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The previous version of this standard, ISO 17025:2005, has been withdrawn and is superseded by the revised version.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