ISO/IEC 17043:2010(E)

ISO/IEC
17043
First edition
2010-02-01
Conformity assessment General
reqirements for !rofi"ien"y testin#

ISO/IEC 17043:2010(E)
Contents
Page
$ore%or& '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''i(
Intro&"tion''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''(
1 S"o!e'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1
2 )ormati(e referen"es'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1
3 *erms an& &efinitions '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1
4 *e"+ni"al ,eqirements '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''4
4'1 General ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''4
4'2 -ersonnel ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''4
4'3 Eqi!ment. a""ommo&ation an& en(ironment ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''/
4'4 0esi#n of !rofi"ien"y testin# s"+emes'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1
4'/ C+oi"e of met+o& or !ro"e&re'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''10
4'1 O!eration of !rofi"ien"y testin# s"+emes''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''11
4'7 0ata analysis an& e(alation of !rofi"ien"y testin# s"+eme reslts ''''''''''''''''''''''''''''''''''''''''''''12
4'2 ,e!orts ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''13
4'3 Commni"ation %it+ !arti"i!ants''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''14
4'10 Confi&entiality'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1/
/ 4ana#ement reqirements'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1/
/'1 Or#ani5ation''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1/
/'2 4ana#ement system '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''11
/'3 0o"ment "ontrol'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''17
/'4 ,e(ie% of reqests. ten&ers an& "ontra"ts''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''12
/'/ S6"ontra"tin# ser(i"es'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''13
/'1 -r"+asin# ser(i"es an& s!!lies ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''13
/'7 Ser(i"e to t+e "stomer''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20
/'2 Com!laints an& a!!eals '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20
/'3 Control of non"onformin# %or7 ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20
/'10 Im!ro(ement '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20
/'11 Corre"ti(e a"tions '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''21
/'12 -re(enti(e a"tions''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''21
/'13 Control of re"or&s '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''22
/'14 Internal a&its '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''22
/'1/ 4ana#ement re(ie%s ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''23
8nne9 8 (informative) *y!es of !rofi"ien"y testin# s"+emes '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''24
8nne9 : (informative) Statisti"al met+o&s for !rofi"ien"y testin#''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''22
8nne9 C (informative) Sele"tion an& se of !rofi"ien"y testin#''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''3/
:i6lio#ra!+y'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''33

ISO/IEC 17043:2010(E)
$ore%or&
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the secialized s!stem for "orld"ide standardization# $ational %odies that are mem%ers of
ISO or IEC articiate in the develoment of International Standards thro&gh technical committees
esta%lished %! the resective organization to deal "ith artic&lar fields of technical activit!# ISO and IEC
technical committees colla%orate in fields of m&t&al interest# Other international organizations' governmental
and non-governmental' in liaison "ith ISO and IEC' also ta(e art in the "or(# In the field of conformit!
assessment' the ISO Committee on conformit! assessment (C)SCO) is resonsi%le for the develoment of
International Standards and *&ides#
International Standards are drafted in accordance "ith the r&les given in the ISO+IEC ,irectives' Part 2#
,raft International Standards are circ&lated to the national %odies for voting# P&%lication as an International
Standard re-&ires aroval %! at least ./ 0 of the national %odies casting a vote#
)ttention is dra"n to the ossi%ilit! that some of the elements of this doc&ment ma! %e the s&%1ect of atent
rights# ISO shall not %e held resonsi%le for identif!ing an! or all s&ch atent rights#
ISO+IEC 1.023 "as reared %! the ISO Committee on conformit! assessment (C)SCO)#
It "as circ&lated for voting to the national %odies of %oth ISO and IEC' and "as aroved %! %oth
organizations#
4his first edition of ISO+IEC 1.023 cancels and relaces ISO+IEC *&ide 23-15166. and
ISO+IEC *&ide 23-25166.' "hich have %een technicall! revised#

ISO/IEC 17043:2010(E)
Intro&"tion
Interla%orator! comarisons are "idel! &sed for a n&m%er of &roses and their &se is increasing
internationall!# 4!ical &roses for interla%orator! comarisons incl&de5
a) eval&ation of the erformance of la%oratories for secific tests or meas&rements and monitoring
la%oratories7 contin&ing erformance8
%) identification of ro%lems in la%oratories and initiation of actions for imrovement "hich' for e9amle' ma!
%e related to inade-&ate test or meas&rement roced&res' effectiveness of staff training and s&ervision'
or cali%ration of e-&iment8
c) esta%lishment of the effectiveness and comara%ilit! of test or meas&rement methods8
d) rovision of additional confidence to la%orator! c&stomers8
e) identification of interla%orator! differences8
f) ed&cation of articiating la%oratories %ased on the o&tcomes of s&ch comarisons8
g) validation of &ncertaint! claims8
h) eval&ation of the erformance characteristics of a method : often descri%ed as colla%orative trials8
i) assignment of val&es to reference materials and assessment of their s&ita%ilit! for &se in secific test or
meas&rement roced&res8 and
1) s&ort for statements of the e-&ivalence of meas&rements of $ational ;etrolog! Instit&tes thro&gh <(e!
comarisons= and s&lementar! comarisons cond&cted on %ehalf of the International >&rea& of
?eights and ;eas&rement (>IP;) and associated regional metrolog! organizations#
Proficienc! testing involves the &se of interla%orator! comarisons for the determination of la%orator!
erformance' as listed in a) to g) a%ove# Proficienc! testing does not &s&all! address h)' i) and 1) %eca&se
la%orator! cometence is ass&med in these alications' %&t these alications can %e &sed to rovide
indeendent demonstrations of la%orator! cometence# 4he re-&irements of this International Standard can
%e alied to man! of the technical lanning and oerational activities for h)' i) and 1)#
4he need for ongoing confidence in la%orator! erformance is not onl! essential for la%oratories and their
c&stomers %&t also for other interested arties' s&ch as reg&lators' la%orator! accreditation %odies and other
organizations that secif! re-&irements for la%oratories# ISO+IEC 1.011 re-&ires accreditation %odies to ta(e
acco&nt of la%oratories7 articiation and erformance in roficienc! testing# 4here is a gro"ing need for
roficienc! testing for other conformit! assessment activities' s&ch as insection or rod&ct certification# ;ost
of the re-&irements in this International Standard al! to those evolving areas' eseciall! regarding
management' lanning and design' ersonnel' ass&ring -&alit!' confidentialit!' and other asects' as
aroriate#
4his International Standard has %een reared to rovide a consistent %asis for all interested arties to
determine the cometence of organizations that rovide roficienc! testing# In doing so it relaces %oth arts
of ISO+IEC *&ide 235166.# ISO+IEC *&ide 23 incl&ded not onl! g&idance on develoment and oeration of
roficienc! testing and selection and &se of roficienc! testing %! la%orator! accreditation %odies' %&t also
&sef&l descritions of t!ical t!es of roficienc! testing# 4his International Standard has reserved and
&dated the rinciles for the oeration of roficienc! testing descri%ed in ISO+IEC *&ide 23 and has retained
in )nne9es ) to C information on t!ical t!es of roficienc! testing schemes' g&idance on aroriate
statistical methods' selection and &se of roficienc! testing schemes %! la%oratories' accreditation %odies'
reg&lator! %odies' and other interested arties#

ISO/IEC 17043:2010(E)
Conformity assessment General reqirements for !rofi"ien"y
testin#
1 S"o!e
4his International Standard secifies general re-&irements for the cometence of roviders of roficienc!
testing schemes and for the develoment and oeration of roficienc! testing schemes# 4hese re-&irements
are intended to %e general for all t!es of roficienc! testing schemes' and the! can %e &sed as a %asis for
secific technical re-&irements for artic&lar fields of alication#
2 )ormati(e referen"es
4he follo"ing referenced doc&ments are indisensa%le for the alication of this doc&ment# For dated
references' onl! the edition cited alies# For &ndated references' the latest edition of the referenced
doc&ment (incl&ding an! amendments) alies#
ISO+IEC 1.00052002' Conformity assessment Vocabulary and general principles
ISO+IEC *&ide 665200.' International vocabulary of metrology Basic and general concepts and associated
terms (VIM)
3 *erms an& &efinitions
For the &roses of this doc&ment' the terms and definitions given in ISO+IEC 1.00052002'
ISO+IEC *&ide 665200. and the follo"ing al!#
3'1
assi#ne& (ale
val&e attri%&ted to a artic&lar roert! of a roficienc! test item
3'2
"oor&inator
one or more individ&als "ith resonsi%ilit! for organizing and managing all of the activities involved in the
oeration of a roficienc! testing scheme
3'3
"stomer
organization or individ&al for "hich a roficienc! testing scheme is rovided thro&gh a contract&al
arrangement
3'4
interla6oratory "om!arison
organization' erformance and eval&ation of meas&rements or tests on the same or similar items %! t"o or
more la%oratories in accordance "ith redetermined conditions
1 / 39
ISO/IEC 17043:2010(E)
3'/
otlier
o%servation in a set of data that aears to %e inconsistent "ith the remainder of that set
$O4E )n o&tlier can originate from a different o&lation or %e the res&lt of an incorrect recording or other gross
error#
3'1
!arti"i!ant
la%orator!' organization or individ&al that receives roficienc! test items and s&%mits res&lts for revie" %! the
roficienc! testing rovider
$O4E In some cases' the articiant can %e an insection %od!#
3'7
!rofi"ien"y testin#
eval&ation of articiant erformance against re-esta%lished criteria %! means of interla%orator! comarisons
$O4E 1 For the &roses of this International Standard' the term <roficienc! testing= is ta(en in its "idest sense and
incl&des' %&t is not limited to5
a) -&antitative scheme @ "here the o%1ective is to -&antif! one or more meas&rands of the roficienc! test item8
%) -&alitative scheme @ "here the o%1ective is to identif! or descri%e one or more characteristics of the roficienc! test
item8
c) se-&ential scheme @ "here one or more roficienc! test items are distri%&ted se-&entiall! for testing or
meas&rement and ret&rned to the roficienc! testing rovider at intervals8
d) sim&ltaneo&s scheme @ "here roficienc! test items are distri%&ted for conc&rrent testing or meas&rement "ithin a
defined time eriod8
e) single occasion e9ercise @ "here roficienc! test items are rovided on a single occasion8
f) contin&o&s scheme @ "here roficienc! test items are rovided at reg&lar intervals8
g) samling @ "here samles are ta(en for s&%se-&ent anal!sis8 and
h) data transformation and interretation @ "here sets of data or other information are f&rnished and the information is
rocessed to rovide an interretation (or other o&tcome)#
$O4E 2 Some roviders of roficienc! testing in the medical area &se the term <E9ternal A&alit! )ssessment (EA))=
for their roficienc! testing schemes' or for their %roader rogrammes' or %oth (see )nne9 ))# 4he re-&irements of this
International Standard cover onl! those EA) activities that meet the definition of roficienc! testing#
3'2
!rofi"ien"y test item
samle' rod&ct' artefact' reference material' iece of e-&iment' meas&rement standard' data set or other
information &sed for roficienc! testing
3'3
!rofi"ien"y testin# !ro(i&er
organization "hich ta(es resonsi%ilit! for all tas(s in the develoment and oeration of a roficienc! testing
scheme
3'10
!rofi"ien"y testin# ron&
single comlete se-&ence of distri%&tion of roficienc! test items' and the eval&ation and reorting of res&lts
to the articiants
2 / 39
ISO/IEC 17043:2010(E)
3'11
!rofi"ien"y testin# s"+eme
roficienc! testing designed and oerated in one or more ro&nds for a secified area of testing' meas&rement'
cali%ration or insection
$O4E ) roficienc! testing scheme might cover a artic&lar t!e of test' cali%ration' insection or a n&m%er of tests'
cali%rations or insections on roficienc! test items#
3'12
ro6st statisti"al met+o&
statistical method insensitive to small deart&res from &nderl!ing ass&mtions s&rro&nding an &nderl!ing
ro%a%ilistic model
3'13
stan&ar& &e(iation for !rofi"ien"y assessment
meas&re of disersion &sed in the eval&ation of res&lts of roficienc! testing' %ased on the availa%le
information
$O4E 1 4he standard deviation alies onl! to ratio and differential scale res&lts#
$O4E 2 $ot all roficienc! testing schemes eval&ate roficienc! %ased on the disersion of res&lts#
3'14
s6"ontra"tor
organization or individ&al engaged %! the roficienc! testing rovider to erform activities secified in this
International Standard and that affect the -&alit! of a roficienc! testing scheme
$O4E 4he term <s&%contractor= incl&des "hat man! roficienc! testing roviders call colla%orators#
3'1/
metrolo#i"al tra"ea6ility
roert! of a meas&rement res&lt "here%! the res&lt can %e related to a reference thro&gh a doc&mented
&n%ro(en chain of cali%rations' each contri%&ting to the meas&rement &ncertaint!
