Quality Excerpts 2001

8/9/2019 Quality Excerpts 2001

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5ere is a blow3by3blow a$$ount of what was un$overed durin" a *uality system review of &I! )arts

6ana"ement res#onsibility

+ll the ri"ht words were in the #ro$edures' and the $om#any does have a *uality #oli$y #ra$ti$ally

tattooed on ea$h em#loyee The *uality mana"er hun" $harts on the wall with $are

&ut the *uality #ersonnel worked for the fun$tional or"ani,ations' and no one was $learly

res#onsible for solvin" *uality #roblems involvin" either the systems or the #rodu$ts + $ertified

o#erator #ro"ram was in effe$t' but there was no way for the o#erators to initiate $orre$tive

a$tion or have the or"ani,ational freedom to #revent non$onformities

This resulted in #ro$esses that were not $a#able and in re#eated non$onforman$es 7o a$tions

were taken to $orre$t the #roblems8 instead' there were $ontinual material review board a$tions

uality system

)ro$edures were written around ISO 9001 re*uirements' but #ersonnel did not know what the

#ro$edures said and were never trained on how the #ro$edures should be a##lied

6anufa$turin" en"ineers' who were never trained on su$h thin"s as "a"e a$$ura$y' "a"e

re#eatability and re#rodu$ibility' or ins#e$tion methods' were used to #erform the *uality #lannin"

This resulted in o#erators usin" "a"es that were not suited for the re*uired a$$ura$y or' in many

$ases' usin" un#roven .althou"h $alibrated/ "a"es for the features bein" ins#e$ted

Contra$t review

Contra$t review was handled by the #ro"ram mana"ement #art of the or"ani,ation hen the#ro"ram transitioned from the develo#ment #hase to #rodu$tion' there was no review of the

#rodu$tion $ontra$t by the *uality or #rodu$tion or"ani,ations

Conse*uently' &I! )arts missed all the $ustomer flowdown su##lier $ontrol issues and #rodu$tion

ins#e$tion re*uirements su$h as sam#lin" #lans and "a"e verifi$ations #rior to #rodu$tion In several

$ases state3of3the3art ins#e$tion methods were bein" used' but the risks asso$iated with their use

were not evaluated with res#e$t to #rodu$t a$$e#tan$e

Desi"n $ontrol

The $ustomer su##lied $om#uter models re"ardin" what the desi"n #arameters should be These

models were translated into numeri$al $ontrol .7C/ and $oordinate measurin" ma$hine .C66/

#ro"rams

hen it $ame time to verify whether the #arts and details met the en"ineerin" re*uirements'

there was no definitive a"reement between the $ustomer and &I! )arts on how the items should be


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measured .In other words' there were no $om#lete drawin" definitions or $om#lete dimensions to

use to verify if the #arts met the desi"n intent/

Do$ument and data $ontrol

hile there was ade*uate do$ument and data $ontrol' the #ro$edures were all maintained online'and only $ertain #ersonnel had a$$ess to the $om#uters

6ost #ersonnel were not trained or even knowled"eable about how to a$$ess the #ro$edures or

lo$ate the ones a##li$able to their :obs This resulted in most tasks bein" #erformed by usin" the

%tribal le"end% method33or worse' by usin" any method that made sense at the time

)ur$hasin"

hile the sele$tion and a##roval of su##liers were ade*uate' $ustomer s#e$ifi$ations and essential

te$hni$al information were not re*uired to be flowed down to subtier su##liers' and the subtier

su##liers were not $ontrolled in any fashion

+lso there was no system to indi$ate what ha##ened when su##lier #erforman$e be"an to fall and

at what fre*uen$y the reviews should be #erformed before there was a need to obtain $orre$tive

a$tion or re#la$e the su##lier This resulted in su##liers that missed te$hni$al re*uirements and

re$ei#t of a lar"e amount of non$om#liant #rodu$t

Customer su##lied #rodu$t

The $ustomer had dire$ted the use of $ertain raw material su##liers by &I! )arts be$ause these

su##liers were known to have #ro#er $ontrols in the $riti$al manufa$turin" #ro$esses

This led &I! )arts to believe that no oversi"ht of these su##liers was ne$essary hile test

re#orts from these su##liers showed that the material was within s#e$ifi$ation' &I! )arts

#erformed no inde#endent verifi$ation or evaluation of the material This resulted in failed #rodu$t

and ar"uments with the $ustomer over res#onsibility

)rodu$t identifi$ation and tra$eability

hile there were #ro$edures and #ro$esses in #la$e to tra$e $riti$al #arts and assure #ro#er

identifi$ation' individual items were not tra$eable to s#e$ifi$ #ro$esses or ins#e$tions This

#re$luded assuran$e that the #rodu$t met all of its re*uirements ;ikewise' the #rodu$t $ould notbe tra$ed to #ro$esses that were later determined to be non$om#liant

)ro$ess $ontrol

&I! )arts had an effe$tive #ro$ess do$umentation system' in$ludin" sho# travelers' a##ro#riate

o#erator si"n3off and ins#e$tion verifi$ations 5owever' when $han"es were made to the #ro$ess or

workarounds were re*uired' there was no $ontrol of these alternative methods or verifi$ation that


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the #ro$ess $han"es a$hieved the same level of *uality that the ori"inal #ro$ess #ossessed +lso 7C

ma$hines and C66 #ro"rams were not $ontrolled or #roven to meet desi"n intent

Ins#e$tion and testin"

Ins#e$tion #lans were in #la$e' and #ro#er ins#e$tion #oints were available 5owever' sam#lin"ins#e$tion was only utili,ed u#on initiation of #art manufa$ture There was no eviden$e that the

#ro$ess was $a#able or that $riti$al $hara$teristi$s were ade*uately $ontrolled before statisti$al

sam#lin" be"an

Control of ins#e$tion' measurin" and test e*ui#ment

hile a robust $alibration and re$all system was in #la$e' there was no verifi$ation of the

measurement software used in some of the advan$ed measurement e*ui#ment

Ins#e$tion and test status

&I! )arts4 em#loyees were all assi"ned stam#s' and there was effe$tive stam# $ontrol 5owever'

there was no eviden$e that the stam#s were used to #re$lude #rodu$t that had not been stam#ed

a##ro#riately

Control of non$onformin" #rodu$t

hile non$onformin" #rodu$t dis$overed internally was se"re"ated and reviewed' there was no

$ontrol over sus#e$t #rodu$t returned from the $ustomer There was also no me$hanism for

re#ortin" to the $ustomer those non$onforman$es that mi"ht have already left the *uality system

Corre$tive a$tion

&I! )arts #rided itself on the thorou"hness of the $orre$tive a$tion #ro$ess it em#loyed One

small #roblem was that this same #ro$ess was not $arried throu"h the su##ly $hain to assure

su##lier $orre$tive and #reventive a$tion

5andlin"' stora"e and delivery

The #ro$edures for handlin" the #arts and shi##in" them were ade*uate' but there were no

$ontrols to assure that the #arts were #ro#erly $leaned' that forei"n ob:e$ts were removed to

#revent blo$ked oil #assa"es' or that the do$umentation that a$$om#anied the shi#ment was not

lost or destroyed

Control of *uality re$ords

7o #roblems were found in this area

Internal *uality audits


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The more we try to make re*uirements "eneri$' the more we need to make sure that the

inter#retations of the re*uirements fit the a##li$ation

?>@>?>7C>

1 +S9100 uality Systems33+eros#a$e336odel for uality +ssuran$e in Desi"n' Develo#ment')rodu$tion' Installation and Servi$in" .arren3dale' )+A So$iety of +utomotive >n"ineers

In$' 1999/

ISO 1B001 +nd ?e"ulatory Com#lian$e

Three ma:or re*uirements must be addressed

by 6arilyn ? &lo$k

6any $om#anies with environmental mana"ement systems .>6S/ also have re"istered *uality

mana"ement systems .6S/ @re*uently' the *uality system re#resentative is desi"nated as the

>6S re#resentative be$ause he or she is knowled"eable about systems

This dual role is almost always true when the 6S and >6S have been inte"rated8 and it is more

ty#i$al than not even when the two systems are established as se#arate' #arallel efforts

uality assuran$e mana"ers attem#tin" to understand the re*uirements of ISO 1B001 often are

$onfused about the referen$es to re"ulatory $om#lian$e ;imited or no #revious ex#osure to

environmental re"ulatory re*uirements leads to *uestions $on$ernin" the role ISO 1B001 #lays in

assurin" re"ulatory $om#lian$e

Three related re*uirements

ISO 1B001 im#oses three related re*uirementsA


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1 +n or"ani,ation must identify all of its environmental le"al obli"ations and be familiar with all

a##li$able environmental laws and re"ulations +dditionally' the or"ani,ation must have some

me$hanism for ensurin" that new le"al obli"ations are identified in a timely fashion

2 The environmental #oli$y must $ontain a $ommitment to understand and $om#ly with all a##li$able

environmental laws and re"ulations ords on #a#er aren4t suffi$ient8 an or"ani,ation must make

every effort to fulfill its $ommitment to do what it says it is "oin" to do

Com#lian$e with identified le"al re*uirements must be evaluated on some self3defined #eriodi$

basis hether an or"ani,ation en"a"es in a $om#rehensive $om#lian$e audit or em#loys a variety of

monitorin" a$tivities' it must know whether all identified le"al re*uirements are bein" met In the

event a re"ulatory non$om#lian$e is identified' the or"ani,ation must take a$tion to $orre$t the

non$om#lian$e and #revent it from re$urrin"

These re*uirements do not im#ose s#e$ifi$ #erforman$e standards on or"ani,ations The

international s$o#e of ISO 1B001' $ou#led with differin" national laws and enfor$ement #oli$ies'

makes it im#ossible to establish a$$e#table #arameters for air emissions' water dis$har"es and

other similar environmental im#a$ts Instead' individual or"ani,ations must a##roa$h these

re*uirements within the $ontext im#osed by national' state or #rovin$ial' and lo$al laws

-S re"ulatory a"en$ies and re"istrars have somewhat different ex#e$tations about the ways in

whi$h a $om#any addresses these three re*uirements

The re"ulatory view

7ot sur#risin"ly' many in the re"ulatory $ommunity and non"overnmental environmental

or"ani,ations *uestion whether ISO 1B001 $ontains suffi$ient em#hasis on re"ulatory $om#lian$e

In order to determine whether ISO 1B001 re"istration results in im#roved re"ulatory $om#lian$e'several efforts were laun$hed shortly after #ubli$ation of the standard in Se#tember 199

The most visible of these efforts is the 6ulti3State orkin" !rou# .6S!/' an or"ani,ation of

state environmental a"en$ies formed in 199 in res#onse to "rowin" state interest in ISO 1B001

and the #otential for environmental enfor$ement flexibility and other state initiatives


