lSrlSO 9(Xl1: 2fl18

AnnexB
(informative)

and ISO90C1:2008
ChangesbetweenISO9001:2000

Table8.1 - ChangesbetweenISO9dt1:2dXl and ISO9001:2008

Prrtgrtph, Addldon
FO 9dtt:2fi10 Flgurc/ (A) or Ancfibd tcrl
Claurc llo. Table/ 9clCbft
ilote (D)

Forewo.cl Para2 D+A in iccodanco withthe rulesgivenin lh€ ISO/IECDirectiws,

lntemationatStandardsareOratred
P6el{ Parl 2.

Foreword Para3, A
S€ntenco1

For€nrord Para4, D+A Att€ntion is drawn to the possibilitythat sorn€ ol the olem€nts of this lFl€f{ali€fal€teffl*Kl
Sentenc€1 documeritrnaybe the subiectof pat€ntrights.
loreryord Para5 o rso soor waspeparedby T€chnicalcommineelso/Tc 176' oua'o
r*erneriener-€*anooe
nanagementand quatityassutrlncf,., SC2, Qualwsystems'
Subcommittee

Fortruord Para 6 o THe ttrird edili+rn el 188 8€er eaneels and replaego $€ @
wilh lsg 9€03:19€4 gld 15€' 9O€E:1091:fr ooretitetoe a l€€hn:eol r€uisien €f lh€6€ deown€nle:
geee:lgg1 and lse 0003:1e94 in th€ goet may uee
Theee erg$i.ari€ne wha€hha*e ,8ed lsg

Para 7 D teng€rin€lttC€€-lhel€+mjetnRy
Forgirvord
r^euran€€',This r€no ^' ^-2"i _l^_ ^ti lC mhaneg

-
;oravord Para8 D AnnexesA-an
8'
Forewod Newpare 7 A Deiails ot ths changes bolwaen th€ thld editktr and ['|is fourth sdition ate giv'en in Annex

1 Para 1, D
Sentonco 2 iy |larylng n€eElt -qrysuEr Ests
ri@

A The desion and implementetion of an organization's quatity management system is influencod

by
risks associated with
a) its organizational slvironmenl chang€ in thel €nvironm€nt. and th€
thal environmsnt

b) its varyino needs:

c) its parlicular obiactivgs:

d) the Products il Pro\rides:

e) rhepracEs6jlsuhus:
strlciure-
L0 lts sizeendorgianizational
quality
Sontenco3 Nowa It is not th€ intontof this hte;nationqlStendstdto impty uniformityin the structureot
new pela managle|nsntsystemsor unibrmity of documenlation.

).1 Para4 A Th|3 InternationalStandad can bo useObY intornalend extornalpartbs, induding.cartification

boder, to assoss tho ofgEnization'sability to m6€t customor, statuiory erd rogulatory
requtrementssnplbgDhloltn-gglllst, and th€ organlzatorts orvnr€quir€m€nts.

0.2 Prra2 D+A Forrn orgEnizationtrr func,tiondbcti\€ly, h has tc igs|itr lhlgmine and man'go rlt'meroul
inl(edactirilhs. An activityor ret of activitiecusino rssouroos,and man8g€din ord€r to €nablc
h€ henailorieton of inputsinto ouFutg' can bs cqridercd as a prooeos'

20
 lS/lSO 9fi11:2m8 '

Table8.1 -Changes betren ISO9fi11:20fltand ISO 9fl11:2flt8 (continuedl

Pangr.ph, Ad!fron
Flgurd (A)or
TeUd
Afutxt
Cl.u.c llo. ErLlh
Nolc (D)

o.2 Para3 A Th€ applbatirn of a rystom of pmcesseswithinan organization,tog€therwilh tho identifcation

ard intsractbns of th€so prcoessos,and thoit managem€ntto prcduca,lhg-dasir€d-oulcamg,
can be r*n€d to as th6'process approach'.

0.3 )ara 1 D+A TJq€f.eoen+€ditieec€TIso9(x)1and ISO 90O4@ are

quality manags.nenlsystemstandatdswhbh have been dssign€d to compl€menloach othsr,
but can also b6 us€d independently.
a'*

1.3 Para3 D+A

b+eeemnt+wgeaee
At lha tim ^f 6rrhli.-ti^h ^t thia lnte?nrtiond Standtftl ISO gfi|4 is under terrbion- Tho rwisot
edfton of ISO gO(X will provide guidance to manag6mant lor aciie\ring sustained success fol
nru omanlration in a mmnlan demandinc- and srrsr chanoino- gnvironmgnt. ISO 9(xX orovlles
a wider bctls on qualiv menagoment th igol
of all inte.estsd oarties and their satisfaction. bv the sv$ematc and conlinual imorowment ol
lhs organizetion's p€rbrmance- Hou,6\rsr. it is nol inlended br c€rtificelbn. rogulatory ol
contractral us€-