$O4E 1 For this definition' a <reference= can %e a definition of a meas&rement &nit thro&gh its ractical realization' or a
meas&rement roced&re incl&ding the meas&rement &nit for a non-ordinal -&antit!' or a meas&rement standard#
$O4E 2 ;etrological tracea%ilit! re-&ires an esta%lished cali%ration hierarch!#
$O4E 3 Secification of the reference m&st incl&de the time at "hich this reference "as &sed in esta%lishing the
cali%ration hierarch!' along "ith an! other relevant metrological information a%o&t the reference' s&ch as "hen the first
cali%ration in the cali%ration hierarch! "as erformed#
$O4E 2 For meas&rements "ith more than one in&t -&antit! in the meas&rement model' each of the in&t -&antit!
val&es sho&ld itself %e metrologicall! tracea%le and the cali%ration hierarch! involved ma! form a %ranched str&ct&re or a
net"or(# 4he effort involved in esta%lishing metrological tracea%ilit! for each in&t -&antit! val&e sho&ld %e commens&rate
"ith its relative contri%&tion to the meas&rement res&lt#
$O4E / ;etrological tracea%ilit! of a meas&rement res&lt does not ens&re that the meas&rement &ncertaint! is
ade-&ate for a given &rose or that there is an a%sence of mista(es#
$O4E B ) comarison %et"een t"o meas&rement standards ma! %e vie"ed as a cali%ration if the comarison is &sed
to chec( and' if necessar!' correct the -&antit! val&e and meas&rement &ncertaint! attri%&ted to one of the meas&rement
standards#
$O4E . 4he IC)C1) considers the elements for confirming metrological tracea%ilit! to %e an &n%ro(en metrological
tracea%ilit! chain to an international meas&rement standard or a national meas&rement standard' a doc&mented
meas&rement &ncertaint!' a doc&mented meas&rement roced&re' accredited technical cometence' metrological
tracea%ilit! to the SI' and cali%ration intervals (see IC)C P-1052002)#
3 / 39
ISO/IEC 17043:2010(E)
1) International Ca%orator! )ccreditation Cooeration#
4 / 39
ISO/IEC 17043:2010(E)
$O4E D 4he a%%reviated term <tracea%ilit!= is sometimes &sed to mean <metrological tracea%ilit!= as "ell as other
concets' s&ch as <samle tracea%ilit!= or <doc&ment tracea%ilit!= or <instr&ment tracea%ilit!= or <material tracea%ilit!='
"here the histor! (<trace=) of an item is meant# 4herefore' the f&ll term of <metrological tracea%ilit!= is referred if there is
an! ris( of conf&sion#
EISO+IEC *&ide 665200.' definition 2#21F
3'11
measrement n"ertainty
&ncertaint! of meas&rement
&ncertaint!
non-negative arameter characterizing the disersion of the -&antit! val&es %eing attri%&ted to a meas&rand'
%ased on the information &sed
$O4E 1 ;eas&rement &ncertaint! incl&des comonents arising from s!stematic effects' s&ch as comonents
associated "ith corrections and the assigned -&antit! val&es of meas&rement standards' as "ell as the definitional
&ncertaint!# Sometimes estimated s!stematic effects are not corrected for %&t' instead' associated meas&rement
&ncertaint! comonents are incororated#
$O4E 2 4he arameter ma! %e' for e9amle' a standard deviation called standard meas&rement &ncertaint! (or a
secified m&ltile of it)' or the half-"idth of an interval' having a stated coverage ro%a%ilit!#
$O4E 3 ;eas&rement &ncertaint! comrises' in general' man! comonents# Some of these ma! %e eval&ated %!
4!e ) eval&ation of meas&rement &ncertaint! from the statistical distri%&tion of the -&antit! val&es from series of
meas&rements and can %e characterized %! standard deviations# 4he other comonents' "hich ma! %e eval&ated %!
4!e > eval&ation of meas&rement &ncertaint!' can also %e characterized %! standard deviations' eval&ated from
ro%a%ilit! densit! f&nctions %ased on e9erience or other information#
$O4E 2 In general' for a given set of information' it is &nderstood that the meas&rement &ncertaint! is associated "ith
a stated -&antit! val&e attri%&ted to the meas&rand# ) modification of this val&e res&lts in a modification of the associated
&ncertaint!#
EISO+IEC *&ide 665200.' definition 2#2BF
4 *e"+ni"al ,eqirements
4'1 General
4he develoment and oeration of roficienc! testing schemes shall %e &nderta(en %! roficienc! testing
roviders having cometence to cond&ct interla%orator! comarisons and access to e9ertise "ith the
artic&lar t!e of roficienc! test items# Proficienc! testing roviders or their s&%contractors shall also have
cometence in the meas&rement of the roerties %eing determined#
$O4E ISO+IEC 1.02/ or ISO 1/1D6 can %e &sed to demonstrate the cometence of a roficienc! testing rovider7s
la%orator!' or the la%orator! s&%contracted to erform tests or meas&rements related to the roficienc! testing schemes#
ISO *&ide 32 can %e &sed to demonstrate the cometence of rod&cers of reference materials that rovide roficienc!
test items#
4'2 -ersonnel
4'2'1 4he roficienc! testing rovider shall have managerial and technical ersonnel "ith the necessar!
a&thorit!' reso&rces and technical cometence re-&ired to erform their d&ties#
4'2'2 4he roficienc! testing rovider7s management shall define the minim&m levels of -&alification and
e9erience necessar! for the (e! ositions "ithin its organization and ens&re those -&alifications are met#
4'2'3 4he roficienc! testing rovider shall &se ersonnel "ho are either emlo!ed %!' or &nder contract to
it# ?here contracted and additional technical and (e! s&ort ersonnel are &sed' the roficienc! testing
rovider shall ens&re that s&ch ersonnel are s&ervised and cometent and that the! "or( in accordance
"ith the management s!stem#
5 / 39
ISO/IEC 17043:2010(E)
$O4E ?here technical e9erts are &sed on an ad-hoc %asis or as art of an advisor! or steering gro& (see 2#2#1#2)'
the e9istence of formal agreements thro&gh' for e9amle' gro& terms of reference or other means' can %e considered to
satisf! this re-&irement#
4'2'4 4he roficienc! testing rovider shall a&thorize secific ersonnel to5
a) select aroriate roficienc! test items8
%) lan roficienc! testing schemes8
c) erform artic&lar t!es of samling8
d) oerate secific e-&iment8
e) cond&ct meas&rements to determine sta%ilit! and homogeneit!' as "ell as assigned val&es and
associated &ncertainties of the meas&rands of the roficienc! test item8
f) reare' handle and distri%&te roficienc! test items8
g) oerate the data rocessing s!stem8
h) cond&ct statistical anal!sis8
i) eval&ate the erformance of roficienc! testing articiants8
1) give oinions and interretations8 and
() a&thorize the iss&e of roficienc! testing reorts#
4'2'/ 4he roficienc! testing rovider shall maintain &-to-date records of the relevant a&thorization(s)'
cometence' ed&cational and rofessional -&alifications' training' s(ills and e9erience of all technical
ersonnel' incl&ding contracted ersonnel# 4his information shall %e readil! availa%le and shall incl&de the
date on "hich cometence to erform their assigned tas(s "as assessed and confirmed#
4'2'1 4he roficienc! testing rovider shall form&late the o%1ectives "ith resect to the ed&cation' training'
and s(ills for each staff mem%er involved "ith the oeration of the roficienc! testing scheme# 4he roficienc!
testing rovider shall have a olic! and roced&res for identif!ing training needs and roviding training of
ersonnel# 4he training rogramme shall %e relevant to the resent and anticiated needs of the roficienc!
testing rovider#
$O4E It is advisa%le to consider the need to retrain staff eriodicall!# Staff training olicies can ta(e acco&nt of
technological change' the need to demonstrate ongoing cometence and aim at contin&al s(ills &grading#
4'2'7 4he roficienc! testing rovider shall ens&re that staff receive the necessar! training to ens&re
cometent erformance of meas&rements' oeration of e-&iment and an! other activities "hich affect the
-&alit! of the roficienc! testing scheme# 4he effectiveness of training activities shall %e eval&ated#
$O4E O%1ective meas&res can %e &sed to assess the attainment of cometence#
4'3 Eqi!ment. a""ommo&ation an& en(ironment
4'3'1 4he roficienc! testing rovider shall ens&re that there is aroriate accommodation for the
oeration of the roficienc! testing scheme# 4his incl&des facilities and e-&iment for roficienc! test item
man&fact&ring' handling' cali%ration' testing' storage and desatch' for data rocessing' for comm&nications'
and for retrieval of materials and records#
4'3'2 4he roficienc! testing rovider shall ens&re that the environmental conditions do not comromise the
roficienc! testing scheme or the re-&ired -&alit! of oerations# Partic&lar care shall %e ta(en "hen
oerations are &nderta(en at sites a"a! from the roficienc! testing rovider7s ermanent facilities or are
6 / 39
ISO/IEC 17043:2010(E)
&nderta(en %! s&%contractors# 4he technical re-&irements for accommodation and environmental conditions
that can affect the roficienc! testing shall %e doc&mented#
4'3'3 )ccess to and &se of areas affecting the -&alit! of roficienc! testing schemes shall %e controlled#
4he roficienc! testing rovider shall determine the e9tent of control %ased on its artic&lar circ&mstances#
4'3'4 4he roficienc! testing rovider shall identif! environmental conditions that can significantl! infl&ence
the -&alit! of the roficienc! test items and an! testing and cali%ration carried o&t' incl&ding conditions that are
re-&ired %! relevant secifications and meas&rement roced&res# 4he roficienc! testing rovider shall
control and monitor these conditions' and shall record all relevant monitoring activities# Gelevant roficienc!
testing activities shall %e stoed "hen the environmental conditions 1eoardize the -&alit! or the oerations
of the roficienc! testing scheme#
$O4E Conditions can incl&de' for e9amle' %iological sterilit!' d&st' electromagnetic dist&r%ances' radiation' h&midit!'
electrical s&l!' temerat&re' and so&nd and vi%rations levels' as aroriate to the technical activities concerned#
4'3'/ 4here shall %e effective searation %et"een neigh%o&ring areas in "hich there are incomati%le
activities# )ction shall %e ta(en to revent cross-contamination#
4'3'1 Proficienc! testing roviders shall ens&re that erformance characteristics of la%orator! methods and
e-&iment &sed to confirm the content' homogeneit! and sta%ilit! of roficienc! testing items are aroriatel!
validated and maintained.
4'4 0esi#n of !rofi"ien"y testin# s"+emes
4'4'1 -lannin#
4'4'1'1 4he roficienc! testing rovider shall identif! and lan those rocesses "hich directl! affect the
-&alit! of the roficienc! testing scheme and shall ens&re that the! are carried o&t in accordance "ith
rescri%ed roced&res#
$O4E Sta(eholders7 interests can %e considered in develoing a lan and relevant information#
4'4'1'2 4he roficienc! testing rovider shall not s&%contract the lanning of the roficienc! testing
scheme (see /#/#2)#
$O4E 4he roficienc! testing rovider can &tilize advice or assistance from an! advisors' e9erts or steering gro&
(see 2#2#1#2)#
4'4'1'3 4he roficienc! testing rovider shall doc&ment a lan %efore commencement of the roficienc!
testing scheme that addresses the o%1ectives' &rose and %asic design of the roficienc! testing scheme'
incl&ding the follo"ing information and' "here aroriate' reasons for its selection or e9cl&sion5
a) the name and address of the roficienc! testing rovider8
%) the name' address and affiliation of the coordinator and other ersonnel involved in the design and
oeration of the roficienc! testing scheme8
c) the activities to %e s&%contracted and the names and addresses of s&%contractors involved in the
oeration of the roficienc! testing scheme8
d) criteria to %e met for articiation8
e) the n&m%er and t!e of e9ected articiants in the roficienc! testing scheme8
f) selection of the meas&rand(s) or characteristic(s) of interest' incl&ding information on "hat the
articiants are to identif!' meas&re' or test for in the secific roficienc! testing ro&nd8
7 / 39
ISO/IEC 17043:2010(E)
g) a descrition of the range of val&es or characteristics' or %oth' to %e e9ected for the roficienc! test
items8
h) the otential ma1or so&rces of errors involved in the area of roficienc! testing offered8
i) re-&irements for the rod&ction' -&alit! control' storage and distri%&tion of roficienc! test items8
1) reasona%le reca&tions to revent coll&sion %et"een articiants or falsification of res&lts' and
roced&res to %e emlo!ed if coll&sion or falsification of res&lts is s&sected8
() a descrition of the information "hich is to %e s&lied to articiants and the time sched&le for the
vario&s hases of the roficienc! testing scheme8
l) for contin&o&s roficienc! testing schemes' the fre-&enc! or dates &on "hich roficienc! test items are
to %e distri%&ted to articiants' the deadlines for the ret&rn of res&lts %! articiants and' "here
aroriate' the dates on "hich testing or meas&rement is to %e carried o&t %! articiants8
m) an! information on methods or roced&res "hich articiants need to &se to reare the test material and
erform the tests or meas&rements8
n) roced&res for the test or meas&rement methods to %e &sed for the homogeneit! and sta%ilit! testing of
roficienc! test items and' "here alica%le' to determine their %iological via%ilit!8
o) rearation of an! standardized reorting formats to %e &sed %! articiants8
) a detailed descrition of the statistical anal!sis to %e &sed8
-) the origin' metrological tracea%ilit! and meas&rement &ncertaint! of an! assigned val&es8
r) criteria for the eval&ation of erformance of articiants8
s) a descrition of the data' interim reorts or information to %e ret&rned to articiants8
t) a descrition of the e9tent to "hich articiant res&lts' and the concl&sions that "ill %e %ased on the
o&tcome of the roficienc! testing scheme' are to %e made &%lic8 and
&) actions to %e ta(en in the case of lost or damaged roficienc! test items#
4'4'1'4 4he roficienc! testing rovider shall have access to the necessar! technical e9ertise and
e9erience in the relevant field of testing' cali%ration' samling or insection' as "ell as statistics# 4his ma! %e
achieved' if necessar!' %! esta%lishing an advisor! gro& (named as aroriate)#
4'4'1'/ 4echnical e9ertise shall %e &sed' as aroriate' to determine matters s&ch as the follo"ing5
a) lanning re-&irements as listed in 2#2#1#38
%) identification and resol&tion of an! diffic&lties e9ected in the rearation and maintenance of
homogeneo&s roficienc! test items' or in the rovision of a sta%le assigned val&e for a roficienc! test
item8
c) rearation of detailed instr&ctions for articiants8
d) comments on an! technical diffic&lties or other remar(s raised %! articiants in revio&s roficienc!
testing ro&nds8
e) rovision of advice in eval&ating the erformance of articiants8
f) comments on the res&lts and erformance of articiants as a "hole and' "here aroriate' gro&s of
articiants or individ&al articiants8
8 / 39
ISO/IEC 17043:2010(E)
g) rovision of advice for articiants ("ithin limits of confidentialit!)' either individ&all! or "ithin the reort8
h) resonding to feed%ac( from articiants8 and
i) lanning or articiating in technical meetings "ith articiants#
4'4'2 -re!aration of !rofi"ien"y test items
4'4'2'1 4he roficienc! testing rovider shall esta%lish and imlement roced&res to ens&re that
roficienc! test items are reared in accordance "ith the lan descri%ed in 2#2#1#
$O4E It is advisa%le that the roficienc! testing rovider give d&e consideration to the rearation of s&fficient
n&m%ers of roficienc! test items' in order to allo" for the need to relace an! s&ch roficienc! test items lost or damaged
d&ring distri%&tion' or intended to %e rovided for &se after the res&lts of the roficienc! testing scheme have %een
eval&ated# S&ch &ses can incl&de training aids for articiants or &se as a reference material#
4'4'2'2 4he roficienc! testing rovider shall esta%lish and imlement roced&res to ens&re aroriate
ac-&isition' collection' rearation' handling' storage and' "here re-&ired' disosal of all roficienc! test items#
4he roced&res shall ens&re that materials &sed to man&fact&re roficienc! test items are o%tained in
accordance "ith relevant reg&lator! and ethical re-&irements#
4'4'2'3 Proficienc! test items sho&ld match in terms of matri9' meas&rands and concentrations' as
closel! as ractica%le' the t!e of items or materials enco&ntered in ro&tine testing or cali%ration#
4'4'2'4 In roficienc! testing schemes that re-&ire articiants to reare or mani&late' or %oth reare
and mani&late' the roficienc! test item and s&%mit it to the roficienc! testing rovider' the roficienc!