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&y 199E' the 6S! had evolved from an informal workin" meetin" to a formal networkin"

or"ani,ation with ele$ted offi$ers One of the "rou#4s ob:e$tives is to enhan$e ISO 1B001

re"ardin" the relationshi# of the >6S to re"ulatory $om#lian$e and #erforman$e re"ardin" all

si"nifi$ant environmental as#e$ts

There does not a##ear to be a $lear $onsensus amon" 6S! members as to the value of ISO

1B001 In a 199E interview' ?obert Ste#hens' 6S! $hair' stated that 6S! %is firmly

$ommitted to the voluntary nature of the ISO 1B001 standard and that this voluntary nature is not

in $onfli$t with the #ubli$ #oli$y "oals Fthe 6S!G is #ursuin"%1 That same month' a 6S!

member su""ested that the lan"ua"e in ISO 1B001 is so loose that it undermines the $redibility of

the standard2

To assist in resolvin" *uestions related to im#lementation of ISO 1B001 and re"ulatory $om#lian$e'

the 6S! laun$hed a resear$h #ro:e$t that same year Information on the effe$t that an >6S has

on re"ulatory $om#lian$e was to be $olle$ted from #ilot #ro:e$ts in a number of states and

or"ani,ed into a database

+t the end of 2000' resear$hers $on$luded that the national database $ould not #rovide any

insi"ht into whether $om#anies with an >6S have hi"her levels of re"ulatory $om#lian$e It shouldbe noted that this #ro:e$t is on"oin" and may #rovide su$h information at some future date

The re"istrars4 #ers#e$tive

>ven thou"h 6S! thinks the :ury is still out' ISO 1B001 re"istrars believe they have attained a

verdi$t &ased on data $olle$ted durin" re"istration audits' many ISO 1B001 >6S lead auditors are

$onvin$ed that an >6S does' in fa$t' im#rove re"ulatory $om#lian$e

In their efforts to address the re*uirement to identify le"al re*uirements' many or"ani,ations

learn about re"ulations with whi$h they were #reviously unfamiliar and with whi$h they should have

been $om#lyin" This in$reased level of awareness $auses su$h or"ani,ations to be$ome $om#liant in

areas #reviously i"nored


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be linked to $lause B2' whi$h re*uires in$lusion in the environmental #oli$y of a $ommitment to

$om#lian$e

hen asked to distin"uish between systemi$ failure and isolated #roblems' 5ansa offered thefollowin"A %If the >6S fails to identify or res#ond a##ro#riately to an isolated non$om#lian$e' the

system non$onforman$e #robably would be $onsidered 4minor4 5owever' if the >6S $onsistently

fails to identify or ade*uately address re"ulatory non$om#lian$es' a total breakdown of the

a##ro#riate element of the mana"ement system would be $ited and would likely be $ate"ori,ed as a

4ma:or4 non$onforman$e%

5ow often are su$h non$onforman$es written= %Seldom'% says 5ansa %e find that our $lient

or"ani,ations are indeed $ommitted to #rote$tin" the environment and re"ulatory $om#lian$e The

stru$ture and voluntary nature of their ISO 1B001 #ro"rams allow them to #roa$tively be$ome

familiar with their le"al obli"ations and address any issues without mu$h of the fear and #ain

histori$ally asso$iated with these issues%

Con$lusion

Durin" the draftin" of ISO 1B001 from 199 to 199' referen$e to re"ulatory $om#lian$e was the

fo$us of mu$h debate amon" members of the -S te$hni$al advisory "rou# .T+!/ $har"ed with

establishin" the offi$ial -S #osition on the environmental mana"ement system standard

The ISO mandated five3year review #ro$ess has #rovided an o##ortunity to a"ain $onsider whether

ISO 1B001 ade*uately addresses this issue 5owever' the de$ision by ISO Te$hni$al Committee

20H not to in$lude any new re*uirements in the ISO 1B001 revision' s$heduled for #ubli$ation in late

2001' rendered this debate moot

It is fair to state that the T+! remains somewhat s#lit on whether ISO 1B001 re*uires additional

lan"ua"e on this #oint Those T+! members re#resentin" federal and state re"ulatory a"en$ies and

non"overnmental environmental or"ani,ations tend to favor more strin"ent lan"ua"e and' therefore'more #res$ri#tive re*uirements about re"ulatory $om#lian$e by those who seek ISO 1B001

re"istration T+! #arti$i#ants from various industry se$tors tend to su##ort $urrent lan"ua"e

#ertainin" to re"ulatory $om#lian$e and resist more strin"ent re*uirements

+dditional lan"ua"e would a##ear to be su#erfluous +ny or"ani,ation in the -nited States is

obli"ated to identify' understand and $om#ly with a##li$able environmental laws and re"ulations The


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de$ision to im#lement ISO 1B001 does not $han"e that obli"ation8 in fa$t' it tends to im#rove an

or"ani,ation4s environmental #erforman$e

The Challen"es T; 9000 ?e*uirements

7ew inter#retations' la$k of ob:e$tive eviden$e $an $ause diffi$ulties

by Sandford ;iebesman

T; 9000' the tele$ommuni$ations *uality mana"ement system standard' #resents several auditin"$hallen"es + derivative of ISO 9000' T; 9000 is defined in two handbooksA a re*uirements

handbook $alled &ook 11 and a metri$s handbook $alled &ook 22

&ook 1 $ontains ISO 9001 #lus T; 90004s E added re*uirements .$alled adders/ &ook 2 $ontains

11 families of measurements .metri$s/

T; 9000 #resents auditin" $hallen"es be$ause many of the added re*uirements demandinter#retations that are new to ISO 9000 auditors' and the auditin" of metri$s is a $om#letely new

ex#erien$e for them In addition' it is diffi$ult to find ob:e$tive eviden$e for some of the

re*uirements

Key su##lements to ISO 9001A199B

The uality >x$ellen$e for Su##liers of Tele$ommuni$ations .u>ST/ @orum' whi$h mana"es T;

9000' ex#anded on the $urrent ISO 9001 re*uirements by takin" the followin" ste#sA

)la$in" more em#hasis on to# mana"ement res#onsibilities

In$reasin" the fo$us on #ro#errobust #lannin"' in$ludin" *uality #lannin"' #ro:e$t #lannin"'

$onfi"uration mana"ement #lannin"' #rodu$t #lannin"' life $y$le #lannin" and test #lannin"

+ddin" re*uirements for $ustomer3su##lier $ommuni$ation


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+ddin" re*uirements em#hasi,in" *uality im#rovement and $ustomer satisfa$tion

+ddin" re*uirements $overin" s#e$iali,ed servi$in" fun$tions

+ddin" re*uirements related to metri$s' in$ludin" definin" tar"ets' tra$kin" data' re#ortin" data

to a $entral database and usin" data to foster $ontinual *uality im#rovement

-sin" the word %should% to indi$ate the #referred a##roa$h Su##liers $hoosin" other a##roa$hes

must be able to demonstrate that their a##roa$h meets the intent of T; 9000 These adders are

referred to as %should adders%

+uditin" $hallen"es

The ma:or $hallen"es fa$ed by auditors have to do with the items identified as key su##lements to

ISO 9001A199B

@or the first su##lement' more em#hasis on to# mana"ement res#onsibilities' adder B211C

re*uires more mana"ement visibility in $ommuni$atin" su##lier #erforman$e feedba$k to the

$om#any work for$e This re*uirement has $aused mana"ement to be $on$erned with revealin"

#ro#rietary information and airin" dirty laundry to asso$iates In some or"ani,ations' leaders

$ommuni$ate throu"h monthly or *uarterly meetin"s and newsletters summari,in" $ustomer

satisfa$tion data' thus #rovidin" some ob:e$tive eviden$e

+nother adder in this $ate"ory' mana"ement $ommitment .B212C1/' re*uires exe$utive

involvement in establishin" and maintainin" $ustomer relations This adder may be diffi$ult to audit

be$ause exe$utives often do not do$ument their $ustomer intera$tions

@or the se$ond key su##lement' an in$reased fo$us on #ro#errobust #lannin"' six adders re*uire

#res$ri#tive #lannin" #ro$essesA

1 )ro:e$t #lannin" .BB2C1/

2 Test #lannin" .BB2C2/


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>nd of life #lannin" .BB2C/

B 6i"ration #lannin" .BB2SB/


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#arty re#air houses Data relatin" to findin"s of no trouble are often not re$orded' and finally'

$olle$tin" and analy,in" $ustomer satisfa$tion data .B21C1/ may be diffi$ult

The fifth key su##lement is the set of added $ustomer servi$in" re*uirements in$luded in elementB19 6any of these adders are linked to other elements' makin" them diffi$ult to auditA

>lement B19C2 .servi$e resour$es/ is linked to B1E .trainin"/

>lement B19C .notifi$ation about #roblems/' B19CB .#roblem severity/' B19C< .#roblem

es$alation/ and B1951 .su##lier4s re$all #ro$ess/ all link to B1B2 .$orre$tive a$tion/

>lement B195S2 .#roblem resolution $onfi"uration mana"ement/ links to BE .#roblem

identifi$ation and tra$eability/

The final key su##lement fo$uses on metri$s and their related re*uirements +uditors may have

issues with metri$s ob:e$tives .B11C1/ be$ause it is diffi$ult to set ob:e$tives for some metri$s'

su$h as the number of #roblem re#orts Others su$h as fix res#onse time and on3time delivery are

easier

It is also diffi$ult to audit the 11 metri$s bein" re#orted to the -niversity of Texas at Dallas' the

re#ository for T; 9000 measurement data' be$ause metri$s are a new $on$e#t to most auditors

+##roved metri$s

>leven metri$s in four $ate"ories were a##roved by the u>ST @orum as followsAB

Those $ommon to hardware' software and servi$es in$ludin" the number of #roblem re#orts'

#roblem re#ort fix res#onse time' overdue fix res#onsiveness' system outa"e measurement and on3

time delivery

?eturn rates' whi$h are related only to hardware

Corre$tive #at$h *uality' feature #at$h *uality' software u#date *uality and release a##li$ation

aborts' whi$h are related only to software

Servi$e *uality for $ate"ories su$h as installation' maintenan$e' re#air' and $all $enter or su##ort

servi$es


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-sin" metri$s to im#rove *uality

T; 9000 is uni*ue in its use of metri$s to determine the *uality level of #rodu$ts and servi$es and

to en$oura"e $ontinual *uality im#rovement

This extension of ISO 9000 into metri$s is ex#e$ted to result in an industry drive to im#rove

overall *uality Certainly' when su##liers know where their #rodu$ts stand relative to the

$om#etition and $ustomers know the *uality level of best in industry' there will be a drive by all

su##liers to im#rove

+uditors will need to establish that the metri$s bein" used are those that are re*uired for the

