Iso TS 16949 2009 - V - Imc PDF

QUY NH
K THUT
ISO/TS
16949
Ti liu ch dng cho mc ch nghin cu v o to
n bn th 3
2009-xx-xx
H thng qun l cht lng

Cc yu cu ring khi p dng ISO 9001:2008
i vi ngnh sn xut t v cc dch v ph
tng i km
Quality management systems
Particular requirements for the application of ISO 9001:2008 for
automotive production and relevant service part organizations
S tham chiu
ISO/TS 16949:2009 (E)
ISO TS 16949:2009 (V)
Mc lc
Trang
Li gii thiu ................................................................................................................................................6

0.1 Khi qut .......................................................................................................................................................... 6
0.2 Cch tip cn theo qu trnh..................................................................................................................... 6
0.3 Mi quan h vi TCVN/ISO 9004 ........................................................................................................... 8
0.4 S tng thch vi cc h thng qun l khc ................................................................................... 8
0.5 Mc ch ca quy nh k thut ny ...................................................................................................... 8
1
Phm vi .................................................................................................................................................9
1.1 Khi qut .......................................................................................................................................................... 9
1.2 p dng............................................................................................................................................................. 9
2
Ti liu vin dn ............................................................................................................................. 10
3
Thut ng v nh ngha ............................................................................................................. 10
3.1 Thut ng v nh ngha trong ngnh t. ..................................................................................... 10
4
H thng qun l cht lng ...................................................................................................... 11
4.1 Yu cu chung ............................................................................................................................................. 11
4.1.1 Cc yu cu chung - b sung .......................................................................................... 12
4.2 Yu cu v h thng ti liu .................................................................................................................... 12
4.2.1 Khi qut ......................................................................................................................... 12
4.2.2 S tay cht lng ........................................................................................................... 13
4.2.3 Kim sot ti liu ............................................................................................................ 13
4.2.3.1 Cc quy nh k thut ................................................................................................. 13
4.2.4 Kim sot h s .............................................................................................................. 13
4.2.4.1 Lu gi h s ............................................................................................................... 14
5
Trch nhim ca lnh o........................................................................................................... 14
5.1 Cam kt ca lnh o ............................................................................................................................... 14
5.1.1 Hiu qu ca qu trnh................................................................................................... 14
5.2 Hng vo khch hng ............................................................................................................................ 14
5.3 Chnh sch cht lng.............................................................................................................................. 14
5.4 Hoch nh .................................................................................................................................................. 15
5.4.1 Mc tiu cht lng ..................................................................................................... 15
5.4.1.1 Mc tiu cht lng - B sung.................................................................................... 15
5.4.2 Hoch nh h thng qun l cht lng ..................................................................... 15
5.5 Trch nhim, quyn hn v trao i thng tin ............................................................................... 15
5.5.1 Trch nhim v quyn hn ............................................................................................ 15
5.5.1.1 Trch nhim i vi cht lng................................................................................. 15
5.5.2 i din ca lnh o..................................................................................................... 16
5.5.2.1 i din khch hng .................................................................................................... 16
5.5.3 Trao i thng tin ni b ............................................................................................... 16
5.6 Xem xt ca lnh o............................................................................................................................... 16
5.6.1 Khi qut......................................................................................................................... 16
5.6.1.1 Thc hin h thng qun l cht lng..................................................................... 16
Cng ty IMC - Nh A1B / 25 Lng H - Ba nh - H Ni
ISO TS 16949:2009 (V)

