ISO/IEC TS 17035:2024 適合性評価 — 検証および検証プログラムのガイドライン | ページ 6

3.1

claim

information declared by the client

Note 1 to entry: The claim is the object of conformity assessment by validation (3.2) / verification (3.3) .

Note 2 to entry: The claim can represent a situation at a point in time or could cover a period of time.

Note 3 to entry: The claim should be clearly identifiable and capable of consistent evaluation or measurement against specified requirements by a validation body (3.4) / verification body (3.5) .

Note 4 to entry: The claim can be provided in the form of a report, a statement, a declaration, a project plan, or consolidated data.

[SOURCE:ISO/IEC 17029:2019, 3.1]

3.2

validation

confirmation of a claim (3.1) , through the provision of objective evidence, that the requirements for a specific intended future use or application have been fulfilled

Note 1 to entry: Objective evidence can come from real or simulated sources.

Note 2 to entry: Validation is considered to be a process to evaluate the reasonableness of the assumptions, limitations, and methods that support a claim about the outcome of future activities.

Note 3 to entry: Validation is applied to claims regarding an intended future use based on projected information (confirmation of plausibility).

Note 4 to entry: In this document, the expression “validation/verification” means either validation or verification (3.3) , or both.

[SOURCE:ISO/IEC 17029:2019, 3.2, modified – The original Note 4 to entry has been deleted and a new Note 4 to entry has been added.]

3.3

verification

confirmation of a claim (3.1) , through the provision of objective evidence, that specified requirements have been fulfilled

Note 1 to entry: Verification is considered to be a process for evaluating a claim based on historical data and information to determine whether the claim is materially correct and conforms with specified requirements.

Note 2 to entry: Verification is applied to claims regarding events that have already occurred or results that have already been obtained (confirmation of truthfulness).

Note 3 to entry: In this document, the expression “validation/verification” means either validation (3.2) or verification, or both.

[SOURCE:ISO/IEC 17029:2019, 3.3, modified – The original Note 3 to entry has been deleted and a new Note 3 to entry has been added.]

3.4

validation body

body that performs validation (3.2)

Note 1 to entry: A validation body can be an organization, or part of an organization.

Note 2 to entry: In this document, the expression “validation/verification body” means either validation body or verification body (3.5) , or both.

[SOURCE:ISO/IEC 17029:2019, 3.4, modified – Note 2 to entry has been added.]

3.5

verification body

body that performs verification (3.3)

Note 1 to entry: A verification body can be an organization, or part of an organization.

Note 2 to entry: In this document, the expression “validation/verification body” means either validation body (3.4) or verification body, or both.

[SOURCE:ISO/IEC 17029:2019, 3.5, modified – Note 2 to entry has been added.]

3.6

validation statement

declaration by the validation body (3.4) of the outcome of the validation (3.2) process

Note 1 to entry: Validation statements can be referred to using specific programme terminology, such as “decisions”, “opinions” or “reports”.

Note 2 to entry: The validation statement reflects only the situation at the point in time it is issued.

Note 3 to entry: The validation statement can be confirming or not confirming the claim (3.1) , with or without comments, according to the programme requirements.

Note 4 to entry: In this document, the expression “validation/verification statement” means either validation statement or verification statement (3.7) , or both.

[SOURCE:ISO/IEC 17029:2019, 3.6, modified – Note 4 to entry has been added.]

3.7

verification statement

declaration by the verification body (3.5) of the outcome of the verification (3.3) process

Note 1 to entry: Verification statements can be referred to using specific programme terminology, such as “decisions”, “opinions” or “reports”.

Note 2 to entry: The verification statement reflects only the situation at the point in time it is issued.

Note 3 to entry: The verification statement can be confirming or not confirming the claim (3.1) , with or without comments, according to the programme requirements.

Note 4 to entry: In this document, the expression “validation/verification statement” means either validation statement (3.6) or verification statement, or both.

[SOURCE:ISO/IEC 17029:2019, 3.7, modified – Note 4 to entry has been added.]

3.8

validation programme

rules, procedures and management for carrying out validation (3.2) activities in a specific sector

Note 1 to entry: Validation programmes can be operated at international, regional, national, sub-national or sector-specific level.

Note 2 to entry: A programme can also be called a “scheme”.

Note 3 to entry: A set of standards able to cover all the requirements of ISO/IEC 17029 can serve as a programme.

Note 4 to entry: In this document, the expression “validation/verification programme” means either validation programme or verification programme (3.9) , or both.

[SOURCE:ISO/IEC 17029:2019, 3.8, modified – Note 4 to entry has been added.]

3.9

verification programme

rules, procedures and management for carrying out verification (3.3) activities in a specific sector

Note 1 to entry: Verification programmes can be operated at international, regional, national, sub-national or sector-specific level.

Note 2 to entry: A programme can also be called a “scheme”.

Note 3 to entry: A set of standards able to cover all the requirements of ISO/IEC 17029 can serve as a programme.

Note 4 to entry: In this document, the expression “validation/verification programme” means either validation programme (3.8) or verification programme, or both.

[SOURCE:ISO/IEC 17029:2019, 3.9, modified – Note 4 to entry has been added.]

3.10

programme owner

person or organization responsible for developing and maintaining a specific validation programme (3.8) or verification programme (3.9)

Note 1 to entry: The programme owner can be the validation body (3.4) / verification body (3.5) itself, a governmental authority, a trade association, a group of validation bodies/verification bodies, an external programme owner or others.

[SOURCE:ISO/IEC 17029:2019, 3.10]

3.11

normative document

document that provides rules, guidelines or characteristics for activities or their results

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.

Note 3 to entry: The terms for different kinds of normative documents are defined considering the document and its content as a single entity.

[SOURCE:ISO/IEC Guide 2:2004, 3.1]