#rodu$ts $overed by the s$o#e of the *uality mana"ement system They will need to assure that the

data $olle$tion methods satisfy &ook 2 re*uirements' establish the reasonableness of the data' lookfor re$ords of submittal as ob:e$tive eviden$e and look for eviden$e that the metri$s were used in

*uality im#rovement

One final noteA &e$ause the new T; 9000 re*uirements are mu$h more detailed than those of ISO

9001' auditin" the tele$ommuni$ation standard takes mu$h more time than auditors usually

estimate

+CK7O;>D!6>7TS

The followin" auditors assisted with this arti$le by #rovidin" information on their T; 9000

ex#erien$esA 6ike 5arder of ;?+' Desmond O4;ou"hlin of 7S+I and )ete Ortolani of Tel$ordia

?>@>?>7C>S

1 T; 9000 uality System ?e*uirements' &ook 1' ?elease 2< .6ilwaukeeA +S uality )ress'

1999/

2 T; 9000 uality System 6etri$s' &ook 2' ?elease 2< .6ilwaukeeA +S uality )ress' 1999/


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uality Systems336odel for uality +ssuran$e in Desi"nDevelo#ment' )rodu$tion' Installation

and Servi$in"' ISO 9001A199B' se$ond edition .!eneva' Swit,erlandA International Or"ani,ation for

Standardi,ation' 199B/

B T; 9000 uality System ?e*uirements .see referen$e 1/

ISO 9001 and ?e"ulatory Com#lian$e In the 6edi$al Devi$e Industry

;a$k of attention to *uality systems $an result in hefty fines' indire$t $osts

by Joe Tsiakals

5undreds of millions of dollars in fines and a$tions have re$ently been levied a"ainst two -S

medi$al devi$e manufa$turers The faults in$luded the failure of to# mana"ement to establish

a##ro#riate *uality systems to hel# ensure that #rodu$ts were safe and o#erations $ould

$onsistently meet a##li$able re*uirements and s#e$ifi$ations

These exam#les of on"oin" enfor$ement a$tions by the -S @ood and Dru" +dministration do not

indi$ate new or sur#risin" initiatives for those of us familiar with the @D+

In one exam#le involvin" +bbott ;aboratories' defe$tive #rodu$t was not identified Instead'

+bbott4s #ra$ti$es for $orre$tive and #reventive a$tion .C+)+/ and for #ro$ess validation were

$alled into *uestion' and other *uality system defi$ien$ies were $ited33to the tune of over 00

million in losses to the bottom line

In a $onsent de"ree of #ermanent in:un$tion the -S Distri$t Court for the 7orthern Distri$t of

Illinois issued a"ainst +bbott on 7ovember 2' 1999' +bbott a"reed to #ay 100 million in fines while

admittin" no "uilt1


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The de$ree #rovided the @D+ invasive su#ervisory ri"hts' with @D+ ex#enses to be #aid by +bbott'

for a minimum of five years The a$tion also re*uired +bbott to in$ur' $onservatively estimated' an

additional 200 million in $osts asso$iated with #rodu$t re$alls and $orre$tive a$tions' ex$ludin"

the lon"3term im#a$t of lost sales and #rodu$t withdrawals

On De$ember 1


18/60

a/ needs to demonstrate its ability to $onsistently #rovide #rodu$t that meets $ustomer and

a##li$able re"ulatory re*uirements' and

b/ aims to enhan$e $ustomer satisfa$tion throu"h the effe$tive a##li$ation of the system' in$ludin"#ro$esses for $ontinual im#rovement of the system and the assuran$e of $onformity to $ustomer

and a##li$able re"ulatory re*uirements

The @D+ re"ulatory re*uirements for medi$al devi$e *uality systems are found in the uality

System ?e"ulation' also known as the S?B The S? was the first revision of the @D+4s medi$al

devi$es ori"inal "ood manufa$turin" #ra$ti$e .!6)/ re"ulation issued in De$ember 19HE

The revision a$hieved the the #rimary #ur#ose of in$or#oratin" many of the new *uality system

$on$e#ts of ISO 9001A199B into the !6)s >ven thou"h desi"n $ontrol was the re$o"ni,ed ma:or

addition' new re*uirements in the S? in$luded those for mana"ement review and C+)+

Ja#an4s a##roa$h to re"ulatin" the desi"n and manufa$turin" of medi$al devi$es is similar to that

of the @D+ ISO 9000 re*uirements are embedded within their $ountry4s re"ulations

Contrastin" with this are the re"ulatory re*uirements for desi"ners and manufa$turers of medi$al

devi$es for the >uro#ean market They must follow the medi$al devi$e dire$tive issued by the

>uro#ean Commission It dire$tly referen$es the use of ISO 9001A199B and ISO 9002A199B as do

the $orres#ondin" re"ulations for Canada and +ustralia 6ost of the rest of the world uses either

the @D+ a##roa$h or the >uro#ean a##roa$h

The influen$e of the se$tor

+ll firms that desi"n' manufa$ture' #ro$ess' #a$k' label and shi# medi$al devi$es are re*uired to$om#ly with "overnmental re"ulations based either dire$tly or indire$tly on the ISO 9000 series It

should not sur#rise anyone that the medi$al devi$e se$tor' althou"h small' is extremely interested

in the develo#ment and the #ro"ression of refinin" re*uirements for ISO 9000


19/60

It4s also not sur#risin" that this se$tor is the only one with its own International Or"ani,ation for

Standardi,ation' known as ISO' te$hni$al $ommittee on *uality mana"ement' ISOTC 210 This

$ommittee is fo$used #rimarily' but not ex$lusively' on the ISO 9000 series develo#ed by another

ISO te$hni$al $ommittee' ISOTC 1H

7or is it sur#risin" that ISOTC 210 had a dis#ro#ortionate level of influen$e in the develo#ment

of ISO 9001A2000 by ISOTC 1H ISOTC members #arti$i#atin" in ISOTC 1H task "rou#s

develo#in" the ISO 9000A2000 series in$luded re#resentatives from the -nited States' -nited

Kin"dom' Ja#an' Swit,erland' the 7etherlands' Denmark and Canada'

Offi$ially' three liaison members re#resented ISOTC 210' ea$h workin" on one of the three

writin" teams for ISO 9001 In$luded amon" these three were the $hairman of ISOTC 210 and

the $onvenor .workin" "rou# $hairman/ of the ISOTC 210 *uality systems workin" "rou# In

addition' a key member of the ISOTC 1H sub$ommittee for definitions has been a member of

ISOTC 210 @our other lon"3term' influential members of ISOTC 1H are from the medi$al

devi$e se$tor

+idin" re"ulated industries

The needs of re"ulated industries were amon" the ma:or $onsiderations identified in the #lannin"

#hase for the new revision' ISO 9001A2000 There are seven referen$es to re"ulatory re*uirementsin the new standard ?e"ulatory $onsiderations are identified under the ISO 9001A2000 $lauses for

s$o#e and mana"ement $ommitment and are in$luded as re*uirements for the desi"n and

develo#ment in#uts of #rodu$ts and #ro$esses

The traditional a##roa$h used by $om#anies for a$hievin" re"ulatory $om#lian$e fo$uses on

individual re*uirements and their $orres#ondin" #ro$edures

This often results in the establishment of extensive bureau$ra$ies of #a#er and those mana"in"

the #a#er >verythin" has to be des$ribed in do$umented #ro$edures' and all work has to be

re$orded This tends to be neither effe$tive nor effi$ient in assurin" that re*uirements are met

Sim#ly fo$usin" on re*uirements and $om#lian$e to these re*uirements results in an ever in$reasin"

array of more re*uirements and #a#er


20/60

The trouble with $om#lex do$ument bureau$ra$ies has been la$k of $larity for to# mana"ement as

to the key issues affe$tin" *uality hat is the a$tual #erforman$e of the #rodu$t= Of the

#ro$ess= 5ow do we $orre$t the #roblems we have now= 5ow do we anti$i#ate #otential #roblems

and take a$tion to avoid them=

)ro$ess a##roa$h and $ontinual im#rovement

Inte"rated throu"hout ISO 9001A2000 are *uality system elements that lead to minimi,in"

$om#lexity and a$hievin" an effe$tive *uality system Two $on$e#ts intertwined throu"hout the

standard are the #ro$ess a##roa$h and $ontinual im#rovement

7ew is the fa$t that the standard is stru$tured now around four main #ro$essesA

1 6ana"ement res#onsibility

2 ?esour$e mana"ement

)rodu$t reali,ation

B 6easurement' analysis and im#rovement

+ #ro$ess model and the #ro$ess a##roa$h are des$ribed in the introdu$tion The a##roa$h

em#hasi,es identifi$ation and mana"ement of numerous linked a$tivities

This a##roa$h hi"hli"hts the im#ortan$e of understandin" and meetin" re*uirements' $onsiderin"

#ro$esses in terms of added value' obtainin" results of #ro$ess #erforman$e and effe$tiveness' and

$ontinual im#rovement of #ro$esses based on ob:e$tive measurement

The solution to many of the #roblems fa$ed by re"ulated industry involves addressin" how

or"ani,ations identify real and #otential defi$ien$ies to im#rove Or"ani,ations are now re*uired to

%#lan and mana"e the #ro$esses ne$essary for the $ontinual im#rovement of the *uality mana"ement

system% Continual im#rovement is also mentioned under the standard4s *uality ob:e$tives and

*uality #lannin" $lauses


21/60

The last $lause of ISO 9001A2000' $lause E' is titled %$ontinual im#rovement% There are s#e$ifi$

re*uirements for $orre$tive a$tion for eliminatin" the $auses of known non$onformities

The re*uirements for #reventive a$tion re*uire determinin" #otential non$onformities and their$auses and takin" a##ro#riate a$tion to #revent their o$$urren$e Of "reat im#ortan$e is the $lause

E lead senten$e that des$ribes a *uality im#rovement loo#

The $lause states that $ontinual im#rovement will be fa$ilitated throu"h %use of the *uality #oli$y'

ob:e$tives' audit results' analysis of data' $orre$tive and #reventive a$tion' and mana"ement

review%

These are seven im#ortant $lauses of the standard that' when linked as an effe$tive set of

#ro$esses' #rovide the ne$essary visibility and involvement of to# mana"ement for makin" surere*uirements are met Six of the $lauses s#e$ifi$ally feed into the mana"ement review

6ana"ement review is the #eriodi$ "atherin" of an or"ani,ation4s to# mana"ement to dis$uss the

$urrent state of *uality and $om#lian$e and to determine a##ro#riate a$tion ith real and

meanin"ful mana"ement reviews it is in$on$eivable that the re"ulatory a$tions mentioned at the

be"innin" of this #a#er $ould o$$ur This last $lause of the standard be$omes the most im#ortant

