iso iec 17043 interlaboratorio

8/13/2019 ISO IEC 17043 Interlaboratorio

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ISO/IEC 17043:2010(E)

ISO/IEC

17043

First edition

2010-02-01

Conformity assessment General

reqirements for !rofi"ien"y testin#


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ISO/IEC 17043:2010(E)

Contents Page

$ore%or& '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''i

Intro&"tion''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''

1 S"o!e'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

2 ormatie referen"es'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

3 *erms an& &efinitions '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

4 *e"+ni"al ,eqirements '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''4

4'1 General ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''4

4'2 -ersonnel ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''4

4'3 Eqi!ment. a""ommo&ation an& enironment ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''

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

4' C+oi"e of met+o& or !ro"e&re'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''10

4' O!eration of !rofi"ien"y testin# s"+emes''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''11

4'7 ata analysis an& ealation of !rofi"ien"y testin# s"+eme reslts ''''''''''''''''''''''''''''''''''''''''''''12

4' ,e!orts ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''134' Commni"ation %it+ !arti"i!ants''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''14

4'10 Confi&entiality'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

ana#ement reqirements'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

'1 Or#ani5ation''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

'2 ana#ement system '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

'3 o"ment "ontrol'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''17

'4 ,eie% of reqests. ten&ers an& "ontra"ts''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

' S6"ontra"tin# seri"es'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

' -r"+asin# seri"es an& s!!lies ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1

'7 Seri"e to t+e "stomer''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20

' Com!laints an& a!!eals '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20

' Control of non"onformin# %or ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20

'10 Im!roement '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20

'11 Corre"tie a"tions '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''21

'12 -reentie a"tions''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''21

'13 Control of re"or&s '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''22

'14 Internal a&its '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''22

'1 ana#ement reie%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#''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''2

8nne9 C (informative) Sele"tion an& se of !rofi"ien"y testin#''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''3

i6lio#ra!+y'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''3


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ISO/IEC 17043:2010(E)

$ore%or&

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the

secialized s!stem for "orld"ide standardization# $ational %odies that are mem%ers of ISO or IEC articiate in the

develoment of International Standards thro&gh technical committees esta%lished %! the resective organization to deal

"ith artic&lar fields of technical activit!# ISO and IEC technical committees colla%orate in fields of m&t&al interest# Other

international organizations' governmental and non-governmental' in liaison "ith ISO and IEC' also tae art in the "or#

In the field of conformit! assessment' the ISO Committee on conformit! assessment (CSCO) is resonsi%le for the

develoment of International Standards and *&ides#

International Standards are drafted in accordance "ith the r&les given in the ISO+IEC ,irectives' Part 2# ,raft International

Standards are circ&lated to the national %odies for voting# P&%lication as an International Standard re&ires aroval %! at

least ./ 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&%ect of atent rights# ISO

shall not %e held resonsi%le for identif!ing an! or all s&ch atent rights#

ISO+IEC 1.03 "as reared %! the ISO Committee on conformit! assessment (CSCO)#

It "as circ&lated for voting to the national %odies of %oth ISO and IEC' and "as aroved %! %oth organizations#

4his first edition of ISO+IEC 1.03 cancels and relaces ISO+IEC *&ide 3-15166. and ISO+IEC *&ide 3-25166.' "hichhave %een technicall! revised#


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ISO/IEC 17043:2010(E)

Intro&"tion

Interla%orator! comarisons are "idel! &sed for a n&m%er of &roses and their &se is increasing internationall!# 4!ical

&roses for interla%orator! comarisons incl&de5

a) eval&ation of the erformance of la%oratories for secific tests or meas&rements and monitoring la%oratories7

contin&ing erformance8

%) identification of ro%lems in la%oratories and initiation of actions for imrovement "hich' for e9amle' ma! %e related to

inade&ate test or meas&rement roced&res' effectiveness of staff training and s&ervision' or cali%ration of e&iment8

c) esta%lishment of the effectiveness and comara%ilit! of test or meas&rement methods8

d) rovision of additional confidence to la%orator! c&stomers8

e) identification of interla%orator! differences8

f) ed&cation of articiating la%oratories %ased on the o&tcomes of s&ch comarisons8

g) validation of &ncertaint! claims8

h) eval&ation of the erformance characteristics of a method : often descri%ed as colla%orative trials8

i) assignment of val&es to reference materials and assessment of their s&ita%ilit! for &se in secific test or meas&rement

roced&res8 and

) s&ort for statements of the e&ivalence of meas&rements of $ational ;etrolog! Instit&tes thro&gh &rea& of ?eights and ;eas&rement (>IP;)

and associated regional metrolog! organizations#

Proficienc! testing involves the &se of interla%orator! comarisons for the determination of la%orator! erformance' as

listed in a) to g) a%ove# Proficienc! testing does not &s&all! address h)' i) and ) %eca&se la%orator! cometence is

ass&med in these alications' %&t these alications can %e &sed to rovide indeendent demonstrations of la%orator!

cometence# 4he re&irements of this International Standard can %e alied to man! of the technical lanning and

oerational activities for h)' i) and )#

4he need for ongoing confidence in la%orator! erformance is not onl! essential for la%oratories and their c&stomers %&t

also for other interested arties' s&ch as reg&lators' la%orator! accreditation %odies and other organizations that secif!

re&irements for la%oratories# ISO+IEC 1.011 re&ires accreditation %odies to tae acco&nt of la%oratories7 articiation

and erformance in roficienc! testing# 4here is a gro"ing need for roficienc! testing for other conformit! assessment

activities' s&ch as insection or rod&ct certification# ;ost of the re&irements in this International Standard al! to those

evolving areas' eseciall! regarding management' lanning and design' ersonnel' ass&ring &alit!' confidentialit!' and

other asects' as aroriate#

4his International Standard has %een reared to rovide a consistent %asis for all interested arties to determine the

cometence of organizations that rovide roficienc! testing# In doing so it relaces %oth arts of ISO+IEC *&ide 35166.#

ISO+IEC *&ide 3 incl&ded not onl! g&idance on develoment and oeration of roficienc! testing and selection and &se

of roficienc! testing %! la%orator! accreditation %odies' %&t also &sef&l descritions of t!ical t!es of roficienc! testing#

4his International Standard has reserved and &dated the rinciles for the oeration of roficienc! testing descri%ed in

ISO+IEC *&ide 3 and has retained in nne9es to C information on t!ical t!es of roficienc! testing schemes'

g&idance on aroriate statistical methods' selection and &se of roficienc! testing schemes %! la%oratories'

accreditation %odies' reg&lator! %odies' and other interested arties#


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ISO/IEC 17043:2010(E)

Conformity assessment General reqirements for !rofi"ien"y

testin#

1 S"o!e

4his International Standard secifies general re&irements for the cometence of roviders of roficienc! testing

schemes and for the develoment and oeration of roficienc! testing schemes# 4hese re&irements are intended to %e

general for all t!es of roficienc! testing schemes' and the! can %e &sed as a %asis for secific technical re&irements

for artic&lar fields of alication#

2 ormatie referen"es

4he follo"ing referenced doc&ments are indisensa%le for the alication of this doc&ment# For dated references' onl!

the edition cited alies# For &ndated references' the latest edition of the referenced doc&ment (incl&ding an!

amendments) alies#

ISO+IEC 1.0005200' 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& &efinitionsFor the &roses of this doc&ment' the terms and definitions given in ISO+IEC 1.0005200' ISO+IEC *&ide 665200. and

the follo"ing al!#

3'1 assi#ne& ale

val&e attri%&ted to a artic&lar roert! of a roficienc! test item

3'2 "oor&inator

one or more individ&als "ith resonsi%ilit! for organizing and managing all of the activities involved in the oeration of a

roficienc! testing scheme

3'3 "stomer

organization or individ&al for "hich a roficienc! testing scheme is rovided thro&gh a contract&al arrangement

3'4 interla6oratory "om!arison

organization' erformance and eval&ation of meas&rements or tests on the same or similar items %! t"o or more

la%oratories in accordance "ith redetermined conditions

3' otlier

o%servation in a set of data that aears to %e inconsistent "ith the remainder of that set

$O4E n o&tlier can originate from a different o&lation or %e the res&lt of an incorrect recording or other gross error#

3' !arti"i!ant

la%orator!' organization or individ&al that receives roficienc! test items and s&%mits res&lts for revie" %! the roficienc!

testing rovider

$O4E In some cases' the articiant can %e an insection %od!#

3'7 !rofi"ien"y testin#

eval&ation of articiant erformance against re-esta%lished criteria %! means of interla%orator! comarisons

