Quality Excerpts 2000

8/9/2019 Quality Excerpts 2000

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ISO 9000:2000: A Shift in Focus

Changes in requirements

by Jack West !ith Char"es A# Cianfrani an$ Jose%h J# &siaka"s

As !e mo'e to the ne(t mi""ennium the ISO 9000 fami"y of qua"ity management system stan$ar$s

is being u%$ate$ to ref"ect a mo$ern un$erstan$ing of qua"ity# In "ast month)s *ua"ity +rogress the

authors re'ie!e$ the reasons changes are nee$e$ an$ $iscusse$ changes that re"ate to

%resentation termino"ogy an$ format# &his artic"e !i"" re'ie! the genera" changes in the actua"

requirements ,refer to the si$ebar -.equirement Changes-/#

&he shift in focus $iscusse$ in "ast month)s artic"e is a"so e'i$ent in the o'era"" change in focus of

some of the requirements# When the authors refer to the requirements this means the

requirements as state$ in ISO 900# &he artic"e is not a$$ressing the ISO 9001 gui$e"ines for

%erformance im%ro'ement !hich !i"" be $iscusse$ in a future artic"e#

&he changes in ISO 900 e(%"aine$ in the fo""o!ing are things that a"" organiations using that

stan$ar$ !i"" ha'e to consi$er an$ a$$ress33assuming that the changes in the secon$ committee

$raft ,C4 2/ actua""y a%%ear in the fina" ISO 900:2000#

For this to ha%%en ISO5C4 2 900:2000 !i"" ha'e to sur'i'e the !or"$!i$e consensus %rocess#

&his com%"e( %rocess inc"u$es se'era" cyc"es of comments an$ 'otes# Assuming the 'ote on C4 2 is

%ositi'e there sti"" !i"" be comments an$ 'otes on a $raft internationa" stan$ar$ an$ fina" $raft

internationa" stan$ar$# It is antici%ate$ that this consensus bui"$ing %rocess !i"" resu"t in the

re'ise$ stan$ar$ being %ub"ishe$ in the fourth quarter of 2000 ,see Figure /#

With this ca'eat "et)s consi$er a sam%"ing of the basic changes containe$ in the current $rafts#

Continua" im%ro'ement

In ISO 900:991 the conce%t of continua" im%ro'ement !as at best im%"ie$# &he 991 e$ition of

the stan$ar$ requires correcti'e an$ %re'enti'e action !hich !hen taken together an$ "inke$ !ith

the management re'ie! requirements an$ qua"ity au$it strong"y im%"y that continua" im%ro'ement is

require$#

6ut there is quite a $ifference bet!een the im%"ie$ requirement in the 991 e$ition an$ the !or$s

in C4 2 of ISO 900:2000# C4 2 c"ear"y states that the organiation estab"ish -a system "e'e"%roce$ure ### to faci"itate continua" im%ro'ement#-

C4 2 inc"u$es the conce%t that the organiation measure %rocess an$ %ro$uct5ser'ice out%ut

ana"ye these $ata an$ inc"u$e them ,a"ong !ith au$it resu"ts an$ so forth/ in the management

re'ie!# &he em%hasis has been shifte$ to require the use of information an$ $ata to continua""y

im%ro'e %erformance#


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Customer satisfaction

One of the most fun$amenta" reasons for the e(istence of ISO 900 is to achie'e customer

satisfaction !ith %ro$ucts an$ ser'ices %ro'i$e$ by an organiation# C4 2 un$erscores the

im%ortance of customer satisfaction by s%ecifica""y requiring measurement of customer satisfaction

an$ $issatisfaction# In a$$ition attention to customer satisfaction is inc"u$e$ in the requirementsof se'era" other e"ements of C4 2#

7easurement of customer $issatisfaction !as a$$e$ $uring the ana"ysis of comments on C4 of

ISO 900:2000 !hich ha$ require$ sim%"e measurement of customer satisfaction# Comments

in$icate$ that it !as unc"ear !hether measurement of $issatisfaction !as sufficient to com%"y !ith

the requirement to measure satisfaction#

Whi"e the basic requirement change a%%ears to be an issue of measurement an$ fee$back there is

more going on here# &he focus of ISO 900 has been shifte$ to one of e(%"icit"y un$erstan$ing an$

satisfying customer requirements nee$s an$ !ants rather than mere"y satisfying the customer)sstate$ requirements# &he shift may be subt"e but it is an im%ortant %oint to un$erstan$ regar$ing

the e'o"ution of the stan$ar$ to a$$ress market nee$s#

Statistica" techniques an$ measurement

ISO 900 has a"!ays require$ measurement of %ro$ucts to ensure conformity !ith requirements

an$ C4 2 is no e(ce%tion#

8se of statistica" techniques is not ne! to ISO 900 but in C4 2 the organiation must not on"y

consi$er but a"so use the a%%ro%riate techniques# An$ the requirement $oes not ust a%%"y to the

%ro$uct rea"iation acti'ities C4 2 a"so requires measurement of %rocesses as !e""# &his is$ifferent from the actua" requirement in the 991 e$ition#

&he organiation !i"" ha'e the free$om to $etermine !hat techniques are use$ an$ !here in the

qua"ity management system to a%%"y these techniques#

Whi"e the change in measurement an$ statistica" techniques is significant it is more significant

that !ith C4 2 $ata must be ana"ye$ an$ %ro'i$e$ as in%ut for management re'ie!# C"ear"y the

intent here is to faci"itate the continua" im%ro'ement of the system through actions base$ on facts#

.e$uce$ sco%e

With ISO 9000:2000 there !i"" be no ISO 9002 or ISO 900;# For most organiations this !i"" not

be an issue#

C4 2 of ISO 900 contains a c"ause that %ermits a re$uction in the sco%e of a qua"ity management

system !ith regar$ to %ro$uct or ser'ice rea"iation#


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&his c"ause $escribes !hat an organiation may not e(c"u$e# It may %ro'e to be some!hat $ifficu"t

for organiations that %erform %ro$uct or ser'ice $esign acti'ities but ha'e o%te$ to use ISO 9002

,e(c"u$ing $esign contro"s from their qua"ity management system/ in the %ast# C4 2 makes it c"ear

that organiations cannot e(c"u$e for con'enience e"ements of the qua"ity system that im%act on

the qua"ity of the %ro$ucts or ser'ices %ro'i$e$ to customers# &his !i"" a"so im%ose a requirement

on au$iting agencies to carefu""y train their au$iting %ersonne"#

Summary of the changes

It has been sai$ that the $e'i" is in the $etai"s# An$ so it may be !ith ISO5C4 2 900:2000# &he

authors ha'e not attem%te$ to co'er a"" the changes in this brief artic"e but rather to high"ight a

fe! of the changes that !i"" affect organiations that $esire to retain or achie'e com%"iance status#

ISO 9000:2000 Shifts Focus of *ua"ity 7anagement System Stan$ar$s

=ook for changes in format %resentation an$ termino"ogy


&his is the first of a series of artic"es e(%"aining the "atest 'ersion ,Committee 4raft 2/ of ISO

9000:2000#

As !e mo'e to the ne(t mi""ennium the ISO 9000 fami"y of qua"ity management system stan$ar$s

is being u%$ate$ to ref"ect a mo$ern un$erstan$ing of qua"ity#

&his artic"e is base$ on the secon$ committee $rafts ,C4 2/ of the three basic stan$ar$s in the

fami"y# &he rea$er shou"$ remember that these $ocuments are subect to change as the stan$ar$s

$e'e"o%ment %rocess continues# &hey shou"$ not be use$ as a basis for changing e(isting

management systems#

&he three basic stan$ar$s in the ISO 9000:2000 fami"y are:

ISO 9000:2000 *ua"ity 7anagement Systems33Fun$amenta"s an$ >ocabu"ary#

ISO 900:2000 *ua"ity 7anagement Systems33.equirements#

ISO 9001:2000 *ua"ity 7anagement Systems33?ui$e"ines for +erformance Im%ro'ement#

@ach of these three $ocuments has its o!n ro"e in the fami"y# ISO 900 !i"" remain the most use$

of the three but the other t!o are usefu" com%anions that shou"$ not be ignore$#


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Conte(t for the u%$ate

O'er the years the !or"$)s 'ie! of ho! qua"ity is create$ an$ assure$ has been e'o"'ing# &his

natura" %rogression $i$ not $irect"y create the nee$ to re'ise the ISO 9000 fami"y but it may be

usefu" to 'ie! the %ro%ose$ re'isions in the conte(t of the e'o"ution of qua"ity thinking#

&he origina" ISO 9000 fami"y !as base$ on the un$erstan$ings of an ear"ier era in !hich qua"ity

!as thought to be %rimari"y a technica" $isci%"ine33the %ur'ie! of the qua"ity %rofessiona"# In the

90s !e $isco'ere$ that this 'ie! !as incom%"ete# We hear$ the s"ogan -*ua"ity is a human

resources %rob"em not a technica" %rob"em#- So %rograms !ere $e'e"o%e$ to get !orkers in'o"'e$ in

qua"ity im%ro'ement#

&o$ay most organiations un$erstan$ that a"" !ork is accom%"ishe$ through %rocesses !hich are

most effecti'e !hen they are acti'e"y manage$# As the 990s a$'ance$ it became c"ear that qua"ity

has both a technica" an$ a human si$e#

&here has a"so been an increasing interest by organiations other than tra$itiona" manufacturing

,such as the ser'ices sector e$ucation go'ernmenta" agencies/ in using ISO 900 as a basis for

qua"ity management# &his has %ro'en to be some!hat a!k!ar$ because ISO 900:991 uses

"anguage that is focuse$ on manufacturing#

It is not sur%rising to fin$ this maturing of qua"ity thinking an$ a%%"ication in the mi$3990s

ref"ecte$ in re'isions to qua"ity system stan$ar$s#

ISO &echnica" Committee ,&C/ B the grou% res%onsib"e for the ISO 9000 fami"y "ong

recognie$ that the stan$ar$s nee$e$ an o'erhau"# In the ear"y 990s the committee %ut %"ans in

%"ace to make the u%$ates# &hese %"ans inc"u$e$ the $e'e"o%ment of s%ecifications for the changesto ensure that the nee$s of users aroun$ the !or"$ !ou"$ be met#

&he s%ecifications out"ine$ ho! the ISO 9000:2000 re'isions !ou"$ reso"'e %ercei'e$

shortcomings !ith the current $ocuments# &hese s%ecifications create$ the criteria for a

significant a$'ancement of the ISO 9000 fami"y an$ ref"ect contem%orary conce%ts of qua"ity

management# &he goa"s of the s%ecifications are summarie$ in the si$ebar -?oa"s for the De!

