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GNO-ISO 9001 QMS REQUIREMENTS
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Save Iso 9001 Qms Requirements For Later INTERNATIONAL Iso
STANDARD 9001
 
Quality management systems —
Requirements
‘jdm de management quits — Ege
‘sowmsramee)150 s001:2000(€)
 
ses Ae Stns cpa
 
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nocy ets meson sng oan ese mh rel Scr si nas oa iaoal
i
 
 
 
A ‘COPYRIGHT PROTECTED DOCUMENT
‘erro a cae t,o a i a nme mr ot ay yy
thonegmotunea, nag pare ue a ase ey hc Ss ae
Somes a, Cana150 9001:2000(6)
Contents reo
1 Scope
1.1 Gomera
12 pletion
2 Normative earences
4 uatty management system
41 Genera requirements
42. Documentation equroments
5 Management esponebity
5.1, Management commitment
52 Customer fous
53. Quay potey
54 Planing
555. Responsbity, autor and communication
156 Management review
16 Resource management
1. Provision of rsouree
7 Product retzation
74. Planning of product eazaton.
12. Customerselated processes.
1.3. Desgn and development...
7A, Purchasing om 7
7.8. Production and service provision.
178. Control of monitoring and measuring equipment
‘Measurement, anys and improvement
 
  
  
  
 
  
 
 
 
 
  
   
 
 
  
 
 
 
  
   
 
  
 
 
 
 
 
   
 
45 Improvement ———
‘Annex A (formate) Corespendence between ISO 9001:2008 and 160 140012008
‘Annex 8 rfomatve) Changes between 15060012000 and 60 9001:2008
Biography.150 9001:2000(6)
Foreword
180 (he Itratona Ogaizton for Standard) fa woe adr ftir stands todas
(ts0\membar baes. The wot of brparing ternal Stancaréeepormaty cared ot heh 190.
{cela ammo. Eaah mama body mnrstd neue fr whi acc conte hasbeen
‘Sinlatad nas ha igh fo be ropeente on at commie mtemonal renzo, goverment oc
‘are govrnmert lon with 1S, apart fe work 150 calabratoe dose wih Iman
‘ceocica Commision (EC) a llr of ctechcal Sanrdzston
 
Intemational Standaresae date in acadance wih eres gen in he ISONEC Dec Pa 2
‘Tho main 16k o tecnical commas Iso prpare Intemational Sadar. Dr hero Sanda
oped by the lec! comes are costs tte mamta bade fer wang. btn 88h
iromtna Stand rogues appro by ast 7% he mam bad asin oe
‘Aton ran ote oss hat some ofthe emis his document may be the jt of patent
ah 60 shat nt be ha reper denn nyo atch pan Mas
180 9001 was prepara by Tenicel Commies ISO/TC 178, Quay management and quay assurance
‘Scores SC, Gualty stam
“This our edon cancals and ces the third eon (10 900200), which has Been amended cay
ms nto tt ands eahaceeompettay wa 120 140012004
 
Dota the changos between thei een and hs our eon tegen Anna 8.150 9001:2000(6)
Introduction
“Th adoption of 2 aukty management sytem should be a sao don ofan eration, Th dion
ndimplementan of an organza culty management system ence by
4) Ra oxanzaonal ernment, changes Mal ervonment and the ks stored with nat
‘reer
1) vain nec,
he prt bcs,
4) to proucs it proies,
) te processes tempos,
1) te sae and orginal srt
114 ot he inter of his nteratonl Standart imply wnicmity nthe suture of ety management
Sysarsorunformiy f octane,
‘The gusty management system reqromens speiiod hs nmatna Standard re complemen o
Inqaemers or rau inomatonmanad "NOTE Tar Gunes sasedng fing
“Th laatonal Standard canbe used by itera and esteral pares, ncng caeston bade, 10
{ese the ovarzaon's aby to moet cucoror, ary and feguon Teuemens epeabe to Be
‘dual ante oruncatan can requremens
“To guaty management princes sate 10 S000 an SO 9004 ave been taken ine conden dag
‘he development a is hematonal Stan.
0.2 Process approach
‘Ts neraonal Sand promotes ie adoption o a process approach hon devon srlomersng as
inoue acne tay manga jn, ence ste scion may
Foran organization to tuncon elective, tas lo deeine and manage rumeout Inked aces. Ax
‘Say ort faces Ung reso and managed nor enale ha raematon ot pts to
fut, canbe consiored asa proces fen he opt fom ane process oa forms hep to the ex
 
‘The apleaton oa ystam of processes mtn n omanzaton, toate wh he etn andineactons
Glneteproceses, and tar management proauca he doses acon, can be mda a8 80 oes
rene
fn adartage of ho process approach to ongoing contol at pov oer te kage between the
Indl precesas won he yee of poceseos, oo wees oe ur contnaion ond meracion.
 
 
‘en used wat a gusty management yt sich an appteach enghaszes te inpcance ot
8} understanding and mecing equtoment,
the need conser processes in ome of added va180 9001:2000(6)
6) ttaingreaut ofprocespatomance and eactvenes, and
comin ererovoment of processes basod on cbactve measurement
‘Tho modal ofa procass based quay managanent syst shown in igue 1 Mata the proces nage
Ppotonied in Causes 0 8. The Musrason shows fal ccs. ley '2 cantar oe i deine
Faqurmets ar inp. Mentoring of extomersastacon request tuations eng ©
{Stoner perception at wher the organston as met he aromerreramets, The oa han
Fart cover al he requis ofthe ormetonal Sant but doesnot Show pocasus 8 dealed
 
OIE dno trates mn ser Ovni FEA nb plata pas POCA nb
Par tala ne ec pee rece dermis ncn wn ied te
‘cower ne
Dec art tprseas
‘uc men ere mesere proce nd pec ogni Flies, eects an equamets od
‘mponorenn
‘et ak eon carina pom proces prance,
‘Continual improvement of
‘the quality management system
   
 
 
customers
 
 
 
 
 
 
 
‘Figure 1 ~ Model oa prosss-base quay manegement syst
“ (20 0-p ned150 9001:2000(6)
(03, Relationship with 160 9004
{806001 an 1809004 are quay management eytem standards whi have bean doned 1 complemen
lok oe bt ean aan be used dependent
 
1506001 epaiios rqurrents lr 2 quay managamant syst fa canbe vee for nara appaon by
‘rgonzaon, or for craton, or for contacts! pupesea. lesa on the elecvereas of te qy
‘management syst n metg ustemetequrerenta
‘A etna of pubiaton of Pi nema! Standard 150 SOO funder ron. The reed eon of
{So Boot at rove gultance 10 management fr acing sustanes sucess fray ergarzaonin9.
amples, dorending, and ever changing, enenment. 150-900 proves aie Sour on quay
‘Ranagement than 150 9001" adeesans he need and omecators ofa ead pares td hee
Eatacon, y tho sjtemats and continua mproneren of We ogra parma, However, ent
inandd lr ceraton ropa ocanrctn use
(04 Compatiiity wit other management systoms
Dung the devopmert of ths itemalonal Sanders, due conideraton as gen othe rovsone of
TS0 '4ao.200¢ to enhance te compat he wo stanaaas forthe batt he wer Somme
‘Amex shows th catepandence beeen #50 G0012008 ar 1S0 "40012004
ie terme Snr on et ce eqns pet as maragei tas sch
‘hose parce 1 wotonmental management cosmatonal haath and sale sogeme cl
Ienapomet ork mananenert Hower, th lrpaoal Suna enaes an Opanzaton to gh
Iiogats te om oust maragemantsyser wth alte manageman syste aquaria. pose
Sorparzaon to aeapitsetting management eyer) moder eslaah gusty managerrt eon
‘compte wih ie equremerts oss eretona Stardar
oko apt ened “INTERNATIONAL STANDARD 150 900%:2000(6)
 
Quality management systems — Requirements
1 Scope
1. Genera
‘Tia neatonal Standard species requirement ra sly management ajatem whe an oxpaniain
) reeds © demonatate ts sily te consstenty prove post that meds cusamer are appcabe
‘Sau andeputr requreens, na
») ime enhance custome! slsacton trough We eve apical the ssa, cing poceseas
{or soriml improvement the sytem a he ssranc’ fear w emer an Sopa
Sitey ana epuetr rogurement
NOTE ne eatin Sian, ee pode o seen
1 roa and oro. cone
2) ayes exposing omnes elton proceso,
NOTE sims anand eadromens canbe petit gure
12 Application
‘A requloments of the tematonal Sanda are generic and oe intended to be apoleble 6 a
‘rps, roars of ype, 2 and prod rode,
‘er ay regan) hie wmatona Standar carat e aps uso he nate negation
[nds product hs can be eaidered br oxauson
‘ner excisions ae mae, chins of oom tts neato Standard ar not cepa loss hace
‘icles ao Inf wo requremonts wih Cluce 7, and sch econ do ot ae the ognize
Shige eprops pro ha mons case’ and spa sry an od
2. Normative references
‘The tolonng rearenced documents ate indepen for the eppcaton of tie doaunart. For dated
‘arenca, oy ha aon ses apna Forundted celeron hele eon ot eeneneed decent
lrclodng any amendment) opie.
80 60002005, Quay management sts — Fandumaniae and weablry
3 Terms and definitions
Forte pusposee lh ocuenthe ems and ions en n 180 9000 apy
“Teohout the tot of Bis nerratonl Stan, hrover te em “PoMie ocr, & ean ao mean180 9001:2000(6)
4 Quality management system
44 Genera requirements
‘The ergarzaton shall etch, documert, implement and muna & qutty manaoemert syst and
‘anny empowefeefecvennse in acrordance wih he raqureants teens! Sundar
“Te organza hat
8) etine the processes needed forte qulty management system aha appcalon trough he
‘ramon (oe 2),
1») etorine he sequence andntaacon of hoe processes,
©) etn eter and msnode meade to ensue th oth Ww opetaon and cont hee processee
gsi tea ecu romain race fs aetna meng
©) moni measure where appa, ard analyse these processes, and
1 inplemert eon necessary o achiev loned rents and cnt erprovement ol ase processes.
Taco processes shall be managed by te organization In accordance wih the raquanents cf his
‘ete an ogization chooses to ctzutce any proces that acs pod confemiy 1 reemets. he
‘ianzaton shal nous coro ove uch prosiese.The ype arene of cai be apps to hen
‘SRenucnd poceceee tole defend wit te Gully managorert ese,
 
NOTE Pra ei te iy rr te es ir ee pect tr mre
(vnc, provac ol eccoces pos ean meaner, ona aims
 