5.6.2 u vo ca vic xem xt .............................................................................................. 17
5.6.2.1 u vo ca xem xt - b sung ................................................................................... 17
5.6.3 u ra ca vic xem xt................................................................................................. 17
6
Qun l ngun lc .......................................................................................................................... 17
6.1 Cung cp ngun lc ................................................................................................................................... 17
6.2.2.1 K nng thit k sn phm ......................................................................................... 18
6.2.2.2 o to ......................................................................................................................... 18
6.3 C s h tng ............................................................................................................................................... 19
6.3.1 Hoch nh nh xng, phng tin v thit b .......................................................... 19
6.3.2 K hoch ng ph vi tnh trng khn cp .................................................................. 19
6.4 Mi trng lm vic ................................................................................................................................. 19
6.4.1 An ton cho nhn s t c cht lng sn phm............................................. 19
6.4.2 V sinh nh xng.......................................................................................................... 19
7
To sn phm .................................................................................................................................. 20
7.1 Hoch nh vic to sn phm .............................................................................................................. 20
7.1.1 Hoch nh vic to sn phm ...................................................................................... 20
7.2 Cc qu trnh lin quan n khch hng .......................................................................................... 21
7.2.1 Xc nh cc yu cu lin quan n sn phm ............................................................. 21
7.2.1.1 Cc c tnh quan trng do khch hng ch nh ...................................................... 21
7.2 Xem xt cc yu cu lin quan n sn phm.............................................................. 21
7.2.2.1 Xem xt cc yu cu lin quan ti sn phm - b sung ............................................ 22
7.2.2.2 Tnh kh thi sn xut ca t chc .............................................................................. 22
7.2.3 Trao i thng tin vi khch hng ............................................................................... 22
7.2.3.1 Trao i thng tin vi khch hng - b sung ............................................................ 22
7.3 Thit k v pht trin .............................................................................................................................. 22
7.3.1 Hoch nh thit k v pht trin ................................................................................ 22
7.3.1.1 Tip cn a chc nng (multidisciplinary approach) .............................................. 23
7.3.2 u vo ca thit k v pht trin ............................................................................... 23
7.3.2.1 u vo ca thit k sn phm .................................................................................. 23
7.3.2.2 u vo ca thit k qu trnh sn xut .................................................................... 23
7.3.2.3 c tnh quan trng .................................................................................................... 24
7.3.3 u ra ca thit k v pht trin.................................................................................. 24
7.3.3.1 u ra ca thit k sn phm - b sung..................................................................... 24
7.3.3.2 u ra ca thit k qu trnh sn xut....................................................................... 24
7.3.4 Xem xt thit k v pht trin ...................................................................................... 25
7.3.4.1 Theo di ....................................................................................................................... 25
7.3.5 Kim tra xc nhn thit k v pht trin ..................................................................... 25
7.3.6 Xc nhn gi tr s dng ca thit k v pht trin .................................................... 25
7.3.6.1 Xc nhn gi tr s dng ca thit k v pht trin - b sung.................................. 26
7.3.7 Kim sot thay i thit k v pht trin ..................................................................... 26
7.4 Mua hng ....................................................................................................................................................... 26
7.4.1 Qu trnh mua hng....................................................................................................... 26
7.4.1.1 S ph hp vi cc quy nh ...................................................................................... 27
3/43
ISO TS 16949:2009 (V)

7.4.1.2 Pht trin h thng qun l cht lng ca nh cung ng ...................................... 27
7.4.1.3 Ngun do khch hng ph duyt ............................................................................... 27
7.4.2 Thng tin mua hng ...................................................................................................... 27
7.4.3 Kim tra xc nhn sn phm mua vo .......................................................................... 27
7.4.3.1 Cht lng sn phm u vo .................................................................................... 28
7.5.1 Kim sot sn xut v cung cp dch v ...................................................................... 28
7.5.1.1 K hoch kim sot ..................................................................................................... 28
7.5.1.2 Hng dn cng vic .................................................................................................. 29
7.5.1.3 Kim tra xc nhn vic sp xp cng vic ................................................................. 29
7.5.1.4 Bo tr phng nga v tin liu .................................................................................. 29
7.5.1.5 Qun l trang b sn xut ............................................................................................ 29
7.5.1.6 Lp tin sn xut .................................................................................................... 30
7.5.1.7 Phn hi thng tin t dch v ..................................................................................... 30
7.5.1.8 Tha thun dch v vi khch hng ........................................................................... 30
7.5.2 Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v ................ 30
7.5.2.1 Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v - B sung
......................................................................................................................................... 31
7.5.3 Nhn bit v xc nh ngun gc ................................................................................. 31
7.5.3.1 Nhn bit v xc nh ngun gc ............................................................................... 31
7.5.4 Ti sn ca khch hng ................................................................................................. 31
7.5.4.1 Cng c sn xut thuc s hu khch hng .............................................................. 31
7.5.5 Bo ton sn phm......................................................................................................... 31
7.5.5.1 Lu kho v kim k ..................................................................................................... 32
7.6 Kim sot thit b theo di v o lng ............................................................................................ 32
7.6.1 Phn tch h thng o .................................................................................................... 32
7.6.2 H s hiu chun/kim tra xc nhn ........................................................................... 33
7.6.3 Nhng yu cu v phng th nghim ............................................................................ 33
7.6.3.1 Phng th nghim ni b............................................................................................. 33
7.6.3.2 Phng th nghim bn ngoi....................................................................................... 33
8
o lng, phn tch v ci tin.................................................................................................. 34
8.1 Khi qut ....................................................................................................................................................... 34
8.1.1 Xc nh nhng cng c thng k ................................................................................. 34
8.1.2 Hiu bit v nhng khi nim thng k c bn ........................................................... 34
8.2 Theo di v o lng ............................................................................................................................... 34
8.2.1 S tho mn ca khch hng ........................................................................................ 34
8.2.1.1 S tho mn ca khch hng - B sung ..................................................................... 34
8.2.2 nh gi ni b .............................................................................................................. 35
8.2.2.1 nh gi h thng qun l cht lng ....................................................................... 35
8.2.2.2 nh gi qu trnh sn xut ....................................................................................... 35
8.2.2.3 nh gi sn phm ...................................................................................................... 35
8.2.2.4 K hoch nh gi ni b............................................................................................ 35
8.2.2.5 Trnh ca cc chuyn gia nh gi ni b ............................................................ 36
8.2.3 Theo di v o lng cc qu trnh .............................................................................. 36
ISO TS 16949:2009 (V)

