INTEHNANONAL STANDARD

Et4

ELL,tt,E,,tL.It,.

tat1tttIt]t14at,-

14|2L).t).

tt).

l.?It

E14)t).t

F

Ouality management systems - Requirements

For rh6 pu'ro6$ or thh docun€nr' rh€ rams md dsrhhorc or€n Ln LSO S000 spplt

nal shnda'd whoE€t lb6 bn !6duor 4dF' I et

quiGmo . Ior a quariv manaqemsnt

d nss& ro damoNr* lb abilrY

" iili-,-"-. r'"*."r a rn" it ro crrodo ad 'pprrdrs

acm.9de..oi|ysppbs|o

d) prcdld hmdd 64 di ruqur.d bv r 5bh6r,

d ary i€i@ ourpd r4dr no ton s6

aE gtm'c fd r€ htm€d b b' appll@hls b s'

o'qan|z.h3'69J'd6!o|typo''b

storaSEndaJd@11db.apo'9ddJ

or'om'tybtrE|..oludo-ashroa:;i;J;; ;ii: 4d b.q,,".*";fii; ;;:;";r r. . p'-b"

" iieo ' ddh o v rd .quraba

2 Normallve r.tercnces

"il iii.i "ir"n'i;a;" . "a *p,,

{ n. !d'iq sny amandm.nb) sPPlb3

sa*oo:2aa5, auary nan'gffi$t .!s

3 Terfrs and detlnlllons

4 ouallry monag.denl sYsl€m

!.1 Gener.l tequlremonrs

-dru:tu h',M 'berhdwns, n

' + o q u a l l y m a 4 a g o m P ' l , y { " _ a d

b) doismino bs sqFrcd aid hbrac

c) dersmrn6 cr 16ia and msrh'is n

d) ens!6 rhe dLbb lV or 'Fourca

E mmib, nssrewhoc apprbd.. md

r) hdsnd' *1oN ree$arv b *hres pLannad rcsu rs aid conrinual mp @s

#i;*ir"lt**]*;";'""*:: :"r"", ":rr:' l;#*l :;;lr'Llf*i*.

";i'ii'i' !.;i:"' *" r

"a a ' i nq'rc'" ddr " do " "oa'-l

I"iii*;:';11,T['[ #i;;i]:if,:iiffn:xx1'fii",fi?ifi:ff1'fltr'l'J l:ff :""ff#'lyll":iTiJTi:f lesssibghildcdbyhdociaas

d pce$ oi h6o4anbtoi3c4ablg

4,2 Docrmentarlon Fq!lrenentt

a) d@umenbd *lomsits o' a qualitv porbv and quarrv obiscljws

c) dod m6iiad procsdu rcs and Gco

a

'9.

g

L14)^

L.)-a:

1;L;14L)-

l,P)-t-LLLItItItltL.1..L.ItL'tat4LtItL.1..14

?l2

Pt".

lso s001:2003(E)

y bm 0 tps ot m6d !m.

ainbtraqla|itymanlalhalincrudss

a) 6o s.ops ol dr6 quality manasa d judiri*ror lor any srcusions

b) rh. d@umenr€d prcsduGs 8*blishsd 'or 'he qGrny mmas6n r sy6

d a desrip'im o' Ih. ilo@bn ber@oi rho pr66sg€5 ol fi€ quallty manasomo nl sysl€n,

ocunor .q,i,"o uv rie qulv n d. F.6*s a€ a spadar iyp€ ol

4 b appp6 ddunmb ror ad6quacy pr s b iss€,

b) io '*bw and updara a n0c6sary

c) ro oisus rhat chans$ and rho cu

d) b snsuG that re o€ii wcions o' appli€b € docuh€nb ab avaiiabl€ at Porft or u56,

s) b onsurc rhar dodn.ib 6marn I

ao'igh@t'_in6dby'hsotsd]zdn

s) toprew !i€ uninrendsd uss or obs

Records $lab shsd to dry d. ovldanco or diro'mr! b 'squiremonrs anquar t mdaq em€nr sy.t€m shlr b0 @iftnod

F.@ds shall 6nah r6eibrs, Rdiv d

ManrqEment resPonslbllltY

s.l Man.genentcommhnent

qua|itymanagsnan|3yslsm,ddconihuaylmprcvigib.'ledi€n.sby

') commuiicarins b $6 oGaniarioi

b) edab lsrinq tha qua ry polict

c) ansuins that quality obladtes a€ gsbblFrEd,

d) €ndlct ns nanaeement rwltus aid

6) enedns rtu ava abnit d resomes

a) is apprcp'ids b r[6 pu'Poso o' ths o4an za' on

b) ricldasacommiheiiloconpLvw 6 rhs sfiatlrv6nBss or 1h6 qualilv

manaq€manl sysem,

nd @iswinq qtrarrrv obiacites

s@]ew€dlolconlinuinqsuilabl||y'

YT't.T

7't

T

TT

YIYY

TI

IT

t

Y

r@ mraqemd sharrereferhdq6rivdl{rss.