).4 Para 1 D+A Thie Intsrnedona+ €tandardFa€ been alignedwith lSe 140eli+996in erd€r lrr enhane€lh€
s€rn atibalilyef ttr€ turgstand
! n..i-^ A^ &-h^-^^j ^t rh!- l^16'-6r;^6-l Qr-hd.rd .ftra .^hairlaEthi wta d6n l^ lh.

rmisirme of ISO I a(Yll .2oM to anhrn.i lhq comoatibilitv of lhe two standards for the benofit o
I'
f
fia rrqr ffi6r rnitu Anncv A qhils lhr mrrasmndence betur€en ISO 3001:2008 anl
ISO 14(X)1:2fiX-

1.1 Bullet a) A providsproductthal meetsajstom€rand

a) needsto @monstrateils abilityto consistently ll
statutoryand regulatoryrequirsmgnts,
applicablE and
i
Bullet b) A b) ajmsto anhjrncoqrstom€rsatisfactionlhroughthe effectiveapplicationof ths syst€m, l,
includingpr$s€s br continualimprov€ment of the systemandthe assutancsof contormitytol
customerand applirnblestatutoryand regulatoryrsguiromenls.
11
Noto D i
oF€Sui€d+t#€lemor
il
A Slandard.the term ?roducf onv applissto
NOTE1 tn this lntomational i
a) a orcdtrctintendodfor.or r€quiredby, a custom€r. j
I
b) any intended ouFul resulting from the product realization procelisas. I

New Note 2 A

1.2 Para 3 Wh?re exclusrons alo made, claims of conbrmity to this lnternational Standard are nt
acceplable unless thgs€ exclusions are limited to requirsmenls within Clause 7, and suc
ex':lusions do not atfect lh€ organization's ability, or responsibility,to provide producl that m€€
customer and applic,ablsstatulory and regulatory requirements.

2 Para 1 D+A The follewing normativ€ d€€urn€nt €entaine p{ovi€bn6 whichi lhresgh .€feren€e in thi€ tg|
ougeeque
amef,dme*+

applying lh€ mr€t re

+e{e{€f,€s€r{€€ratoEtediti€n ef the normati\€ Co6umentref€.r€d leapplies, Membe.e of lsg a

A The lollowing ref€renced documents are indispensablo for the applicalion of this document. I
dated referglces. only the odition cited applies. For undated ret€rences. the latest edition of I
referenced document (including arry amen ies,

D+A fSO 900O:?09s2Q05. Quality management systems- Fundamentals and vocabulary

FYFiO !001 :20{18

T.bb 8.1 -ChsrgeE bcrucen iSO gmlf,C0ornd FiO9m1:2fl18 (continued)

Irr{rTt|, ffi
FlflIItt4M Figurd (A)or ArrG#brt
Chu.. Io. Trblc,
IoiG (D)

Para 1 D+A ro, tre prrposes of this lhc|lmnl |trbnr.Jal+|adeil, th€ t6rms and dsfinitions given in
ISO 90m apply.

3 Paras2.3 )
@ '-'T!list' r3ed h |se g€gl:t994,endreb|o te {1€
rhe'tern b€etbdion' ropttcsotr€ brm
'
slee*e**

1.1 3ulet a) D+A r) ilsmfy fbtemfrin the ptoccss€si!.ded br the gualitymanagpmontsystomand their
rpplicationthougfrout lho organization(.ce 1.2)'

4.1 Bullete) A ?) monitor,measureUhe&ldi:abh, erd an$pe thes€ processes'ancl

4.1 Para 4 D+A Wherean orggnizationchoos€sto otJboutooenyprocessthat afiecls productconbrmity utilhla

requirementithg organization shallensurecon6l or€r suc,hprocosses.Thqtyp€andextentol
co;trol to be applied-totheseoutsourcedomcecsesshalt be definedwithin the qualiry
management syst€m.

