BS EN ISO/IEC 17029:2019 - Conformity Assessment. General principles and requirements for validation and verification bodies

BS EN ISO/IEC 17029:2019

Conformity Assessment. General principles and requirements for validation and verification bodies

Status : Current   Published : November 2019



This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.

Bodies operating according to this document can provide validation/verification as a first-party, second-party or third-party activity. Bodies can be validation bodies only, verification bodies only, or provide both activities.

This document is applicable to validation/verification bodies in any sector, providing confirmation that claims are either plausible with regards to the intended future use (validation) or truthfully stated (verification). However, results of other conformity assessment activities (e.g. testing, inspection and certification) are not considered to be subject to validation/verification according to this document. Neither are situations where validation/verification activities are performed as steps within another conformity assessment process.

This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation/verification processes and procedures.

This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or other forms of recognition of validation/verification bodies by international or regional organizations, governments, regulatory authorities, programme owners, industry bodies, companies, clients or consumers.


This document contains generic requirements and is neutral with regard to the validation/verification programme in operation. Requirements of the applicable programmes are additional to the requirements of this document.

Standard NumberBS EN ISO/IEC 17029:2019
TitleConformity Assessment. General principles and requirements for validation and verification bodies
Publication Date27 November 2019
Normative References(Required to achieve compliance to this standard)ISO/IEC 17000
Informative References(Provided for Information)ISO 50047, ISO 15189, ISO 14064-3, ISO 15489-1, ISO/IEC 17050, ISO/IEC 17020, ISO 17742, ISO 17743, ISO/IEC 17025, ISO 14020, ISO 14016, ISO 14040, ISO 50046, ISO 19011, ISO/IEC 17007, ISO 14065, ISO 31000, ISO 17741, ISO 50015, ISO 9001, ISO/IEC 17021-1:2015, ISO/IEC 17065:2012, ISO 9000:2015
International RelationshipsEN ISO/IEC 17029:2019,ISO/IEC 17029:2019
Draft Superseded By18/30362895 DC
DescriptorsDesign principles, Risk assessment, Conformity, Certification (approval), Certification systems
Title in FrenchÉvaluation de la conformité. Principes généraux et exigences pour les organismes de validation et de vérification
Title in GermanKonformitätsbewertung. Allgemeine Grundsätze und Anforderungen an Stellen, die Validierungs- und Verifizierungstätigkeiten durchführen
ISBN978 0 580 99079 3
File Size2.151 MB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Access, view and download standards with multiple user access, across multiple sites with BSOL

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version

Worldwide Standards
We can source any standard from anywhere in the world