$O4E 1 For the &roses of this International Standard' the term


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ISO/IEC 17043:2010(E)

h) data transformation and interretation @ "here sets of data or other information are f&rnished and the information is rocessed to

rovide an interretation (or other o&tcome)#

$O4E 2 Some roviders of roficienc! testing in the medical area &se the term


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ISO/IEC 17043:2010(E)

1052002)#

1) International a%orator! ccreditation Cooeration#

$O4E D 4he a%%reviated term


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ISO/IEC 17043:2010(E)

c) erform artic&lar t!es of samling8

d) oerate secific e&iment8

e) cond&ct meas&rements to determine sta%ilit! and homogeneit!' as "ell as assigned val&es and associated

&ncertainties of the meas&rands of the roficienc! test item8

f) reare' handle and distri%&te roficienc! test items8

g) oerate the data rocessing s!stem8

h) cond&ct statistical anal!sis8

i) eval&ate the erformance of roficienc! testing articiants8

) give oinions and interretations8 and

) a&thorize the iss&e of roficienc! testing reorts#

4'2' 4he roficienc! testing rovider shall maintain &-to-date records of the relevant a&thorization(s)' cometence'

ed&cational and rofessional &alifications' training' sills and e9erience of all technical ersonnel' incl&ding contracted

ersonnel# 4his information shall %e readil! availa%le and shall incl&de the date on "hich cometence to erform their

assigned tass "as assessed and confirmed#

4'2' 4he roficienc! testing rovider shall form&late the o%ectives "ith resect to the ed&cation' training' and sills for

each staff mem%er involved "ith the oeration of the roficienc! testing scheme# 4he roficienc! testing rovider shall

have a olic! and roced&res for identif!ing training needs and roviding training of ersonnel# 4he training rogrammeshall %e relevant to the resent and anticiated needs of the roficienc! testing rovider#

$O4E It is advisa%le to consider the need to retrain staff eriodicall!# Staff training olicies can tae acco&nt of technological change'

the need to demonstrate ongoing cometence and aim at contin&al sills &grading#

4'2'7 4he roficienc! testing rovider shall ens&re that staff receive the necessar! training to ens&re cometent

erformance of meas&rements' oeration of e&iment and an! other activities "hich affect the &alit! of the roficienc!

testing scheme# 4he effectiveness of training activities shall %e eval&ated#

$O4E O%ective meas&res can %e &sed to assess the attainment of cometence#

4'3 Eqi!ment. a""ommo&ation an& enironment

4'3'1 4he roficienc! testing rovider shall ens&re that there is aroriate accommodation for the oeration of the

roficienc! testing scheme# 4his incl&des facilities and e&iment for roficienc! test item man&fact&ring' handling'

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

records#

4'3'2 4he roficienc! testing rovider shall ens&re that the environmental conditions do not comromise the roficienc!

testing scheme or the re&ired &alit! of oerations# Partic&lar care shall %e taen "hen oerations are &ndertaen at

sites a"a! from the roficienc! testing rovider7s ermanent facilities or are &ndertaen %! s&%contractors# 4he technical

re&irements for accommodation and environmental conditions that can affect the roficienc! testing shall %e

doc&mented#

4'3'3ccess to and &se of areas affecting the &alit! of roficienc! testing schemes shall %e controlled#

4he roficienc! testing rovider shall determine the e9tent of control %ased on its artic&lar circ&mstances#

4'3'4 4he roficienc! testing rovider shall identif! environmental conditions that can significantl! infl&ence the &alit! of

the roficienc! test items and an! testing and cali%ration carried o&t' incl&ding conditions that are re&ired %! relevant

secifications and meas&rement roced&res# 4he roficienc! testing rovider shall control and monitor these conditions'

and shall record all relevant monitoring activities# Gelevant roficienc! testing activities shall %e stoed "hen the

environmental conditions eoardize the &alit! or the oerations of the roficienc! testing scheme#

$O4E Conditions can incl&de' for e9amle' %iological sterilit!' d&st' electromagnetic dist&r%ances' radiation' h&midit!' electrical s&l!'

temerat&re' and so&nd and vi%rations levels' as aroriate to the technical activities concerned#

4'3' 4here shall %e effective searation %et"een neigh%o&ring areas in "hich there are incomati%le activities# ction

shall %e taen to revent cross-contamination#

4'3' Proficienc! testing roviders shall ens&re that erformance characteristics of la%orator! methods and e&iment

&sed to confirm the content' homogeneit! and sta%ilit! of roficienc! testing items are aroriatel! validated and

maintained.

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

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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 Staeholders7 interests can %e considered in develoing a lan and relevant information#

4'4'1'2 4he roficienc! testing rovider shall not s&%contract the lanning of the roficienc! testing scheme (see /#/#2)#

$O4E 4he roficienc! testing rovider can &tilize advice or assistance from an! advisors' e9erts or steering gro& (see ##1#)#

4'4'1'3 4he roficienc! testing rovider shall doc&ment a lan %efore commencement of the roficienc! testing scheme

that addresses the o%ectives' &rose and %asic design of the roficienc! testing scheme' incl&ding the follo"ing

information and' "here aroriate' reasons for its selection or e9cl&sion5

a) the name and address of the roficienc! testing rovider8

%) the name' address and affiliation of the coordinator and other ersonnel involved in the design and oeration of the

roficienc! testing scheme8

c) the activities to %e s&%contracted and the names and addresses of s&%contractors involved in the oeration of the

roficienc! testing scheme8

d) criteria to %e met for articiation8

e) the n&m%er and t!e of e9ected articiants in the roficienc! testing scheme8

f) selection of the meas&rand(s) or characteristic(s) of interest' incl&ding information on "hat the articiants are toidentif!' meas&re' or test for in the secific roficienc! testing ro&nd8

g) a descrition of the range of val&es or characteristics' or %oth' to %e e9ected for the roficienc! test items8

h) the otential maor 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

) reasona%le reca&tions to revent coll&sion %et"een articiants or falsification of res&lts' and roced&res to %e

emlo!ed if coll&sion or falsification of res&lts is s&sected8

) a descrition of the information "hich is to %e s&lied to articiants and the time sched&le for the vario&s hases of

the roficienc! testing scheme8

l) for contin&o&s roficienc! testing schemes' the fre&enc! or dates &on "hich roficienc! test items are to %e

distri%&ted to articiants' the deadlines for the ret&rn of res&lts %! articiants and' "here aroriate' the dates on

"hich testing or meas&rement is to %e carried o&t %! articiants8

m) an! information on methods or roced&res "hich articiants need to &se to reare the test material and erform the

tests or meas&rements8

n) roced&res for the test or meas&rement methods to %e &sed for the homogeneit! and sta%ilit! testing of roficienc! test

items and' "here alica%le' to determine their %iological via%ilit!8

o) rearation of an! standardized reorting formats to %e &sed %! articiants8

) a detailed descrition of the statistical anal!sis to %e &sed8

) the origin' metrological tracea%ilit! and meas&rement &ncertaint! of an! assigned val&es8

r) criteria for the eval&ation of erformance of articiants8

s) a descrition of the data' interim reorts or information to %e ret&rned to articiants8

t) a descrition of the e9tent to "hich articiant res&lts' and the concl&sions that "ill %e %ased on the o&tcome of the

roficienc! testing scheme' are to %e made &%lic8 and

&) actions to %e taen in the case of lost or damaged roficienc! test items#

4'4'1'4 4he roficienc! testing rovider shall have access to the necessar! technical e9ertise and e9erience in the

relevant field of testing' cali%ration' samling or insection' as "ell as statistics# 4his ma! %e achieved' if necessar!' %!

esta%lishing an advisor! gro& (named as aroriate)#

4'4'1' 4echnical e9ertise shall %e &sed' as aroriate' to determine matters s&ch as the follo"ing5

a) lanning re&irements as listed in ##1#38

%) identification and resol&tion of an! diffic&lties e9ected in the rearation and maintenance of

homogeneo&s roficienc! test items' or in the rovision of a sta%le assigned val&e for a roficienc! test item8

c) rearation of detailed instr&ctions for articiants8

d) comments on an! technical diffic&lties or other remars raised %! articiants in revio&s roficienc! testing ro&nds8

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ISO/IEC 17043:2010(E)

e) rovision of advice in eval&ating the erformance of articiants8

f) comments on the res&lts and erformance of articiants as a "hole and' "here aroriate' gro&s of articiants or

individ&al articiants8

g) rovision of advice for articiants ("ithin limits of confidentialit!)' either individ&all! or "ithin the reort8

h) resonding to feed%ac from articiants8 and

i) lanning or articiating in technical meetings "ith articiants#

4'4'2 -re!aration of !rofi"ien"y test items

4'4'2'1 4he roficienc! testing rovider shall esta%lish and imlement roced&res to ens&re that roficienc! test items are

reared in accordance "ith the lan descri%ed in ##1#

$O4E It is advisa%le that the roficienc! testing rovider give d&e consideration to the rearation of s&fficient n&m%ers of roficienc!