8.2.3.1 Theo di v o lng qu trnh sn xut. ................................................................. 36
8.2.4 Theo di v o lng sn phm................................................................................... 36
8.2.4.1 Kim tra kch thc v th nghim chc nng ........................................................ 37
8.2.4.2 Ngoi quan ................................................................................................................... 37
8.3 Kim sot sn phm khng ph hp ................................................................................................... 37
8.3.1 Kim sot sn phm khng ph hp b sung ........................................................... 38
8.3.2 Kim sot sn phm c lm li ................................................................................. 38
8.3.3 Thng tin cho khch hng ............................................................................................. 38
8.3.4 S khc t ca khch hng ......................................................................................... 38
8.4 Phn tch d liu ......................................................................................................................................... 38
8.4.1 Phn tch v s dng d liu ......................................................................................... 39
8.5 Ci tin ........................................................................................................................................................... 39
8.5.1 Ci tin lin tc .............................................................................................................. 39
8.5.1.1 Ci tin thng xuyn ca T chc ........................................................................... 39
8.5.1.2 Ci tin qu trnh sn xut.......................................................................................... 39
8.5.2 Hnh ng khc phc ................................................................................................... 39
8.5.2.1 Gii quyt vn ......................................................................................................... 40
8.5.2.2 Chng sai li (Error proofing) .................................................................................... 40
8.5.2.3 Tc ng ca hnh ng khc phc ........................................................................... 40
8.5.2.4 Phn tch / th nghim sn phm b loi .................................................................. 40
8.5.3 Hnh ng phng nga ................................................................................................ 40
Ph lc A ...................................................................................................................................................... 41
K hoch kim sot............................................................................................................................................ 41
A.1 Cc giai on ca k hoch kim sot .......................................................................... 41
A.2 Cc yu t ca k hoch kim sot ............................................................................... 41
Ti liu tham kho ................................................................................................................................... 43
5/43
ISO TS 16949:2009 (V)
Li gii thiu
0.1 Khi qut
ISO 9001:2008, H thng qun l cht lng Cc yu cu
Gii thiu chung
0.1 Khi qut
Chp nhn mt h thng qun l cht lng nn l mt quyt nh chin lc ca t chc. Vic
thit k v p dng h thng qun l cht lng ca t chc ph thuc vo:
a)
mi trng ca t chc, cc thay i v nhng ri ro trong mi trng ,
b) cc nhu cu khc nhau,

c)
cc mc tiu ring bit,
d) cc sn phm cung cp,

e)
cc qu trnh c s dng,
f)
quy m v c cu ca t chc.
Mc ch ca tiu chun ny khng nhm dn n s ng nht v cu trc ca cc h thng

qun l cht lng hoc s ng nht ca h thng ti liu.
Cc yu cu ca h thng qun l cht lng quy nh trong tiu chun ny b sung cho cc
yu cu i vi sn phm. Thng tin "Ch thch" l hng dn hiu ng hoc lm r cc
yu cu cn ch thch.
Tiu chun ny c th c s dng cho ni b v t chc bn ngoi, k c cc t chc chng
nhn, nh gi kh nng p ng cc yu cu ca khch hng, cc yu cu lut nh v ch
nh p dng cho sn phm cng nh cc yu cu ring ca t chc.
Cc nguyn tc qun l cht lng nu trong ISO 9000 v ISO 9004 c xem xt khi xy
dng tiu chun ny.
0.2 Cch tip cn theo qu trnh