.e'isions#-

6asic changes

&!o ty%es of changes are a%%arent !ith the "atest committee $rafts# &here are:

Changes in %resentation termino"ogy an$ format#

Changes in the actua" requirements#

&his artic"e %resents an o'er'ie! of the changes in %resentation termino"ogy an$ format# Future

artic"es !i"" high"ight changes in requirements in ISO 900#


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*ua"ity management %rinci%"es

As an initia" ste% a"ong the roa$ to the ISO 9000:2000 re'isions &C B $e'e"o%e$ a consensus on

a set of qua"ity management %rinci%"es ,*7+s/# &he %rinci%"es !ere $e'e"o%e$ after research of the

qua"ity conce%ts in use aroun$ the !or"$# 7any in%ut sources !ere consi$ere$#

@ight %rinci%"es resu"te$ from this !ork an$ they ha'e been use$ as a foun$ation for the re'isions

,see si$ebar -&he @ight *ua"ity 7anagement +rinci%"es-/# &hese %rinci%"es a%%ear in both ISO 9000

an$ ISO 9001#

Whi"e the %rinci%"es !ere a basis for $e'e"o%ing ISO 900 they $o not forma""y a%%ear in that

$ocument# @ach %rinci%"e has a %"ace !ithin the ISO 900 requirements but the e(tent of

a%%"ication to ISO 900 is quite "imite$ com%are$ to its a%%"ication in the ne! ISO 9001# ISO 9001

uses each %rinci%"e fu""y to he"% organiations $ri'e for e(ce""ence#

Format an$ %resentation

&he format of ISO 900 an$ ISO 9001 has been change$ to "ink the qua"ity management system

!ith the %rocesses fo""o!e$ by most organiations# &he requirements of ISO 900 are no! gi'en as

four %rimary %rocesses#

&he interre"ationshi% of these four %rocesses in the qua"ity management system is sho!n

gra%hica""y in the qua"ity management %rocess mo$e" in Figure !hich is re%ro$uce$ !ith the

%ermission of the Internationa" Stan$ar$s Organiation ,ISO/# &he mo$e" may change as the

stan$ar$s %rogress through the $raft stages# @ach %rocess is $escribe$ be"o!:

7anagement res%onsibi"ity337anagement sets $irection an$ obecti'es of the system#

.esource management33.esources are $etermine$ %ro'i$e$ an$ manage$#

+ro$uct an$5or ser'ice rea"iation management ,ca""e$ %rocess management in Committee 4raft /33

+rocesses are estab"ishe$ for creating an$ $e"i'ering the organiation)s %ro$ucts an$ ser'ices an$

are 'erifie$ an$ manage$# +ro$uct rea"iation %rocesses take in%uts from customers in the form of

requirements nee$s an$5or !ants an$ con'ert them into the %ro$ucts an$ ser'ices that satisfy

customer requirements#

7easurement ana"ysis an$ im%ro'ement33+ro$ucts %rocesses an$ customer satisfaction or

$issatisfaction are measure$# Au$its are con$ucte$ of the qua"ity management system# 4ata areana"ye$ an$ resu"ts %ro'i$e$ as in%ut to the management re'ie! %rocess# &he $ata an$ ana"ysis are

use$ to im%ro'e the system continua""y#

&ermino"ogy


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&here has been a maor effort to use e'ery$ay @ng"ish terms that are easi"y un$erstoo$# &his is

more $ifficu"t than it !ou"$ seem# For e(am%"e the first committee $raft attem%te$ to a'oi$

argon by using common !or$s#

8nfortunate"y a carefu" rea$ing of the $raft re'ea"e$ that many of these common !or$s ha'e

se'era" meanings# In many cases !hen !or$s !ere use$ mu"ti%"e times in the $raft the 'arious usesha$ $ifferent inten$e$ meanings# 7uch of this has been correcte$ !ith the C4 2 but sim%"e

"anguage remains a cha""enge#

A goo$ e(am%"e of a shift to common "anguage is the !or$ use$ to $escribe an organiation that

im%"ements ISO 900# In the 991 e$ition the term -su%%"ier- is use$# &his is $eri'e$ from the

initia" focus of ISO 900 as a too" to be use$ in a contractua" re"ationshi% bet!een a customer an$ a

su%%"ier# &he ISO 900:2000 $rafts ha'e use$ the term -organiation- to $escribe the entity that

im%"ements the stan$ar$ an$ the term -su%%"ier- has its norma" @ng"ish meaning#

Changes in actua" requirements

&his artic"e has $iscusse$ reasons for a change in focus for the ISO 9000:2000 stan$ar$s an$ has

intro$uce$ the qua"ity management %rinci%"es# It has a"so re'ie!e$ changes in format %resentation

an$ termino"ogy# Subsequent artic"es in this series !i"" $iscuss the *7+s in more $etai" %articu"ar"y

the changes in requirements that are inc"u$e$ in the secon$ committee $raft of ISO 900:2000#

&he Art of Creating a Stan$ar$

It)s easier to be a critic than a %"ay!right

by Char"es A# Cianfrani !ith Jeffrey


7/89

$e'e"o%ment %rocess is im%"emente$# A sim%"ifie$ o'er3'ie! of the %rocess im%"emente$ for the

u%$ate of ISO 900:991 an$ ISO 9001:991 is sho!n in Figure #

Working grou%s ,W?s/ are assigne$ to $ea" !ith a s%ecific stan$ar$iation %roect co'ering more

than one stan$ar$# W? !as estab"ishe$ un$er SC2 to $e'e"o% the 2000 re'isions to ISO 900

an$ ISO 9001# @ach member bo$y of &C B5SC 2 !as %ermitte$ to nominate four e(%erts to thisW?#

&he 8nite$ States has eight in$i'i$ua"s in'o"'e$ $irect"y or in$irect"y in the creation of ISO 900

an$ ISO 9001# &hese inc"u$e e(%ert re%resentati'es "iaison re%resentati'es an$ the o'era""

%roect "ea$er Jeffrey


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com%uter $ri'en %roectors to re'ie! sort cut an$ %aste thousan$s of comments on the first

committee $raft ,C4 /# 4uring a !eek ust %rior to the fu"" W? meeting this grou% $e'ote$ 000

intense man3hours to assure effecti'e a$u$ication of comments#

W? !ith the a%%ro'a" of SC 2 member bo$ies institute$ an im%ortant a$'ance o'er %ast

%roce$ures !hen it $eci$e$ to use %roect management metho$o"ogy for the entire $e'e"o%ment%rocess33from $e'e"o%ing the management an$ %roect %"ans to customer nee$s ana"ysis an$

communications to 'erification an$ 'a"i$ation %ro$uct intro$uction an$ %ro$uct su%%ort#

&his entire s%ectrum of acti'ity !as broken $o!n for !ork by 2B task grou%s# @ach grou% ha$ a

carefu""y $efine$ task an$ a task monitor to he"% remo'e roa$b"ocks# =ike!ise each grou% !as

carefu""y staffe$ !ith a ba"ance$ set of e(%erts# &he +"anning an$ O%erations &ask ?rou% manage$

the interre"ationshi%s among the task grou%s# See Figure 2 for the the organiationa" structure

use$ by W? an$ Figure ; for the !ork structure break$o!n#

A $ecision by W? to manage the $e'e"o%ment of ISO 900:2000 an$ ISO 9001:2000 ust "ikethe $e'e"o%ment of any ne! %ro$uct33in other !or$s to fo""o! the requirements $efine$ in ISO

900 C"ause 1#133ha$ a %rofoun$ effect on the u%$ate# @ar"y on W? a$ministere$ an e(tensi'e

!or"$!i$e sur'ey of customer nee$s# 7ore than 00 %eo%"e from 10 countries res%on$e$# @ar"y in

the $e'e"o%ment %rocess %artici%ants agree$ that to achie'e as c"ean a re"ease of this ne!

stan$ar$ as %ossib"e the %rocess must incor%orate among many other things robust an$ forma"

'erification an$ 'a"i$ation#

>erification is an interna" W? %rocess that in$e%en$ent"y checks the $rafts of the stan$ar$s

!ith the $esign s%ecifications an$ %roect obecti'es# &his %ro'i$es quick fee$back to the $rafting

grou%s on ho! !e"" they are achie'ing their obecti'es an$ a$hering to the $esign s%ecifications#

>a"i$ation is an e(terna" %rocess that $irect"y checks ho! !e"" the ne! $raft stan$ar$s are

meeting customer nee$s# W? structure$ a 'a"i$ation %rocess to get $irect user fee$back

e(%ecting that changes !ou"$ become necessary as a resu"t#

On a !or"$!i$e basis ; countries an$ ;; organiations ,12 from the 8nite$ States/ %artici%ate$

in the C4 2 'a"i$ation %rocess# As sho!n o'er an$ o'er again in the in$ustria" sector the 'a"i$ation

%rocess yie"$s im%ortant fee$back# &his fee$back !as use$ to re'ise C4 2 an$ resu"te$ in a more

robust $raft internationa" stan$ar$ ,4IS/# &here is another 'a"i$ation %rocess sche$u"e$ in the

%roect %"an for the 4IS stage of re'ision# &he %rocess for this ne(t ste% !as a%%ro%riate"y

re'ise$ to incor%orate "essons "earne$ from the C4 stage#

Another im%ortant a$'ance resu"ting from a$$ressing the $e'e"o%ment of the 2000 u%$ates as

%ro$uct $e'e"o%ment %roects !as the incor%oration of both %ro$uct intro$uction an$ %ro$uct

su%%ort in the sco%e of the $e'e"o%ment %rocess#


9/89

.egar$ing the structure an$ content of the stan$ar$ e'o"'ing changes ref"ect a gro!ing

un$erstan$ing of the nee$s of customers in a"" maor %ro$uct an$ ser'ice sectors# 6a"ance !as

sought in a$$ressing the qua"ity management system requirements of har$!are ser'ice %rocesse$

materia" an$ soft!are customers an$ %ro$ucers# 7any of the ne! im%ro'ements are a ref"ection of

this migration from the origina" stan$ar$ !ith its har$!are focus to one that a%%"ies equa""y !e"" to

the ser'ice an$ soft!are sectors#

&he 8#S# %artici%ation in the actua" !riting of the "anguage of the stan$ar$ focuse$ on meeting the

nee$s of the %ri'ate sector because more than 9G of the e(%erience base of the 8#S# e(%erts an$

a 'ast maority of 8#S# users are from that sector# &he %rimary concern of the 8#S#

re%resentati'es !as to a$$ress the requirements an$ nee$s of these users !ith a goa" of creating

a stan$ar$ that can a$$ 'a"ue "o!er costs an$ achie'e customer satisfaction#

Some maor changes in the re'ise$ stan$ar$s !ere base$ on a $esire to im%ro'e com%atibi"ity

bet!een ISO 900 an$ ISO 100 the en'ironmenta" management stan$ar$# 7ost of the changes

to im%ro'e the com%atibi"ity !ith ISO 1000 !ere ma$e in the ear"ier W?s an$ in C4 an$ C4 2#

It has been obser'e$ that the %resent $raft is some!hat "onger than the current stan$ar$# As

c"arity an$ sim%"ification are %ursue$ !or$s an$ %aragra%hs are a$$e$# A"so a$$ing to the

stan$ar$s) "ength is the nee$ to make crysta" c"ear requirements that !ere a"!ays inten$e$ but

%re'ious"y !ere not e(%"icit"y state$#

An e(am%"e is continua" im%ro'ement# In 9B an$ 991 stan$ar$s !riters be"ie'e$ that

im%ro'ement !as c"ear"y man$ate$ by the "inke$ requirements of management re'ie! correcti'e

an$ %re'enti'e action an$ interna" au$it#


10/89

.eso"ution of !hat to inc"u$e in ISO 900:2000 has generate$ the most $ebate an$ com%romise in

the o'era"" effort to %ro$uce an u%$ate$ ba"ance$ stan$ar$ that is tru"y generic an$ a%%ro%riate

for a"" ty%es of users# &his $ebate !i"" continue u% to the 'ery "ast moment as the stan$ar$

%rogresses to its fina" re"ease$ form#

ISO5&C B has a track recor$ of successfu""y %ro$ucing stan$ar$s that a$$ 'a"ue# &he "ast 2years of e(%erience !ith ISO 900 $emonstrate that the stan$ar$ $oes %ro'i$e a usefu" mo$e" for

most organiations33one that has %ositi'e"y contribute$ to meeting organiationa" obecti'es#

&he authors be"ie'e that ISO 900:2000 an$ ISO 9001:2000 !i"" %ro'e to be e'en more usefu"

an$ 'a"uab"e to organiations than their %re$ecessors#

&he +ros an$ Cons of Sector3S%ecific Stan$ar$s

+a%er!ork nightmare or increase$ benefitsH

by =es"ie Dorris

Sector3s%ecific qua"ity stan$ar$s are requirements $e'e"o%e$ by a %articu"ar in$ustry to a$$ress

s%ecific nee$s or requirements# 4es%ite the %ercei'e$ f"e(ibi"ity of the ISO 9000 series of qua"ity

management system ,*7S/ stan$ar$s the qua"ity %rofession has !itnesse$ the $e'e"o%ment of

se'era" sector3s%ecific $ocuments an$ stan$ar$s such as AS 9000 ,aeros%ace/ *S39000

