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International Organization for Standardization

www.iso.org
SMA/November 2007

ISO/IEC 17025:2005

ISO/IEC 17025:2005
by Mr. Sean Mac Curtain Hea o! Con!ormity A""e""ment / CASCO Secretary

CASCO/DEVCO workshop, Tunis, Tunisia 12 13 o!"#$"r 2007


SMA/November 2007

ISO/IEC 17025:2005

What is Accreditation
ISO/IEC 17025 contain" t$e criteria nece""ary !or a %aboratory to im&%ement in or er !or it to &er!orm it" te"t 'or( com&etent%y Accre itation i" in e&en ent an !orma% reco)nition o! t$e com&etence a %aboratory to &er!orm "&eci!ic te"t" etc. *$e criteria t$at a %aboratory mu"t com&%y 'it$ to be internationa%%y acce&tab%e i" ISO/IEC 17025.

SMA/November 2007

ISO/IEC 17025:2005

ISO/IEC 17025
1.

hese are the !ase re"#ire$ents necessar% for a la!orator% to !e a!le to i$&le$ent and o&erate to de$onstrate it is co$&etence
*$ey are not ,"u&er- re.uirement" Co"t /o! com&%iance an /or Accre itation0 i" co"t o! ac$ievin) con"i"tent%y )oo re"u%t" Co"t o! not $avin) con"i"tent%y )oo re"u%t" cou% be muc$ $i)$er

1.

17025 foc#s is on'


Mana)ement re.uirement" an *ec$nica% re.uirement" Anne1 A Cro"" re!erence to ISO 2001 Anne1 3 4ui e%ine" !or e"tab%i"$in) a&&%ication !or "ector !ie% "

SMA/November 2007

ISO/IEC 17025:2005

I(AC )(A *)#t#al +ecognition Arrange$ent,


-eer E.al#ation -rocess *ISO/IEC 170/0,

Accreditation 0od% in co#ntr% A *ISO/IEC 17011,

+ecognition

Accreditation 0od% in co#ntr% 0 *ISO/IEC 17011,

(a!orator% in co#ntr% A *ISO/IEC 17025,

(a!orator% in Co#ntr% 0 *ISO/IEC 17025,

est/Cali!ration +es#lts

+ecognition of E"#i.alence

est /Cali!ration +es#lts

SMA/November 2007

ISO/IEC 17025:2005

+ecognition and rade


It i" )enera%%y a)ree by t$e 6*O t$at t$e bi))e"t ob"tac%e to tra e i" Non *ari!! *ec$nica% 3arrier" i.e. /*3*7"0 It i" in t$e intere"t o! a%% to overcome t$e"e an to eve%o& a mean" o! reco)ni8in) t$e tec$nica% in!ra"tructure an out&ut !rom one country in anot$er country a" bein) e.uiva%ent

SMA/November 2007

ISO/IEC 17025:2005

ISO/IEC 17025 1 So$e iss#es


Sco&e'
Inc%u e" "am&%in) It cover" "tan ar met$o "9 non "tan ar met$o " an %aboratory eve%o&e met$o " Inc%u e" 1"t9 2n an #r :arty %aboratorie" NO* IN*EN;E; *O 3E <SE; AS A 3ASIS =O> CE>*I=ICA*ION O= ?A3O>A*O>IES Cau"e" con!u"ion i! not a $ere to IA= >e"o%ution in Sy ney ta(en on t$i" >e)u%ator" may "&eci!y a itiona% re.uirement" uni.ue to t$eir nee "

Meet &rinci&%e" o! ISO 2001.

SMA/November 2007

ISO/IEC 17025:2005

ISO/IEC 17025 1 So$e iss#es


/.1 )anage$ent re"#ire$ents
?e)a% entity Con!%ict o! intere"t e!ine an re%ation"$i& ocumente /:art o! %ar)er or).0 Im&artia%ity /+.1.5 b0 an !ree om !rom commercia%/!inancia% &re""ure" '$ic$ mi)$t in!%uence Au )ement !or #r &arty activitie" /Note 20 Have &o%icie" in &%ace to avoi invo%vement in activitie" t$at 'ou% ne)ative%y e!!ect con!i ence in it" com&etence9 im&artia%ity9 Au )ement or o&erationa% inte)rity. Have Mana)ement an *ec$nica% "ta!! /"u!!icient0 an 'it$ a e.uate aut$ority.

SMA/November 2007

ISO/IEC 17025:2005

ISO/IEC 17025 1 So$e iss#es


/.2 )anage$ent S%ste$
Mu"t $ave im&%emente a MS a&&ro&riate !or it" "co&e an activitie" / ocumente to e1tent nece""ary to a""ure .ua%ity o! re"u%t0 <n er"too by a%% in or). an communicate to a%% /+.2.2 0 Sy"tem mu"t be ocumente +.2.2 *o& mana)ement mu"t emon"trate commitment

/.2 3oc#$ent control


A&&rova% an i""ue B >evie'e an a&&rove /uni.ue%y i enti!ie 0 ;ocument c$an)e" B by ori)ina% !unction. A%tere te1t $i)$%i)$te

SMA/November 2007

ISO/IEC 17025:2005

ISO/IEC 17025 1 So$e iss#es


/./ +e.iew of re"#ests4 tenders and contracts
Have &roce ure" in &%ace !or t$i" />ecor " o! revie' mu"t be avai%ab%e0 Have nece""ary re"ource" ;i!!erence" re"o%ve be!ore acce&tance Can be ora% or ocumente /contract0 /Note0 =or revie' o! "im&%e or routine re"u%t" / ate an initia%" o! &er"on oin) te"t "u!!icient0 B Note in +.2.2 >e&etitive te"t" B >evie' at initia% "ta)e on%y a" %on) a" unc$an)e

/.5 S#!contracting
<"e o! a com&etent "ubcontractor /cou% be one t$at com&%ie" 'it$ ISO/IEC 170250 A vi"e cu"tomer an obtain a&&rova% /in 'ritin)0 Maintain a re)i"ter or "ubcontractor"
SMA/November 2007

ISO/IEC 17025:2005 10

ISO/IEC 17025 1 So$e iss#es


/.7 C#sto$er ser.ice
*$e %aboratory "$a%% obtain !ee bac( !rom cu"tomer" an ana%y8e !or &o""ib%e im&rovement.

/.5 Co$&laints /.6 Control of nonconfor$ing testing/cali!ration wor7


:o%icie" B &roce ure" im&%emente "$a%% inc%u e >e"&on"ibi%itie" an aut$ority Eva%uation Correction ta(en ,imme iate%y>e"&on"ibi%ity !or aut$ori8in) re"um&tion o! 'or( i" e!ine

SMA/November 2007

ISO/IEC 17025:2005 11

ISO/IEC 17025 1 So$e iss#es


/.10 I$&ro.e$ent
S$a%% continua%%y im&rove e!!ectivene"" o! MS t$rou)$ ana%y"i"

/.11 Correcti.e action


S$a%% e"i)nate an )ive aut$ority !or im&%ementin) Corrective Action S$a%% "tart 'it$ a cau"e ana%y"i" /ana%y"i" o! a%% &otentia% cau"e"0 I enti!y a%% &otentia% corrective action" /"e%ect an im&%ement0 S$a%% monitor corrective action" e!!ectivene""

/.12 -re.entati.e Actions


Nee e im&rovement" an &otentia% "ource" o! NC "$a%% be i enti!ie Action &%an" eve%o&e '$en i enti!ie
SMA/November 2007

ISO/IEC 17025:2005 12

ISO/IEC 17025 1 So$e iss#es


/.12 Control of +ecords
>ea i%y retrievab%e :rotect an bac( u& nee e

/.1/ Internal a#dits


;one &erio ica% B A%% e%ement" o! "y"tem ;one by traine an .ua%i!ie "ta!! '$ere ever &ermitte by &er"on" in e&en ent o! activitie" to be au ite

/.15 )anage$ent +e.iew


I enti!ie" '$at "$ou% be con"i ere :erio /12 mont$" B note0
SMA/November 2007

ISO/IEC 17025:2005 1#

ISO/IEC echnical +e"#ire$ents


5.2 -ersonnel
Com&etent .ua%i!ie a&&ro&riate%y on ba"i" o! e ucation9 trainin)9 e1&erience an emon"trate "(i%%" :er"on" '$o )ive o&inion" an inter&retation" o! te"t re"u%t" "$ou% $ave a .ua%i!ication" :o%icy to i enti!y trainin) nee " E!!ectivene"" o! trainin) "$a%% be ca%cu%ate Aut$ori8e "&eci!ic "ta!! !or "&eci!ic 'or( itiona%

5.2 Acco$$odation and En.iron$ent


A&&ro&riate an A e.uate 6$ere e!!ect" te"t" mu"t be ocumente /con ition"0 :revent cro"" contamination Acce"" contro%%e
SMA/November 2007

ISO/IEC 17025:2005 1+

ISO/IEC echnical +e"#ire$ents


5./ est and cali!ration $ethods and .alidation

In"truction" on u"e o! a%% e.ui&ment an $an %in) o! item" ;eviation !rom met$o " ocumente an Au"ti!ie aut$ori8e an acce&te by cu"tomer Stan ar " o not nee to be "u&&%emente / re'ritten Se%ection o! met$o B meet" cu"tomer nee " an a&&ro&riate Can u"e internationa%9 re)iona%9 nationa% or &ub%i"$e by re&ortab%e tec$nica% or)ani8ation"/Aourna% or "&eci!ie by manu!acturer ?aboratory eve%o&e met$o " C '$en nece""ary9 a&&rove by cu"tomer an va%i ate Non "tan ar te"t met$o " va%i ate

