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ISO17025:2017新版中出现的9个定义,最后2个需要特别注意

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1、3.1 impartiality

公正性
 
  presence of objectivity
 
  客观性的存在。
 
  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:客观性意味着不存在或已解决利益冲突,不会对实验室(3.6)的活动产生不利影响。
 
  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:其他可用于表示公正性的要素的术语有:独立、无利益冲突、没有成见、没有偏见、中立、公平、思想开明、不偏不倚、不受他人影响、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  [SOURCE: ISO/IEC 170211:2015, 3.2, modified — The words “the certification body” have been replaced by “the laboratory” in Note 1 to entry.]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“实验室”代替“认证机构”]
 
2、3.2 Complaint

投诉
 
  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
 
  任何人员或组织向实验室(3.6)就其活动或结果表达不满意,并期望得到回复的行为。
 
  [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and the words “a conformity assessment body or accreditation body, relating to the activities of that body” have been replaced by “a laboratory, relating to the activities or results of that laboratory”.]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—删除了“除申诉外”,以“实验室就其活动或结果”代替“合格评定机构或认可机构就其活动”]

3、3.3 interlaboratory comparison

实验室间比对
 
  organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions
 
  按照预先规定的条件,由两个或多个实验室对相同或类似的物品进行测量或检测的组织、实施和评价。
 
  [SOURCE: ISO/IEC 17043:2010, 3.4]
 
  [源自: ISO/IEC 17043:2010, 3.4]

4、3.4 intralaboratory comparison

实验室内比对
 
  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
 
  按照预先规定的条件,在同一实验室(3.6)内部对相同或类似的物品进行测量或检测的组织、实施和评价。
 
5、3.5 proficiency testing

能力验证
 
  evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons (3.3)
 
  利用实验室间比对,按照预先制定的准则评价参加者的能力。
 
  [SOURCE: ISO/IEC 17043:2010, 3.7, modified — Notes to entry have been deleted.]
 
  [源自: ISO/IEC 17043:2010, 3.7—修改:删除了注]
 
6、3.6 Laboratory

实验室
 
  body that performs one or more of the following activities:
 
  — testing
 
  — calibration
 
  — sampling, associated with subsequent testing or calibration
 
  从事下列一个或多个活动的机构
 
  ——检测
 
  ——校准
 
  ——与后续检测或校准相关的抽样
 
  Note 1 to entry: In the context of this document, “laboratory activities” refer to the three above-mentioned activities.
 
  注1:在本标准中,“实验室活动”指上述三种活动。
 
7、3.7 decision rule

判定规则
 
  rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement
 
  当声明与规定要求的符合性时,描述如何考虑测量不确定度的规则。
 
8、3.8 Verification

验证
 
  provision of objective evidence that a given item fulfils specified requirements
 
  提供客观证据证明给定项目满足规定要求。
 
  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:证实在测量取样量小至10mg时,对于相关量值和测量程序而言,给定标准物质的均匀性与其声称的一致。
 
  EXAMPLE 2 Confirmation that performance properties or legal requirements of a measuring system are achieved.
 
  例2:证实已达到测量系统的性能或法定要求。
 
  EXAMPLE 3 Confirmation that a target measurement uncertainty can be met.
 
  例3:证实满足目标测量不确定度。
 
  Note 1 to entry: When applicable, measurement uncertainty should be taken into consideration.
 
  注1:适用时,应当考虑测量不确定度。
 
  Note 2 to entry: The item may be, for example, a process, measurement procedure, material, compound, or measuring system.
 
  注2:项目可以是,例如一个过程、测量程序、物质、化合物或测量系统。
 
  ?Note 3 to entry: The specified requirements may be, for example, that a manufacturer’s specifications are met.
 
  注3:规定要求可以是如满足生产商的规定。
 
  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:法制计量中的验证,如在VIML和通常的合格评定中的定义,是指对测量系统的检查并加标记和/或出具验证证书。(在我国的法制计量领域,“verification”翻译为“检定”)
 
  Note 5 to entry: Verification should not be confused with calibration. Not every verification is a validation (3.9).
 
  注5:验证不应当与校准混淆。不是每个验证都是确认。
 
  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:在化学中,验证活性或所含实体的特性时,需要描述该实体或活性的结构或特性。
 
  [SOURCE: ISO/IEC Guide 99:2007, 2.44]
 
  [源自: ISO/IEC 指南99:2007,2.44]
 
9、3.9 Validation

确认
 
  verification (3.8), where the specified requirements are adequate for an intended use
 
  对规定要求满足预期用途的验证(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:一个通常用于测量水中氮的质量浓度的测量程序,也可被确认为可用于测量人体血清中氮的质量浓度。

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