,automoti'e/ &@ Su%%"ement to *S39000 ,too"ing an$ equi%ment/ >4A # ,?erman automoti'e/ &=

9000 ,te"ecommunications/ an$ 7.A ,me$ica" $e'ices/#

A"though the sector3s%ecific requirements either $irect"y or in$irect"y use the ISO 900 *7S

stan$ar$ as a %"atform maintaining at "east some consistency among them their im%act on in$ustry

an$ qua"ity management cannot be ignore$# &his artic"e takes a brief "ook at the %ros an$ cons of

sector3s%ecific stan$ar$s an$ the res%onse of qua"ity organiations to their creation#

?enera" concerns


11/89

It a%%ears that a"though the sector3s%ecific stan$ar$s are base$ on ISO 900 they !i"" ine'itab"y

%"ace increase$ %ressures on in$ustry su%%"iers# For e(am%"e athy


12/89

In the cases of both *S39000 an$ &= 9000 the requirements of the "arge customers in the

in$ustry ha'e been stan$ar$ie$ !hich shou"$ make com%"iance by their key su%%"iers much easier#

So for maor su%%"iers to a s%ecific sector the effect of sector $ocuments can be %ositi'e: &hey

ha'e one set of requirements rather than a set from each of their maor customers#

San$for$ =iebesman ISO manager for qua"ity an$ customer satisfaction at =ucent &echno"ogies

an$ a member of &C B state$ -@'ery in$ustry is $ifferent an$ has $ifferent requirements# As

"ong as they Ksector3s%ecific stan$ar$sL are base$ on the ISO 900 stan$ar$ they are goo$#-

=iebesman is a member of the *u@S& Forum !hich is creating the &= 9000 stan$ar$# 4ra!ing from

that e(%erience he a"so e(%"aine$ -In our case !e are e(ten$ing the 'a"ue of ISO 900 by

inc"u$ing %erformance measurements or metrics in our stan$ar$#-

A mi(e$ bagH

.obert W# +each *7S consu"tant !ho !as instrumenta" in the $e'e"o%ment an$ gro!th of se'era"

stan$ar$s a$$e$ -&here are "egitimate obser'ations that ISO 900 is either strict $efiniti'e or

$eman$ing for the su%%"iers to meet the in$i'i$ua" nee$s# @'i$ence in the auto in$ustry has %ro'en

that sector3s%ecific requirements are a $efinite im%ro'ement on ISO 900 for certain in$ustries#

ISO 900 is a generic stan$ar$ an$ !hen $efine$ that !ay ho! $o you raise the bar !here it

a%%"ies or !hen it is necessaryH We can)t ho!e'er raise the bar for e'eryone# For some ISO 900

!ou"$ be a%%ro%riate but for others a sector3s%ecific stan$ar$ is necessary#-

Sector3s%ecific *7S stan$ar$s ha'e been the cata"yst for increase$ o%%ortunities %ro'i$ing

benefits that may not ha'e been a'ai"ab"e through ISO 900 a"one# For e(am%"e the *u@S& Forum

foun$ that sim%"y !orking on &= 9000 together has brought com%anies an$ their su%%"iers c"oser

estab"ishing ne! %artnershi%s an$ increase$ communication# &his in%ut !i"" u"timate"y a""o! su%%"iers

to ha'e greater inf"uence an$ more contro" !ithin their market%"ace a situation not rea$i"ya'ai"ab"e through ISO 900#

.A6)s %osition


13/89

&he .egistration Accre$itation 6oar$ ,.A6/ res%onsib"e for %ro'i$ing accre$itation ser'ices for

ISO 9000 *7S registrars be"ie'es the $e'e"o%ment of sector3s%ecific stan$ar$s is not on"y

unnecessary but a"so counter%ro$ucti'e#

.A6 thinks the ISO 9000 fami"y)s f"e(ibi"ity a""o!s for broa$ a%%"ication to a fu"" range of business

acti'ities e"iminating the nee$ for s%ecia"ie$ stan$ar$s# In a$$ition .A6 %oints out that sector3

s%ecific stan$ar$s ha'e a"so create$ a nee$ for s%ecia"ie$ au$itors an$ au$itor training courses

the im%acts of !hich remain to be seen#

De'erthe"ess .A6 has a$$resse$ in$ustry)s $esire to create s%ecia"ie$ stan$ar$s an$ $e'e"o%e$ a

s%ecific accre$itation %rocess# .A6 e(%"ains the requirements of this %rocess by stating -For its

%art the in$ustry grou% that s%onsors the %rogram must maintain the su%%"ementary requirements

it has $e'e"o%e$ $efine the au$itor qua"ifications s%ecific to that %rogram an$ sanction the

training that is $e'e"o%e$ to %ro'i$e those s%ecia" au$itor ski""s#-

In a$$ition .A6 sai$ the in$ustry grou% must a"so %ro'i$e e'i$ence of su%%ort of the %rogram

being %ro%ose$ !ithin its in$ustry an$ must inc"u$e the base requirements of ISO 900 'erbatim in

its %rogram#

ISO an$ &C B res%on$

&he Internationa" Organiation for Stan$ar$iation)s ,ISO/ %rimary %ur%ose is to $e'e"o% an$

%ub"ish internationa" stan$ar$s !hi"e using in%ut from an$ achie'ing consensus among go'ernment

in$ustry an$ others# ISO)s &C B is res%onsib"e for the qua"ity stan$ar$s# Consi$ering their ro"e

in stan$ar$s $e'e"o%ment ho! ha'e ISO an$ &C B a$$resse$ the $e'e"o%ment of sector3s%ecific

stan$ar$s an$ more im%ortant in$ustry)s s%ecia"ie$ nee$sH

-O'er the years &C B has ha$ a sector3s%ecific stan$ar$s %o"icy !hich is inc"u$e$ in ISO

$irecti'es- sai$ West# -&his %o"icy has $iscourage$ the $e'e"o%ment of such $ocuments !ithin ISO#

Consequent"y most of the sector3s%ecific $ocuments !e ha'e seen ha'e not been issue$ by ISObut rather by in$ustry consortia# Since most ha'e been $e'e"o%e$ outsi$e of ISO there has been

"itt"e o%%ortunity to harmonie their requirements#-

6ut ISO hasn)t ignore$ in$ustry)s request for more s%ecia"ie$ stan$ar$s an$ has been taking

ste%s to further a$$ress them# -8sing the e'o"ution of $raft technica" re%ort K4&.L 919 as an


14/89

e(am%"e- West e(%"aine$ -sector re%resentati'es state they ha'e nee$s that they fee" are not

met by the basic ISO 9000 fami"y#

-&he ISO &echnica" 7anagement 6oar$ K&76L $irecte$ &C B to re'ie! the sector3s%ecific

stan$ar$s %o"icy !ith an eye to!ar$ meeting the sectors) nee$s# As a resu"t &76 authorie$ a %i"ot

%roect !ith the automoti'e in$ustry to create a $ocument that harmonies *S39000 the ?erman>4A # an$ other @uro%ean auto in$ustry $ocuments K4&. 919L# 6ase$ on the resu"ts of the

%i"ot I e(%ect &C B to %ro%ose a re'ise$ sector3s%ecific stan$ar$s %o"icy sometime in 999#-

A"though !e ha'e !itnesse$ the $e'e"o%ment of mu"ti%"e sector3s%ecific *7S stan$ar$s there are

sti"" fe!er unique requirements for su%%"iers# Secon$ the sector3s%ecific stan$ar$s continue to

ref"ect the !i$e"y use$ requirements of ISO 900 maintaining consistency among in$ustries#

Fina""y the ne! cha""enges for registrars consu"tants an$ trainers ha'e yet to be fu""y e'a"uate$

but are a 'ariab"e that shou"$ be monitore$#

So !hat ha'e !e "earne$H ?eorge =ofgren *7S %resi$ent of .A6 summarie$ the $e'e"o%ment ofsector3s%ecific stan$ar$s by stating -We)re mo'ing a!ay from the generic into the s%ecific# It is

neither a %ositi'e nor a negati'e# What !e $on)t !ant to see is a set of %hi"oso%hies that !ou"$ be

counter%ro$ucti'e# So far they offer refinements to the generic %rocess#-

&= 9000 *ua"ity System .equirements .oote$ in ISO 900

&he ne! te"ecommunications in$ustry stan$ar$ takes sha%e

by James +# ?i"$ers"ee'e

&= 9000 is a ne! set of te"ecommunications qua"ity system requirements base$ on ISO 900 an$

incor%orating %erformance measurements or metrics# It has been in $e'e"o%ment since January

99#

&he $e'e"o%ment effort has been "e$ by the *ua"ity @(ce""ence for Su%%"iers of

&e"ecommunications =ea$ershi% Forum ,*u@S& Forum/ ma$e u% of the !or"$)s "ea$ing

te"ecommunications ser'ice %ro'i$ers ,&S+s/ an$ their su%%"iers#


15/89

&he *u@S& Forum an$ its !ork came about in an effort to re$uce the annua" cost of %oor qua"ity

!ithin the te"ecommunications in$ustry estimate$ at M0 to M bi""ion annua""y# Wor"$!i$e

%urchases from the in$ustry)s su%%"iers are estimate$ at more than M2 bi""ion in %ro$ucts an$

ser'ices annua""y#

&he %ur%ose of &= 9000 is to $efine the te"ecommunications qua"ity system requirements for the

$esign $e'e"o%ment %ro$uction $e"i'ery insta""ation an$ maintenance of %ro$ucts an$ ser'ices# In

su%%ort of these requirements &= 9000 !i"" a"so incor%orate effecti'e cost3 an$ %erformance3

base$ metrics to measure %rogress an$ e'a"uate resu"ts of qua"ity system im%"ementation#

&= 9000 !i"" be $efine$ in t!o han$books: &= 9000 *ua"ity System .equirements ,*S.s/ an$ &=9000 *ua"ity System 7etrics ,*S7s/# @ach of these !i"" inc"u$e a section %ertaining to a"" users

as !e"" as sections focusing on har$!are soft!are an$ ser'ices# &his corres%on$s to the three

registration o%tions ,or any combination/ that are a'ai"ab"e:

&= 90003


16/89

&he &= 9000 *S7


17/89

ser'ice functions an$ further gro!th of the %ositi'e re"ationshi% bet!een customers an$ their

su%%"iers#

&he requirements are bui"t on current"y use$ in$ustry stan$ar$s inc"u$ing ISO 900 7a"co"m6a"$rige Dationa" *ua"ity A!ar$ criteria 6e""core S@I an$ ISO 220B stan$ar$s# &= 9000

combines a%%"icab"e e"ements from a"" of these stan$ar$s an$ metho$o"ogies into one in$ustry3

s%ecific mutua""y agree$3u%on set of requirements to be fo""o!e$ by e'eryone in the

te"ecommunications in$ustry#

&= 9000 metrics offer a ba"ance$ set of measures an$ effecti'e means to communicate an$ monitor

actua" resu"ts# 7etrics enab"e &S+s an$ su%%"iers to measure 'arious attributes of qua"ity such as

numbers of system fai"ures bi""ing errors an$ $e"i'ery %rob"ems# &he &= 9000 *S7


18/89

As forum a$ministrator AS* has a"rea$y assume$ res%onsibi"ity for the %ro$uction an$

$istribution of the han$books but !i"" gra$ua""y increase its in'o"'ement unti" it has assume$ its fu""

res%onsibi"ities not "ater than 4ecember 999#

AS*)s %rimary functions !i"" inc"u$e con$uct of genera" business management of %rogram

res%onsibi"ities management of accre$itation bo$y an$ registrar $uties a$ministration of

membershi% an$ $istribution an$ %ub"ishing of a%%ro'e$ requirements an$ co""atera" marketing

materia"s#

&he registration %rocess for &= 9000 is current"y being $e'e"o%e$ by the .egistrar Accre$itation

6oar$ ,.A6/ an$ the Stan$ar$s Counci" of Cana$a ,SCC/ in consu"tation !ith the *u@S& Forum#

-&he criteria for qua"ifying as a registrar are $ictate$ to a "arge $egree by the criteria in the &=

9000 *S.


