ISO17025：2017新版中出現的9個定義，最後2個需要特別注意！

3.1 impartiality

公正性

presence of objectivity

客觀性的存在。

Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory (3.6).

注1：客觀性意味著不存在或已解決利益衝突，不會對實驗室（3.6）的活動產生不利影響。

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”.

注2：其他可用於表示公正性的要素的術語有：獨立、無利益衝突、沒有成見、沒有偏見、中立、公平、思想開明、不偏不倚、不受他人影響、平衡。

[SOURCE: ISO/IEC 170211:2015, 3.2, modified — The words “the certification body” have been replaced by “the laboratory” in Note 1 to entry.]

[源自: ISO/IEC 17021-1:2015, 3.2，修改—在注1中以“實驗室”代替“認證機構”]

3.2 Complaint

投訴

expression of dissatisfaction by any person or organization to a laboratory (3.6), relating to the activities or results of that laboratory, where a response is expected

任何人員或組織向實驗室（3.6）就其活動或結果表達不滿意，並期望得到回複的行為。

[SOURCE: ISO/IEC 17000:2004, 6.5, modified — The words “other than appeal” have been deleted, and the words “a conformity assessment body or accreditation body, relating to the activities of that body” have been replaced by “a laboratory, relating to the activities or results of that laboratory”.]

[源自: ISO 17000:2004, 6.5 修改—刪除了“除申訴外”，以“實驗室就其活動或結果”代替“合格評定機構或認可機構就其活動”]

3.3 interlaboratory comparison

實驗室間比對

organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions

按照預先規定的條件，由兩個或多個實驗室對相同或類似的物品進行測量或檢測的組織、實施和評價。

[SOURCE: ISO/IEC 17043:2010, 3.4]

[源自: ISO/IEC 17043:2010, 3.4]

3.4 intralaboratory comparison

實驗室內比對

organization, performance and evaluation of measurements or tests on the same or similar items, within the same laboratory (3.6), in accordance with predetermined conditions

按照預先規定的條件，在同一實驗室（3.6）內部對相同或類似的物品進行測量或檢測的組織、實施和評價。

3.5 proficiency testing

能力驗證

evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons (3.3)

利用實驗室間比對，按照預先製定的準則評價參加者的能力。

[SOURCE: ISO/IEC 17043:2010, 3.7, modified — Notes to entry have been deleted.]

[源自: ISO/IEC 17043:2010, 3.7—修改:刪除了注]

3.6 Laboratory

實驗室

body that performs one or more of the following activities:

— testing

— calibration

— sampling, associated with subsequent testing or calibration

從事下列一個或多個活動的機構

——檢測

——校準

——與後續檢測或校準相關的抽樣

Note 1 to entry: In the context of this document, “laboratory activities” refer to the three above-mentioned activities.

注1：在本標準中，“實驗室活動”指上述三種活動。

3.7 decision rule

判定規則

rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement

當聲明與規定要求的符合性時，描述如何考慮測量不確定度的規則。

3.8 Verification

驗證

provision of objective evidence that a given item fulfils specified requirements

提供客觀證據證明給定項目滿足規定要求。

EXAMPLE 1 Confirmation that a given reference material as claimed is homogeneous for the quantity value and measurement procedure concerned, down to a measurement portion having a mass of 10 mg.

例1：證實在測量取樣量小至10mg時，對於相關量值和測量程序而言，給定標準物質的均勻性與其聲稱的一致。

EXAMPLE 2 Confirmation that performance properties or legal requirements of a measuring system are achieved.

例2：證實已達到測量係統的性能或法定要求。

EXAMPLE 3 Confirmation that a target measurement uncertainty can be met.

例3：證實滿足目標測量不確定度。

Note 1 to entry: When applicable, measurement uncertainty should be taken into consideration.

注1：適用時，應當考慮測量不確定度。

Note 2 to entry: The item may be, for example, a process, measurement procedure, material, compound, or measuring system.

注2：項目可以是，例如一個過程、測量程序、物質、化合物或測量係統。

Note 3 to entry: The specified requirements may be, for example, that a manufacturer’s specifications are met.

注3：規定要求可以是如滿足生產商的規定。

Note 4 to entry: Verification in legal metrology, as defined in VIML, and in conformity assessment in general, pertains to the examination and marking and/or issuing of a verification certificate for a measuring system.

注4：法製計量中的驗證，如在VIML和通常的合格評定中的定義，是指對測量係統的檢查並加標記和/或出具驗證證書。（在我國的法製計量領域，“verification”翻譯為“檢定”）

Note 5 to entry: Verification should not be confused with calibration. Not every verification is a validation (3.9).

注5：驗證不應當與校準混淆。不是每個驗證都是確認。

Note 6 to entry: In chemistry, verification of the identity of the entity involved, or of activity, requires a description of the structure or properties of that entity or activity.

注6：在化學中，驗證活性或所含實體的特性時，需要描述該實體或活性的結構或特性。

[SOURCE: ISO/IEC Guide 99:2007, 2.44]

[源自: ISO/IEC 指南99:2007，2.44]

3.9 Validation

確認

verification (3.8), where the specified requirements are adequate for an intended use

對規定要求滿足預期用途的驗證（3.8）。

EXAMPLE A measurement procedure, ordinarily used for the measurement of mass concentration of nitrogen in water, may be validated also for measurement of mass concentration of nitrogen in human serum.

示例：一個通常用於測量水中氮的質量濃度的測量程序，也可被確認為可用於測量人體血清中氮的質量濃度。

[SOURCE: ISO/IEC Guide 99:2007, 2.45]

[源自: ISO/IEC 指南99:2007，2.45]