test items' in order to allo" for the need to relace an! s&ch roficienc! test items lost or damaged d&ring distri%&tion' or intended to %e

rovided for &se after the res&lts of the roficienc! testing scheme have %een eval&ated# S&ch &ses can incl&de training aids for

articiants or &se as a reference material#

4'4'2'2 4he roficienc! testing rovider shall esta%lish and imlement roced&res to ens&re aroriate ac&isition'

collection' rearation' handling' storage and' "here re&ired' disosal of all roficienc! test items#

4he roced&res shall ens&re that materials &sed to man&fact&re roficienc! test items are o%tained in accordance "ith

relevant reg&lator! and ethical re&irements#4'4'2'3 Proficienc! test items sho&ld match in terms of matri9' meas&rands and concentrations' as closel! as ractica%le'

the t!e of items or materials enco&ntered in ro&tine testing or cali%ration#

4'4'2'4 In roficienc! testing schemes that re&ire articiants to reare or mani&late' or %oth reare and mani&late'

the roficienc! test item and s&%mit it to the roficienc! testing rovider' the roficienc! testing rovider shall iss&e

instr&ctions for rearation' acaging and transort of the roficienc! test item#

4'4'3 ;omo#eneity an& sta6ility

4'4'3'1 Criteria for s&ita%le homogeneit! and sta%ilit! shall %e esta%lished and shall %e %ased on the effect that

inhomogeneit! and insta%ilit! "ill have on the eval&ation of the articiants7 erformance#

$O4E 1 4he re&irements in this s&%cla&se are intended to ens&re that ever! articiant receives comara%le roficienc! test items'

and that these roficienc! test items remain sta%le thro&gho&t the roficienc! testing# Caref&l lanning' man&fact&re and shiing are

necessar! to achieve this' and testing is &s&all! needed to confirm it#

$O4E 2 In some cases' it is not feasi%le for roficienc! test items to %e s&%ected to homogeneit! and sta%ilit! testing#

S&ch cases "o&ld incl&de' for e9amle' "hen limited material is availa%le to reare roficienc! testing items#

$O4E 3 In some cases' materials that are not s&fficientl! homogeneo&s or sta%le are the %est availa%le8 in s&ch cases' the! can still %e

&sef&l as roficienc! test items' rovided that the &ncertainties of the assigned val&es or the eval&ation of res&lts tae d&e acco&nt of

this (see >#3#1#3 and ISO 13/2D5200/' nne9 >)#

$O4E Considerations for homogeneit! and sta%ilit! are f&rther disc&ssed in ISO *&ide 3' ISO *&ide 3/ and ISO 13/2D#

4'4'3'2 4he roced&res for the assessment of homogeneit! and sta%ilit! shall %e doc&mented and cond&cted' "here

alica%le' in accordance "ith aroriate statistical designs# ?here ossi%le' the roficienc! testing rovider shall &se a

statisticall! random selection of a reresentative n&m%er of roficienc! test items from the "hole %atch of test material in

order to assess the homogeneit! of the material#

$O4E In some cases' the &se of a random stratified or s!stematic selection of roficienc! test items from the "hole %atch is more

aroriate#

4'4'3'3 4he assessment of homogeneit! shall normall! %e erformed after the roficienc! test items have %een acaged

in the final form and %efore distri%&tion to articiants &nless' for e9amle' sta%ilit! st&dies indicate that the! sho&ld %e

stored in %&l form#

$O4E 1 Homogeneit! can %e demonstrated rior to acaging "here no infl&ence of acaging is reasona%l! e9ected#

$O4E 2 On some occasions' homogeneit! testing cannot %e carried o&t rior to distri%&tion for ractical' technical or logistical reasons#

4'4'3'4 Proficienc! test items shall %e demonstrated to %e s&fficientl! sta%le to ens&re that the! "ill not &ndergo an!

significant change thro&gho&t the cond&ct of the roficienc! testing' incl&ding storage and transort conditions# ?hen this

is not ossi%le' the sta%ilit! shall %e &antified and considered as an additional comonent of the meas&rement

&ncertaint! associated "ith the assigned val&e of the roficienc! test item' and+or taen into acco&nt in the eval&ation

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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 roert! val&es to %e determined

in the roficienc! testing scheme shall %e confirmed %! the roficienc! testing rovider rior to distri%&tion#

4'4'3' In circ&mstances "here homogeneit! and sta%ilit! testing is not feasi%le' the roficienc! testing rovider shall

demonstrate that the roced&res &sed to collect' rod&ce' acage and distri%&te the roficienc! test items are s&fficient

for the &rose of the roficienc! testing#

4'4'4 Statisti"al &esi#n

4'4'4'1 Statistical designs shall %e develoed to meet the o%ectives of the scheme' %ased on the nat&re of the data

(&antitative or &alitative' incl&ding ordinal and categorical)' statistical ass&mtions' the nat&re of errors' and the

e9ected n&m%er of res&lts (see >#3#2#2)#

$O4E 1 Statistical design covers the rocess of lanning' collection' anal!sis and reorting of the roficienc! testing scheme data#

Statistical designs are often %ased on stated o%ectives for the roficienc! testing scheme' s&ch as detection of certain t!es of errors

"ith secified o"er or determination of assigned val&es "ith secified meas&rement &ncertaint!#

$O4E 2 ,ata anal!sis methods co&ld var! from the ver! simle (e#g# descritive statistics) to the comle9' &sing statistical models "ith

ro%a%ilistic ass&mtions or com%inations of res&lts for different roficienc! test items#

$O4E 3 In cases "here the roficienc! testing scheme design is mandated %! a secification given %!' for e9amle' a c&stomer'

reg&lator! a&thorit! or accreditation %od!' the statistical design and data anal!sis methods can %e taen directl! from the secification#

$O4E In the a%sence of relia%le information needed to rod&ce a statistical design' a reliminar! interla%orator! comarison can %e

&sed#

4'4'4'2 4he roficienc! testing rovider shall doc&ment the statistical design and data anal!sis methods to %e &sed to

identif! the assigned val&e and eval&ate articiant res&lts' and shall rovide a descrition of the reasons for their

selection and ass&mtions &on "hich the! are %ased# 4he roficienc! testing rovider shall %e a%le to demonstrate that

statistical ass&mtions are reasona%le and that statistical anal!ses are carried o&t in accordance "ith rescri%ed

roced&res#

4'4'4'3 In designing a statistical anal!sis' the roficienc! testing rovider shall give caref&l consideration to the follo"ing5

a) the acc&rac! (tr&eness and recision) as "ell as the meas&rement &ncertaint! re&ired or e9ected for each

meas&rand or characteristic in the roficienc! testing8

%) the minim&m n&m%er of articiants in the roficienc! testing scheme needed to meet the o%ectives of the statistical

design8 in cases "here there is an ins&fficient n&m%er of articiants to meet these o%ectives or to rod&ce statisticall!

meaningf&l anal!sis of res&lts' the roficienc! testing rovider shall doc&ment' and rovide to articiants' details of the

alternative aroaches &sed to assess articiant erformance8

c) the relevance of significant fig&res to the reorted res&lt' incl&ding the n&m%er of decimal laces8

d) the n&m%er of roficienc! test items to %e tested or meas&red and the n&m%er of reeat tests' cali%rations or

meas&rements to %e cond&cted on each roficienc! test item or for each determination8

e) the roced&res &sed to esta%lish the standard deviation for roficienc! assessment or other eval&ation criteria8

f) roced&res to %e &sed to identif! or handle o&tliers' or %oth8

g) "here relevant' the roced&res for the eval&ation of val&es e9cl&ded from statistical anal!sis8 and

h) "here aroriate' the o%ectives to %e met for the design and the fre&enc! of roficienc! testing ro&nds#

4'4' 8ssi#ne& ales

4'4''1 4he roficienc! testing rovider shall doc&ment the roced&re for determining the assigned val&es for the

meas&rands or characteristics in a artic&lar roficienc! testing scheme# 4his roced&re shall tae into acco&nt the

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

for its &rose#

$O4E ;etrological tracea%ilit! is not al"a!s ossi%le or aroriate#

4'4''2 Proficienc! testing schemes in the area of cali%ration shall have assigned val&es "ith metrological tracea%ilit!'

incl&ding meas&rement &ncertaint!#

4'4''3 For roficienc! testing schemes in areas other than cali%ration' the relevance' needs and feasi%ilit! for

metrological tracea%ilit! and associated meas&rement &ncertaint! of the assigned val&e shall %e determined %! taing

into acco&nt secified re&irements of articiants or other interested arties' or %! the design of the roficienc! testing

