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p. Bianco June 20131111/31/31/31/31
Focus on reliable test results.
Paolo Bianco – EA LC Chair
p. Bianco June 20132222/31/31/31/31
EA Organizational structure
EA Advisory
Board
General
Assembly
Executive
CommitteeSecretariat
Multilateral
Agreement
council
(MAC)
Horizontal
Harmonisation
Committee
Laboratory
Committee
Inspection
Committee
Certification
Committee
Communications
& Publications
Committee
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• ISO/IEC 17025. General requirements for the
competence of testing and calibration laboratories.
• ISO 15189. Medical laboratories -- Particular
requirements for quality and competence.
• ISO 22870. Point-of-care testing (POCT) --
Requirements for quality and competence.
• CEN TS 15675. Air quality. Measurement of
stationary source emissions. Application of EN
ISO/IEC 17025:2005 to periodic measurements.
• Other Sector standards (WADA, AEMCRLP,
Bluetooth, EPA energy saving, etc.)
Standards for laboratories
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Conformity evaluation standards
Certification Bodies
PersonnelManagement
SystemProduct
ISO/IEC 17024 ISO/IEC 17021 ISO/IEC 17065
Person
Certification
Standards
for personnel
Management
System
Certification.
ISO 9001
ISO 14001
Sector schemes..
Product
Certification
Product
standards
Test and
calibration
Test and calibration
Standards/methods
Inspection
Inspection
Standards
Laboratories
ISO/IEC 17025
Inspection
Bodies
ISO/IEC 17020
Supplier
Supplier's declaration of conformity ISO/IEC 17050-1, ISO/IEC 17050-2
ISO 19011, EN
473 (PND), EN
287 (welders)
Road signs,
tiles, biologic,
OGM,
building
materials,
elettrici,..
EN ISO/IEC 17011General requirements for accreditation bodies accrediting conformity assessment bodies
ISO 15189
Proficiency test
Providers
ISO/IEC 17043
Reference
Materials
Producers
ISO Guide 34
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Standards evolutionISO Guide 25:1978
ISO/IEC Guide
25:1982
ISO/IEC G 25:1990
EN 45001:1989
ISO/IEC 17025:1999
EN ISO/IEC 17025:2000
ISO/IEC 17025:2005
ISO 9000:1987 Series
ISO TC/176
ISO 9000:1994 Series
ISO 9000:2000 SeriesISO 15189:2003
ISO 15189:2007
ISO 9000:2008 Series
�Laboratorie
s
MS �
CEN TS 15675
WADA, AEMCLRP..
ISO 15189:2012
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Calibration ISO/IEC 17025: total 2598
16419
28
24
105
431
2
446
49
17
146
29
28
20
19
50
1518
15
1
94
101
21
57
8690
54
73
64
380
4
0
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Testing ISO/IEC 17025: total 12833 (+9% in 2 years)
973246
215
249
490
1231
20
2014
109
147
637
347
136
149
87
309
9198
123
6
480
1084
494
243
86396
228
376
318
1255
14
7
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Medical ISO 15189: total 1871 (+80 % in2 years)
1
56
11
127
129
15
394
17
10
23
31
11
6
57
9
7
18
8821
11
4826
27
3
5
1
1
0
0
3
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PTP ISO/IEC 17043 total: 116 (+90% in 3 years)
4
7
0
11
14
0
10
4
0
5
3
2
0
0
0
0
2
10
15
52
3
24
0
0
0
0
0
4
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Laboratory Committee Terms of Reference.
a) to harmonize the implementation of the
standard ISO/IEC 17011 with a view to the
assessment and accreditation of laboratories
against ISO/IEC 17025, ISO 15189, ISO/IEC
17043 and other relevant standards and to
elaborate guidance documents where necessary
b) to discuss and where appropriate to develop a
European view on issues to be discussed in
ILAC or other international organizations and to
make available to LC members documents from
ILAC AIC and other relevant ILAC documents
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Laboratory Committee Terms of Reference.