19/89

Internationa" %artici%ation

One of the *u@S& Forum)s goa"s for &= 9000 !as that it become internationa""y acce%te$33

im%ro'ing the qua"ity an$ re$ucing the cost of %oor qua"ity of te"ecommunications g"oba""y# 6ut the

maority of the !ork on the $e'e"o%ment of &= 9000 has taken %"ace insi$e Dorth American

bor$ers con$ucte$ by ser'ice %ro'i$ers an$ their su%%"iers#


20/89

organiationa" structure %roce$ures an$ %rocesses !i"" satisfy qua"ity obecti'es# *ua"ity %"anning

suggests continuous im%ro'ement#

&he ISO 900 qua"ity system requirement is $esigne$ to accommo$ate ongoing interna" an$

e(terna" au$its of the qua"ity system at "east once a year an$ more frequent"y !hen nee$e$ to

maintain the integrity of the *7S#

E 1#;33Contract re'ie!# &he %ur%ose of this requirement is to ensure that a"" !ritten materia"s

creating %atient e(%ectations are accurate# &his means that customer requirements are estab"ishe$

before engaging in a contract an$ some %erson in the organiation is res%onsib"e for seeing that

contract requirements are fu"fi""e$#

ISO 900 1#; focuses on the fact that the %atient un$erstan$s an$ ackno!"e$ges ethica" issues

such as confi$entia"ity %ri'acy security communications in regar$ to anesthesia %"ans an$ consents

an$ or$ers ,such as a$mission an$ $ischarge/ an$ forma""y agrees !ith any contracts affecting his

or her rights as a %atient#

E 1#1334esign contro"# 4esign contro" has a broa$ a%%"ication for hea"th care %ro'i$ers# It $efines

the ste%s that must be taken by the hos%ita" !hen ne! or a$$itiona" ser'ices are consi$ere$ for

im%"ementation# It cou"$ in'o"'e $esigning a %"an to contro" %atient f"o! or a s%ecific ser'ice such as

a ne! neonata" care faci"ity e(%an$e$ onco"ogy %rogram or off3site human immuno$eficiency 'irus

,/ treatment faci"ity#

E 1#334ocument an$ $ata contro"# &his c"ause requires that the qua"ity system %ro'i$e time"y

access to a%%ro'e$ instructions for the accurate an$ time"y %ro'ision of %atient care an$ su%%ort

functions# &he right $ocuments must be a'ai"ab"e an$ in$e(e$ so they are rea$i"y accessib"e#

&he c"ause requires that %ro'i$ers estab"ish an$ maintain $ocumente$ %roce$ures an$ that

%ertinent $ocuments an$ $ata are a'ai"ab"e at a"" "ocations !here o%erations essentia" to the

effecti'e functioning of the qua"ity system are %erforme$# A"" charges must be a%%ro'e$ an$ a""

obso"ete $ocuments must be %rom%t"y remo'e$#


21/89

E 1#B33Contro" of customer su%%"ie$ %ro$uct# Any items that are use$ in the $e"i'ery of ser'ices

but are not the %ro%erty of the hea"th care %ro'i$er must be i$entifie$ an$ contro""e$# ?i'en the

mi( of interna" an$ e(terna" customers in hea"th care settings this area $eser'es serious attention#

E 1#33+ro$uct i$entification an$ traceabi"ity# In hea"th care settings this c"ause has a s%ecia"

a%%"ication# +atient recor$s an$ %atient acti'ities are genera""y connecte$ to a %articu"ar %atientthrough the use of unique i$entification numbers# et for some %ro'i$ers !ho interact !ith

%atients in out%atient settings each a$mission is treate$ as unique an$ not effecti'e"y "inke$ !ith

%rior a$missions or tests# &his can create a %a%er nightmare as !e"" as %ro'i$e inefficient but

e(%ensi'e %atient ser'ice#

E 1#933+rocess contro"# &his c"ause co'ers a broa$ range of ser'ices in hea"th care settings# +u"aski

Community A $escribes %rocess contro" as the %ro'ision of -in$i'i$ua"ie$

%"anne$ %atient care in the setting that most a%%ro%riate"y su%%orts the %atients) nee$s#- ,It cou"$

inc"u$e contro""e$ con$itions concerning the use of suitab"e equi%ment an$ !orking en'ironment or

monitoring an$ contro" of suitab"e %rocess %arameters an$ ser'ice con$itions to c"ear"y state$criteria for !orkmanshi%#

S%ecia" %rocesses cou"$ inc"u$e areas such as surgery obstetrics %hysica" thera%y ra$io"ogy

anesthesia onco"ogy an$ res%iratory thera%y#

E 1#033Ins%ection an$ testing# &his c"ause in'o"'es the obecti'e monitoring of the accuracy an$

time"iness of %atient care an$ a"" su%%orting functions that affect that care# It inc"u$es qua"ity

checks assessments an$ ins%ections at a"" %rocess stages from a$mission through %atient

$ischarge#

Areas inc"u$e$ !ou"$ be %re3a$mission testing an$ a$mission in3%rocessing of %atients an$ %ro$ucts

,for e(am%"e Is this !hat !as or$ere$H


22/89

E 1#;33Contro" of nonconforming %ro$uct# In hea"th care settings nonconforming %ro$uct a"so

inc"u$es nonconforming ser'ice#

Donconforming %ro$ucts cou"$ be an im%ro%er"y functioning magnetic resonance imaging ,7.I/

machine an in3'itro $iagnostic com%uter that is out of ca"ibration in3'itro reagents that $o not

meet %urchasing requirements or steri"e $ra%es in %ackaging that !as %uncture$ in transit#

Donconforming ser'ices cou"$ be e"ectrica" outages that shut $o!n a surgica" room untraine$

%ersonne" con$ucting a %atient testing %roce$ure or a "oss of critica" %atient recor$s#

ISO 900 requires that hea"th care %ro'i$ers fo""o! estab"ishe$ %roce$ures to %re'ent uninten$e$

use or insta""ation# Donconforming %ro$uct or ser'ice must be e'a"uate$ an$ its root cause

$etermine$ to %re'ent a reccurrence of the nonconformity#

E 1#133Correcti'e an$ %re'enti'e action# &his requires s%ecia" attention in hea"th care settings# As

note$ nonconformities can a%%ear in both %ro$ucts an$ ser'ices# Fortunate"y correcti'e an$

%re'enti'e action in ISO 900 systems is a"so $ri'en by the interna" au$it %rocess !hich i$entifies

nonconformities $ri'es correcti'e an$ %re'enti'e action an$ re%orts correcti'e actions %rocesses

an$ any qua"ity tren$s to management re'ie! on a %erio$ic basis# It is one of the strengths of an

ISO 900 *7S#

E 1#33


23/89

Further interna" au$itors must ha'e qua"ity training certificates on recor$# &raining must be

$ocumente$ an$ a centra" training recor$s $atabase must be %reser'e$#

With the increase$ hiring of tem%orary em%"oyees au$itors e'a"uate to see if %eo%"e ha'e been

traine$ to $o their obs#

E 1#933Ser'icing# &his can co'er ser'icing equi%ment or %ro'i$ing ser'ices to customers# It a"so can

inc"u$e interna" su%%"iers#

E 1#2033Statistica" techniques# Whi"e at first b"ush statistica" techniques might seem remote

statistica" %rocess contro" has been use$ !ith great effect in hea"th care management# It can

%ro'i$e significant insight to the efficacy of the system an$ areas that shou"$ be a$$resse$#

ISO 900 registration is re"ati'e"y ne! to hea"th care %ro'i$ers# &he first hos%ita" to register to

an ISO 900 *7S $i$ so in January 99# .egistration to ISO 900 by a qua"ifie$ hea"th care

registrar %ro'i$e$ the requisite thir$ %arty a%%ro'a" that satisfie$ state "icensing an$ certification

requirements an$ reimbursement by state an$ fe$era" agencies#

C"ear"y ISO 900 registration offers some %o!erfu" im%ro'ements to other accre$itation

%rograms# A"though others are better kno!n an$ recognie$ among hea"th care %ro'i$ers it shou"$

be note$ that ISO 900 registration offers a $isci%"ine$ an$ systematic a%%roach to hea"th care as

it has to other manufacturing an$ ser'ice in$ustries#

Whi"e it might seem $aunting at first a $ocumente$ interna""y manage$ ISO 900 qua"ity

management system subect to frequent e(terna" re'ie! ,once estab"ishe$/ is easier to maintain

financia""y "ess $eman$ing an$ ca%ab"e of offering better ser'ice to its customers#

&he 6ig +icture

A conte(t for ISO 900 an$ ISO 9001

by Jose%h J# &siaka"s !ith Char"es A# Cianfrani an$ Jack West

&his is %art four of a series of artic"es on the year 2000 re'ision of the ISO 9000 series# &he first

three artic"es e(%"aine$ changes in requirements format %resentation an$ termino"ogy an$ in the

%rocesses an$ a%%roaches use$ for $e'e"o%ing the re'isions# &his artic"e !i"" e"aborate on the bigger

%icture: the maor $ri'ing force for the change an$ the corres%on$ing res%onse#


24/89

Is the ISO 9000 series of qua"ity management stan$ar$s one of the greatest con games of a""

timeH What)s the 'a"ueH Are its critics ustifie$H Or are they confuse$ by a "ack of un$erstan$ing

of the ro"e of ISO 900H Shou"$ changes be ma$e in or$er to $ea" !ith this confusionH

What rea$er hasn)t hear$ criticisms about ISO 900H

E ISO 9000 $oes not ensure qua"ity# If you s%ecify garbage you !i"" get garbage#

E ISO 9000 is 'ery e(%ensi'e to im%"ement !ith questionab"e benefits#

E Instea$ of $rafting use"ess $ocuments for meeting stan$ar$s it is more im%ortant to ana"ye an$

im%ro'e the manufacturing %rocess#

E We $o 6a"$rige ,the 7a"co"m 6a"$rige Dationa" *ua"ity A!ar$/# ISO 9000 is the o"$ %ara$igm of

an interna" o'er"ay qua"ity %rogram im%"ying that qua"ity costs money#

E ISO 9000)s focus on conformity means that it $oesn)t a$$ress customer3$ri'en qua"ity#

A"though there are grains of truth in each of the abo'e misconce%tions these criticisms some

from su%%ose$"y informe$ e(%erts are a"" !i$e"y off the mark# &hey originate %artia""y in the

frustration that comes from unrea"ie$ or unrea"istic e(%ectations or from e(%ectations that arise

from $ifferent a%%roaches#

From these an$ other criticisms ho!e'er it became c"ear that a key moti'ation for the 2000

re'ision of the ISO 9000 series shou"$ be to a$$ress the organiationa" nee$ to ensure qua"ity

%ro'i$e for meeting customer nee$s an$ requirements create efficient an$ "o! cost o%erations an$

achie'e market%"ace success#


25/89

+ara$o(ica""y in "ight of a"" the criticism there are more than 2B0000 organiations current"y

registere$ to ISO 900# @ach of these organiations has im%"emente$ a system an$ retains

e(terna" au$itors to obtain an$ maintain its registration# An$ the u%!ar$ tren$ is continuing#

&o un$erstan$ !hy the ISO 9000 series of qua"ity management stan$ar$s has been so !i$e"y

embrace$ it)s im%ortant to see the big %icture# On"y then $oes one un$erstan$ the maor $ri'ing

force for change an$ the corres%on$ing res%onse of ISO &echnica" Committee B ,ISO5&C B/

through $e'e"o%ment of an a"igne$ %air of stan$ar$s that are $esigne$ to be use$ together#

&!o maor a%%roaches

&he efforts of go'ernments to "o!er tra$e barriers a"ong !ith a $ri'e for internationa" markets

tough com%etition an$ customer %ressures on su%%"iers ha'e a"" resu"te$ in great focus on qua"ity#

