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The new version of ISO17025 is being revised and is expected to be released in 2017

Release date: 2016-08-24

是实验室认可服务的国际标准,目前最新版本是 2005 5 月发布的,全称是 ISO/IEC17025:2005 《检测和校准实验室能力的通用要求》。 ISO17025 is an international standard for laboratory accreditation services. The latest version was released in May 2005 , and its full name is ISO / IEC17025: 2005 "General Requirements for the Ability of Testing and Calibration Laboratories." 标准是由国际标准化组织 ISO/CASCO (国际标准化组织 / 合格评定委员会)制定的实验室管理标准,该标准的前身是 ISO/IEC 导则 25:1990 《校准和检测实验室能力的要求》。 The ISO17025 standard is a laboratory management standard developed by the International Organization for Standardization ISO / CASCO (International Organization for Standardization / Conformity Assessment Committee). The predecessor of the standard is ISO / IEC Guide 25: 1990 "Requirements for the Competence of Calibration and Testing Laboratories." 国际实验室认可合作组织( ILAC The international organization that manages laboratory accreditation is the International Laboratory Accreditation Cooperation ( ILAC ) .

 

ISO/IEC17025:2005 标准发布以来,迄今为止已 11 年未调整过了,但最近 11 年全球科技取得了日新月异的变化,并且 ISO9001 2015 也于 2015 9 月正式发布,为便于 ISO/IEC17025:2005 标准与 ISO9001 标准的协调一致,标准起草委员会 也于 2015 1月 正式着手修订 ISO/IEC17025:2005 标准。 Since the ISO / IEC17025: 2005 standard was issued, it has not been adjusted for 11 years so far , but the global technology has made rapid changes in the last 11 years, and ISO9001 : 2015 was also officially released in September 2015. : The 2005 standard is harmonized with the ISO9001 standard. The Standard Drafting Committee also formally started to revise the ISO / IEC17025: 2005 standard in January 2015 .

 

ISO/IEC17025 ISO/CAS/WG44 第一次工作组会议上,工作组对以下 10 个问题进行了讨论: At the first ISO / IEC17025 ISO / CAS / WG44 working group meeting, the working group discussed the following 10 issues:  

 

、是保留 ISO/IEC17025 2005 标准的现有标题,还是按 CASCO 惯例在标题中加上 合格评定 ,即 合格评定检测和校准实验室能力通用要求 ,工作组将在下次会议上对此做出决定。 1. Whether to retain the existing title of the ISO / IEC17025 : 2005 standard, or add " conformity assessment " to the title in accordance with CASCO practice , that is, " general requirements for the competence of conformity assessment testing and calibration laboratories " , the working group will be at the next meeting Decide on this.

 

、在 适用范围 是否单独提及 抽样 活动 ,对此与会代表争议比较大,有些机构将抽样作为单独的活动来认可,但标准的所有条款并不全部适用于抽样,因此并不是所有工作组成员都支持在适用范围中特别提及抽样。 2. Whether the " sampling " activity is mentioned separately in the " Scope of Application " is a big controversy for the participants. Some organizations recognize sampling as a separate activity, but not all the provisions of the standard are applicable to sampling. Not all members of the working group supported the special mention of sampling in the scope of application. Moreover, the definition of the meaning of sampling itself is also unclear. Whether it is on-site sampling or laboratory subsampling has different meanings and effects. The working group will discuss this further.

 

、是否在正文中 加入 ISO/IEC17021 标准第 4 条款的 原则 大多数工作组成员不赞成增加加 原则 一节,主要原因是原则不构成要求,而花了大量时间和精力写出的内容,实验室可以不遵守,意义不大。 3. Whether to include the " principle " of the ISO / IEC17021 standard in the text. Most members of the working group do not support the addition of a " principle " section. The main reason is that the principle does not constitute a requirement, and it takes a lot of time and effort to write it. The content of the laboratory can be non-compliance, meaningless. 原则 一节纳入其中,主要是有助于实验室对标准的理解。 However, a few members supported the inclusion of the Principles section, mainly to help the laboratory understand the standard.

 

是否删除 ISO/IEC17025 2005 标准第 1 . 5 条款 本标准不包含实验室运作中应符合的法规和安全要求 的陈述 因为标准中规定的要求并未考虑各国的法律法规,因此没有必要陈述,工作组将在下次会议再予决定。 4. Whether to delete the statement of ISO / IEC17025 : 2005 standard clause 1.5 " This standard does not include the regulations and safety requirements that should be met in the operation of the laboratory " , because the requirements specified in the standard do not take into account the laws and regulations of various countries, so There is no need to state, the working group will decide again at the next meeting.

 

、标准中提及的 管理体系 是否改为 质量管理体系 将由 CASCO 来决定。 5. Whether the " management system " mentioned in the standard is changed to " quality management system " will be decided by CASCO .

 

、因有些实验室也做 合格 判定,意见与解释的内容是否需要包含此内容 ,工作组将留 的待进一步讨论。 6. As some laboratories also make " qualified " judgments, whether the content of opinions and explanations need to include this content , the working group will leave a " note " for further discussion.