c) to support European Accreditation Bodies in the
implementation of decisions taken by ILAC and EA
and to coordinate related activities where
appropriate;
d) to cooperate with relevant working parties of
related European organizations, especially as far as
the implementation of the standards defining
technical and organizational competence of
laboratories is concerned, in particular the
recognised stakeholders and, if appropriate, to
approve guidance documents drafted by these
organizations as EA advisory documents;
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Laboratory Committee Terms of Reference.
e) to cooperate with the other EA committees on a
regular basis;
f) to cooperate with other regional accreditation co-
operations in the field of calibration and testing;
g) to review the results of interlaboratory
comparisons provided by reliable providers in
designated fields (WG ILC), in order to:
- have an overview of the comparability of calibration
and test results provided by accredited laboratories;
- draw the necessary conclusions for the further
development of assessment practices;
- have a general opinion about the efficiency of the
MLA in the field of calibration and testing;
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Laboratory Committee Terms of Reference.
h) to advise the General Assembly, the Executive
Committee and the other Committees in all matters
related to laboratory accreditation;
i) to perform any other task specified by the EA
General Assembly;
j) to nominate the EA/LC representatives to the PLG
and to other joint Working groups with
Stakeholders, such as the EEE-PT;
k) to develop the LC knowledge database by:
- clarifying status and use of LC results;
- setting up, maintaining and making available a list
of Frequently Asked Questions and responses.
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Laboratory Committee Terms of Reference.
LCMeetings
EA/LC will meet when considered necessary by the
Chairperson, by the EA General Assembly or by at
least one third of its members. EA/LC will, however,
meet at least once a year. Generally twice a year.
Management Group
The LC Management Group (MG) prepares the
work of the LC. The MG is led by the Chairperson.
Members are Vice Chair, convenors of the working
groups and the technical networks. The MG
meetings are arranged in conjunction with the LC
meetings.
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WORKING GROUPS
Working Groups are established for well-defined tasks.
Terms of Reference will be defined by the LC. They will
report to EA/LC at each meeting.
The convenors are nominated by EA/LC. Members of the
Working Groups are representatives of Accreditation Bodies
and representatives from interested parties, Recognized
Stakeholders mainly laboratory organisations. They are
invited by their convenors.
The Working Groups will co-ordinate their activities with the
activities of Working Groups of other regional accreditation
co-operations and ILAC. They will exchange results with
these groups whenever possible.
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WORKING GROUPS FOR INTERLABORATORY
COMPARISONS IN THE FIELD OF CALIBRATION
AND TESTING
The aim of Working Groups for ILCs (testingand calibration) activity is to demonstrate thecomparability of the results of the accreditedlaboratories through the participation tointernational proficiency tests. The EAMembers are invited to nominate accreditedlaboratories to participate to the relevant ILC.
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The Working Groups for ILCs (testing andcalibration) shall identify the needs for EAinitiated comparison on a 5 year rolling plan.The ILC plans shall be presented to the LCfor approval annually.The Working Groups will discuss theoutcome of Intercomparisons (ILCs).These Intercomparisons are mainly providedby EURAMET members for calibration andprovided by IRMM and other professionalproviders for testing.
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The Working Group Health Care deals withthe application of ISO 15189 and relatedstandards (ISO 22870. Point-of-care testing)to the medical laboratories.The main issues on the floor are the ISO15189:2012, the multi-site accreditation andthe POCT.It is now also involved in the EuropeanBreast Cancer Project, which is managed bythe JRC Ispra.
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JOINT WORKING GROUPS
Joint Working Groups (groups working jointly with
other organizations) will follow the same rules as
Working Groups unless otherwise agreed upon by
the organizations concerned. Each Joint Working
Group will appoint a representative to be a member
of EA/LC.
The EA representatives of EEE-PT members are
nominated by the EA/LC for a period of two years.
The EA representatives are requested to report
about the EEE-PT activity at each LC meetings. The
EEE-PT will coordinate its work with the WGs for
ILCs.
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TECHNICAL NETWORKS
Technical networks (TN) are established by the LC to
stimulate discussion and harmonisation in selected
technical fields. The TNs operate by suitable electronic
means led by a convenor.