0.2 Cch tip cn theo qu trnh
Tiu chun ny khuyn khch vic chp nhn cch tip cn theo qu trnh khi xy dng, thc
hin v ci tin hiu lc ca h thng qun l cht lng, nng cao s tha mn ca khch
hng thng qua vic p ng yu cu ca h.
vn hnh mt cch c hiu lc, t chc phi xc nh v qu n l nhiu hot ng c lin h
mt thit vi nhau. Hot ng hoc t hp cc hot ng tip nhn cc u vo v chuyn
thnh cc u ra c th c coi nh mt qu trnh. Thng thng u ra ca qu trnh ny
phi l u vo ca qu trnh tip theo.
Vic p dng mt h thng cc qu trnh trong t chc, cng vi s nhn bit v mi tng tc
gia cc qu trnh ny, cng nh s qun l chng to thnh u ra mong mun, c th
c coi nh "cch tip cn theo qu trnh".
u th ca cch tip cn theo qu trnh l vic kim sot lin tc s k t ni cc qu trnh ring
l trong h thng cc qu trnh, cng nh s kt hp v tng tc gia cc qu trnh .
Khi c s dng trong h thng qun l cht lng, cch tip cn trn nhn mnh tm quan
trng ca:
ISO TS 16949:2009 (V)

a)
vic hiu v p ng cc yu cu,
b) nhu cu xem xt qu trnh v mt gi tr gia tng,

c)
c c kt qu v vic thc hin v hiu lc ca qu trnh, v
d) ci tin lin tc qu trnh trn c s o lng khch quan.

M hnh h thng qun l cht lng da trn qu trnh nu Hnh 1 minh ha s kt ni
ca qu trnh c trnh by trong cc iu t 4 n 8. M hnh ny th hin rng khch hng
ng mt vai tr quan trng trong vic xc nh cc yu cu c xem nh u vo. Vic theo
di s tho mn ca khch hng i hi c s nh gi cc thng tin lin quan n s chp
nhn ca khch hng, chng hn nh cc yu cu ca khch hng c c p ng hay khng.
M hnh nu Hnh 1 khng phn nh cc qu trnh mc chi tit, nhng bao qut tt c cc
yu cu ca tiu chun ny.
CH THCH: Phng php lun quen thuc "Lp k hoch - Thc hin - Kim tra - Hnh ng" (PDCA)
c th p dng cho mi qu trnh. C th m t tm tt PDCA nh sau:
Lp k hoch: Thit lp mc tiu v cc qu trnh cn thit c c cc kt qu ph hp vi cc
yu cu ca khch hng v chnh sch ca t chc.
Thc hin: Thc hin cc qu trnh.
Kim tra: Theo di v o lng cc qu trnh v sn phm theo cc chnh sch, mc tiu v cc yu
cu i vi sn phm v bo co cc kt qu.
Hnh ng: C cc hnh ng ci tin lin tc vic thc hin qu trnh.
Hnh 1: M hnh v H thng qun l cht lng da trn qu trnh

7/43
ISO TS 16949:2009 (V)
0.3 Mi quan h vi TCVN/ISO 9004

0.3 Mi quan h vi ISO 9004
ISO 9001 v ISO 9004 l cc tiu chun v h thng qun l cht lng, c thit k s
dng ng thi, nhng cng c th c s dng mt cch c lp.
ISO 9001 quy nh cc yu cu i vi h thng qun l cht lng, c th c s dng trong
ni b t chc cho vic chng nhn hoc cho cc mc ch hp ng. Tiu chun ny tp trung
vo hiu lc ca h thng qun l cht lng trong vic tha mn yu cu khch hng.
Vo thi im cng b tiu chun ny, ISO 9004 ang c sot xt. Bn tiu chun ISO 9004
c sot xt phi a ra hng dn cho lnh o t c nhng thnh cng bn vng
cho mi t chc trong mt mi trng phc tp vi nhng i hi kht khe v lin tc thay
i. ISO 9004 quan tm n qun l cht lng rng hn so vi ISO 9001; tiu chun ny
hng vo nhu cu v mong i ca tt c cc bn quan tm cng nh vic tha mn ca h
thng qua vic ci tin lin tc v c h thng cc hot ng ca t chc. Tuy nhin, tiu chun
ny khng dng chng nhn, quy nh bt buc hoc k kt hp ng.
Ch thch : Nhn thc v vic s dng tm nguyn tc ca qun l cht lng nu trong ISO
9000:2005 v ISO 9004:2000 cn c lnh o cao nht truyn t v vn dng trong t
chc
0.4 S tng thch vi cc h thng qun l khc

