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In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency

Clinical chemistry and laboratory medicine, 2024-01, Vol.62 (1), p.e1-e3

2024

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Recommendation for the review of biological reference intervals in medical laboratories

Clinical chemistry and laboratory medicine, 2016-12, Vol.54 (12), p.1893-1900

2016

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Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis

Clinical chemistry and laboratory medicine, 2022-01, Vol.60 (1), p.33-43

2022

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ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro -Diagnostics Regulation

Clinical chemistry and laboratory medicine, 2023-03, Vol.61 (4), p.608

2023

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ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro -Diagnostics Regulation: Joint opinion of task force on European regulatory affairs and working group accreditation and ISO/CEN standards of the European Federation of Clinical Chemistry and Laboratory Medicine

Clinical chemistry and laboratory medicine, 2023-03, Vol.61 (4), p.608-626

2023

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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)

Clinical chemistry and laboratory medicine, 2015-07, Vol.53 (8), p.1173

2015

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Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories

Clinical chemistry and laboratory medicine, 2017-03, Vol.55 (3)

2017

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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

Advances in laboratory medicine, 2024-03, Vol.5 (2), p.109-114

2024

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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

Advances in laboratory medicine, 2024-06, Vol.5 (2), p.103-108

2024

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Implementation of a care pathway based computerized order entry system streamlines test ordering and offers tools for benchmarking clinical practice

Informatics in medicine unlocked, 2023, Vol.41, p.101308, Article 101308

2023

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Performance of strip-based glucose meters and cassette-based blood gas analyzer for monitoring glucose levels in a surgical intensive care setting

Clinical chemistry and laboratory medicine, 2016-01, Vol.54 (1), p.169

2016

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Fructosamine 3-kinase-related protein and deglycation in human erythrocytes

Biochemical journal, 2004-08, Vol.382 (Pt 1), p.137-143

2004

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An approach for determining allowable between reagent lot variation

Clinical chemistry and laboratory medicine, 2022-04, Vol.60 (5), p.681-688

2022

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In reply to: Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability

Clinical chemistry and laboratory medicine, 2023-10, Vol.61 (11), p.e218-e220

2023

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Practice-oriented quality specifications for therapeutic drug monitoring

Clinical chemistry (Baltimore, Md.), 2014-03, Vol.60 (3), p.559-560

2014

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APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data

Clinical chemistry and laboratory medicine, 2024-03, Vol.62 (4), p.597-607

2024

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Improving the laboratory result release process in the light of ISO 15189:2012 standard

Clinica chimica acta, 2021-11, Vol.522, p.167-173

2021

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Current evidence and future perspectives on the effective practice of patient-centered laboratory medicine

Clinical chemistry (Baltimore, Md.), 2015-04, Vol.61 (4), p.589-599

2015

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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

Clinical chemistry and laboratory medicine, 2020-03, Vol.58 (3), p.361-367

2020

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Practical approach for medical validation of therapeutic drug monitoring results

Clinical chemistry and laboratory medicine, 2016-03, Vol.54 (3), p.e97

2016

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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

Clinical chemistry and laboratory medicine, 2019-04, Vol.57 (4), p.459-464

2019

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Organisation and quality monitoring for point-of-care testing (POCT) in Belgium: proposal for an expansion of the legal framework for POCT into primary health care

Acta clinica belgica (English ed. Online), 2022-04, Vol.77 (2), p.329-336

2022

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Creatinine reference values in ELBW infants: impact of quantification by Jaffe or enzymatic method

The journal of maternal-fetal & neonatal medicine, 2012-09, Vol.25 (9), p.1678-1681

2012

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Performance of cassette-based blood gas analyzers to monitor blood glucose and lactate levels in a surgical intensive care setting

Clinical chemistry and laboratory medicine, 2013-07, Vol.51 (7), p.1417-1427

2013

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Accreditation process in European countries - an EFLM survey

Clinical chemistry and laboratory medicine, 2016-04, Vol.54 (4), p.545

2016

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In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency

Recommendation for the review of biological reference intervals in medical laboratories

Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis

ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro -Diagnostics Regulation

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)

Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories

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

EFLM Working Group Accreditation and ISO/CEN standards on dealing with ISO 15189 demands for retention of documents and examination objects

Implementation of a care pathway based computerized order entry system streamlines test ordering and offers tools for benchmarking clinical practice

Performance of strip-based glucose meters and cassette-based blood gas analyzer for monitoring glucose levels in a surgical intensive care setting

Fructosamine 3-kinase-related protein and deglycation in human erythrocytes

An approach for determining allowable between reagent lot variation

In reply to: Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability

Practice-oriented quality specifications for therapeutic drug monitoring

APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data

Improving the laboratory result release process in the light of ISO 15189:2012 standard

Current evidence and future perspectives on the effective practice of patient-centered laboratory medicine

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

Practical approach for medical validation of therapeutic drug monitoring results

Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element

Organisation and quality monitoring for point-of-care testing (POCT) in Belgium: proposal for an expansion of the legal framework for POCT into primary health care

Creatinine reference values in ELBW infants: impact of quantification by Jaffe or enzymatic method

Performance of cassette-based blood gas analyzers to monitor blood glucose and lactate levels in a surgical intensive care setting

Accreditation process in European countries - an EFLM survey

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