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BSI对实验室能力测试国际标准进行修订

发布时间: 2018-07-03 09:52:02   审校:睿智   浏览次数:
来源:https://www.bsigroup.com/en-GB/about-bsi/media-centre/press-releases/2018/may/international-standard  

BSI已经修订了其测试和校准实验室能力标准,ISO 17025测试和校准实验室能力的一般要求。

该项标准的制定旨在提高对实验室运作的信心。此项标准规定了实验室的能力、公正性和实验室一致操作的一般要求;这些要求包括要求实验室证明其能够胜任工作,并能够产生有效的结果。

监管机构、实验室客户、组织和使用同行评估的方案、认证机构和其他机构将使用ISO 17025来确认或承认实验室的能力。

该项标准的上一个版本ISO 17025:2005已被撤销,并被修订版所取代。

与以前版本相比,主要变化是:

——本版采用了基于风险的思想,这使得规定性要求得以降低,并被基于性能的要求所取代。

——在对流程、过程、文件信息和组织责任的要求方面,具有更大的灵活性。

——增加关于实验室的定义。

BSI治理和弹性部负责人安妮·海斯(Anne Hayes)表示:“最近修订的ISO 17025是测试校准实验室的任何组织或个人——尤其是监管机构——必须具备的标准。 ISO 17025适用于所有从事实验室活动的组织,不论其人数如何。”

该项标准涉及风险和机会,为提高管理体系的有效性、取得更好的成果和防止负面影响奠定了基础。实验室负责决定哪些风险和机会需要解决。

标准中有“过程要求”部分,涉及报告的通用要求和具体要求(测试、校准或抽样);校准证书的要求;报告符合性声明。 同时符合本文件的实验室也将按照ISO 9001中的原则运作。

下列组织作为推进委员会成员参与了ISO 17025的制定:BMTA(英国测量和测试协会); CSA集团; EMCTLA(EMC测试实验室协会); 环境署; 是德科技英国有限公司; 国家物理实验室(NPL); UKAS(UK认证服务)。

 

International standard for competency testing of laboratories revised

BSI, the business standards company, has revised its standard for competency of testing and calibration laboratories, ISO 17025 General requirements for the competence of testing and calibration laboratories.

The standard was developed with the objective of promoting confidence in the operation of laboratories. It specifies the general requirements for the competence, impartiality and consistent operation of laboratories; these include requirements for laboratories to demonstrate that they operate competently, and are able to generate valid results.

Regulatory authorities, laboratory customers, organizations and schemes using peer-assessment, accreditation bodies, and others will use ISO 17025 in confirming or recognizing the competence of laboratories.

The previous version of this standard, ISO 17025:2005, has been withdrawn and is superseded by the revised version.

The main changes compared to the previous edition of this standard are:

-       An adoption of risk-based thinking applied in this edition, which 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

Anne Hayes, Head of Governance and Resilience at BSI, said: “Recently revised ISO 17025 is a must-have standard for any organization or individual that tests calibration laboratories – in particular regulatory authorities.  ISO 17025 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.”

The standard addresses both risks and opportunities, establishing 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.

There is a section in the standard for “process requirements”, which covers common and specific requirements for reports (test, calibration or sampling); requirements for calibration certificates; and reporting statements of conformity. Laboratories that conform to this document will also operate generally in accordance with the principles in ISO 9001.

The following organizations were involved in the development of ISO 17025 as members of the steering committee: BMTA (British Measurement & Testing Association); CSA Group; EMCTLA (EMC Test Labs Association); Environment Agency; Keysight Technologies UK Ltd; National Physical Laboratory (NPL); UKAS (UK Accreditation Service).

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