#art for tyin" everythin" to"ether

+voidin" bureau$rati$ #itfalls

ISO 9001A2000 has been develo#ed so or"ani,ations $an avoid the #itfalls and ineffi$ien$ies

asso$iated with the traditional bureau$rati$ and #ie$emeal a##roa$h to meetin" re*uirements This

new standard is offered as a key for a$hievin" an overar$hin" ob:e$tive of the to# mana"ement of

the medi$al devi$e industryA to obtain a hi"hly effe$tive *uality system that meets all $ustomer and

re"ulatory re*uirements

Im#lementin" ISO 9001A2000

>arly feedba$k indi$ates six areas of $hallen"e

by John > %Ja$k% est


22/60

ISO 9001A2000 .+7SIISO+S 900132000/ has now been available for several months This

new edition of ISO 9001' whi$h is based on the ei"ht *uality mana"ement #rin$i#les' re#resents a

si"nifi$ant de#arture from the 19EH and 199B versions The #rin$i#les were reviewed in detail in an

earlier standards $olumn1

Durin" roundtable dis$ussions at seminars I $ondu$ted this year usin" the new standard .and in

2000 usin" the last two drafts/' I re$eived feedba$k from several hundred or"ani,ations

In "eneral the #arti$i#ants in these dis$ussions were very satisfied with the new standard In fa$t'

most have been enthusiasti$ about its additional fo$us on the role of to# mana"ement and on

$ustomers' its sim#lified do$umentation re*uirements and the s#e$ifi$ in$lusion of the $on$e#t of$ontinual im#rovement

I asked ea$h of these roundtable "rou#s to identify $hallen"es and solutions related to

im#lementin" the new ISO 9001 It is not sur#risin" that some of the thin"s #eo#le really like about

the new standard also turn out to be $hallen"in" The issues that a##ear im#ortant from an

im#lementation #oint of view $an be summari,ed in six $ate"ories

1 7ew stru$ture of the standard

The new standard is stru$tured differently from the 203element model of earlier versions In fa$t'

the new model is better $onne$ted with the way or"ani,ations are normally mana"ed' so new users

find it mu$h easier to work with &ut or"ani,ations transitionin" from the 199B version often

initially mention the new stru$ture as a ma:or $hallen"e

+fter some dis$ussion' however' most users are able to see how to demonstrate $om#lian$e with

the new standard by usin" a matrix or by revisin" only their to# level *uality manuals >ven then' the

new stru$ture remains $hallen"in" for or"ani,ations that did not use the #ro$ess a##roa$h in initial

system develo#ment


23/60

2 )ro$ess a##roa$h

ISO 9001A2000 re*uires identifi$ation of the #ro$esses of the *uality mana"ement system' alon"

with their se*uen$e and intera$tions In effe$t' this means the *uality mana"ement system mustrefle$t the a$tual way in whi$h the or"ani,ation o#erates This is normally a$$om#lished by usin"

te$hni*ues su$h as #ro$ess ma##in"

+ ma:ority of the or"ani,ations re#orted they used this a##roa$h in establishin" their $urrent

*uality mana"ement system On the other hand' a minority said they had develo#ed their

do$umented system usin" the earlier standard33but without real $onsideration of the #ro$esses in

the business

@or this latter "rou#' ado#tion of the #ro$ess a##roa$h re#resents a si"nifi$ant $hallen"e In some

$ases' these or"ani,ations re#orted they had $reated %shadow% *uality systems in whi$h the a$tual

*uality mana"ement #ro$esses are *uite different from those des$ribed in the do$umented manual

and #ro$edures

Or"ani,ations findin" themselves in this situation must think hard about their a##roa$h to the new

standard 6ost of this minority a"reed' however' the use of the new a##roa$h will hel# them ali"n

their written #ro$esses with a$tual #ra$ti$e to $reate a more effe$tive system

+n im#lementation module that #rovides insi"ht into the use of the #ro$ess a##roa$h is available2

Sim#lified do$umentation re*uirements

One of the key ob:e$tives of the revision #ro$ess was to make the new ISO 9001 user friendly for

small or"ani,ations hile the *uality mana"ement system must still be des$ribed fully in the

do$umentation needed to ensure its effe$tiveness' the number of system level do$umented

#ro$edures s#e$ifi$ally $alled out has been redu$ed33from 1E in the 199B version to six in 2000


24/60

The notes in $lause B2 #rovide "ood "uidan$e on the extent to whi$h an or"ani,ation should "o to

do$ument its system -nfortunately' some or"ani,ations think auditors will $ontinue to demand

do$umented #ro$edures where they have no value +nd some auditors say they are unable or

unwillin" to audit without do$umentation

here do$umentation of a #ro$ess has no value and the $riteria of the notes in $lause B2 have

been met' or"ani,ations should stand their "round and resist $reatin" useless #a#erwork

In su$h $ases' auditors need to learn to assure #ro$ess effe$tiveness by talkin" to multi#le

individuals33from to# mana"ers or su#ervisors to workers who $arry out the #ro$ess In that way'

auditors $an determine whether the #ro$ess is a$tually $arried out as intended by the leadershi#

On the other hand' auditors should seriously *uestion #ro$esses where there is a la$k of su$h

ali"nment

B @o$us on the role of to# mana"ement

The new ISO 9001 has a "reater em#hasis on the role of to# mana"ement than earlier versions In

fa$t' to# mana"ers are assi"ned s#e$ifi$ new res#onsibilities

In the *uality #oli$y' leadershi# must in$lude a $ommitment to meetin" re*uirements and to

$ontinual im#rovement of *uality mana"ement system effe$tiveness To# mana"ers must also ensure

re*uirements are determined and met

There are ma:or robust re*uirements for mana"ement review' in$ludin" its use to identify

im#rovement o##ortunities 6ost roundtable #arti$i#ants see this em#hasis as a #ositive shift in

fo$us and an o##ortunity to im#rove the involvement of senior leaders in the *uality mana"ement

system &ut others are $on$erned they will not be able to "ain the re*uired level of $ommitment

Certainly' the transition to the new standard is a "ood time for *uality #rofessionals to

demonstrate the benefits of senior mana"ement involvement


25/60

for measurin" $ustomer satisfa$tion' but the data are not #rovided in a form that $an be used

within the *uality mana"ement system

In either $ase' these or"ani,ations will need to address this "a# durin" the transition #eriod

In$lusion of desi"n and develo#ment

There is a $hallen"e for the / orld Con"ress this

6ar$h in Detroit The s#eaker went on to list a number of *uality #ro"rams' su$h as $om#anywide

*uality $ontrol' kai,en and total *uality $ontrol' that have $ome and "one sin$e that time


26/60

hen you look at these #ro"rams' you find many indeed share $ommon elements that have been

identified' *uantified and ex#lained from many different an"les +s the s#eaker said' the basi$

$on$e#ts have been around for some time They are still not widely de#loyed' however +meri$an

industry a##arently loves to innovate' but stru""les to im#lement the fundamentals of *ualitymana"ement

@or *uality #ro"rams to be su$$essful' mana"ement must take an a$tive role in their

im#lementation )lenty of "uidelines are available in the work of *uality leaders su$h as >dwards

Demin" and in more re$ently develo#ed standards and #ro"rams su$h as ISO 9000A2000 +n

or"ani,ation $an now $ombine elements from several sour$es to tailor a *uality mana"ement system

that meets its s#e$ifi$ needs The key to su$$ess in any #ro"ram' however' is for mana"ement to

follow throu"h

+nd Demin" said

In his book Out of the Crisis' Demin" refle$ted on the information he shared with the Ja#anese in

19


27/60

Demin" said redu$tion of variation $ould be #rovided throu"h the sin"le sour$in" of su##liers 5e

advo$ated lon"3term relationshi#s based on trust and #romoted the $ontinual im#rovement of

testin" $a#ability for #rodu$ts' servi$es' #ro$esses' ma$hines' methods' ins#e$tion and distribution

5e stressed the $onsumer is the most im#ortant $onsideration throu"hout the #rodu$t reali,ation#ro$ess

ISO 9001A2000' $lause


28/60

Demin" added *uality must be built in at the desi"n sta"eE ISO 9001A2000 now #la$es more

em#hasis on u#3front *uality #lannin" be$ause an or"ani,ation $an have the most influen$e on

#rodu$t *uality durin" the #lannin" sta"e

S39000 re*uires use of the industry +dvan$ed )rodu$t uality )lannin" .+))/ and Control )lan

manual' whi$h #rovides the tem#late and $he$klists for #rodu$t reali,ation

It is im#ortant that $ertain a$tivities be $ondu$ted earlier in the #rodu$t reali,ation $y$le than

others and that all the ri"ht thin"s be done The +)) is a "ood model for hardware and has

a##li$ations for other se$tors

Durin" desi"n and develo#ment' a re$ord should define the #rodu$t' #ro$ess or servi$e

$hara$teristi$s and their re*uirements These should be based on $onsumer resear$h and the

or"ani,ation4s #rodu$t knowled"e' and they should take into a$$ount the ex#e$ted life of the

#rodu$t' durability' reliability and maintainability

>fforts to error #roof the #rodu$t and #ro$esses should be made from the be"innin" of #lannin"

and $ontinue throu"h $orre$tive and #reventive a$tion This is to #revent #roblems33whi$h was

Demin"4s #oint when he said to $ease de#enden$e on ins#e$tion

)arti$ularly where error #roofin" is not in$or#orated into #rodu$t or servi$e desi"n' the *uality

$hara$teristi$s should be evaluated for risk of failure .for exam#le' failure mode effe$ts analysis

exer$ises/ Then the *uality or $ontrol #lan should address how $onformity will be a$hieved and

measured later in the reali,ation #hase

here the #rodu$t desi"n does not #revent non$onforman$es at the $hara$teristi$ level' work

instru$tions should tell o#erators how to miti"ate the effe$ts of #otential #roblems33what to do

when thin"s "o wron" and how to o#erate #ro$esses $orre$tly

)ro$ess $a#ability or #erforman$e needs to be mat$hed with the #rodu$t and #ro$ess re*uirements

and $onsumer ex#e$tations The #ro$ess $a#ability should be determined and monitored statisti$ally


29/60

over time 6ana"ement should be trained to understand whi$h measures are a##ro#riate and how to

inter#ret what the data are tellin" them about #ro$ess variation

The most im#ortant numbers

Demin" said the $entral $hallen"e of mana"ement is to better understand the meanin" of variation

and the #ro$esses bein" mana"ed9 5is $ontention was that where mana"ement is in$om#etent' it

mana"es the out$ome by numbers @or exam#le' to $om#ensate for a la$k of knowled"e of

#ro$esses' mana"ement may mandate some yearly #er$enta"e of im#rovement in a s#e$ified

