Establishing Reference Systems in Laboratory Medicine on the Basis of ISO/CEN Standards

Lothar Siekmann

سند علمی

Establishing Reference Systems in Laboratory Medicine on the Basis of ISO/CEN Standards

Lothar Siekmann

چکیده

ISO/IEC has issued several International Standards concerning the concept of traceability in laboratory medicine. prEN ISO 17511 Metrological traceability of values assigned to calibrators and control materials, prEN ISO 18153 Metrological traceability of values for catalytic concentrations of enzymes assigned to calibrators and control materials, prEN ISO 15193 Presentation of reference measurement procedures, prEN ISO 15194 Description of reference materials prEN ISO 15195 Requirements for reference laboratories The concept of traceability provides the most important strategy to achieve comparable measurement results independent of the laboratory and the applied measurement procedure. The implementation of this concept requires the development of further vertical standards by international organisations, the development of reference measurement procedures, the provision of reference materials, the establishing of a global infrastructure which approves reference procedures, reference materials and reference laboratories. The activities of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the Joint Committee on Traceability in Laboratory Medicine (JCTLM) for the establishing of reference systems on the basis of ISO standards are demonstrated in some examples.

اسناد مشابه

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).
سند علمی۲۰۱۵Clinical chemistry and laboratory medicineMarc H M Thelen, Florent J L A Vanstapel, Christos Kroupis, Ines Vukasovic
The recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accre
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
مقاله‌ی دسترسی آزاد۲۰۲۰Clinical Chemistry and Laboratory Medicine (CCLM)RoseriRoelofsen-de Beer, JosWielders, GuilaineBoursier, TatjanaVodnik
Patient Summary and medicines reconciliation: application of the ISO/CEN EN 13606 standard in clinical practice.
سند علمی۲۰۱۱Studies in health technology and informaticsFrancisco J Farfán Sedano, Marta Terrón Cuadrado, Yolanda Castellanos Clemente, Pablo Serrano Balazote
The comparison of the patient's current medication list with the medication being ordered when admitted to Hospital, identifying omissions, duplications, dosing errors, and potential interactions, constitutes the core process of medicines reconciliation. Access to the medication
Implementation of reference systems in laboratory medicine.
سند علمی۲۰۰۰Clinical chemistryM M Müller
In laboratory medicine, meaningful measurements are essential for the diagnosis, risk assessment, treatment, and follow-up of patients; therefore, methods applied in diagnostic measurements must be accurate, precise, specific, and comparable among laboratories (1 ). A given analy
Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard.
سند علمی۲۰۰۸Annali dell'Istituto superiore di sanitaEtty Feller
Laboratories with a quality system accredited to the ISO/IEC 17025 standard have a definite advantage, compared to non-accredited laboratories, when preparing their facilities for the implementation of the principles of good laboratory practice (GLP) of the Organisation for Econo
Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: I. Analyte definition and proposal of a candidate reference method International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Standardization of Carbohydrate-deficient Transferrin (IFCC-WG-CDT)
سند علمی۲۰۰۷Jan-Olof Jeppsson, Torsten Arndt, Jos P.M. Wielders, Raymond F. Anton
An alcohol-associated change in the serum transferrin glycoform pattern, carbohydrate-deficient transferrin This position paper was commissioned by IFCC, but it does 1) not carry any official endorsement by IFCC. IFCC Sections printed in J. Clin. Chem. Clin. Biochem. are 2) liste

Establishing Reference Systems in Laboratory Medicine on the Basis of ISO/CEN Standards

چکیده

اسناد مشابه

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).

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

Patient Summary and medicines reconciliation: application of the ISO/CEN EN 13606 standard in clinical practice.

Implementation of reference systems in laboratory medicine.

Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard.