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THE ISO 9000 FAMILY
Presented By
Mark JessenUnderwriters Laboratories
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Agenda
The ISO 9000 Family
hy !om"anies Im"lement ISO 9000
Im"a#t on B$siness %es$lts
The &n'ineers %ole in ISO 9000
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What is The ISO 9000 Family?
Three !ore International Standards
(sso#iate standards) te#hni#al s$""orts and
'$ides
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What is The ISO 9000 Family?
(sso#iated with the *amily are
+ISO2T% .0.3 1$idan#e on statisti#al
te#hni/$es
+I&! 405006. 7e"endability mana'ement
+ISO .0004 1$idelines to /$ality in "ro8e#t
mana'ement+ISO 1$idelines *or #on*i'$ration mana'ement
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ISO 9001
:ey standard in the *amily
!ontains /$ality mana'ement system
re/$irements
%e/$irements a""li#able to any kind o*
or'aniation
7oes not di#tate how re/$irements sho$ld
be a#hie-ed
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ISO 9001
Or'anied by key b$siness "ro#esses
+,$ality mana'ement system
+Mana'ement
+%eso$r#es
+Prod$#t realiation
+Meas$rement) analysis and im"ro-ement
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ISO 9001
O-er ;
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ISO 9000
,$ality Mana'ement F$ndamentals+%ole o* to" mana'ement
+($ditin' the /$ality mana'ement system+%ole o* statisti#al te#hni/$es
>o#ab$lary
+,$ality "lannin'+!$stomer satis*a#tion
+!ontin$al im"ro-ement
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ISO 900
ISO 900. ? &**e#ti-eness
ISO 900 ? &**i#ien#y
@ot a '$ide to im"lement ISO 900.
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What the ISO 9000 Family is not
( *amily o* "rod$#t standards
( '$arantee o* "rod$#t /$ality
( method to res#$e a tro$bled #om"any
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Why !om"anies Im"lement ISO 9000
Meet #$stomer re/$irements
Meet re'$latory re/$irements
Im"ro-e /$ality
In#rease "ro*itability
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Im"a#t on $%siness &es%lts
ISO 900. "romotes @ot enterin' into #ommitments that the
or'aniation #annot meet Identi*i#ation and mana'ement o* reso$r#es
needed to meet or'aniational ob8e#ti-es
Pro#esses desi'ned to meet or'aniational
ob8e#ti-es %ed$#tion in waste
!ontin$al im"ro-ement o* the /$alitymana'ement system
Satis*ied #$stomers
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ISO 9000
!om"anies may ele#t to obtain
+%e'istration to ISO 900.
Third "arty initial and on6'oin' e-al$ation
O-er 30)000 re'istrations in @orth (meri#a
+!om"lian#e to ISO 900.
Internal e**ort
%e'istration is only "ossible to ISO 900.
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ISO 9000
%e'istration and #om"lian#e re/$ire a$dit o* the/$ality mana'ement system
($ditors inter-iew "ersonnel and assess ob8e#ti-ee-iden#e thro$'ho$t the #om"any
($ditors ask *o$r basi# /$estions+ Is the "ro#ess identi*ied and de*inedA
+ (re res"onsibilities assi'nedA+ (re "ro#ed$res im"lemented and maintainedA
+ Is the "ro#ess e**e#ti-e in a#hie-in' the re/$iredres$ltsA
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The Enginee's &ole in ISO 9000
&n'ineers workin' in /$ality mana'ement may beres"onsible *or im"lementation o* the entire
standard+ Pro8e#t mana'ement task
ISO 900. Pro#esses o"erated 2 mana'ed byte#hni#al "ersonnel may in#l$de
+ 7esi'n and de-elo"ment+ Plannin' o* "rod$#t realiation
+ In*rastr$#t$re
+ ork en-ironment
+ Monitorin' and meas$rement o* "rod$#t and "ro#esses
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The Enginee's &ole in ISO 9000
ISO 9000 does not "res#ribe a s"e#i*i# a""roa#h
+ Or'aniation #an desi'n the "ro#ess as e**i#ient or
ine**i#ient as desired ISO 9000 does re/$ire ;. #ate'ories o* re#ords be
maintained
+ 7esi'n re-iew
+ 7esi'n -alidation
+ Mana'ement re-iew
+ Internal /$ality a$dit
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The Enginee's &ole in ISO 9000
!la$se 35.6 7esi'n and 7e-elo"ment
Plannin' ()%'ing design and de*elo"ment
"lanning+ the o'gani,ation shall dete'mine-+)esign and de*elo"ment stages
+&e*ie.+ *e'ifi#ation+ *alidation that a'e
a""'o"'iate to ea#h design "hase+&es"onsi/ilities and a%tho'ities fo' design and
de*elo"ment
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The Enginee's &ole in ISO 9000
!la$se 35
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Additional Info'mation
F$rther in*ormation re'ardin' the ISO 9000
standards #an be obtained atC
+wwwiso#h
http://www.iso.ch/http://www.iso.ch/ -
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S%mma'y
Thank yo$ *or yo$r attention
(ny ,$estionsA