$hara$teristi$ uality' however' is about effe$tive #ro$ess mana"ement

To Demin"' the most im#ortant numbers were what he $alled %unknown% and %unknowable%10 +n

exam#le of this would be the unknown $osts in$urred when a $ustomer is lost due to a #oor *uality

ex#erien$e +n understandin" of this idea should motivate mana"ement to $ontinually im#rove the

#rodu$t and #ro$ess inde#endent of *uality mandates

)ro$ess mana"ement involves the use of metri$s Im#lementin" effe$tive metri$s starts with

identifi$ation of the key #rodu$t or servi$e $hara$teristi$s to measure It is not #ra$ti$al to

measure all $hara$teristi$s

One #sy$holo"y of measurement maintains that what "ets measured im#roves In the automotive

industry' #art a##roval is obtained when the sele$ted $hara$teristi$s meet re*uirements 5ow to

determine whether they meet the re*uirements is the $hallen"e of the measurement system It

in$ludes testin"

The :ourney should not sto# with initial a##roval' however 6ana"ement should work to $ontinually

im#rove the #ro$esses to redu$e variation' in$rease $ustomer satisfa$tion and lower $osts

ISO 9001A2000 now in$or#orates the measurin" and monitorin" of the #rodu$t' #ro$ess and *uality

system This is a si"nifi$ant im#rovement over the #revious version of the standard These

re*uirements $an drive the use of a##ro#riate *uality measures throu"hout the or"ani,ation


30/60

Constan$y of #ur#ose

In his 1B )oints' Demin" says mana"ement must $reate $onstan$y of #ur#ose toward im#rovement

of #rodu$t and servi$e 5e shows how :ob mobility inhibits $onstan$y The results are failure to

establish the lon"3term relationshi#s ne$essary to en$oura"e su##liers to invest in innovation and

the $reation of fear and mistrust in the work for$e' whi$h leads to a la$k of #ride in workmanshi#

and' in turn' to #oor *uality and more turnover11

In the -S automotive industry' work on what be$ame S39000 started about 1< years a"o

;eadershi# of this effort was by ei"ht different men o$$u#yin" the #ositions of vi$e #resident for

#ur$hasin" or #ro$urement and su##ly at three different automakersA Chrysler' @ord and !6

7ever before in the industry had there been a *uality manual with three $om#any lo"os on the

front 7ever before had the industry utili,ed a third3#arty inde#endent auditin" fun$tion to *ualify

su##liers

hile the develo#ment of S39000 started with modest efforts' a do$umented lon"3term vision

of su$$ess was $rafted with in#ut from some forward thinkin" su##liers There were re"ularreviews with the vi$e #residents to re#ort #ro"ress and u#date the #lan

Des#ite leadershi# mobility' a $onstan$y of #ur#ose for this effort remained ithout it' S39000

would never have ha##ened' and automotive su##liers would still be fa$ed with numerous *uality

re*uirements' in$onsistent use of terminolo"y and multi#le $ustomer *uality system audits on an

annual basis

Other se$tor do$uments su$h as T; 9000' the tele$ommuni$ations *uality mana"ement standard'

have also been develo#ed usin" the S39000 model as in#ut

Institute leadershi#


31/60

Demin" $alled for true leadershi# to substitute for a number of mana"ement #ra$ti$es One of his

$entral tenets was that leadershi# should hel# em#loyees do a better :ob To Demin" the ma:ority

of #roblems in an or"ani,ation were under the dire$t $ontrol of mana"ement' not the workers

This $on$e#t has shown u# in lean manufa$turin" as %su##ort for the em#loyee% It has shown u# as

%sim#lifyin"% and %standardi,in"% in the < S4s .a Ja#anese #ro"ram that also in$ludes sortin"'

swee#in" and sustainin"/ It involves stru$turin" the :ob so the em#loyee $an s#end a hi"her

#er$enta"e of time on value added work

The vast ma:ority of the time a raw material s#ends bein" transformed into finished "oods involves

nonvalue added a$tivities su$h as waitin"' movin" and stora"e

In Demin"4s 1B )oints' leadershi# was also to be the substitute for *uotas and mana"ement by

numbers .numeri$al "oals/ 6ana"ement was to work on the system to make it better for the

em#loyees +lthou"h this would take time away from other ur"en$ies' it was to be a #riority

+ si"nifi$ant se$tion of a re$ent book about Ja$k el$h' C>O of !>' was devoted to leadershi# In

the $ha#ter %Sto# 6ana"in" and Start ;eadin"'% el$h refutes the $onventional wisdom aboutmana"ement4s role .monitorin"' su#ervisin" and $ontrollin"/ and ar"ues that %mana"ers muddle%

while %leaders ins#ire%12

One #rimary way they $an ins#ire the work for$e is to make $ontinual im#rovements in the systems

to make the em#loyees4 :obs easier and more #rodu$tive

Trainin" and $om#eten$e

Demin" advo$ated on3the3:ob trainin"1 One of his 1B )oints was to institute a vi"orous #ro"ram

of edu$ation and self3im#rovement


32/60

The new ISO 9000 re*uires $om#eten$e' and trainin" is listed as one of several ways to a$hieve it

In the automotive standard ISO TS 19B9' trainin" on the :ob is a s#e$ifi$ re*uirement

The effe$tiveness of trainin" should be #eriodi$ally reviewed 5i"h work for$e turnover demandsre#etition of basi$ trainin" initiatives @or exam#le' a $om#any may #rovide initial trainin" sessions

in statisti$al #ro$ess $ontrol' variation and tools to measure *uality .su$h as $ontrol $harts and run

$harts/ 5owever' as the trained em#loyees move on to other :obs' $om#anies need to tea$h su$h

$on$e#ts to their su$$essors

>m#loyees in the same assi"nments $ould also benefit from further trainin" in more advan$ed

$on$e#ts' #arti$ularly when data indi$ate they fall outside of the $ommon $ause variation as tau"ht

by Demin"

Trainin" in the fundamentals of *uality mana"ement should be institutionali,ed ?e$o"ni,in" this'

T; 9000' the tele$ommuni$ation standard' re*uires all em#loyees' in$ludin" to# mana"ers who have a

dire$t im#a$t on #rodu$t *uality' be trained in fundamental $on$e#ts of $ontinual im#rovement'

#roblem solvin" and $ustomer satisfa$tion1B

6any or"ani,ations are usin" new em#loyee orientation manuals to #rovide basi$ trainin"

Information from su$h manuals $an now be loaded onto $om#any eb sites to #rovide easy a$$ess

and better $han"e mana"ement @or this reason' many or"ani,ations now use ele$troni$ media for

their *uality manuals and #ro$edures

Continual im#rovement

Demin" stressed the need for $ontinual im#rovement of the system of #rodu$tion and servi$e in his

1B )oints 5e linked it to $ost redu$tions' whi$h lead to #rodu$tivity im#rovements and the $hain

rea$tion $aused by *uality

Demin" #romotes alter Shewhart4s #lan3do3$he$k3a$t $y$le' often known as the %Demin" $y$le'%

for $ontinual im#rovement of ea$h element of the #rodu$t reali,ation #ro$ess1< shown in @i"ure 1

.# H/ S39000 and ISO TS 19B9 detail the need for $ontinual im#rovement that must extend to

#rodu$t $hara$teristi$s


33/60

Or"ani,ations are either "rowin" or dyin" daily To "row' or"ani,ations must be mana"ed well and

$ommitted to im#rovin" faster than the $om#etition

-sin" the mana"ement system

@or sustainability and "rowth' an or"ani,ation should desi"n and im#lement a mana"ement systembased on the fundamentals of *uality To start' ISO 9001A2000 $an #rovide a tem#late that should

be enhan$ed with other elements to drive effi$ien$y and effe$tiveness

ith a##ro#riate metri$s' status $an be known and im#rovements a$hieved' $ontinually in$reasin"

$ustomer satisfa$tion +s we have seen' the $on$e#ts and methods have been do$umented for

de$ades It is #ast the time for im#lementation &ut as Demin" stated' su##ort of to# mana"ement

is not enou"h 6ana"ement must know what it must do' and these obli"ations $annot be dele"ated1

+uditin" ISO 9001A2000

Challen"es arise be$ause some of the re*uirements aren4t s#e$ifi$ or tra$eable

by J) ?ussell

&e$ause many of its $lauses are non#res$ri#tive33they don4t $ontain s#e$ifi$ or tra$eable

re*uirements33some *uality #rofessionals are ex#ressin" $on$ern about the auditability of ISO

9001A2000' the new *uality mana"ement standard

%+uditability% refers to the $a#ability of a##lyin" audit te$hni*ues for #ositive verifi$ation of

re*uirements If $onforman$e to re*uirements is not verifiable and tra$eable' the $redibility of theaudit fun$tion .audit #ro"ram' re"istrar or re"ulatory oversi"ht/ $ould be *uestioned

@irst' however' it is im#ortant to #oint out that most of the ISO 9001A2000 $lauses $ontain very

s#e$ifi$ and tra$eable re*uirements @or exam#le' the internal audit $lause ISO 9001A2000A E22

re*uirements in$lude the followin"A


34/60

1 + do$umented #ro$edure

2 +uditin" at #lanned intervals

+udit #lannin" based on status and im#ortan$e

B ?e#ortin" of results


35/60

#ro$essin" to final destination% There is no re*uirement for a #ro$edure' s$hedule' ins#e$tion' #lan'

method or re$ord

This re*uirement is so "eneral it is #ossible for an or"ani,ation bein" audited to believe it $ansim#ly de$lare $onforman$e to the re*uirement and $hallen"e the auditor to #rove otherwise

&e$ause that $an be like lookin" for a needle in a haysta$k' it is im#ortant for the auditor to take

the o##osite a##roa$h by $hallen"in" the auditee to show why there is no needle in the haysta$k

To audit the less #res$ri#tive $lauses' the auditor must verify the or"ani,ation $onforms to the

intent of the re*uirements of the standard by determinin" whether an a##roa$h has been

established' im#lemented' maintained and im#roved

This te$hni*ue lends itself to several of the $lauses of ISO 9001A2000 @or some $lauses the

auditor must seek to determine the existen$e of a #ro$ess' how it was #lanned and im#lemented' its

out$omes and whether mana"ement determines on"oin" effe$tiveness

hat to ask

+n auditor mi"ht ask the followin" *uestions for the less #res$ri#tive $lausesA

Is there a #lan or method for $onformin" to the re*uirements= hat is it= 5as it been

established= +udit eviden$e may in$lude an outline' flow$hart' markin"s in a work area' #ro$edure'

work instru$tions' s#e$ifi$ations or $riteria Clause H1 $ontains re*uirements to be $onsidered for

