Sei sulla pagina 1di 35

ISO/IEC 17043:2010(E)

ISO/IEC 17043
First edition 2010-02-01

Conformity assessment General req irements 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 ,eq irements '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''4 4'1 General ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''4 4'2 -ersonnel ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''4 4'3 Eq i!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(al ation of !rofi"ien"y testin# s"+eme res lts ''''''''''''''''''''''''''''''''''''''''''''12 4'2 ,e!orts ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''13 4'3 Comm ni"ation %it+ !arti"i!ants''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''14 4'10 Confi&entiality'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1/ / 4ana#ement req irements'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1/ /'1 Or#ani5ation''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1/ /'2 4ana#ement system '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''11 /'3 0o" ment "ontrol'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''17 /'4 ,e(ie% of req ests. ten&ers an& "ontra"ts''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''12 /'/ S 6"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)

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the s ecialized s!stem for "orld"ide standardization# $ational %odies that are mem%ers of ISO or IEC artici ate in the develo ment of International Standards thro&gh technical committees esta%lished %! the res ective 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 res onsi%le for the develo ment 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 a 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 res onsi%le for identif!ing an! or all s&ch atent rights# ISO+IEC 1.023 "as re ared %! 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 a have %een technicall! revised# roved %! %oth organizations# 4his first edition of ISO+IEC 1.023 cancels and re laces ISO+IEC *&ide 23-15166. and ISO+IEC *&ide 23-25166.' "hich roval %! at

ISO/IEC 17043:2010(E)

Intro& "tion
Interla%orator! com arisons are "idel! &sed for a n&m%er of &r oses and their &se is increasing internationall!# 4! ical &r oses for interla%orator! com arisons incl&de5 a) eval&ation of the erformance of la%oratories for s ecific tests or meas&rements and monitoring la%oratories7 contin&ing erformance8 %) identification of ro%lems in la%oratories and initiation of actions for im rovement "hich' for e9am le' ma! %e related to inade-&ate test or meas&rement roced&res' effectiveness of staff training and s& ervision' or cali%ration of e-&i ment8 c) esta%lishment of the effectiveness and com ara%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 artici ating la%oratories %ased on the o&tcomes of s&ch com arisons8 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 s ecific 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! com arisons= lementar! com arisons cond&cted on %ehalf of the International >&rea& of ?eights and ;eas&rement (>IP;) and s&

and associated regional metrolog! organizations# Proficienc! testing involves the &se of interla%orator! com arisons 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! com etence is ass&med in these a lications' %&t these a lications can %e &sed to rovide inde endent demonstrations of la%orator! lied to man! of the technical lanning and com etence# 4he re-&irements of this International Standard can %e a o erational 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 s ecif! re-&irements for la%oratories# ISO+IEC 1.011 re-&ires accreditation %odies to ta(e acco&nt of la%oratories7 artici ation and erformance in roficienc! testing# 4here is a gro"ing need for roficienc! testing for other conformit! assessment activities' s&ch as ins ection or rod&ct certification# ;ost of the re-&irements in this International Standard a other as ects' as a ro riate# l! to those evolving areas' es eciall! regarding management' lanning and design' ersonnel' ass&ring -&alit!' confidentialit!' and 4his International Standard has %een re ared to rovide a consistent %asis for all interested arties to determine the com etence of organizations that rovide roficienc! testing# In doing so it re laces %oth arts of ISO+IEC *&ide 235166.# ISO+IEC *&ide 23 incl&ded not onl! g&idance on develo ment and o eration of roficienc! testing and selection and &se of roficienc! testing %! la%orator! accreditation %odies' %&t also &sef&l descri tions of t! ical t! es of roficienc! testing# 4his International Standard has reserved and & dated the rinci les for the o eration of roficienc! testing descri%ed in ISO+IEC *&ide 23 and has retained in )nne9es ) to C information on t! ical t! es of g&idance on a ro riate statistical methods' selection and &se of accreditation %odies' reg&lator! %odies' and other interested arties# roficienc! testing schemes' roficienc! testing schemes %! la%oratories'

ISO/IEC 17043:2010(E)

Conformity assessment General req irements for !rofi"ien"y testin#

1 S"o!e
4his International Standard s ecifies general re-&irements for the com etence of roviders of roficienc! testing schemes and for the develo ment and o eration 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 s ecific technical re-&irements for artic&lar fields of a lication# lication of this doc&ment# For dated references' onl!

2 )ormati(e referen"es
4he follo"ing referenced doc&ments are indis ensa%le for the a the edition cited a amendments) a lies# lies# For &ndated references' the latest edition of the referenced doc&ment (incl&ding an!

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 &r oses of this doc&ment' the terms and definitions given in ISO+IEC 1.00052002' ISO+IEC *&ide 665200. and the follo"ing a l!# 3'1 assi#ne& (al e val&e attri%&ted to a artic&lar ro ert! of a roficienc! test item 3'2 "oor&inator one or more individ&als "ith res onsi%ilit! for organizing and managing all of the activities involved in the o eration 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' 3'/ o tlier o%servation in a set of data that a 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 artici ant can %e an ins ection %od!#

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 ears 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#

3'7 !rofi"ien"y testin# eval&ation of artici ant erformance against re-esta%lished criteria %! means of interla%orator! com arisons
$O4E 1 For the &r oses 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) sam ling @ "here sam les are ta(en for s&%se-&ent anal!sis8 and

1 / 39

ISO/IEC 17043:2010(E)
h) data transformation and inter retation @ "here sets of data or other information are f&rnished and the information is rocessed to rovide an inter retation (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 sam le' rod&ct' artefact' reference material' iece of e-&i ment' 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 res onsi%ilit! for all tas(s in the develo ment and o eration of a roficienc! testing scheme 3'10 !rofi"ien"y testin# ro n& single com lete se-&ence of distri%&tion of artici ants 3'11 !rofi"ien"y testin# s"+eme roficienc! testing designed and o erated in one or more ro&nds for a s ecified area of testing' meas&rement' cali%ration or ins ection
$O4E ) roficienc! testing scheme might cover a artic&lar t! e of test' cali%ration' ins ection or a n&m%er of tests' cali%rations or ins ections on roficienc! test items#

roficienc! test items' and the eval&ation and re orting of res&lts to the

3'12 ro6 st statisti"al met+o& statistical method insensitive to small de art&res from &nderl!ing ass&m tions s&rro&nding an &nderl!ing ro%a%ilistic model 3'13 stan&ar& &e(iation for !rofi"ien"y assessment meas&re of dis ersion &sed in the eval&ation of res&lts of roficienc! testing' %ased on the availa%le information
$O4E 1 4he standard deviation a lies onl! to ratio and differential scale res&lts# $O4E 2 $ot all roficienc! testing schemes eval&ate roficienc! %ased on the dis ersion of res&lts#

3'14 s 6"ontra"tor organization or individ&al engaged %! the roficienc! testing rovider to erform activities s ecified 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 ro ert! 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 S ecification 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 &r ose or that there is an a%sence of mista(es# $O4E B ) com arison %et"een t"o meas&rement standards ma! %e vie"ed as a cali%ration if the com arison 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 com etence' metrological tracea%ilit! to the SI' and cali%ration intervals (see IC)C P-

2 / 39

ISO/IEC 17043:2010(E)

1) International Ca%orator! )ccreditation Coo eration# $O4E D 4he a%%reviated term <tracea%ilit!= is sometimes &sed to mean <metrological tracea%ilit!= as "ell as other conce ts' s&ch as <sam le 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 meas rement n"ertainty &ncertaint! of meas&rement &ncertaint! non-negative arameter characterizing the dis ersion of the -&antit! val&es %eing attri%&ted to a meas&rand' %ased on the information &sed
$O4E 1 ;eas&rement &ncertaint! incl&des com onents arising from s!stematic effects' s&ch as com onents 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! com onents are incor orated# $O4E 2 4he arameter ma! %e' for e9am le' a standard deviation called standard meas&rement &ncertaint! (or a s ecified m&lti le of it)' or the half-"idth of an interval' having a stated coverage ro%a%ilit!# $O4E 3 ;eas&rement &ncertaint! com rises' in general' man! com onents# 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 com onents' "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 e9 erience 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 ,eq irements

