Committee on Quality and Regulations. Liverpool, 7 October 2014 Wim Huisman

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1 Committee on Quality and Regulations Liverpool, 7 October 2014 Wim Huisman

2 C Quality and Regulations 2 Working groups WG Accreditation and ISO/CEN Standards Chaired by Michel Vaubourdolle (FR) WG IVD Directive Chaired by Christos Kroupis (GR)

3 Members: Irina GHITA Romania Florent VANSTAPEL Belgium Ines VUKASOVIC Croatia WG Accreditation and ISO/CEN Standards Guilaine BOURSIER (Member-Young Scientist ) France Corresponding members: Edward BARRETT Ireland Maria LOHMANDER Sweden Pika MESKO BRGULJAN Slovenia Marc THELEN The Netherlands Francisco BERNABEU Spain Christos KROUPIS Greece Ludek SPRONGL Czech Rep. Tatjana VODNIK Serbia

4 WG IVD Directive Members: Javier GELLA Spain Ilenia INFUSINO Italy Marc THELEN The Netherlands Corresponding members: Bernard GOUGET France Nuthar JASSAM UK Maria LOHMANDER Sweden Marit Sverresdotter SYLTE Norway

5 WG Accreditation and ISO/CEN Standards Liaise with EC and Accrediting institutions to ensure needs of Laboratory Medicine Accepted as stakeholder by CEN in TC140, the technical committee on laboratory medicine Accepted as stakeholder by ISO in ISO TC212, responsible in WG1 for ISO15189, ISO22870 and some Technical specifications on Risk Management, etc

6 WG Accreditation, liaise Registered stakeholder in EA (European cooperation on Accreditation), and active in the Health Care Committee/WG. Items handled: explanation on assessment for ISO15189, training for new edition of ISO15189, accreditation for POCT and its link to ISO15189, Risk management, attention pre-analytical phase, measurement uncertainty and usage flexible scope Perfect linkage with work in ISOTC212

7 WG Accreditation Promotion of ISO15189 under flexible scope Presentations in congresses of EFLM et al. Publications about present state and developments (see list in web site) The new questionnaire together with EA (Cofrac) will be presented in EuroLab Paris Working on guidelines for retention time, flexible scope, measurement uncertainty, and verification of reference values

8 WG IVD Directive Restoration of linkage with EDMA, who are present with 2 consultants in WG Main topic draft IVD Regulation (replacing the IVD directive and more obligatory in each country, which has effect on in house testing, post market surveillance, traceability, information to laboratories, classification of the ivd s, etc. Combined interest about specific aspects in relation to accreditation

9 WG IVD Directive IVD Regulation Some diversity between EDMA and laboratories, e.g. in house testing (when allowed), extensiveness of information, etc. Both have tried to influence the European Parliament, and specifically the point of view in their countries. WG has send around information to the societies how to act. It is a continuing item, because the draft has been delayed

10 WG IVD, regulation Lot to lot variation in reagent manufacturing: collect information and communication with EDMA and authorities Calibration of instruments in relation with accreditation needs, trying to develop a common point of view with industry Together with EDMA lobbying about planned restriction in use of components used in small amounts in many kits

11 WG Accreditation and IVD Dissemination information to national societies Possibility to ask for speakers at national congresses Publications (see EFLM web site) Training for assessment is under consideration of WG accreditation. Within EA a task force has made an inventory about the ways NAB s organize calibration of assessments, and how their complaint system functions

12 C-QR activities and EFLM Strategic plan

13 Message to Societies Be involved in all levels important for decisions on standards, guidelines, IVD regulation and accreditation Standard Bodies: do the voting in ISO and CEN Departments of Health: decide about what is obliged in a country and are involved in draft IVD Regulation Bodies publishing Guidelines, like CLSI CEN and ISO through active participation in WG Accreditation and IVD of EFLM National Accreditation Bodies on national base and in EA through EFLM

ILNAS-EN 14136: /2004

ILNAS-EN 14136: /2004 05/2004 National Foreword This European Standard EN 14136:2004 was adopted as Luxembourgish Standard in May 2004. Every interested party, which is member of an organization based in Luxembourg, can participate