testing rovider shall iss&e instr&ctions for rearation' ac(aging and transort of the roficienc! test item#
4'4'3 ;omo#eneity an& sta6ility
4'4'3'1 Criteria for s&ita%le homogeneit! and sta%ilit! shall %e esta%lished and shall %e %ased on the
effect that inhomogeneit! and insta%ilit! "ill have on the eval&ation of the articiants7 erformance#
$O4E 1 4he re-&irements in this s&%cla&se are intended to ens&re that ever! articiant receives comara%le
roficienc! test items' and that these roficienc! test items remain sta%le thro&gho&t the roficienc! testing# Caref&l
lanning' man&fact&re and shiing are necessar! to achieve this' and testing is &s&all! needed to confirm it#
$O4E 2 In some cases' it is not feasi%le for roficienc! test items to %e s&%1ected to homogeneit! and sta%ilit! testing#
S&ch cases "o&ld incl&de' for e9amle' "hen limited material is availa%le to reare roficienc! testing items#
$O4E 3 In some cases' materials that are not s&fficientl! homogeneo&s or sta%le are the %est availa%le8 in s&ch cases'
the! can still %e &sef&l as roficienc! test items' rovided that the &ncertainties of the assigned val&es or the eval&ation of
res&lts ta(e d&e acco&nt of this (see >#3#1#3 and ISO 13/2D5200/' )nne9 >)#
$O4E 2 Considerations for homogeneit! and sta%ilit! are f&rther disc&ssed in ISO *&ide 32' ISO *&ide 3/ and
ISO 13/2D#
4'4'3'2 4he roced&res for the assessment of homogeneit! and sta%ilit! shall %e doc&mented and
cond&cted' "here alica%le' in accordance "ith aroriate statistical designs# ?here ossi%le' the
roficienc! testing rovider shall &se a statisticall! random selection of a reresentative n&m%er of roficienc!
test items from the "hole %atch of test material in order to assess the homogeneit! of the material#
$O4E In some cases' the &se of a random stratified or s!stematic selection of roficienc! test items from the "hole
%atch is more aroriate#
4'4'3'3 4he assessment of homogeneit! shall normall! %e erformed after the roficienc! test items have
%een ac(aged in the final form and %efore distri%&tion to articiants &nless' for e9amle' sta%ilit! st&dies
indicate that the! sho&ld %e stored in %&l( form#
9 / 39
ISO/IEC 17043:2010(E)
$O4E 1 Homogeneit! can %e demonstrated rior to ac(aging "here no infl&ence of ac(aging is reasona%l!
e9ected#
$O4E 2 On some occasions' homogeneit! testing cannot %e carried o&t rior to distri%&tion for ractical' technical or
logistical reasons#
4'4'3'4 Proficienc! test items shall %e demonstrated to %e s&fficientl! sta%le to ens&re that the! "ill not
&ndergo an! significant change thro&gho&t the cond&ct of the roficienc! testing' incl&ding storage and
transort conditions# ?hen this is not ossi%le' the sta%ilit! shall %e -&antified and considered as an additional
comonent of the meas&rement &ncertaint! associated "ith the assigned val&e of the roficienc! test item'
and+or ta(en into acco&nt in the eval&ation criteria#
4'4'3'/ ?hen roficienc! test items from revio&s ro&nds are retained for f&t&re &se' the roert! val&es
to %e determined in the roficienc! testing scheme shall %e confirmed %! the roficienc! testing rovider rior
to distri%&tion#
4'4'3'1 In circ&mstances "here homogeneit! and sta%ilit! testing is not feasi%le' the roficienc! testing
rovider shall demonstrate that the roced&res &sed to collect' rod&ce' ac(age and distri%&te the
roficienc! test items are s&fficient for the &rose of the roficienc! testing#
4'4'4 Statisti"al &esi#n
4'4'4'1 Statistical designs shall %e develoed to meet the o%1ectives of the scheme' %ased on the nat&re
of the data (-&antitative or -&alitative' incl&ding ordinal and categorical)' statistical ass&mtions' the nat&re of
errors' and the e9ected n&m%er of res&lts (see >#3#2#2)#
$O4E 1 Statistical design covers the rocess of lanning' collection' anal!sis and reorting of the roficienc! testing
scheme data# Statistical designs are often %ased on stated o%1ectives for the roficienc! testing scheme' s&ch as detection
of certain t!es of errors "ith secified o"er or determination of assigned val&es "ith secified meas&rement &ncertaint!#
$O4E 2 ,ata anal!sis methods co&ld var! from the ver! simle (e#g# descritive statistics) to the comle9' &sing
statistical models "ith ro%a%ilistic ass&mtions or com%inations of res&lts for different roficienc! test items#
$O4E 3 In cases "here the roficienc! testing scheme design is mandated %! a secification given %!' for e9amle' a
c&stomer' reg&lator! a&thorit! or accreditation %od!' the statistical design and data anal!sis methods can %e ta(en directl!
from the secification#
$O4E 2 In the a%sence of relia%le information needed to rod&ce a statistical design' a reliminar! interla%orator!
comarison can %e &sed#
4'4'4'2 4he roficienc! testing rovider shall doc&ment the statistical design and data anal!sis methods
to %e &sed to identif! the assigned val&e and eval&ate articiant res&lts' and shall rovide a descrition of
the reasons for their selection and ass&mtions &on "hich the! are %ased# 4he roficienc! testing rovider
shall %e a%le to demonstrate that statistical ass&mtions are reasona%le and that statistical anal!ses are
carried o&t in accordance "ith rescri%ed roced&res#
4'4'4'3 In designing a statistical anal!sis' the roficienc! testing rovider shall give caref&l consideration
to the follo"ing5
a) the acc&rac! (tr&eness and recision) as "ell as the meas&rement &ncertaint! re-&ired or e9ected for
each meas&rand or characteristic in the roficienc! testing8
%) the minim&m n&m%er of articiants in the roficienc! testing scheme needed to meet the o%1ectives of
the statistical design8 in cases "here there is an ins&fficient n&m%er of articiants to meet these
o%1ectives or to rod&ce statisticall! meaningf&l anal!sis of res&lts' the roficienc! testing rovider shall
doc&ment' and rovide to articiants' details of the alternative aroaches &sed to assess articiant
erformance8
c) the relevance of significant fig&res to the reorted res&lt' incl&ding the n&m%er of decimal laces8
10 / 39
ISO/IEC 17043:2010(E)
d) the n&m%er of roficienc! test items to %e tested or meas&red and the n&m%er of reeat tests' cali%rations
or meas&rements to %e cond&cted on each roficienc! test item or for each determination8
e) the roced&res &sed to esta%lish the standard deviation for roficienc! assessment or other eval&ation
criteria8
f) roced&res to %e &sed to identif! or handle o&tliers' or %oth8
g) "here relevant' the roced&res for the eval&ation of val&es e9cl&ded from statistical anal!sis8 and
h) "here aroriate' the o%1ectives to %e met for the design and the fre-&enc! of roficienc! testing ro&nds#
4'4'/ 8ssi#ne& (ales
4'4'/'1 4he roficienc! testing rovider shall doc&ment the roced&re for determining the assigned
val&es for the meas&rands or characteristics in a artic&lar roficienc! testing scheme# 4his roced&re shall
ta(e into acco&nt the metrological tracea%ilit! and meas&rement &ncertaint! re-&ired to demonstrate that the
roficienc! testing scheme is fit for its &rose#
$O4E ;etrological tracea%ilit! is not al"a!s ossi%le or aroriate#
4'4'/'2 Proficienc! testing schemes in the area of cali%ration shall have assigned val&es "ith
metrological tracea%ilit!' incl&ding meas&rement &ncertaint!#
4'4'/'3 For roficienc! testing schemes in areas other than cali%ration' the relevance' needs and
feasi%ilit! for metrological tracea%ilit! and associated meas&rement &ncertaint! of the assigned val&e shall %e
determined %! ta(ing into acco&nt secified re-&irements of articiants or other interested arties' or %! the
design of the roficienc! testing scheme#
$O4E 4he re-&ired metrological tracea%ilit! chain can differ deending on the t!e of roficienc! test item' the
meas&rand or characteristic' and the availa%ilit! of tracea%le cali%rations and reference materials#
4'4'/'4 ?hen a consens&s val&e is &sed as the assigned val&e (see )nne9 >)' the roficienc! testing
rovider shall doc&ment the reason for that selection and shall estimate the &ncertaint! of the assigned val&e
as descri%ed in the lan for the roficienc! testing scheme#
4'4'/'/ 4he roficienc! testing rovider shall have a olic! regarding the disclos&re of assigned val&es#
4he olic! shall ens&re that articiants cannot gain advantage from earl! disclos&re#
4'/ C+oi"e of met+o& or !ro"e&re
4'/'1 Particiants shall normall! %e e9ected to &se the test method' cali%ration or meas&rement roced&re
of their choice' "hich sho&ld %e consistent "ith their ro&tine roced&res# 4he roficienc! testing rovider ma!
instr&ct articiants to &se a secified method in accordance "ith the design of the roficienc! testing scheme#
4'/'2 ?here articiants are ermitted to &se a method of their choice' the roficienc! testing rovider
shall5
a) have a olic! and follo" a roced&re regarding comarison of res&lts o%tained %! different test or
meas&rement methods8
%) %e a"are of "hich different test or meas&rement methods for an! meas&rand are technicall! e-&ivalent'
and ta(e stes to assess articiants7 res&lts &sing these methods accordingl!#
11 / 39
ISO/IEC 17043:2010(E)
4'1 O!eration of !rofi"ien"y testin# s"+emes
4'1'1 Instr"tions for !arti"i!ants
4'1'1'1 4he roficienc! testing rovider shall give articiants s&fficient rior notice %efore sending
roficienc! test items' roviding the date on "hich the roficienc! test items are li(el! to arrive or to %e
desatched' &nless the design of the roficienc! testing scheme ma(es it inaroriate to do so#
4'1'1'2 4he roficienc! testing rovider shall give detailed doc&mented instr&ctions to all articiants#
Instr&ctions to articiants shall incl&de5
a) the necessit! to treat roficienc! test items in the same manner as the ma1orit! of ro&tinel! tested
samles (&nless there are artic&lar re-&irements of the roficienc! testing scheme "hich re-&ire
deart&re from this rincile)8
%) details of factors "hich co&ld infl&ence the testing or cali%ration of the roficienc! test items' e#g# the
nat&re of the roficienc! test items' conditions of storage' "hether the roficienc! testing scheme is
limited to selected test methods' and the timing of the testing or meas&rement8
c) detailed roced&re for rearing or conditioning' or %oth rearing and conditioning' of the roficienc! test
items %efore cond&cting the tests or cali%rations8
d) an! aroriate instr&ctions on handling the roficienc! test items' incl&ding an! safet! re-&irements8
e) an! secific environmental conditions for the articiant to cond&ct tests or cali%rations' or %oth' and' if
relevant' an! re-&irement for the articiants to reort relevant environmental conditions d&ring the time
of the meas&rement8
f) secific and detailed instr&ctions on the manner of recording and reorting test or meas&rement res&lts
and associated &ncertainties# If the instr&ctions incl&de reorting of the &ncertaint! of the reorted res&lt
or meas&rement' this shall incl&de the coverage factor and' "henever ractica%le' the coverage
ro%a%ilit!8
$O4E 4his instr&ction &s&all! incl&des arameters s&ch as the &nits of meas&rement' the n&m%er of significant
fig&res or decimal laces and reorting %asis (e#g# on dr! "eight' or <as received=)#
g) the latest date for the rovider to receive the roficienc! testing or meas&rement res&lts for anal!sis8
h) information on the contact details of the roficienc! testing rovider for en-&iries8 and
i) instr&ctions on ret&rn of the roficienc! test items' "hen alica%le#
4'1'2 -rofi"ien"y test items +an&lin# an& stora#e
4'1'2'1 4he roficienc! testing rovider shall ens&re that roficienc! test items are aroriatel! identified
and segregated and cannot %ecome contaminated or degraded' from the time of rearation to their
distri%&tion to articiants#
4'1'2'2 4he roficienc! testing rovider shall rovide sec&re storage areas or stoc( rooms' or %oth' "hich
revent damage or deterioration of an! roficienc! test item %et"een rearation and distri%&tion# )roriate
roced&res for a&thorizing desatch to' and receit from' s&ch areas shall %e defined#
4'1'2'3 ?hen aroriate' the condition of stored or stoc(ed roficienc! test items' chemicals and
materials shall %e assessed at secified intervals d&ring their storage life in order to detect ossi%le
deterioration#
4'1'2'4 ?here otentiall! hazardo&s roficienc! test items' chemicals and materials are &sed' facilities
shall %e availa%le to ens&re their safe handling' decontamination and disosal#
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ISO/IEC 17043:2010(E)
4'1'3 -a"7a#in#. la6ellin# an& &istri6tion of !rofi"ien"y test items
4'1'3'1 4he roficienc! testing rovider shall control ac(aging and la%elling rocesses to the e9tent
necessar! to ens&re conformit! "ith relevant national' regional' or international safet! and transort
re-&irements#
$O4E 4he roer distri%&tion of roficienc! test items can resent severe ro%lems for some t!es of material' e#g#
those "hich re-&ire &ninterr&ted storage in cold conditions or "hich sho&ld not %e e9osed to I-ra!s' shoc( or vi%ration#
;ost t!es of chemical materials "o&ld %enefit from air-tight ac(aging to avoid contamination %! atmosheric
contaminants' e#g# f&el vao&rs or engine e9ha&st gases "hich can %e enco&ntered d&ring transort#
4'1'3'2 4he roficienc! testing rovider shall secif! relevant environmental conditions for the transort of
roficienc! test items# ?here relevant' the roficienc! testing rovider shall monitor the ertinent
environmental conditions of the roficienc! test item d&ring transort and assess the imact of environmental
infl&ences on the roficienc! test item#
4'1'3'3 In roficienc! testing schemes "here articiants are re-&ired to transort the roficienc! test
items to other articiants' doc&mented instr&ctions for this transort shall %e s&lied#
4'1'3'4 4he roficienc! testing rovider shall ens&re that la%els are sec&rel! attached to the ac(aging of
individ&al roficienc! test items and are designed to remain legi%le and intact thro&gho&t the roficienc!
