kSIST FprEN ISO/IEC 17007:2025

SLOVENSKI STANDARD
oSIST prEN ISO/IEC 17007:2024
01-december-2024
Ugotavljanje skladnosti - Napotki za pripravo normativnih dokumentov, primernih
za uporabo pri ugotavljanju skladnosti (ISO/IEC DIS 17007:2024)
Conformity assessment - Guidance for drafting normative documents suitable for use for
conformity assessment (ISO/IEC DIS 17007:2024)
Konformitätsbewertung - Leitlinien zur Erarbeitung von geeigneten normativen
Dokumenten für die Konformitätsbewertung (ISO/IEC DIS 17007:2024)
Évaluation de la conformité - Directives pour la rédaction de documents normatifs
appropriés pour l'évaluation de la conformité (ISO/IEC DIS 17007:2024)
Ta slovenski standard je istoveten z: prEN ISO 17007
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
oSIST prEN ISO/IEC 17007:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO/IEC 17007:2024
oSIST prEN ISO/IEC 17007:2024
DRAFT
International
Standard
ISO/IEC DIS 17007
ISO/CASCO
Conformity assessment — Guidance
Secretariat: ISO
for drafting normative documents
Voting begins on:
suitable for use for conformity
2024-10-14
assessment
Voting terminates on:
2025-01-06
Évaluation de la conformité — Directives pour la rédaction
de documents normatifs appropriés pour l'évaluation de la
conformité
ICS: 03.120.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
© ISO/IEC 2024
ISO/IEC DIS 17007:2024(en)
oSIST prEN ISO/IEC 17007:2024
DRAFT
ISO/IEC DIS 17007:2024(en)
International
Standard
ISO/IEC DIS 17007
ISO/CASCO
Conformity assessment — Guidance
Secretariat: ISO
for drafting normative documents
Voting begins on:
suitable for use for conformity
assessment
Voting terminates on:
Évaluation de la conformité — Directives pour la rédaction
de documents normatifs appropriés pour l'évaluation de la
conformité
ICS: 03.120.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
This document is circulated as received from the committee secretariat.
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO/IEC 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
© ISO/IEC 2024
ISO/IEC DIS 17007:2024(en)
© ISO/IEC 2024 – All rights reserved
ii
oSIST prEN ISO/IEC 17007:2024
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 3
4.1 General .3
4.2 Principle 1: separation of types of provisions .4
4.3 Principle 2: neutrality towards parties performing conformity assessment activities .5
4.4 Principle 3: functional approach to conformity assessment .5
4.5 Principle 4: comparability of conformity assessment results.6
4.6 Principle 5: good practice in conformity assessment .6
5 Guidance for the development of normative documents stating specified requirements
for objects of conformity assessment . 7
6 Guidance for the development of normative documents stating specific methods and
procedures for individual conformity assessment activity . 8
7 Guidance for the development of normative documents stating rules and methodology
for conformity assessment . 9
Annex A (informative) The CASCO toolbox .11
Annex B (informative) Approach to identify specified requirements, methods and procedures,
rules and methodology for conformity assessment . 14
Bibliography . 17

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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing Documents is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation 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 and
www.iec.ch/national-committees.

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Introduction
This document provides principles and guidance on how to develop normative documents, such as standards,
technical specifications, codes of practice and regulations, so that they are concise and clear, especially in
the context of any subsequent conformity assessment activity.
Conformity assessment is a demonstration that specified requirements are fulfilled and includes activities
such as but not limited to assessment, auditing, design review, evaluation, examination, inspection, testing,
surveillance, validation, verification, and certification. The methods and procedures for performing specific
individual conformity assessment activities can be combined under rules and methodology through which
approvals, certificates, consents, licenses, labels, markings, marks of conformity, permissions, reports and
various forms of statements are issued.
This document is intended for the following users:
— standards developers;
— industry associations and consortia;
— purchasers;
— regulatory authorities;
— consumers and non-government groups;
— accreditation bodies;
— conformity assessment bodies;
— conformity assessment scheme owners; and
— other interested parties, e.g. insurance organizations.
This document is intended to assist the above users in developing normative documents suitable for use
in conformity assessment at national, regional or international levels, both in regulated or non-regulated
applications.
Users of this document may also find useful information in the ISO/IEC Directives, ISO/IEC 17060 Conformity
assessment Code of good practice, ISO/IEC 17067 Conformity assessment — Fundamentals of product
certification and guidelines for product certification schemes and the WTO Agreement on Technical Barriers
to Trade, Annex 3, Code of Good Practice for the Preparation, Adoption and Application of Standards.
ISO/IEC Directives, Part 2, also covers aspects for conformity assessment, mandatory for standards
developers in ISO, IEC and ISO/IEC committees.
This document also includes reference to documents in the domain of conformity assessment, known as the
CASCO toolbox. These are principally the work of CASCO in cooperation with IEC. Reference to these generic
publications is included to emphasise that they contain internationally agreed, globally applied provisions
covering conformity assessment. Reliance on these publications as requirements for conformity assessment
facilitates acceptance of results around the world.
To make this document as usable as possible, technical terminology has been avoided as much as possible.
However, in some cases, the use of some technical terminology was necessary. For example, the requirements
in normative documents can relate to many different areas, e.g. a particular material, product, service,
installation, data, information, process, system, person or body. In a conformity assessment context, these
are all examples of an “object of conformity assessment”.
In the field of conformity assessment “object of conformity assessment” or “object” (see 3.3) is a generic
term used to represent anything that can fulfil specified requirements. In a normative document suitable
for use in conformity assessment, the term “object of conformity assessment” or “object” would not be used.
A normative document should include a scope which either explicitly or implicitly defines the related object
of conformity assessment, for example, a type of product, process, service, installation, design, land used

