This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation\/verification as conformity assessment activities.<\/p>\n
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.<\/p>\n
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.<\/p>\n
This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation\/verification processes and procedures.<\/p>\n
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.<\/p>\n
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.<\/p>\n<\/div>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5 General requirements 5.1 Legal entity 5.2 Responsibility for validation\/verification statements 5.3 Management of impartiality <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.4 Liability 6 Structural requirements 6.1 Organizational structure and top management <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 6.2 Operational control 7 Resource requirements 7.1 General 7.2 Personnel <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 7.3 Management process for the competence of personnel <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 7.4 Outsourcing 8 Validation\/verification programme 9 Process requirements 9.1 General <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 9.2 Pre-engagement <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 9.3 Engagement 9.4 Planning <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 9.5 Validation\/verification execution <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 9.8 Facts discovered after the issue of the validation\/verification statement 9.9 Handling of appeals <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 9.10 Handling of complaints 9.11 Records <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 10 Information requirements 10.1 Publicly available information 10.2 Other information to be available <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 10.3 Reference to validation\/verification and use of marks 10.4 Confidentiality 11 Management system requirements 11.1 General <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 11.2 Management review <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 11.3 Internal audits 11.4 Corrective action 11.5 Actions to address risks and opportunities <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 11.6 Documented information <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Annex A (informative) Elements of validation\/verification programmes <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Annex B (informative) Terms and concepts defined by ISO\/IEC 17029 <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Annex C (informative) Illustration of validation\/verification application <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Conformity Assessment. General principles and requirements for validation and verification bodies<\/b><\/p>\n |