iv
Introduction
This document is aligned with ISO/IEC 17029 which provides principles and requirements for bodies
providing validation/verification services. ISO/IEC 17029 is a generic standard that can apply to validation/
verification bodies in any economic sector or industry. It is distinct from other standards for conformity
assessment bodies in that it requires the object of conformity to be a claim, and for this to be validated
and/or verified in accordance with a validation or verification programme. Validation/verification bodies
operating in accordance with ISO/IEC 17029 can provide services as first-, second- or third-party activities.
This document is also aligned with sector-specific applications of ISO/IEC 17029, such as ISO 14065 which
references the requirements of ISO/IEC 17029 and includes specific requirements related to bodies that
validate or verify environmental information.
To validate or verify a claim, validation/verification bodies must often review large amounts of data and
information, including aspects such as the suitability of the boundaries of the claim; the way data has been
defined, collected and recorded; how quantification and calculation methods that support the claim have
been undertaken; and provision of a professional judgement on matters that are material or significant to
the claim.
The issuance of a validation or verification statement will normally be a one-off attestation based on the
information available at that point in time. Validation/verification statements normally do not have a period
of validity associated with them. Each subsequent validation/verification is a new separate conformity
assessment and is not considered to be a surveillance activity that supports an original or previous
validation/verification statement.
The result of validation or verification activities will frequently be a validation or verification statement.
These statements normally provide an opinion from the validation or verification body on the plausibility
of a claim that is made about the future based on projected data (validation), or the truthfulness of the
claim based on historical data (verification). The results from a validation and verification programme can
sometimes be combined to support a claim (e.g. a mixed engagement or in the management of similar or
related programmes). Validation/verification bodies can also be asked to undertake a validation/verification
process and issue a report of their findings, but without any formal statement or opinion on the plausibility
or truthfulness of the claim being made.
NOTE This is often referred to undertaking validation or verification activities on the basis of Agreed Upon
Procedures (AUP).
Within ISO/IEC 17029, there is a requirement for validation/verification bodies to operate within the
context of at least one validation or verification programme. Within ISO/IEC 17029 requirements, there
are many references to validation/verification programmes, and it is expected that validation/verification
programmes give direction to the validation/verification body. The importance of appropriate validation/
verification programmes when undertaking validation/verification activities in accordance with
ISO/IEC 17029 is critical to the correct operation of this type of conformity assessment.
ISO/IEC 17029:2019, Annex A also provides a comprehensive informative list of elements to be considered in
the development and operation of validation/verification programmes. The content of ISO/IEC 17029:2019,
Annex A has been included and amplified in this document.
To assist in the development, operation and recognition of validation/verification programmes suitable for
use with ISO/IEC 17029, this document covers the following:
a) an overview of validation/verification programmes in the context of ISO/IEC 17029;
b) development of validation/verification programmes;
c) recognition of validation/verification programmes.
© ISO/IEC 2024 – All rights reserved
v
Technical Specification ISO/IEC TS 17035:2024(en)
Conformity assessment — Guidelines for validation and
verification programmes
1 Scope
This document provides guidance to validation/verification programme owners, validation/verification
bodies and interested parties on the development, content and operation of validation/verification
programmes.
When implemented by validation/verification bodies, this document is intended to be used in conjunction
with ISO/IEC 17029 and sector-specific applications of ISO/IEC 17029.
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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
claim
information declared by the client
Note 1 to entry: The claim is the object of conformity assessment by validation (3.2)/verification (3.3).
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.
[SOURCE: ISO/IEC 17029:2019, 3.1]
3.2
validation
confirmation of a claim (3
...
Technical
Specification
ISO/IEC TS 17035
First edition
Conformity assessment —
2024-09
Guidelines for validation and
verification programmes
Évaluation de la conformité — Lignes directrices pour les
programmes de validation et de vérification
Reference number
© ISO/IEC 2024
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO/IEC 2024 – All rights reserved
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Validation/Verification programmes . 4
4.1 General .4
4.2 Programme content .5
4.2.1 Scope of validation/verification .5
4.2.2 Competence, impartiality and operation of validation/verification bodies .5
4.2.3 Steps for the validation/verification process .6
4.2.4 Evidence gathering activities .6
4.2.5 Reporting .7
4.3 Programme development . .7
4.4 Programme maintenance, review and improvement .8
5 Programme owner . 9
Annex A (informative) Clarification of logo/symbol/mark . 10
Annex B (informative) Recognition of validation/verification programmes .12
Annex C (informative) Questions to help recognize a validation/verification programme . 14
Bibliography . 17
© ISO/IEC 2024 – All rights reserved
iii
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 or www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any
claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC had not
received notice of (a) patent(s) which may be required to implement this document. However, implementers
are cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall not be held
responsible for identifying any or all such patent rights.