testing ro&nd#
4'1'3'/ 4he roficienc! testing rovider shall follo" a roced&re to ena%le the confirmation of deliver! of
the roficienc! test items#
$O4E 4his co&ld %e achieved in accordance "ith 2#B#1#1 %! as(ing articiants to inform the roficienc! testing
rovider if roficienc! test items have not %een received in line "ith the sched&le of dates rovided#
4'7 0ata analysis an& e(alation of !rofi"ien"y testin# s"+eme reslts
4'7'1 0ata analysis an& re"or&s
4'7'1'1 )ll data rocessing e-&iment and soft"are shall %e validated in accordance "ith roced&res
%efore %eing %ro&ght into &se# Com&ter s!stem maintenance shall incl&de a %ac(-& rocess and s!stem
recover! lan# 4he res&lts of s&ch maintenance and oerational chec(s shall %e recorded#
4'7'1'2 Ges&lts received from articiants shall %e recorded and anal!sed %! aroriate methods#
Proced&res shall %e esta%lished and imlemented to chec( the validit! of data entr!' data transfer' statistical
anal!sis' and reorting#
4'7'1'3 ,ata anal!sis shall generate s&mmar! statistics and erformance statistics' and associated
information consistent "ith the statistical design of the roficienc! testing scheme#
4'7'1'4 4he infl&ence of o&tliers on s&mmar! statistics shall %e minimized %! the &se of ro%&st statistical
methods or aroriate tests to detect statistical o&tliers#
4'7'1'/ 4he roficienc! testing rovider shall have doc&mented criteria and roced&res for dealing "ith
test res&lts that ma! %e inaroriate for statistical eval&ation' e#g# miscalc&lations' transositions and other
gross errors#
4'7'1'1 4he roficienc! testing rovider shall have doc&mented criteria and roced&res to identif! and
manage roficienc! test items that have %een distri%&ted and are s&%se-&entl! fo&nd to %e &ns&ita%le for
erformance eval&ation' e#g# %eca&se of inhomogeneit!' insta%ilit!' damage or contamination#
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ISO/IEC 17043:2010(E)
4'7'2 E(alation of !erforman"e
4'7'2'1 4he roficienc! testing rovider shall &se valid methods of eval&ation "hich meet the &rose of
the roficienc! testing scheme# 4he methods shall %e doc&mented and incl&de a descrition of the %asis for
the eval&ation# 4he eval&ation of erformance shall not %e s&%contracted (see /#/#2)#
4'7'2'2 ?here aroriate for the &rose of the roficienc! testing scheme' the roficienc! testing
rovider shall rovide e9ert commentar! on the erformance of articiants "ith regard to the follo"ing5
a) overall erformance against rior e9ectations' ta(ing meas&rement &ncertainties into acco&nt8
%) variation "ithin and %et"een articiants' and comarisons "ith an! revio&s roficienc! testing ro&nds'
similar roficienc! testing schemes' or &%lished recision data8
c) variation %et"een methods or roced&res8
d) ossi%le so&rces of error ("ith reference to o&tliers) and s&ggestions for imroving erformance8
e) advice and ed&cational feed%ac( to articiants as art of the contin&al imrovement roced&res of
articiants8
f) sit&ations "here &n&s&al factors ma(e eval&ation of res&lts and commentar! on erformance imossi%le8
g) an! other s&ggestions' recommendations or general comments8 and
h) concl&sions#
$O4E It can %e &sef&l to rovide individ&al s&mmar! sheets for articiants eriodicall! d&ring or after comletion of
a artic&lar roficienc! testing scheme# 4hese can incl&de &dated s&mmaries of erformance for individ&al articiants
over s&ccessive roficienc! testing ro&nds of a contin&o&s roficienc! testing scheme# S&ch s&mmaries can %e f&rther
anal!sed and trends highlighted' if re-&ired#
4'2 ,e!orts
4'2'1 Proficienc! test reorts shall %e clear and comrehensive and incl&de data covering the res&lts of all
articiants' together "ith an indication of the erformance of individ&al articiants# 4he a&thorization of the
final reort shall not %e s&%contracted (see /#/#2)#
$O4E ?here all original data cannot %e reorted to articiants' a s&mmar! of the res&lts' e#g# in ta%&lated or
grahical form' can %e s&lied#
4'2'2 Georts shall incl&de the follo"ing' &nless it is not alica%le or the roficienc! testing rovider has
valid reasons for not doing so5
a) the name and contact details for the roficienc! testing rovider8
%) the name and contact details for the coordinator8
c) the name(s)' f&nction(s)' and signat&re(s) or e-&ivalent identification of erson(s) a&thorizing the reort8
d) an indication of "hich activities are s&%contracted %! the roficienc! testing rovider8
e) the date of iss&e and stat&s (e#g# reliminar!' interim' or final) of the reort8
f) age n&m%ers and a clear indication of the end of the reort8
g) a statement of the e9tent to "hich res&lts are confidential8
h) the reort n&m%er and clear identification of the roficienc! testing scheme8
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ISO/IEC 17043:2010(E)
i) a clear descrition of the roficienc! test items &sed' incl&ding necessar! details of the roficienc! test
item7s rearation and homogeneit! and sta%ilit! assessment8
1) the articiants7 res&lts8
() statistical data and s&mmaries' incl&ding assigned val&es and range of acceta%le res&lts and grahical
disla!s8
l) roced&res &sed to esta%lish an! assigned val&e8
m) details of the metrological tracea%ilit! and meas&rement &ncertaint! of an! assigned val&e8
n) roced&res &sed to esta%lish the standard deviation for roficienc! assessment' or other criteria for
eval&ation8
o) assigned val&es and s&mmar! statistics for test methods+roced&res &sed %! each gro& of articiants
(if different methods are &sed %! different gro&s of articiants)8
) comments on articiants7 erformance %! the roficienc! testing rovider and technical advisers8
-) information a%o&t the design and imlementation of the roficienc! testing scheme8
r) roced&res &sed to statisticall! anal!se the data8
s) advice on the interretation of the statistical anal!sis8 and
t) comments or recommendations' %ased on the o&tcomes of the roficienc! testing ro&nd#
$O4E For contin&o&s roficienc! testing schemes' it can %e s&fficient to have simler reorts' s&ch that man! of the
elements in this cla&se co&ld %e e9cl&ded from ro&tine reorts' %&t incl&ded in roficienc! testing scheme rotocols or in
eriodic s&mmar! reorts that are availa%le to articiants#
4'2'3 Georts shall %e made availa%le to articiants "ithin lanned timescales# In se-&ential roficienc!
testing schemes' e#g# "here the t&rn-aro&nd time ma! %e ver! long' and in schemes involving erisha%le
materials' reliminar! or anticiated res&lts ma! %e rovided %efore final res&lts are disclosed#
$O4E 4his allo"s for earl! investigation of ossi%le error#
4'2'4 4he roficienc! testing rovider shall have a olic! for the &se of reorts %! individ&als and
organizations#
4'2'/ ?hen it is necessar! to iss&e a ne" or amended reort for a roficienc! testing scheme' this shall
incl&de the follo"ing5
a) a &ni-&e identification8
%) a reference to the original reort that it relaces or amends8 and
c) a statement concerning the reason for the amendment or re-iss&e#
4'3 Commni"ation %it+ !arti"i!ants
4'3'1 4he roficienc! testing rovider shall ma(e detailed information availa%le a%o&t the roficienc! testing
scheme# 4his shall incl&de5
a) relevant details of the scoe of the roficienc! testing scheme8
%) an! fees for articiation8
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ISO/IEC 17043:2010(E)
c) doc&mented eligi%ilit! criteria for articiation8
d) confidentialit! arrangements8 and
e) details of ho" to al!#
4'3'2 Particiants shall %e advised romtl! %! the roficienc! testing rovider of an! changes in roficienc!
testing scheme design or oeration#
4'3'3 4here shall %e doc&mented roced&res for ena%ling articiants to aeal against the eval&ation of
their erformance in a roficienc! testing scheme# 4he availa%ilit! of this rocess shall %e comm&nicated to
roficienc! testing scheme articiants#
4'3'4 Gelevant records of comm&nications "ith articiants shall %e maintained and retained' as
aroriate#
4'3'/ If the roficienc! testing rovider iss&es statements of articiation or erformance' the! shall contain
s&fficient information to not %e misleading#
4'10 Confi&entiality
4'10'1 4he identit! of articiants in a roficienc! testing scheme shall %e confidential and (no"n onl! to
ersons involved in the oeration of the roficienc! testing scheme' &nless the articiant "aives
confidentialit!#
4'10'2 )ll information s&lied %! a articiant to the roficienc! testing rovider shall %e treated as
confidential#
$O4E Particiants can elect to "aive confidentialit! "ithin the roficienc! testing scheme for the &roses of
disc&ssion and m&t&al assistance' e#g# to imrove erformance# Confidentialit! can also %e "aived %! the articiant for
reg&lator! or recognition &roses# In most instances' the roficienc! testing res&lts can %e rovided to the relevant
a&thorit! %! the articiants themselves#
4'10'3 ?hen an interested art! re-&ires the roficienc! testing res&lts to %e directl! rovided %! the
roficienc! testing rovider' the articiants shall %e made a"are of the arrangement in advance of
articiation#
4'10'4 In e9cetional circ&mstances' "hen a reg&lator! a&thorit! re-&ires roficienc! testing res&lts to %e
directl! rovided to the a&thorit! %! the roficienc! testing rovider' the affected articiants shall %e notified
of this action in "riting.
/ 4ana#ement reqirements
/'1 Or#ani5ation
/'1'1 4he roficienc! testing rovider' or the organization of "hich it is art' shall %e an entit! that is legall!
identifia%le and acco&nta%le#
/'1'2 It is the resonsi%ilit! of the roficienc! testing rovider to carr! o&t its roficienc! testing oerations in
s&ch a "a! as to meet the re-&irements of this International Standard and to satisf! the needs of the
articiants' reg&lator! a&thorities and organizations roviding recognition#
/'1'3 4he management s!stem shall cover "or( carried o&t in the roficienc! testing rovider7s ermanent
facilities' at sites a"a! from its ermanent facilities' and in associated temorar! facilities#
/'1'4 If the roficienc! testing rovider is art of an organization erforming other activities' then the
roficienc! testing rovider shall identif! the resonsi%ilities of (e! ersonnel in the organization that have an
16 / 39
ISO/IEC 17043:2010(E)
involvement in or co&ld have infl&ence on the roficienc! test activities' in order to identif! otential conflicts of
interest# ?here otential conflicts of interest are identified' roced&res shall %e &t in lace to ens&re that all
activities of the roficienc! testing rovider are cond&cted "ith imartialit!#
/'1'/ 4he roficienc! testing rovider shall5
a) have managerial and technical ersonnel "ho' irresective of other resonsi%ilities' have the a&thorit!
and reso&rces needed to carr! o&t their d&ties' incl&ding the imlementation' maintenance and
imrovement of the management s!stem' and to identif! the occ&rrence of deart&res from the
management s!stem or from the roced&res for roviding roficienc! testing schemes' and to initiate
actions to revent or minimize s&ch deart&res8
%) have arrangements to ens&re that its management and ersonnel are free from an! &nd&e internal or
e9ternal commercial' financial and other ress&res that ma! adversel! affect the -&alit! of their "or(8
c) have olicies and roced&res to ens&re the rotection of its articiants7 confidential information and
rorietar! rights' incl&ding roced&res for their rotection d&ring electronic storage and transmission8
d) have olicies and roced&res to avoid involvement in an! activities that might diminish confidence in its
cometence' imartialit!' 1&dgement or oerational integrit!8
e) define the organization and management str&ct&re' its lace in an! arent organization' and the
relationshis %et"een -&alit! management' technical oerations and s&ort services8
f) secif! the resonsi%ilit!' a&thorit!' interrelationshis and re-&ired cometence of all ersonnel "ho
manage' erform or verif! "or( affecting the -&alit! of the oeration of roficienc! testing schemes8
g) ens&re that the ersonnel are a"are of the relevance and imortance of their activities and ho" the!
contri%&te to the achievement of the o%1ectives of the management s!stem8
h) rovide ade-&ate s&ervision of technical staff' incl&ding trainees' %! ersons familiar "ith roced&res for
each activit!8
i) have technical management "hich has overall resonsi%ilit! for the technical oerations and the rovision
of the reso&rces needed to ens&re the re-&ired -&alit! of roficienc! testing schemes' incl&ding access to
the necessar! technical e9ertise and e9erience in the relevant field of testing' cali%ration or insection'
as "ell as statistics' as indicated in 2#2#1#28
1) aoint a mem%er of staff as -&alit! manager (named as aroriate) "ho' irresective of other d&ties
and resonsi%ilities' shall have defined resonsi%ilit! and a&thorit! for ens&ring that the management
s!stem is imlemented and follo"ed at all times8 the -&alit! manager shall have direct access to the
highest level of management at "hich decisions are ta(en on the roficienc! testing rovider7s olicies or
reso&rces8 and
() aoint de&ties for (e! managerial ersonnel#
$O4E ?here roficienc! testing roviders have a small n&m%er of ersonnel' individ&als can have more than one
f&nction and it can %e imractical to aoint de&ties for all ma1or f&nctions#
/'1'1 4o management shall ens&re that aroriate comm&nication rocesses are esta%lished "ithin the
organization and that comm&nication ta(es lace regarding the effectiveness of the management s!stem#
/'2 4ana#ement system
/'2'1 4he roficienc! testing rovider shall esta%lish' imlement and maintain a management s!stem
aroriate to its scoe of activities' incl&ding the t!e' range and vol&me of roficienc! testing that it rovides#
/'2'2 4he roficienc! testing rovider shall define and doc&ment its olicies' rogrammes' roced&res and
instr&ctions to the e9tent necessar! to ass&re the -&alit! of all asects of roficienc! testing# 4he s!stem7s
17 / 39
ISO/IEC 17043:2010(E)
doc&mentation shall %e comm&nicated to' &nderstood %!' availa%le to' and imlemented %! the aroriate
ersonnel#
$O4E 4hese asects incl&de' %&t are not limited to' roficienc! test item -&alit! (e#g# homogeneit! and sta%ilit!)'
