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INTEHNANONAL STANDARD
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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
[email protected] '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$t .!s
3 Terfrs and detlnlllons
Page 2
4 ouallry monag.denl sYsl€m
!.1 Gener.l tequlremonrs
-dru:tu h',M 'berhdwns, n
' + o q u a l l y m a 4 a g o m P ' l , y { " _ a d
b) doismino bs sqFrcd aid hbrac
c) dersmrn6 cr 16ia and msrh'is n
d) ens!6 rhe dLbb lV or 'Fourca
E mmib, nssrewhoc apprbd.. md
r) hdsnd' *1oN ree$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
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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
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') commuiicarins b $6 oGaniarioi
b) edab lsrinq tha qua ry polict
c) ansuins that quality obladtes a€ gsbblFrEd,
d) €ndlct ns nanaeement rwltus aid
6) enedns rtu ava abnit d resomes
a) is apprcp'ids b r[6 pu'Poso o' ths o4an za' on
b) ricldasacommiheiiloconpLvw 6 rhs sfiatlrv6nBss or 1h6 qualilv
manaq€manl sysem,
nd @iswinq qtrarrrv obiacites
s@]ew€dlolconlinuinqsuilabl||y'
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r@ mraqemd sharrereferhdq6rivdl{rss.
;.d$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
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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
Page 6
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
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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
Page 8
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 .$6ntiarror dssioi and d46 opmonl
7.3.3 D6rsn and d.velopmenr ourplE
doGroemantinpd sndsharrbs sppdsd prorlo Graa5a
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Dasien and d6€ropm6ii ouFurs sha I
a) n€ar rh6 iipur cq! 6nenb ror d€
b) prcuds spprcp ar€ inromafon ro
4 conb n or Ers€ncs prcdud s6s
d) spsrry rho chahcto'L,lrca or {i€ p
prannsdaftissmsnb (Ps7.3.1)
r) id ovaruara rh. abrly o{ rhs Gurb or derqn and dmtopmanr ro mool Eqqk€h€ft, and
b) ro rdsn$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
Page 10
"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) [email protected] sq pnsnlandqlarft
.) s. or sP.drr m6sode ad p@6duGs
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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$tm€nb
s) b. p'or6cbd rrcm damaso and dg
56and@odlh.€|idityo'lh6pl6v4u ipmmrb lo | l dndb6n |on i
d vairi€rion sball ba maliiainsd (3.e 42 4)
Page 12
haablilyo|compudsoll}?l€bsrst rhs rnbndod appricdbn sh.r b
mpuk, sofr€€ b *ftt h! iikndd apprka{on mdd rtD.dt h.oda ib
A Measur€nent, analyds and lmprcvemenl
3: Monlionng and h€$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\
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€'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
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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 [email protected] $|m'
ns i6o lhgp 'ooudb€{v$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
Page 14
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
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'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