4'1 General
4he develo ment and o eration of roficienc! testing schemes shall %e &nderta(en %! roficienc! testing roviders having com etence to cond&ct interla%orator! com arisons and access to e9 ertise "ith the artic&lar t! e of roficienc! test items# Proficienc! testing roviders or their s&%contractors shall also have com etence in the meas&rement of the ro erties %eing determined#
$O4E ISO+IEC 1.02/ or ISO 1/1D6 can %e &sed to demonstrate the com etence 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 com etence of rod&cers of reference materials that rovide roficienc! test items#

4'2 -ersonnel 4'2'1 4he 4'2'2 4he roficienc! testing roficienc! testing rovider shall have managerial and technical ersonnel "ith the necessar! a&thorit!' reso&rces and technical com etence re-&ired to erform their d&ties# rovider7s management shall define the minim&m levels of -&alification and e9 erience 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 em lo!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 com etent and that the! "or( in accordance "ith the management s!stem#
$O4E ?here technical e9 erts 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 e9am le' 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 s ecific ersonnel to5 a) select a ro riate roficienc! test items8 %) lan roficienc! testing schemes8

3 / 39

ISO/IEC 17043:2010(E)
c) erform artic&lar t! es of sam ling8 d) o erate s ecific e-&i ment8 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) re are' handle and distri%&te roficienc! test items8 g) o erate the data rocessing s!stem8 h) cond&ct statistical anal!sis8 i) eval&ate the erformance of roficienc! testing artici ants8 1) give o inions and inter retations8 and () a&thorize the iss&e of roficienc! testing re orts# 4'2'/ 4he roficienc! testing rovider shall maintain & -to-date records of the relevant a&thorization(s)' com etence' ed&cational and rofessional -&alifications' training' s(ills and e9 erience of all technical ersonnel' incl&ding contracted ersonnel# 4his information shall %e readil! availa%le and shall incl&de the date on "hich com etence to erform their assigned tas(s "as assessed and confirmed# 4'2'1 4he roficienc! testing rovider shall form&late the o%1ectives "ith res ect to the ed&cation' training' and s(ills for each staff mem%er involved "ith the o eration 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 antici ated 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 com etence 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 com etent

erformance of meas&rements' o eration of e-&i ment 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 com etence#

4'3 Eq i!ment. a""ommo&ation an& en(ironment

4'3'1 4he roficienc! testing rovider shall ens&re that there is a ro riate accommodation for the o eration of the roficienc! test item man&fact&ring' handling' roficienc! testing scheme# 4his incl&des facilities and e-&i ment for records# 4'3'2 4he roficienc! testing rovider shall ens&re that the environmental conditions do not com romise the roficienc! testing scheme or the re-&ired -&alit! of o erations# Partic&lar care shall %e ta(en "hen o erations are &nderta(en at sites a"a! from the roficienc! testing rovider7s ermanent facilities or are &nderta(en %! s&%contractors# 4he technical re-&irements for accommodation and environmental conditions that can affect the 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 s ecifications 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 sto ed "hen the

cali%ration' testing' storage and des atch' for data rocessing' for comm&nications' and for retrieval of materials and

roficienc! testing shall %e

environmental conditions 1eo ardize the -&alit! or the o erations of the roficienc! testing scheme#
$O4E Conditions can incl&de' for e9am le' %iological sterilit!' d&st' electromagnetic dist&r%ances' radiation' h&midit!' electrical s& tem erat&re' and so&nd and vi%rations levels' as a ro riate to the technical activities concerned#

4'3'/ 4here shall %e effective se aration %et"een neigh%o&ring areas in "hich there are incom ati%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-&i ment &sed to confirm the content' homogeneit! and sta%ilit! of maintained. roficienc! testing items are a ro riatel! validated and

4'4 0esi#n of !rofi"ien"y testin# s"+emes

4 / 39

ISO/IEC 17043:2010(E)
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 develo ing 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' e9 erts 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' information and' "here a &r ose and %asic design of the roficienc! testing scheme' incl&ding the follo"ing ro riate' 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 o eration of the roficienc! testing scheme8 c) the activities to %e s&%contracted and the names and addresses of s&%contractors involved in the o eration of the roficienc! testing scheme8 d) criteria to %e met for artici ation8 e) the n&m%er and t! e of e9 ected artici ants in the roficienc! testing scheme8 f) selection of the meas&rand(s) or characteristic(s) of interest' incl&ding information on "hat the identif!' meas&re' or test for in the s ecific roficienc! testing ro&nd8 g) a descri tion of the range of val&es or characteristics' or %oth' to %e e9 ected 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 artici ants or falsification of res&lts' and roced&res to %e em lo!ed if coll&sion or falsification of res&lts is s&s ected8 () a descri tion of the information "hich is to %e s& 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 ro riate' the dates on distri%&ted to artici ants' the deadlines for the ret&rn of res&lts %! artici ants and' "here a "hich testing or meas&rement is to %e carried o&t %! artici ants8 m) an! information on methods or roced&res "hich artici ants need to &se to re are 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 a lica%le' to determine their %iological via%ilit!8 o) re aration of an! standardized re orting formats to %e &sed %! artici ants8 ) a detailed descri tion 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 artici ants8 s) a descri tion of the data' interim re orts or information to %e ret&rned to artici ants8 t) a descri tion of the e9tent to "hich artici ant 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 e9 ertise and e9 erience in the relevant field of testing' cali%ration' sam ling or ins ection' as "ell as statistics# 4his ma! %e achieved' if necessar!' %! esta%lishing an advisor! gro& (named as a 4'4'1'/ 4echnical e9 ertise shall %e &sed' as a a) lanning re-&irements as listed in 2#2#1#38 %) identification and resol&tion of an! diffic&lties e9 ected in the re aration 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) re aration of detailed instr&ctions for artici ants8 d) comments on an! technical diffic&lties or other remar(s raised %! artici ants in revio&s roficienc! testing ro&nds8 ro riate)# ro riate' to determine matters s&ch as the follo"ing5 lied to artici ants and the time sched&le for the vario&s hases of artici ants are to

5 / 39

ISO/IEC 17043:2010(E)
e) rovision of advice in eval&ating the erformance of artici ants8 f) comments on the res&lts and erformance of artici ants as a "hole and' "here a individ&al artici ants8 g) rovision of advice for artici ants ("ithin limits of confidentialit!)' either individ&all! or "ithin the re ort8 h) res onding to feed%ac( from artici ants8 and i) lanning or artici ating in technical meetings "ith artici ants# 4'4'2 -re!aration of !rofi"ien"y test items 4'4'2'1 4he roficienc! testing rovider shall esta%lish and im lement roced&res to ens&re that roficienc! test items are re ared 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 re aration of s&fficient n&m%ers of roficienc! test items' in order to allo" for the need to re lace 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 artici ants or &se as a reference material#

ro riate' gro& s of artici ants or

4'4'2'2 4he

roficienc! testing

rovider shall esta%lish and im lement

roced&res to ens&re a

ro riate ac-&isition'

collection' re aration' handling' storage and' "here re-&ired' dis osal 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 artici ants to re are or mani &late' or %oth re are 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 re aration' ac(aging and trans ort 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 artici ants7 erformance#
$O4E 1 4he re-&irements in this s&%cla&se are intended to ens&re that ever! artici ant receives com ara%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 shi 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 e9am le' "hen limited material is availa%le to re are 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# ing are

4'4'3'2 4he a

roced&res for the assessment of homogeneit! and sta%ilit! shall %e doc&mented and cond&cted' "here ro riate statistical designs# ?here ossi%le' the roficienc! testing rovider shall &se a

lica%le' in accordance "ith a

statisticall! random selection of a re resentative 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 a ro riate#

