National foreword

This Published Document is the UK implementation of ISO/IEC TS 17035:2024.

The UK participation in its preparation was entrusted to Technical Committee CAS/1, Conformity assessment.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

This publication is not to be regarded as a British Standard.

Compliance with a Published Document cannot confer immunity from legal obligations.

This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 September 2024.

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.

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:

an overview of validation/verification programmes in the context of ISO/IEC 17029;
development of validation/verification programmes;
recognition of validation/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

3 Terms and definitions

4 Validation/Verification programmes

4.1 General

4.2 Programme content

4.3 Programme development

4.4 Programme maintenance, review and improvement

5 Programme owner

5.1

5.2

Bibliography

PD ISO/IEC TS 17035:2024

Conformity assessment. Guidelines for validation and verification programmes

Current

Published:

30 Sep 2024