characterization (e#g# e-&iment cali%ration and method validation)' assignment of roert! val&es (e#g# &se of aroriate
statistical roced&res)' eval&ation of articiant erformance' distri%&tion of roficienc! test items' storage and transort
roced&res' statistical treatment of test res&lts' and reorting#
/'2'3 4he roficienc! testing rovider7s management s!stem olicies related to -&alit!' incl&ding a -&alit!
olic! statement' shall %e defined in a -&alit! man&al (named as aroriate)# 4he overall o%1ectives shall %e
esta%lished and revie"ed d&ring management revie"# 4he -&alit! olic! statement shall %e iss&ed &nder the
a&thorit! of to management# It shall incl&de at least the follo"ing5
a) the management7s commitment to the -&alit! of its roficienc! testing services to articiants and other
c&stomers8
%) the management7s statement of the standard of service8
c) the &rose of the management s!stem related to -&alit!8
d) a re-&irement that all ersonnel concerned "ith the roficienc! testing activities familiarize themselves
"ith the -&alit! doc&mentation and imlement the olicies and roced&res in their "or(8 and
e) the management7s commitment to coml! "ith this International Standard and to contin&all! imrove the
effectiveness of the management s!stem#
/'2'4 4o management shall rovide evidence of commitment to the develoment and imlementation of
the management s!stem and to contin&all! imroving its effectiveness#
/'2'/ 4o management shall comm&nicate to the organization the imortance of meeting c&stomer
re-&irements' as "ell as stat&tor! and reg&lator! re-&irements#
/'2'1 4he -&alit! man&al shall incl&de or ma(e reference to the s&orting roced&res' incl&ding technical
roced&res# It shall o&tline the str&ct&re of the doc&mentation &sed in the management s!stem#
/'2'7 4he roles and resonsi%ilities of technical management and the -&alit! manager' incl&ding their
resonsi%ilit! for ens&ring comliance "ith this International Standard' shall %e defined in the -&alit! man&al#
/'2'2 4o management shall ens&re that the integrit! of the management s!stem is maintained "hen
changes to the management s!stem are lanned and imlemented#
/'3 0o"ment "ontrol
/'3'1 General
4he roficienc! testing rovider shall esta%lish and maintain roced&res to control all doc&ments that form
art of its management s!stem (internall! generated' or from e9ternal so&rces)' s&ch as reg&lations'
standards' other normative doc&ments' roficienc! testing scheme rotocols' test or cali%ration methods' or
%oth test and cali%ration methods' as "ell as dra"ings' soft"are secifications' instr&ctions and man&als#
/'3'2 0o"ment a!!ro(al an& isse
/'3'2'1 )ll doc&ments iss&ed as art of the management s!stem shall %e revie"ed and aroved for &se
%! a&thorized ersonnel rior to iss&e# ) master list or e-&ivalent doc&ment control roced&re identif!ing the
c&rrent revision stat&s and distri%&tion of doc&ments in the management s!stem shall %e esta%lished and %e
readil! availa%le' in order to revent the &se of invalid or o%solete doc&ments' or %oth#
18 / 39
ISO/IEC 17043:2010(E)
/'3'2'2 4he roced&res adoted shall also ens&re that5
a) a&thorized editions of aroriate doc&ments are availa%le at all locations "here activities essential to the
effective oeration of roficienc! testing schemes are erformed8
%) doc&ments are eriodicall! revie"ed and &dated' as necessar!' to ens&re contin&ing s&ita%ilit! and
comliance "ith alica%le re-&irements8
c) invalid or o%solete doc&ments are romtl! removed from all oints of iss&e or &se' or other"ise ass&red
against &nintended &se8 and
d) o%solete doc&ments retained for either legal or (no"ledge reservation &roses are s&ita%l! mar(ed#
/'3'2'3 ;anagement s!stem doc&ments generated %! the roficienc! testing rovider shall %e &ni-&el!
identified# S&ch identification shall incl&de the date of iss&e or revision identification' or %oth' age n&m%ering'
the total n&m%er of ages or a mar( to signif! the end of a doc&ment' and the iss&ing a&thorit!+a&thorities#
/'3'3 0o"ment "+an#es
/'3'3'1 Changes to doc&ments shall %e revie"ed and aroved %! the same f&nction that erformed the
original revie" and aroval' &nless secificall! designated other"ise# 4he designated ersonnel shall have
access to ertinent %ac(gro&nd information &on "hich to %ase their revie" and aroval#
/'3'3'2 ?here ractica%le' the altered or ne" te9t shall %e identified in the doc&ment or the aroriate
attachments#
/'3'3'3 If the roficienc! testing rovider7s doc&ment control s!stem allo"s for the amendment of
doc&ments %! hand' ending re-iss&e of the doc&ments' the roced&res and a&thorities for s&ch amendments
shall %e defined# )mendments shall %e clearl! mar(ed' initialled and dated# ) revised doc&ment shall %e
iss&ed as soon as ractica%le#
/'3'3'4 Proced&res shall %e esta%lished to descri%e ho" changes in doc&ments maintained in
com&terized s!stems are made and controlled#
/'4 ,e(ie% of reqests. ten&ers an& "ontra"ts
/'4'1 4he roficienc! testing rovider shall esta%lish and maintain olicies and roced&res for the revie" of
re-&ests' tenders and contracts# 4hese revie"s shall ens&re that5
a) the re-&irements' incl&ding those for test and cali%ration methods' meas&ring e-&iment and roficienc!
test items to %e &sed' are ade-&atel! defined' doc&mented and &nderstood8
%) the roficienc! testing rovider has the caa%ilit! and reso&rces to meet the re-&irements8 and
c) the roficienc! testing scheme is technicall! aroriate#
$O4E 1 4his revie" is artic&larl! imortant "hen a c&stomer re-&ests a roficienc! testing scheme to %e created for
a secific &rose or for a different level or fre-&enc! of articiation from that normall! offered#
$O4E 2 4his revie" can %e simlified "hen the roficienc! test scheme is f&ll! descri%ed in a catalog&e or other notice'
and the articiant is enrolling for a ro&tine shiment#
/'4'2 Gecords of s&ch revie"s' incl&ding an! changes' shall %e maintained# Gecords shall also %e
maintained of ertinent disc&ssions "ith a c&stomer relating to the c&stomer7s re-&irements' or the res&lts of
the "or( d&ring the eriod of e9ec&tion of the contract' or %oth#
/'4'3 4he revie" shall cover all asects of the re-&est' incl&ding an! "or( that is s&%contracted %! the
roficienc! testing rovider#
19 / 39
ISO/IEC 17043:2010(E)
/'4'4 4he articiants and other c&stomers' as aroriate' shall %e informed of an! deviation in the
contract or agreed roficienc! testing scheme design#
/'4'/ If a re-&est or contract is amended after the roficienc! testing scheme is &nder"a!' the same revie"
rocess shall %e reeated and an! amendments shall %e comm&nicated to all affected ersonnel#
/'/ S6"ontra"tin# ser(i"es
/'/'1 ?hen a roficienc! testing rovider s&%contracts "or(' the roficienc! testing rovider shall
demonstrate that the s&%contractors7 e9erience and technical cometence are s&fficient for their assigned tas(s
and that the! coml! "ith the relevant cla&ses of this International Standard and other aroriate standards#
/'/'2 4he roficienc! testing rovider shall not s&%contract the lanning of the roficienc! test scheme (see
2#2#1#2)' the eval&ation of erformance (see 2#.#2#1) or the a&thorization of the final reort (see 2#D#1)#
$O4E 4his does not recl&de the roficienc! testing rovider &tilizing advice or assistance from an! advisors'
e9erts or steering gro&#
/'/'3 4he roficienc! testing rovider shall inform articiants' in advance and in "riting' of services that
are' or ma! %e' s&%contracted#
$O4E 4his notification can' for e9amle' ta(e the form of a statement in the roficienc! testing scheme
doc&mentation' s&ch as the follo"ing5 <Jario&s asects of the roficienc! testing scheme can from time to time %e
s&%contracted# ?hen s&%contracting occ&rs' it is laced "ith a cometent s&%contractor and the roficienc! testing
rovider is resonsi%le for this "or(#=
/'/'4 4he roficienc! testing rovider shall %e resonsi%le to the articiants and other c&stomers for the
s&%contractor7s "or(' e9cet in the case "here a reg&lator! a&thorit! secifies "hich s&%contractor is to %e
&sed#
/'/'/ 4he roficienc! testing rovider shall maintain a register of all s&%contractors &sed in the oeration of
roficienc! testing schemes' incl&ding the scoe of s&%contracting and a record of the cometence
assessment against relevant arts of this International Standard and other aroriate standards for the "or(
in -&estion#
/'1 -r"+asin# ser(i"es an& s!!lies
/'1'1 4he roficienc! testing rovider shall have a olic! and roced&re(s) for the selection of services and
s&lies that it &ses and that affect the -&alit! of its roficienc! testing schemes# Proced&res shall e9ist for the
&rchase' recetion and storage of reagents' roficienc! test items' reference materials and other
cons&ma%le materials relevant for the roficienc! testing schemes#
/'1'2 4he roficienc! testing rovider shall ens&re that &rchased s&lies' e-&iment and cons&ma%le
materials that affect the -&alit! of roficienc! testing schemes are not &sed &ntil the! have %een insected or
other"ise verified as coml!ing "ith secifications or re-&irements# Gecords of actions ta(en to chec(
comliance shall %e maintained#
/'1'3 P&rchasing doc&ments for items affecting the -&alit! of roficienc! testing schemes shall contain data
descri%ing the services and s&lies ordered# 4hese &rchasing doc&ments shall %e revie"ed and aroved
for technical content rior to release#
/'1'4 4he roficienc! testing rovider shall eval&ate s&liers of critical s&lies and services "hich affect
the -&alit! of roficienc! testing schemes# 4he roficienc! testing rovider shall maintain records of these
eval&ations' and list those s&liers that are aroved#
$O4E It is &nderstood that some roficienc! testing roviders can %e re-&ired to imlement their &rchasing
roced&res in accordance "ith olicies defined %! their arent coman! or a host organization#
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ISO/IEC 17043:2010(E)
/'7 Ser(i"e to t+e "stomer
/'7'1 4he roficienc! testing rovider shall %e "illing to cooerate "ith articiants and other c&stomers in
clarif!ing c&stomers7 re-&ests and in monitoring the roficienc! testing rovider7s erformance in relation to
the "or( erformed' rovided that the roficienc! testing rovider ass&res confidentialit! to its articiants#
/'7'2 4he roficienc! testing rovider shall see( feed%ac(' %oth ositive and negative' from its c&stomers#
4he feed%ac( shall %e &sed and anal!sed to imrove the management s!stem' roficienc! testing schemes'
and c&stomer service#
$O4E E9amles of the t!es of feed%ac( incl&de c&stomer satisfaction s&rve!s and revie" of roficienc! testing
reorts "ith c&stomers#
/'2 Com!laints an& a!!eals
4he roficienc! testing rovider shall have a olic! and follo" a roced&re for the resol&tion of comlaints and
aeals received from articiants' c&stomers or other arties# Gecords shall %e maintained of all comlaints'
aeals' investigations and corrective actions ta(en %! the roficienc! testing rovider#
/'3 Control of non"onformin# %or7
/'3'1 4he roficienc! testing rovider shall have a olic! and roced&re(s) that shall %e imlemented "hen
an! asect of its activities does not conform to its o"n roced&res or the agreed re-&irements of its c&stomers#
4he olic! and roced&re(s) shall ens&re that5
a) the resonsi%ilities and a&thorities for the management of nonconforming "or( are designated and
actions (incl&ding halting "or( of ongoing rogrammes and "ithholding reorts' as necessar!) are
defined and ta(en "hen nonconforming "or( is identified8
%) an eval&ation of the significance of the nonconforming "or( is made8
c) a decision on the need for action and timescale is ta(en immediatel!' together "ith an! decision a%o&t
the acceta%ilit! of the nonconforming "or(8
d) roficienc! testing scheme articiants and other c&stomers' as aroriate' are informed and the
nonconforming roficienc! test items or reorts alread! sent to articiants are recalled or disregarded8
and
e) the resonsi%ilit! for a&thorization of the res&mtion of "or( is defined#
$O4E Identification of nonconforming "or( or ro%lems "ith the management s!stem or "ith technical activities can
occ&r at vario&s laces "ithin the management s!stem and technical oerations# E9amles are articiant comlaints'
management revie"s and internal or e9ternal a&dits' -&alit! control' rearations of roficienc! test items' homogeneit!