;.d$Ebadid FffihFd.'h ba qFrt'v po r.v

a) rhe p annLng or rh6 qua v hana96as*6rsrh.qla lvoblodiws aid

b) $siniog't otlhs quaitvmanas anqs to rhs qualirv nanastnod

i-d-thd"*";d b.@, rcq,r'Mswl'hinlh6oN'izatronTheqUJtyobedvssha|L

5.3 R$ponslblllty,lulhorltvard..nmun|caron

5.5'1R6pons|b||llyaid'ulhodly

gZaaLLE1-t;La4Lltl-Pl-)-

)-

)-

14ItItIt)-

LIt1..ItL.L.LLLa,aLP?Itlz1414Lt.f.F

s.5.2 [r.n.s.mnr r€pr.ronbrave

lV and aurhoiv ,ar in.lud€s

r) ens!, ns drat prcc6s6s ns€dsd lor ts quarrry manaeamsnr sydsm ats

b) ,opodns ro 'op ndnaqonsnt on tha ps'lomanca or b6 qualiry manas

c) €nsuiis dr€ prcnoron or awaGi

NoE rh6 GFroibr't d a maiaems

n rabs praca Gqadins rho Btudwr€ss or m6 qua ty nsas0n6nt

rop hanassm€nr shall wi€w rhs olganlarionl qualiry managsh.nt sFlom, d plmmd ld€daE, ro .Bm. lEconrnliiq surrabllry adaqu&y and

g3lolhoqua|itymadaqomanlsy8lsm'ic|udhq$€qua|[yponcyad

dr b6 mrdrarred (s. 4r.1).

Tlrs idgut b Fanassn€nr t4r6w shar

c) pree$ potdhanB md prcduo' @iromrrr,

d) srus or p@onri€ and corcdlre aciiom,

6) io lq.up acirons r6m PBlo6 m

0 .hadesmd6urdaiadrh€q€rrymanaesnsnrsyslaniand

s) rc@nmondatrons lor lnpMh€d

l.a sharr rnc ud. ey dsrdons ffd actroF B abd to

a) imp66nod or Iha atrsllwn€ss ot ltu qlalry haiasohent lystam ed rb Pro@369

b) imprd6hod ol Prcdud Grarsd b

ea) io imp em€nr aid nainh n tho quariiy manaeemsnl $rsm and mirinua

b) io sihan.a cudoner salc,ac' oi by

on lom i t y top6du . i req ! r cmanGshabs

s6ib6alebddtsdLyolhd€lybypoEomd

a) dersmrtre rhs iac6ssary empo k afisctns dnromiv ro producr

ab other aclions ro achred tho nedssry comp6'6nca

ua irv obi.cri6s, and

mahb i aPprcp'iat€ &ords ol sduar

66dedloacliowconlorfrityloprcdu.ircqui€menc. lnrr6rtrdus n

4 bu rdhss, wo,k.pms fd asmiakd uinl6

b) p'o.sss €qu pmsnt (bdrh ha'dwar. and €orsarc) and

c) suppoilnq soMss Fuoh s tampon oommu n halron o' hromarron svsrsns)'

s p s f u n e d i c t r d n g p l $ . a 'hnp660rc,hlndiyrlhbgqWh64

LE

LItl"t"bLLL.L.L.LtItItL.It14ItL.L.1414ItItl/t,a)L.la14,2

?L.bF;-

ISO 9001:2003(E)

7,1 Pr.nnhq ol pFducl @llallon

", Lat;" shair b" 6dsr.bd * h 'li€ | rha qua rv manasonsnr sld6m

ri planning prcdud Earl2atoi, rli€ orlanlalron sharl ddcmho b€ d owhs, s apprcpnaF:

a) @ariq oqet€s and Gquicm.nis rq tha pbd@l:

h) th6 nesd ro dhbr sh pmss6s6 and documonL, and 1o prolido csourc$ spoc lic ro rh' pEduct

c) 'oquidd v6'mdion, valldation, mopodud sd ths dfi.rb tor Pbdud eepb..:

dl D@d6 n..d€d Io pdid6 €vid€rca rhat $€ Earrzallon pr@s$os and Eullns product m0or rcqurEm6nts

Tha olQut ot this plannins .hall bo In

NdE r A odr.n sp&!-r h! prco 'o & ser. plod obldo'c'nkr€

t me EquEmfb ers h 73 ro he

z2 cuslom€rBlaledpec63..