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.
In the IEC, see www.iec.ch/understanding-standards.
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 and
www.iec.ch/national-committees.
© ISO/IEC 2024 – All rights reserved
iv
Introduction
This document is aligned with ISO/IEC 17029 which provides principles and requirements for bodies
providing validation/verification services. ISO/IEC 17029 is a generic standard that can apply to validation/
verification bodies in any economic sector or industry. It is distinct from other standards for conformity
assessment bodies in that it requires the object of conformity to be a claim, and for this to be validated
and/or verified in accordance with a validation or verification programme. Validation/verification bodies
operating in accordance with ISO/IEC 17029 can provide services as first-, second- or third-party activities.
This document is also aligned with sector-specific applications of ISO/IEC 17029, such as ISO 14065 which
references the requirements of ISO/IEC 17029 and includes specific requirements related to bodies that
validate or verify environmental information.
To validate or verify a claim, validation/verification bodies must often review large amounts of data and
information, including aspects such as the suitability of the boundaries of the claim; the way data has been
defined, collected and recorded; how quantification and calculation methods that support the claim have
been undertaken; and provision of a professional judgement on matters that are material or significant to
the claim.
The issuance of a validation or verification statement will normally be a one-off attestation based on the
information available at that point in time. Validation/verification statements normally do not have a period
of validity associated with them. Each subsequent validation/verification is a new separate conformity
assessment and is not considered to be a surveillance activity that supports an original or previous
validation/verification statement.
The result of validation or verification activities will frequently be a validation or verification statement.
These statements normally provide an opinion from the validation or verification body on the plausibility
of a claim that is made about the future based on projected data (validation), or the truthfulness of the
claim based on historical data (verification). The results from a validation and verification programme can
sometimes be combined to support a claim (e.g. a mixed engagement or in the management of similar or
related programmes). Validation/verification bodies can also be asked to undertake a validation/verification
process and issue a report of their findings, but without any formal statement or opinion on the plausibility
or truthfulness of the claim being made.
NOTE This is often referred to undertaking validation or verification activities on the basis of Agreed Upon
Procedures (AUP).
Within ISO/IEC 17029, there is a requirement for validation/verification bodies to operate within the
context of at least one validation or verification programme. Within ISO/IEC 17029 requirements, there
are many references to validation/verification programmes, and it is expected that validation/verification
programmes give direction to the validation/verification body. The importance of appropriate validation/
verification programmes when undertaking validation/verification activities in accordance with
ISO/IEC 17029 is critical to the correct operation of this type of conformity assessment.
ISO/IEC 17029:2019, Annex A also provides a comprehensive informative list of elements to be considered in
the development and operation of validation/verification programmes. The content of ISO/IEC 17029:2019,
Annex A has been included and amplified in this document.
To assist in the development, operation and recognition of validation/verification programmes suitable for
use with ISO/IEC 17029, this document covers the following:
a) an overview of validation/verification programmes in the context of ISO/IEC 17029;
b) development of validation/verification programmes;
c) recognition of validation/verification programmes.
© ISO/IEC 2024 – All rights reserved
v
Technical Specification ISO/IEC TS 17035:2024(en)
Conformity assessment — Guidelines for validation and
verification programmes
1 Scope
This document provides guidance to validation/verification programme owners, validation/verification
bodies and interested parties on the development, content and operation of validation/verification
programmes.
When implemented by validation/verification bodies, this document is intended to be used in conjunction
with ISO/IEC 17029 and sector-specific applications of ISO/IEC 17029.
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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
claim
information declared by the client
Note 1 to entry: The claim is the object of conformity assessment by validation (3.2)/verification (3.3).
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.
[SOURCE: ISO/IEC 17029:2019, 3.1]
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.
© ISO/IEC 2024 – All rights reserved
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: In this document, the expression “validation/verification” means either validation or verification (3.3),
or both.
[SOURCE: ISO/IEC 17029:2019, 3.2, modified – The original Note 4 to entry has been deleted and a new Note
4 to entry has been added.]
3.3
verification
confirmation of a claim (3.1), through the provision of objective evidence, that specified requirement
...
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