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ISO/IEC 17043:2010(E)

scheme#

$O4E 4he re&ired metrological tracea%ilit! chain can differ deending on the t!e of roficienc! test item' the meas&rand or

characteristic' and the availa%ilit! of tracea%le cali%rations and reference materials#

4'4''4 ?hen a consens&s val&e is &sed as the assigned val&e (see nne9 >)' the roficienc! testing rovider shall

doc&ment the reason for that selection and shall estimate the &ncertaint! of the assigned val&e as descri%ed in the lan

for the roficienc! testing scheme#

4'4'' 4he roficienc! testing rovider shall have a olic! regarding the disclos&re of assigned val&es#

4he olic! shall ens&re that articiants cannot gain advantage from earl! disclos&re#

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

4''1 Particiants shall normall! %e e9ected to &se the test method' cali%ration or meas&rement roced&re of their

choice' "hich sho&ld %e consistent "ith their ro&tine roced&res# 4he roficienc! testing rovider ma! instr&ct articiants

to &se a secified method in accordance "ith the design of the roficienc! testing scheme#

4''2 ?here articiants are ermitted to &se a method of their choice' the roficienc! testing rovider shall5

a) have a olic! and follo" a roced&re regarding comarison of res&lts o%tained %! different test or meas&rement

methods8

%) %e a"are of "hich different test or meas&rement methods for an! meas&rand are technicall! e&ivalent' and tae stes

to assess articiants7 res&lts &sing these methods accordingl!#4' O!eration of !rofi"ien"y testin# s"+emes

4''1 Instr"tions for !arti"i!ants

4''1'1 4he roficienc! testing rovider shall give articiants s&fficient rior notice %efore sending roficienc! test items'

roviding the date on "hich the roficienc! test items are liel! to arrive or to %e desatched' &nless the design of the

roficienc! testing scheme maes it inaroriate to do so#

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

Instr&ctions to articiants shall incl&de5

a) the necessit! to treat roficienc! test items in the same manner as the maorit! of ro&tinel! tested samles (&nless

there are artic&lar re&irements of the roficienc! testing scheme "hich re&ire deart&re from this rincile)8

%) details of factors "hich co&ld infl&ence the testing or cali%ration of the roficienc! test items' e#g# the nat&re of the

roficienc! test items' conditions of storage' "hether the roficienc! testing scheme is limited to selected test methods'

and the timing of the testing or meas&rement8

c) detailed roced&re for rearing or conditioning' or %oth rearing and conditioning' of the roficienc! test items %efore

cond&cting the tests or cali%rations8

d) an! aroriate instr&ctions on handling the roficienc! test items' incl&ding an! safet! re&irements8

e) an! secific environmental conditions for the articiant to cond&ct tests or cali%rations' or %oth' and' if relevant' an!

re&irement for the articiants to reort relevant environmental conditions d&ring the time of the meas&rement8

f) secific and detailed instr&ctions on the manner of recording and reorting test or meas&rement res&lts and associated

&ncertainties# If the instr&ctions incl&de reorting of the &ncertaint! of the reorted res&lt or meas&rement' this shall

incl&de the coverage factor and' "henever ractica%le' the coverage ro%a%ilit!8

$O4E 4his instr&ction &s&all! incl&des arameters s&ch as the &nits of meas&rement' the n&m%er of significant fig&res or decimal

laces and reorting %asis (e#g# on dr! "eight' or


13/35

ISO/IEC 17043:2010(E)

assessed at secified intervals d&ring their storage life in order to detect ossi%le deterioration#

4''2'4 ?here otentiall! hazardo&s roficienc! test items' chemicals and materials are &sed' facilities

shall %e availa%le to ens&re their safe handling' decontamination and disosal#

4''3 -a"a#in#. la6ellin# an& &istri6tion of !rofi"ien"y test items

4''3'1 4he roficienc! testing rovider shall control acaging and la%elling rocesses to the e9tent necessar! to ens&re

conformit! "ith relevant national' regional' or international safet! and transort re&irements#

$O4E 4he roer distri%&tion of roficienc! test items can resent severe ro%lems for some t!es of material' e#g# those "hich

re&ire &ninterr&ted storage in cold conditions or "hich sho&ld not %e e9osed to -ra!s' shoc or vi%ration#

;ost t!es of chemical materials "o&ld %enefit from air-tight acaging to avoid contamination %! atmosheric contaminants' e#g# f&el

vao&rs or engine e9ha&st gases "hich can %e enco&ntered d&ring transort#

4''3'2 4he roficienc! testing rovider shall secif! relevant environmental conditions for the transort of roficienc! test

items# ?here relevant' the roficienc! testing rovider shall monitor the ertinent environmental conditions of the

roficienc! test item d&ring transort and assess the imact of environmental infl&ences on the roficienc! test item#

4''3'3 In roficienc! testing schemes "here articiants are re&ired to transort the roficienc! test items to other

articiants' doc&mented instr&ctions for this transort shall %e s&lied#

4''3'4 4he roficienc! testing rovider shall ens&re that la%els are sec&rel! attached to the acaging of individ&al

roficienc! test items and are designed to remain legi%le and intact thro&gho&t the roficienc! testing ro&nd#4''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 #B#1#1 %! asing articiants to inform the roficienc! testing rovider if roficienc!

test items have not %een received in line "ith the sched&le of dates rovided#

4'7 ata analysis an& ealation of !rofi"ien"y testin# s"+eme reslts

4'7'1 ata analysis an& re"or&s

4'7'1'1 ll data rocessing e&iment and soft"are shall %e validated in accordance "ith roced&res %efore %eing

%ro&ght into &se# Com&ter s!stem maintenance shall incl&de a %ac-& rocess and s!stem recover! lan# 4he res&lts

of s&ch maintenance and oerational checs shall %e recorded#

4'7'1'2 Ges&lts received from articiants shall %e recorded and anal!sed %! aroriate methods# Proced&res shall %e

esta%lished and imlemented to chec the validit! of data entr!' data transfer' statistical anal!sis' and reorting#

4'7'1'3 ,ata anal!sis shall generate s&mmar! statistics and erformance statistics' and associated information consistent

"ith the statistical design of the roficienc! testing scheme#

4'7'1'4 4he infl&ence of o&tliers on s&mmar! statistics shall %e minimized %! the &se of ro%&st statistical methods or

aroriate tests to detect statistical o&tliers#

4'7'1' 4he roficienc! testing rovider shall have doc&mented criteria and roced&res for dealing "ith test res&lts that

ma! %e inaroriate for statistical eval&ation' e#g# miscalc&lations' transositions and other gross errors#

4'7'1' 4he roficienc! testing rovider shall have doc&mented criteria and roced&res to identif! and manage roficienc!

test items that have %een distri%&ted and are s&%se&entl! fo&nd to %e &ns&ita%le for erformance eval&ation' e#g#

%eca&se of inhomogeneit!' insta%ilit!' damage or contamination#

4'7'2 Ealation of !erforman"e

4'7'2'1 4he roficienc! testing rovider shall &se valid methods of eval&ation "hich meet the &rose of the roficienc!

testing scheme# 4he methods shall %e doc&mented and incl&de a descrition of the %asis for the eval&ation# 4he

eval&ation of erformance shall not %e s&%contracted (see /#/#2)#

4'7'2'2 ?here aroriate for the &rose of the roficienc! testing scheme' the roficienc! testing rovider shall rovide

e9ert commentar! on the erformance of articiants "ith regard to the follo"ing5

a) overall erformance against rior e9ectations' taing meas&rement &ncertainties into acco&nt8

%) variation "ithin and %et"een articiants' and comarisons "ith an! revio&s roficienc! testing ro&nds' similar

roficienc! testing schemes' or &%lished recision data8

c) variation %et"een methods or roced&res8

d) ossi%le so&rces of error ("ith reference to o&tliers) and s&ggestions for imroving erformance8

e) advice and ed&cational feed%ac to articiants as art of the contin&al imrovement roced&res of articiants8