0.4 S tng thch vi cc h thng qun l khc
Trong qu trnh xy dng tiu chun ny, cc iu khon ca tiu chun ISO 14001:2005 c
xem xt k cng nhm tng cng tnh tng thch ca hai tiu chun v li ch ca cng ng
ngi s d ng. Ph lc A nu ra s tng ng gia ISO 9001:2008 v ISO 14001:2004.
Tiu chun ny khng bao gm cc yu cu c th cho cc h thng qun l khc, nh cc h
thng qun l mi trng, qun l an ton v sc kho ngh nghip, qun l ti chnh hoc
qun l ri ro. Tuy nhin, tiu chun ny gip t chc ho hp v hp nht h thng qun l
cht lng ca mnh vi cc yu cu ca h thng qun l c lin quan. T chc c th iu
chnh h thng qun l hin hnh ca mnh nhm mc ch thit lp mt h thng qun l cht
lng ph hp vi cc yu cu ca tiu chun ny.
0.5 Mc ch ca quy nh k thut ny

Quy nh k thut ny nhm xy dng mt h thng qun l cht lng cung cp vic ci tin
thng xuyn, nhn mnh n phng nga v gim bin ng v lng ph trong chui cung
cp.
Quy nh k thut ny, kt ni vi cc yu cu ca khch hng xc nh cc yu cu i vi
H h thng qun l cht lng c bn cho nhng t chc no lm theo ti liu ny.
Quy nh k thut ny nhm trnh nh gi chng nhn nhiu ln v cung cp mt cch tip
cn chung i vi h thng qun l cht lng trong ngnh sn xut t v cc t chc cung
cp ph tng, dch v tng ng.
QUY NH K THUT
ISO TS 16949:2009 (V)
H thng qun l cht lng - Cc yu cu ring khi p dng ISO 9001:2008

i vi ngnh sn xut t v cc dch v ph tng i km
1
Phm vi
1.1 Khi qut

1
Phm vi
1.1
Khi qut
Tiu chun ny quy nh cc yu cu i vi h thng qun l cht lng khi mt t chc:

a) cn chng t kh nng cung cp mt cch n nh sn phm p ng cc yu cu ca khch
hng cng nh cc yu cu ca lut nh v ch nh thch hp; v
b) mun nng cao s tho mn ca khch hng thng qua vic p dng c hiu lc h thng,
bao gm c cc qu trnh ci tin lin tc h thng v m bo s ph hp vi cc yu
cu ca khch hng, yu cu lut nh v ch nh c p dng.
CH THCH 1: Trong tiu chun ny, thut ng "sn phm" ch p dng cho:
a) sn phm d kin cung cp cho khch hng hoc khch hng yu cu,
b) mi u ra d kin l kt qu ca qu trnh to sn phm.
CH THCH 2: Cc yu cu lut nh v ch nh c th c th hin nh cc yu cu php l.
Quy nh k thut ny, lin kt vi ISO 9001:2008, xc nh cc yu cu ca h thng qun l

