ISO/IEC 17029:2019 適合性評価 — 妥当性確認および妥当性確認機関の一般原則と要件 | ページ 6

3.1

claim

information declared by the client (3.13)

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.

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: Figure C.1 illustrates the application of validation.

[SOURCE:ISO 9000:2015, 3.8.13, modified — The words “of a claim” and “future” have been added to the definition and the Notes to entry have been modified.]

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: Figure C.2 illustrates the application of verification.

[SOURCE:ISO 9000:2015, 3.8.12, modified — The words “of a claim” have been added to the definition and the Notes to entry have been modified.]

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.

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.

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.

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.

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 this document can serve as a programme.

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 this document can serve as a programme.

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 17065:2012, 3.11, modified — The term “scheme owner” has been replaced with “programme owner” and the words “certification scheme” have been replaced with “validation programme or verification programme” in the definition.]

3.11

scope of validation/verification

3.12

impartiality

presence of objectivity

Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence activities of the validation body (3.4) / verification body (3.5) .

Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “independence”, “freedom from conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-handedness”, “detachment”, “balance”.

[SOURCE:ISO/IEC 17021-1:2015, 3.2, modified — The words “subsequent activities of the certification body” have been replaced with “activities of the validation body/verification body” in Note 1 to entry.]

3.13

client

organization or person requesting validation (3.2) / verification (3.3)

3.14

consultancy

participation in establishing the claim (3.1) that will be the object of validation (3.2) / verification (3.3)

Note 1 to entry: The term “consultancy” is used in relation to activities of validation bodies (3.4) / verification bodies (3.5) , their personnel and organizations related or linked to the validation bodies/verification bodies.

Note 2 to entry: Participation in establishing the claim also includes involvement in design of the object leading to the claim or providing object specific expertise that supports the preparation of the claim.

Note 3 to entry: Arranging training and participating as a trainer is not considered as consultancy, provided that ここで, the course relates to the claim that will be the object of validation/verification, it is confined to the provision of generic information; i.e. the trainers should not provide client (3.13) specific solutions.

3.15

level of assurance

degree of confidence in the claim (3.1)

Note 1 to entry: The levels of assurance and the conditions to achieve them can be defined in the programme (e.g. absolute, reasonable, limited).

3.16

material

significant to intended users

Note 1 to entry: Materiality is the concept that misstatements, individually or aggregated, can influence the reliability of the claim (3.1) or decisions made by the intended user.

Note 2 to entry: Materiality can be qualitative or quantitative.