NOTE2 An -wusaced ows ia pecs ath azar nets sly management a wich
‘etrgnamon noses ohne paraoesty an en
NOTE. Exerc! vuoi recees nt otc anche mapa ony
Sit ry pny ern hoe ene ns saad
9) ea em ct td en in yo ops el na
1) he peta mich conte oes shred
he capi aoa the csr cr ahh pcan 74
42 Documentation requirements
421. General
Tho quality management esta documentation shal cide
2) ouuanted eatomens oa quay pally and quay cojectves,
1) quay mann,
©} documented procures ans recor road by hi nterational Standard nd
4 cocumerts,nclang record, dearined bythe erginizaion to be necessary to eae the elective
‘ong, opstaton and cont te rosa.
2 elcome180 9001:200%)
NOTE 1 hae the om “ocsneied pocatus” appears wh 8 mtn! Stn, fe mae hat he
‘edi tetas, Snanats ane ond sane eg omnes aut
‘ner mre rca’ hraquumen or ocumered ocr mayb oven ma ne Sat
NOTE? Th trot quty management tm donarataton can om ne opson am do
2) fe sea chrpnaan adie fas,
1) ew eampesy oes rf herent. on
©) campatanes o pearl
NOTES. The cunt cin te nay rye omen
422 aly manual
“The organza sha ete and main a quit manual ht inde
2) ecm oe any managment eas fd ten ay exons
b) the docunenis proses estabichod foto quay managemor 5m, oleate to thm, and
6} desertion a the nteracton betoren he proceses a he quay managemart sen.
Documents requed by he quay manager system sha be cnotad. Reco tea special pe
_Scumert ar sal be conteled accord ee equreonts enn 4.2.4
‘A docuanted ocr shale etablahadto dane the cons needed
8) to aperove document or adeauay ior ee,
») toreiow and update as necessary and approve documents,
©) to omure tat changes and he curorrevion satus of doouments are oid
entire tat evant versions of ppcalte dcuments te eae at poise,
4) muro tat documents roman gb and ray Wont,
1) tw eure that documents fetal ig dtemind the organization tobe necasay fo the tanning
‘nd epenton oe qty management sysem se Wered and hor draton onee. an
4) prevent he unronded use of becete documents, ano apy eutable Wenseatn to ham ay ae
‘olor any purpose.
424 contol otrecorde
Recor etatiched o prove evidence of conlomiy 6 reqs ano th atlsv operation of he
‘ay management stash be ora
‘The cxgantzaton shal estat a docunerod locodute o dene te contls needed fo the dentate,
‘oragepoecton rete, eenson an sapetion of eco
cor sa emai gle, ea ents an eorte.
‘5 Management responsibility,
5:1 Management commitment
“op management shal provi edenes of 48 conmimént othe deeopment and plementation of he
ay mangement sym acon impeowig fs atectvonose by150 9001:2000(6)
9 sonmanian oe oanion te mpranst msng cto wa a ater dy
1) exabehing te quay po
©) erauing ha quality cjecties aa atabiches,
canaicing managenes reviews an
nau e avalainyoreeouens
52 Customer focus
Top management shal ensue that customer requirements re dlemined and are met wth the am of
manag aster calc (coe 7.21 and 82).
53 Qualty ptiey
“Yop management sha once that heavy poy
8) appropriate othe purpose ot te crparzaton,
») Inca commana comp wath reqemens and cntruay improve he eevee the guy
‘management yom,
©) proves tamu or etablahing anc eviwing ly objects,
communica andundertod wine option, and
2) terened or contig suet.
154 Planning
54:1 uly objectives
‘op management sa ensure hat ually abject, cng those needed Wo meet equremet fox pric,
{ata a ae astached rant unre andl win re panzaton. The qa eechee chal
smears and conan wh gay py.
 
542. Quolty management sytem planning
Top manegement shal ensure that
£8) tho planing of he quay manapoment yom care atin oder tomeet the requromons renin 41
(hate ay aches and
me apy o the qually management elem Is meniained when changes Io he quay manegemort
Stem re sane sod pao
‘55 Responsiiity, authorty and communication
5.8.1 Responsiby and autnorty
“Top managemort sia ensure hat responsbities and ators are dened and communized win the
panto,
4 ‘e000 spt sed80 9001:2000(6)
52 management representative
‘op managoment shal appoint a member ofthe oarizaten's maragemant who, Mespectio of ther
‘etponsie, shal have responetty and autho tat neues
4) enauing that pocesos needed forth qulty management Systm re exalted, implemented and
©) ig a9 mrp an pan he gy manson pn day nd
©) ensuing We promotion ol anaronae of customer quarts trougheat he orpzton.
NOTE The responsi maogenet psi can nl non wh nol pares cn mar lng
te suntymarcemen aon
“op management shal ensure that appropiate communcaton processes are edablshed win the
panaaton and tet communication takes Pas regarding ta seseness of he uaty anagenert
Sr
‘56 Management review
“op management shal evi the crparzans quit management sya, ped rena to ena
ining uty. adequacy ana efecivones Tis Yoon shel ice eseatng opporuntas ot
Impoveort and te ned or anges to the qulty mangement Seem, slong te aly poey and
ay cs.
 
esos om management eis shal be maintained (6642.4),
a2 Review input
‘Tho mputo managoment view shal nd romaton on
9) ret of es,
1) customer eeack,
©) process penomance and produc conor
4) staus of preven and coecte actions
6) fotowap scons tom prvous management reviews,
1) changs that cou tc te quty management system, and
6) recaneendatons for mprovenant
B83 Review output
‘The ouput am te managent ew hal nce any datos and atone ltd
8) improveent ofthe stevens fhe qualy management Sysam and is roses,
1) improveent of prot resto customer requirements and
2) remnce neat
com -st ta 5180 9001:2009(6)
6 Resource management
6:1. Provision of resources.
‘The erartzatin shal dtemin ane rodeo resource needed
4) rlomont and mann the quay msnagiment system an coninalyinprove ks tletvanses, and
1) tw enhance customar salacton by meting customer requirements
(62 Human resources
Persona porrming Wor afetng conor to produ equeements shal be competent othe basis et
Spore educa, waning sli sod exenence
NOTE oxide canbe ale cy inset ty erlang ewe he
‘Say Mangere en
422 Competence, traning and amaronees
‘The xganzaon hall
8) atarine he necessary compotone for personnal performing work acing corm to product
reurement
where appeal, prvi ning or ke oar cons fo achow the necessary compen,
©) elu hesectraras fhe actos kon,
9 naire thats prsonel ae aware of te rela and porta of he ace and how hey
‘Sonate oe echevoment of he quay econ end
1 sna apropst eont ol etc, ining, ale and experience (0842.4,
6.2 infrastructure
‘The ergurizaton shal dlermine, provide and main the nkastucure needed © aco carom to
roa requremets fast cis, a appeal,
 
2) bulge workspace and asecle tos,
1) proses eqdpmant (ot harare and etre, rd
©) stoping sve eu a trangpo, communion einloxmaton systems).
4 Work environment
{he aetna rian mnt wrk ee need ae nant prot
NOTE The tm wot emonman ie ese cinoma ich wk permed ng sh
rorormenener oso euch as empires,
‘ 200 n-ne mand50 9001:2000(6)
7. Product realization
174. Planning of product realization
‘Te exgonizaion shal pln and develop the processes neaded or pod! reat. Planning pros
‘eatzton sab consort thereunto he oer processes ote qual) Manageme yaar
conn,
In planing grout eaizatn, e organization sa detain he owing, aprepie:
8) ual objects and rquremente rhe pod
b) the need etabsh processes and documents, ano provide resources spect athe rod
©) reid vention, van, anton, messurnent,epecion and fee aioe space tthe
rset and th entra or post czoptace,
(4) ecaneneded prod evkdance hal he telzabon processes ad ing prod met egies
(craea
“he cupt lth ning sal ben ao atte forthe cpniztons method pean,
NOTE A samen epi te proses of he guy manana eon fing he rot razon
Poste) nd ezaento bu sedtoa spats psa pat conan asters al ak
 