?.,.1 D.b;d'o" .' €cd-.*

ft6 oaanlarion shdll dst€mlio

d ruou€m6nb3p&n6dby lhoou66 | | re ' yandp49rd0 |h lyd i l i s ,sns but nscase'v ror spaortr€d or 'ro

o) sbtuory and Esulatory requrcmdaEd nsssary bY tha oamraen

?.2 B.vraw or qdBn.nlr Elarad ro rh. pbducl

' "illi.-*i;;;-

*-r o -dpt a pbdi, b 16 cus'oma, (o s su;;e,ir d de". a@pLrca o' d"-ssE b wd3 o o d.6) rd lran €n*c hl

b) @rftd or odd rcquibm€nb ditr6

cl th. o4anizarron hs lh6 abilitv ro n

whsrc lho dstomst Ptdrdas no dooconrimad by rha oEmlElon bsioG accophnB

b) enquidos,co 66oroderhand

c) dsbm6'kodback,licludiiocustomercompLarnb

7,3 Deslgn dnd deveropmenr

Irhadsllqn anddselopm6nrorprcdud

rannins bb o'sanizaliod sharr d€hm n'

a) th6 d6s sn and dowropmed sasos,

b) ihe d 4, w. rimlion and Erdal

c) rhs 'dsponsrbiLiri6 and aulhoririss

m € lHodw lo rmda mmd.

P ann ns ol$ur shall b6 updar6d, as apprcp'iate as rh6 d6lqi and dM opm€nt prcs'63sos

;;"d s'.',.v", -'."."-"".

lain€d lsoa 4 2 4) rh€s6 hpds

a) tundioiai and padonanca Gqur€msdF,

b) appricabra stauorv and '6qurbrv rcqur'mails

c) rh6r€ applcab a, irormariondorv

d) ohar '.qunsn6ic .$6ntiarror dssioi and d46 opmonl

7.3.3 D6rsn and d.velopmenr ourplE

doGroemantinpd sndsharrbs sppdsd prorlo Graa5a

'1

lIJJIJ

,t

I,|

IaI,|

aI{

I

tu,

aaLL,L.Lt-L1-l-tLl4Lt)"

|a)4)..

Lt)-

LItItItItItItIt1..1..L14L.1..)tLL.

EIt14111..LL

F

lso 9001:2003(E)

Dasien and d6€ropm6ii ouFurs sha I

a) n€ar rh6 iipur cq! 6nenb ror d€

b) prcuds spprcp ar€ inromafon ro

4 conb n or Ers€ncs prcdud s6s

d) spsrry rho chahcto'L,lrca or {i€ p

prannsdaftissmsnb (Ps7.3.1)

r) id ovaruara rh. abrly o{ rhs Gurb or derqn and dmtopmanr ro mool Eqqk€h€ft, and

b) ro rdsn$y any prcbrero and p6po

dwsropnsd dass(E bsrns r4iawd. nd mv mssary dms ahar b€

vai, caloi sha r b6 p6'tum6d n acmdanca wftn pannsd aGi semenb (ss 7.3.I ) 1o on*rc md $s dss s i

o-s 5\at bd mr' b'r6d (r.6 4.2..).

snnsd sransamenrs (soo 7.3.1) ro

6r pEclicabts vandaron shalt bo oo

D6si0n and d4aropm€nt chansas sha

3ny nscs$ary acfoc Ehar bs

ro lperr 0d pu'cha. €qurcm.n6. rh€ tF6

"i" i"'i:,"i":i q"r".*" cn.'r roi$kdhn

iiii""lili"ii" i"i . ;ii;"t,a -" "

a) €quir.nenb h' apprcv.r o, prcdu

b) GquiGmon6 ror quarmcadn or psGoni€r' and

.) quality manasomanr sysbn cquraman's

qlscy or .Psclrrad Puchd. .6quiGh

',{'3V.||canonolpudh$.npoducr

pu(has€d p6dlcr m6oE spocrred Pu

l:""'ii-:.i.i-1i''i"- "';iJ ;-"a

"a-*'- "dis;."ts *d "'hd

d

7,s Peducrbn and 3€mlc. Provrsron

7.5.1 contrct or pbdu'$on .nd i.'rcs pdl.bn

.4dbhdrcndiom,fu|in.lUda'sa!p|ksb'

