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新版ISO/IEC 17025 刚刚发布

发布时间: 2018-01-31 13:56:41   审校:睿智   浏览次数:
来源:https://www.iso.org/news/ref2250.html  

关于检测和校准实验室能力的最受欢迎的标准于近日修订完毕,修订后的新标准将实验室环境及工作实践中出现的最新变化纳入标准中。

ISO/IEC 17025:2017检测和校准实验室能力的通用要求》,是一项国际标准,供世界范围内进行校准和检测活动的实验室进行参考。

实验室活动的核心在于产生受到广泛认可的有效结果。ISO/IEC 17025:2017允许实验室实施健全的质量体系,并证明它们具备足够的技术能力,能够产生有效且可靠的结果。

通过让各国更为广泛地认可实验室产生的结果,ISO/IEC 17025:2017还有助于促进实验室与其他机构进行合作。检测报告与证书可以由一个国家接受另一个国家的,而不需要进一步的检测;同时,从而改善国际贸易。

为了反映市场情况与技术领域中的最新变化,该标准的新版本包含当今实验室的活动以及新的工作方式,涵盖信息技术中的技术变革、用词与发展,并将最新版ISO 9001质量管理体系纳入考虑范围。

SO/IEC 17025由合格评定委员会(CASCO)第44工作组(CASCO/WG 44)修订,该小组的三位会议召集人告诉我们为何新版ISO/IEC 17025对于实验室而言极为重要。

自新标准发布之日起三年内,已获得ISO/IEC 17025:2005认可的实验室需要根据新版标准修改它们的程序。《ILAC-ISO联合公报》说明了进行转变的时限要求。

ISO/IEC 17025:2017是由ISO与国际电工委员会(IEC)共同制定,由ISO合格评定委员会(CASCO)负责。

在2017版本的标准中有哪些主要变化?

·   对范围作了修改,以涵盖与后续校准及检测相关的检测、校准与取样。

·   现在的流程方法与更新的标准中的流程方法相匹配,这些标准包括ISO 9001(质量管理)、ISO 15189(医学实验室质量)与ISO/IEC 17021-1(对审核和认证机构的要求)等。

·   新标准更为关注信息技术,并加入了计算机系统的使用、电子文件、电子版结果及报告的生成。

·   新增一个章节,介绍了“基于风险的思维”这一理念。

 

New edition of ISO/IEC 17025 just published

The most popular standard for the competence of testing and calibration laboratories has just been updated, taking into account the latest changes in laboratory environment and work practices.

ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, is the international reference for laboratories carrying out calibration and testing activities around the world.

Producing valid results that are widely trusted is at the heart of laboratory activities. ISO/IEC 17025:2017 allows laboratories to implement a sound quality system and demonstrate that they are technically competent and able to produce valid and reliable results.

ISO/IEC 17025 also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.

In order to reflect the latest changes in market conditions and technology, the new edition of the standard encompasses the activities and new ways of working of laboratories today. It covers technical changes, vocabulary and developments in IT techniques and takes into consideration the latest version of ISO 9001 on quality management.

The three Convenors of CASCO working group 44 (CASCO/WG 44) that revised the standard tell us why the new version of ISO/IEC 17025 is so important for laboratories:

Laboratories already accredited to ISO/IEC 17025:2005 will need to transition their processes to the new version within a three-year period from the publication date of the new standard. The Joint ILAC-ISO Communiqué explains this timeframe transition.

ISO/IEC 17025:2017 was developed jointly by ISO and the International Electrotechnical Commission (IEC) under the responsibility of the ISO Committee on conformity assessment (CASCO).

What are the main changes in the 2017 version?

·   The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing.

·   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 standard has now a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.

·   A new chapter introduces the concept of risk-based thinking.

 

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