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for a specific purpose, management system, conformity assessment body, etc. In this document, the term
“object of conformity assessment” or “object” is used so that this document can be applied to any individual
normative document regardless of the scope of the normative document.

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oSIST prEN ISO/IEC 17007:2024
DRAFT International Standard ISO/IEC DIS 17007:2024(en)
Conformity assessment — Guidance for drafting normative
documents suitable for use for conformity assessment
1 Scope
This document provides principles and guidance for developing normative documents that contain:
— specified requirements for the object of conformity assessment;
— specific methods and procedures for individual conformity assessment activity (e.g. test methods);
— rules and methodology for conformity assessment (as part of conformity assessment schemes, including
provisions for organizations that undertake conformity assessment).
This document is intended for use by standards developers, industry associations and consortia, purchasers,
regulatory authorities, consumers and non-government groups, accreditation bodies, conformity
assessment bodies, conformity assessment scheme owners, and other interested parties, such as insurance
organizations.
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 17000:2020, 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
specified requirements
need or expectation that is stated
Note 1 to entry: Specified requirements can be stated in normative documents (3.2).
Note 2 to entry: Specified requirements can be detailed or general.
[SOURCE: ISO/IEC 17000:2020, 5.1.]
3.2
normative document

documents that provide:
a) specified requirements for the object of conformity assessment;
b) specific methods and procedures for individual conformity assessment activity (e.g. test methods); or

© ISO/IEC 2024 – All rights reserved
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c) rules and methodology for conformity assessment (as part of conformity assessment schemes, including
provisions for organizations that undertake conformity assessment).
Note 1 to entry: The term “normative document” is a generic term that covers such documents as standards, technical
specifications, codes of practice and regulations.
Note 2 to entry: A “document” is to be understood as any medium with information recorded on or in it.
[SOURCE: ISO/IEC Guide 2:2004, 3.1, modified with Note 3 deleted]
3.3
object of conformity assessment
object
entity to which specified requirements (3.1) apply
EXAMPLE Product, process, service, system, installation, project, data, design, material, claim, person, body or
organization, or any combination thereof.
Note 1 to entry: The term “body” is used in this document to refer to conformity assessment bodies and accreditation
bodies. The term “organization” is used in its general meaning and may include bodies according to the context. The
more specific ISO/IEC Guide 2 definition of an organization as a body based on membership is not applicable to the
field of conformity assessment.
[SOURCE: ISO/IEC 17000:2020, 4.2]
3.4
conformity assessment
demonstration that specified requirements are fulfilled
Note 1 to entry: The process of conformity assessment as described in the functional approach in ISO/IEC 17000:2020
Annex A can have a negative outcome, i.e. demonstrating that the specified requirements are not fulfilled.
Note 2 to entry: Conformity assessment is explained in ISO/IEC 17000:2020 Annex A as a series of functions.
Note 3 to entry: This document does not include a definition of “conformity”. “Conformity” does not feature in the
definition of “conformity assessment”. Nor does this document address the concept of compliance
[SOURCE: ISO/IEC 17000:2020, 4.1 modified NOTE 2 deleted]
3.5
conformity assessment activity
any activity contributing to any of the functions in the functional approach described in
ISO/IEC 17000:2020 Annex A
Note 1 to entry: Conformity assessment activities include but are not limited to testing, auditing, examination,
evaluation, inspection, validation, verification, certification, and accreditation.
3.6
conformity assessment body
body that performs conformity assessment activities, excluding accreditation
[SOURCE: ISO/IEC 17000:2020, 4.6]
3.7
accreditation
third-party attestation related to a conformity assessment body, conveying formal demonstration of its
competence, impartiality and consistent operation in performing specific conformity assessment activities
[SOURCE: ISO/IEC 17000:2020, 7.7]