NOTE 2 Te ernzten may ako ety he wearanens shen 7. 0 We dope of pact etn
72 Customerelated processes
721 Datermination of requirements alata tthe product
‘Tho oganzaton shat determine
4) rogues speciady he csomet cn th equtement fo every an petdeiery aces,
1) roqdamente not stated byte customer bt cater fr spected or etanded ute, whee krown,
sary an egtry requirement pablo o the product. end
ny son reiternis contiderednecesiy ty the option.
NOTE Fecaary soles ce eagle cone ude marany ovine, cata cgsone wc 6
‘mosis on ond sonore tio 80 cyl eps
1722. Reviow of requirements alata tothe product
‘The ertrizaon sh rvew requirments rated ote proc. This review shale conducod pir to
‘Te crgnzatonsconmient sippy «pedo he cstmer (og submis tone accopance ot
‘intact rrr, erapnce of hunges arta oor) nd ch nae a
8) product oguremens ar deta
1») contactor eer regutement tenga Wate previously exgrocsed ae reeled an
©) the rparization has he bly o mee he dined requirement
care othe eeu te revew natn ating tom he evi habe masa (ee 42.4),
ore te custames proves no documented statement frequament he curloner ngurements shel be
ented y te organization bets acrptncs
eco 20m Agere ,180 9001:2000(6)
Where pot equremen are changed he cguniatin shall ensure ta relevant doce re amended
{ard ha evant porenne ao modo par fhe changed requromers
NOTE Ins sun nc a un ee, mal ene et ae re ta wre can cer
‘strep omaon uo br oa avrg mae
“Tho organization shal etrmine and inplamenteflecivearangoments fo communicating we customers
28) produeteomaton,
ena, contacts odarhanding, citing amendert and
©) cle eaback,nddng ester compl,
73 Design and development
173: Design and development planning
“Tm oxgantzaton sha plan and contol he deg and development of rc.
uring th sgn and detopmet planing te omgenizton a deine
2) the design and dereopant tage,
1) the ren vricalon an valaion ht are arora each exon ae development stags, and
the rape ar suo or dsign aed deeopmend
‘Te crpartzaton sl manage he refaces between dere gous moved i design and desert
rae cece conmuniaon and Gea esa ol responsi
Planning culpa be update, a appropri, the det and development roarecas
NOTE esi nd celoment ee, eter and wan hav eet pape. Tey can become and
‘ered spo ney conan bo habe sts poss an co
732 Design
 