Note1 D+A NOTE1 Process€s needed br the quality managementsystem referr€d to above €h€sl6
includeprocessesbr managementactiviti€s,pfovisionof resources,produclrealization.and
measurement,analvsisand imptoirement.
loutsourced process' is a procsss thal ths organization. neodF.for its qualis,
4.'l New NOTE2 An
Notes 2 & 3 ,.',"nioan.,"nt "r"tr- *d ,rhi.h th" or*nizrtion "hoo."" to hrua oar{oraad bt "n art.-"t
padtr

responsi6ility of conformity to all customer. statutory end regulatory requirements Th€ type and
oxtent of contrc{ to be applied to the outsoulced process can be influenced bt' lactors such as
Jlie porential impaci of the out'ourced prmss on the organization's caf'ability lo provide
product that conforms to requirements.
b) the degree to which the conlrol for the process is shared'
cFfhe cai'ability of achieving the necessary control through the application of 7.4.

1.2.1 Bulletc) A Standard'aNl

c) documentedppceduresalrl-lg&offlsrequiredby this International

Bulletd) A+D ri) documentsj0cudrogltratds,ne€deddeterminedby the organization lo be necessarvlo

t.2.1
ensurethe etfectiv€planning,op€rationandcontrolof its proc€ssesand

4.2.1 Bullel e) D
'documented procedure' appears within this International siandard,
4.2.1 Note I NOTE 1 Where the term
this means that th€ procedure is established, documented, implemented and maintained A
single document may addrFss ['l€ req|irernents tof one or more procedures- A requirement for a

A
') to ensurethat documentsof externalorigindeterminedby the organizatip.n
tQ.be.ne@SSaIy
1.2.3 3ulletf)
br the planningand operationof the quality managemenisystem are identifiedand their
conholled,and
Jistribution

4.2.4 Para 1 D+A Records ehall$e established aFCfieia{ain€C to provide evidence of conformity to requirements
and of the etfectiv€ operation ot th€ quality management system shall be controlled. Re€€fd€

The organizati-onshall establisb a documenled procedure shal+-be-eslabli€h€d to deline th€

contrG needed tor the identification,storage, protecti|)n, retrieval, retention tim€ and disposition
of records.
Records shall remaif legible- readily

A management
i"j r"n"g"ntent shallappointa memberof lbe organization's of
who,irrespective
5.J.Z Para 1
andauthoritylhat includes
shallhaveresponsibility
otherresponsibilili€s,

6.2.1 Para
.l +D Personnelperformingwork affectingconicrmityto product quality reouitementsthall De
education,training,skillsand experience'
competenton the basisol appropriate

New Note A NOTE Conforrnity

performinganytaskwithinthe qua

22
 lS/lSO 9fl!1 : 2flt8

Tabfe8.1 - changes betncen rso 9fllr:2fixt and rso

9fit1:200g (continuedl
Paragraph/ Addltlon
lS0 9001:2000 Flgure/ (A) ot
Clau3eilo. Table/ Delc$ee Anrended lert
Note (D)
5.2.2 Clausetitle A + D u4nrng ano awareness encHr€inhg
8.2.2 Bullets A+O thonec€ssary
a)&b) :l- j13TiT: compst€nce
cl qualivrequirements,
forpersonnliperforr@
ProCfu
b) where apolicabr€, provido training or tak€ other
actions to €a$sqHhs€e+€€d6 achieve the
necessrw oomoetence,
t.3 Bulletc) A q+rllr ttr tg lsucnas transport,comrnunication
or informationsystems).
6.4 NeYvNots A

7.1 Bulletb)
-
lA + O b) the need to ""f"U
product;
7.1 Bulletc) v, 'er''ev rs,,,rwrur. %rruar*xr, montonng, measurement.
inspection and test activities
spectfbto theprodrctandthecrireriafo, projucTiGffi";
7.2.1 Bulletc) +A v, -q(urer)r anq regutarory requrements r€latsd
apllicable to the produc{, and
Bullotd), +A d) any additionar reqrirements d€toffiin€c considered
necessary by the organization.
NewNote
orovistons
recycllng or find disposal. ,s_suo-as
3.1 NewNote
-
NOfE DesignanOCFt/e

7.3.2 Paa2 lo + e ''* Js 'rpurs snar De.revrewect br adequagy.

Requirements shail be comprete
Jnambiguousand nol in conffict with each other.
7.3.3 )ara I D+A ' "e vu+'uro sr qss{rn ano oe\€'opm€nt shail
be pfeyided-i"*-d"f*_tha+.nabres in a forn
iu.ilabl€lat verificefion against the de-signanu oevetopmeniinput
and shail be approved prior tc