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3.8
accreditation body
authoritative body that performs accreditation
Note 1 to entry: The authority of an accreditation body can be derived from government, public authorities, contracts,
market acceptance or scheme owners
[SOURCE: ISO/IEC 17000:2020, 4.7]
3.9
conformity assessment scheme
conformity assessment programme
set of rules and procedures that describes the objects of conformity assessment, identifies the specified
requirements and provides the methodology for performing conformity assessment
Note 1 to entry: A conformity assessment scheme can be managed within a conformity assessment system.
Note 2 to entry: A conformity assessment scheme can be operated at an international, regional, national sub-national,
or industry sector level.
Note 3 to entry: A scheme can cover all or part of the conformity assessment functions explained in Annex A.
[SOURCE: ISO/IEC 17000:2020, 4.9]
3.10
methodology
systematic collection of methods
Note 1 to entry: In conformity assessment, a systematic approach, or collection of methods, for performing activities
in the functions described in ISO/IEC 17000 Annex A (the Functional Approach) is one part of a conformity assessment
scheme (3.9). Individual demonstrations performed in accordance with the same conformity assessment scheme will
follow the same methodology.
Note 2 to entry: A method or procedure for a specific individual activity within the Functional Approach (e.g. a
sampling protocol, test method, calibration method, inspection procedure, a general plan for an audit of a management
system, a general plan for validation or verification of a type of claim, the formatting of a statement of conformity, etc.)
can be included or referenced in the methodology provided in a conformity assessment scheme. However, a method
or procedure for a specific individual activity is not by itself a methodology for demonstrating fulfilment of specified
requirements as represented by the Functional Approach.
4 Principles
4.1 General
4.1.1 The principles listed below are the basis for the subsequent guidance in this document. This
document does not provide specific guidance for all situations that can occur. Nevertheless, following the
below principles, users of this document can receive guidance for any situations:
— principle 1: separation types of provisions (see 4.2);
— principle 2: neutrality towards parties performing conformity assessment activities (see 4.3);
— principle 3: functional approach to conformity assessment (see 4.4);
— principle 4: comparability of conformity assessment results (see 4.5);
— principle 5: good practice in conformity assessment (see 4.6).
4.1.2 Types of provisions in normative documents can be:
a) specified requirements for the object of conformity assessment;

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ISO/IEC DIS 17007:2024(en)
b) specific methods and procedures for individual conformity assessment activities (e.g. test methods);
c) rules and methodology for conformity assessment (as part of conformity assessment schemes, including
provisions for organizations that undertake conformity assessment).
4.2 Principle 1: separation of types of provisions
4.2.1 Normative documents stating specified requirements for objects of conformity assessment should
not contain the methodology (3.10) for demonstrating fulfilment of the specified requirements.
4.2.2 Normative documents stating specified requirements for objects of conformity assessment can
include methods and procedures for individual conformity assessment activities e.g. for sampling and
testing when necessary to provide repeatable and reproducible results. In such a situation, the methods
and procedures should be separated from those requirements (e.g. in separate sections). (See 3.10 for the
difference between a method for an individual activity and a methodology.)
4.2.3 Per the definition of conformity assessment scheme, a scheme “provides” a methodology, but a
scheme only “identifies” (as opposed to “includes”) the specified requirements for an object of conformity
assessment. As suggested by this definition, the methodology for a demonstration should be stated in a
document separate from the document with the specified requirements. This separation is important since
different users of the specified requirements for an object of conformity assessment can adopt different
methodologies for demonstrating fulfilment of those specified requirements. A normative document setting
specified requirements for objects of conformity assessment should not restrict choices for the methodology
for demonstrations of fulfilment.
4.2.4 In addition, the normative document setting specified requirements for objects of conformity
assessment will apply to the provider of the object of conformity assessment. The methodology will apply
to those bodies performing a demonstration of these specified requirements being fulfilled. With the
methodology in a separate document, clear contracts, agreements, and regulations etc. can invoke the
applicable document to the pertinent party and thus effectively mandate fulfilment of specified requirements
by providers and adherence to the methodology by bodies.
4.2.5 Examples of methodology that should not be in the same document as the specified requirements
for the object of conformity assessment and the methods and procedures for specific individual activities
include:
a) whether one or more activities will be performed as first, second or third-party activities (see the
neutrality principle in ISO/IEC Directives Part 2 Clause 33.1);
b) the location for the selection of samples of the object of conformity assessment;
c) the type of certificate, mark, letter, report, listing on websites to be issued during attestation to indicate
a demonstration of fulfilment has been completed; and
d) the type of ongoing surveillance activities (if any) to be performed to assure the statement of conformity
remains valid.
4.2.6 The benefits for maintaining a separation between the sets of provisions include:
a) more rigorous consideration in specifying each set of provisions within their proper and individual
contexts;
b) easier reference to the separate sets of provisions for authorities such as regulators;
c) greater use of the normative document by parties that are not intending to use all the sets of provisions,
for example using only the set of provisions for the object of conformity assessment, without intending
to use the set of provisions related to rules and methodology for conformity assessment;

