Module Certification (Regulations)
Introduction
ISO/IEC 17025 is an international standard developed by ISO (International Organization for Standardization) that establishes the requirements that testing and calibration laboratories must meet.[1] It is a Quality standard that is based on the ISO 9000 series of standards, although it introduces a series of essential technical requirements to achieve the accreditation of testing and calibration laboratories. The accreditation of testing and calibration laboratories is achieved through regional entities that participate in international collaboration networks. The ISO/IEC 17025[2] standard is applied by testing and calibration laboratories with the aim of demonstrating that they are technically competent and that their results are true. The current version is the third edition of 2017.[3].
The standard addresses topics such as: the technical competence of personnel, the ethical conduct of personnel, the use of well-defined tests and calibration procedures, participation in expertise tests and contents of tests reports and certificates.
History
The ISO/IEC 17025 Standard replaces the previous ISO/IEC Guide 25 (General requirements for the competence of calibration and
testing laboratories)[4] and the European standard EN 45001 (General criteria for the operation of testing laboratories [UNE, 1991]) providing new requirements in the aspects of the responsibilities and commitment of senior management and placing greater emphasis on continuous improvement according to the PDCA method") and dialogue with the client.
It was published in Spain in July 2000 as UNE-EN ISO/IEC 17025, being a translation of the European standard [UNE, 2000], from which the criteria for the certification of laboratories are derived, established by the National Accreditation entity ENAC.[5].
Structure and content
After its update in 2017, the new version of the ISO/IEC 17025:2017 standard is grouped into eight sections and two annexes. The content of the standard (ES) ISO/IEC 17025:2017 is broken down below:[6].
Unlike the previous version, this new 2017 version features important changes, including an alignment with ISO 9001 and a reduction in prescriptive requirements. Which results in a restructuring of the chapters of the standard, where the two previous major sections (Management Requirements and Technical Requirements) have been modified by the five new major sections discussed in the structure. Other important aspects that have been modified are the recognition of sampling activities, computerized systems have been incorporated for the management of laboratory data and its evaluation, as well as the terminology has been updated.[7].
References
- [1] ↑ «www.invemar.org.co».: http://www.invemar.org.co/redcostera1/invemar/docs/RinconLiterario/2009/noviembre/IA_39.pdf
- [2] ↑ «Análisis de la nueva ISO/IEC 17025:2017 respecto a Equipamiento y Sistemas Informatizados».: https://www.oqotech.com/blog/validacion-de-sistemas-informatizados/analisis-de-la-nueva-iso-iec-170252017-respecto-a-equipamiento-y-sistemas-informatizados/
- [3] ↑ 14:00-17:00. «ISO/IEC 17025:2017». ISO (en inglés). Consultado el 15 de junio de 2022.: https://www.iso.org/cms/render/live/en/sites/isoorg/contents/data/standard/06/69/66912.html
- [4] ↑ CASCO/WG 25 (2004), General requirements for the competence of testing and calibration laboratories (en inglés) .: http://www.cala.ca/ISO-IEC%20FDAM%2017025.pdf
- [5] ↑ CGA-ENAC-LEC25 (2009), Criterios generales para la acreditación de laboratorios de ensayo y calibración según norma UNE-EN ISO/IEC 17025 (en esp) .: http://www.enac.es/c/document_library/get_file?folderId=144&name=CGA_ENAC_LCL_Rev_1.pdf
- [6] ↑ «Estructura de la Norma UNE-EN ISO 17025:2017». 1 de septiembre de 2023. Consultado el 1 de abril de 2023.: https://heskouricalidad.es/wp-content/uploads/2022/10/Heskouri-Calidad-Estructura-ISO-17025_2017.pdf