4 rh6 a€ikbrLny dr inro.mdron 'h3t d

b) ihe availabilty o' rcd< Insrrudiois as is.$arli

c) rh€ Gs ot sihb € oqu pndr'

d) be ava a6lity and lss o' nonlro'

6) dr6 hprsh.n'aton or monrioins a

0 0i6 imp €msntalon or prodlcr 6re

;-;;l';;;;d - ",*4*".":;;;;ri;:; sr€, i oodu; s 1 rs o hr' $v6 f^ bom @ €-d

vafdalion 3harr d€monsvat€ ths ab tv or 'h6€ pffs$s b &his c'Md c$rb

ssm€ibto.1h6sprds$tsincldhq asappli'at'le

a) dsfiion c'ib'ra ror rdisw and aPP

b) app@.Ior sq pnsnlandqlarft

.) s. or sP.drr m6sode ad p@6duGs

L

TELt

t;L;.-

1;1414l4)2l.b2l414)4L.)-

LItltL1..LItL.L.Lzl.L.La.1..

Elalz

E11l-

F

rcquidnsr. b, Hdds GF 4.2,.) and

7'5-3|d.nl|'|oal|onandt'eab|lhy

M rdsn[t rhs prcdud bY slrbbls m*

idsni{y thd Poducr shtus with dpe

wriaGIGcoabi|ity]sa€qun6m€n|'l

dii lmlbihdtrigEn8nltsansaE6y

lh.uslomolplopodywhsithundelG6dbydr€oEaiE'lon'n]asganialionshanld6nti|y'€l|ly'pol{iaidgbguadcudomslprcpsdy

€prcdud'|layc6lom*pmp€dyhd marntarn re6'ds (5€e 4.2.4).

NoccudmUprcFydhdd6h|dbdm|p@6nyandpg,eiadsb,

7,5-5 Pr6srudlon or prcduol

haid ins padiaghs doEsa and prct&uor. PGsmfo n ehar d$ appry b ri

7.5 Conrrcl othonfionng.nd na.srrlng .qulpment

dasvid€rcso|mlomllyolprcdudlo

who€ nsmsary to €nsuE €l d rusulb,'me*uiis dquioh€nt shil

ai s@ri6d riioMls, or prlor ro us, agardd n6asurcn6nt si4dads

I bd .eodod (!as 4r.4)i

b) b. ddjusad or rs.adlusr.d a5 ne6ssa'y;

c) haw rdsdind on h odff b ds's

d) b6 sarsqlad.d toh adj$tm€nb

s) b. p'or6cbd rrcm damaso and dg

56and@odlh.€|idityo'lh6pl6v4u ipmmrb lo | l dndb6n |on i

d vairi€rion sball ba maliiainsd (3.e 42 4)

haablilyo|compudsoll}?l€bsrst rhs rnbndod appricdbn sh.r b

mpuk, sofr€€ b *ftt h! iikndd apprka{on mdd rtD.dt h.oda ib

A Measur€nent, analyds and lmprcvemenl

3: Monlionng and h€$uEment

a) 10 d6norcta16 conrom ry to pmdud rcqu reh6G,

b) io 3nsur6 .on'om v or ih0 qudiry

c) io conr nlalry rFpde rh€ e,lddiw

- l=l.,1\

)

/4

<1.)

€'ro.n$c or m6 qBrrv mdasam€o m 6 l p € c p i o n a s l o $ 6 s 6 t 1 h s

,,ib.. &b.";e,n€o 'rccc q ' t rdop_ olseqbrbF,.$ rdry!

b d d b m i n s * h d n o l h s q u a l l y

sib (366 7 1), to rhs Gqui6mdnb ol

b) is €fi€ci€ry ihp €m6ibd and mainrarnsd

,"- o "g

i-".o" *"or* te '*

""1-"J J,"]"!a. it'i;. *t ".

. -"

d €quiremenrslorPainrisand

sha lbsna r dn6d(s6642n l

-i.-", i-"", 'rc .re. --*. .

a.a

-

?)-aL14

E)aa-l;t -

1;laIt).t,.

,,tL.LLL).