and sta%ilit! tests' data anal!sis' instr&ctions to articiants' and materials handling and storage#
/'3'2 ?here the eval&ation indicates that nonconforming "or( co&ld rec&r or that there is do&%t a%o&t the
comliance of the roficienc! testing rovider or s&%contractor "ith their o"n olicies and roced&res' the
corrective action roced&re in /#11 shall %e romtl! follo"ed#
/'10 Im!ro(ement
4he roficienc! testing rovider shall contin&all! imrove the effectiveness of its management s!stem thro&gh
the &se of the -&alit! olic!' -&alit! o%1ectives' a&dit res&lts' anal!sis of data' corrective and reventive
actions and management revie"#
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ISO/IEC 17043:2010(E)
/'11 Corre"ti(e a"tions
/'11'1 General
4he roficienc! testing rovider shall esta%lish a olic! and roced&re(s) and shall designate aroriate
ersonnel for imlementing corrective actions "hen nonconforming "or( or deart&res from the olicies and
roced&res in the management s!stem or technical oerations have %een identified#
$O4E See /#6#1' $ote#
/'11'2 Case analysis
4he roced&re for corrective action shall start "ith an investigation to determine the root ca&se(s) of the
ro%lem#
$O4E Ca&se anal!sis is the (e! and sometimes the most diffic&lt art in the corrective action roced&re# Often' the
root ca&se is not o%vio&s and th&s a caref&l anal!sis of all otential ca&ses of the ro%lem is re-&ired# Potential ca&ses
co&ld incl&de c&stomer re-&irements' roficienc! test items and their secifications' methods and roced&res' staff s(ills
and training' cons&ma%le s&lies' rearations of roficienc! test items' homogeneit! and sta%ilit! tests' statistical design'
instr&ctions to articiants' and materials handling and storage#
/'11'3 Sele"tion an& im!lementation of "orre"ti(e a"tions
/'11'3'1 ?here corrective action is needed' the roficienc! testing rovider shall identif! otential
corrective actions# It shall select and imlement the action(s) most li(el! to eliminate the ro%lem and to
revent rec&rrence#
/'11'3'2 Corrective actions shall %e aroriate to the magnit&de and ris( of the ro%lem#
/'11'3'3 4he roficienc! testing rovider shall doc&ment and imlement an! re-&ired changes res&lting
from corrective action investigations#
/'11'4 4onitorin# of "orre"ti(e a"tions
4he roficienc! testing rovider shall monitor the res&lts to ens&re that the corrective actions ta(en have %een
effective#
/'11'/ 8&&itional a&its
?here the identification of nonconforming activities or deart&res from a&thorized roced&res cast do&%ts on
the comliance of the roficienc! testing rovider "ith its o"n olicies and roced&res' or on its comliance
"ith this International Standard' the roficienc! testing rovider shall ens&re that the aroriate areas of
activit! are a&dited in accordance "ith /#12 as soon as ossi%le#
$O4E S&ch additional a&dits often follo" the imlementation of the corrective actions to confirm their effectiveness#
)n additional a&dit can %e necessar! onl! "hen a serio&s iss&e or ris( to the roficienc! testing scheme is identified#
/'12 -re(enti(e a"tions
/'12'1 )reas for imrovements and otential so&rces of nonconforming "or(' either technical or concerning
the management s!stem' shall %e identified# ?hen imrovement oort&nities are identified' or if reventive
action is re-&ired' action lans shall %e develoed' imlemented and monitored' to red&ce the li(elihood of
s&ch nonconforming "or( and to ta(e advantage of the oort&nities for imrovement#
/'12'2 )n! roced&re for reventive action shall incl&de the initiation of s&ch actions and alication of
controls to ens&re that the! are effective#
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ISO/IEC 17043:2010(E)
/'13 Control of re"or&s
/'13'1 General
/'13'1'1 4he roficienc! testing rovider shall esta%lish and maintain roced&res for identification'
collection' inde9ing' access' filing' storage' maintenance and disosal of records# A&alit! records shall incl&de
reorts from internal a&dits and management revie"s' as "ell as records of corrective and reventive actions#
/'13'1'2 )ll records shall %e legi%le and shall %e stored and retained in s&ch a "a! that the! are readil!
retrieva%le in facilities that rovide a s&ita%le environment to revent damage or deterioration and to revent
loss# Getention times of records shall %e esta%lished#
$O4E Gecords can %e in the form of an! t!e of media' s&ch as hard co! or electronic storage media#
/'13'1'3 )ll records shall %e (et sec&re and confidential' and in accordance "ith relevant reg&lator!
re-&irements#
/'13'1'4 4he roficienc! testing rovider shall follo" roced&res to rotect and %ac(-& records stored
electronicall! and to revent &na&thorized access or amendment of these records#
/'13'2 *e"+ni"al re"or&s
/'13'2'1 4he roficienc! testing rovider shall retain records of all technical data relating to each
roficienc! testing ro&nd for a defined eriod' incl&ding' %&t not necessaril! limited to5
a) res&lts of homogeneit! and sta%ilit! testing8
%) instr&ctions to articiants8
c) articiants7 original resonses8
d) collated data for statistical anal!sis8
e) information re-&ired for reorts (see 2#D)8 and
f) final reorts (s&mmar! or individ&al' or %oth)#
$O4E 1 It is advisa%le to retain s&fficient information to esta%lish an a&dit trail for the rocessing of res&lts from
roficienc! testing ro&nds#
$O4E 2 4echnical records are acc&m&lations of data and information "hich res&lt from carr!ing o&t all roficienc!
testing activities# 4he! can incl&de forms' contracts' "or( sheets' "or( %oo(s' chec( sheets' "or( notes' s&%-contractor
reorts and articiant feed%ac(#
/'13'2'2 ,ata entr!' chec(ing and calc&lations shall %e recorded at the time the! are made and shall %e
identifia%le to the secific tas( and to the ersonnel resonsi%le#
/'13'2'3 ?hen mista(es occ&r in records and alterations are made' actions shall %e ta(en to5
a) identif! the change and date of alteration8
%) avoid loss of original data8 and
c) identif! the erson ma(ing the alteration#
/'14 Internal a&its
/'14'1 4he roficienc! testing rovider shall cond&ct internal a&dits of its activities eriodicall!' and in
accordance "ith a redetermined sched&le and roced&re' in order to verif! that its oerations contin&e to
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ISO/IEC 17043:2010(E)
coml! "ith the re-&irements of the management s!stem and this International Standard# 4he internal a&dit
rogramme shall address all elements of the management s!stem' incl&ding the technical roced&res and
roficienc! test item rearation' storage and distri%&tion' as "ell as reorting activities for the oeration of a
roficienc! testing scheme# It is the resonsi%ilit! of the -&alit! manager to lan and organize a&dits as
re-&ired %! the sched&le and re-&ested %! management# Internal a&dits shall %e carried o&t %! trained and
-&alified ersonnel "ho are' "herever reso&rces ermit' indeendent of the activit! to %e a&dited#
$O4E It is advisa%le that the rogramme for internal a&diting of the management s!stem %e comleted ever!
12 months#
/'14'2 ?hen a&dit findings cast do&%t &on the effectiveness of the oerations' incl&ding the s&ita%ilit! and
correctness of roficienc! test items' roced&res' statistical eval&ations and data resentation' the roficienc!
testing rovider shall ta(e timel! corrective action and shall notif! its c&stomers or articiants' or %oth' in
roficienc! testing schemes "hose activities ma! have %een affected#
/'14'3 4he area of a&dited activit!' the a&dit findings and an! corrective actions that arise from them shall %e
recorded#
/'14'4 Follo"-& a&dit activities shall verif! and record the imlementation and effectiveness of an!
corrective actions ta(en#
/'1/ 4ana#ement re(ie%s
/'1/'1 In accordance "ith a re-determined sched&le and roced&re' the roficienc! testing rovider7s to
management shall eriodicall! cond&ct a revie" of the roficienc! testing rovider7s management s!stem and
roficienc! testing activities' in order to ens&re their contin&ed s&ita%ilit! and effectiveness and to introd&ce
an! necessar! changes or imrovements# 4he revie" shall ta(e acco&nt of5
a) the s&ita%ilit! of olicies and roced&res8
%) reorts from management and s&ervisor! ersonnel8
c) the o&tcome of recent internal a&dits8
d) corrective and reventive actions8
e) assessments %! e9ternal %odies8
f) changes in the vol&me and t!e of "or(8
g) c&stomer' advisor! gro& or articiant feed%ac(8
h) comlaints and aeals8
i) recommendations for imrovement8 and
1) other relevant factors' s&ch as reso&rces and staff training#
$O4E 1 ) t!ical eriod for cond&cting a management revie" is once ever! 12 months#
$O4E 2 Ges&lts can feed into the roficienc! testing rovider7s lanning s!stem and can incl&de the o%1ectives and
action lans#
$O4E 3 ) management revie" incl&des consideration of related s&%1ects at reg&lar management meetings#
$O4E 2 ?here the roficienc! testing rovider is art of a larger organization' it can %e aroriate to hold a searate
revie" meeting to cover roficienc! testing activities#
/'1/'2 Findings from management revie"s' and the actions that arise from them' shall %e recorded# 4he
management shall ens&re that those actions are discharged "ithin an aroriate and agreed timescale#
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ISO/IEC 17043:2010(E)
8nne9 8
(informative)
*y!es of !rofi"ien"y testin# s"+emes
8'1 General
Proficienc! testing has %ecome an essential asect of la%orator! ractice in all areas of testing' cali%ration
and insection# Proficienc! testing schemes var! according to the needs of the sector in "hich the! are &sed'
the nat&re of the roficienc! test items' the methods in &se and the n&m%er of articiants# Ho"ever' in their
simlest form' most roficienc! testing schemes ossess the common feat&re of comarison of res&lts
o%tained %! one la%orator! "ith those o%tained %! one or more different la%oratories#
4he nat&re of the test or meas&rement erformed in roficienc! testing schemes governs the method of
comaring erformance# 4here are three %asic t!es of la%orator! e9aminations5 -&antitative' -&alitative and
interretive#
4he res&lts of a -&antitative meas&rement are n&merical and are reorted on an interval or a ratio scale#
4ests for -&antitative meas&rement ma! var! in their recision' tr&eness' anal!tical sensitivit!' and
secificit!# In -&antitative roficienc! testing schemes' n&merical res&lts are &s&all! anal!sed statisticall!#
4he res&lts of -&alitative tests are descritive and reorted on a categorical or ordinal scale' e#g# identit!
of micro-organisms' or %! identification of the resence of a secific meas&rand (s&ch as a dr&g or a
grading of a characteristic)# )ssessment of erformance %! statistical anal!sis ma! not %e aroriate for
-&alitative e9aminations#
In interretive tests' the <roficienc! testing item= is a test res&lt (e#g# a descritive morholog! statement)'
a set of data (e#g# to determine a cali%ration line) or other set of information (e#g# a case st&d!)'
concerning an interretative feat&re of the articiant7s cometence#
Other roficienc! testing schemes have additional feat&res deending on their o%1ective' as o&tlined in
definition 3#.' $ote 1' a) to h)# Some common alications of those t!es of roficienc! testing are disc&ssed
%elo" and ill&strated in Fig&re )#1# 4hese schemes ma! %e <single occasion= and erformed once' or
<contin&o&s= and erformed at reg&lar intervals#
8'2 Seqential !arti"i!ation s"+emes
Se-&ential articiation schemes (sometimes (no"n as meas&rement comarison schemes) involve the
roficienc! test item %eing circ&lated s&ccessivel! from one articiant to the ne9t (i#e# se-&ential
articiation)' or occasionall! circ&lated %ac( to the roficienc! testing rovider for rechec(ing# ;odel 1 in
Fig&re )#1 rovides a %rief s&mmar! of this t!e of design' and the (e! feat&res are t!icall! those descri%ed
%elo"#
a) ) reference la%orator! that is caa%le of roviding a metrologicall! tracea%le assigned val&e "ith
s&fficientl! small meas&rement &ncertaint! and relia%ilit! for the roficienc! test item is &sed# For
categorical or ordinal roerties' the assigned val&e sho&ld %e determined %! consens&s of e9erts or
other a&thoritative so&rce# It ma! %e necessar! for the roficienc! test item to %e chec(ed at secific
stages d&ring the cond&ct of the roficienc! testing scheme' in order to ens&re that there is no significant
change in the assigned val&e#
%) 4he individ&al meas&rement res&lts are comared "ith the assigned val&e esta%lished %! the reference
la%orator!# 4he coordinator sho&ld ta(e into acco&nt the claimed meas&rement &ncertaint! of each
25 / 39
ISO/IEC 17043:2010(E)
articiant' or the claimed level of e9ertise# It ma! %e diffic&lt to comare res&lts on a gro& %asis as
there ma! %e relativel! fe" articiants having meas&rement caa%ilities that closel! match each other#
c) Schemes involving se-&ential articiation ta(e time (in some cases' !ears) to comlete# 4his ca&ses a
n&m%er of diffic&lties' s&ch as
ens&ring the sta%ilit! of the item'
the strict monitoring of the circ&lation among articiants and the time allo"ed for meas&rement %!
individ&al articiants' and
the need to s&l! feed%ac( on individ&al erformance d&ring the scheme7s imlementation' rather
than "aiting &ntil it finishes#
d) Proficienc! test items (meas&rement artefacts) &sed in this t!e of roficienc! test can incl&de' for
e9amle' meas&rement reference standards (e#g# resistors' micrometers and fre-&enc! co&nters) or' in
medical rogrammes' histolog! slides "ith confirmed diagnoses#
e) Schemes that follo" this design %&t that are limited to sit&ations "here a single articiant is tested
indeendentl! are often called <meas&rement a&dits=#
f) In some sit&ations' the assigned val&e for a roficienc! test item ma! %e determined %! consens&s' after
all articiants (or in some sit&ations' a s&%set of articiants) have comleted the meas&rement
comarison#
8'3 Simltaneos !arti"i!ation s"+emes
8'3'1 General
Sim&ltaneo&s articiation roficienc! testing schemes &s&all! involve randoml! selected s&%-samles from a
so&rce of material %eing distri%&ted sim&ltaneo&sl! to articiants for conc&rrent testing# In some schemes'
articiants are re-&ired to ta(e samles' "hich are then considered to %e the roficienc! test items for
anal!sis# )fter comletion of the testing' the res&lts are ret&rned to the roficienc! testing rovider and
comared "ith the assigned val&e(s) to give an indication of the erformance of the individ&al articiants and
the gro& as a "hole# E9amles of roficienc! test items &sed in this t!e of scheme incl&de food' %od! fl&ids'
agric&lt&ral rod&cts' "ater' soils' minerals and other environmental materials# In some cases' searate
ortions of revio&sl! esta%lished reference materials are circ&lated# )dvice or ed&cational comments are
t!icall! art of the reort ret&rned to articiants %! the roficienc! testing rovider "ith the aim of romoting
imrovement in erformance# ;odel 2 in Fig&re )#1 reresents t!ical roficienc! testing schemes of this t!e'
&s&all! for testing la%oratories# ;odel 3 resents a t!e of scheme that is fre-&entl! &sed in con1&nction "ith
sim&ltaneo&s roficienc! testing schemes' for oversight or ed&cational &roses#
)s disc&ssed in )nne9 >' assigned val&es for these roficienc! testing schemes ma! %e determined in a
variet! of "a!s# Ho"ever' either eval&ations of erformance are %ased on consens&s val&es from articiants
(all articiants' or a s&%set of <e9erts=) or eval&ations can %e on the %asis of indeendentl!-determined
assigned val&es#
Kno"n val&e schemes &se assigned val&es that are determined indeendentl! of the articiants and involve
rearation of roficienc! test items "ith a n&m%er of (no"n meas&rands or characteristics# Certified
reference materials can also %e &sed in these schemes' as their certified val&e and meas&rement &ncertaint!
can %e &sed directl!# ) direct comarison can also %e made %et"een a roficienc! test item and a certified
reference material &nder reeata%ilit! conditions# Ho"ever' care sho&ld %e ta(en to ens&re that the certified
reference material is closel! comara%le "ith a roficienc! test item# Proficienc! test items from revio&s
roficienc! testing ro&nds ma! %e &sed in this t!e of scheme' if the item has demonstrated sta%ilit!#
One secial alication of roficienc! testing' often called <%lind= roficienc! testing' is "here the roficienc!
