FINAL DRAFT INTERNATIONAL
STANDARD
ISO/IEC
17025
General requirements for the competence of testing and calibration
laboratories
检测和校准实验室能力的通用要求
Reference number
ISO/IEC  17025:2017(E)
ISO/CEN PARALLEL PROCESSING
Foreword 前言
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. In the field of conformity assessment, ISO and the International Electrotechnical Commission (IEC) develop joint ISO/IEC documents under the management of the ISO Committee on Conformity assessment (ISO/CASCO). ISO(国际标准化组织)是一个世界性的国家标准机构联合会(ISO成员机构)。国际标准的编制工作通常是通过ISO 技术委员会进行的。各成员机构对设立技术委员会的主题感兴趣，有权代表该委员会。国际组织、政府和非政府组织以及ISO，也参与了这项工作。在符合性评估领域，ISO和国际电工委员会(IEC)在符合性评估委员会(ISO / CASCO)的管理下制定了ISO / IEC联合文件。
The procedures used to develop this document and those intended for its further maintenance are described in the
ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives). 在ISO / IEC指示第1部分中描述了用于开发本文件的程序和用于进一步维护的程序。特别需要注意的是不同类型的ISO文件需要不同的审批标准。本文件是根据ISO / IEC指令，第2部分(见www .iso .org/指令)的编辑规则起草的.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents). 提请注意本文件的某些内容可能是专利权的主题。ISO不应负责识别任何或所有这些专利权。在本文件的开发过程中所确定的任何专利权的细节，将在所收到的专利声明的ISO列表中介绍(见www .iso .org/专利).
Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. 本文件所使用的任何商业名称都是为方便用户而提供的信息，不构成背书。
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html. 对于标准的自愿性质说明，ISO特定术语的含义与符合性评估有关的表达，以及ISO在贸易技术壁垒中遵守世界贸易组织(WTO)原则的信息，请参阅以下网址:www .iso .org/ iso/ foreword .html
This document was prepared by the ISO Committee on Conformity Assessment (CASCO) and circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. 该文件由ISO评定委员会(CASCO)编写，并分发给ISO和IEC的国家机构投票，并得到两个组织的批准。
The main changes compared to the previous edition are as follows:
— the risk-based thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements;
— there is greater flexibility than in the previous edition in the requirements for processes, procedures, documented information and organizational responsibilities;
— a definition of “laboratory” has been added (see 3.6 ). 与上一版相比，主要变化如下: ——本版所采用的基于风险的思想，使一些规定性的需求减少，并以基于业绩的要求取代它们;
——在过程、程序、成文信息和组织责任方面，比以前的版本有更大的灵活性;
——增加了“实验室”的定义(见3.6)。
Introduction 引言
This document has been developed with the objective of promoting confidence in the operation of laboratories. This document contains requirements for laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that conform to this document will also operate generally in accordance with the principles of ISO 9001. 制定本标准的目的是增强对实验室运作的信任。本标准包含了实验室能够证明其运作能力，并且能够产生出有效结果的要求。符合本标准的实验室通常也是依据ISO9001的原则来运作的。
This document requires the laboratory to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects.
The laboratory is responsible for deciding which risks and opportunities need to be addressed. 本标准要求实验室计划并采取措施应对风险和机遇。同时应对风险和机遇是提升管理体系有效性、取得改进效果、以及预防负面效应的基础。实验室有责任确定要应对哪些风险和机遇。
The use of this document will facilitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and in the harmonization of standards and procedures. The acceptance of results between countries is facilitated if laboratories conform to this document. 使用本标准将促进实验室与其他机构的合作，有助于相互间信息和经验的交流，也有助于标准和程序的协调统一。如果实验室符合本标准，将促进结果的国际互认。
In this document, the following verbal forms are used: — “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2. 在本标准中，使用了以下动词形式： ——“应”表示要求；
——“应当”表示建议；
——“可”表示可以；
——“能”表示可能或能力。
ISO/IEC工作导则第2部分中对这些动词做了更详细的说明。
ISOIEC 17025:2017 General requirements for the competence of testing and calibration laboratories ISOIEC 17025:2017检测和校准实验室能力的通用要求
1 SCOPE    1 范围
This document specifies the general requirements for competence, impartiality and consistent operation of laboratories. 本标准规定了实验室能力、公正性以及持续运作的通用要求。
This document is applicable to all organizations performing laboratory activities, regardless of the number of personnel 本标准适用于所有从事实验室活动的组织，不论其人员数量多少。
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accr
editation bodies, and others use this document in confirming or recognizing the competence of laboratories 实验室的客户、法定管理机构、采用同行评审的组织和制度、认可机构及其他机构使用本标准确认或认可实验室能力。
2 Normative references    2 规范性引用文件
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 本标准引用了下列文件，这些文件的部分或全部内容构成了本标准的要求。对注明日期的参考文件，只采用引用的版本；对没有注明日期的参考文件，采用最新的版本（包括任何的修订）。
ISO/IEC Guide 991), International vocabulary of metrology — Basic and general concepts and associated terms (VIM)
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles ISO/IEC 指南99 国际计量学词汇—基本和通用概念及相关术语ISO/IEC 17000 合格评定—词汇和通用原则
3 Terms and definitions    3 术语和定义
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and
ISO/IEC 17000 and the following apply. ISO/IEC 指南99 和ISO/IEC 17000 中界定的以及下述术语和定义适用于本标准。
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at www .iso .org/ obp
— IEC Electropedia: available at documents安卓版破解版
www .electropedia .org/ ISO和IEC维护的用于标准化的术语数据库地址如下： ——ISO在线浏览平台：/obp ——IEC电子开放平台：/
3.1 impartiality    3.1 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：客观性意味着利益冲突不存在或已解决，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：客观、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 17021-1:2015, 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”]
3.2 Complaint    3.2 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, a
nd 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 interlaboratory comparison    3.3 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] 3.4 intralaboratory comparison    3.4 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    3.5 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]
3.6 Laboratory    3.6 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    3.7 判定规则
rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement 当声明符合规定要求时，描述如何考虑测量不确定度的规则。
3.8 Verification    3.8 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。

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