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 artici ants &nless' for e9am le' sta%ilit! st&dies indicate that the! sho&ld %e stored in %&l( form#
$O4E 1 Homogeneit! can %e demonstrated rior to ac(aging "here no infl&ence of ac(aging is reasona%l! e9 ected# $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 trans ort conditions# ?hen this is not ossi%le' the sta%ilit! shall %e -&antified and considered as an additional com onent 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

6 / 39

ISO/IEC 17043:2010(E)
criteria# 4'4'3'/ ?hen roficienc! test items from revio&s ro&nds are retained for f&t&re &se' the ro ert! 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 for the &r ose of the roficienc! testing# 4'4'4 Statisti"al &esi#n 4'4'4'1 Statistical designs shall %e develo ed 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&m tions' the nat&re of errors' and the e9 ected n&m%er of res&lts (see >#3#2#2)#
$O4E 1 Statistical design covers the rocess of lanning' collection' anal!sis and re orting 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 s ecified o"er or determination of assigned val&es "ith s ecified meas&rement &ncertaint!# $O4E 2 ,ata anal!sis methods co&ld var! from the ver! sim le (e#g# descri tive statistics) to the com le9' &sing statistical models "ith ro%a%ilistic ass&m tions or com%inations of res&lts for different roficienc! test items# $O4E 3 In cases "here the roficienc! testing scheme design is mandated %! a s ecification given %!' for e9am le' 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 s ecification# $O4E 2 In the a%sence of relia%le information needed to rod&ce a statistical design' a reliminar! interla%orator! com arison can %e &sed#

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

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 artici ant res&lts' and shall rovide a descri tion of the reasons for their rescri%ed selection and ass&m tions & on "hich the! are %ased# 4he roficienc! testing rovider shall %e a%le to demonstrate that statistical ass&m tions are reasona%le and that statistical anal!ses are carried o&t in accordance "ith 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 e9 ected for each meas&rand or characteristic in the roficienc! testing8 %) the minim&m n&m%er of artici ants 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 artici ants 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 artici ants' details of the alternative a roaches &sed to assess artici ant erformance8 roficienc! test items to %e tested or meas&red and the n&m%er of re eat tests' cali%rations or c) the relevance of significant fig&res to the re orted res&lt' incl&ding the n&m%er of decimal laces8 d) the n&m%er of 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 a 4'4'/'1 4he ro riate' the o%1ectives to %e met for the design and the fre-&enc! of roficienc! testing ro&nds# roficienc! testing rovider shall doc&ment the artic&lar roced&re for determining the assigned val&es for the roced&re shall ta(e into acco&nt the 4'4'/ 8ssi#ne& (al es meas&rands or characteristics in a for its &r ose#
$O4E ;etrological tracea%ilit! is not al"a!s ossi%le or a ro riate#

roficienc! testing scheme# 4his

metrological tracea%ilit! and meas&rement &ncertaint! re-&ired to demonstrate that the roficienc! testing scheme is fit

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 s ecified re-&irements of artici ants or other interested arties' or %! the design of the roficienc! testing

7 / 39

ISO/IEC 17043:2010(E)
$O4E 4he re-&ired metrological tracea%ilit! chain can differ de ending on the t! e of characteristic' and the availa%ilit! of tracea%le cali%rations and reference materials# roficienc! test item' the meas&rand or

4'4'/'4 ?hen a consens&s val&e is &sed as the assigned val&e (see )nne9 >)' the for the roficienc! testing scheme#

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 4'4'/'/ 4he roficienc! testing rovider shall have a olic! regarding the disclos&re of assigned val&es# 4he olic! shall ens&re that artici ants cannot gain advantage from earl! disclos&re#

4'/ C+oi"e of met+o& or !ro"e& re

4'/'1 Partici ants shall normall! %e e9 ected to &se the test method' cali%ration or meas&rement to &se a s ecified method in accordance "ith the design of the roficienc! testing scheme# 4'/'2 ?here artici ants are ermitted to &se a method of their choice' the roficienc! testing rovider shall5 a) have a methods8 %) %e a"are of "hich different test or meas&rement methods for an! meas&rand are technicall! e-&ivalent' and ta(e ste s to assess artici ants7 res&lts &sing these methods accordingl!# olic! and follo" a roced&re regarding com arison of res&lts o%tained %! different test 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 artici ants

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 artici ants 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 des atched' &nless the design of the roficienc! testing scheme ma(es it ina Instr&ctions to artici ants shall incl&de5 a) the necessit! to treat roficienc! test items in the same manner as the ma1orit! of ro&tinel! tested sam les (&nless there are artic&lar re-&irements of the roficienc! testing scheme "hich re-&ire de art&re from this rinci le)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 re aring or conditioning' or %oth re aring and conditioning' of the roficienc! test items %efore cond&cting the tests or cali%rations8 d) an! a ro riate instr&ctions on handling the roficienc! test items' incl&ding an! safet! re-&irements8 e) an! s ecific environmental conditions for the artici ant to cond&ct tests or cali%rations' or %oth' and' if relevant' an! re-&irement for the artici ants to re ort relevant environmental conditions d&ring the time of the meas&rement8 f) s ecific and detailed instr&ctions on the manner of recording and re orting test or meas&rement res&lts and associated &ncertainties# If the instr&ctions incl&de re orting of the &ncertaint! of the re orted 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 re orting %asis (e#g# on dr! "eight' or <as received=)#

ro riate to do so#

4'1'1'2 4he roficienc! testing rovider shall give detailed doc&mented instr&ctions to all artici ants#

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 a 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 a 4'1'2'2 4he roficienc! testing rovider shall ro riatel! identified and segregated revent and cannot %ecome contaminated or degraded' from the time of re aration to their distri%&tion to artici ants# rovide sec&re storage areas or stoc( rooms' or %oth' "hich re aration and distri%&tion# ) ro riate damage or deterioration of an! roficienc! test item %et"een 4'1'2'3 ?hen a ro riate' the condition of stored or stoc(ed roced&res for lica%le#

a&thorizing des atch to' and recei t from' s&ch areas shall %e defined# roficienc! test items' chemicals and materials shall %e

8 / 39

ISO/IEC 17043:2010(E)
assessed at s ecified 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 dis osal# 4'1'3 -a"7a#in#. la6ellin# an& &istri6 tion 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 trans ort re-&irements#
$O4E 4he ro er 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 e9 osed 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 %! atmos heric contaminants' e#g# f&el va o&rs or engine e9ha&st gases "hich can %e enco&ntered d&ring trans ort#

4'1'3'2 4he roficienc! testing rovider shall s ecif! relevant environmental conditions for the trans ort of roficienc! test items# ?here relevant' the 4'1'3'3 In 4'1'3'4 4he roficienc! testing rovider shall monitor the ertinent environmental conditions of the roficienc! test items to other ac(aging of individ&al roficienc! test item d&ring trans ort and assess the im act of environmental infl&ences on the roficienc! test item# roficienc! testing schemes "here roficienc! testing artici ants are re-&ired to trans ort the lied# artici ants' doc&mented instr&ctions for this trans ort shall %e s&

rovider shall ens&re that la%els are sec&rel! attached to the

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 artici ants 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(al ation of !rofi"ien"y testin# s"+eme res lts
4'7'1 0ata analysis an& re"or&s 4'7'1'1 )ll data rocessing e-&i ment 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(-& of s&ch maintenance and o erational chec(s shall %e recorded# 4'7'1'2 Ges&lts received from artici ants shall %e recorded and anal!sed %! a ro riate methods# Proced&res shall %e esta%lished and im lemented to chec( the validit! of data entr!' data transfer' statistical anal!sis' and re orting# 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 a ro riate tests to detect statistical o&tliers# ro riate for statistical eval&ation' e#g# miscalc&lations' trans ositions and other gross errors# erformance eval&ation' e#g# 4'7'1'/ 4he roficienc! testing rovider shall have doc&mented criteria and roced&res for dealing "ith test res&lts that ma! %e ina 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 %eca&se of inhomogeneit!' insta%ilit!' damage or contamination# 4'7'2 E(al ation of !erforman"e 4'7'2'1 4he roficienc! testing rovider shall &se valid methods of eval&ation "hich meet the &r ose of the roficienc! testing scheme# 4he methods shall %e doc&mented and incl&de a descri tion of the %asis for the eval&ation# 4he eval&ation of erformance shall not %e s&%contracted (see /#/#2)# 4'7'2'2 ?here a ro riate for the &r ose of the roficienc! testing scheme' the roficienc! testing rovider shall rovide e9 ert commentar! on the erformance of artici ants "ith regard to the follo"ing5 a) overall erformance against rior e9 ectations' ta(ing meas&rement &ncertainties into acco&nt8 %) variation "ithin and %et"een artici ants' and com arisons "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 im roving erformance8 e) advice and ed&cational feed%ac( to artici ants as art of the contin&al im rovement roced&res of artici ants8 rocess and s!stem recover! lan# 4he res&lts

