European Federation of National Associations of

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European Federation of National Associations of
Measurement, Testing and Analytical Laboratories
DRAFT EUROLAB Position Paper
Selection of PT-providers and RM producers by accredited
laboratories
Background
The EA Multilateral Agreements (MLAs) are essential for the European and international
recognition of accreditation and lately efforts has been made on expanding it to also cover
accreditation of Proficiency Testing Providers (PTPs) and Reference Material Producers
(RMPs).
In 2010 requirements for PTPs were established in the new standard ISO/IEC 17043,
“Conformity assessment — General requirements for proficiency testing” – i.e. as a conformity
assessment standard in the ISO 17000 series of standards.
Based on this the accreditation community represented by EA (and the NABs) and ILAC (on the
international scale) has been even more keen on requesting from accredited laboratories that
they must participate in PTs (…or at least ILCs; Inter-Laboratory Comparisons).
Accredited laboratories (in accordance with ISO/IEC 17025) benefit in many cases from PT
participation for the sake of documenting the quality of their services - IF they can find relevant
PT schemes in relation to their specific activities, and if these are affordable compared to costs
for other QA measures! Because on the other hand the laboratories can (rightly) claim that the
standard “only” mentions PT-participation as one possible way of documenting QA among a
number of other possibilities (acc. to Cl. 5.9 in the standard).
EUROLAB TCQA is very focused on this field of use of PTs by accredited laboratories AND the
efforts towards having good and relevant PT schemes (or ILCs) available for the laboratories.
A special Task Force Group (ILC/PT TFG) has even been established within TCQA with the
purpose of following the development in the field closely.
Another way of documenting good quality in the laboratories is by use of Reference Materials
(RMs; or CRMs , Certified Reference Materials).
The availability of good RMs/CRMs is crucial to laboratories in their aim for establishing
reliability of their measurement methods (e.g. as an important tool in validation of these
analytical methods within chemistry and microbiology) – and in many cases even the best way
of proving (some kind of !) traceability
Arguments
Along with the development described above and a tendency among NABs to focus very much
(mostly!) on the accredited laboratories’ performance in PTs during assessments, the fear
among laboratories has been expressed, that the new efforts towards accrediting PT providers
may lead the NABs to accept ONLY participation in accredited schemes - i.e. the risk of a socalled ‘Closed Shop’ situation where laboratories will not be free to select providers of their own
choice1.
A number of arguments can be raised against such a policy among NABs:
1
In the discussions within ILAC regarding possible decrease of the frequency of surveillance visits IF
laboratories perform well in PTs, it has even been argued that this could only be considered if such PTs
were arranged by accredited providers!
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page 2 of 2 pages
o According to ISO/IEC 17025 the laboratories are the only ones responsible for proving the
quality of their own services
- i.e. laboratories must decide themselves, whether they see participation in PTs as a
feasible tool for documentation of Quality Assurance (acc. to cl. 5.9)
- and the laboratories must in that case be allowed to find the best provider according to
their actual needs
o Selection of PT providers should be seen in the same way as selecting other products and
services to supplement the activities in the laboratory, where the laboratory will always be
responsible for the products/services purchased (acc. to Cl. 4.6)
(In this case the laboratory may of course benefit from selecting an accredited provider – if
the offered schemes are relevant – but otherwise the laboratory must use other means of
securing the quality from their service provider)
o It is in many cases difficult to find relevant PT schemes for the specific testing within a
laboratory, and for that sake initiative may be taken to arrange more in-formal ILCs (if no
other means for documenting QA can be established). Such schemes should be equally
accepted by NABs compared to formal (accredited) PTs
o Many PT providers (especially small providers for very specific schemes) are not
interested in spending the resources for becoming accredited – although they arrange
schemes of very fine quality
o There may be created a market of 1st and 2nd class PTPs
o Dealing only with accredited PTPs will be an extra cost for the accredited laboratories
o Similar arguments as those above can be raised for RMPs!
__
Conclusions
The request of competence in PTP and RMPs is rising in Europe. Present European economic
situation might be taken into account and additional burdens on the laboratories and other
conformity assessment bodies (CABs) concerning costs and efforts should not put on them. It
will be necessary a strong effort for harmonization among NABs in relation to establish
minimum level of requirements to ensure competence.
EUROLAB’s position
EUROLAB will defend accredited laboratories’ rights to freely select their own service providers
– incl. PT providers and RM producers
The organization does not improve of any policy among NABs towards recommending only
accredited PTPs or RMPs – or accepting only, respectively giving priority to, performance
results from such or use of such RMs
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