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新版ISO17025:2017中的9个概念

实验室认可/资质认定

  • 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 thelaboratory(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。
    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。
    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。
    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。
    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。
    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。
    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。
    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。
    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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  • 西瓜猫猫西瓜

    第1楼2018/01/03

    senke版主,最近你们文件修改的咋样呢?

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  • senke

    第2楼2018/01/03

    应助达人

    没修订,时刻在关注标准动态,然后就是学习新版的知识。
    CNAS出来前不会修订的,我们复评审不会出现在明年9月之后,没压力

    西瓜猫猫西瓜(vivi_vivi) 发表:senke版主,最近你们文件修改的咋样呢?

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  • 玉树临风

    第3楼2018/01/03

    谢谢分享,斑竹自己翻译的?

0
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  • 西瓜猫猫西瓜

    第4楼2018/01/03

    我们好像也没复评,今年,嘿嘿嘿嘿
    一起偷着乐
    我们报名了3月后的培训,到时候一起改

    senke(lifen4607) 发表: 没修订,时刻在关注标准动态,然后就是学习新版的知识。
    CNAS出来前不会修订的,我们复评审不会出现在明年9月之后,没压力

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  • senke

    第5楼2018/01/03

    应助达人

    自己翻译叫原创,这是分享的

    玉树临风(mm_msn) 发表:谢谢分享,斑竹自己翻译的?

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  • mxfung

    第6楼2018/03/19

    版主,可否分享下文件修改换版心得呀?

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  • senke

    第7楼2018/03/22

    应助达人

    心得?还没换呢,等大家的换版计划

    mxfung(mxfung) 发表:版主,可否分享下文件修改换版心得呀?

0
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