9 / 39

ISO/IEC 17043:2010(E)
f) sit&ations "here &n&s&al factors ma(e eval&ation of res&lts and commentar! on erformance im ossi%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 artici ants roficienc! testing scheme# 4hese can incl&de & dated s&mmaries of if re-&ired# eriodicall! d&ring or after com letion of a artic&lar artici ants over s&ccessive erformance for individ&al

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'

4'2 ,e!orts
4'2'1 Proficienc! test re orts shall %e clear and com rehensive and incl&de data covering the res&lts of all artici ants' together "ith an indication of the erformance of individ&al artici ants# 4he a&thorization of the final re ort shall not %e s&%contracted (see /#/#2)#
$O4E ?here all original data cannot %e re orted to artici ants' a s&mmar! of the res&lts' e#g# in ta%&lated or gra hical form' can %e s& lied#

4'2'2 Ge orts shall incl&de the follo"ing' &nless it is not a not doing so5

lica%le or the roficienc! testing rovider has valid reasons for

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 re ort8 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 re ort8 f) age n&m%ers and a clear indication of the end of the re ort8 g) a statement of the e9tent to "hich res&lts are confidential8 h) the re ort n&m%er and clear identification of the roficienc! testing scheme8 i) a clear descri tion of the 1) the artici ants7 res&lts8 () statistical data and s&mmaries' incl&ding assigned val&es and range of acce ta%le res&lts and gra hical dis la!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 artici ants (if different methods are &sed %! different gro& s of artici ants)8 ) comments on artici ants7 erformance %! the roficienc! testing rovider and technical advisers8 -) information a%o&t the design and im lementation of the roficienc! testing scheme8 r) roced&res &sed to statisticall! anal!se the data8 s) advice on the inter retation 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 sim ler re orts' s&ch that man! of the elements in this cla&se co&ld %e e9cl&ded from ro&tine re orts' %&t incl&ded in roficienc! testing scheme rotocols or in eriodic s&mmar! re orts that are availa%le to artici ants#

roficienc! test items &sed' incl&ding necessar! details of the

roficienc! test item7s

re aration and homogeneit! and sta%ilit! assessment8

4'2'3 Ge orts shall %e made availa%le to

artici ants "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 ntici ated 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 re orts %! individ&als and organizations# 4'2'/ ?hen it is necessar! to iss&e a ne" or amended re ort for a roficienc! testing scheme' this shall incl&de the follo"ing5 a) a &ni-&e identification8 %) a reference to the original re ort that it re laces or amends8 and

10 / 39

ISO/IEC 17043:2010(E)
c) a statement concerning the reason for the amendment or re-iss&e#

4'3 Comm ni"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 sco e of the roficienc! testing scheme8 %) an! fees for artici ation8 c) doc&mented eligi%ilit! criteria for artici ation8 d) confidentialit! arrangements8 and e) details of ho" to a l!# 4'3'2 Partici ants shall %e advised rom tl! %! the roficienc! testing rovider of an! changes in roficienc! testing scheme design or o eration# 4'3'3 4here shall %e doc&mented scheme artici ants# 4'3'4 Gelevant records of comm&nications "ith artici ants shall %e maintained and retained' as a information to not %e misleading# ro riate# 4'3'/ If the roficienc! testing rovider iss&es statements of artici ation or erformance' the! shall contain s&fficient roced&res for ena%ling artici ants to a eal 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

4'10 Confi&entiality
4'10'1 4he identit! of artici ants in a roficienc! testing scheme shall %e confidential and (no"n onl! to ersons involved in the o eration of the roficienc! testing scheme' &nless the artici ant "aives confidentialit!# 4'10'2 )ll information s& lied %! a artici ant to the roficienc! testing rovider shall %e treated as confidential#
$O4E Partici ants can elect to "aive confidentialit! "ithin the roficienc! testing scheme for the &r oses of disc&ssion and m&t&al assistance' e#g# to im rove erformance# Confidentialit! can also %e "aived %! the artici ant for reg&lator! or recognition &r oses# In most instances' the roficienc! testing res&lts can %e rovided to the relevant a&thorit! %! the artici ants themselves#

4'10'3 ?hen an interested art! re-&ires the roficienc! testing res&lts to %e directl! rovided %! the roficienc! testing rovider' the artici ants shall %e made a"are of the arrangement in advance of artici ation# 4'10'4 In e9ce tional circ&mstances' "hen a reg&lator! a&thorit! re-&ires "riting. roficienc! testing res&lts to %e directl! rovided to the a&thorit! %! the roficienc! testing rovider' the affected artici ants shall %e notified of this action in

/ 4ana#ement req irements

/'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 res onsi%ilit! of the roficienc! testing rovider to carr! o&t its roficienc! testing o erations in s&ch a "a! as to meet the re-&irements of this International Standard and to satisf! the needs of the 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 tem orar! facilities# /'1'4 If the roficienc! testing rovider is art of an organization erforming other activities' then the roficienc! testing rovider shall identif! the res onsi%ilities of (e! ersonnel in the organization that have an 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 im artialit!# /'1'/ 4he roficienc! testing rovider shall5 a) have managerial and technical ersonnel "ho' irres ective of other res onsi%ilities' have the a&thorit! and reso&rces needed to carr! o&t their d&ties' incl&ding the im lementation' maintenance and im rovement of the management s!stem' and to identif! the occ&rrence of de art&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 de art&res8 %) have arrangements to ens&re that its management and ersonnel are free from an! &nd&e internal or e9ternal artici ants' reg&lator!

11 / 39

ISO/IEC 17043:2010(E)
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 artici ants7 confidential information and ro rietar! 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 com etence' im artialit!' 1&dgement or o erational integrit!8 e) define the organization and management str&ct&re' its lace in an! arent organization' and the relationshi s %et"een -&alit! management' technical o erations and s& ort services8 f) s ecif! the res onsi%ilit!' a&thorit!' interrelationshi s and re-&ired com etence of all ersonnel "ho manage' erform or verif! "or( affecting the -&alit! of the o eration of roficienc! testing schemes8 g) ens&re that the ersonnel are a"are of the relevance and im ortance 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 res onsi%ilit! for the technical o erations and the reso&rces needed to ens&re the re-&ired -&alit! of indicated in 2#2#1#28 1) a oint a mem%er of staff as -&alit! manager (named as a ro riate) "ho' irres ective of other d&ties and res onsi%ilities' shall have defined res onsi%ilit! and a&thorit! for ens&ring that the management s!stem is im lemented 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 () a 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 im ractical to a oint de &ties for all ma1or f&nctions#

rovision of the

roficienc! testing schemes' incl&ding access to the necessar!

technical e9 ertise and e9 erience in the relevant field of testing' cali%ration or ins ection' as "ell as statistics' as

oint de &ties for (e! managerial

/'1'1 4o management shall ens&re that a

ro riate 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' im lement and maintain a management s!stem a sco e 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 as ects of roficienc! testing# 4he s!stem7s doc&mentation shall %e ro riate ersonnel#
ro riate statistical roced&res)' eval&ation

ro riate to its

comm&nicated to' &nderstood %!' availa%le to' and im lemented %! the a

$O4E 4hese as ects incl&de' %&t are not limited to' roficienc! test item -&alit! (e#g# homogeneit! and sta%ilit!)' characterization (e#g# e-&i ment cali%ration and method validation)' assignment of ro ert! val&es (e#g# &se of a and re orting# of artici ant erformance' distri%&tion of roficienc! test items' storage and trans ort roced&res' statistical treatment of test res&lts'