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ISO/IEC 17043:2010(E)

f) sit&ations "here &n&s&al factors mae eval&ation of res&lts and commentar! on erformance imossi%le8

g) an! other s&ggestions' recommendations or general comments8 and

h) concl&sions#

$O4E It can %e &sef&l to rovide individ&al s&mmar! sheets for articiants eriodicall! d&ring or after comletion of a artic&lar

roficienc! testing scheme# 4hese can incl&de &dated s&mmaries of erformance for individ&al articiants over s&ccessive

roficienc! testing ro&nds of a contin&o&s roficienc! testing scheme# S&ch s&mmaries can %e f&rther anal!sed and trends highlighted'

if re&ired#

4' ,e!orts

4''1 Proficienc! test reorts shall %e clear and comrehensive and incl&de data covering the res&lts of all articiants'

together "ith an indication of the erformance of individ&al articiants# 4he a&thorization of the final reort shall not %e

s&%contracted (see /#/#2)#

$O4E ?here all original data cannot %e reorted to articiants' a s&mmar! of the res&lts' e#g# in ta%&lated or grahical form' can %e

s&lied#

4''2 Georts shall incl&de the follo"ing' &nless it is not alica%le or the roficienc! testing rovider has valid reasons for

not doing so5

a) the name and contact details for the roficienc! testing rovider8

%) the name and contact details for the coordinator8c) the name(s)' f&nction(s)' and signat&re(s) or e&ivalent identification of erson(s) a&thorizing the reort8

d) an indication of "hich activities are s&%contracted %! the roficienc! testing rovider8

e) the date of iss&e and stat&s (e#g# reliminar!' interim' or final) of the reort8

f) age n&m%ers and a clear indication of the end of the reort8

g) a statement of the e9tent to "hich res&lts are confidential8

h) the reort n&m%er and clear identification of the roficienc! testing scheme8

i) a clear descrition of the roficienc! test items &sed' incl&ding necessar! details of the roficienc! test item7s

rearation and homogeneit! and sta%ilit! assessment8

) the articiants7 res&lts8

) statistical data and s&mmaries' incl&ding assigned val&es and range of acceta%le res&lts and grahical disla!s8

l) roced&res &sed to esta%lish an! assigned val&e8

m) details of the metrological tracea%ilit! and meas&rement &ncertaint! of an! assigned val&e8

n) roced&res &sed to esta%lish the standard deviation for roficienc! assessment' or other criteria for eval&ation8

o) assigned val&es and s&mmar! statistics for test methods+roced&res &sed %! each gro& of articiants (if different

methods are &sed %! different gro&s of articiants)8

) comments on articiants7 erformance %! the roficienc! testing rovider and technical advisers8

) information a%o&t the design and imlementation of the roficienc! testing scheme8

r) roced&res &sed to statisticall! anal!se the data8

s) advice on the interretation of the statistical anal!sis8 and

t) comments or recommendations' %ased on the o&tcomes of the roficienc! testing ro&nd#

$O4E For contin&o&s roficienc! testing schemes' it can %e s&fficient to have simler reorts' s&ch that man! of the elements in this

cla&se co&ld %e e9cl&ded from ro&tine reorts' %&t incl&ded in roficienc! testing scheme rotocols or in eriodic s&mmar! reorts that

are availa%le to articiants#

4''3 Georts shall %e made availa%le to articiants "ithin lanned timescales# In se&ential roficienc! testing

schemes' e#g# "here the t&rn-aro&nd time ma! %e ver! long' and in schemes involving erisha%le materials' reliminar!

or nticiated res&lts ma! %e rovided %efore final res&lts are disclosed#

$O4E 4his allo"s for earl! investigation of ossi%le error#

4''4 4he roficienc! testing rovider shall have a olic! for the &se of reorts %! individ&als and organizations#

4'' ?hen it is necessar! to iss&e a ne" or amended reort for a roficienc! testing scheme' this shall incl&de the

follo"ing5

a) a &ni&e identification8

%) a reference to the original reort that it relaces or amends8 and

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ISO/IEC 17043:2010(E)

c) a statement concerning the reason for the amendment or re-iss&e#

4' Commni"ation %it+ !arti"i!ants

4''1 4he roficienc! testing rovider shall mae detailed information availa%le a%o&t the roficienc! testing scheme# 4his

shall incl&de5

a) relevant details of the scoe of the roficienc! testing scheme8

%) an! fees for articiation8

c) doc&mented eligi%ilit! criteria for articiation8

d) confidentialit! arrangements8 and

e) details of ho" to al!#

4''2 Particiants shall %e advised romtl! %! the roficienc! testing rovider of an! changes in roficienc!

testing scheme design or oeration#

4''3 4here shall %e doc&mented roced&res for ena%ling articiants to aeal against the eval&ation of their

erformance in a roficienc! testing scheme# 4he availa%ilit! of this rocess shall %e comm&nicated to roficienc! testing

scheme articiants#

4''4 Gelevant records of comm&nications "ith articiants shall %e maintained and retained' as aroriate#

4'' If the roficienc! testing rovider iss&es statements of articiation or erformance' the! shall contain s&fficient

information to not %e misleading#4'10 Confi&entiality

4'10'1 4he identit! of articiants in a roficienc! testing scheme shall %e confidential and no"n onl! to ersons involved

in the oeration of the roficienc! testing scheme' &nless the articiant "aives confidentialit!#

4'10'2ll information s&lied %! a articiant to the roficienc! testing rovider shall %e treated as confidential#

$O4E Particiants can elect to "aive confidentialit! "ithin the roficienc! testing scheme for the &roses of disc&ssion and m&t&al

assistance' e#g# to imrove erformance# Confidentialit! can also %e "aived %! the articiant for reg&lator! or recognition &roses# In

most instances' the roficienc! testing res&lts can %e rovided to the relevant a&thorit! %! the articiants themselves#

4'10'3 ?hen an interested art! re&ires the roficienc! testing res&lts to %e directl! rovided %! the roficienc! testing

rovider' the articiants shall %e made a"are of the arrangement in advance of articiation#

4'10'4 In e9cetional circ&mstances' "hen a reg&lator! a&thorit! re&ires roficienc! testing res&lts to %e directl!

rovided to the a&thorit! %! the roficienc! testing rovider' the affected articiants shall %e notified of this action in

"riting.

ana#ement reqirements

'1 Or#ani5ation

'1'1 4he roficienc! testing rovider' or the organization of "hich it is art' shall %e an entit! that is legall! identifia%le

and acco&nta%le#

'1'2 It is the resonsi%ilit! of the roficienc! testing rovider to carr! o&t its roficienc! testing oerations in s&ch a "a!

as to meet the re&irements of this International Standard and to satisf! the needs of the articiants' reg&lator!

a&thorities and organizations roviding recognition#

'1'3 4he management s!stem shall cover "or carried o&t in the roficienc! testing rovider7s ermanent facilities' at

sites a"a! from its ermanent facilities' and in associated temorar! facilities#

'1'4 If the roficienc! testing rovider is art of an organization erforming other activities' then the roficienc! testing

rovider shall identif! the resonsi%ilities of e! ersonnel in the organization that have an involvement in or co&ld have

infl&ence on the roficienc! test activities' in order to identif! otential conflicts of interest# ?here otential conflicts of

interest are identified' roced&res shall %e &t in lace to ens&re that all activities of the roficienc! testing rovider are

cond&cted "ith imartialit!#

'1' 4he roficienc! testing rovider shall5

a) have managerial and technical ersonnel "ho' irresective of other resonsi%ilities' have the a&thorit! and reso&rces

needed to carr! o&t their d&ties' incl&ding the imlementation' maintenance and imrovement of the management

s!stem' and to identif! the occ&rrence of deart&res from the management s!stem or from the roced&res for roviding

roficienc! testing schemes' and to initiate actions to revent or minimize s&ch deart&res8

%) have arrangements to ens&re that its management and ersonnel are free from an! &nd&e internal or e9ternal

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ISO/IEC 17043:2010(E)

commercial' financial and other ress&res that ma! adversel! affect the &alit! of their "or8

c) have olicies and roced&res to ens&re the rotection of its articiants7 confidential information and rorietar! rights'

incl&ding roced&res for their rotection d&ring electronic storage and transmission8

d) have olicies and roced&res to avoid involvement in an! activities that might diminish confidence in its cometence'

imartialit!' &dgement or oerational integrit!8

e) define the organization and management str&ct&re' its lace in an! arent organization' and the relationshis %et"een

&alit! management' technical oerations and s&ort services8

f) secif! the resonsi%ilit!' a&thorit!' interrelationshis and re&ired cometence of all ersonnel "ho manage' erform

or verif! "or affecting the &alit! of the oeration of roficienc! testing schemes8

g) ens&re that the ersonnel are a"are of the relevance and imortance of their activities and ho" the! contri%&te to the

achievement of the o%ectives of the management s!stem8

h) rovide ade&ate s&ervision of technical staff' incl&ding trainees' %! ersons familiar "ith roced&res for each activit!8

i) have technical management "hich has overall resonsi%ilit! for the technical oerations and the rovision of the

reso&rces needed to ens&re the re&ired &alit! of roficienc! testing schemes' incl&ding access to the necessar!