test item is indisting&isha%le from normal c&stomer items or samles received %! the la%orator!# 4his t!e of
roficienc! testing can %e diffic&lt' since it re-&ires coordination "ith a normal la%orator! c&stomer# In addition'
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ISO/IEC 17043:2010(E)
%eca&se of &ni-&e ac(aging and shiing needs' %&l( rocessing is &s&all! not feasi%le and homogeneit!
testing is diffic&lt#
8'3'2 S!lit<le(el &esi#ns
) common design for roficienc! testing is the <slit-level= design' "here similar (%&t not identical) levels of
meas&rand are incl&ded in t"o searate roficienc! test items# 4his design is &sed to estimate the
articiant7s recision at a secific level of a meas&rand# It avoids ro%lems associated "ith relicate
meas&rements on the same roficienc! test item' or "ith the incl&sion of t"o identical roficienc! test items in
the same roficienc! testing ro&nd#
8'3'3 S!lit<sam!le testin# s"+emes
One secial t!e of roficienc! testing design that is often &sed %! articiants7 c&stomers and some
reg&lator! %odies is the <slit-samle= design#
$O4E 4his design is not to %e conf&sed "ith a slit-level design' "hich is disc&ssed in )#3#2#
4!icall!' slit-samle roficienc! testing involves comarisons of the data rod&ced %! small gro&s of
articiants (often onl! t"o)# In these roficienc! testing schemes' samles of a rod&ct or a material are
divided into t"o or more arts' "ith each articiant testing one art of the samle (see Fig&re )#1' model /)#
Lses for this t!e of scheme incl&de identif!ing oor acc&rac!' descri%ing consistent %ias and verif!ing the
effectiveness of corrective actions# 4his design ma! %e &sed to eval&ate one or %oth articiants as s&liers
of testing services' or in cases "here there are too fe" articiants for aroriate eval&ation of res&lts#
Lnder s&ch schemes' one of the articiants ma! %e considered to oerate at a higher metrological level (i#e#
lo"er meas&rement &ncertaint!)' d&e to the &se of reference methodolog! and more advanced e-&iment'
etc#' or thro&gh confirmation of its o"n erformance thro&gh satisfactor! articiation in a recognized
interla%orator! comarison scheme# Its res&lts are considered to %e the assigned val&es in s&ch comarisons
and it ma! act as an advisor! or mentor la%orator! to the other articiants comaring slit-samle data "ith it#
8'3'4 -artial<!ro"ess s"+emes
Secial t!es of roficienc! testing involve the eval&ation of articiants7 a%ilities to erform arts of the
overall testing or meas&rement rocess# For e9amle' some e9isting roficienc! testing schemes eval&ate
articiants7 a%ilities to transform and reort a given set of data (rather than cond&ct the act&al test or
meas&rement)' to ma(e interretations %ased on a given set of data or roficienc! testing items' s&ch as
stained %lood films for diagnosis' or to ta(e and reare samles or secimens in accordance "ith a
secification#
8'4 E9ternal qality assessment (E=8) !ro#rammes
EA) rogrammes (s&ch as those rovided for la%orator! medicine e9aminations) offer a variet! of
interla%orator! comarison schemes %ased on this traditional roficienc! testing model' %&t "ith %roader
alication of the schemes descri%ed in )#2 and )#3 and ill&strated in Fig&re )#1# ;an! EA) rogrammes are
designed to rovide insight into the comlete ath of "or(flo" of the la%orator!' and not 1&st the testing
rocesses# ;ost EA) rogrammes are contin&o&s schemes that incl&de long term follo"-& of la%orator!
erformance# ) t!ical feat&re of EA) rogrammes is to rovide ed&cation to articiants and romote -&alit!
imrovement# )dvisor! and ed&cational comments comrise art of the reort ret&rned to articiants to
achieve this aim#
Some EA) rogrammes assess erformance of re-anal!tical and ost-anal!tical hases of testing' as "ell
as the anal!tical hase# In s&ch EA) rogrammes' the nat&re of the roficienc! test item ma! differ
significantl! from that &sed in traditional roficienc! testing schemes# 4he <roficienc! test item= ma! %e a
-&estionnaire or case st&d! (see Fig&re )#1' model 3) circ&lated %! the EA) rovider to each articiant for
ret&rn of secific ans"ers# )lternativel!' re-anal!tical information ma! accoman! the roficienc! test item'
re-&iring the articiant to select an aroriate aroach to testing or interretation of res&lts' and not 1&st to
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ISO/IEC 17043:2010(E)
erform the test# In <samle revie"= schemes' articiants ma! %e re-&ired to rovide the <roficienc! test
items= to the EA) rovider (see Fig&re )#1' model 2)# 4his ma! ta(e the form of a rocessed secimen or
samle (e#g# stained slide or fi9ed tiss&e)' la%orator! data (e#g# test res&lts' la%orator! reorts or -&alit!
ass&rance+control records) or doc&mentation (e#g# roced&res or method verification criteria)#
a ,eending ho" the assigned val&e is derived' it "ill %e either determined rior to the distri%&tion of the roficienc! test
items or after the ret&rn of articiant res&lts#
$i#re 8'1 E9am!les of "ommon ty!es of !rofi"ien"y testin# s"+emes
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ISO/IEC 17043:2010(E)
8nne9 :
(informative)
Statisti"al met+o&s for !rofi"ien"y testin#
:'1 General
Proficienc! test res&lts can aear in man! forms' sanning a "ide range of data t!es and &nderl!ing
statistical distri%&tions# 4he statistical methods &sed to anal!se the res&lts need to %e aroriate for each
sit&ation' and so are too varied to %e secified in this International Standard# ISO 13/2D descri%es referred
secific methods for each of the sit&ations disc&ssed %elo"' %&t also states that other methods ma! %e &sed
as long as the! are statisticall! valid and are f&ll! descri%ed to articiants# Some of the methods in
ISO 13/2D' eseciall! for homogeneit! and sta%ilit! testing' are modified slightl! in the ILP)C2) 4echnical
Geort <4he International Harmonized Protocol for the roficienc! testing of anal!tical chemistr!
la%oratories=E1DF# 4hese doc&ments also resent g&idance on design and vis&al data anal!sis# Other
references ma! %e cons&lted for secific t!es of roficienc! testing schemes' e#g# meas&rement comarison
schemes for cali%ration#
4he methods disc&ssed in this anne9 and in the referenced doc&ments cover the f&ndamental stes common
to nearl! all roficienc! testing schemes' i#e#
a) determination of the assigned val&e'
%) calc&lation of erformance statistics'
c) eval&ation of erformance' and
d) reliminar! determination of roficienc! test item homogeneit! and sta%ilit!#
?ith ne" roficienc! testing schemes' initial agreement %et"een res&lts is often oor' d&e to ne" -&estions'
ne" forms' artificial test items' oor agreement of test or meas&rement methods' or varia%le meas&rement
roced&res# Coordinators ma! have to &se ro%&st indicators of relative erformance (s&ch as ercentiles) &ntil
agreement imroves# Statistical methods ma! need to %e refined once articiant agreement has imroved
and roficienc! testing is "ell esta%lished#
4his anne9 does not consider statistical methods for anal!tical st&dies other than for treatment of roficienc!
test data# ,ifferent methods ma! %e needed to imlement the other &ses of interla%orator! comarison data
listed in the Introd&ction#
:'2 0etermination of t+e assi#ne& (ale an& its n"ertainty
:'2'1 4here are vario&s roced&res availa%le for the esta%lishment of assigned val&es# 4he most common
roced&res are listed %elo" in an order that' in most cases' "ill res&lt in increasing &ncertaint! for the
assigned val&e# 4hese roced&res involve the &se of5
a) (no"n val&es : "ith res&lts determined %! secific roficienc! test item form&lation (e#g# man&fact&re or
dil&tion)8
%) certified reference val&es : as determined %! definitive test or meas&rement methods (for -&antitative
tests)8
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ISO/IEC 17043:2010(E)
2) International Lnion of P&re and )lied Chemistr!#
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ISO/IEC 17043:2010(E)
c) reference val&es : as determined %! anal!sis' meas&rement or comarison of the roficienc! test item
alongside a reference material or standard' tracea%le to a national or international standard8
d) consens&s val&es from e9ert articiants : e9erts ("hich ma!' in some sit&ations' %e reference
la%oratories) sho&ld have demonstra%le cometence in the determination of the meas&rand(s) &nder test'
&sing validated methods (no"n to %e highl! acc&rate and comara%le to methods in general &se8
e) consens&s val&es from articiants : &sing statistical methods descri%ed in ISO 13/2D and the ILP)C
International Harmonized Protocol' and "ith consideration of the effects of o&tliers#
:'2'2 )ssigned val&es sho&ld %e determined to eval&ate articiants fairl!' !et to enco&rage agreement
among test or meas&rement methods# 4his is accomlished thro&gh selection of common comarison gro&s
and the &se of common assigned val&es' "herever ossi%le#
:'2'3 Proced&res for determining the &ncertaint! of assigned val&es are disc&ssed in detail in ISO 13/2D
and the ILP)C International Harmonized Protocol' for each common statistic &sed (as mentioned a%ove)#
)dditional information on &ncertaint! is also rovided in ISO+IEC *&ide 6D-3#
:'2'4 Statistical methods for determining the assigned val&e for -&alitative data (also called <categorical= or
<nominal= val&es)' or semi--&antitative val&es (also called <ordinal= val&es) are not disc&ssed in ISO 13/2D or
the ILP)C International Harmonized Protocol# In general' these assigned val&es need to %e determined %!
e9ert 1&dgement or man&fact&re# In some cases' a roficienc! testing rovider ma! &se a consens&s val&e'
as defined %! agreement of a redetermined ma1orit! ercentage of resonses (e#g# D00 or more)# Ho"ever'
the ercentage &sed sho&ld %e determined %ased on o%1ectives for the roficienc! testing scheme and the
level of cometence and e9erience of the articiants#
:'2'/ O&tliers are statisticall! treated as descri%ed %elo"#
a) O%vio&s %l&nders' s&ch as those "ith incorrect &nits' decimal oint errors' and res&lts for a different
roficienc! test item sho&ld %e removed from the data set and treated searatel!# 4hese res&lts sho&ld
not %e s&%1ect to o&tlier tests or ro%&st statistical methods#
%) ?hen articiants7 res&lts are &sed to determine assigned val&es' statistical methods sho&ld %e in lace
to minimize the infl&ence of o&tliers# 4his can %e accomlished "ith ro%&st statistical methods or %!
removing o&tliers rior to calc&lation# In larger or ro&tine roficienc! testing schemes' it ma! %e ossi%le
to have a&tomated o&tlier screens' if 1&stified %! o%1ective evidence of effectiveness#
c) If res&lts are removed as o&tliers' the! sho&ld %e removed onl! for calc&lation of s&mmar! statistics#
4hese res&lts sho&ld still %e eval&ated "ithin the roficienc! testing scheme and %e given the aroriate
erformance eval&ation#
$O4E ISO 13/2D descri%es a secific ro%&st method for determination of the consens&s mean and standard
deviation' "itho&t the need for o&tlier removal#
:'2'1 Other considerations are o&tlined %elo"#
a) Ideall!' if assigned val&es are determined %! articiant consens&s' the roficienc! testing rovider
sho&ld have a roced&re to esta%lish the tr&eness of the assigned val&es and for revie"ing the
distri%&tion of the data#
%) 4he roficienc! testing rovider sho&ld have criteria for the acceta%ilit! of an assigned val&e in terms of
its &ncertaint!# In ISO 13/2D and in the ILP)C International Harmonized Protocol' criteria are rovided
that are %ased on a goal to limit the effect that &ncertaint! in the assigned val&e has on the eval&ation' i#e#
the criteria limit the ro%a%ilit! of having a articiant receive an &nacceta%le eval&ation %eca&se of
&ncertaint! in the assigned val&e#
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ISO/IEC 17043:2010(E)
:'3 Cal"lation of !erforman"e statisti"s
:'3'1 -erforman"e for qantitati(e reslts
:'3'1'1 Proficienc! test res&lts often need to %e transformed into a erformance statistic' in order to aid
interretation and to allo" comarison "ith defined o%1ectives# 4he &rose is to meas&re the deviation from
the assigned val&e in a manner that allo"s comarison "ith erformance criteria# Statistical methods ma!
range from no rocessing re-&ired to comle9 statistical transformations#
:'3'1'2 Performance statistics sho&ld %e meaningf&l to articiants# 4herefore' statistics sho&ld %e
aroriate for the relevant tests and %e "ell &nderstood or traditional "ithin a artic&lar field#
:'3'1'3 Commonl! &sed statistics for -&antitative res&lts are listed %elo"' in order of increasing degree of
transformation of articiants7 res&lts#
a) 4he difference' D' is calc&lated &sing E-&ation (>#1)5
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ISO/IEC 17043:2010(E)
:'3'2 -erforman"e for qalitati(e an& semi<qantitati(e reslts
:'3'2'1 For -&alitative or semi--&antitative res&lts' if statistical methods are &sed' the! m&st %e
aroriate for the nat&re of the resonses# For -&alitative data (also called <categorical= data)' the
aroriate techni-&e is to comare a articiant7s res&lt "ith the assigned val&e# If the! are identical' then
erformance is acceta%le# If the! are not identical' then e9ert 1&dgement is needed to determine if the res&lt
is fit for its intended &se# In some sit&ations' the roficienc! testing rovider ma! revie" the res&lts from
articiants and determine that a roficienc! testing item "as not s&ita%le for eval&ation' or that the assigned
val&e "as not correct# 4hese determinations sho&ld %e art of the lan for the scheme and &nderstood %! the
articiants in advance of the oeration of the scheme#
:'3'2'2 For semi--&antitative res&lts (also called <ordinal= res&lts)' the techni-&es &sed for -&alitative
data (>#3#2#1) are aroriate# Ordinal res&lts incl&de' for e9amle' resonses s&ch as grades or ran(ings'
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ISO/IEC 17043:2010(E)
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ISO/IEC 17043:2010(E)
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ISO/IEC 17043:2010(E)
e9ands the criteria to allo" a statistical test of the estimate of inhomogeneit! and insta%ilit!' relative to the
same criterion recommended in ISO 13/2D#
:'/'2 4here are different needs for re-&irements in ISO *&ide 32 and ISO *&ide 3/' "hich are for
determining reference val&es for certified reference materials' incl&ding their &ncertainties# ISO *&ide 3/ &ses
statistical anal!sis of variance to estimate the <%ottle-to-%ottle= varia%ilit! and <"ithin-%ottle= varia%ilit! (as
aroriate)' and s&%se-&entl! &ses those variances as comonents of the &ncertaint! of the assigned val&e#
*iven the need to estimate comonents acc&ratel! for certified reference materials' the n&m%er of randoml!