/'2'3 4he

roficienc! testing

rovider7s management s!stem

olicies related to -&alit!' incl&ding a -&alit!


statement' shall %e defined in a -&alit! man&al (named as a revie"ed d&ring management revie"# 4he -&alit! management# It shall incl&de at least the follo"ing5

ro riate)# 4he overall o%1ectives shall %e esta%lished and

olic! statement shall %e iss&ed &nder the a&thorit! of to

a) the management7s commitment to the -&alit! of its roficienc! testing services to artici ants and other c&stomers8 %) the management7s statement of the standard of service8 c) the &r ose 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 im lement the olicies and roced&res in their "or(8 and e) the management7s commitment to com l! "ith this International Standard and to contin&all! im rove the effectiveness of the management s!stem# /'2'4 4o management shall rovide evidence of commitment to the develo ment and im lementation of the management s!stem and to contin&all! im roving its effectiveness# /'2'/ 4o management shall comm&nicate to the organization the im ortance of meeting c&stomer re-&irements' as "ell

12 / 39

ISO/IEC 17043:2010(E)
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 res onsi%ilities of technical management and the -&alit! manager' incl&ding their res onsi%ilit! for ens&ring com liance "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 im lemented#

/'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 s ecifications' instr&ctions and man&als# /'3'2 0o" ment a!!ro(al an& iss e /'3'2'1 )ll doc&ments iss&ed as art of the management s!stem shall %e revie"ed and a roved 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# /'3'2'2 4he roced&res ado ted shall also ens&re that5 a) a&thorized editions of a ro riate doc&ments are availa%le at all locations "here activities essential to the effective o eration 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 com liance "ith a lica%le re-&irements8 c) invalid or o%solete doc&ments are rom tl! 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 &r oses 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 a and a roved %! the same f&nction that erformed the original revie" ersonnel shall have access to ertinent roval# ro riate attachments# roval' &nless s ecificall! designated other"ise# 4he designated

%ac(gro&nd information & on "hich to %ase their revie" and a

/'3'3'2 ?here ractica%le' the altered or ne" te9t shall %e identified in the doc&ment or the a

/'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 req ests. 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-&i ment and roficienc! test items to %e &sed' are ade-&atel! defined' doc&mented and &nderstood8 %) the roficienc! testing rovider has the ca a%ilit! and reso&rces to meet the re-&irements8 and c) the roficienc! testing scheme is technicall! a ro riate#
$O4E 1 4his revie" is artic&larl! im ortant "hen a c&stomer re-&ests a roficienc! testing scheme to %e created for a s ecific &r ose or for a different level or fre-&enc! of artici ation from that normall! offered# $O4E 2 4his revie" can %e sim lified "hen the roficienc! test scheme is f&ll! descri%ed in a catalog&e or other notice' and the

13 / 39

ISO/IEC 17043:2010(E)
artici ant is enrolling for a ro&tine shi ment#

/'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 e9ec&tion of the contract' or %oth# /'4'3 4he revie" shall cover all as ects of the re-&est' incl&ding an! "or( that is s&%contracted %! the roficienc! testing rovider# /'4'4 4he artici ants and other c&stomers' as a 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 re eated and an! amendments shall %e comm&nicated to all affected ersonnel# ro riate' shall %e informed of an! deviation in the contract or agreed eriod of

/'/ S 6"ontra"tin# ser(i"es

/'/'1 ?hen a roficienc! testing rovider s&%contracts "or(' the roficienc! testing rovider shall demonstrate that the s&%contractors7 e9 erience and technical com etence are s&fficient for their assigned tas(s and that the! com l! "ith the relevant cla&ses of this International Standard and other a ro riate 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 re ort (see 2#D#1)#
$O4E 4his does not recl&de the roficienc! testing rovider &tilizing advice or assistance from an! advisors' e9 erts or steering gro& #

/'/'3 4he roficienc! testing rovider shall inform artici ants' in advance and in "riting' of services that are' or ma! %e' s&%contracted#
$O4E 4his notification can' for e9am le' ta(e the form of a statement in the roficienc! testing scheme doc&mentation' s&ch as the follo"ing5 <Jario&s as ects of the roficienc! testing scheme can from time to time %e s&%contracted# ?hen s&%contracting occ&rs' it is laced "ith a com etent s&%contractor and the roficienc! testing rovider is res onsi%le for this "or(#=

/'/'4 4he roficienc! testing rovider shall %e res onsi%le to the artici ants and other c&stomers for the s&%contractor7s "or(' e9ce t in the case "here a reg&lator! a&thorit! s ecifies "hich s&%contractor is to %e &sed# /'/'/ 4he roficienc! testing rovider shall maintain a register of all s&%contractors &sed in the o eration of roficienc! testing schemes' incl&ding the sco e of s&%contracting and a record of the com etence assessment against relevant arts of this International Standard and other a ro riate standards for the "or( in -&estion# lies that it

/'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& storage of reagents' &ses and that affect the -&alit! of its roficienc! testing schemes# Proced&res shall e9ist for the &rchase' rece tion and roficienc! test items' reference materials and other cons&ma%le materials relevant for the lies' e-&i ment and cons&ma%le materials that roficienc! testing schemes# /'1'2 4he roficienc! testing rovider shall ens&re that &rchased s& affect the -&alit! of roficienc! testing schemes are not &sed &ntil the! have %een ins ected or other"ise verified as com l!ing "ith s ecifications or re-&irements# Gecords of actions ta(en to chec( com liance 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& rior to release# /'1'4 4he roficienc! testing rovider shall eval&ate s& s& liers that are a roved# 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
$O4E It is &nderstood that some roficienc! testing roviders can %e re-&ired to im lement their &rchasing roced&res in accordance "ith olicies defined %! their arent com an! or a host organization#

lies ordered# 4hese &rchasing doc&ments shall %e revie"ed and a

roved for technical content

/'7 Ser(i"e to t+e " stomer

/'7'1 4he roficienc! testing rovider shall %e "illing to coo erate "ith artici ants 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 artici ants# /'7'2 4he roficienc! testing rovider shall see( feed%ac(' %oth ositive and negative' from its c&stomers#

14 / 39

ISO/IEC 17043:2010(E)
4he feed%ac( shall %e &sed and anal!sed to im rove the management s!stem' c&stomer service#
$O4E E9am les of the t! es of feed%ac( incl&de c&stomer satisfaction s&rve!s and revie" of c&stomers# roficienc! testing re orts "ith

roficienc! testing schemes' and

/'2 Com!laints an& a!!eals

4he roficienc! testing rovider shall have a olic! and follo" a roced&re for the resol&tion of com laints and a received from artici ants' c&stomers or other arties# Gecords shall %e maintained of all com laints' a investigations and corrective actions ta(en %! the roficienc! testing rovider# eals eals'

/'3 Control of non"onformin# %or7

/'3'1 4he roficienc! testing rovider shall have a olic! and roced&re(s) that shall %e im lemented "hen an! as ect 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 res onsi%ilities and a&thorities for the management of nonconforming "or( are designated and actions (incl&ding halting "or( of ongoing rogrammes and "ithholding re orts' 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 acce ta%ilit! of the nonconforming "or(8 d) roficienc! testing scheme artici ants and other c&stomers' as a ro riate' are informed and the nonconforming roficienc! test items or re orts alread! sent to artici ants are recalled or disregarded8 and e) the res onsi%ilit! for a&thorization of the res&m tion 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 o erations# E9am les are internal or e9ternal a&dits' -&alit! control' re arations of instr&ctions to artici ants' and materials handling and storage# artici ant com laints' management revie"s and roficienc! test items' homogeneit! and sta%ilit! tests' data anal!sis'