 

申诉是否适用于实验室的活动 ,如果实验室做合格判定的话申诉可能是适用的,但如何区分投诉和申诉,工作组还需要进一步讨论。 7. Whether the appeal is applicable to the activities of the laboratory. The appeal may be applicable if the laboratory makes a qualified judgment, but how to distinguish the complaint from the appeal, the working group needs further discussion.

 

、考虑是 贴加图表展示实验室的过程 ,以有助于对标准的理解,工作组已草拟此过程图,并在下一次会议上决定是否在标准中加入此流程图。 8. Consider whether to add diagrams to show the laboratory's process to help understand the standard. The working group has drafted this process diagram and decided at the next meeting whether to include this flowchart in the standard.

 

、标准中有待强化的内容可能包括:信息系统对数据的采集和运算以及报告,以及对能力验证参加要求。 9. Contents to be strengthened in the standard may include: information system collection and calculation of data and reports, and requirements for participation in proficiency testing.

 

、对于 客户 一词,是用 customer 还是用 client 10. For the word " customer " , whether to use customer or client . CASCO 决定,对于本标准,二者没有差异,只是选择哪个用词。 The final decision is made by CASCO . For this standard, there is no difference between the two, only which word is chosen.

 

ISO/CASCO/WG44 第一次工作组会议上,按 CASCO 政策,初步确定修订版 ISO/IEC17025 主体结构如下: At the first working group meeting of ISO / CASCO / WG44 , according to CASCO policy, the main structure of the revised ISO / IEC17025 was initially determined as follows:

 

、范围 1.Scope

、规范性引用文件 2. Normative references

、术语和定义 3. Terms and definitions

、通用要求 4.General requirements

公正性 4.1 Fairness

保密性 4.2 Confidentiality

、结构要求 5.Structural requirements

  Organizational structure and top management

、资源要求 6 , resource requirements

人员 6.1 personnel

设施和环境 6.2 Facilities and environment

分包 6.3 Subcontracting

服务和采购品供应 6.4 Service and Procurement Supplies

设备 6.5 Equipment

计量溯源性 6.6 Metrological traceability

通用要求 6.6.1 General requirements

特定要求 6.6.2 Specific requirements

参考标准和标准物质 6.6.3 Reference standards and reference materials

、过程要求 7 , process requirements

检测和校准过程 7.1 Testing and calibration process

合同评审 7.1.1 Contract review

抽样 7.1.2 Sampling

检测和校准物品的处置 7.1.3 Disposal of test and calibration items

测量不确定度的评定 7.1.4 Evaluation of measurement uncertainty

数据控制 7.1.5 Data Control

报告 7.1.6 Report

支持过程 7.2 Support process
质量保证 7.2.1 Quality Assurance

检测和校准方法及方法确认 7.2.2 Testing and calibration methods and method validation

不符合工作 7_2.3 not working

投诉 7.2.4 Complaints

技术记录 7.2.5 Technical Record

、管理要求 8. Management requirements

方式 8.1 Way

总则 8.1.1 General

方式 A 8.1.2 Mode A

方式 B 8.1.3 Mode B

管理体系 ( 方式 A) 8.2 Management System ( Method A)

文件控制 ( 方式 A) 8.3 Document Control ( Mode A)

总则 8.3.1 General

文件批准和发布 8.3.2 Document approval and release

文件更改 8.3.3 File changes

记录保存 ( 方式 A) 8.4 Record keeping ( Method A)

客户服务 ( 方式 A) 8.5 Customer Service ( Option A)

改进 ( 方式 A) 8.6 Improvement ( Mode A)

纠正措施 ( 方式 A) 8.7 Corrective Action ( Option A)

总则 8.7.1 General

原因分析 8.7.2 Cause Analysis

纠正措施的选择和实施 8.7.3 Selection and implementation of corrective actions

纠正措施的监控 8.7.4 Monitoring of corrective actions

附加审核 8.7.5 Additional audit

预防措施 ( 方式 A) 8.8 Preventive measures ( Option A)

内部审核 ( 方式 A) 8.9 Internal audit ( Method A)

管理评审 ( 方式 A 8.10 Management Review ( Method A )

 

ISO/CASCO/WG44 已根据第一次会议的讨论结果,于 2015 6 月形成了第一版的 ISO/IECWD-17025 标准,并在工作组内部征求意见。 At present, ISO / CASCO / WG44 has formed the first version of the ISO / IECWD-17025 standard in June 2015 based on the discussion results of the first meeting , and solicited opinions within the working group. ISO/lEC17025 标准的总体框架和相应章节的主体内容,并形成正式的 ISO/IECWD17025 标准。 The second meeting will be held in Geneva, Switzerland, at which time the overall framework of the revised ISO / lEC17025 standard and the main content of the corresponding chapters will be fully determined , and a formal ISO / IECWD17025 standard will be formed .

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