technical e9ertise and e9erience in the relevant field of testing' cali%ration or insection' as "ell as statistics' as

indicated in ##1#8

) aoint a mem%er of staff as &alit! manager (named as aroriate) "ho' irresective of other d&ties andresonsi%ilities' shall have defined resonsi%ilit! and a&thorit! for ens&ring that the management s!stem is imlemented

and follo"ed at all times8 the &alit! manager shall have direct access to the highest level of management at "hich

decisions are taen on the roficienc! testing rovider7s olicies or reso&rces8 and ) aoint de&ties for e! managerial

ersonnel#

$O4E ?here roficienc! testing roviders have a small n&m%er of ersonnel' individ&als can have more than one f&nction and it can

%e imractical to aoint de&ties for all maor f&nctions#

'1' 4o management shall ens&re that aroriate comm&nication rocesses are esta%lished "ithin the organization

and that comm&nication taes lace regarding the effectiveness of the management s!stem#

'2 ana#ement system

'2'1 4he roficienc! testing rovider shall esta%lish' imlement and maintain a management s!stem aroriate to its

scoe of activities' incl&ding the t!e' range and vol&me of roficienc! testing that it rovides#

'2'2 4he roficienc! testing rovider shall define and doc&ment its olicies' rogrammes' roced&res and instr&ctions to

the e9tent necessar! to ass&re the &alit! of all asects of roficienc! testing# 4he s!stem7s doc&mentation shall %e

comm&nicated to' &nderstood %!' availa%le to' and imlemented %! the aroriate ersonnel#

$O4E 4hese asects incl&de' %&t are not limited to' roficienc! test item &alit! (e#g# homogeneit! and sta%ilit!)' characterization (e#g#

e&iment cali%ration and method validation)' assignment of roert! val&es (e#g# &se of aroriate statistical roced&res)' eval&ation

of articiant erformance' distri%&tion of roficienc! test items' storage and transort roced&res' statistical treatment of test res&lts'

and reorting#

'2'3 4he roficienc! testing rovider7s management s!stem olicies related to &alit!' incl&ding a &alit! olic!

statement' shall %e defined in a &alit! man&al (named as aroriate)# 4he overall o%ectives shall %e esta%lished and

revie"ed d&ring management revie"# 4he &alit! olic! statement shall %e iss&ed &nder the a&thorit! of to

management# It shall incl&de at least the follo"ing5

a) the management7s commitment to the &alit! of its roficienc! testing services to articiants and other c&stomers8

%) the management7s statement of the standard of service8

c) the &rose of the management s!stem related to &alit!8

d) a re&irement that all ersonnel concerned "ith the roficienc! testing activities familiarize themselves "ith the &alit!

doc&mentation and imlement the olicies and roced&res in their "or8 and

e) the management7s commitment to coml! "ith this International Standard and to contin&all! imrove the effectiveness

of the management s!stem#

'2'4 4o management shall rovide evidence of commitment to the develoment and imlementation of the

management s!stem and to contin&all! imroving its effectiveness#

'2' 4o management shall comm&nicate to the organization the imortance of meeting c&stomer re&irements' as "ell

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ISO/IEC 17043:2010(E)

as stat&tor! and reg&lator! re&irements#

'2' 4he &alit! man&al shall incl&de or mae reference to the s&orting roced&res' incl&ding technical roced&res# It

shall o&tline the str&ct&re of the doc&mentation &sed in the management s!stem#

'2'7 4he roles and resonsi%ilities of technical management and the &alit! manager' incl&ding their resonsi%ilit! for

ens&ring comliance "ith this International Standard' shall %e defined in the &alit! man&al#

'2' 4o management shall ens&re that the integrit! of the management s!stem is maintained "hen changes to the

management s!stem are lanned and imlemented#

'3 o"ment "ontrol

'3'1 General

4he roficienc! testing rovider shall esta%lish and maintain roced&res to control all doc&ments that form art of its

management s!stem (internall! generated' or from e9ternal so&rces)' s&ch as reg&lations' standards' other normative

doc&ments' roficienc! testing scheme rotocols' test or cali%ration methods' or %oth test and cali%ration methods' as

"ell as dra"ings' soft"are secifications' instr&ctions and man&als#

'3'2 o"ment a!!roal an& isse

'3'2'1ll doc&ments iss&ed as art of the management s!stem shall %e revie"ed and aroved for &se %! a&thorized

ersonnel rior to iss&e# master list or e&ivalent doc&ment control roced&re identif!ing the c&rrent revision stat&s and

distri%&tion of doc&ments in the management s!stem shall %e esta%lished and %e readil! availa%le' in order to revent the&se of invalid or o%solete doc&ments' or %oth#

'3'2'2 4he roced&res adoted shall also ens&re that5

a) a&thorized editions of aroriate doc&ments are availa%le at all locations "here activities essential to the effective

oeration of roficienc! testing schemes are erformed8

%) doc&ments are eriodicall! revie"ed and &dated' as necessar!' to ens&re contin&ing s&ita%ilit! and comliance "ith

alica%le re&irements8

c) invalid or o%solete doc&ments are romtl! removed from all oints of iss&e or &se' or other"ise ass&red against

&nintended &se8 and

d) o%solete doc&ments retained for either legal or no"ledge reservation &roses are s&ita%l! mared#

'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 o"ment "+an#es

'3'3'1 Changes to doc&ments shall %e revie"ed and aroved %! the same f&nction that erformed the original revie"

and aroval' &nless secificall! designated other"ise# 4he designated ersonnel shall have access to ertinent

%acgro&nd information &on "hich to %ase their revie" and aroval#

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

'3'3'3 If the roficienc! testing rovider7s doc&ment control s!stem allo"s for the amendment of doc&ments %! hand'

ending re-iss&e of the doc&ments' the roced&res and a&thorities for s&ch amendments shall %e defined# mendments

shall %e clearl! mared' 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 ,eie% of reqests. ten&ers an& "ontra"ts

'4'1 4he roficienc! testing rovider shall esta%lish and maintain olicies and roced&res for the revie" of re&ests'

tenders and contracts# 4hese revie"s shall ens&re that5

a) the re&irements' incl&ding those for test and cali%ration methods' meas&ring e&iment and roficienc! test items to

%e &sed' are ade&atel! defined' doc&mented and &nderstood8

%) the roficienc! testing rovider has the caa%ilit! and reso&rces to meet the re&irements8 and

c) the roficienc! testing scheme is technicall! aroriate#

$O4E 1 4his revie" is artic&larl! imortant "hen a c&stomer re&ests a roficienc! testing scheme to %e created for a secific

&rose or for a different level or fre&enc! of articiation from that normall! offered#

$O4E 2 4his revie" can %e simlified "hen the roficienc! test scheme is f&ll! descri%ed in a catalog&e or other notice' and the

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ISO/IEC 17043:2010(E)

articiant is enrolling for a ro&tine shiment#

'4'2 Gecords of s&ch revie"s' incl&ding an! changes' shall %e maintained# Gecords shall also %e maintained of ertinent

disc&ssions "ith a c&stomer relating to the c&stomer7s re&irements' or the res&lts of the "or d&ring the eriod of

e9ec&tion of the contract' or %oth#

'4'3 4he revie" shall cover all asects of the re&est' incl&ding an! "or that is s&%contracted %! the roficienc! testing

rovider#

'4'4 4he articiants and other c&stomers' as aroriate' shall %e informed of an! deviation in the contract or agreed

roficienc! testing scheme design#

'4' If a re&est or contract is amended after the roficienc! testing scheme is &nder"a!' the same revie" rocess shall

%e reeated and an! amendments shall %e comm&nicated to all affected ersonnel#

' S6"ontra"tin# seri"es

''1 ?hen a roficienc! testing rovider s&%contracts "or' the roficienc! testing rovider shall demonstrate that the

s&%contractors7 e9erience and technical cometence are s&fficient for their assigned tass and that the! coml! "ith the

relevant cla&ses of this International Standard and other aroriate standards#

''2 4he roficienc! testing rovider shall not s&%contract the lanning of the roficienc! test scheme (see ##1#2)' the

eval&ation of erformance (see #.#2#1) or the a&thorization of the final reort (see #D#1)#

$O4E 4his does not recl&de the roficienc! testing rovider &tilizing advice or assistance from an! advisors' e9erts or steering

gro

''3 4he roficienc! testing rovider shall inform articiants' in advance and in "riting' of services that are' or ma! %e'

s&%contracted#

$O4E 4his notification can' for e9amle' tae the form of a statement in the roficienc! testing scheme doc&mentation' s&ch as the

follo"ing5


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ISO/IEC 17043:2010(E)

4he feed%ac shall %e &sed and anal!sed to imrove the management s!stem' roficienc! testing schemes' and

c&stomer service#

$O4E E9amles of the t!es of feed%ac incl&de c&stomer satisfaction s&rve!s and revie" of roficienc! testing reorts "ith

c&stomers#

' Com!laints an& a!!eals

4he roficienc! testing rovider shall have a olic! and follo" a roced&re for the resol&tion of comlaints and aeals

received from articiants' c&stomers or other arties# Gecords shall %e maintained of all comlaints' aeals'

investigations and corrective actions taen %! the roficienc! testing rovider#

' Control of non"onformin# %or

''1 4he roficienc! testing rovider shall have a olic! and roced&re(s) that shall %e imlemented "hen an! asect of

its activities does not conform to its o"n roced&res or the agreed re&irements of its c&stomers#