7any agree that qua"ity ser'es as a maor unifying %rinci%"e of business# &he many $iffering

metho$s for achie'ing qua"ity ha'e coa"esce$ into t!o main qua"ity management a%%roaches:

E ISO 900 qua"ity management systems ,inc"u$ing ISO 9002 an$ ISO 900;/ !hich focus on

%rocess management#

E +erformance e(ce""ence mo$e"s !hich focus on resu"ts oriente$ im%ro'ements# &he 'arious

nationa" or regiona" qua"ity a!ar$ %rograms such as the 6a"$rige A!ar$ the 4eming +rie an$ the

@uro%ean *ua"ity A!ar$ a"ong !ith efforts such as the Si( Sigma %rocess best characterie the

%erformance e(ce""ence mo$e"s# ISO 9001:991 as a gui$ance stan$ar$ for qua"ity management

a"so has ha$ a focus on %erformance e(ce""ence# It uses ISO 900 as the basic system an$ gi'es

gui$ance on im%ro'ing a"" as%ects of the qua"ity system inc"u$ing achie'ing im%ro'e$ %erformance of

the cost of qua"ity an$ continua" qua"ity im%ro'ement#

@ach of these t!o a%%roaches33ISO 900 an$ %erformance e(ce""ence33is "egitimate# Organiations

that embrace one of these a%%roaches ty%ica""y engage in many e"ements of the other a%%roach#

6oth a%%roaches in fact nee$ to be embrace$#


26/89

&he rea" issues in'o"'e un$erstan$ing the goa"s of each a%%roach the ro"es to be %"aye$ by them in

%ro'i$ing 'a"ue to an organiation an$ the !ays in !hich they might be integrate$ into one cohesi'e

qua"ity system# 7uch of the confusion to$ay arises because of the ten$ency by %ractitioners to

%romote one a%%roach by em%hasiing the $ifferences an$ ina$equacies of the other# Instea$ it is

better to embrace both a%%roaches in a unifie$ manner#

7as"o!)s


27/89

7oti'ation for the "o!er nee$s is to a'oi$ $eficiency !hi"e se"f3actua"ie$ %eo%"e are gro!th

oriente$ an$ continua""y e(%an$ing their interests an$ contributions to society# Fu"fi""ment at the

highest "e'e"s of the hierarchy ten$s to be e%iso$ic# 7as"o! "ater re$efine$ se"f3actua"iation as a

function of frequency of %eak e(%eriences#

&he *ua"ity


28/89

&here are other maor $ifferences bet!een the base an$ the to% of the hierarchy# &he base is

$efine$ by a qua"ity system consisting of a minimum set of actions that must be %erforme$# In

or$er to be ab"e to %ro'i$e customer confi$ence the system must be ab"e to be au$ite$# It either

com%"ies or it $oesn)t# .equirements are fu"fi""e$ or organiations are in noncom%"iance# +ro$uct is$efecti'e or acce%tab"e# Customers either com%"ain or $on)t# &he base can be consi$ere$ as a

binary territory# *ua"ity at the base $ea"s !ith meeting those as%ects of customer satisfaction

achie'e$ through conformance to requirements#

In shar% contrast to this is the nature of the !or"$ abo'e the base# Abo'e the base the !or"$

e(ists on a continuum# Strengthening com%etiti'eness $e%en$s u%on %ursuit of o%erationa"

e(ce""ence33referre$ to as e(ce""ent or su%erior or !or"$3c"ass qua"ity#

Organiations must "ook outsi$e of themse"'es an$ benchmark for the best %ractices an$ the best

resu"ts to gain un$erstan$ing of !hat they must $o# Success $e%en$s on $e%"oyment throughout the

organiation an$ e'er im%ro'ing resu"ts# Abo'e the base organiations nee$ concern themse"'es not

on"y !ith %resent but a"so !ith future customer nee$s#

Whereas an organiation must meet a"" the requirements at the base in or$er to %ass a com%"iance

au$it an$ achie'e registration no organiation e'er fu""y arri'es at the to% of the *ua"ity


29/89

%ro$ucts are among the most critica" as e'i$ence$ by the fact that go'ernments consi$er it

necessary to regu"ate them#

As an e(am%"e "et)s "ook at one ty%e of me$ica" $e'ice33a heart 'a"'e#


30/89

Since %erformance e(ce""ence $oes not require the rigor of a qua"ity management system to be

sustaine$ it is best im%"emente$ in the conte(t of ISO 900# A"though some might argue that not

a"" %ro$ucts are as critica" as me$ica" $e'ices isn)t it ob'ious that ISO 900 shou"$ come firstH A

maor %art of the 2000 re'ision !as the restructuring an$ carefu" crafting of ISO 900 to be

generica""y a%%ro%riate for a"" organiations an$ for a"" ty%es of %ro$ucts inc"u$ing ser'ices an$

soft!are# &he nature an$ e(tent of the s%ecific requirements for a gi'en qua"ity system are

$e%en$ent on the nature of the %ro$uct sie an$ ty%e of organiation com%"e(ity an$ interaction

of the %rocesses an$ com%etence of %ersonne"# For e(am%"e ISO 900 a%%"ie$ to a business of 2

em%"oyees is significant"y $ifferent from its a%%"ication to a business of 000 em%"oyees a"" other

as%ects being equa"#

Whi"e ISO 900 is necessary for assuring the meeting of qua"ity requirements it is not sufficient

for the organiation)s continuing success# &hrough its systems a%%roach ISO 900 sets the

foun$ation for efficiency an$ "o! cost %ro$uction but it $oes not $ea" $irect"y !ith cyc"e timere$uction "o! cost materia" higher %ro$ucti'ity or any of the other means of achie'ing com%etiti'e

a$'antage#

+erformance e(ce""ence $oes $ea" !ith these nee$s# @(ecuti'e management may use %erformance

e(ce""ence or an equi'a"ent a%%roach to achie'e o%erationa" e(ce""ence# 6y their 'ery nature the

too"s of %erformance e(ce""ence !ork best in the %roect3by3%roect mo$e# As %roects are

com%"ete$ focus ten$s to shift to other %roects !ithout a$equate institutiona"iation# An$ so the

gains may be "ost#

As in the 7as"o! mo$e" achie'ement at the highest "e'e" of the *ua"ity


31/89

E ISO 900:2000 co'ers qua"ity management system requirements#

E ISO 9001:2000 %ro'i$es gui$ance for %erformance im%ro'ement#

From the initia" %ub"ication of the ISO 9000 series in 9B ISO 9001 ser'e$ as gui$ance for

achie'ing im%ro'e$ %erformance# *uite natura""y !ith the %ressure of au$its for conformity to

ISO 900 ISO 9001 has been a"" but ignore$# Fe! e'en kno! of its e(istence#

One of the changes im%"emente$ by the 991 re'ision of the ISO 9000 series !as a"ignment

bet!een ISO 9001 an$ ISO 900 in or$er to a""o! integration of the t!o stan$ar$s# &he a"ignment

!i"" be com%"ete$ !ith the u%coming re'ision !hich uses matching c"ause numbers an$ tit"es toachie'e a much higher $egree of consistency bet!een the t!o#

A$$itiona""y a set of eight qua"ity %rinci%"es has been $e'e"o%e$ by ISO5&C B to ser'e as the

necessary "inkage bet!een the base ,ISO 900/ an$ higher "e'e"s that are abo'e the base ,ISO

9001/#

Why ISO 9000:2000H

If one !ere to gather re%resentati'es on qua"ity !or"$!i$e from a"" ty%es of organiations an$

ha'e them $escribe a system to ensure qua"ity by %re'enting %ro$uct an$ ser'ice fai"ures an$ fie"$

reca""s the resu"t !ou"$ be ISO 900:2000# It encom%asses the requirements at the base of the

hierarchy of qua"ity nee$s#

=ike!ise if one !ere to gather re%resentati'es on qua"ity !or"$!i$e from a"" ty%es of organiations

an$ ha'e them $escribe a%%roaches to %ro'i$e for market%"ace success through efficient

o%erations an$ com%etiti'e a$'antage an equi'a"ent or an a%%ro(imation of ISO 9001:2000 !ou"$

emerge# It %ro'i$es gui$ance for a"" of those acti'ities of a qua"ity nature that nee$ to be

consi$ere$ abo'e the base#


32/89

&he first artic"e in this series ,October 999/ out"ine$ the technica" reasons for the changes

s%ecifie$ in the $esign $ocuments for the 2000 re'ision# &hese reasons inc"u$e$ the nee$ to

achie'e a consistent %air of qua"ity management system stan$ar$s33ISO 900:2000 an$ ISO

9001:2000# From a big %icture stan$%oint the ne! re'ision faci"itates ra%i$ an$ smooth %rogression

from base"ine qua"ity to %erformance e(ce""ence#

&o ensure qua"ity an$ market%"ace success a"" organiations nee$ to embrace both the

requirements !ithin ISO 900 an$ the %erformance im%ro'ement gui$ance !ithin ISO 9001#

&he ne(t artic"e is this series !i"" e(%"ain ho! these %rinci%"es an$ their a%%"ication are a""o!ing

fu"fi""ment of a tru"y unifie$ consistent %air of stan$ar$s#

DO&@S

&he *ua"ity


33/89

7any successfu" qua"ity %rograms starte$ !ith actions not a $efine$ %hi"oso%hy# Often the most

successfu" organiations act first an$ on"y "ater take the time to $efine the basis for their actions#

&he same has been true of the ISO 9000 fami"y of stan$ar$s# +ast e$itions of the ISO 9000

fami"y !ere %rimari"y base$ on %ractices i$eas an$ conce%ts that ha'e !orke$# &hese !ere

conso"i$ate$ into a co""ection of e"ements that !ere $eeme$ necessary for a qua"ity system by the

e(%erts from aroun$ the !or"$ !ho ser'e$ on &echnica" Committee ,&C/ B# &his %ragmatic

foun$ation has ser'e$ !e"" an$ the stan$ar$s ha'e become the most !i$e"y use$ in the

Internationa" Stan$ar$s Organiation)s ,ISO/ history#

&he ISO 9000:2000 re'ision continues to contain much of this %ragmatism# Sufficient time ha$e"a%se$ to make it feasib"e to state the %rinci%"es u%on !hich qua"ity management is rea""y base$#

Instea$ of being set out first !ith %ractice fo""o!ing the conce%ts an$ %rinci%"es of qua"ity

management in the re'ision ha'e e'o"'e$ from actua" %ractice#

4uring the mi$3990s ISO &C B estab"ishe$ a !orking grou% !ith the charter to research basic

qua"ity management %rinci%"es ,*7+s/ an$ $e'e"o% a brochure to e(%"ain them# &hat !ork resu"te$

in the i$entification of fun$amenta" %rinci%"es ,see the si$ebar -&he @ight *ua"ity 7anagement

+rinci%"es-/ !hich are inten$e$ to be the basis of the entire system#

Whi"e it is im%ortant to un$erstan$ an$ a%%"y the %rinci%"es in the $e'e"o%ment of qua"ity

management systems it is equa""y im%ortant to un$erstan$ that the %rinci%"es $o not contain

au$itab"e requirements#

&he $e'e"o%ment of the %rinci%"es !as a $ifficu"t task# &he !orking grou% assemb"e$ an$ re'ie!e$ a

'ast array of $ocuments on the subect of qua"ity systems inc"u$ing qua"ity a!ar$ criteria fromaroun$ the !or"$#

Attaining consensus on core *7+s require$ t!o internationa" ba""ots an$ consume$ a"most fi'e

years of !ork# &he resu"t !as a coherent set of %rinci%"es# ISO is e(%ecte$ to %ub"ish a brochure

on the %rinci%"es an$ their a%%"ication sometime in 2000#


34/89

&he %rinci%"es can "ea$ to qua"ity e(ce""ence for an organiation that is !i""ing to continuous"y focus

its efforts on fo""o!ing them# &his artic"e $escribes the re"ationshi% of the first four qua"ity

management %rinci%"es to the requirements $ocument ,ISO 900:2000/ an$ to the gui$e"ines of