cht lng cho thit k v pht trin, sn xut v, khi c th, lp t v dch v ca ngnh t
v cc sn phm lin quan.
Quy nh k thut ny p dng ti cc a im ca t chc, ni ch to cc ph tng sn xut
v/hoc dch v theo yu cu ca khch hng.
Cc chc nng h tr, d ti ch hay tch bit (nh cc trung tm thit k, cc tr s phi
hp, cc trung tm phn phi), hnh thnh nn a im nh gi nu chng h tr a im
chnh, nhng khng th t c mt chng ch ring r khi chng nhn theo quy nh k
thut ny.
Quy nh k thut ny c th c p dng trong ton b dy chuyn sn xut t.
1.2 p dng
1.2 p dng
Cc yu cu trong tiu chun ny mang tnh tng qut v nhm p dng cho mi t chc khng
phn bit loi hnh, quy m v sn phm cung cp.
Khi c bt k yu cu no ca tiu chun ny khng th p dng c do bn cht ca t chc
v c th ca sn phm, c th xem xt yu cu ny nh mt ngoi l.
Khi c ngoi l, vic cng b ph hp vi tiu chun ny khng c chp nhn tr phi cc
ngoi l ny c gii hn trong phm vi cc yu cu ca iu 7, v cc ngoi l ny khng nh
hng n kh n ng hay trch nhim ca t chc trong vic cung cp sn phm p ng cc
yu cu ca khch hng, cc yu cu lut nh v ch nh thch hp.
9/43
ISO TS 16949:2009 (V)

i vi quy nh k thut ny, iu khon ngoi tr duy nht cho php lin quan ti mc 7.3,
khi t chc khng chu trch nhim v thit k v pht trin sn phm.
iu khon ngoi tr ny khng bao gm vic thit k qu trnh sn xut
Ti liu vin dn

2 Ti liu vin dn
Ti liu vin dn di y rt cn thit cho vic p dng tiu chun ny. i vi cc ti liu ghi
nm cng b th p dng bn c nu. i vi cc ti liu khng ghi nm cng b th p dng
bn mi nht, bao gm c cc sa i.
TCVN ISO 9000:2007, H thng qun l cht lng - C s v t vng.
Thut ng v nh ngha

3 Thut ng v nh ngha
Tiu chun ny s dng cc thut ng v nh ngha trong ISO 9000. Trong tiu chun ny,
thut ng "sn phm" cng c ngha "dch v".
3.1 Thut ng v nh ngha trong ngnh t.

3.1.1
K hoch kim sot (control plan)
M t bng vn bn cc h thng v qu trnh cn thit kim sot sn phm (xem Annex A).
3.1.2
T chc chu trch nhim thit k
T chc c thm quyn lp quy nh sn phm mi hay thay i chng.

Ch thch: Trch nhim ny bao gm c th nghim v kim tra xc nhn kt qu thc hin thit k
trong p dng do khch hng quy nh.
3.1.3
Chng sai li (error proofing)
Thit k v trin khai sn phm v qu trnh sn xut ngn nga sn xut sn phm khng
ph hp.
3.1.4
Phng th nghim
Ni kim tra, th nghim hay hiu chun, c th bao gm, nhng khng ch, th ha, kim
tng, kch thc, vt l, in hay tin cy.
3.1.5
Phm vi th nghim
Ti liu c kim sot cha:

cc php th, nh gi v hiu chun c th c thc hin bi mt phng th nghim
c nng lc.
danh mc cc thit b tin hnh cc hot ng trn
danh mc cc phng php v tiu chun thc hin cc hot ng trn
3.1.6
Sn xut
Qu trnh lm hay ch to:

vt liu sn xut
cc chi tit sn xut hay dch v
10
ISO TS 16949:2009 (V)

cc t hp lp rp, hay
x l nhit, hn, sn, m hay cc dch v hon thin khc
3.1.7
Bo tr tin liu (predictive maintenance)
Hot ng da trn d liu qu trnh nhm trnh cc vn khi bo tr bng cch d on

trc loi s c c th xy ra.
3.1.8
Bo tr phng nga
Hnh ng c k hoch loi b nguyn nhn hng hc ca thit b v gin on khng c

d kin trc i vi sn xut v c coi nh u vo ca thit k qu trnh sn xut.
3.1.9
Chi ph vn chuyn ph tri (premium freight)
Chi ph ph tri do giao hng khng ng k hoch hay mun,

CH THCH: iu ny c th gy ra bi phng php, s lng, hay giao hng khng ng lch trnh
hay mun,
3.1.10 V tr xa (remote location)

a im h tr cho hin trng v c cc qu trnh phi sn xut.
3.1.11 Hin trng (site)
a im c cc qu trnh sn xut lm gia tng gi tr
3.1.12 c trng c bit (special characteristic)
c trng sn phm hay thng s qu trnh c th nh hng n an ton hay s ph hp i
vi ch nh, s thch hp, chc nng, s thc hin hay vic x l tip theo ca sn phm.
4.1 Yu cu chung
4
4.1
Yu cu chung
T chc phi xy dng, lp vn bn, thc hin, duy tr h thng qun l cht lng v ci tin
lin tc hiu lc ca h thng theo cc yu cu ca tiu chun ny.
T chc phi:
a)
xc nh cc qu trnh cn thit trong h thng qun l cht lng v p dng chng trong
ton b t chc (xem 1.2),
b) xc nh trnh t v mi tng tc ca cc qu trnh ny,