selected samles ma! e9ceed "hat is needed for roficienc! testing' "here the main o%1ective is to chec( for
&ne9ected inconsistencies in %atches of man&fact&red roficienc! test items#
:'/'3 Sta%ilit! is normall! chec(ed to ens&re that the meas&rand(s) did not change d&ring the co&rse of the
ro&nd# )s secified in ISO 13/2D' the ILP)C International Harmonized Protocol and ISO *&ide 3/'
roficienc! test items sho&ld %e tested &nder the variet! of conditions that occ&r in the normal oeration of a
roficienc! testing scheme' e#g# conditions of shiing and handling "hen distri%&ted to articiants# 4he
criterion for acceta%le insta%ilit! is the same as the criterion for inhomogeneit! in ISO 13/2D' altho&gh
t!icall! "ith fe"er tests or meas&rements#
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ISO/IEC 17043:2010(E)
8nne9 C
(informative)
Sele"tion an& se of !rofi"ien"y testin#
C'1 General
4his anne9 esta%lishes rinciles for the selection and &se of roficienc! testing schemes %! articiants and
other interested arties# 4his anne9 is also intended to romote the harmonized &se of roficienc! testing
schemes %! interested arties (e#g# accreditation %odies' reg&lator! %odies' or c&stomers of the articiant)#
Since res&lts from roficienc! testing schemes ma! %e &sed in the eval&ation of a articiant7s erformance' it
is imortant that %oth the interested arties and articiants have confidence in the develoment and
oeration of the roficienc! testing schemes#
It is also imortant for articiants to have a clear &nderstanding of the olicies of the interested arties for
articiation in s&ch roficienc! testing schemes' the criteria the! &se for 1&dging s&ccessf&l erformance in
roficienc! testing schemes' and their olicies and roced&res for follo"ing & an! &nsatisfactor! res&lts from
a roficienc! test ro&nd# Ho"ever' aart from secific re-&irements from reg&lator! %odies' it is the
resonsi%ilit! of the articiants themselves to select the aroriate roficienc! testing scheme and to
eval&ate their res&lts correctl!#
It sho&ld %e recognized' ho"ever' that interested arties also ta(e into acco&nt the s&ita%ilit! of test data
rod&ced from activities other than roficienc! testing schemes' incl&ding' for e9amle' res&lts of articiants7
o"n internal -&alit! control roced&res "ith control samles' comarison "ith slit-samle data from other
articiants and erformance on tests of certified reference materials# 4herefore' "hen selecting a roficienc!
testing scheme' the articiant sho&ld ta(e into consideration the other -&alit! control activities that are
availa%le or have alread! %een erformed#
C'2 Sele"tion of !rofi"ien"y testin# s"+emes
C'2'1 Ca%oratories (and other t!es of articiants) need to select roficienc! testing schemes that are
aroriate for their scoe of testing or scoe of cali%ration# 4he roficienc! testing schemes selected sho&ld
coml! "ith the re-&irements of this International Standard#
C'2'2 In selecting a roficienc! testing scheme' the follo"ing factors sho&ld %e considered5
a) the tests' meas&rements or cali%rations involved sho&ld match the t!es of tests' meas&rements or
cali%rations erformed %! the articiant8
%) the availa%ilit! to interested arties of details a%o&t the scheme design' roced&res for esta%lishment of
assigned val&es' instr&ctions to articiants' statistical treatment of data' and the final s&mmar! reort8
c) the fre-&enc! at "hich the roficienc! testing scheme is oerated8
d) the s&ita%ilit! of the organizational logistics for the roficienc! testing scheme (e#g# timing' location'
samle sta%ilit! considerations' distri%&tion arrangements) relevant to the gro& of articiants roosed
for the roficienc! testing scheme8
e) the s&ita%ilit! of accetance criteria (i#e# for 1&dging s&ccessf&l erformance in the roficienc! test)8
f) the costs8
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ISO/IEC 17043:2010(E)
g) the roficienc! testing rovider7s olic! on maintaining articiants7 confidentialit!8
h) the timescale for reorting of res&lts and for anal!sis of erformance data8
i) the characteristics that instil confidence in the s&ita%ilit! of roficienc! test items (e#g# homogeneit!'
sta%ilit!' and' "here aroriate' metrological tracea%ilit! to national or international standards)8
1) its conformance "ith this International Standard#
$O4E Some roficienc! testing schemes can incl&de tests "hich are not an e9act match for the tests erformed %!
the articiant (e#g# the &se of a different national standard for the same determination)' %&t it can still %e technicall!
1&stified to articiate in the roficienc! testing scheme if the treatment of the data allo"s for consideration of an!
significant differences in test methodolog! or other factors#
C'3 -oli"ies on !arti"i!ation in !rofi"ien"y testin# s"+emes
C'3'1 If relevant' interested arties sho&ld doc&ment their olicies for articiation in roficienc! testing
schemes8 s&ch doc&mented olicies sho&ld %e &%licl! availa%le to la%oratories and other interested arties#
C'3'2 Iss&es "hich sho&ld %e addressed in articiation olicies for secific roficienc! testing schemes
incl&de5
a) "hether articiation in secific roficienc! testing schemes is mandator! or vol&ntar!8
%) the fre-&enc! of articiation8
c) the criteria &sed %! the interested art! to 1&dge satisfactor! or &nsatisfactor! erformance8
d) "hether articiants ma! %e re-&ired to articiate in follo"-& roficienc! testing schemes if
erformance is 1&dged to %e &nsatisfactor!8
e) ho" the res&lts of roficienc! testing "ill %e &sed in the eval&ation of erformance and s&%se-&ent
decisions8
f) details of the interested art!7s olic! on reserving articiants7 confidentialit!#
C'4 >se of !rofi"ien"y testin# 6y !arti"i!ants
C'4'1 Particiants sho&ld dra" their o"n concl&sions a%o&t their erformance from an eval&ation of the
organization and design of the roficienc! testing scheme# Gevie"s sho&ld consider the relation %et"een the
roficienc! testing scheme and the needs of the articiant7s c&stomers# 4he information that sho&ld %e ta(en
into consideration incl&des5
a) the origin and character of roficienc! test items8
%) the test and meas&rement methods &sed and' "here ossi%le' the assigned val&es for artic&lar test or
meas&rement methods8
c) the organization of the roficienc! testing scheme (e#g# the statistical design' the n&m%er of relicates' the
meas&rands' the manner of e9ec&tion)8
d) the criteria &sed %! the roficienc! testing rovider to eval&ate the articiants7 erformance8
e) an! relevant reg&lator!' accreditation or other re-&irements#
C'4'2 Particiants sho&ld maintain their o"n records of erformance in roficienc! testing' incl&ding the
o&tcomes of investigations of an! &nsatisfactor! res&lts and an! s&%se-&ent corrective or reventive actions#
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ISO/IEC 17043:2010(E)
C'/ >se of reslts 6y intereste& !arties
C'/'1 8""re&itation 6o&ies
C'/'1'1 4he re-&irements for an accreditation %od! "ith regard to &se of roficienc! testing are secified
in ISO+IEC 1.01152002' .#1/#
$O4E F&rther olicies on roficienc! testing relevant to the comliance of accreditation %odies "ith re-&irements for
mem%ershi in the IC)C m&t&al recognition arrangement are secified in IC)C P-6#
C'/'1'2 4he res&lts from roficienc! testing schemes are &sef&l for %oth articiants and accreditation
%odies# 4here are' ho"ever' limitations on the &se of s&ch res&lts to determine cometence# S&ccessf&l
erformance in a secific roficienc! testing scheme ma! reresent evidence of cometence for that e9ercise'
%&t ma! not reflect ongoing cometence# Similarl!' &ns&ccessf&l erformance in a secific roficienc! testing
scheme ma! reflect a random deart&re from a articiant7s normal state of cometence# It is for these
reasons that roficienc! testing sho&ld not %e the onl! tool &sed %! accreditation %odies in their accreditation
rocesses#
C'/'1'3 For articiants reorting &nsatisfactor! res&lts' the accreditation %odies sho&ld have olicies to
a) ens&re that the articiants investigate and comment on their erformance "ithin an agreed time-frame'
and ta(e aroriate corrective action'
%) ("here necessar!) ens&re that the articiants &nderta(e an! s&%se-&ent roficienc! testing to confirm
that an! corrective actions ta(en %! them are effective' and
c) ("here necessar!) ens&re that on-site eval&ation of the articiants is carried o&t %! aroriate technical
assessors to confirm that corrective actions are effective#
C'/'1'4 4he accreditation %odies sho&ld advise their accredited %odies of the ossi%le o&tcomes of
&nsatisfactor! erformance in a roficienc! testing scheme# 4hese ma! range from contin&ing accreditation
s&%1ect to s&ccessf&l attention to corrective actions "ithin agreed time-frames' temorar! s&sension of
accreditation for the relevant tests (s&%1ect to corrective action)' thro&gh to "ithdra"al of accreditation for the
relevant tests#
$O4E *enerall! sea(ing' the otions selected %! an accreditation %od! "ill deend on the histor! of erformance of
the articiant over time and from the most recent on-site assessments#
C'/'1'/ 4he accreditation %odies sho&ld have olicies for feed%ac( from accredited %odies relating to
action ta(en on the %asis of res&lts of roficienc! testing schemes' artic&larl! for &nsatisfactor! erformance#
C'/'2 Ot+er intereste& !arties
C'/'2'1 Particiants ma! need to demonstrate their cometence to other interested arties' s&ch as
c&stomers or in a s&%contracting mandate# Proficienc! testing res&lts' as "ell as other -&alit! control activities'
can %e &sed to demonstrate cometence' altho&gh this sho&ld not %e the onl! activit!#
$O4E Proficienc! testing data &sed to validate claims of cometence are normall! &sed %! organizations in
con1&nction "ith other evidence' s&ch as accreditation# See C#/#1#2#
C'/'2'2 It is the resonsi%ilit! of the articiants to ens&re that the! have rovided all the aroriate
information to interested arties "ishing to eval&ate the articiants as to their cometence#
C'1 >se of !rofi"ien"y testin# 6y re#latory 6o&ies
C'1'1 4he res&lts from roficienc! testing schemes are &sef&l for reg&lator! %odies that need to eval&ate the
erformance of articiants covered %! reg&lations#
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ISO/IEC 17043:2010(E)
C'1'2 If the roficienc! testing scheme is oerated %! a reg&lator! %od!' it sho&ld %e oerated in
accordance "ith the re-&irements of this International Standard#
C'1'3 Geg&lator! %odies that &se indeendent roficienc! testing roviders sho&ld
a) see( doc&mentar! evidence that the roficienc! testing schemes coml! "ith the re-&irements of this
International Standard %efore recognizing the roficienc! testing scheme' and
%) disc&ss "ith articiants the scoe and oerational arameters of the roficienc! testing scheme' in order
that the articiants7 erformance ma! %e 1&dged ade-&atel! in relation to the reg&lations#
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ISO/IEC 17043:2010(E)
:i6lio#ra!+y
E1F ISO+IEC *&ide 6D-3' Uncertainty of measurement Part ! "uide to t#e e$pression of uncertainty in
measurement (*L;5166/)
E2F ISO+IEC 1.01152002' Conformity assessment "eneral re%uirements for accreditation bodies
accrediting conformity assessment bodies
E3F ISO+IEC 1.02/' "eneral re%uirements for t#e competence of testing and calibration laboratories
E2F ISO 3/32-1& 'tatistics Vocabulary and symbols Part (! "eneral statistical terms and terms used
in probability
E/F ISO /.2/-1' )ccuracy (trueness and precision) of measurement met#ods and results Part (!
"eneral principles and definitions
EBF ISO /.2/-2' )ccuracy (trueness and precision) of measurement met#ods and results Part *! Basic
met#od for t#e determination of repeatability and reproducibility of a standard measurement met#od
E.F ISO /.2/-2' )ccuracy (trueness and precision) of measurement met#ods and results Part +! Basic
met#ods for t#e determination of t#e trueness of a standard measurement met#od
EDF ISO 13/2D5200/' 'tatistical met#ods for use in proficiency testing by interlaboratory comparisons
E6F ISO 1/1D6' Medical laboratories Particular re%uirements for %uality and competence
E10F ISO *&ide 32' "eneral re%uirements for t#e competence of reference material producers
E11F ISO *&ide 3/' ,eference materials "eneral and statistical principles for certification
E12F ISO+4S 21.2D' "uide to t#e use of repeatability& reproducibility and trueness estimates in
measurement uncertainty estimation
E13F E$ 1213B' Use of e$ternal %uality assessment sc#emes in t#e assessment of t#e performance of in
vitro diagnostic e$amination procedures
E12F )S4; E1301-6/' 'tandard "uide for Proficiency -esting by Interlaboratory Comparisons
E1/F Standards for EA) schemes in la%orator! medicine# Jersion 2#02' ,ecem%er 2002# Clinical Patholog!
)ccreditation (LK) Ctd# Sheffield' LK
E1BF $ational Occ&ational Standards for E9ternal A&alit! )ssessment' HCS-EA)1 to HCS-EA)12#
Cometence Frame"or( for Healthcare Science# ("""#s(illsforhealth#org#&(+)
E1.F ELG)CHE;+CI4)C *&ide C*2' .uantifying Uncertainty in )nalytical Measurement' 2nd edition' 2000
E1DF 4HO;PSO$ ;#' ECCISO$ S#C#G#' ?OO, G#' <4he International Harmonized Protocol for the roficienc!
testing of anal!tical chemistr! la%oratories= (ILP)C 4echnical Geort)' in Pure and )pplied C#emistry'
Jol# .D' $o# 1' # 12/-16B' 200B
E16F IC)C P-65200/' I/)C Policy for Participation in 0ational and International Proficiency -esting )ctivities
E20F IC)C P-1052002' I/)C Policy on -raceability of Measurement ,esults
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