7.3.3 Bulletb) o qPl/.spilqrq tflrormanontor purchasing, production

and br sgrvice orovision
7.3.3 New Note A

7.3.7 Paras1 & 2 No text -w,v'! g.'v ss'e,r,',,.rsill qnanEres snal D€ rctgntltied
and records
maintained. The changes shall
change. be rerriewed,
wrified and vaidhed,.as "pp.d;t,;;'Jpprou"o
Paras rwiew of desig'land daneropment beforeimpremenrarion. The
changessriarLincruJe Jaiuation ot the effea of the ctranges
now on constituentparrs and productatreacryoerivereo-
mergsd iecords of the resurtso, the reviewof
changesand any necessaryactionsshall'bemaintaineJiseeq.z.+1.
7.5.1 Bulletd) D+A $,v qvgtrqv,{ry qilu use or monloflng
anO measuring danieee equiomenl,
7.5.1 Bullet0 A 0 tho implsmentation
ot t
7.5.2 Para 1 D+A Theorganizationsha||Va|idateanyprocessesfo,p,oou"tioffi
resurtingouFur cannotbe veriti€duv,syosgcygntrnonirorinior r"""urement T$ieinefudee-aal
ffi.*a*L as a conssouence.
deficiencies
becomeapparentonryaftertheproductis
ln use or tho sorvicehasbeendelivered.
7.5.3 Para2 A The organizationshallidentif rh€ productstatus
with r€spectlo monitoringi.nd measurement
requtrsmentsthroucfioutoroduct reAliTetil
7.5.3 Para3 D+A r''v'v 'ses@,'(r ru d raqurremenr, rns
organization shail contror ank€eFd the unrque
dentification of fre product and maintain recoris
i;;;.m.
7.5.4 Paral, D+ A !' ."', vsors"qr ',rep€rryrs n,sr,oamagedor otherwise
Sentence3 foundto b€ unsuitabr€
for use,rfi+ehdl
@*defiaintain€d@
customerand mahtainrecords(see4.2.4).
Note A NOTE Custornerprop€rtycan includeintellectualproperty
and personatdata.

23
lStlSO 9d)1 :2fl18

Tabfe8.1 - changes betwrconlso 9001:2dD and lso 9001:2fit8 (continuedl

P.r.gt4th, Addltlon
F (r lttr !:ann Flgurd (A) or Am.ndadist
Ghurc l{o. Trbb/ DcldeF
llot (D)
processingand d.etiv€ry
r.5.5 Para I D+A 160 o,sani.atot ctrattposeno-tre ee*cmilet prquci dning ht?rnal
intgrded desdnaltm in oder tlr meinteinmnbrmitv lo r.qdrareOlt. +hio Ap appJicaHo'
to the
p,"".rotion shall indrxh ioenrincamn, handfing, pad€sns, storags and protection'
brseerrrationstraltalso apptyto the constituont parts of e product'

7.6 Tide D+A Control ol moniloring and moasuring dqri€€€lqtli@gol

7.6 Para 1 D+A rt'"o'g.ni."tl*sha|td€tarmineth€'nonitoringandmeasurementtob€undertakonandtho

of
ilff1g ;"d measuringdeiooe sguimed ne€ded to provid€ sridenc€ of contormiiy
Drcductto dslermin€drsqrirom€t$t {e€o+itl).

7.6 Bulleta) A aluecarroratedorrerified'q-bolh.atsp€cifi€dht,srvab,olprio.tous€'againstmea$Jrem€nt

no such
sianAarC"tta"""U€ to inl€rnalionalor nationaltneiasutam€ntstandards;where
(ree-4.2Jl;
atandard3€xist.th€ basis usedbr calibrationor verificationshall b€ recorded

7.4 Bulletc) D+A ;

ci harb ident'ficathn in ordor to dstelmine its calibretkrn sia$Ig;
(see 4'2'4)'
r.6 Para 4, Nownil n"-rO" of ttt" resultsot calibrationard wdficalbn shall b€ maintainod
Senteric€ 3 para5,
rithout
change.

7.6 Nde D+A

wouta
HOrg Confnnetionot t|e alitiv A comFurerstftare to satisrythe intenOpaaqpti*.lbn
ilffi-hEEEverir.rcarkrnFconfiguralivr managernentle maintainils suitat'iliryfor use-

t.1 BuS6ta) D+A N) todemonstrateconbrmity@'

New Not6 A rr^E r.^ir^;M ^'dMa' mn induds obtainino inout lrom sourcegluah-gl
mredirn
,.2.1 ryeyl
dlusinass anabtsis.comoliments-mnanry daims and dederlQgd9.
i
lhe
,.2.2 Para2 lA I}g-"le"t*o|auditorsanoconcuaofauditssha||€nsuroobjectivrtyandimpartialityo'
Sent6rrc83 | ardil proc€6s.
Adocume -e0$llll+rusugrr*r
t.2.2 l,l€lr Para 3
nsdtc