c)
xc nh cc chun mc v phng php cn thit m bo vn hnh v kim sot cc

qu trnh ny c hiu lc,
d) m bo sn c cc ngun lc v thng tin cn thit h tr vic vn hnh v theo di

cc qu trnh ny,
e)
theo di, o lng khi thch hp v phn tch cc qu trnh ny, v
f)
thc hin cc hnh ng cn thit t c kt qu d nh v ci tin lin tc cc qu

trnh ny.
T chc phi qun l cc qu trnh theo cc yu cu ca tiu chun ny.

11/43
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Khi t chc chn ngun bn ngoi cho bt k qu trnh no nh hng n s ph hp ca sn
phm vi cc yu cu, t chc phi m bo kim sot c nhng qu trnh . Cch thc v
mc kim sot cn p dng cho nhng qu trnh s dng ngun bn ngoi ny phi c
xc nh trong h thng qun l cht lng.
CH THCH 1: Cc qu trnh cn thit i vi h thng qun l cht lng nu trn bao gm c cc
qu trnh v cc hot ng qun l, cung cp ngun lc, to sn phm, o lng, phn tch v ci tin.
CH THCH 2: Qu trnh s dng ngun bn ngoi l qu trnh t chc cn cho h thng qun l cht
lng ca mnh v la chn bn ngoi thc hin.
CH THCH 3: Vic m bo kim sot cc qu trnh s dng ngun bn ngoi khng loi tr c
trch nhim ca t chc v s ph hp vi tt c cc yu cu ca khch hng, lut nh v ch nh.
Loi v mc kim sot cn p dng vi cc qu trnh s dng ngun bn ngoi c th b nh hng
bi cc yu t nh:
a) tc ng tim n ca qu trnh s dng ngun bn ngoi n kh nng ca t chc trong vic cung
cp sn phm ph hp vi cc yu cu,
b) mc chia s vic kim sot qu trnh,
c) kh nng t c kim sot cn thit thng qua vic p dng 7.4.
4.1.1 Cc yu cu chung - b sung

Vic m bo kim sot ton b cc qu trnh c ngun bn ngoi khng loi tr vic t chc
chu trch nhim v s ph hp i vi tt c cc yu cu ca khch hng.
Ch thch: xem thm 7.4.1 v 7.4.1.3
4.2 Yu cu v h thng ti liu

4.2.1 Khi qut
4.2
Yu cu v h thng ti liu
4.2.1 Khi qut

Cc ti liu ca h thng qun l cht lng phi bao gm:
a)
cc vn bn cng b v chnh sch cht lng v mc tiu cht lng,
b) s tay cht lng,

c)
cc th tc dng vn bn v h s theo yu cu ca tiu chun ny, v
d) cc ti liu, bao gm c h s, c t chc xc nh l cn thit m bo hoch nh,

vn hnh v kim sot c hiu lc cc qu trnh ca t chc.
CH THCH 1: Khi thut ng "th tc dng vn bn" xut hin trong tiu chun ny, th th tc phi
c xy dng, lp thnh vn bn, thc hin v duy tr. Mt ti liu ring r c th cp ti yu cu
vi mt hay nhiu th tc. Yu cu v th tc dng vn bn c th c cp trong nhiu ti liu.
CH THCH 2: Mc vn bn ho h thng qun l cht lng ca mi t chc c th khc nhau tu
thuc vo:
a) quy m ca t chc v loi hnh hot ng,
b) s phc tp v s tng tc gia cc qu trnh, v
c) nng lc nhn s.
CH THCH 3: H thng ti liu c th bt k dng hoc loi phng tin no.
12
ISO TS 16949:2009 (V)

4.2.2 S tay cht lng
4.2.2 S tay cht lng
T chc phi thit lp v duy tr s tay cht lng trong bao gm:
a)
phm vi ca h thng qun l cht lng, bao gm c cc ni dung chi tit v l gii v bt
c ngoi l no (xem 1.2),
b) cc th tc dng vn bn c thit lp cho h thng qun l cht lng hoc vin dn

n chng v,
c)
m t s tng tc gia cc qu trnh trong h thng qun l cht lng.
4.2.3 Kim sot ti liu