ISO 9001:2000# +rinci%"es fi'e through eight !i"" be $iscusse$ in the 7arch issue#

+rinci%"e 33Customer Focuse$ Organiation

Organiations $e%en$ on their customers an$ therefore shou"$ un$erstan$ current an$ future

customer nee$s meet customer requirements an$ stri'e to e(cee$ customer e(%ectations#

.e"ationshi% to ISO 900:2000

E At the basic qua"ity management "e'e" the organiation)s focus shou"$ a$$ress not on"y the

contro" of $efine$ characteristics but a"so the un$erstan$ing of o'era"" customer nee$s# @'en a

qua"ity management system ,*7S/ containing minimum requirements ,such as an ISO 900

com%"iant *7S/ shou"$ focus on customer requirements throughout a"" %rocesses#

@(am%"es inc"u$e %rocesses for contract re'ie! ne! %ro$uct $esign an$ correcti'e action# An

intense focus on i$entifying customer requirements may be the sing"e biggest 'a"ue in a$o%ting ISO

900 as a mo$e" for the *7S for an organiation#

E A *7S ty%ica""y inc"u$es "inking customer com%"aint an$ returns %rocesses to $ata ana"ysis# &hese

%rocesses %ro'i$e the beginnings of a systematic means of un$erstan$ing customer fee$back in

or$er to %re'ent future %rob"ems from $e'e"o%ing#


E In re"ation to ISO 9001:2000 one can en'ision an organiation that has com%"ete kno!"e$ge of

its customers33their current an$ future nee$s an$ %erce%tions#


35/89

7any organiations c"aim to ha'e this kno!"e$ge33e'en !ith no qua"ity system at a""# &hey might

%oint to their sa"es or research an$ $e'e"o%ment $e%artments as ha'ing the customer insight

nee$e$ to un$erstan$ such things e'en !ithout interacting !ith customers ,the -fie"$ of $reams-

syn$rome/# For some organiations this is a$equate#

6ut in a tota" qua"ity management ,&*7/ en'ironment such kno!"e$ge is not ust consi$ere$ on an

in$i'i$ua" basis nor is it the %ur'ie! of on"y a fe! $e%artments# Information shou"$ instea$ be

co""ecte$ systematica""y throughout the organiation from many sources an$ integrate$ into a

%rocess that %ro'i$es a coherent an$ ba"ance$ 'ie! of customer an$ market%"ace nee$s an$ !ants#

E At the &*7 "e'e" sharing customer information an$ $ata is a"so %er'asi'e in the organiation#&here are %rocesses to $efine customer %erce%tions of organiationa" %erformance an$ $ri'e

market %erformance by affecting changes in customer %erce%tions of ho! !e"" their e(%ectations

are met#

E 8"timate"y the organiation is ab"e to ca%ture markets an$ create "oya"ty because of %referre$

%ro$ucts an$ ser'ices at attracti'e %rices !hi"e a$$ressing the requirements an$ nee$s of interna"

customers as !e""#

+rinci%"e 233=ea$ershi%

=ea$ers estab"ish unity of %ur%ose an$ $irection of the organiation# &hey shou"$ create an$

maintain the interna" en'ironment in !hich %eo%"e can become fu""y in'o"'e$ in achie'ing the

organiation)s obecti'es#


In any organiation there are "ea$ers at a"" "e'e"s# Certain"y to% management is res%onsib"e for

%ro'i$ing the 'ision an$ strategic $irection for a"" as%ects of the business inc"u$ing the 'ision for

qua"ity management an$ the *7S#


36/89

E For e'ery $imension of the *7S there shou"$ be a "ea$ershi% %resence assuring that a"" interna"

an$ e(terna" %rocesses are being structure$ an$ o%erate$ in a !ay that ma(imies interna"

%ro$ucti'ity an$ e(terna" customer satisfaction#


E In organiations using ISO 9001 to stri'e for e(ce""ence "ea$ershi% can become more %ersona"

!ith managers continua""y %ro'i$ing e(am%"es of beha'iors that faci"itate creation of high "e'e"s of

customer satisfaction#

E At this "e'e" the organiation)s "ea$ers treat qua"ity as a strategic issue# &arget setting an$

management re'ie! are ongoing acti'ities an$ "ea$ers fu""y integrate the qua"ity an$ human

resources %"ans of the organiation !ith strategic business %"ans#

+rinci%"e ;33In'o"'ement of +eo%"e

+eo%"e at a"" "e'e"s are the essence of an organiation an$ their fu"" in'o"'ement enab"es their

abi"ities to be use$ for the organiation)s benefit#


E A basic qua"ity management system assures that in$i'i$ua"s in'o"'e$ in !ork are fu""y qua"ifie$ an$

ca%ab"e of carrying out the %rocesses to !hich they are assigne$# &raining an$ %rocess qua"ification

ha'e been mastere$ by the organiation an$ are integra" e"ements of the *7S not anafterthought#

E +eo%"e are res%ecte$ for their abi"ity to contribute to im%ro'ement# @(am%"es inc"u$e $ynamic

%artici%ation in the correcti'e action %rocess an$ %artici%ation on teams to intro$uce ne! %ro$ucts

or %rocesses im%ro'e safety an$ con$uct other acti'ities#


37/89


E Organiations at this "e'e" ha'e mastere$ the art of fu""y engaging em%"oyees in their obs an$

acti'e"y in'o"'ing them in the im%ro'ement %rocess#

E &here is a %rocess for communication bet!een "ea$ershi% an$ a"" em%"oyees# &he "ea$ers focus on

achie'ing fu"" a"ignment bet!een the goa"s of the organiation an$ the %ersona" goa"s of in$i'i$ua"

em%"oyees#

Organiations at this "e'e" ten$ to share business $ata an$ information !ith a"" em%"oyees# &hey $o

this to make certain e'eryone has the same un$erstan$ing of goa"s targets an$ obecti'es#

+rinci%"e 133+rocess A%%roach

A $esire$ resu"t is achie'e$ more efficient"y !hen re"ate$ resources an$ acti'ities are manage$ as

a %rocess#

.e"ationshi% to 900:2000

A fun$amenta" $imension of 900:2000 is the a$o%tion of the %rocess a%%roach to a"" !ork

%erforme$ by an organiation# &he ne! %rocess mo$e" !ith its im%"ications about ho! to carry out

!ork un$er contro""e$ con$itions shou"$ be much easier to use than the o"$ mo$e" !as since it

re%resents the !ay most organiations rea""y o%erate33as a series of connecte$ in%uts an$ out%uts#

E When a basic qua"ity management system is %resent the organiation !i"" ha'e c"ear"y $efine$ the

%rocesses for $esigning %ro$ucing an$ $e"i'ering the %ro$uct or ser'ice# +rocesses for ensuring

that customer requirements are met !i"" ha'e been $efine$ an$ im%"emente$# Contro" of %ro$uct

an$ ser'ice qua"ity !i"" ha'e mo'e$ u%stream from contro" on"y of %rocess out%uts to contro" of the

%rocess itse"f#


38/89

E &he organiation shou"$ a"so ha'e the other %rocesses $iscusse$ in ISO 900 for such acti'ities

as correcti'e an$ %re'enti'e action au$its management re'ie!s an$ so on#


E In re"ation to ISO 9001:2000 an organiation is focuse$ on the o%timiation of resources in each%rocess# Its cu"ture says that the %rocesses can a"!ays be im%ro'e$ an$ acti'ity is %resent in the

organiation to make %"anne$ im%ro'ements#

E &he organiation !i"" be using %rocess measures e(tensi'e"y an$ there is c"ear un$erstan$ing of

%rocess %erformance# &he measures of %rocess out%uts are regu"ar"y corre"ate$ !ith measures

taken at key %oints in the %rocess to he"% i$entify actions nee$e$ to make these im%ro'ements#

*ua"ity management %rinci%"es fi'e through eight !i"" be $iscusse$ in the 7arch issue#

Foun$ation of the ISO 9000:2000 fami"y


=ast month !e $iscusse$ the first four of eight fun$amenta" qua"ity %rinci%"es i$entifie$ by ISO

&echnica" Committee ,&C/ B as the basis for the ISO 9000:2000 re'isions# &his month !e

continue !ith %rinci%"es fi'e through eight# ,A"" eight are %resente$ in the si$ebar/#

Whi"e these eight %rinci%"es $o not contain au$itab"e requirements it is im%ortant to un$erstan$

their re"ationshi% to the requirements of the 2000 re'isions to both ISO 900 an$ ISO 9001# &he

a%%"ication of the %rinci%"es can "ea$ to qua"ity e(ce""ence for an organiation#

+ast e$itions of the ISO 9000 fami"y !ere %rimari"y base$ on %ractices i$eas an$ conce%ts# &hese!ere conso"i$ate$ into a co""ection of %ragmatic e"ements by &C B an$ the ISO 9000:2000

re'ision continues to contain much of this %ragmatism#

+rinci%"e 33System A%%roach to 7anagement


39/89

I$entifying un$erstan$ing an$ managing a system of interre"ate$ %rocesses for a gi'en obecti'e

im%ro'e the organiation)s effecti'eness an$ efficiency#


E With the $e'e"o%ment of a basic qua"ity management system the organiation mo'es to integrate

the %rocesses for creating the %ro$uct or ser'ice !ith those %rocesses that 'erify that the

%ro$uct or ser'ice meets customer nee$s#

E At this "e'e" the em%hasis is on $e'e"o%ing a qua"ity management system that is suitab"e for the

organiation)s situation an$ effecti'e in assuring that customer requirements are met#

E &he cha""enge at this "e'e" is to create an effecti'e system !ith fu""y integrate$ %rocesses !hi"e

a'oi$ing unnee$e$ %a%er!ork an$ bureaucracy#

E At this "e'e" the %ur%ose of the qua"ity management system is to achie'e customer satisfaction#

Fu""y effecti'e systems at this "e'e" use measures of customer satisfaction a"ong !ith other $ata to

%erform $ay3to3$ay management an$ $ecision making# &he management re'ie! %rocess has mature$

an$ uses these $ata a"ong !ith au$it resu"ts to assess system effecti'eness#


E In re"ation to ISO 9001:2000 the organiation fu""y un$erstan$s an$ manages the interactions

among the 'arious %rocesses in the business# +rocesses are a"igne$ !ith each other an$ !ith thegoa"s of the organiation#

E At this "e'e" the organiation is focuse$ on achie'ing resu"ts by continua""y im%ro'ing the

management system# Whi"e achie'ing customer satisfaction remains a key $ri'er of business


40/89

success the organiation no! can use $ata on its %rocesses a"ong !ith customer fee$back for

strategic $ecision making an$ o'era"" business %"anning#

+rinci%"e 33Continua" Im%ro'ement

Continua" im%ro'ement shou"$ be a %ermanent obecti'e of the organiation#


E At this "e'e" there are mature an$ robust correcti'e action %rocesses an$ a %re'enti'e action%rocess is in %"ace#

E &he organiation is focuse$ on im%ro'ing the effecti'eness of the qua"ity management system

base$ on facts ,see %rinci%"e B/ obtaine$ from %er'asi'e measurement %rocesses ,in other !or$s

use of statistica" metho$s/#


E At this "e'e" "ea$ers are estab"ishing targets an$ goa"s base$ on key measures of customer

satisfaction an$ interna" %erformance# &here is a $ri'e to reach cha""enging im%ro'ement goa"s#

=ea$ers themse"'es are in'o"'e$ in the im%ro'ement %rocess an$ %ro'i$e resources to ensure

targets are met#

E &he organiation is focuse$ on efficient"y meeting future customer nee$s an$ on achie'ingbusiness resu"ts through the qua"ity management system#

+rinci%"e B33Factua" A%%roach to 4ecision 7aking


41/89

@ffecti'e $ecisions are base$ on the ana"ysis of $ata an$ information#


E Facts an$ $ata are use$ in the qua"ity management system to make $ecisions re"ate$ to the

system)s o%erations# &he information is gaine$ from ana"ysis of au$it resu"ts correcti'e actions

