Search Results - "Lohmander, Maria"
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EFLM Working Group Accreditation and ISO/CEN standards on dealing with ISO 15189 demands for retention of documents and examination objects
Published in Advances in laboratory medicine (26-06-2024)“…Many aspects of the activity of a medical laboratory have to be documented so as to facilitate the maintenance of the ongoing quality of service. As a…”
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Grupo de Trabajo de la EFLM sobre Acreditación y Normas ISO/CEN sobre cómo abordar los requisitos de la norma ISO15189 sobre retención de documentación y muestras
Published in Advances in laboratory medicine (08-03-2024)“…Gran parte de la actividad en el laboratorio clínico debe quedar documentada para facilitar el mantenimiento de la calidad del servicio, lo que deriva en la…”
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An approach for determining allowable between reagent lot variation
Published in Clinical chemistry and laboratory medicine (26-04-2022)“…Clinicians trust medical laboratories to provide reliable results on which they rely for clinical decisions. Laboratories fulfil their responsibility for…”
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Recommendation for the review of biological reference intervals in medical laboratories
Published in Clinical chemistry and laboratory medicine (01-12-2016)“…This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical…”
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Improving the laboratory result release process in the light of ISO 15189:2012 standard
Published in Clinica chimica acta (01-11-2021)“…The ISO 15189:2012 standard section 5.9.1 requires laboratories to review results before release, considering quality control, previous results, and clinical…”
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Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation
Published in Clinical chemistry and laboratory medicine (01-03-2020)“…This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN…”
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Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element
Published in Clinical chemistry and laboratory medicine (01-04-2019)“…ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological…”
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Accreditation process in European countries - an EFLM survey
Published in Clinical chemistry and laboratory medicine (01-04-2016)“…Accreditation is a valuable resource for medical laboratories. The development of quality systems based on ISO 15189 has taken place in many laboratories in…”
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Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)
Published in Clinical chemistry and laboratory medicine (01-07-2015)“…The recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and…”
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