It)t|tItItLLLaL14141..LLhl-aLtLats??fPFnb

lSO9001:2003(E)

ielron ol th. aorions llrsn and rh6 r€podlns o' srifl'aton Eub

ft. dcmiarof sha l aF y 6Ji:Hs n dhls m.aJEm6d or rtu quartrv.*,nmenr

"vaam po-**. rha I t d o0 pftEs. b 3or@

,ri""8J """r1

w-; pm*a "*

o aG not &Hmo 6'codon .no cotuci* ocron !h!L, b' br'n e

l;;**";iep"pair. *- o 'u .nhnhv ro .d!d t!6rBmdon6dd@fungsolfr.qdlynmsgngil$|m'

ns i6o lhgp 'ooudb€{v$a lp rcdud'i.i,rcfii"t r"* ** .a. -i't' *dr ba dnisd our d .pp'oP'rab ecoa! d rh€ pddd €ar 4!on D@sh ;ddrcs *i$ rs u$mo dEt6hanL Gss 7 1) Evlder. o'ot mrv wm D' dop,Es crcna

Rd6ds6halrrndi€t lh6 peEon(s) tu$otrtrns *l** a p.dua fr,t a"rlv.i lo lho dsbn4 (s 42 4)'

ad L{r rhs cs$d .ftrsMdb,jJi i.iii* rii;

"*grd"at *"pbbd, urrs$ oth.Mrss appr'r'.d bv e '€ ent dutho'lv and kha.

3.3 Contot ot nonconlomrng pEducl

fta orcm'add 6tlr srsulo $tr podud thld dosr .ot M on b p6oJ;i|ji;;;;ri -"+"d;;;;d"r*'v A d"tu".'bd p'*jdu.

"ii"i,"L' na i"

"bd '*rc*',t* *d .uthd,16 r.' doahs *h mmn'omho pbdud

wh6F .Dprldblq tha o'ganla0m lha I dd t h non@nrdhrd! p'ldud !v

ar oy br .o a.do^ to € imlnab tr€ d.1..1.d nonff'omrtY

b) W drhodzhs lb 6., rcls*o or &ephn6 hdd ssslon bv a rclffinr 6utnotiv 'nd' wht6

soo||@hl.,byt'scugiomoi

d) ahkhs acdon lo p'sdud. t o qlnal int€ndsd @d or oppllctlonl

s s1b6 o' pobnlralsff€crs ol tno norcontrmitv wh'n -oroft'tri'g

Ddud b dobclod afh' d6rrEry o' usa E dd6d

hn non6^rorni4 ptoducl b oftotd lt sharr bo eubisd b G4odraid b dsmmrEb co"lomv b ba

R&ordr ot rh. idu6 .l nondnromfti.s and sv lubtquBnr eiN qktn, Includho oonEelont obulngd

6han bo marn h€d (s.42.4.

i i | a - ^ ] l i *am"q* r I v . * ,g "n .dByndra robg4 |udbwho;i{;;;;; o, h" q"niv ;.1ae";od ry$sm c'n b. rad. ftrs shdr h

monlbdns dd mor.uErent .nd tm

r) .u{ontrsrshdhn (96 3.2.r),

b) onromrt io prcduol EqurenodE {s0.3 2.4),

c) cha€d'rsrre md t€ds d p(*a32lands,2.4), and

]J' l

qn))

44nn),

J,J]J]J)'11

nlt l

nqiql

2l l4

4

'M rho 6rkc0€nsss ot lh6or rh6 quarit poro, qualL9 objsdlvs, audir @uris, aiarysrs or

quariry mnassmsnr sysrsm rhreuqh lh6 B6dara, €tudiw 3id pr6Enl]6 aclos and

a) ruv swinq norcmb'm B (rncrudris mrom.i 6hp artu),

b) debh nrns th6 d6s o' ion6n'o'mrriss.

c) eruatris th6 need lor acton to 6nsuc rhar nonconlomrn€s do not @u4

d) deb mhrns and rnpbmailhe adoi io€d.d,

E €61ds or ha Isurb o' ac'ron hk6n (&s 4.r.4), Md

r) revresns rhs efiscu@na$ or rha c

a) d6r6mininspordntrarnon.6tom

b) Mluaring $o i66d ror adion ro prc€nr o@ur5n6 oi non@nbmrl6s,

c) dordmininq and inprandnlds dolion neoddd,

d) 'e.o'ds o' r€sults o' don raken (365 4.2.4), and

s) €vrosino Ih6 aribdlwn€ss or s6