4he olic! and roced&re(s) shall ens&re that5

a) the resonsi%ilities and a&thorities for the management of nonconforming "or are designated and actions (incl&ding

halting "or of ongoing rogrammes and "ithholding reorts' as necessar!) are defined and taen "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 taen immediatel!' together "ith an! decision a%o&t the acceta%ilit!of the nonconforming "or8

d) roficienc! testing scheme articiants and other c&stomers' as aroriate' are informed and the

nonconforming roficienc! test items or reorts alread! sent to articiants are recalled or disregarded8 and

e) the resonsi%ilit! for a&thorization of the res&mtion of "or is defined#

$O4E Identification of nonconforming "or or ro%lems "ith the management s!stem or "ith technical activities can occ&r at vario&s

laces "ithin the management s!stem and technical oerations# E9amles are articiant comlaints' management revie"s and

internal or e9ternal a&dits' &alit! control' rearations of roficienc! test items' homogeneit! and sta%ilit! tests' data anal!sis'

instr&ctions to articiants' and materials handling and storage#

''2 ?here the eval&ation indicates that nonconforming "or co&ld rec&r or that there is do&%t a%o&t the comliance of

the roficienc! testing rovider or s&%contractor "ith their o"n olicies and roced&res' the corrective action roced&re in

/#11 shall %e romtl! follo"ed#

'10 Im!roement

4he roficienc! testing rovider shall contin&all! imrove the effectiveness of its management s!stem thro&gh the &se of

the &alit! olic!' &alit! o%ectives' a&dit res&lts' anal!sis of data' corrective and reventive actions and management

revie"#

'11 Corre"tie a"tions

'11'1 General

4he roficienc! testing rovider shall esta%lish a olic! and roced&re(s) and shall designate aroriate ersonnel for

imlementing corrective actions "hen nonconforming "or or deart&res from the olicies and roced&res in the

management s!stem or technical oerations have %een identified#

$O4E See /#6#1' $ote#

'11'2 Case analysis

4he roced&re for corrective action shall start "ith an investigation to determine the root ca&se(s) of the ro%lem#

$O4E Ca&se anal!sis is the e! and sometimes the most diffic&lt art in the corrective action roced&re# Often' the root ca&se is not

o%vio&s and th&s a caref&l anal!sis of all otential ca&ses of the ro%lem is re&ired# Potential ca&ses co&ld incl&de c&stomer

re&irements' roficienc! test items and their secifications' methods and roced&res' staff sills and training' cons&ma%le s&lies'

rearations of roficienc! test items' homogeneit! and sta%ilit! tests' statistical design' instr&ctions to articiants' and materials

handling and storage#

'11'3 Sele"tion an& im!lementation of "orre"tie a"tions

'11'3'1 ?here corrective action is needed' the roficienc! testing rovider shall identif! otential corrective actions# It

shall select and imlement the action(s) most liel! to eliminate the ro%lem and to revent rec&rrence#

'11'3'2 Corrective actions shall %e aroriate to the magnit&de and ris of the ro%lem#

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ISO/IEC 17043:2010(E)

'11'3'3 4he roficienc! testing rovider shall doc&ment and imlement an! re&ired changes res&lting from corrective

action investigations#

'11'4 onitorin# of "orre"tie a"tions

4he roficienc! testing rovider shall monitor the res&lts to ens&re that the corrective actions taen have %een effective#

'11' 8&&itional a&its

?here the identification of nonconforming activities or deart&res from a&thorized roced&res cast do&%ts on the

comliance of the roficienc! testing rovider "ith its o"n olicies and roced&res' or on its comliance "ith this

International Standard' the roficienc! testing rovider shall ens&re that the aroriate areas of activit! are a&dited in

accordance "ith /#1 as soon as ossi%le#

$O4E S&ch additional a&dits often follo" the imlementation of the corrective actions to confirm their effectiveness#

n additional a&dit can %e necessar! onl! "hen a serio&s iss&e or ris to the roficienc! testing scheme is identified#

'12 -reentie a"tions

'12'1 reas for imrovements and otential so&rces of nonconforming "or' either technical or concerning the

management s!stem' shall %e identified# ?hen imrovement oort&nities are identified' or if reventive action is

re&ired' action lans shall %e develoed' imlemented and monitored' to red&ce the lielihood of s&ch nonconforming

"or and to tae advantage of the oort&nities for imrovement#

'12'2n! roced&re for reventive action shall incl&de the initiation of s&ch actions and alication of controls to ens&rethat the! are effective#

'13 Control of re"or&s

'13'1 General

'13'1'1 4he roficienc! testing rovider shall esta%lish and maintain roced&res for identification' collection' inde9ing'

access' filing' storage' maintenance and disosal of records# A&alit! records shall incl&de reorts from internal a&dits and

management revie"s' as "ell as records of corrective and reventive actions#

'13'1'2ll 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#

'13'1'3ll records shall %e et sec&re and confidential' and in accordance "ith relevant reg&lator! re&irements#

'13'1'4 4he roficienc! testing rovider shall follo" roced&res to rotect and %ac-& records stored electronicall! and

to revent &na&thorized access or amendment of these records#

'13'2 *e"+ni"al re"or&s

'13'2'1 4he roficienc! testing rovider shall retain records of all technical data relating to each roficienc! testing ro&nd

for a defined eriod' incl&ding' %&t not necessaril! limited to5

a) res&lts of homogeneit! and sta%ilit! testing8

%) instr&ctions to articiants8

c) articiants7 original resonses8

d) collated data for statistical anal!sis8

e) information re&ired for reorts (see #D)8 and

f) final reorts (s&mmar! or individ&al' or %oth)#

$O4E 1 It is advisa%le to retain s&fficient information to esta%lish an a&dit trail for the rocessing of res&lts from roficienc! testing

ro&nds#

$O4E 2 4echnical records are acc&m&lations of data and information "hich res&lt from carr!ing o&t all roficienc! testing activities#

4he! can incl&de forms' contracts' "or sheets' "or %oos' chec sheets' "or notes' s&%-contractor reorts and articiant

feed%ac#

'13'2'2 ,ata entr!' checing and calc&lations shall %e recorded at the time the! are made and shall %e identifia%le to the

secific tas and to the ersonnel resonsi%le#

'13'2'3 ?hen mistaes occ&r in records and alterations are made' actions shall %e taen to5

a) identif! the change and date of alteration8

%) avoid loss of original data8 and

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ISO/IEC 17043:2010(E)

c) identif! the erson maing the alteration#

'14 Internal a&its

'14'1 4he roficienc! testing rovider shall cond&ct internal a&dits of its activities eriodicall!' and in accordance "ith a

redetermined sched&le and roced&re' in order to verif! that its oerations contin&e to coml! "ith the re&irements of

the management s!stem and this International Standard# 4he internal a&dit rogramme shall address all elements of the

management s!stem' incl&ding the technical roced&res and roficienc! test item rearation' storage and distri%&tion'

as "ell as reorting activities for the oeration of a roficienc! testing scheme# It is the resonsi%ilit! of the &alit!

manager to lan and organize a&dits as re&ired %! the sched&le and re&ested %! management# Internal a&dits shall %e

carried o&t %! trained and &alified ersonnel "ho are' "herever reso&rces ermit' indeendent of the activit! to %e

a&dited#

$O4E It is advisa%le that the rogramme for internal a&diting of the management s!stem %e comleted ever! 12 months#

'14'2 ?hen a&dit findings cast do&%t &on the effectiveness of the oerations' incl&ding the s&ita%ilit! and correctness of

roficienc! test items' roced&res' statistical eval&ations and data resentation' the roficienc! testing rovider shall tae

timel! corrective action and shall notif! its c&stomers or articiants' or %oth' in roficienc! testing schemes "hose

activities ma! have %een affected#

'14'3 4he area of a&dited activit!' the a&dit findings and an! corrective actions that arise from them shall %e recorded#

'14'4 Follo"-& a&dit activities shall verif! and record the imlementation and effectiveness of an! corrective actionstaen#

'1 ana#ement reie%s

'1'1 In accordance "ith a re-determined sched&le and roced&re' the roficienc! testing rovider7s to management

shall eriodicall! cond&ct a revie" of the roficienc! testing rovider7s management s!stem and roficienc! testing

activities' in order to ens&re their contin&ed s&ita%ilit! and effectiveness and to introd&ce an! necessar! changes or

imrovements# 4he revie" shall tae acco&nt of5

a) the s&ita%ilit! of olicies and roced&res8

%) reorts from management and s&ervisor! ersonnel8

c) the o&tcome of recent internal a&dits8

d) corrective and reventive actions8

e) assessments %! e9ternal %odies8

f) changes in the vol&me and t!e of "or8

g) c&stomer' advisor! gro& or articiant feed%ac8

h) comlaints and aeals8

i) recommendations for imrovement8 and

) 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%ectives and action lans#

$O4E 3 management revie" incl&des consideration of related s&%ects at reg&lar management meetings#

$O4E ?here the roficienc! testing rovider is art of a larger organization' it can %e aroriate to hold a searate revie" meeting

to cover roficienc! testing activities#

'1'2 Findings from management revie"s' and the actions that arise from them' shall %e recorded# 4he management

shall ens&re that those actions are discharged "ithin an aroriate and agreed timescale#

8nne9 8

(informative)

*y!es of !rofi"ien"y testin# s"+emes8'1 General

Proficienc! testing has %ecome an essential asect of la%orator! ractice in all areas of testing' cali%ration and insection#

Proficienc! testing schemes var! according to the needs of the sector in "hich the! are &sed' the nat&re of the roficienc!

