ISO/IEC TS 17035
(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-julij-2024
Ugotavljanje skladnosti - Smernice za programe validacije in verifikacije
Conformity assessment - Guidelines for validation and verification programmes
Ta slovenski standard je istoveten z: ISO/IEC DTS 17035
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.
FINAL DRAFT
Technical
Specification
ISO/IEC DTS 17035
ISO/CASCO
Conformity assessment —
Secretariat: ISO
Guidelines for validation and
Voting begins on:
verification programmes
2024-05-14
Voting terminates on:
2024-07-09
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/IEC DTS 17035:2024(en) © ISO/IEC 2024
FINAL DRAFT
ISO/IEC DTS 17035:2024(en)
Technical
Specification
ISO/IEC DTS 17035
ISO/CASCO
Conformity assessment —
Secretariat: ISO
Guidelines for validation and
Voting begins on:
verification programmes
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO/IEC 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/IEC DTS 17035:2024(en) © ISO/IEC 2024
© ISO/IEC 2024 – All rights reserved
ii
ISO/IEC DTS 17035:2024(en)
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 .6
4.3 Programme development . .7
4.4 Programme maintenance, review and improvement .8
5 Programme owner . 8
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
ISO/IEC DTS 17035:2024(en)
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
ISO/IEC DTS 17035:2024(en)
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 resulting validation or verification statement will normally be a one-off attestation based on the
information available at that point in time. Validation or 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
FINAL DRAFT Technical Specification ISO/IEC DTS 17035:2024(en)
Conformity assessment — Guidelines for validation and
verification programmes
1 Scope
This document provides guidance to validation/verification programme owners and to validation/
verification bodies 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)
...
FINAL DRAFT
Technical
Specification
ISO/IEC DTS 17035
ISO/CASCO
Conformity assessment —
Secretariat: ISO
Guidelines for validation and
Voting begins on:
verification programmes
2024-05-14
Voting terminates on:
2024-07-09
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/IEC DTS 17035:2024(en) © ISO/IEC 2024
FINAL DRAFT
ISO/IEC DTS 17035:2024(en)
Technical
Specification
ISO/IEC DTS 17035
ISO/CASCO
Conformity assessment —
Secretariat: ISO
Guidelines for validation and
Voting begins on:
verification programmes
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO/IEC 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/IEC DTS 17035:2024(en) © ISO/IEC 2024
© ISO/IEC 2024 – All rights reserved
ii
ISO/IEC DTS 17035:2024(en)
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 .6
4.3 Programme development . .7
4.4 Programme maintenance, review and improvement .8
5 Programme owner . 8
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
ISO/IEC DTS 17035:2024(en)
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
ISO/IEC DTS 17035:2024(en)
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 resulting validation or verification statement will normally be a one-off attestation based on the
information available at that point in time. Validation or 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
FINAL DRAFT Technical Specification ISO/IEC DTS 17035:2024(en)
Conformity assessment — Guidelines for validation and
verification programmes
1 Scope
This document provides guidance to validation/verification programme owners and to validation/
verification bodies 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,
...
ISO/IEC DTS 17035:2024(en)
Deleted: TS
Deleted: 20xx(E
ISO CASCO
Deleted: WG66/
Secretariat: ISO
Date: 2024-04-28
Deleted: .01.29
Conformity assessment — Guidelines for validation and verification programmes
Deleted: –
Deleted: /
Deleted: (schemes)
Deleted: ¶
DTS stage¶
¶
Warning for WDs and CDs¶
This document is not an ISO International Standard. It is
distributed for review and comment. It is subject to
change without notice and may not be referred to as an
International Standard.¶
Recipients of this draft are invited to submit, with their
comments, notification of any relevant patent rights of
which they are aware and to provide supporting
documentation.¶
¶
¶
¶
Deleted: ISO/IEC DTS 17035
© ISO/IEC 2024
Deleted: 2023
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 Deleted: www.iso.org
Published in Switzerland
Deleted: ii © ISO 2024 – All rights reserved
ISO/IEC DTS 17035:2024(en)
Deleted:
Contents
Foreword . iv
Deleted: Foreword iv¶
Introduction v¶
Introduction . v
1 Scope 1¶
2 Normative references 1¶
1 Scope . 1
3 Terms and definitions 1¶
4 Validation/Verification programmes 4¶
2 Normative references . 1
4.1 General 4¶
3 Terms and definitions . 1
4.2 Programme content 5¶
4.2.1 Scope of validation/verification 5¶
4 Validation/Verification programmes. 4
4.2.2 Competence, impartiality and operation of
4.1 General . 4
validation/verification bodies 5¶
4.2 Programme content . 5
4.2.3 Steps for the validation/verification
process 5¶
4.2.1 Scope of validation/verification . 5
4.2.4 Evidence gathering activities 6¶
4.2.2 Competence, impartiality and operation of validation/verification bodies . 5
4.2.5 Reporting 6¶
4.2.3 Steps for the validation/verification process . 6
4.3 Programme development 7¶
4.2.4 Evidence gathering activities . 7
4.4 Programme maintenance, review and
4.2.5 Reporting . 7
improvement 7¶
5 Programme owner 8¶
4.3 Programme development . 7
Annex A Clarification of logo/symbol/mark
4.4 Programme maintenance, review and improvement . 8
(informative) 9¶
5 Programme owner . 9 A.1 general 9¶
A.2 Rules for issuing and using marks (see
Annex A (informative) Clarification of logo/symbol/mark . 10
ISO/IEC 17029:2019, 10.3.1) 9¶
Annex B Recognition of validation/verification
A.1 General . 10
programmes (schemes) (informative) 11¶
B.1 General 11¶
A.2 Rules for issuing and using marks . 10
B.2 Validation/verification programmes 11¶
Annex B (informative) Recognition of validation/verification programmes . 12 B.3 Responsibilities for programme owners 12¶
Annex C Questions that can be used by
B.1 General . 12
organizations to recognize validation/verification
programme 13¶
B.2 Validation/verification programmes . 12
Bibliography 16¶
...
