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ISO/IEC 17025进入最终修订阶段

发布时间: 2017-12-27 10:41:16   审校:睿智  

校准、测试、分析样品是全球60,000多个实验室的日常工作,但如何才能向客户保证其结果的可信度呢?

多年来,ISO/IEC 17025测试和标定实验室能力的一般要求已成为欲证明实验室有着提供具可信性结果的能力的国际参考标准。

ISO和IEC共同发布的国际标准中包含了一系列要求,使实验室能够提高产生一致且有效结果的能力。

但是,自上次发布标准以来,实验室环境已发生翻天覆地的变化,所以修订标准、整合重大变化就迫在眉睫了。修订标准的工作组召集人之一史蒂夫·西德尼(Steve Sidney)解释说:“上一版的ISO/IEC 17025是2005年发布的。 此后,市场状况发生了巨大变化,我们认为可以

对标准进行改进。”

工作组召集人赫里贝·朔恩(Heribert Schorn)同样参加了IECEE(电工设备和部件合格评定制度),他补充说:“标准需要修订,以使它能涵盖从上一个版本出版以来行业内日新月异的技术变革、发展和IT技术。此外,该项标准也兼顾了ISO 9001新版本。

对于IEC合格评定领域而言,该项标准意义非凡,因为它概述了IECEE、IECEx、IECQ和IECRE一致性评定系统内运行的所有合格评定方案和程序中测试的基本要求。

该项标准的复审工作开始于2015年2月,是由国际实验室认可合作组织(ILAC)和南非标准局(SABS)联合提出的,SABS是ISO成员,并是IEC国家委员会,。该项标准的修订进入国际标准最终草案(FDIS)阶段,即发布前的最后一步。

史蒂夫·西德尼(Steve Sidney)

来听史蒂夫·西德尼讲述ISO/IEC 17025修订的主要变化

主要变化

ISO/IEC 17025的修订考虑了现今实验室的活动和工作方式。主要变化如下:

过程方法与ISO 9001(质量管理)、ISO 15189(医疗实验室质量)和ISO/IEC 17021-1(审核 和认证机构要求)等新标准相匹配。修订的标准强调过程产生的结果,而不是任务和步骤的详细描述。

随着人们越来越关注信息技术,该标准现也意识到结合计算机系统、电子记录、生成电子结果和报告的重要性。现代实验室越来越多地使用信息和通信技术,因此工作组认为把这一主题独立成章是有必要的。

新版本的标准其中一章是关于基于风险的思考,并描述了与新版本的《ISO 9001:2015质量管理体系》的共同点。

更新术语后,世界会更一致。事实上,由于电子版本兴起,硬拷贝手册、记录、报告这些词正在慢慢淘汰。示例包括更改国际计量学词汇(VIM)以及ISO/IEC术语的一致性,是一套通用术语和定义,符合所有标准的合格评定。

采用一种新的结构,使标准与其他现有的ISO/IEC合格评定标准相一致,如ISO/IEC 17000系列合格评定标准。

范围已经修订,涵盖实验室所有活动,包括测试、标定以及随后相关抽样的测试、标定。

应用ISO/IEC 17025有助于实验室和其他机构之间合作。另外,工作组召集人沃伦·默克尔(Warren Merkel)解释说,它有助于信息和经验的交流,并协调标准和程序。“ISO/IEC 17025以多种方式影响实验室提供的结果。该项标准要求实验室人员的能力需要达到标准,并对其

设备的标定和维护,以及生成数据的整体过程都作了相关规定。这要求实验室不断思考和实践,以确保流程受到控制,数据可靠性得到保证。”当实验室符合标准时,各国之间产生的结果也将得到更广泛的认可。

ISO和合格评定委员会(CASCO)IEC共同制定的新版ISO/IEC 17025将取代2005年版本,预计在今年年底公布。

 

ISO/IEC 17025 moves to final stage of revision

Calibration as well as testing and analysing a sample is the daily practice of more than 60 000 laboratories worldwide, but how can they reassure customers about the reliability of their results?

Over the years, ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, has become the international reference for testing and calibration laboratories wanting to demonstrate their capacity to deliver trusted results. The International Standard, published jointly by ISO and IEC (International Electrotechnical Commission), contains a set of requirements enabling laboratories to improve their ability to produce consistently valid results.

However, the laboratory environment has changed dramatically since the standard was last published, leading to the decision to revise the standard and integrate significant changes. Steve Sidney, one of the Convenors of the working group revising the standard, explains: “The last version of ISO/IEC 17025 was published in 2005. Since then, market conditions have changed and we felt we could bring some improvements to the standard.”

Heribert Schorn, working group Convenor who also participates in IECEE (System of Conformity Assessment Schemes for Electrotechnical Equipment and Components), adds: “The revision was needed to cover all the technical changes, technical developments and developments in IT techniques that the industry has seen since the last version. Additionally, the standard takes into consideration the new version of ISO 9001.”

This standard is of high significance for the IEC Conformity Assessment Community as it outlines the basic requirements for testing within all Conformity Assessment Schemes and Programmes operating within the IECEE, IECEx, IECQ and IECRE Conformity Assessment Systems.

The review was started in February 2015 as a result of a joint proposal by the International Laboratory Accreditation Cooperation (ILAC) and the South African Bureau of Standards (SABS), who is a member of ISO and hosts the IEC National Committee. The standard’s revision process has now reached the Final Draft International Standard (FDIS) stage, the last leg of development before publication.

Steve Sidney

Listen to Steve Sidney explaining the main changes in the revision of ISO/IEC 17025

The main changes

The revision of ISO/IEC 17025 takes into account the activities and new ways of working of laboratories today. The main changes are as follow:

The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies). The revised standard puts the emphasis on the results of a process instead of the detailed description of its tasks and steps.

With a stronger focus on information technologies, the standard now recognizes and incorporates the use of computer systems, electronic records and the production of electronic results and reports. Modern-day laboratories work increasingly with information and communication technologies and the working group felt it was necessary to develop a chapter on this topic.

The new version of the standard includes a chapter on risk-based thinking and describes the commonalities with the new version of ISO 9001:2015, Quality management systems – Requirements.

The terminology has been updated to be more in step with today’s world and the fact that hard-copy manuals, records and reports are slowly being phased out in favour of electronic versions. Examples include changes to the International Vocabulary of Metrology (VIM)and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.

A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards such as the ISO/IEC 17000 series on conformity assessment.

The scope has been revised to cover all laboratory activities including testing, calibration and the sampling associated with subsequent calibration and testing.

Using ISO/IEC 17025 facilitates cooperation between laboratories and other bodies. It assists in the exchange of information and experience and helps harmonize standards and procedures, as Warren Merkel, another Convenor of the working group, explains. “ISO/IEC 17025 impacts the results delivered by laboratories in a number of ways. The standard requires them to meet criteria for competence of their personnel, the calibration and maintenance of their equipment and the overall processes they use to generate the data. This requires laboratories to think and operate in a way that ensures their processes are under control and their data are reliable.” Results also gain wider acceptance between countries when laboratories conform to the standard.

Developed jointly by ISO and IEC in the Committee on conformity assessment (CASCO), the new version of ISO/IEC 17025 will replace the 2005 version and is scheduled for publication at the end of this year.

 


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