%rocess %erformance customer com%"aints an$ other sources#

E Ana"ysis ten$s to be focuse$ on $ata that can be use$ to im%ro'e customer satisfaction an$ the

efficiency an$ effecti'eness of the qua"ity management system#


E 4ecisions an$ actions are base$ on the ana"yses of a broa$ range of $ata# Customer $ata are

$eri'e$ by using a"" a'ai"ab"e "istening %osts to un$erstan$ !hat is im%ortant an$ make $ecisions

that !i"" im%ro'e the organiation)s market %osition# &echniques such as focus grou%s sur'eys an$

tracking stu$ies are routine"y use$ to obtain facts that !i"" assure un$erstan$ing of customer

nee$s an$ requirements#

E Information is $eri'e$ from ana"ysis of $ata an$ from the inno'ati'e i$eas of a"" members of the

organiation# &he focus is on im%ro'ing %ro$ucti'ity !hi"e e"iminating !aste an$ re!ork an$

enhancing market 'a"ue#

+rinci%"e 337utua""y 6eneficia" Su%%"ier .e"ationshi%s

An organiation an$ its su%%"iers are inter$e%en$ent an$ a mutua""y beneficia" re"ationshi%

enhances the abi"ity of both to create 'a"ue#



42/89

E With the $e'e"o%ment of a qua"ity management system an organiation !i"" ha'e $efine$

%rocesses an$ $ocument requirements su%%"iers must meet# &here !i"" a"so be %rocesses in %"ace to

re'ie! an$ e'a"uate su%%"iers) abi"ities to meet those requirements an$ assess the congruence of

organiation an$ su%%"ier obecti'es#


E &he focus ten$s to change as organiations estab"ish strategic a""iances or %artnershi%s !ith

su%%"iers# In many cases organiations in'o"'e su%%"iers 'ery ear"y in $efining requirements for

oint $e'e"o%ment an$ in broa$3base$ concurrent engineering#

E Organiations !ork !ith su%%"iers to $e'e"o% mutua" trust res%ect an$ commitment to customer

satisfaction# 7utua" efforts focusing on continua" im%ro'ement become the norm of o%eration for

both %arties#

E Integration of the su%%"ier qua"ity %rocess !ith other efforts re"ate$ to su%%"ier systems

becomes common#

.e"ationshi% of %rinci%"es an$ %rocess

In an ear"ier artic"e in this series a %rocess mo$e" !as intro$uce$# It shou"$ be c"ear ho!e'er

that there is a significant re"ationshi% bet!een an organiation)s %rocesses an$ %rinci%"es# In$ee$

t!o of the %rinci%"es %oint out that a"" !ork is best manage$ as a 'a"ue a$$ing %rocess an$ that the

qua"ity management system is rea""y a co""ection of %rocesses#

&he re"ationshi% of %rocesses to the %rinci%"e of customer focus shou"$ a"so be c"ear: @ach %rocess

has customers !ith requirements that must be un$erstoo$ an$ met as !e"" as su%%"iers !ho %ro'i$ein%uts to those %rocesses an$ are critica" to successfu" o%erations#

&he %eo%"e in an organiation shou"$ be using $ata an$ inno'ation to continua""y im%ro'e

%erformance# From beginning to en$ an organiation)s success is $ri'en by the "ea$ershi% of its

managers an$ em%"oyees as it im%"ements its !ork an$ a$$s 'a"ue through many interconnecte$

seria" an$ %ara""e" %rocesses#

Integration is the key

+erha%s the most im%ortant conce%t the %rinci%"es es%ouse is the notion of integration# &he o'era""

management system33its "ea$ers %rocesses $ata %eo%"e an$ su%%"iers33!orks best !hen fu""yintegrate$#

&he eight qua"ity management %rinci%"es !hen consistent"y a%%"ie$ across an organiation shou"$

en3gen$er o%tima" o'era"" %erformance !hich !i"" "ea$ to %erformance e(ce""ence far more

effecti'e"y than a series of in$i'i$ua""y o%timie$ acti'ities#


43/89

Why *S39000 Was 4e'e"o%e$ An$ What)s in Its Future

Auto su%%"iers !ere troub"e$ by mu"ti%"e s%ecifications an$ stan$ar$s

by .# 4an .ei$

&he question -Why *S39000H- is frequent"y aske$ by %eo%"e in'o"'e$ !ith stan$ar$s but outsi$e

of the auto in$ustry# Sur%rising"y it !as not a Chrys"er For$ or ?enera" 7otors i$ea# Actua""y the

automoti'e su%%"iers suggeste$ it an$ !hi"e automoti'e stan$ar$iation !ork began in 9 the

%rob"em a%%eare$ much ear"ier#

ears ago customers !ere c"oser to their su%%"iers# &hink back to the rura" genera" store# &he

customer cou"$ go to the %ro%rietor to %urchase or barter for goo$s# If the qua"ity of the goo$s

!as foun$ to be %oor the customer cou"$ return to the store an$ $ea" $irect"y !ith the %ro%rietor

to get satisfaction#

With the a$'ent of the In$ustria" Age the $istance bet!een customers an$ su%%"iers increase$#

As the %o%u"ation gre! ne! com%anies !ere forme$ an$ fitte$ into materia" su%%"y chains# It

became $ifficu"t for com%anies to obtain !hat is ca""e$ the -'oice of the customer#-

As an interim ste% su%%"iers !orke$ to a s%ecification# As s%ecifications mu"ti%"ie$ termino"ogy

became $ifficu"t to un$erstan$# &here !ere mu"ti%"e terms !ith the same meaning an$ terms that

ha$ mu"ti%"e meanings# O'er time mu"ti%"e s%ecifications "e$ to stan$ar$s $e'e"o%ment#

6y the mi$390s su%%"iers !ere subect to numerous mi"itary nationa" an$ customer stan$ar$s#

Some com%anies $e$icate$ fu""3time em%"oyees to each customer account ust to un$erstan$ the

'arying qua"ity requirements#

Situation !orse for &ier &!o su%%"iers


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For &ier &!o su%%"iers33those !ho se"" to a tier one su%%"ier33the situation !as !orse# &hey !ere

subect to numerous unique &ier One su%%"ier qua"ity stan$ar$s !hich incor%orate$ their o!n

stan$ar$s !ith those of the fina" customer# In a$$ition these &ier &!o su%%"iers ty%ica""y ha'e

fe!er resources !ith !hich to $ea" !ith the 'ariation than &ier One su%%"iers ha'e#

6y 9B the ISO 9000 fami"y of qua"ity management system stan$ar$s !as re"ease$# &he use of

ISO 9000 %romote$ the use of consistent qua"ity termino"ogy internationa""y an$ resu"te$ in

significant harmoniation# &he stan$ar$s !ere s"o! to take root in the 8nite$ States ho!e'er#

Chrys"er For$ an$ ?7 e"ecte$ to use the ISO 900 stan$ar$ as the base requirements for the

automoti'e sector $ocument ca""e$ *S39000# &his ha%%ene$ main"y because there !as a !i$es%rea$

rumor that com%anies !ou"$ ha'e to be ISO 9000 certifie$ by the mi$3990s in or$er to $o

business in @uro%e#

Whi"e nothing in ISO 9000 !as obectionab"e to the 6ig &hree automakers it "acke$ some

e"ements that !ere in automoti'e in$ustry $ocuments at that time such as business %"ans customer

satisfaction continuous im%ro'ement manufacturing ca%abi"ities an$ much of the a$'ance$ qua"ity

%"anning content#

&o$ay there are a number of sector3s%ecific ISO 9000 base$ qua"ity system stan$ar$s or

requirements for e(am%"e AS9000 an$ the ne! AS900 ,aeros%ace/ an$ &= 9000

,te"ecommunications/#


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&his 99 sur'ey a"so corre"ate$ great"y !ith the 99B 'ersion of the same sur'ey !hich ha$ o'er

00 res%on$ents#2 &hat sur'ey in$icate$ a ;3to3 return on tota" costs an$ a"most B3to3 return on

the certification bo$y costs# &he qua"ity benefits in terms of %arts %er mi""ion ,++7/ $efects

in$icate$ that about ha"f the su%%"iers im%ro'e$ their ++7 by about 0G#

&his is in contrast to the benefits of ISO 9000# In a 999 7c?ra!


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Automoti'e in$ustry re%resentati'es !ere in'ite$ to %artici%ate in the ISO 9000 re'ision for the

year 2000 to see if ISO 9000 cou"$ incor%orate enough a$$itiona" content to a'oi$ the nee$ for

sector s%ecific a$$itions#


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ins%ection#- &hese are %articu"ar"y e'i$ent in $ocuments !ithin the same %ro$uct category#


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A recent e(am%"e of this focus on the customer is American Air"ines !hich announce$ it !ou"$

re'ise current aircraft to %ro'i$e a$$itiona" "egroom for %assenger comfort#

.@F@.@DC@S

# 99 Annua" *ua"ity Sur'ey .e%ort ,Southfie"$ 7I: Automoti'e In$ustry Action ?rou% KAIA?L99/#

2# -99B AIA?5AS* *ua"ity Sur'ey .esu"ts- %resente$ at the 99B *ua"ity Sur'ey Worksho%

7arch B in Do'i 7I#

;# ISO 9000 Sur'ey )99: An Ana"ytica" &oo" &o Assess the Costs 6enefits an$ Sa'ings of ISO

9000 .egistration %re%are$ by *ua"ity Systems 8%$ate an$ +"e(us Cor%# ,De! ork: 7c?ra!3


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As the mi"itary DASA an$ the entire aeros%ace in$ustry began to "ook for cost sa'ings one of the

first an$ most "ogica" ste%s !as the e"imination of $ua" or re$un$ant qua"ity systems an$ the

a$o%tion of a sing"e %rocess for qua"ity assurance#

In the ear"y )90s the 4e%artment of 4efense ,4o4/ hea$ of acquisition ca""e$ for a sing"e %rocess

initiati'e an$ aske$ 4o4 %rocurement officers to $ro% as many contract s%ecific requirements as

%ossib"e an$ a$o%t commercia" %ractices instea$# Since there !as no other rea$i"y a'ai"ab"e

stan$ar$ in %"ace at the time ISO 900:9B ,an$ subsequent"y 991/ !as easi"y acce%te$ as the

commercia" equi'a"ent qua"ity system#

Another thing that ma$e the ISO 9000 series of stan$ar$s a%%ea"ing !as the gro!ing su%%"ier

base# As %ro$ucts gre! in com%"e(ity the nee$ for cost containment an$ re$uction became more

%re'a"ent# An increasing amount of the O@7)s !ork !as contracte$ out so the maor O@7s !ere

"ooking for a sim%"e cost effecti'e too" to contro" qua"ity in the aeros%ace su%%"ier community#

Whi"e an e(ce""ent mo$e" for a qua"ity system ISO 900 ,an$ ISO 9002/ is minima"ist an$ neither

fu"fi""s a"" the nee$s of the in$ustry nor co'ers the regu"atory requirements# So it ha$ to be

su%%"emente$# Su%%"ementa" requirements !ere easi"y !ritten into the qua"ity %rograms of the

O@7s but they sti"" cause$ %ro"iferation of f"o! $o!n requirements to the su%%"ier base# &his !as

es%ecia""y true in commercia" a'iation !here the Fe$era" A'iation A$ministration ,FAA/ sees the

su%%"ier community as an e(tension of the %rime manufacturer#

4e'e"o%ment of an aeros%ace in$ustry stan$ar$

&he %rob"em of $u%"icati'e an$ contra$ictory requirements !as "ong recognie$ by the aeros%ace

in$ustry an$ se'era" attem%ts !ere ma$e a"ong the !ay to fin$ a satisfactory so"ution#

8#S# aeros%ace com%anies "earne$ the har$ "esson that %ro$uct an$ ser'ice qua"ity as a $eterminant

in customer se"ection is no! on %ar !ith %rice $e"i'ery an$ %erformance# &he %rob"em !ith f"o!