development inputs
Imps renin to roel equremert shal be determined an cots mained (884.24) Thee pte
‘otra
8} rts and perbemanca equremen,
2) sopate sory and equ rogements
©). where appeal, itomaton devs tom previous Sr dass and
9. ctor eqdremons escort odoin and development.
‘Tho inns shal be ovioned br adaquacy Reiromens shal be compo, unambiguous ag natn coiet,
1733 Design ond development outputs
‘Tho eutputs of dsin an development shal be na om sutabe for veliaon aga! cetign and
ovloment pan salle approve pr lass180 9001:2000(€)
Design and deepen cups sal
2) moet he np eaten or desgn and deeopment,
1) pro appt ntnmatin fo pursing, prediction and sence provi,
2) contain or relrene pro acceptance citar snd
spec te characters te pot hat we esentl ri ean proper ue
[NOTE Ibmaton resin ann evn an rue ete resent weit
748 Design and development review
‘sma sagen sana ews fen and deve sabe poms ners wih
8) to eval te aio resis of Sesign an development o met requremens. and
1) toldonty ary probioms ane propose nacascary actors.
Parkgate in suc rovaws shal le reproentaives of functons coneemed th the design and
Serica tag iar Fecs herons te eve oy Reman atone habe
7.28 Design end development vriation
\eieaon shat be primes in accordance wh lame aangaments 6c 7.3.) 16 exe hat he design
‘nd devsopmant eps Rave met he Sen and evelopment rps reqaran Resor of he reste
‘hovoreaan and any nocstary sce sa bo mamaed (eco 2.)
‘TAS Design and development valation
Design an denlopmant vation abe prlomed in accordance with lnned srangiment (8 73.110
‘ras thatthe rauing produ copale of rating tho fequemerts the speed ppaon oF
‘Mende se, were lon. Wheeer prctctl, van shat be complete por ft deter) ot
Sloman othe produ Moco ofthe rate of walten and any nootamry scone sal be
‘manip (seo)
1787 Contol of design and development changes
‘asin and dovlopment change shal be Kens ang recor marae. The changes sal be eons,
‘ted and ‘vaidae, e8 apopsl, andpprned Enos iglomersion. The fw & Seon and
“ovlopmar changos eta nce eelyaton of te aft oh changos on consiuat parte and product
‘Senay dvred Records ofthe fsa cf the Toe of changes td ey neces acne al be
mantis (oe 42),
74 Purchasing
741 Purchasing process
‘he xgarzaion shal ensure hat puchased product conto spect purchase eqatements. The ype
Anderton of corr apd wo fe supper and the prcased prods abe depend upon the lec of
‘hopureased pect on subsequent pred ealzson rhe a roa150 9001:2000(6)
“Te organtzaton shal oyu and slat supplrs based on te aby to sup prodtnaeconnce with
(he eranzatore raquremets Cher or selocon, evhiaon and r-eaeaton shal be seabed
Records fhe resto evans an any necessary acon aig om the evahtion sale aettned
(waz
Purchasing fomaton shal descr te posi obs purchased, nung, whee Sepepa
2) roqueanis for approval of product, procedures, processus and equpmet.
»)requements or qatiicaton of perenne and
©) quay management est requirements
Reggio ten estoy seca pas emer po Re conmanean 6
7.43 Vora of purchased product
“The ogenizaton shal establah and implement he inspection roe cs necessary for ensuing a
Purchosed rod mets speed purchase requment
ere the oraizaion or is cusomer ints © perm vocation atthe suppl's proces, the
{ancl chelates ened vercatonorangenens rated of rai ease ne po
‘75 Production and service provision
1754 Conto of production and serie provision
‘The organization stall plan and cay cut protucton and saree provdon under contd conden
Contd condone ahah, apgcate,
2) te evlohty a dematon Mel descibes he caress he proc,
1b) te avaoinyo work nstucsons, 8 racessany
te seo ule equoment,
te aalaity ane of mantaing and mascring aqme,
©) te elmeraton of mentoring and measurement and
1th tmplomertation of product reoaso, every and post-devry actos,
"782 Villsion ot processes for production and service provision
‘The exgntzaton sal aidte ey roease production ad ervienprvlon hare he rming out
net fe eiled by subsequent o messin and, as a concoqenen, atcowsies Become
‘pparet ony ater hepedet i ue rh eres has bun dared
‘alan ha domonsrt tho aby of hece procesoso achive plamed ret
‘The cxgarzabon shal etch erangoment fo thus pocatesinclena ak appa,
8) eines cetera fr revaw ane appro ofthe proses
1) epprom ot eqdpment and qulicaton arco,
©} toot specte matods and procedures,180 9001:2000(6)
1) reaquemrts roc (6242.4), and
©) aio,
1184 Wenieton and tracey
er ppropi theorerizaton a erty prod by sue maa hough prot elton,
‘Tho cgnlation shal dort tho produ sas wih respec to mantorng and maeseementrequremens
‘houghau prod aati,
‘Were race ta equitemet he eriizton sal con he unique deiicatinof he product and
main records fb0 42
NOTE, ame nary sat, cron manageact man by wh Kn sn ANY He
184 Customer property
“Te cxarzton shal ence care nth customer propery while tis under te organization’ convo or bing
{ted by he oganzaion. The organization hal ery, vert. pclact an sleque customer ror,
[rode fr ue or itevporton no the produc Many cst rope ios raged or ore hd
{Ste unsuade ous. oanizaton shel part sto te cute and main ears fase 428.
NOTE Cmte ery canine cad rope nd pro i
1788 Preservation of product
“Tho cranzaton shal prosrve the pros uring ies processing and delve to Be ended deainason
inert inn covormay to fecutmens. As apes, preservation shal close ene aon
anding, ockagg, oops and protection, Preseraton shal is appt te cone are a prods
"78 Control of monitoring and measuring equipment
“The exganlaton shal detemine We morning ed measurement be undoaken ad the mentoring ad
‘measuring eauipmert neded to provide even of conrmiye podul deletmined equrerents
“The cxanzaton sha ett procseas oan et montorng and measrement an be cared at and
‘card oun amarmer a conan ah the anton an nsourmer certs
ere naeasary to ener val ess, ascng aque sha
4) be catbratad ove, both specie inter, o proto use, gaint masirement standards
‘cea intmaon or nena messiremen standart where no Sah sancede St. he est
tied cltraton or veriaton shel beecoaed ate 25
1b) beaut or eased at ecesary,
have ontioaton nero deterine is cara tah
6) be sloquared tom adjusters tht would vat he measure res:
1) be protected Ko damage and deliratin ding handing, msnenance ad ac,
nation, the egarizaton sa assess and ecto waly of the previous messing res ban the
‘sumer eure ot to anor te requreeris. The ogenzaton shall ake appepate action onthe
‘Stuer andany produ! ected,
Record of he rest of caltraton and vertetion calle mand (e424.10 9001:2000(€)
‘en used in the motoring and measurement of spect equemets Be ayo compere to
“teste tended spate shal be conned. The shal be oer iar tial ser eonmed
SSretesmy
NOTE Contato of ily of cmp sare ost he ere sean woul py ice
‘eit an ott mars maha ey we
{8 Measurement, analysis and improvement
81 Goneral
{he orenzaton allen adnpamer honoring massvanen says and nroreert pans
8) tedemenstate canto padi egurenent,
1») tense confry othe quay management system and
©) tconnualy mproe the atecthanaes he aay management yee,
This shat include determination of ppleble mathods,ncung acta ectniques, andthe etn of hel
182 Monitoring and measurement
‘As one othe measremens of he peramence ol te qusly management sytem, the arizaton shal
‘monte rematln rain Yo cist" percepts to whether te eranzason hea el cstomet
‘equrerant The metodo eianin an using he ormaton salle deters
NOTE. Manat sane peptc cn ii tating pt fom anon uch cone seen sry
et led a orn sa ann a Sera ee) Seo
1922 Intralot
‘Te organization sll conduct inemnal austs a pared inenals © delarnne wheber he quay
‘manapument system
2) caro the planed anangement (e711 the requrements fis tenon Sanda arto
‘he uly management system requrerartsoabished byte organ, and
1») Soest irplemerted ane maintained,
‘An aust prganee shal be plana aking ito conieaten he stan and mporanco othe pocesses and
‘Sraets be sustea ae wel asthe ast of prvous ate Tho aud ser Scope, Hequncy and memos
‘halve dened. Tha sloton of ude and condo of adr sal ensre Soc marly a he
Slt proces Audtos shal mat aus hr own werk
| documented procedure shal be eased deine the reagan snd reqs or pnng and
ondcing sud, extashing records end epring resus
eco he st i th reste hal be sinned oe 42.4)
“The managoment responsible forthe aaa bong ated shall onset ay necasary corectens and
flmecve echos re then wihout undue dey 1 smal Saaced oncom th nar cues
2 (0 m00-Anpumunae80 9001:2008(6)
Fotow-p sles shal ince the weston ofthe atone taken andthe epoing af vetetion rent
(eons
NOTE 0150 1801 auton
1425 Monitoring and measurement of processes
‘The orgarzaton stall ep state mato fr montang an whee appa, meinen lhe aly
‘management sytem processes. There meade shal somondrne th shy the wocuanes to acre
[anos rsut” Wer pinned eats ere nt acieed,Soreton an conectve aston sal be taken, oo
Srpeprate
NOTE_When suring sublets. ial at aganeaton cnr he oe ener of monong
{ereasroant apo che precses nn wer gnome eee pose ean
‘Sedenteshcienear ee uy meager Sa
{824 Nontoring and measurement of product
‘he orpartzaton shall movtor and maasie te characteris of the product ely tht product
‘aqueanis eve ban mathe sl be carted ou appropri sage of he rst ean rosest
interns wih snes ranger encase wine expos ca
Records shal cate the poran(s) autozng lease of roto dalvery tthe cusomer (te 4.24.
“Tesla ol proc and every see one customer sl proceed ni he dann amangerens
Lg Pomerat cmp, bes oan aso 8 ae san wars
‘opel by he costar
£82 Control of nonconforming product
‘The cxganzaton shall ane thal padi which oes at arr lo prot agutonets sido sd
‘led reverts marae ea or nny A documenta poorest be exlahadts dfn he
‘Ste and ltd reponabie and auras or Gesng wih nncinirang prod
 