B.3 Responsibilities for programme owners . 13
Annex C (informative) Questions to help recognize a validation/verification programme . 15
Bibliography . 19
Deleted:
Deleted:
Deleted:
© ISO/IEC 2024 – All rights reserved
iii
Deleted: ISO/IEC DTS 17035
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Deleted: is a
Commission) form the specialized system for worldwide standardization. National bodies that are
Deleted: federation of national standards
members of ISO or IEC participate in the development of International Standards through technical
Deleted: (
committees established by the respective organization to deal with particular fields of technical activity.
Deleted: member bodies). The work
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 Deleted: preparing
work.
Deleted: is normally carried out
Deleted: ISO
The procedures used to develop this document and those intended for its further maintenance are
Deleted: . Each member body interested in a subject for
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
which a technical committee has been
different types of document should be noted. This document was drafted in accordance with the editorial
Deleted: has the right to be represented on that
rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives or
committee. International
www.iec.ch/members_experts/refdocs).
Deleted: ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
electrotechnical standardization.
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any
Deleted: ISO documents
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,
Deleted: 2 (see www.iso.org/directives
implementers are cautioned that this may not represent the latest information, which may be obtained
Deleted: draws
from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall
Deleted: takes
not be held responsible for identifying any or all such patent rights.
Deleted: . ISO
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 Deleted: ), see www.iso.org/iso/foreword.html
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).
Deleted: ISO/
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- Deleted: www.iso.org/members.html
committees.
Deleted: iv © ISO 2024 – All rights reserved
ISO/IEC DTS 17035:2024(en)
Deleted:
Introduction
Deleted: 0.1
This document is aligned with ISO/IEC 17029 which provides principles and requirements for bodies
Deleted: provides guidance on the development and
operation of validation/verification programmes
providing validation/verification services. ISO/IEC 17029 is a generic standard that can apply to
(schemes) that are intended to be used by
validation/verification bodies in any economic sector or industry. It is distinct from other standards for
validation/verification bodies fulfilling the requirements
conformity assessment bodies in that it requires the object of conformity to be a claim, and for this to be
of…
validated and/or verified in accordance with a validation or verification programme.
Deleted: Conformity Assessment – General principles and
Validation/verification bodies operating in accordance with ISO/IEC 17029 can provide services as first-
requirements for validation/verification bodies.¶
, second- or third-party activities.
¶
0.2 ISO/IEC 17029 is an international standard that
This document is also aligned with sector-specific applications of ISO/IEC 17029, such as ISO 14065
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which references the requirements of ISO/IEC 17029 and includes specific requirements related to
bodies that validate or verify environmental information. Deleted: ‘claim’
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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
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been defined, collected and recorded; how quantification and calculation methods that support the claim
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have been undertaken; and provision of a professional judgement on matters that are material or
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significant to the claim.
0.3
The resulting validation or verification statement will normally be a one-off attestation based on the
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information available at that point in time. Validation or verification statements normally do not have a
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period of validity associated with them. Each subsequent validation/verification is a new separate
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conformity assessment and is not considered to be a surveillance activity that supports an original or .
previous validation/verification statement.
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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
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of a claim that is made about the future based on projected data (validation), or the truthfulness of the
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claim based on historical data (verification). The results from a validation and verification programme
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can sometimes be combined to support a claim (e.g. a mixed engagement or in the management of similar
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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
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opinion on the plausibility or truthfulness of the claim being made.
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NOTE This is often referred to undertaking validation or verification activities on the basis of Agreed Upon
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Procedures (AUP).
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Within ISO/IEC 17029, there is a requirement for validation/verification bodies to operate within the
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context of at least one validation or verification programme. Within ISO/IEC 17029 requirements, there
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are many references to validation/verification programmes, and it is expected that
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validation/verification programmes give direction to the validation/verification body. The importance of
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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. Deleted: This is highlighted in the Introduction clause of
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ISO/IEC 17029:2019, Annex A also provides a comprehensive informative list of elements to be
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considered in the development and operation of validation/verification programmes. The content of
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ISO/IEC 17029:2019, Annex A has been included and amplified in this document.
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To assist in the development, operation and recognition of validation/verification programmes suitable
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for use with ISO/IEC 17029, this document covers the following:
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a) an overview of validation/verification programmes in the context of ISO/IEC 17029;
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b) development of validation/verification programmes;
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c) recognition of validation/verification programmes.
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© ISO/IEC 2024 – All rights reserved
v
ISO/IEC DTS 17035:2024(en)
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Conformity assessment — Guidelines for validation and
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verification programmes
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1 Scope
This document provides guidance to validation/verification p
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