8.2.2 Para3 Nor rtre reepeibHffiee ang reguirernsntobr planning ano oottd€€tittgeudits' ond+eF+epe*ing
para 4 F€stt+{i d€€um€alo4fio€odt}|c
D+A Rsrds of tho eudtb;nd thsh rgsulrs3hel be maitrttin€d (se€izil

t.2.2 Para 4 Now rt'"'*"g"'"ntregporrsib|ebfthoaloabohgaudit€dshal|ansuretha|anynocegserv

Sontonce 1 gara5 ,orsaions- anA coneairm actions are tak€n wilhorrt undue delay to €liminats detoctod
ronconbrmitbs and theit cau8es.
See lSol9olt for guidance'
9.2.2 Note D+A
as
s.2.3 Para1 D when planned r€sults ar€ nol edliorod, coat€c'tbnand corf€Gliw adion shall be takon,
Sentence3 approp-riat@.

t.2.3 N€|v Nob A --^ -*hr .ffi.i.ta t6 mrtr of ils oroc€ss€s in relaliAnl(
- *t tf*Outn""t of th" Ou"t'O
nanagemenl q,istsm-
product to r'8rity thal
8.2.4 Parat A Th" "rr""Eat"n ah"ll r-iror anc measure the draracierbtics of the
prooua loqJrr€mqrts harr€been metl'This sfiall be caniod out at appropriatostag€s of th€
'ptooua
t*Jr."rion ptoooesin accordancarvithh€ Plannedarnngements (see 7'1)' Eviftnce-ol
conb?mitywith |he acc€pilancacribtia lhall be maintahed'

D+A ecordsshall indicat€

Pata2
the person(s)authodzirg ml€ssoof prodrc{ br ddiyErvto th6 customor(s€o 4.2.4).

Pa'a 3 D+A M Tha rdera of Product and deliwry.of seruicq to the

.-r-t"t rtnil nA prccood nrdf Sre-pbnnedatrangetnentt (!€e 7.1) Itav€ beol catisfactodb
c",tftoi"d, mbo!;$€ilile aepmrt by a rtnrf Euftqfiy and' nvhereEpplba6o' by fic
oJElormc

24
 ISflSO 9001 :2008

TabfeB.1- changes betweenlso 9001:2000and lso 9001:2008(continuedl

Paragraph/ Adrllian
ISO9001:20d) Figure/ (A)or
ClauseNo. Table/ Amendedtext
Note (D)
8.3 P a r a1 , D+A @ibili{,ies and asthoritiesfer dealing with nen€enbrming pr€ds€t
Sentence 2

3.3 Para2 A Where applicable.the organizationshall deal with nonconformingproductby one or more of th€
following v/ays:

8.3 New A d) by tlking action appropriate to thq €ffects. or potential effects. ot the nonconformity wheL
bulletd)

Para 3 Moved to neeergs-+gn

be Para 4 €en6€s6i€ns ebtainedr €hall b€ rnaintaired (see ,1,^,4)

Para 4 Moved io When nonconlormingproduct is corrected it shall be subject to re-verificationto

demonstrale
be Para 3 conformityto the requirements.
Records of the nature of nonconformitiesand any subsequent actions taken, includinq
concessionsobtained,shall be mAintained(see 4.2.4).

Para 5 Now new Whec+eneea{e+mrFgpr€du€f i€+e{e€t€d€ft €{d€liYery-ero@

bulletd) take€€lieFafprepr;ate te the effe€ts; €r
Bot€r*ial €f{e€le;€Fth€ nen€enfe+mitv.
8.4 Bullet b) D+A b) conformityto productrequirements(see+el) (see 8.2.4).
Bulletc) A c) characteristicsand ttends of processosand producls,includingopportunitiesfor preventive
action (see 8.2.3 and 8.2_4),and

Bulletd) A d) suppliers(see 7.4),

8.5.2 Para1 D+A The organizalionshalltakeactionlo eliminatethe ett€e causesof nonconformities

in orderto
preventrecurrence.
8.5.2 Bulletf) A f) rwiewing the effectiveness of the corrective action taken.
8.5.3 Bullet e) A e) reviewing the €tfectivoness ot the prevenlive action laken.
Ann6x A Atl D+A Updatedto reflect ISO 9001:2008 rnercus/SO t 4OOt:2004
{nnexI Atl D+A Updatedto retlectISO9001:2OOB
versuslSO go|t:2000
Bibliography New and D+A updated to reflectnew standards(inctudingtso 9004,cunentty under revision),nrn "dit,on" o,,
amended standards,ot withdnwn standads.
references

25