Since its inception, the international quality standard ISO/IEC 17025 has been revised twice. The most recent edition adopted a new structure to align with other conformity assessment and quality management standards, harmonized the terminology with the International Vocabulary of Metrology and introduced the concept of risk-based thinking. This paper disseminates the experience of the IAEA Radiation Safety Technical Services Laboratory in successful transition and re-accreditation to ISO/IEC 17025:2017. It covers all stages of the transition cycle: from conducting a gap analysis between the existing quality system and the requirements in the revised standard, updating the corresponding quality documents, developing training and communication plans for laboratory personnel, to monitoring the changes and improving the system through auditing, management review and participation in proficiency testing schemes. Lessons learned about building operational resilience and maintaining a business continuity management system to prepare for, respond to, and recover from disruptions are considered.
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http://dx.doi.org/10.1093/rpd/ncac209 | DOI Listing |
Clin Chem Lab Med
January 2025
SKML, Nijmegen, The Netherlands.
The EN ISO 15189:2022 standard, titled "Medical laboratories - Requirements for quality and competence," is a significant update to the regulations for medical laboratories. The revised standard was published on December 6, 2022, replacing both EN ISO 15189:2012 and EN ISO 22870:2016. Key objectives of the revision include: 1.
View Article and Find Full Text PDFJ Hazard Mater
December 2024
Department of Sciences and Technological Innovation, University of Piemonte Orientale, Viale Teresa Michel 11, 15121 Alessandria, Italy.
Per- and polyfluoroalkyl substances' (PFAS) extreme persistence has been linked to many adverse effects on human health including increased risk of certain cancers. This study presents the development and validation of a new, highly sensitive method for the quantification of 32 PFAS in human serum using online solid-phase extraction (SPE) coupled with ultra-high performance liquid chromatography-high resolution mass spectrometry (UHPLC-HRMS). Legacy and emerging PFAS were targeted.
View Article and Find Full Text PDFBMC Vet Res
December 2024
Chemical and Veterinary Investigation Office Westphalia, Arnsberg, Germany.
Background: Paratuberculosis, caused by Mycobacterium avium subspecies paratuberculosis (MAP), is a chronic granulomatous enteritis that affects domestic and wild ruminants and camelids. The disease has rarely been reported in alpacas in Germany. This publication describes epidemiologically independent cases of paratuberculosis in two alpacas in Germany.
View Article and Find Full Text PDFInt J Med Inform
February 2025
Department of Informatics and Systems, Faculty of Computer Science, University of Murcia, Murcia 30100, Spain. Electronic address:
Objective: This article deals with the complex process of obtaining security requirements for e-Health applications. It introduces a tailored audit and validation methodology particularly designed for e-Health applications. Additionally, it presents a comprehensive security catalog derived from primary sources such as law, guides, standards, best practices, and a systematic literature review.
View Article and Find Full Text PDFJMIR Med Inform
September 2024
Institute of Medical Information/Medical Library, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Background: Data element repositories facilitate high-quality medical data sharing by standardizing data and enhancing semantic interoperability. However, the application of repositories is confined to specific projects and institutions.
Objective: This study aims to explore potential issues and promote broader application of data element repositories within the medical field by evaluating and analyzing typical repositories.
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