‘Whore paca, te orgarizaton shall dea wih nonconoming produ one or ote othe owing Ways:
8) by taking acon late he detects nanconomiy,
1) by authoring is uso, rlas0 or acceptance under concession by a rove! auholy and, whore
‘ppleabie, ye customer
by ahirg acon rele ts rg mended use or appteaton
by wing acton apeopittthe tots of pole tts, he rarcontormity ate noncnleming
Prods detcad oer very ore has re,
nen oncanfoming pod corectat shal be subject -ileaton ornate contr tthe
reitemers.
econo the atte of donors ac any subsequent ects ike, ncn concessions tained
hale manaind (se 24,
84 Analysis of
‘The ergarizaton shal deterine, cot and anaes appre data to demons tho sutbity and
‘acterose et te gusty managemst sytem nd To suse where con grove ot he
Socrones te patty anaerert ayiom ean be mate The sl ede dn peered a oS
trenton aa macauremat and rom oer evar sources.
 
2
etc0 Aten 2180 8001:2000(6)
‘The ana of data sal provide omaton tig to
2) etstomer satsacton (600821),
1) canomiy t rodit requremens ote 8.24),
© aden a tee pects and pret, weg cpr pen aan
 
4
pls (0074)
85 improvement
145.1. Contnuat improvement
“he erricaton shal cna imrove he ives che quy managonen ye trough fe use
Fe ely pay. waltyebocbes. aut Yeu, aralyee of dara, coreave an provi Solon wd
‘management oe
82 Comocte ction
‘he organization sal tke acton elma he causes of noncrfmies ioe opeve recarencs
Coren actors shal be apogee tthe sect he nncanomes encour
‘A documenta proces shal bo ealihed to dfn eitoment for
5) evening nencontrmiles cng esta corel).
1) etrminng ne coves noncotormtin,
©) eftsing he noe fraction tenure hat rencontre ont ec,
4) eterinng an ingen action needs,
©) recor he ess of acto then (464.24), and
4) rovewing ne atectenes of he corocve acon akon
 
crpnzaton shall doin acon oaliminato he causes of poten! nocoromis inorirto revert
tte coerce, Prevents actons sale apyopie oe eect ots poten poems
 
A docmanod procedure shal be etched define rogiramens or
tare potent noncontomites an et cuss,
1) evaluating me ned or acton prevent curence ot nencontrmis,
©) tering and implementing acon need
1) reco let acon kan 08 4.2.4), sd
©) revenge tcvenses one revere acton kn,
“ (20208 HpmreAnnex A
(informative)
180 9001:2009(6)
Correspondence between ISO 9001:2008 and ISO 14001:2004
Table At —Covrespondence between 10 8002008 and 150140012004,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
frooacton Go or
Jrccos sons lo2
fasta an 150 904 ba
[const th onermsnavonee soins [oa
Scns cie i
liteton 2
faut mongers ssi iv oy) i
somal easreno ler far
[scorers sures iso) lez
fas man ina
ingot seni i coats
Nonmrenent onsen ist fe
leosonare ~ [se aa
fate Iss fez
mine a Isa ea
fay eactiee fear aaa
vat raperet tem ang isa ans
Fess ery ae [65
[esenatiy nd sano
Wnaaeent ese
sagen io (9)
———_—
ene
 
 
 
50nd180 9001:2000(6)
“Table At — Correspondence between 1500012008 and 150 140012004 (conned
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[ens mame oe i
[raion eevee [ai [2 [Reanon repay ncaa
[Honor sou ie ise
fore [a2 [24 [corps urna ond ora
[Sores ang nd wares [a22 [442 [Canoes ating ond res
lense Joao  espobay anny
rot eee |neioneratn depen ey)
[aman fect aan [Sees
[cso id poses ti oa
[owen arguteraseanciowe 727 [37 neonatal ome
jpea| laa eo andose quran
1.48 operation xa!
[Reson droatenons wma We oat [727 At [enowre meas
cma cnn faa [sas [eonmnosion
[Desir odpm io i
sor anddowtprertowrera [23 [ane [Opomsond creat
Dslr on omer ps fra [a4 [Open ont
Desir werepmer osu [733[248_[Opomtonatcnt a
lesan andcotrmerteven a
Destro deter vrei [ras [246 [Opetont onrt
ein escepen eeion [736 [248 [Open cnet
elder and erdoonet chase |737 [4a _|Opetnal cos
rr iz
[ascosbmansees [Ai [0 (Opal
\rcteigtiewtn [PAB [0A [penton tcl
|wrecaon ot puomsd si [43 [246 [operat coal
[poauston roves oven ooh) [75
[coma pesucon aso noane |? [4A [Opes corel
[ant roses ox podcion andsance [72 [448 [Opts cowl
l>ewaer —
[estes a aca bss
[Pesonaion of peat Ps [ea [Ooms come —
[cote monte andaeasurg eqipmen [78 [481 [None and messironar
[veasomet ants anroener ie oni|® [25 [obec ie. —
[ecnot [ai [a8 [Newnan nesuoner
 
 
 
 
 
 
 
 
 
 
 
16 econ -apames180 9001:2000()
‘Table At — Correspondence between 10 80012008 and 150140012004 contin
 
 
 
 
 
 
 
 
 
 
 
[sag antasiemer of ras aaa [ast ao amit
las.2_ [evasion ct contenee
[Sait oon a [a3 [247 [Emenee peprenes elapse
les erin, conve eo ant ran
Fra rae Ce
Frere a -
[enna inromer last nicer
[eects rots and progmmee)
fo luengerert oon
rsa naar |
 
 
 
a180 o001:20004€)
“able A2 — Correspondence between 150 14001:2004 and 150 90012008
 