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d) greater use of the provisions where assessment methods and procedures can be used for several
specified objects, or one object can be subjected to multiple methods and procedures; and
e) greater flexibility in the application and choice for the rules and methodology for conformity assessment
such as specifying the use of self-declared conformity (declaration, first-party activity)or certification
(third-party activity), with or without further specifications such as the need for a conformity
assessment body to be accredited or belong to a peer assessment group.
4.2.7 As background to Principle 1, ISO/IEC normative documents, including standards, are voluntary.
Users of standards can require their use in a wide variety of situations (e.g. through regulations or contracts).
To enable the greatest flexibility in the identification and use of standards it is important to separate
different types of requirements which users can then select to suit their needs. If the standard was written
to encompass the requirements for the object of conformity assessment and also mixes in the requirements
for subsequent conformity assessment activities this then predetermines how the standard can be applied,
and it might not be relevant or practical for the standard users’ needs. In this case the standard will not be
used. Specified requirements for the object of conformity assessment should be separated from the rules
and methodology for conformity assessment. The user has the flexibility to specify the combination of
standards to best fulfil their needs. To be clear, this does not prohibit standards developers from developing
requirements for the object of conformity assessment on the one hand, and the rules and methodology for
conformity assessment on the other, as long as they are separated and can be specified independently of
one another (e.g., in a separate document, part of the standard such as IEC 60947-1,-2 or ISO 14064-1, -2, -3.,
informative annex, etc.).
4.3 Principle 2: neutrality towards parties performing conformity assessment activities
Normative documents that contain specified requirements for objects of conformity assessment should be
written so that demonstrating conformity of the objects to the specified requirements can be either a first,
second or third-party activity:
— activity that is performed by a person or organization that provides or is of the object of conformity
assessment (first-party activity);
— activity that is performed by a person or organization with a user interest of the object of conformity
assessment such as a user or purchaser (second-party activity);
— activity that is performed by a person or organization that is independent of the provider of the object of
conformity assessment and has no user interest in the object (third-party activity);
NOTE 1 Examples of users of documents that contain specified requirements for objects of conformity assessment
who choose first, second, and third-party demonstration activities include:
— a facility operator providing a supplier’s declaration of conformity (SDoC; first party activity) for not exceeding
levels of hazardous materials in waste;
— purchasing organizations performing audits of suppliers’ fulfilment of quality management system standards
(second-party activity);
— regulatory authority requiring product certification (third-party activity) based on regulatory requirements
applicable to the product before it enters the market.
4.4 Principle 3: functional approach to conformity assessment
4.4.1 Rules and methodology for conformity assessment should be based on the “functional approach to
conformity assessment”, consisting of the following functions:
a) selection planning and preparation activities (especially sampling , if used) to collect or produce all the
information and input needed for the subsequent determination function activities;
b) determination activities to develop complete information regarding fulfilment of the specified
requirements by the object of conformity assessment or its sample;

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c) review, decision, attestation:
i. review: consideration of the suitability, adequacy and effectiveness of selection and determination
activities, and the results of those activities, with regard to fulfilment of specified requirements by
an object of conformity assessment;
ii. decision: conclusion, based on the results of review that fulfilment of specified requirements has or
has not been demonstrated;
iii. attestation: issue of a statement (statement of conformity), based on a decision that fulfilment of
specified requirements has been demonstrated.
NOTE a statement made in the determination function that the samples or items subjected to determination
activities meet specified requirements is different from the statement of conformity in the review, decision,
attestation function since the latter is a statement that more broadly indicates a suitable, adequate and
effective demonstration has been completed.
d) Su
...