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ISO/IEC 17043:2010(E)

test items' the methods in &se and the n&m%er of articiants# Ho"ever' in their simlest form' most roficienc! testing

schemes ossess the common feat&re of comarison of res&lts o%tained %! one la%orator! "ith those o%tained %! one or

more different la%oratories#

4he nat&re of the test or meas&rement erformed in roficienc! testing schemes governs the method of comaring

erformance# 4here are three %asic t!es of la%orator! e9aminations5 &antitative' &alitative and interretive#

4he res&lts of a &antitative meas&rement are n&merical and are reorted on an interval or a ratio scale#

4ests for &antitative meas&rement ma! var! in their recision' tr&eness' anal!tical sensitivit!' and secificit!# In

&antitative roficienc! testing schemes' n&merical res&lts are &s&all! anal!sed statisticall!#

4he res&lts of &alitative tests are descritive and reorted on a categorical or ordinal scale' e#g# identit! of micro-

organisms' or %! identification of the resence of a secific meas&rand (s&ch as a dr&g or a grading of a characteristic)#

ssessment of erformance %! statistical anal!sis ma! not %e aroriate for &alitative e9aminations#

In interretive tests' the


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re&ired to tae samles' "hich are then considered to %e the roficienc! test items for anal!sis# fter comletion of the

testing' the res&lts are ret&rned to the roficienc! testing rovider and comared "ith the assigned val&e(s) to give an

indication of the erformance of the individ&al articiants and the gro& as a "hole# E9amles of roficienc! test items

&sed in this t!e of scheme incl&de food' %od! fl&ids' agric&lt&ral rod&cts' "ater' soils' minerals and other environmental

materials# In some cases' searate ortions of revio&sl! esta%lished reference materials are circ&lated# dvice or

ed&cational comments are

t!icall! art of the reort ret&rned to articiants %! the roficienc! testing rovider "ith the aim of romoting

imrovement in erformance# ;odel 2 in Fig&re #1 reresents t!ical roficienc! testing schemes of this t!e' &s&all! for

testing la%oratories# ;odel 3 resents a t!e of scheme that is fre&entl! &sed in con&nction "ith sim&ltaneo&s

roficienc! testing schemes' for oversight or ed&cational &roses#

s disc&ssed in nne9 >' assigned val&es for these roficienc! testing schemes ma! %e determined in a variet! of "a!s#

Ho"ever' either eval&ations of erformance are %ased on consens&s val&es from articiants (all articiants' or a s&%set

of

transform and reort a given set of data (rather than cond&ct the act&al test or meas&rement)' to mae interretations

%ased on a given set of data or roficienc! testing items' s&ch as stained %lood films for diagnosis' or to tae and reare

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ISO/IEC 17043:2010(E)

samles or secimens in accordance "ith a secification#

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

EA rogrammes (s&ch as those rovided for la%orator! medicine e9aminations) offer a variet! of interla%orator!

comarison schemes %ased on this traditional roficienc! testing model' %&t "ith %roader alication of the schemes

descri%ed in #2 and #3 and ill&strated in Fig&re #1# ;an! EA rogrammes are designed to rovide insight into the

comlete ath of "orflo" of the la%orator!' and not &st the testing rocesses# ;ost EA rogrammes are contin&o&s

schemes that incl&de long term follo"-& of la%orator! erformance# t!ical feat&re of EA rogrammes is to rovide

ed&cation to articiants and romote &alit! imrovement# dvisor! and ed&cational comments comrise art of the

reort ret&rned to articiants to achieve this aim#

Some EA rogrammes assess erformance of re-anal!tical and ost-anal!tical hases of testing' as "ell as the

anal!tical hase# In s&ch EA rogrammes' the nat&re of the roficienc! test item ma! differ significantl! from that &sed

in traditional roficienc! testing schemes# 4he


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a ,eending ho" the assigned val&e is derived' it "ill %e either determined rior to the distri%&tion of the roficienc! test items or after

the ret&rn of articiant res&lts#

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

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ISO/IEC 17043:2010(E)

8nne9

(informative)

Statisti"al met+o&s for !rofi"ien"y testin#

'1 General

Proficienc! test res&lts can aear in man! forms' sanning a "ide range of data t!es and &nderl!ing statistical

distri%&tions# 4he statistical methods &sed to anal!se the res&lts need to %e aroriate for each sit&ation' and so are too

varied to %e secified in this International Standard# ISO 13/2D descri%es referred secific methods for each of the

sit&ations disc&ssed %elo"' %&t also states that other methods ma! %e &sed as long as the! are statisticall! valid and are

f&ll! descri%ed to articiants# Some of the methods in ISO 13/2D' eseciall! for homogeneit! and sta%ilit! testing' are

modified slightl! in the ILPC2) 4echnical Geort


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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 #1)5

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'3'2 -erforman"e for qalitatie an& semi#3#2#1) are

aroriate# Ordinal res&lts incl&de' for e9amle' resonses s&ch as grades or ranings'

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e9ands the criteria to allo" a statistical test of the estimate of inhomogeneit! and insta%ilit!' relative to the same criterion

recommended in ISO 13/2D#

''2 4here are different needs for re&irements in ISO *&ide 3 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


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ISO/IEC 17043:2010(E)

scheme8

e) the s&ita%ilit! of accetance criteria (i#e# for &dging s&ccessf&l erformance in the roficienc! test)8

f) the costs8

g) the roficienc! testing rovider7s olic! on maintaining articiants7 confidentialit!8

h) the timescale for reorting of res&lts and for anal!sis of erformance data8

i) the characteristics that instil confidence in the s&ita%ilit! of roficienc! test items (e#g# homogeneit!' sta%ilit!' and' "here

aroriate' metrological tracea%ilit! to national or international standards)8

) its conformance "ith this International Standard#

$O4E Some roficienc! testing schemes can incl&de tests "hich are not an e9act match for the tests erformed %! the articiant (e#g#

the &se of a different national standard for the same determination)' %&t it can still %e technicall! &stified to articiate in the roficienc!

testing scheme if the treatment of the data allo"s for consideration of an! significant differences in test methodolog! or other factors#

C'3 -oli"ies on !arti"i!ation in !rofi"ien"y testin# s"+emes

C'3'1 If relevant' interested arties sho&ld doc&ment their olicies for articiation in roficienc! testing schemes8 s&ch

doc&mented olicies sho&ld %e &%licl! availa%le to la%oratories and other interested arties#

C'3'2 Iss&es "hich sho&ld %e addressed in articiation olicies for secific roficienc! testing schemes incl&de5

a) "hether articiation in secific roficienc! testing schemes is mandator! or vol&ntar!8

%) the fre&enc! of articiation8c) the criteria &sed %! the interested art! to &dge satisfactor! or &nsatisfactor! erformance8

d) "hether articiants ma! %e re&ired to articiate in follo"-& roficienc! testing schemes if erformance is &dged to

%e &nsatisfactor!8

e) ho" the res&lts of roficienc! testing "ill %e &sed in the eval&ation of erformance and s&%se&ent decisions8

f) details of the interested art!7s olic! on reserving articiants7 confidentialit!#

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

C'4'1 Particiants sho&ld dra" their o"n concl&sions a%o&t their erformance from an eval&ation of the organization and

design of the roficienc! testing scheme# Gevie"s sho&ld consider the relation %et"een the roficienc! testing scheme

and the needs of the articiant7s c&stomers# 4he information that sho&ld %e taen into consideration incl&des5

a) the origin and character of

iso iec 17043 interlaboratorio

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