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1
Nyt fra ILAC og EA
Erik Øhlenschlæger,
International Manager DANAK, ILAC AIC Chair
2
3
4
EA MLA antal akkrediteringer
The scope of the ILAC MRA:
• Calibration laboratories using ISO/IEC 17025;
• Testing laboratories using ISO/IEC 17025;
• Medical testing laboratories using ISO 15189; and
• Inspection bodies using ISO/IEC 17020.
På vej de næste 3 år:
• Proficiency testing ISO 17043 (EA MLA undervejs)
• Reference Materials baseret på ISO 17034:2016
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6
Arbejdsgrupper i ILAC AIC:
7
Main
Standard
Convenor(s) Associated Liaison Documents
WG 17025
(WG8 Fire
testing &
WG 10
Forensics)
ISO/IEC
17025
(more than 75
% of CAB´s
spread on two
MRA’s)
To be elected OIML, Andre Barel
IEC, Regina Robertson, Erik
Oehlenschlaeger
ITU, chair
EGOLF André Barel, RvA
Forensics, ENFSI JWG with
IC and ISO TC 272, Pam
Bordner, ASCLD-LAB
G8
G17
G19
G24
P9
WG Medical
(WG6)
ISO 15189
Zhai Peijun IFCC (Regina Robertson,
NATA)
TC212 (Zhai Peijun, CNAS,
Phil Barnes, IANZ)
TC212 WG 1 ISO 15189
(Zhai Peijun, CNAS)
ISO/TC 212 WG2
Uncertainty Document: Zhai
Peijun, Hu Dongmei, CNAS
G26
Arbejdsopgaver for AIC:
8
Main
Standard
Convenor(s) Associated Liaison Documents
WG RMP
(WG3)
ISO 17034 Lorraine
Turner
REMCO (He Ping, CNAS
and Lorraine Turner, UKAS)
IAGRM
WG PTP
(WG12-PTWG)
ISO/IEC
17043
Brian
Brookman
P13
Arbejdsopgaver for AIC:
Horisontale arbejdsgrupper
9
Topic Convenor(s) Associated Liaison
WG2 Metrology issues,
including JCTLM, VIM
and GUM
Erik
Oehlenschlaeger,
DANAK
BIPM (Erik
Oehlenschlaeger
Neville Taylor
and Dana
Leaman)
JCTLM (Regina
Robertson)
JCGM, Erik
Oehlenschlaeger
JCGM WG1,
Steeve Sydney
JCGM WG2,
Hidetaki Imai
P14
P10
WG4 Scopes of
Accreditation,
Andre Barel, RvA G18
Øvrige arbejdsgrupper
10
Topic Convenor Liaison
WG5 Accreditation of
Sampling, convener
WG7* Accreditation of
Horse Racing
Laboratories,
Terence Wan, HKAS
and HKJC
G7
WG11 Assessor qualification ISO 19011, Dana
Leaman, NVLAP,
Pete Unger, A2LA
G3 and G11
Case studies
WG9 ILAC/WADA Liaison
Group,
Regina Robertson,
NATA and Victoria
Ivanova, WADA
WADA
WG JWG AIC/LC revision
of ISO 17025
Zhang Mingxia,
CNAS (AIC) and Jeff
Gust, NCLSI (LC)
CASCO WG44 Kept separate –
could be
transferred to
WG 17025
WG VIM and GUM Referred to
WG2
Dokumentoversigt
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Document 2017 2018 2019 2020 2021 2022 2023
ILAC P9:06/2014 ILAC Policy for Participation in
Proficiency Testing Activities
R
ILAC P10:01/2013 ILAC Policy on Traceability of
Measurement Results
R
ILAC P13:10/2010 Application of ISO/IEC 17011
for the Accreditation of Proficiency Testing
Providers
R!
ILAC P14:01/2013 ILAC Policy for Uncertainty in
Calibration
R
Dokumentoversigt
12
Document 2017 2018 2019 2020 2021 2022 2023
ILAC G3:08/2012 Guidelines for Training Courses for
Assessors Used by Accreditation Bodies
R
ILAC G7:02/2016 Accreditation Requirements and Operating
Criteria for Horseracing Laboratories
R
ILAC G8:03/2009 Guidelines on the Reporting of
Compliance with Specification – under revision
R!
ILAC G11:07/2006 ILAC Guidelines on Qualifications &
Competence of Assessors and Technical Experts – under
revision
R!
ILAC G17:2002 Introducing the Concept of
Uncertainty of Measurement in Testing in Association
with the Application of the Standard ISO/IEC 17025 –
under revision
R!
ILAC G18:04/2010 Guideline for the Formulation of
Scopes of Accreditation for Laboratories – under
revision
R!
ILAC G19:08/2014 Modules in a Forensic Science Process R
ILAC G24:2007 Guidelines for the determination of
calibration intervals of measuring instruments – under
revision
R!
ILAC G26:07/2012 Guidance for the Implementation of a
Medical Laboratory Accreditation System – under revision
R
EA dokumenter
(Fed tekst relevant for ILAC, rød markering er obligatoriske)
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EA-2/15:M EA Requirements for the Accreditation of Flexible Scopes
EA-2/18:INF Guidelines for Accreditation Bodies on the content of the scopes of
accreditation for Proficiency testing providers
EA-4/02:M Expression of the Uncertainty of Measurement in Calibration. Supplement 1 -
2.
EA-4/09:G Accreditation for Sensory Testing Laboratories.
EA-4/14:INF The Selection and Use of Reference Materials
EA-4/15:G Accreditation for Non-Destructive Testing.
EA-4/16:M guidelines on the expression of uncertainty in quantitative testing.
EA-4/17:M EA Position Paper on the description of scopes of accreditation of medical
laboratories
EA-4/18:INF Guidance on the level and frequency of proficiency testing
participation
EA-4/20:G Guidance for the Assessment of Laboratories against EN ISO 15189 and EN
ISO 22870
MLA strukturens 5 niveauer
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Hvorfor overtager ILAC den harmoniserende rolle?
ILAC P12:04/2009 Harmonization of ILAC Work with the
Regions:
….
3. At any time ILAC may decide that the global
implications of the work item are such that the region
should be invited by ILAC through the ILAC Executive
or equivalent ILAC committee to convert the work item
into an ILAC work item, with the region taking the lead
on the development at the ILAC level.
….
Note: Historisk set har EA overleveret mange
dokumenter til ILAC, hvorefter disse er blevet globale
politikker eller guides. 15
Nyt fra EA’ laboratoriekomite
Beslutning om udvikling af nye dokumenter:
• Guidance document for the Accreditation of Pesticide
Residues Analysis in Food and Feed
Revision af
• EA-4/17:M EA position paper on the description
of scopes of accreditation of medical laboratories
• EA-4/20:G Guidance for the Assessment of
Laboratories against EN ISO 15189 and EN ISO
22870 (POCT)
16