/'3'2 ?here the eval&ation indicates that nonconforming "or( co&ld rec&r or that there is do&%t a%o&t the com liance 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 rom tl! follo"ed#

/'10 Im!ro(ement
4he roficienc! testing rovider shall contin&all! im rove 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"#

/'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 a im lementing corrective actions "hen nonconforming "or( or de art&res from the management s!stem or technical o erations have %een identified#
$O4E See /#6#1' $ote#

ro riate ersonnel for roced&res in the

olicies and

/'11'2 Ca se 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 re arations of otential ca&ses of the ro%lem is re-&ired# Potential ca&ses co&ld incl&de c&stomer lies' artici ants' and materials re-&irements' roficienc! test items and their s ecifications' methods and roced&res' staff s(ills and training' cons&ma%le s& roficienc! test items' homogeneit! and sta%ilit! tests' statistical design' instr&ctions to 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 im lement the action(s) most li(el! to eliminate the ro%lem and to revent rec&rrence# /'11'3'2 Corrective actions shall %e a ro riate to the magnit&de and ris( of the ro%lem#

15 / 39

ISO/IEC 17043:2010(E)
/'11'3'3 4he roficienc! testing rovider shall doc&ment and im lement 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 de art&res from a&thorized com liance of the roficienc! testing rovider "ith its o"n olicies and International Standard' the roficienc! testing rovider shall ens&re that the a accordance "ith /#12 as soon as ossi%le#
$O4E S&ch additional a&dits often follo" the im lementation 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#

roced&res cast do&%ts on the

roced&res' or on its com liance "ith this ro riate areas of activit! are a&dited in

/'12 -re(enti(e a"tions

/'12'1 )reas for im rovements and otential so&rces of nonconforming "or(' either technical or concerning the ort&nities are identified' or if reventive action is management s!stem' shall %e identified# ?hen im rovement o "or( and to ta(e advantage of the o that the! are effective# ort&nities for im rovement# lication of controls to ens&re

re-&ired' action lans shall %e develo ed' im lemented and monitored' to red&ce the li(elihood of s&ch nonconforming /'12'2 )n! roced&re for reventive action shall incl&de the initiation of s&ch actions and a

/'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 dis osal of records# A&alit! records shall incl&de re orts 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 (e t 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 artici ants8 c) artici ants7 original res onses8 d) collated data for statistical anal!sis8 e) information re-&ired for re orts (see 2#D)8 and f) final re orts (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 re orts and feed%ac(# artici ant

/'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 s ecific tas( and to the ersonnel res onsi%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

16 / 39

ISO/IEC 17043:2010(E)
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 o erations contin&e to com l! "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 re aration' storage and distri%&tion' as "ell as re orting activities for the o eration of a carried o&t %! trained and -&alified a&dited#
$O4E It is advisa%le that the rogramme for internal a&diting of the management s!stem %e com leted ever! 12 months#

roficienc! testing scheme# It is the res onsi%ilit! of the -&alit! ermit' inde endent of the activit! to %e

manager to lan and organize a&dits as re-&ired %! the sched&le and re-&ested %! management# Internal a&dits shall %e ersonnel "ho are' "herever reso&rces

/'14'2 ?hen a&dit findings cast do&%t & on the effectiveness of the o erations' 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 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 im lementation and effectiveness of an! corrective actions ta(en# artici ants' or %oth' in roficienc! testing schemes "hose

/'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 im rovements# 4he revie" shall ta(e acco&nt of5 a) the s&ita%ilit! of olicies and roced&res8 %) re orts 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 artici ant feed%ac(8 h) com laints and a eals8 i) recommendations for im rovement8 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 a to cover roficienc! testing activities# ro riate to hold a se arate revie" meeting

/'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 a ro riate and agreed timescale#

8nne9 8 (informative) *y!es of !rofi"ien"y testin# s"+emes

8'1 General
Proficienc! testing has %ecome an essential as ect of la%orator! ractice in all areas of testing' cali%ration and ins ection# Proficienc! testing schemes var! according to the needs of the sector in "hich the! are &sed' the nat&re of the roficienc!

17 / 39

ISO/IEC 17043:2010(E)
test items' the methods in &se and the n&m%er of artici ants# Ho"ever' in their sim lest form' most roficienc! testing schemes ossess the common feat&re of com arison 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 com aring erformance# 4here are three %asic t! es of la%orator! e9aminations5 -&antitative' -&alitative and inter retive# 4he res&lts of a -&antitative meas&rement are n&merical and are re orted on an interval or a ratio scale# 4ests for -&antitative meas&rement ma! var! in their recision' tr&eness' anal!tical sensitivit!' and s ecificit!# In -&antitative roficienc! testing schemes' n&merical res&lts are &s&all! anal!sed statisticall!# 4he res&lts of -&alitative tests are descri tive and re orted on a categorical or ordinal scale' e#g# identit! of microorganisms' or %! identification of the resence of a s ecific meas&rand (s&ch as a dr&g or a grading of a characteristic)# )ssessment of erformance %! statistical anal!sis ma! not %e a ro riate for -&alitative e9aminations# In inter retive tests' the < roficienc! testing item= is a test res&lt (e#g# a descri tive mor holog! 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 inter retative feat&re of the artici ant7s com etence# Other roficienc! testing schemes have additional feat&res de ending on their o%1ective' as o&tlined in definition 3#.' $ote 1' a) to h)# Some common a lications 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 Seq ential !arti"i!ation s"+emes

Se-&ential artici ation schemes (sometimes (no"n as meas&rement com arison schemes) involve the roficienc! test item %eing circ&lated s&ccessivel! from one artici ant to the ne9t (i#e# se-&ential artici ation)' 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 ca a%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 ro erties' the assigned val&e sho&ld %e determined %! consens&s of e9 erts or other a&thoritative so&rce# It ma! %e necessar! for the roficienc! test item to %e chec(ed at s ecific 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 com ared "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 artici ant' or the claimed level of e9 ertise# It ma! %e diffic&lt to com are res&lts on a gro& meas&rement ca a%ilities that closel! match each other# c) Schemes involving se-&ential artici ation ta(e time (in some cases' !ears) to com lete# 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 artici ants' and the need to s& finishes# d) Proficienc! test items (meas&rement artefacts) &sed in this t! e of histolog! slides "ith confirmed diagnoses# e) Schemes that follo" this design %&t that are limited to sit&ations "here a single artici ant is tested inde endentl! 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 artici ants (or in some sit&ations' a s&%set of artici ants) have com leted the meas&rement com arison# roficienc! test can incl&de' for e9am le' rogrammes' meas&rement reference standards (e#g# resistors' micrometers and fre-&enc! co&nters) or' in medical l! feed%ac( on individ&al erformance d&ring the scheme7s im lementation' rather than "aiting &ntil it artici ants and the time allo"ed for meas&rement %! individ&al %asis as there ma! %e relativel! fe" artici ants having

8'3 Sim ltaneo s !arti"i!ation s"+emes

8'3'1 General
Sim&ltaneo&s artici ation roficienc! testing schemes &s&all! involve randoml! selected s&%-sam les from a so&rce of material %eing distri%&ted sim&ltaneo&sl! to artici ants for conc&rrent testing# In some schemes' artici ants are

18 / 39

ISO/IEC 17043:2010(E)
re-&ired to ta(e sam les' "hich are then considered to %e the roficienc! test items for anal!sis# )fter com letion of the testing' the res&lts are ret&rned to the roficienc! testing rovider and com ared "ith the assigned val&e(s) to give an indication of the erformance of the individ&al artici ants and the gro& as a "hole# E9am les 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' se arate ed&cational comments are t! icall! art of the re ort ret&rned to artici ants %! the roficienc! testing rovider "ith the aim of romoting im rovement in erformance# ;odel 2 in Fig&re )#1 re resents 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 &r oses# )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 artici ants (all artici ants' or a s&%set of <e9 erts=) or eval&ations can %e on the %asis of inde endentl!-determined assigned val&es# Kno"n val&e schemes &se assigned val&es that are determined inde endentl! of the artici ants and involve re aration 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 com arison can also %e made %et"een a roficienc! test item and a certified reference material &nder re eata%ilit! conditions# Ho"ever' care sho&ld %e ta(en to ens&re that the certified reference material is closel! com ara%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 s ecial a lication of roficienc! testing' often called <%lind= roficienc! testing' is "here the roficienc! test item is indisting&isha%le from normal c&stomer items or sam les 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' %eca&se of &ni-&e ac(aging and shi ing needs' %&l( rocessing is &s&all! not feasi%le and homogeneit! testing is diffic&lt# ortions of revio&sl! esta%lished reference materials are circ&lated# )dvice or