$o!n requirements an$ mu"ti%"e au$its ha$ not $iminishe$ in the su%%"ier community# With the high

costs of $esign an$ $e'e"o%ment an$ the %re'a"ence of oint %artnershi%s most com%anies are both

su%%"iers an$ customers to each other as !e"" as to their 'ast su%%"ier net!orks#


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In 99 se'era" maor aeros%ace manufacturers recogniing the nee$ for uniform su%%"ier

requirements came together un$er the umbre""a of AS* an$ create$ the American Aeros%ace

*ua"ity ?rou% ,AA*?/# AA*?)s origina" aim !as to %rocure higher qua"ity an$ "o!er cost materia"s

an$ ser'ices faster an$ more re"iab"y from a stab"e "ong3term su%%"ier base# &he first effort !as inthe same area !here other in$ustries such as automoti'e ha$ a"rea$y ma$e significant %rogress33

%rocess 'ariation re$uction# One area of 'ariation re$uction targete$ by the AA*? !as the

mu"ti%"e qua"ity system requirements an$ s%ecifications im%ose$ on the aeros%ace su%%"ier

community#

&he AA*? first $iscusse$ the use of ISO 900 as a stan$a"one $ocument# 4iscussions !ith the

automoti'e in$ustry about the creation an$ use of *S39000 firm"y %"ante$ the conce%t that an ISO

900 base$ $ocument tai"ore$ for aeros%ace !as $oab"e#

&he first %ro$uct of this attem%t at an in$ustry stan$ar$ !as %ub"ishe$ by the Society of

Automoti'e @ngineers ,SA@/ in October 99 as A.4 9000# Subsequent to this interim %ub"ication

some changes occurre$ !ithin the AA*? not the "east of !hich !as that the grou% "eft the

umbre""a of AS* an$ became an SA@ Aeros%ace Counci" subcommittee# &he AA*? began to see its

mission as creating requirements an$ so"utions an$ bringing homogeneity to the qua"ity si$e of the

in$ustry# .efinement of the A.4 9000 $ocument "e$ to a fina" re"ease of a stan$ar$ ca""e$ AS9000

in 7ay of 99B#

Why is an aeros%ace stan$ar$ necessaryH Some 'ery key conce%ts33not the "east of !hich are safe

re"iab"e an$ maintainab"e %ro$ucts33are missing from ISO 900# Aeros%ace in$ustry customers

,air"ines 4o4 a'iation %ub"ic DASA an$ others/ e(%ect an$ $eman$ that qua"ity systems em%"oye$

by manufacturers assure that %ro$ucts are safe an$ re"iab"e %erform as inten$e$ an$ o%erate

norma""y !hen maintaine$ in accor$ance !ith the requirements of the manufacturer#

Another ca'eat is the recognition that in matters %ertaining to ci'i" a'iation the FAA an$ ci'i"

a'iation authorities of other countries ha'e the fina" say on acce%tab"e %ractices an$ %roce$ures

$uring the $esign $e'e"o%ment manufacture assemb"y an$ testing of ci'i" aeros%ace %ro$ucts#


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AS9000 focuses on areas that are im%ortant to the aeros%ace in$ustry# It recognies the

re"ationshi%s an$ requirements of the regu"atory agencies# It recognies that the su%%"ier

community is an e(tension of its o!n %rocesses an$ %roce$ures an$ therefore must be tight"y

contro""e$ to re$uce 'ariation# It focuses on %rocesses !hose sensiti'ity can ha'e e(treme

consequences to the %ro$uct)s safety re"iabi"ity an$ %erformance# AS9000 a$$e$ ; ne!

requirements in the areas of:

1#233*ua"ity system an$ %"anning#

1#334ocument an$ $ata contro"#

1#33+rocurement#

1#933+rocess contro"#

1#;33Contro" of nonconforming materia"#

Some unique items inc"u$e the requirement for foreign obect $amage contro"33one of the most

%re'a"ent an$ %otentia""y $ea$"y %rob"ems in the in$ustry# It %uts em%hasis on the com%"ete su%%"y

chain for any errors may ha'e $isastrous effects# It %uts em%hasis on the contro" of %rocesses an$

%rocess %"anning33not ust the %rocess itse"f but the too"ing equi%ment soft!are an$ %eo%"e

in'o"'e$# Any 'ariations from the s%ecifie$ requirements can bui"$ in "atent $efects that cannot be

to"erate$ in ser'ice# Fina""y it increases $ocumentation of resu"ts requirements since many times at

the en$ of the $ay the on"y e'i$ence that %rocesses !ere correct"y %erforme$ is the $ocumente$

e'i$ence create$ !hi"e the !ork !as being %erforme$#

7aking the stan$ar$ g"oba"

Whi"e satisfie$ !ith the resu"t of AS9000 the AA*? recognie$ that a"" the O@7s o%erate

g"oba""y so it !as necessary to inc"u$e the !or"$!i$e aeros%ace su%%"ier community# &o this en$


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ISO &C B ,the Internationa" Organiation for Stan$ar$iation technica" committee for qua"ity

system stan$ar$s/ an$ other sectors !ere a%%roache$ about sector s%ecific stan$ar$s# &he

%ro%osa" for an internationa" stan$ar$ !as reecte$ at the time an$ tab"e$ for further stu$y#

In 99 ISO &C 20 ,aeros%ace/ agree$ to s%onsor Working ?rou% ,W?/ to create an ISO

technica" %a%er for qua"ity system requirements using AS9000 as a basis a"ong !ith a corres%on$ing

@uro%ean $ocument ca""e$ %r@D 90003#

W? inc"u$e$ the 8nite$ States Cana$a 6rai" 7e(ico @ng"an$ S%ain France ?ermany China

Ja%an an$ others# A"" recognie$ the nee$ for a s%ecific in$ustry stan$ar$# &here !as one maor

%rob"em: If %ub"ishe$ by ISO &C 20 the stan$ar$ !ou"$ take a$$itiona" time an$ !ou"$ "ose its

9000 number as $i$ the simi"ar effort by the automoti'e in$ustry ,ISO5&S 919 the

internationa" 'ersion of *S39000/#

So the $ecision !as ma$e to ha'e the harmonie$ $ocument sti"" base$ on the @ng"ish 'ersion of

ISO 900:991 %ub"ishe$ by each in$i'i$ua" country)s aeros%ace association or stan$ar$s bo$y# In

the 8#S# the harmonie$ stan$ar$ is an SA@ $ocument AS900#2 In @uro%e it is A@C7A @D900

an$ in Ja%an it is SJAC900# Others are yet to come as 900 numbere$ $ocuments#


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1#1##334ocumentation of $esign 'erification an$ 'a"i$ation#

1#1##2334esign 'erification an$ 'a"i$ation testing#

1#9##33+ro$uction $ocumentation#

1#9##233Contro" of %ro$uction %rocess changes#

1#9##;33Contro" of %ro$uction equi%ment too"s an$ numerica" contro" %rograms#

1#0#33First artic"e ins%ection#

&he creation of this $ocument has a"so ha$ other $esirab"e effects# It has he"%e$ s%a!n the

creation of the Internationa" Aeros%ace *ua"ity ?rou% ,IA*?/ a !or"$!i$e association of

aeros%ace com%anies#

6eyon$ a qua"ity system stan$ar$

&he creation of IA*? "e$ to other !or"$!i$e 'ariation re$uction %roects# &hese inc"u$e:

# Common questionnaires for an au$it on the 900 series of stan$ar$s#

2# Common or simi"ar certification %rocesses for the 900 requirements by registrars#

;# *ua"ity system stan$ar$ for the re%air an$ o'erhau" of aeros%ace %ro$ucts#

1# *ua"ity system stan$ar$ for $istributors#

# Common nonconformance $ocumentation#


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# Common first artic"e ins%ection %rocess#

B# Common %rocess a%%ro'a" requirements ,simi"ar to %ro$uction %art a%%ro'a" requirements or

++A+ in automoti'e/#

&hese an$ many other %roects are a"" aime$ at getting the su%%"y chain focuse$ on the qua"ity of%rocesses re$uction of 'ariations an$ increase$ re"iabi"ity an$ safety of %ro$ucts#

&he future

Since most of the recent !ork !as base$ on ISO 900:991 another committee has been forme$

!ithin the IA*? to u%$ate the 900 $ocument to coinci$e !ith the ISO 900:2000 re'isions# &he

e(%ectation is that the ne! IA*? $ocument !i"" "ag the re"ease of the ISO 900:2000 'ersion by

about 2 months an$ !i"" attem%t to conso"i$ate some of the s%ecific a$$itions#

&here are %rob"ems !ith the %ro%ose$ year 2000 'ersion of the ISO 900 stan$ar$ for the

aeros%ace in$ustry# &he conso"i$ation of e"ements in the stan$ar$ e"iminate$ s%ecific "anguage$eeme$ beneficia" in $escribing requirements# Areas such as qua"ity %"anning %rocess contro"

measuring an$ test equi%ment an$ ins%ection ha'e been change$ enough that !e ha'e some !ork to

$o to $eci$e the best !ay to make the in$ustry e(%ectations c"ear#


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by 7ari"yn .# 6"ock

4es%ite o'er!he"ming simi"arities bet!een ISO 100 @n'ironmenta" 7anagement Systems33

S%ecification With ?ui$ance for 8se an$ ISO 900 base$ qua"ity systems the 'ast maority ofqua"ity assurance managers are as unfami"iar !ith ISO 100 to$ay as !hen it !as %ub"ishe$ in

99#

&he current ISO 900 re'ision effort !ith its focus on com%atibi"ity bet!een the t!o stan$ar$s

e(acerbates the mis%erce%tion that im%"ementing ISO 100 !ithin a qua"ity registere$ com%any is

$ifficu"t at best# With %ub"ication of ISO 900:2000 antici%ate$ short"y an o'er'ie! of the

simi"arities bet!een the t!o stan$ar$s is !arrante$#

&he numbere$ e"ements containe$ in ISO 100 are "oose"y organie$ to ref"ect %"anning

im%"ementation an$ e'a"uation acti'ities# &he greatest $ifferences bet!een ISO 100 an$ ISO

900 are foun$ in the area of %"anning# Im%"ementation an$ e'a"uation requirements are a"most

i$entica"#

Among the fi'e en'ironmenta" management system ,@7S/ %"anning e"ements ISO 100 requires

i$entification of en'ironmenta" as%ects an$ e'a"uation of their im%acts# Sim%"y state$ an as%ect is

any e"ement of an organiation)s acti'ities that can interact !ith the en'ironment#

&ake %aint as an e(am%"e of an as%ect# An en'ironmenta" im%act !ou"$ be a change to the

en'ironment that resu"ts from an as%ect33for e(am%"e emission of 'o"ati"e organic com%oun$s into

the air or "an$ or groun$!ater contamination resu"ting from $is%osa" of use$ %aint containers in a

"an$fi""#

.emarkab"e simi"arities

&here is no com%arab"e requirement in ISO 900 ho!e'er once en'ironmenta" as%ects an$ im%acts

are i$entifie$ remaining %"anning e"ements are remarkab"y simi"ar# ISO 100 requires $e'e"o%ment

of an en'ironmenta" %o"icy statement ust as ISO 900 man$ates a qua"ity %o"icy statement#


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ISO 100 a"so requires the articu"ation of en'ironmenta" obecti'es an$ targets an$ estab"ishment

of a forma" %rogram to achie'e them# &hese acti'ities are simi"ar to the qua"ity %"anning com%onent

in ISO 900#

Fina""y ISO 100 %"anning efforts require that an organiation is kno!"e$geab"e about its

en'ironmenta" "ega" ob"igations# ISO 900:991 $oes not $irect"y a$$ress this issue ho!e'er it is

in$irect"y a$$resse$ un$er %rocess contro" !hich $oes require com%"iance !ith reference

stan$ar

Quality Excerpts 2000

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