SMA/November 2007

ISO/IEC 17025:2005 15

ISO/IEC echnical +e"#ire$ents


5./ est and cali!ration $ethods and .alidation *contin#ed,
Da%i ation o! Met$o " ;e!ine" va%i ation a" ,:articu%ar re.uirement" !or a "&eci!ic inten e u"e are !u%!i%%e ?aboratorie" va%i ate non "tan ar met$o "9 %aboratorie" eve%o&e 9 "tan ar met$o " u"e out"i e inten e "co&e. C >ecor va%i ation E"timation o! <ncertainty C :roce ure to e"timate <OM C 6$ere met$o " inc%u e" an e!ine" <OM t$en it i" e"tab%i"$e /ISO 5725 4ui e to e1&re""ion o! <OM0 Contro% o! ata C A e.uate c$ec(" C So!t'are ocumente an va%i ate
SMA/November 2007

ISO/IEC 17025:2005 15

ISO/IEC echnical +e"#ire$ents


5.5 E"#i&$ent
Nee " a%% e.ui&ment !or te"t". A%%o'" u"e o! out"i e e.ui&ment Ca%ibration "c$e u%e" O&erate by aut$ori8e &er"on" Maintenance an "tora)e E.ui&ment %abe%%e Sa!e)uar e !rom a Au"tment" '$ic$ cou% inva%i ate it

5.8 )eas#re$ent tracea!ilit%


Ca%ibrate be!ore u"e Ca%ibration traceab%e to SI Sy"tem Ca%ibration %aboratorie" unbro(en %in( to :rimary Stan ar "/Secon ary Stan ar "
SMA/November 2007

ISO/IEC 17025:2005 17

ISO/IEC echnical +e"#ire$ents


5.7 )eas#re$ent tracea!ilit%
,A ca%ibration certi!icate bearin) an accre itation bo y %o)o !rom a ca%ibration %aboratory accre ite to t$i" Internationa% Stan ar 9 !or t$e ca%ibration concerne i" "u!!icient evi ence o! traceabi%ity o! t$e ca%ibration ata re&orte .*e"tin) %aboratorie" >e!erence Stan ar " an >e!erence Materia%" Ca%ibration o! >e!. Stan ar " B traceabi%ity /on%y u"e !or t$i" &ur&o"e0 >e!. Materia%" traceab%e to SI <nit" i! &o""ib%e or C>M Interme iate c$ec(" Sam&%in) Sam&%in) &%an an &roce ure" '$en it carrie" out "am&%in) at %ocation '$ere one. 3a"e on "tati"tica% met$o " /'$ere avai%ab%e0

SMA/November 2007

ISO/IEC 17025:2005 1@

ISO/IEC echnical +e"#ire$ents


5.5 9andling of test and cali!ration ite$s
:roce ure" !or tran"&ort9 recei&t9 $an %in) :rotection9 "tora)e9 ;i"&o"a% I enti!yin) te"t item"

5.6 A""urin) t$e .ua%ity o! te"t an ca%ibration re"u%t" &roce ure" !or monitorin)
t$e va%i ity o! te"t" an ca%ibration"

5.10 +e&orting of res#lts


Accurate%y an c%ear%y unambi)uou"%y an obAective%y <"ua%%y in a re&ort an a%% in!ormation in it nece""ary !or inter&retation A%%o'" o! "im&%i!ie re&ortin) /in!ormation "ti%% nee " to be avai%ab%e0

SMA/November 2007

ISO/IEC 17025:2005 12

ISO/IEC echnical +e"#ire$ents


est re&orts and cali!ration certificates
I enti!ie" a%% in!ormation nee e 6$ere a&&%icab%e <OM !or be"t re&ort" <OM !or ca%ibration certi!icate" Evi ence t$at mea"urement" are traceab%e /ca%ibration0 6$en "tatement o! com&%iance" i" ma e <OM "$a%% be ta(en into account /Ca%ibration0 No recommen ation on ca%ibration interna%
SMA/November 2007

ISO/IEC 17025:2005 20

ISO/IEC echnical +e"#ire$ents


O&inions and Inter&retation
;ocument ba"i" u&on '$ic$ inter&retation i" u"e C%ear%y mar(e a" "uc$ Not con!u"e 'it$ in"&ection" an :ro uct certi!ication Subcontracte re"u%t" c%ear%y i enti!ie Ca%ibration Certi!ication i""ue to t$e contractin) %aboratory

SMA/November 2007

ISO/IEC 17025:2005 21

han7 %o# for %o#r attention : An% "#estions ; MacCurtainEi"o.or) b%ee(erEi"o.or) emorineEi"o.or)
SMA/November 2007

ISO/IEC 17025:2005 22