8'3'2 S!lit<le(el &esi#ns

) common design for roficienc! testing is the <s lit-level= design' "here similar (%&t not identical) levels of meas&rand are incl&ded in t"o se arate roficienc! test items# 4his design is &sed to estimate the artici ant7s recision at a s ecific level of a meas&rand# It avoids ro%lems associated "ith re licate 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 s ecial t! e of roficienc! testing design that is often &sed %! artici ants7 c&stomers and some reg&lator! %odies is the <s lit-sam le= design#
$O4E 4his design is not to %e conf&sed "ith a s lit-level design' "hich is disc&ssed in )#3#2#

4! icall!' s lit-sam le roficienc! testing involves com arisons of the data rod&ced %! small gro& s of artici ants (often onl! t"o)# In these roficienc! testing schemes' sam les of a rod&ct or a material are divided into t"o or more arts' "ith each artici ant testing one art of the sam le (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 artici ants as s& cases "here there are too fe" artici ants for a ro riate eval&ation of res&lts# liers of testing services' or in

Lnder s&ch schemes' one of the artici ants ma! %e considered to o erate at a higher metrological level (i#e# lo"er meas&rement &ncertaint!)' d&e to the &se of reference methodolog! and more advanced e-&i ment' etc#' or thro&gh confirmation of its o"n erformance thro&gh satisfactor! artici ation in a recognized interla%orator! com arison scheme# Its res&lts are considered to %e the assigned val&es in s&ch com arisons and it ma! act as an advisor! or mentor la%orator! to the other artici ants com aring s lit-sam le data "ith it#

8'3'4 -artial<!ro"ess s"+emes

S ecial t! es of roficienc! testing involve the eval&ation of artici ants7 a%ilities to erform arts of the overall testing or meas&rement rocess# For e9am le' some e9isting roficienc! testing schemes eval&ate artici ants7 a%ilities to transform and re ort a given set of data (rather than cond&ct the act&al test or meas&rement)' to ma(e inter retations %ased on a given set of data or roficienc! testing items' s&ch as stained %lood films for diagnosis' or to ta(e and re are

19 / 39

ISO/IEC 17043:2010(E)
sam les or s ecimens in accordance "ith a s ecification#

8'4 E9ternal q ality assessment (E=8) !ro#rammes

EA) rogrammes (s&ch as those rovided for la%orator! medicine e9aminations) offer a variet! of interla%orator! lication of the schemes com arison schemes %ased on this traditional roficienc! testing model' %&t "ith %roader a

descri%ed in )#2 and )#3 and ill&strated in Fig&re )#1# ;an! EA) rogrammes are designed to rovide insight into the com lete 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 artici ants and Some EA) romote -&alit! im rovement# )dvisor! and ed&cational comments com rise erformance of re-anal!tical and ost-anal!tical art of the re ort ret&rned to artici ants to achieve this aim# rogrammes assess 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 artici ant for ret&rn of s ecific ans"ers# )lternativel!' re-anal!tical information ma! accom an! the roficienc! test item' re-&iring the artici ant to select an a ro riate a roach to testing or inter retation of res&lts' and not 1&st to erform the test# In <sam le revie"= schemes' artici ants 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 s ecimen or sam le (e#g# stained slide or fi9ed tiss&e)' la%orator! data (e#g# test res&lts' la%orator! re orts or -&alit! ass&rance+control records) or doc&mentation (e#g# roced&res or method verification criteria)#

20 / 39

ISO/IEC 17043:2010(E)

a ,e ending 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 artici ant res&lts#

$i# re 8'1 E9am!les of "ommon ty!es of !rofi"ien"y testin# s"+emes

21 / 39

ISO/IEC 17043:2010(E)

8nne9 : (informative) Statisti"al met+o&s for !rofi"ien"y testin#

:'1 General
Proficienc! test res&lts can a ear in man! forms' s anning a "ide range of data t! es and &nderl!ing statistical ro riate for each sit&ation' and so are too distri%&tions# 4he statistical methods &sed to anal!se the res&lts need to %e a

varied to %e s ecified in this International Standard# ISO 13/2D descri%es referred s ecific 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 artici ants# Some of the methods in ISO 13/2D' es eciall! for homogeneit! and sta%ilit! testing' are modified slightl! in the ILP)C 2) 4echnical Ge ort <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 s ecific t! es of roficienc! testing schemes' e#g# meas&rement com arison schemes for cali%ration# 4he methods disc&ssed in this anne9 and in the referenced doc&ments cover the f&ndamental ste s 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 im roves# Statistical methods ma! need to %e refined once artici ant agreement has im roved 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 im lement the other &ses of interla%orator! com arison data listed in the Introd&ction#

:'2 0etermination of t+e assi#ne& (al e 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 %! s ecific 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
2) International Lnion of P&re and ) lied Chemistr!#

c) reference val&es : as determined %! anal!sis' meas&rement or com arison 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 e9 ert artici ants : e9 erts ("hich ma!' in some sit&ations' %e reference la%oratories) sho&ld have demonstra%le com etence in the determination of the meas&rand(s) &nder test' &sing validated methods (no"n to %e highl! acc&rate and com ara%le to methods in general &se8 e) consens&s val&es from artici ants : &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 artici ants fairl!' !et to enco&rage agreement among test or meas&rement methods# 4his is accom lished thro&gh selection of common com arison 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

22 / 39

ISO/IEC 17043:2010(E)
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 %! e9 ert 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! artici ants# :'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 se aratel!# 4hese res&lts sho&ld not %e s&%1ect to o&tlier tests or ro%&st statistical methods# %) ?hen artici ants7 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 accom lished "ith ro%&st statistical methods or %! removing o&tliers calc&lation# In larger or ro&tine roficienc! testing schemes' it ma! %e 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 a eval&ation#
$O4E ISO 13/2D descri%es a s ecific ro%&st method for determination of the consens&s mean and standard deviation' "itho&t the need for o&tlier removal#

ercentage of res onses (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 com etence and e9 erience of the

rior to

ossi%le to have a&tomated o&tlier screens' if

ro riate erformance

:'2'1 Other considerations are o&tlined %elo"# a) Ideall!' if assigned val&es are determined %! artici ant 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 acce ta%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 artici ant receive an &nacce ta%le eval&ation %eca&se of &ncertaint! in the assigned val&e#

:'3 Cal" lation of !erforman"e statisti"s

:'3'1 -erforman"e for q antitati(e res lts
:'3'1'1 Proficienc! test res&lts often need to %e transformed into a erformance statistic' in order to aid inter retation and to allo" com arison "ith defined o%1ectives# 4he com le9 statistical transformations# :'3'1'2 Performance statistics sho&ld %e meaningf&l to artici ants# 4herefore' statistics sho&ld %e a 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 artici ants7 res&lts# a) 4he difference' D' is calc&lated &sing E-&ation (>#1)5 ro riate for the &r ose is to meas&re the deviation from the assigned val&e in a manner that allo"s com arison "ith erformance criteria# Statistical methods ma! range from no rocessing re-&ired to

23 / 39

ISO/IEC 17043:2010(E)

24 / 39

ISO/IEC 17043:2010(E)

:'3'2 -erforman"e for q alitati(e an& semi<q antitati(e res lts

:'3'2'1 For -&alitative or semi--&antitative res&lts' if statistical methods are &sed' the! m&st %e a of the res onses# For -&alitative data (also called <categorical= data)' the a ro riate for the nat&re ro riate techni-&e is to com are a

artici ant7s res&lt "ith the assigned val&e# If the! are identical' then erformance is acce ta%le# If the! are not identical' then e9 ert 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 artici ants 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 artici ants in advance of the o eration 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 a ro riate# Ordinal res&lts incl&de' for e9am le' res onses s&ch as grades or ran(ings'