 
Fresno
watery an 00 04
[conti wh oe menagerie
 
scope cy
sean
 
 
Narain ernie
 
[ems a ee
 
fe
lrvermen rangement son eoteieie
[ty aegenen son le
 
[Seren wacroner
[espana auory and common (|
low
entity a ur
 
eres
 
Ieper content
lay ptey
(conan ire
 
sin it
Piaming oa
 
[enwenmers asc
[osama of requtomans ited 1 ta
frosa
deo ogromet tao pat
 
Joes
 
fost ac
[ousty maragonent sytem neg
{cont ronan
 
 
[rotenone an
 
[esses rns esnsly arutry
jorge conmeror
 
[conte vine nose
(tre sow) eral
[carpeting arama
 
 
 
 
 
 
lboameraan |Oonmernionequrenei) Gow
 
 
 
 
0588s mes$80 9001:2000(6)
“Table A2 — Correspondence between 180 14001:2004 and 180 90012008 (conned
 
—T
 
[Semana cat fe
Frenne ea aan
fostered proces ie ny)
lownmnnaton of requonas rad 16
frost
[Rede ct ouemerts dhe ade
[sn and detrei
[aan end deporte
re
[slg ans dng een
eon ane vector
ously an elmer aioe
[ort sian an emma cares
[psc raton
eter operas petit
Jrticton rdserce oven ey)
[conte passa reeves pov
sono eeboe te otc ad sere
[pow
Present pact
 
[onl et nner
 
 
easronet nj rd mre a oy
‘eeott rim cng wasprert
i
Mertong ansesasnart of press
Montorg ant easel op
Iain
 
Faia tama wae
omg and manera of rat
 
msi crim amon J
Iran
 
 
 
raceme ew ike
 
 
 
wenger nmin
buansgomet ew
sw ost
aw oot150 9001:2000(6)
Annex B
(informative)
Changes between ISO 9001:2000 and ISO 9001:2008
“Table 8.1 — Changes betwen 60 900:2000 and 80 9001-2008
 
 
 
 
 
["Gvecite| ‘| seen ‘mente
sr [er
[ea Female oominai anaes
fieens |?" * Gacy be ma ee ane
 
 
 
 
 
[Fosse aor [aa aie ne aon ana na I
rae, [> fiecnantaeimninan aaa qa mamemareemesness]
[2ciiez |” [peggons ana enantio peansmssrteronr apse]
 
 
 
 
[sama fa) at i a i ane Bw emi eo |
(a [nm yey naa,
 
 
 
 
 
 
 
 
 
~ e008 septanued180 9001:20006)
 
 
 
 
[rns [OA | sDovet reas rah mracttesber sah openers il
‘le .— Gams bre 090110 80 ee nnd
esas | ic. samen
Se TE RR RR |
[Sata eposoc te nammrnomnieimclama|
aSmecttereomaca
3 a aC
ne tsar
ey argent a ste ah hao acoso sah a
 
 
 
 
 
jy
 
 
 
jum fo pore tat Sante asi pe pe oy te pode
Imnnr 2 [ane say any am ae ee pee
sya rcr ona acne tc ato ems
[asta premeictravsimesnntaltccmencute smeacoronir |
‘the! ae asaya
by) svimdsdadat tng tomes aeons
 
 
 
oon sptemaes a150 9001:2000(6)
‘Table 8.1 — Changes betwoen 80 901:2000 and 180 9001:2008 (conn
 
 
 
 
 
["Eecenite | ‘ne! |oton <<
TS [Sostotear
F Pas) paiang ang ca nn SRO ae Renn a
(Stig taatc manson
7 Jara JOA et i smn iB oy megeentem ior
[nite eeepc cpa as
ieee [eaaet fy aa a a oR a RO
 
 
 
 
 
 
 
 
 
 
ker Wise JOA TE | Posse need te gl magn pan ord ae
(ey aera ss es non a a
fe Ten, (REE aa ana sc ae pen Se a
fees" aren eh Sanaa ose hasta yo a
[ite set aay moms ce gh eon ZA,
[kat —Joaee—|k ese ceased hina ns
[rar ——Joamea Java, Sema ena ron atid ye oper ebeT
{nme sare ses sa
[eat ia > fens nnd Sint
fav fat fh ete se an a ee
Jat pas — ooh ra tie a a eee Ce |
[Siete ates gems gay enone ya
nee eee
vane cas one on a
 
[iar rant hire po mel ae eal
[Ree teens eterno
‘At cay tat ity was ab]
    
 
Inner [sone contest aan. fe yy una
[mwas mara80 9001:2008(6),
-1— Changes between 1800012000 and 180 901:208 (conve
 
ee [we
 
[a ieee [v0 [orem aaa
 
fate racers aT RI A aT IT]
Keel i de ang ta eran a enone
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[foam oii i, eng mmm oon ai
Frat Jaro omy any penn aad ae sa
fans, foe |) ay stn quan sonido ne Ben
(cease
[57 fovna [oa san tmnt neni dc aca nel
[Grbac aia mnt a sacs
fae fra [ova he a a a wT a
fsa fran [oA ie aot in tds ene bf ae a
CS eng oa ren paraiso ea
fas Joao fo
[nces [Sans eno mccoy econ havo mand bee
[53 [fant 60% | ston sa aon ay nome pain og we en eo
|e tat rns
fs jane — > [i sa aie pac ne emai aah mane
Fas fon J=* ie ay mga cana a i a na Hr
P= fem pei, co ae ere iw
|siteesnsmenanicser fess nn anon HAL
 
 
 
eos apenas10 9001:2000(6)
“Table 1 — Changes baweon 10 900:2000 and 150 9001:2008 (contre)
 
 
jase" | ic. nn
SS
 
 
 
 
 
 
 
lo meatal
[tas nthe ab int
p= Joana Joo
 
 
 
 
[Fo fm oo ate ra 8 eR mae
Ite, xan in sy oem any eee at
laa) [ova a) warnmanie oon rrenansoast nator
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
™ co-signed50 9001:2000()
“Table 2.1 — changes between IS0 900:2000 and 180 9001:2008(ontnch
 
|zzoonsao| Fara | “Ae
TP a eee oe cae om]
\nemmsgmio tao wnt se one na eporbe
(ie esis a
 
 
 
lee 7 fia
> im |h a ipa opera a ica niece tenance
Jaana rn of te mo remo n-ne atoning
ele et iteracmree sos
Jess evn sensing pena ate ants euizn al
sta” ca i
 
