Committee on Quality and Regulations Liverpool, 7 October 2014 Wim - - PowerPoint PPT Presentation

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Committee on Quality and Regulations Liverpool, 7 October 2014 Wim - - PowerPoint PPT Presentation

Apr 16, 2023 160 likes •308 views

Committee on Quality and Regulations Liverpool, 7 October 2014 Wim Huisman C Quality and Regulations 2 Working groups WG Accreditation and ISO/CEN Standards Chaired by Michel Vaubourdolle (FR) WG IVD Directive Chaired by Christos

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SLIDE 1

Committee on Quality and Regulations

Liverpool, 7 October 2014 Wim Huisman

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SLIDE 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)

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SLIDE 3

WG Accreditation and ISO/CEN Standards

Members:

  • Irina GHITA Romania
  • Florent VANSTAPEL Belgium
  • Ines VUKASOVIC Croatia
  • Guilaine BOURSIER (Member-Young Scientist ) France

Corresponding members:

Edward BARRETT Ireland Francisco BERNABEU Spain Maria LOHMANDER Sweden Christos KROUPIS Greece Pika MESKO BRGULJAN Slovenia Ludek SPRONGL Czech Rep. Marc THELEN The Netherlands Tatjana VODNIK Serbia

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SLIDE 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

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SLIDE 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

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SLIDE 6

WG Accreditation, liaise…

  • Registered stakeholder in EA (European cooperation
  • n 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
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SLIDE 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

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SLIDE 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

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SLIDE 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

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SLIDE 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

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SLIDE 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

  • f assessments, and how their complaint system

functions

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SLIDE 12

C-QR activities and EFLM Strategic plan

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SLIDE 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