The TNs offer the EA ABs an informal platform for
discussion and exchange of experience and of technical
expertise and assessors.
The members of the TNs are the AB nominated persons
actively engaged in the particular field of the TN
The convenor of the TN, preferably a member of the LC, is
nominated by the LC for a period of two years. The
convenor or co-convenor reports on the activity of the TN
at each LC meetings.
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The LC evaluates the need for the TN biannually. New TNs
are established based on the need and interest of the LC
members.
ACTIVE TECHNICAL NETWORKS
TN Calibration (traceability issues, now ILAC P10)
TN Electrical-mechanical (fire testing, material testing)
TN Environment (stack emission, sampling, water frame
directive)
TN Food-feed (official control, GMO, residual analysis)
TN Forensic, cooperates with ENFSI (European Network
of Forensic Science Institutes) and EWDTS (European
Workplace Drug Testing Society)
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TASK FORCE GROUPS
The LC, its committees and its technical networks
can establish Task Force Groups for a defined
task. The chairman or convenor under whose
jurisdiction the TFG is established shall propose
Terms of Reference for the TFG. The terms of
reference shall be approved in the
committee/working group. A clear time frame for
the task shall be defined. The LC secretary will
keep a list of the active TFGs, their tasks and
composition. Stakeholder members can be
nominated to the TFGs.
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TASK FORCE GROUPS
TFG Opinions and Interpretation has been set up
in order to harmonize the approach of the
accreditation bodies in the accreditation of
opinions and interpretation.
TFG accreditation of PTP and RMP in view of the
expansion of the EA MLA. (see next slides)
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APLAC has already included in its MLA theaccreditation of RMP, IAAC is going to dothe same.
These activities will be covered under theILAC MRA in the not too distant future.
ILAC R6:07/2012 already shows that PTPand RMP accreditation activities are in theILAC MRA structure.
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Annex 1 Structure of the ILAC Arrangement
LEVEL 2 TESTING InspectionCALIBRATION
ISO/IEC 17011
Scope of accreditation
ISO 15189 ISO/IEC 17025 ISO/IEC 17020
ISO 22870
LEVEL 1
LEVEL 3
LEVEL 4
LEVEL 5
ISO/IEC 17025
ISO 15195
ISO/IEC 17043
PROfICIENCY
TESTING
Reference
material
PRODUCTION
ISO Guide 34 +
ISO/IEC 17025
WADA ISL
ILAC R6:07/2012Activities today
under the
ILAC MRA
Future
expansion of
the MRA
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PTP Accreditation: ISO/IEC 17043
RMP Accreditation - there are differentapproaches:
• Accredited as testing
• Accredited as calibration
• Accredited as product certification
• Activity outside the MLA:– ISO Guide 34
– ISO Guide 34 + ISO/IEC 17025
Need for harmonization.
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RMP Accreditation.
ILAC Resolution GA 16.20
As ISO Guide 34:2009 includes normativereferences to ISO/IEC 17025 and ISO 15189,the General Assembly resolves thataccreditation of reference material producersis conducted in accordance with ISO Guide34:2009 alone. In addition ILAC R6:07/2012will be amended to reflect this decision.
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RMP Accreditation.
APLAC has already published in 2010 theAPLAC Requirements for and Guidance onReference Material Producer Assessment andthe Resulting Scope of Accreditation – APLACTC 008.
IAAC has drafted the “IAAC Mandatory andnon-mandatory application for the assessmentand accreditation of reference materialproducers”
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Possible problems:
• Impartiality: if the AB offers PTs there
would be competition with the
accredited body, not allowed by
ISO/IEC 17011.
• The same if the AB or a related body
produces CRMs.
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EA LC has established a Task ForceGroup with the following goals:
• Revision of existing documents (e.g.EA-2/09)
• Definition of harmonized criteria foraccreditation of PTP and RMP
• Seminars on ISO/IEC 17043 and ISOGuide 34
• Training of peer evaluators (MAC)
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Thank you for your attention