i so overview

8/12/2019 i So Overview

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THE ISO 9000 FAMILY

Presented By

Mark JessenUnderwriters Laboratories


2/22

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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7/22

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


9/22

ISO 9001

O-er ;


10/22

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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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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!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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!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

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