 
 
fsx Joao ova oot torn aaa
Jaws [a
 
 
 
 
 
fener ew aa Joa
 
 
 
 
 
 
 
least stages mand 2s10 9001:2000(6)
Bibliography
In) 180 9004-—, Mantging for he susianed success of an oyancaten— A quay management
sopoach
{21 180 1001-2007, auaty management Customer steacon — Gudolines fr cose of ond fr
‘nanan.
{81-180 190022004, uaty management — Cutamar atfacton — Guanes fr compa handing o
‘rumeaions
1H) 190109022007, Qusty managemant— Customer siteacton— Gunes fr cept rater
‘exon e opaiatons
15} 190 1000520, vay management sstms — Gussines quay plans
{6} 180 100062009, vay management systems — Guteines or quaty management n poets
[mI 180100072008, vay management sstome — Guseines confguaton management
{8} 190 100122008, Measumentmanagemen systems — Requiem or measurement ress ad
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{10} 180 100142006, aut management — Guisenes or realzng hana and aconame banat
[11] 180 10015190, avast management — uisetnes bang
{12} 18078 10017208, snc on attic tchiqus SO 901.2000
{13} 180 1001620, Gunes re selection f quay management system cnsutants dws ht
[14] 190 140012004, Eminent management «ystems — Reauemants wih guidance ruse
105) 180 1801:2002, sda or quay andr envionment manapament systems aucsing
{06} 166609002003, oped management— Par: Dopendabiy marapement sysoms
[07] tec 611602006, Design view
{10} 190" 9000:2004, Setare angering — Guidelines forthe apptcaton of 180 90012000 fo
‘puter stare
[19] Quay management rine 10, 2001
(20) 150 9000 Secon and use, 180, 2008
[Pt] 1906001 kr Smet Business — What od; Adie rom SOVTE 1763, 180, 2002
“Toe pub Revlon 150 9042000)
2) hola om wt ps
2) Tae upd nd lg wth 0 01-2008
26 ‘etosieh snp rat(22) 180 Managomont store ®
{23} Reterence wo sos:
eps org
pra 76.00
prin ores?
aguante 78ASe001AusAngPractesGrO¥p
1A roy pen ne, pos carrera cong laa err eng 6 60%
‘respons spay sari, nasang newt‘ ar rpornason ty Sue ors und be
‘ester 80 Coa Seton soo)
©0200 -A8 pe es z180 9001:2000(6)
Ics 02,120.10ISO 900:
‘Question
  
Proc. Ret
000 AUDIT CHECKLIST
‘Comments
 
‘4 Quality Management System
44 General Requirements
{emer aca ily marapenee
‘Semin scares wth aren 10 O07?
Inte elecvras ef he cunt management som
inated?
 
2 een ty
Spier ete,
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9 Sopetorccr enna ton
7
° cermasegeametertte
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‘esevoceses?
er oases hat alt rot conor wt,
ult areca eh cons
‘fe arcasos aod wie uate
sanagument rst
 
 
 
 
 
 
{42 Documentation Requirements
43 424 General
Daa the quay managed ston doomeniaon
2) Decne omen ot uly yan
‘ali obfetias?
»)- Guat Mona
©) Dscumente rocadres rege 150801?
1) Deepa and ye egorzaten oro
eae eg ns va
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122 Gaay Manca!
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©) Descaton ote naan tesa
escsue fi ually mame rea?
 
 
0
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se socunant rior ne ny menoyenert
Seemann
‘erent aby coe mes?
1) Aero ect aoe oro ase?
Ron pia recy eared
o enmity arstemnn
© Seana ete sparactone?
» xp menace
soeainee
® Sexietnraedoemae
2) roving a unronsdie of caele
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ve td en eased and mained pode
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‘hoces oar le ny manapos Sen?
is ner yon lated en
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1 Management Commitment
es opmangarant rod oence ot
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‘Sequaty management tn africa!
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‘inorlone fect stoma as wl ax
‘puns da eure?
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4) Conan managonet roves?Ne. ‘Question
 
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2) Easy ey esos?
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53 Qualy Pokey
3 | ros tpmanogement ensue at guy ey
4) 6 coyote purpose a ania?
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4 Pinning
54:1 Quay Objectives
 
 
 
 
    
   
 
 
 
 
“542 Quality Management System Panning
17 | sar cp maine mars an sae ded
pias
18 | et osetia png docrets? (ea. cul,
‘rani res wt ton, uly iar)
  
 
 
155 Responsibility, Authorly and
‘Communication
55:1 Responsibity and Authory
Has op manoguent nse hat sprain
hee ld canada
1552 Management Representative
 
  
      
 
  
pumeradeamarnted?
Rearing parapet on prema
hel moran om eng56 Management Review
561 General
14 | Dom ety marapenar roe hw aty
‘ang sya planar, ona
Sonn say cacy an eecenes?
15 | Ace comorttis foc narovemen xh aed
 
 
 
   
a
 
 
   
  
  
 
562 Review input
17 | comeinasstominagant mew is nmaon
9) Rests ofeudts?
) customer odbc?
Stu otaravenv and corse actions?
©) Process prformanc and prod 2
 
 
 
 
 
 
 
 
 
 
 
 
6 Resource Management
 
 
© Resource Management
61. Provsion of Resources
+ | He esau ben determined sd roid
me‘competency.
‘iecin rod un ee ot conrae
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1622 Competency, awareness and alin
 
63 ifrastucture
Toaceve nla ou, dos ne rian
‘ny poe anon Wo oc eh
5) Bugs, Wosspe ee essed es?
) cess Ease Naor and afer?
 
 
 
 
 
 
 
 
 
 
 
 
7 Product Realization
 
 
7 Product Realization
7A Planning of Realization Process
‘epeming cle epanzatn' od reaaaten
‘Stat win earners eer pocoae of
‘ems management sen
‘th loin te dela hen sang he
ocresence
1) Cully ocean regen fhe
pret
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=) Raced oreo, vatton, meron,
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72 Customer-Relaed Processes
124 Determination of Roqulrmonts Related
forthe Product
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73 Design and Development‘Question
 
8
73:1 Design and Development Planing
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732 Design and Development Inputs
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733 _ Design and Development Ovputs
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1135 Design and Development Verifestion
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736 Design and Development Valdton
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727 Control of Design and Development
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