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BS EN ISO/IEC 17029:2019

BS EN ISO/IEC 17029:2019

$167.15

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

Published By Publication Date Number of Pages
BSI 2019 42
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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.

NOTE

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.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
15 4 Principles
4.1 General
4.2 Principles for the validation/verification process
4.2.1 Evidence-based approach to decision making
4.2.2 Documentation
4.2.3 Fair presentation
4.3 Principles for validation/verification bodies
4.3.1 Impartiality
16 4.3.2 Competence
4.3.3 Confidentiality
4.3.4 Openness
4.3.5 Responsibility
4.3.6 Responsiveness to complaints
4.3.7 Risk-based approach
17 5 General requirements
5.1 Legal entity
5.2 Responsibility for validation/verification statements
5.3 Management of impartiality
18 5.4 Liability
6 Structural requirements
6.1 Organizational structure and top management
19 6.2 Operational control
7 Resource requirements
7.1 General
7.2 Personnel
20 7.3 Management process for the competence of personnel
21 7.4 Outsourcing
8 Validation/verification programme
9 Process requirements
9.1 General
22 9.2 Pre-engagement
23 9.3 Engagement
9.4 Planning
24 9.5 Validation/verification execution
25 9.6 Review
9.7 Decision and issue of the validation/verification statement
9.7.1 Decision
9.7.2 Issue of the validation/verification statement
26 9.8 Facts discovered after the issue of the validation/verification statement
9.9 Handling of appeals
27 9.10 Handling of complaints
9.11 Records
28 10 Information requirements
10.1 Publicly available information
10.2 Other information to be available
29 10.3 Reference to validation/verification and use of marks
10.4 Confidentiality
11 Management system requirements
11.1 General
30 11.2 Management review
31 11.3 Internal audits
11.4 Corrective action
11.5 Actions to address risks and opportunities
32 11.6 Documented information
34 Annex A (informative) Elements of validation/verification programmes
36 Annex B (informative) Terms and concepts defined by ISO/IEC 17029
38 Annex C (informative) Illustration of validation/verification application
39 Bibliography

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BS EN ISO/IEC 17029:2019
$167.15