25 / 39

ISO/IEC 17043:2010(E)

26 / 39

ISO/IEC 17043:2010(E)

27 / 39

ISO/IEC 17043:2010(E)
e9 ands 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 a variances as com onents of the &ncertaint! of the assigned val&e# *iven the need to estimate com onents acc&ratel! for certified reference materials' the n&m%er of randoml! selected sam les ma! e9ceed "hat is needed for roficienc! testing' "here the main o%1ective is to chec( for &ne9 ected 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 s ecified 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 o eration of a roficienc! testing scheme' e#g# conditions of shi ing and handling "hen distri%&ted to artici ants# 4he criterion for acce ta%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# ro riate)' and s&%se-&entl! &ses those

8nne9 C (informative) Sele"tion an& se of !rofi"ien"y testin#

C'1 General
4his anne9 esta%lishes interested rinci les for the selection and &se of roficienc! testing schemes %! artici ants and other arties# 4his anne9 is also intended to romote the harmonized &se of roficienc! testing schemes %! artici ant7s erformance' it is

interested arties (e#g# accreditation %odies' reg&lator! %odies' or c&stomers of the artici ant)# Since res&lts from roficienc! testing schemes ma! %e &sed in the eval&ation of a arties and im ortant that %oth the interested roficienc! testing schemes# It is also im ortant for artici ants to have a clear &nderstanding of the olicies of the interested arties for artici ation 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' a art from s ecific re-&irements from reg&lator! %odies' it is the res onsi%ilit! of the a ro riate roficienc! testing scheme and to eval&ate their res&lts correctl!# artici ants themselves to select the artici ants have confidence in the develo ment and o eration of the

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 e9am le' res&lts of artici ants7 o"n internal -&alit! control roced&res "ith control sam les' com arison "ith s lit-sam le data from other artici ants and erformance on tests of certified reference materials# 4herefore' "hen selecting a roficienc! testing scheme' the artici ant 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 artici ants) need to select roficienc! testing schemes that are a their sco e of testing or sco e of cali%ration# 4he 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 artici ant8 %) 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 artici ants' statistical treatment of data' and the final s&mmar! re ort8 c) the fre-&enc! at "hich the roficienc! testing scheme is o erated8 d) the s&ita%ilit! of the organizational logistics for the roficienc! testing scheme (e#g# timing' location' sam le sta%ilit! considerations' distri%&tion arrangements) relevant to the gro& of artici ants ro osed for the roficienc! testing ro riate for roficienc! testing schemes selected sho&ld com l! "ith the

28 / 39

ISO/IEC 17043:2010(E)
scheme8 e) the s&ita%ilit! of acce tance criteria (i#e# for 1&dging s&ccessf&l erformance in the roficienc! test)8 f) the costs8 g) the roficienc! testing rovider7s olic! on maintaining artici ants7 confidentialit!8 h) the timescale for re orting 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 a ro riate' 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 artici ant (e#g# the &se of a different national standard for the same determination)' %&t it can still %e technicall! 1&stified to artici ate 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 artici ation 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 artici ation olicies for s ecific roficienc! testing schemes incl&de5 a) "hether artici ation in s ecific roficienc! testing schemes is mandator! or vol&ntar!8 %) the fre-&enc! of artici ation8 c) the criteria &sed %! the interested art! to 1&dge satisfactor! or &nsatisfactor! erformance8 d) "hether artici ants ma! %e re-&ired to artici ate in follo"-& %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 artici ants7 confidentialit!# roficienc! testing schemes if erformance is 1&dged to

C'4 >se of !rofi"ien"y testin# 6y !arti"i!ants

C'4'1 Partici ants 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 artici ant7s 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 re licates' the meas&rands' the manner of e9ec&tion)8 d) the criteria &sed %! the roficienc! testing rovider to eval&ate the artici ants7 erformance8 e) an! relevant reg&lator!' accreditation or other re-&irements# C'4'2 Partici ants 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#

C'/ >se of res lts 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 s ecified in ISO+IEC 1.01152002' .#1/#
$O4E F&rther olicies on roficienc! testing relevant to the com liance of accreditation %odies "ith re-&irements for mem%ershi in the IC)C m&t&al recognition arrangement are s ecified in IC)C P-6#

C'/'1'2 4he res&lts from roficienc! testing schemes are &sef&l for %oth artici ants and accreditation %odies# 4here are' ho"ever' limitations on the &se of s&ch res&lts to determine com etence# S&ccessf&l erformance in a s ecific roficienc! testing scheme ma! re resent evidence of com etence for that e9ercise' %&t ma! not reflect ongoing com etence# Similarl!' &ns&ccessf&l erformance in a s ecific roficienc! testing scheme ma! reflect a random de art&re from a artici ant7s normal state of com etence# 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 artici ants re orting &nsatisfactor! res&lts' the accreditation %odies sho&ld have olicies to a) ens&re that the artici ants investigate and comment on their erformance "ithin an agreed time-frame' and ta(e a ro riate

29 / 39

ISO/IEC 17043:2010(E)
corrective action' %) ("here necessar!) ens&re that the artici ants &nderta(e an! s&%se-&ent roficienc! testing to confirm that an! ro riate technical assessors to corrective actions ta(en %! them are effective' and c) ("here necessar!) ens&re that on-site eval&ation of the artici ants is carried o&t %! a confirm that corrective actions are effective# C'/'1'4 4he accreditation %odies sho&ld advise their accredited %odies of the erformance in a ossi%le o&tcomes of &nsatisfactor! roficienc! testing scheme# 4hese ma! range from contin&ing accreditation s&%1ect to s&ccessf&l

attention to corrective actions "ithin agreed time-frames' tem orar! s&s ension of accreditation for the relevant tests (s&%1ect to corrective action)' thro&gh to "ithdra"al of accreditation for the relevant tests#
$O4E *enerall! s ea(ing' the o tions selected %! an accreditation %od! "ill de end on the histor! of erformance of the artici ant 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 Partici ants ma! need to demonstrate their com etence 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 com etence' altho&gh this sho&ld not %e the onl! activit!#
$O4E Proficienc! testing data &sed to validate claims of com etence are normall! &sed %! organizations in con1&nction "ith other evidence' s&ch as accreditation# See C#/#1#2#

C'/'2'2 It is the res onsi%ilit! of the

artici ants to ens&re that the! have

rovided all the a

ro riate information to

interested arties "ishing to eval&ate the artici ants as to their com etence#

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 artici ants covered %! reg&lations# C'1'2 If the roficienc! testing scheme is o erated %! a reg&lator! %od!' it sho&ld %e o erated in accordance "ith the re-&irements of this International Standard# C'1'3 Geg&lator! %odies that &se inde endent roficienc! testing roviders sho&ld a) see( doc&mentar! evidence that the roficienc! testing schemes com l! "ith the re-&irements of this International Standard %efore recognizing the roficienc! testing scheme' and %) disc&ss "ith artici ants the sco e and o erational arameters of the roficienc! testing scheme' in order that the artici ants7 erformance ma! %e 1&dged ade-&atel! in relation to the reg&lations#

30 / 39

ISO/IEC 17043:2010(E)

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 $ational Occ& ational Standards for E9ternal A&alit! )ssessment' HCS-EA)1 to HCS-EA)12# Com etence Frame"or( for Healthcare Science# ("""#s(illsforhealth#org#&(+) E1.F ELG)CHE;+CI4)C *&ide C*2' .uantifying Uncertainty in )nalytical Measurement' 2nd edition' 2000 E1DF 4HO;PSO$ ;#' ECCISO$ S#C#G#' ?OO, G#' <4he International Harmonized Protocol for the roficienc! testing of anal!tical chemistr! la%oratories= (ILP)C 4echnical Ge ort)' 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

31 / 39