#lannin" the reali,ation #ro$esses

5as it been im#lemented .de#loyed/= +udit eviden$e may in$lude the existen$e of re$ords'

$orroboration by multi#le interviews or observations

5ave #lanned results been a$hieved= +udit eviden$e may in$lude trend dia"rams' re$ords' bar

$harts' matri$es or $om#arisons Data $olle$ted to meet $lause EB re*uirements may be hel#ful

.for exam#le' data summaries' analyses' metri$s and #erforman$e indi$ators/

Is there im#rovement= 5as the system#ro$ess been $han"ed= +udit eviden$e may be $han"es to

do$uments' desi"ns or the ways business is $ondu$ted


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The auditor should kee# a re$ord or lo" of the audit eviden$e to show $onforman$e and

non$onforman$e for tra$eability and to #rovide $onsisten$y from audit to audit >xam#les of audit

eviden$e and #erha#s lo" entries may be in$luded as #art of the audit re#ort

The answers

To start' the or"ani,ation bein" audited mi"ht des$ribe how the re*uirements are addressed in the

*uality manual33as an overview' exe$utive briefin" or in #ro$edures &ased on the des$ri#tion and

the re*uirement in the standard' the auditor $an interview #ersonnel to $olle$t audit eviden$e' usin"

either o#en3ended or $losed3ended interview *uestion te$hni*ues

+ $losed3ended *uestion will result in s#e$ifi$ yes' no or item by item answers 7ormally o#en3

ended *uestions "ive us more information' but it is u# to the auditor to sort and determine the

relevan$e of the information

The same is true for non#res$ri#tive re*uirements They are o#en3ended' and it is u# to the

auditor to mat$h the information with the re*uirement and determine relevan$e In some interview

situations' an auditor may be surrounded by #eo#le ready to #rovide information needed to verify$onforman$e to the re*uirement +s one #erson leaves to find a memo or $he$klist' another is ready

to seek out the next #ie$e of eviden$e .re$ord' #ro$edure or $hart/ the auditor needs to verify

$onforman$e to re*uirements

In ea$h situation the auditor must determine the a##ro#riate data $olle$tion #lan to ensure the

information is free from bias + worksheet is an ideal tool for listin" the $lause or re*uirement on

the left and re$ordin" the eviden$e #rovided in a s#a$e to the ri"ht

The te$hni*ue for verifi$ation of a non#res$ri#tive re*uirement is' %Show me how you $onform to

this re*uirement with the existen$e of a #lan .a##roa$h/' its im#lementation' a$hievement of

#lanned results and $ontinual im#rovement%


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The key is to follow the #lan byA

>xaminin" the #lan addressin" the re*uirement

>xaminin" the im#lementation of the #lan

>xaminin" the a$hievement .out$omes/ of the #lan

>xaminin" the im#rovement of the #lan

Determinin" $onforman$e or non$onforman$e

On$e the or"ani,ation bein" audited has had an o##ortunity to #rovide eviden$e and the auditor has

made his or her observations' it is time to determine $onforman$e or non$onforman$e

!ood audit #ra$ti$e also re*uires the auditor to indi$ate the im#ortan$e of the non$onformities

dete$ted Some non$onformities re#resent hi"h risk to the or"ani,ation' while others re#resent low

risk One of the sim#lest methods to "au"e im#ortan$e is to $lassify non$onformities as ma:or or

minor >a$h or"ani,ation should establish its own $lassifi$ation system

The auditor must make a :ud"ment based on the data #resented and audit #ro"ram "uidelines todetermine if there is $onforman$e' a minor non$onforman$e or ma:or non$onforman$e The

$redibility of the audit fun$tion will be *uestioned unless there is $onsisten$y in :ud"ment between

the auditor and or"ani,ation bein" audited

The measurement system should be fair' unbiased' $onsistent and standardi,ed One method is to

assess first the #lannin" and im#lementation and then the results .out$omes/ of the #ro$ess @or

exam#le' an auditor4s "uideline for assessin" the #lannin" and im#lementation may stateA

6a:or non$onforman$eA 7o #ro$ess is evident from the information #resented' or there is #artialim#lementation but si"nifi$ant "a#s still exist

6inor non$onforman$eA There are sound methods but some minor "a#s in de#loyment

Conforman$eA Sound methods are fully im#lemented


38/60

@or assessin" the results and out$omes' the "uidelines may stateA

6a:or non$onforman$eA There are no data' limited data or data that $an4t be assessed a"ainst

$riteria

6inor non$onforman$eA There are some trend data' and they $an be evaluated a"ainst ob:e$tives

and $riteria &ut the data are not $om#rehensive or bein" maintained

Conforman$eA Com#rehensive and $urrent trend data $an be evaluated a"ainst ISO 9001 $riteria to

determine $onforman$e

)re#arin" for the audit

To audit to ISO 9001A2000 and other non#res$ri#tive standards' auditors will need to use new

audit te$hni*ues to verify $onforman$e and #rovide tra$eability In #re#arin" for the audit'

auditors may re*uest the $om#letion of a survey that s#ells out how re*uirements are addressed

+uditors may also evaluate *uality mana"ement #lans and ob:e$tives +t the o#enin" meetin"' the

methods and te$hni*ues that will be used durin" the audit should be shared with the or"ani,ation

bein" audited

Durin" the #erforman$e of the audit' o#en3ended te$hni*ues should be used to verify the intent of

the re*uirement has been addressed Observations should be re$orded on $he$klists' in lo" books or

by $om#letin" worksheets to ensure tra$eability of $onforman$e as well as non$onforman$e The

de"ree or im#ortan$e of what was found must be determined and re#orted to the $lient and area or

or"ani,ation audited

Caveat >m#tor


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Standards and audits will have value only if or"ani,ations bein" audited33and their $ustomers33

demand it

by Dale K !ordon

hat does it take to have a $om#etent third3#arty audit of your *uality mana"ement system=

Surely' if you were doin" it yourself' you would know exa$tly where to look to find the weakest

links in the system +n internal audit should "ive you a "ood idea of what is ri"ht and what needs

im#rovement hy' then' is so mu$h bein" made of havin" a third #arty #erform an audit :ust so you

$an have a #ie$e of #a#er or #la*ue to han" on the wall and show to your $ustomers=

It4s the #ra$ti$al way

>ver sin$e the world a"reed on standards for *uality mana"ement systems .the ISO 9000 series/'

we have $ome to believe if we show eviden$e our o#erations meet these standards' we $an #rovide

some level of $onfiden$e to our $ustomers

They $an be $onfident be$ause they know there are systems' #ro$esses and $ontrols in #la$e to

assure #rodu$t $onforman$e and $ontinuous im#rovement in o#erations +n in3de#th audit of a

*uality system is the a$$e#ted method of demonstratin" this $onforman$e

To have audits #erformed by all our $ustomers in this "lobal e$onomy is neither a #ra$ti$al nor a

$ost effe$tive use of resour$es33es#e$ially as we look at the de#th and breadth of the su##ly $hain'

from raw material or $on$e#t to #rodu$t and servi$e

e have therefore devised a #ro$ess by whi$h we hire su##osedly im#artial third #arties .often

$alled re"istrars or $ertifi$ation bodies/ to audit *uality mana"ement systems If we are $om#liant

with the ne$essary or a##ro#riate standard' they #rovide us with $ertifi$ation .$alled re"istration

outside the -nited States/


40/60

@or $ustomers to have $onfiden$e in the re"istrars hired by our or"ani,ations' we re*uire they be

a$$redited by an offi$ial a$$reditation body' whi$h may or may not be tied to a "overnment

$ontrolled #ro$ess of a##roval

@inally' in order for these a$$reditation bodies to a"ree the #ro$ess of a$$reditation is e*uivalent

from one lo$ation .$ountry/ to the next' the a$$reditation bodies have "otten to"ether to si"n

a"reements and audit ea$h other4s #ro$esses

It sounds reliable

To further ensure $onfiden$e in the system' the ISO 10011 series of auditin" standards attem#ts

to des$ribe auditin" re*uirements as followsA

+uditors need to know somethin" about the standard they are measurin" or"ani,ations a"ainst

They should know somethin" about the ty#es of #ro$esses bein" audited' the or"ani,ation bein"

audited and its $ustomers

They should have the knowled"e' the tem#erament and ex#erien$e in auditin" to be $redible

It sounds #retty $om#li$ated' doesn4t it= +t the same time' the various levels of $ontrol and the

auditin" re*uirements make it sound #retty reliable' and that4s what $ustomers are #ayin" for

The #roblems

This $ertifi$ation #ro$ess has been in #la$e for more than 10 years 5ow is it doin"= Is it asreliable as it sounds= Is it as reliable as it ou"ht to be=

The a$tual results of this auditin" system are mixed 6any fine re"istration $om#anies are now

doin" business' but some are not deliverin" what they advertise33unless the ob:e$tive is a


41/60

meanin"less #ie$e of #a#er Certifi$ationre"istration has be$ome a bi" deal involvin" lots of money

+s more $om#etitors have entered the field' more variability has entered the #ro$ess

It4s ama,in" to me the number of times I have heard $om#anies "oin" to "reat len"ths to #re#arefor audits by develo#in" elaborate #lans to assure auditors are ke#t busy and the real work of the

or"ani,ation is not ex#osed

Similarly' I have heard $ountless tales of auditors who had little knowled"e of the or"ani,ations

they were auditin"' #oor auditin" skills or even in$om#lete or in$orre$t knowled"e of the standard

In an extreme $ase' I saw an auditor #ro$eed to tell a $lient how it should be $om#lyin" with thestandard >ven worse are auditors who tell their $lients how to #erform a "iven #ro$ess or what

should be $han"ed in the system to satisfy an audit findin"

+uditors aren4t su##osed to do any of these thin"s The #ur#ose of an audit is sim#ly to establish

the standard is bein" met and assist the $lient in identifyin" weaknesses in its systems The

out$ome of this #ro$ess should be some assuran$e to the $lient and its $ustomers the system is

workin" and a$$om#lishin" its ob:e$tives

ho4s in $har"e=

The $lient of the audit should be in $har"e The $lient should demand $a#able' honest and

meanin"ful examinations in ex$han"e for the money bein" #aid The or"ani,ation4s internal audits

should lead to $ontinuous im#rovements8 the third3#arty #ro$ess should only be a validation that the

$om#any4s existin" *uality system works as desi"ned

&ut if elaborate measures are taken to de$eive or #la$ate a third3#arty auditor or if the auditor or

audit #ro$ess is flawed' that #ur#ose will be lost


42/60

+ bi" $on$ern is that neither the audit $lient nor those who rely on the $ertifi$ates have dire$t

in#ut into the oversi"ht and review of the third3#arty #ro$ess hile the a$$reditation bodies are

doin" what they $an within their #urview' as with the audit itself' they are :ust sam#lin" the

