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ABSTRACT Revised ISO 15189 was published in December 2022. In SIPMeL Recommendations M1, requirements are presented from chapters 5 (organization and management requirements) and 8 (management system requirements). The M1 Recommendations consider it necessary to refer to other ISO documents, not all of which are cited in ISO 15189.
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Excellence in clinical laboratories: the standard ISO 15189:2007
Microbiologia Medica, 2010 I laboratori clinici operano in stretto contatto con i pazienti e collaborano direttamente alla loro cura, in modo corresponsabile con i medici e i reparti ospedalieri.
Antonio Scipioni +3 more
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How ISO-15189 laboratory accreditation assures patient safety? [PDF]
Journal of Medical Biochemistry, 2012 Healthcare is a complex profession involving the state-of-art technology and sometimes leading to unintentional harm. Many factors contribute to the occurrence of medical errors.
Serteser Mustafa +3 more
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Metrology in an ISO 15189 accredited medical biology laboratory
International Journal of Metrology and Quality Engineering, 2014 All French medical biology laboratories must be accredited according to ISO 15189 for all tests conducted. Metrology is therefore critical and covers a wide variety of areas.
Guichet C., Pellegrinelli S.
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THE MANAGEMENT OF MEDICAL ANALYSIS LABORATORIES AND BIOLOGICAL RISK PREVENTION [PDF]
Journal of Defense Resources Management, 2013 The increasing number of reports on biological terrorist threats identified at international level raised serious challenges not only for the scientists but also for people responsible of population health.
Mihaela BARCAN
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Conformity Evaluation of Afinion 2 Analyzer Maintainability: Compliance Practicality for Philippine National Standard PNS ISO 15189:2013 Accreditation. [PDF]
Acta Med Philipp, 2023 Dayrit GB +5 more
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A pilot study of on-site evaluation as external quality assessment for ISO 15189 accreditation of laboratories performing next-generation sequencing oncology tests. [PDF]
J Clin Lab Anal, 2023 Ravzanaadii M +4 more
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Journal of Laboratory MedicineEnsuring result comparability across identical analyzers is critical in high-throughput clinical laboratories. ISO 15189:2022 emphasizes this requirement (clause 7.3.7.4), particularly for assays with low within-subject biological variation (BV), where ...
Doruk Özlem Gürsoy +6 more
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ISO 15189 Accreditation in the Asia–Pacific Region
Indian Journal of Clinical BiochemistryAbstract Laboratory accreditation may be mandatory in some countries, and ISO 15189 is the most relevant international standard. Despite this, there are few laboratories globally that are accredited. The aim of this paper is to present information on the number of laboratories accredited in the Asia–Pacific region and to which ...
Tony Badrick +3 more
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Iranian Journal of Public Health, 2007 Background: Quality assurance is implemented by the framework for the ISO 9001- 2000 " Quality Management System "and ISO 15189: 2003. QA system will be more efficient if every organization's employees are commitment to QA implementation.
H Dargahi +1 more
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