#ro$ess

hat some se$tors have done

Se$tors su$h as aeros#a$e' automotive and tele$ommuni$ations have su##lemented ISO 9001

re*uirements' re$o"ni,in" the value is not only in the standard' but also in its $onsisten$y of

a##li$ation To $ontrol variables' many of the se$tor s#e$ifi$ standards they develo#ed mandate

auditor knowled"e' trainin" and the #ro$ess by whi$h the audit is #erformed

Some se$tors have "one as far as to #ut stri$t $ontrols on auditor trainin"8 others re"ulate

*ualifi$ations and ex#erien$e In ea$h $ase it is the se$tors that know their #ro$esses' systems and

$ustomers They make the determination of how an audit $an determine $om#lian$e

It4s u# to the $ustomers of the auditors

The $lients of the audit are in the same #osition as these se$tors and should exer$ise similar

ri"hts with the re"istration $om#anies It4s u# to the $ustomers to demand their money4s worth' in

both the #ro$ess and the results They should demand a##ro#riate behavior and a hi"h level of

knowled"e and $om#eten$y from the auditor so the end result will be a thorou"h' a$$urate and

$om#lete audit

It4s not out of line to re*uest the #roof of *ualifi$ations' knowled"e and ex#erien$e of an auditor

#rior to lettin" him or her in the door33in fa$t' this information should be re*uired If an auditor is

not satisfa$tory' he or she should be refused and a suitable #erson found If the auditor4s behavior

be$omes una$$e#table durin" an audit' the re"istration $om#any should be asked to dis$ontinue the

audit until a re#la$ement $an be sent

If the audit itself is not thorou"h enou"h to test the system' a $om#laint should be lod"ed and a

re*uest made to have a more $om#lete examination

Sound $ra,y= hy= Of what #ur#ose and value is the $ertifi$ation #ro$ess if it has no inte"rity=


43/60

ISO 1B000 ?evisions ;ikely To &e 6inor

?e$ommendations make additional do$umentation' re"ulatory $om#lian$e and external

$ommuni$ation unlikely

by 6arilyn ? &lo$k

The ISO 1B001 environmental mana"ement standard rea$hes its fifth anniversary this Se#tember

The International Or"ani,ation for Standardi,ation' known as ISO' re*uires a review of its

standards every five years to determine whether they should be retained' revised or res$inded

+t the June 2000 annual meetin" of ISO Te$hni$al Committee .TC/ 20H' dele"ates determined

ISO 1B001' >nvironmental mana"ement systems33S#e$ifi$ation with "uidan$e for use' should be

revised This effort was "uided by three #re$e#tsA

?evisions should $larify the intent of existin" lan"ua"e

;an"ua"e should be modified to im#rove $om#atibility with ISO 9001A2000

?evisions should not be substantive

One year later' a draftin" "rou# has #re#ared its re$ommendations' whi$h are s$heduled for

dis$ussion as this $olumn "oes to #ress ?e#resentatives from around the world will thrash out

$on$erns until $onsensus is rea$hed on the $han"es to be in$or#orated into a draft do$ument for

$onsideration by national standards bodies

It is anti$i#ated the draft do$ument will be reviewed by the -S Te$hni$al +dvisory !rou# to ISO

TC 20H at its meetin" this Se#tember

Of the 29 $han"es #ro#osed' 1 are $lassified solely as $larifi$ation and five as im#rovin"

$om#atibility >i"ht are $lassified as both This arti$le will dis$uss only the most si"nifi$ant

$han"es


44/60

+nnex + un$han"ed

Interestin"ly' no $han"es have been offered for +nnex +' the "uidan$e for im#lementin" an

environmental mana"ement system .>6S/ This is the $ase even thou"h the ori"inal .$urrent/

version notes' %Text may be in$luded in a future revision% in the se$tions on o#erational $ontrol'

emer"en$y #re#aredness' and monitorin" and measurement

So while many users of ISO 1B001 were under the im#ression that these se$tions would be

addressed in a revision effort' there have been no re$ommendations yet &ut ISO 1B00B' the

"uideline on #rin$i#les and te$hni*ues to su##ort im#lementation of an >6S' is under"oin" a

$om#rehensive revision

Definition $han"es

Six definitions in ISO 1B001 have been re$ommended for modifi$ation to enhan$e user

understandin" @or exam#le' definition E' environmental #erforman$e' would be $han"ed to

%results of an or"ani,ation4s mana"ement of its environmental as#e$ts%

Similarly' definition 9' environmental #oli$y' would be modified as %overall intention and dire$tion

of an or"ani,ation related to the environment as formally ex#ressed by to# mana"ement%

@inally' definition 1' #revention of #ollution' would be rewritten as %use of #ro$esses' #ra$ti$es'

materials' #rodu$ts or ener"y to avoid' minimi,e or $ontrol .se#arately or in $ombination/ the

$reation or emission of #ollutants and waste' in order to redu$e overall adverse environmental

im#a$ts%

Dis$ussion of "eneral re*uirements .ISO 1B001' $lause B1/ would be ex#anded -nlike the $urrent

version' whi$h states an >6S must be %established and maintained'% the #ro#osed revision re*uires

an >6S must be %established' do$umented' im#lemented' maintained and $ontinually im#roved% This

se$tion4s #ro#osed revision "oes on to re*uire that or"ani,ations define the s$o#e of their >6Ss


45/60

>nvironmental as#e$ts

In an effort to $larify $lause B1' environmental as#e$ts' the first #ara"ra#h would be broken

into se$tions The #ro#osed first #ara"ra#h now re*uires #ro$edures toA

%Identify the environmental as#e$ts of its a$tivities' #rodu$ts or servi$es .in$ludin" #otential or

new develo#ments' and new or modified a$tivities/ that it $an $ontrol and over whi$h it $an be

ex#e$ted to have an influen$e%

%Determine those as#e$ts that have or $an have si"nifi$ant im#a$ts on the environment%

The addition of %#otential% develo#ments a##ears to $onstitute a substantive $han"e be$ause it

adds a new re*uirement This is likely to "enerate dis$ussion and' therefore' may be rewritten for

future drafts

The draftin" "rou# also re$ommended the final senten$e in the first #ara"ra#h of $lause B1 be

moved to $reate a new se$ond #ara"ra#h The lan"ua"e moves away from a narrow fo$us on the role

of si"nifi$ant as#e$ts in establishin" environmental ob:e$tives to a broader fo$us on the

relationshi# of si"nifi$ant as#e$ts and im#lementation of the >6S

+lthou"h no re$ommendation has been made at this time to $han"e the title of $lause BB

.environmental mana"ement #ro"ram/' it was ex#e$ted to be dis$ussed this summer +s written' the

re*uirements in this se$tion are dire$ted at a$hievement of arti$ulated ob:e$tives and tar"ets

This is not $onveyed by the title and $auses $onfusion amon" those attem#tin" to understand and

im#lement ISO 1B001 re*uirements

Three $han"es have been su""ested for $lause BB2 on trainin"' awareness and $om#eten$eA

@irst' the last #ara"ra#h would be re#ositioned to be$ome the first #ara"ra#h This would $han"e

the em#hasis from #rovidin" trainin" to ensurin" em#loyees are $om#etent' and it would

a$knowled"e $om#eten$e may be a$hieved throu"h means other than trainin"' su$h as edu$ation and

ex#erien$e


46/60

Se$ond' the term %#ersonnel% would be re#la$ed by %any #erson% This would broaden the "rou# of

individuals who must be $om#etent from em#loyees to anyone who $an $reate a si"nifi$ant

environmental im#a$t' su$h as $ontra$tors or tem#orary workers

@inally' a note would be added at the end of the $lause to ex#lain the term %member'% whi$h

a##ears in the #ara"ra#h $on$ernin" awareness trainin" %6ember% would in$lude volunteer' #artner'board member or any other ty#e of nonem#loyee

Communi$ation

The final #ara"ra#h in $lause BB' $ommuni$ation' has been addressed 7ew lan"ua"e would

re*uire an or"ani,ation to %de$ide whether to $ommuni$ate externally on its si"nifi$ant

environmental as#e$ts% This is an effort to eliminate $onfusion that has surrounded there*uirement to $onsider #ro$esses for external $ommuni$ation

Clause BB6S audit would be$ome B


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The se$ond #ara"ra#h of $lause B' mana"ement review' would be rewritten to s#e$ify in#uts to

the mana"ement review and re*uired out#uts In#uts in$lude results of >6S audits' $han"in"

$ir$umstan$es and follow3u# a$tions from #revious mana"ement reviews Out#uts in$lude #ossible

$han"es to #oli$y' ob:e$tives and other elements of the system to fulfill the $ommitment to$ontinual im#rovement

?e$ommendations for $om#atibility

The title of the standard would be $han"ed to >nvironmental mana"ement systems33re*uirements

with "uidan$e for use This refle$ts the title ISO 9001A2000' %uality mana"ement systems33

?e*uirements

Clause BB1' stru$ture and res#onsibility' would be renamed %?esour$es' roles' res#onsibility and

authority% It is somewhat un$lear why this $han"e is $ate"ori,ed as a$hievin" "reater $om#atibility

with ISO 9001A2000' be$ause the *uality standard devotes one $lause .6S manual8 and unlike the $urrent version

of ISO 1B001' it would not re*uire a des$ri#tion of >6S $ore elements

Clause B


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ex#anded beyond identifi$ation' maintenan$e and dis#osition of environmental re$ords 6aintenan$e

would be re#la$ed by %stora"e' #rote$tion and retrieval of re$ords%

It is im#ortant to note the $han"es #resented here are far from $on$lusive ?eaders familiar with

the ISO standards3writin" #ro$ess know every word will be examined in ex$ru$iatin" detail

>*ually im#ortant' however' is the messa"e $onveyed by this first set of re$ommendationsA There

is unlikely to be any substantive $han"e to ISO 1B001' either in terms of $ontent or formattin"

.numberin"/

Individuals who were worried the new version of ISO 1B001 would bear little resemblan$e to the

old are likely to be #leased with this initial effort at im#rovement Or"ani,ations in the #ro$ess of

desi"nin" or that have already im#lemented an environmental mana"ement system based on ISO

1B001A199 will find they have to make relatively few modifi$ations to demonstrate $onforman$e to

the revised version

Those who ho#ed the revision effort would im#ose additional do$umentation re*uirements or

re*uire "reater attention to re"ulatory $om#lian$e and external $ommuni$ation are likely to be

disa##ointed

ISO 9000A2000 )rodu$t Su##ort Initiative

>ffort to #rovide value to users "rows out of standards validation work

by Sandford ;iebesman and Jim 6ro,

hen the International Or"ani,ation for Standardi,ation' known as ISO' Te$hni$al Committee .TC/

1H be"an the #ro$ess of draftin" revised editions of the ISO 9000 series in 199' a si"nifi$ant

"oal was to verify and validate the drafts to ensure they fulfilled TC 1H4s ob:e$tives and #rovidedadded value for their users

Verifi$ation $onsisted of $he$kin" the drafts a"ainst the s#e$ifi$ations des$ribin" the

$ommittee4s understandin" of user needs Validation $onsisted of obtainin" feedba$k from users on

the ability of the draft standards to meet their needs


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Verifi$ation and validation of the ISO 9000A2000 family of standards were $ondu$ted as s#e$ial

#ro:e$ts from 199E to 2000 @eedba$k from #arti$i#atin" or"ani,ations resulted in im#rovements

to the drafts

The su$$essful validation effort made the -S Te$hni$al +dvisory !rou# .T+!/ to ISOTC 1H

re$o"ni,e the value of the validation #ro$ess The T+! a"reed to $ondu$t the ISO 9001A2000

#rodu$t su##ort initiative .)SI/ as a me$hanism for #rovidin" information that will im#rove the

ability of or"ani,ations to understand and a##ly ISO 9001A2000 in their *uality mana"ement

systems .6Ss/

The vision of the -S T+! is to #rovide #rodu$t su##ort and to $ontinue validation a$tivitiesresultin" in useful in#uts for future revisions of the ISO 9000 family The )SI will be a resour$e

that enhan$es the value of the ISO 9000A2000 family' hel#s or"ani,ations $onform to ISO

9001A2000 and #rovides in#uts on im#lementation ex#erien$e to the -S T+! and ISOTC 1H

ho are the )SI $ustomers=

The followin" are $onsidered the $ustomers of the )SIA

Or"ani,ations in the #ro$ess of a$hievin" 6S $onforman$e to ISO 9001A2000

Or"ani,ations $onsiderin" ISO 9001 im#lementation efforts

?e"istrars and a$$reditation bodies

Trainers and $onsultants

The -S T+! to ISOTC 1H

Several strate"ies will be used to fulfill the vision of the )SIA

Develo# the ID>+S .information' dis$ussion' exam#les' analysis and sour$es/ #ro"ram to #rovide

hel# to or"ani,ations durin" im#lementation This hel# will be in the form of information in res#onse

to *uestions' dis$ussion "enerated throu"h a listserv eb site and other sour$es' analysis of issues

and referen$es to sour$es of information 5owever' some *uestions that $ould result in


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inter#retations may be sent to the -S T+! inter#retations $oordinator for ISO TC 1H' 6or"an

5all of the -niversity of 6aryland 5is $ommittee will review these *uestions and determine

whether to #rovide them to TC 1H

6aintain a )SI survey as a me$hanism for summari,in" issues' #roblem areas' su$$esses' $osts and

the added value of $onforman$e a$ross a broad s#e$trum of or"ani,ations

Develo# $ase studies to #rovide in3de#th information about the $onforman$e #ro$ess a$ross a

s#e$ified s#e$trum of or"ani,ational si,es .small with fewer than stimate of resour$es used for $onforman$e

>stimate of value added by ISO standards $onforman$e

The survey is #osted on a )SI survey eb site at wwwas*or"mr#sisurveyhtml' where it $an befilled out online by or"ani,ations that have a$hieved ISO 9001A2000 $onforman$e

6ost *uestions are multi#le $hoi$e' some use s$roll down features and a few re*uire brief answers

The intent is for the survey to be easy to use and *ui$k to $om#lete and for it to #rovide valuable

data for two #ur#osesA


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To #rovide *uantifiable measurements of the ex#erien$es of or"ani,ations im#lementin" and usin"

ISO 9001A2000 These measurements $an be used to alter and enhan$e -S and ISO introdu$tory

su##ort efforts and may be submitted as feedba$k for future revisions of the standards

To #ubli$i,e and #romote the use of ISO 9001A2000 throu"h re#orts of the survey results and

$ase studies demonstratin" real3world im#lementation It is ex#e$ted #ositive feedba$k from ISO9001A2000 $onformin" or"ani,ations will hel# other or"ani,ations in their *uest for $om#lian$e

?esults from the )SI will be disseminated throu"h various mediaA eb sites' +S #ubli$ations'

#ubli$ations $overin" ISO 9000 .for exam#le' the Informed Outlook' uality Systems -#date and

uality Di"est/ and business #ubli$ations @eedba$k will be #rovided to the -S T+! and ISOTC

1H for the next revision of the standards

>x#e$ted deliverables

The followin" are the deliverables envisioned by the -S T+!A

)ostin" of im#lementation information "athered by ID>+S on the eb site The information will be

or"ani,ed by the ma:or #ro$esses of ISO 9001A2000 and linked to the ei"ht *uality mana"ement

#rin$i#les that framed the ISO 9000 revisions

)eriodi$ analysis and #ostin" of results from the survey of ISO 9001A2000 $onformin"or"ani,ations

Develo#ment of $ase studies ali"ned with the )SI survey

Develo#ment of a )SI eb site mana"ed by +S to #rovide $ontinual results of the ID>+S

#ro"ram' $ontinuin" surveys of ISO 9001A2000 $onformin" or"ani,ations8 a summary of survey

results8 and individual $ase studies and a summari,ation of su$$essfully $onformin" or"ani,ations by

si,e' #rodu$t $ate"ories and industry

)ubli$ation of at least one arti$le in uality )ro"ress ea$h year summari,in" survey results

Contribution of at least one arti$le on $ase studies in uality )ro"ress

Develo#ment of several $ase studies as arti$les in the Informed Outlook ea$h year

Issuan$e of a re#ort to the -S T+! summari,in" information about ISO 9001A2000

im#lementation by the first *uarter of 200B


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Com#letion of a #lan to study the use of ISO 900BA2000 for 6S #erforman$e im#rovement by

Jan 1' 2002

@ive subteams

This su##ort initiative for the introdu$tion of the ISO 9000 revisions is bein" led by Sandy;iebesman and su##orted by the -S T+! and +S The followin" five subteams were $reated to

a$$om#lish the "oals of the )SIA

Subteam one' led by 7an$y Jenne:ohn of the -niversity of is$onsin3Stout' is res#onsible for the

ID>+S #ro"ram This subteam will analy,e information on a #eriodi$ basis' #ublish results on the

)SI eb site and #ublish arti$les on results from the ID>+S #ro"ram

Subteam two' led by ?on &er"lund of 6?I International' is res#onsible for the )SI survey This

subteam will analy,e information from the survey and #ublish that information and analysis

Subteam three' led by Joe !reen of KV@ uad Cor#' is res#onsible for $ondu$tin" $ase studiesand analy,in" the results

Subteam four' led by $onsultant 5erb 6onni$h' is res#onsible for dire$t su##ort of the

#arti$i#atin" or"ani,ations The subteam $onsists of re"ional $oordinators who will hel# #romote the

initiative in their re"ions' identify #arti$i#atin" or"ani,ations' hel# them lo$ate resour$es and

su##ort them durin" their efforts The re"ional $oordinators areA John &roomfield' uality

6ana"ement International .6id3+tlanti$ ?e"ion/8 Si Daily' California 6anufa$turin" Te$hnolo"y

Center .@ar est ?e"ion/8 7an$y Jenne:ohn' -niversity of is$onsin3Stout .6idwest ?e"ion/8

Dennis Kelly' !eor"ia Te$h -niversity .Southeast ?e"ion/8 5erb 6onni$h' $onsultant .Southwest

?e"ion/8 ?i$hard Vinton' ?aytheon .7ortheast ?e"ion/8 Ken Sowder' &e$htel &NT Idaho ;;C.)a$ifi$ 7orthwest ?e"ion/

Subteam five will be made u# of staff from +S and the Informed Outlook' who will have a

number of su##ort res#onsibilities su$h as $ommuni$ations' #ubli$ations' referen$es' marketin"'

database and eb site

S$hedule

The )SI was ki$ked off on +u" 1' 2001' with the first dissemination of ID>+S results The

ki$koff marked the initiation of the survey and the $ase study effort It is ex#e$ted that the

initiative will last at least three years

e anti$i#ate #rovidin" information for or"ani,ations that will hel# them effe$tively use and

$onform to ISO 9001A2000 In addition' we ex#e$t to #rovide in#uts to ISOTC 1H that will be

used in the next revision of the ISO 9000 family


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ithin its do$umented *uality .and re"ulatory $om#lian$e/ system' a medi$al devi$e manufa$turer

should have a hi"h3level #ro$edure that des$ribes its C+)+ #ro"ram The basi$ se$tions of this

#ro$edure are des$ribed in this arti$le

)ur#ose and s$o#e of C+)+

The #ur#ose of a C+)+ subsystem is to $olle$t and analy,e information' identify and investi"ate

#rodu$t and *uality #roblems' and take a##ro#riate and effe$tive $orre$tive and #reventive a$tion

to #revent their re$urren$e

@i"ure 1 de#i$ts the s$o#e of a$tivities "enerally en$om#assed within the $orre$tive and #reventivea$tion subsystem under the SIT

C+)+ should be viewed as an umbrella system that allows a $om#any to assess its entire #ro"ram

The s$o#e of any $orre$tive and #reventive a$tion system must in$lude the verifi$ation or validation

of $orre$tive and #reventive a$tions

+dditional elements in$lude $ommuni$atin" $orre$tive and #reventive a$tion a$tivities to those

res#onsible' #rovidin" relevant information for mana"ement review and do$umentin" those

a$tivities These a$tivities are essential in dealin" effe$tively with #rodu$t and *uality #roblems'

#reventin" their re$urren$e and #reventin" or minimi,in" devi$e failures

-nder the C+)+ umbrella' the or"ani,ation should in$lude all a$tivities and #ro$esses taken to

eliminate the $auses of #otential non$onformin" #rodu$ts' #ro$esses and $onditions within its

do$umented *uality system @or most manufa$turers of medi$al devi$es' these a$tivities in$lude

their methods forA

Com#laint handin" .21 C@? E2019E/

6edi$al devi$e re#ortin" .21 C@? E0/

?e#orts of $orre$tions and removals .21 C@? E0/

)rodu$t re$alls .21 C@? E10/


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)ostmarket surveillan$e .for $om#anies assessed under the 6edi$al Devi$e Dire$tive 9B2>>C

from the >uro#ean >$onomi$ Community/

uality audits .21 C@? E2022/

7on$onformin" #rodu$ts' #ro$esses and $onditions .21 C@? E2090 for non$onformin" #rodu$ts/

Devi$e tra$kin"' as a##ro#riate .21 C@? E21/

?es#onsibilities and authorities

+ssi"nment of res#onsibilities and authorities for the $orre$tive and #reventive a$tion system .see

the sidebar' %Key Definitions%/ will vary amon

Quality Excerpts 2001

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