4.2.3 Kim sot ti liu
Cc ti liu theo yu c u ca h thng qun l cht lng phi c kim sot. H s cht
lng l mt loi ti liu c bit v phi c kim sot theo cc yu cu nu trong 4.2.4 .
T chc phi lp mt th tc dng vn bn xc nh vic kim sot cn thit nhm:
a)
ph duyt ti liu v s tha ng trc khi ban hnh,
b) xem xt, cp nht khi cn v ph duyt li ti liu,

c)
m bo nhn bit c cc thay i v tnh trng sa i hin hnh ca ti liu,
d) m bo cc phin bn ca cc ti liu thch hp sn c ni s dng,

e)
m bo ti liu lun r rng v d nhn bit,
f)
m bo cc ti liu c ngun gc bn ngoi m t chc xc nh l cn thit cho vic

hoch nh v vn hnh h thng qun l cht lng c nhn bit v vic phn phi
chng c kim sot, v
g)
ngn nga vic v tnh s dng cc ti liu li thi v p dng cc du hiu nhn bit thch
hp nu chng c gi li v bt k mc ch no.
4.2.3.1 Cc quy nh k thut

T chc phi c mt qu trnh nhm m bo vic xem xt kp thi, phn phi v trin khai tt
c cc quy nh/ tiu chun k thut v cc thay i ca chng da trn lch trnh do khch
hng yu cu. Vic xem xt kp thi phi c thc hin nhanh nht c th, v khng c
vt qu hai tun lm vic.
T chc phi duy tr h s v ngy thng p dng cc thay i trong sn xut. Vic p dng
ny bao gm c cc ti liu c cp nht.
Ch thch: S thay i trong cc tiu chun/quy nh ny yu cu mt h s cp nht v s ph duyt
ca khch hng i vi cc chi tit sn xut khi cc quy nh ny c vin dn trong h s thit k
hoc nu chng nh hng ti cc ti liu ca qu trnh ph duyt chi tit sn xut, v d nh k hoch
kim sot, FMEA, v.v...
4.2.4 Kim sot h s

ISO 9001:2008, H thng qun l cht lng Ca c ye u cau
4.2.4 Kim sot h s
13/43
ISO TS 16949:2009 (V)

Phi kim sot h s c thit lp cung cp bng chng v s ph hp vi cc yu cu v
vic vn hnh c hiu lc ca h thng qun l cht lng.
T chc phi lp mt th tc bng vn bn xc nh cch thc kim sot cn thit i vi
vic nhn bit, bo qun, bo v, s dng, thi gian lu gi v hu b h s.
H s phi lun r rng, d nhn bit v d s dng.
Ch thch 1: Hu b bao gm c chuyn quyn s dng
Ch thch 2: "H s" cng bao gm c cc h s do khch hng yu cu
4.2.4.1 Lu gi h s
Vic kim sot h s phi tho mn cc yu cu lut nh v ca khch hng
Trch nhim ca lnh o
5.1 Cam kt ca lnh o

5
Trch nhim ca lnh o
5.1
Cam kt ca lnh o
Lnh o cao nht phi cung cp bng chng v s cam kt ca mnh i vi vic xy dng v
thc hin h thng qun l cht lng v ci tin lin tc hiu lc ca h thng bng cch:
a)
truyn t cho t chc v tm quan trng ca vic p ng cc yu cu ca khch hng

cng nh cc yu cu ca lut nh v ch nh,
b) thit lp chnh sch cht lng,

c)
m bo vic thit lp cc mc tiu cht lng,
d) tin hnh vic xem xt ca lnh o, v

e)
m bo sn c cc ngun lc.
5.1.1 Hiu qu ca qu trnh

Lnh o cao nht phi xem xt cc qu trnh to sn phm v cc qu trnh h tr nhm m
bo tnh hiu lc v hiu qu ca chng.
5.2 Hng vo khch hng

5.2
Hng vo khch hng
Lnh o cao nht phi m bo rng cc yu cu ca khch hng c xc nh v p ng

nhm nng cao s tho mn khch hng (xem 7.2.1 v 8.2.1).
5.3 Chnh sch cht lng

5.3
Chnh sch cht lng
Lnh o cao nht phi m bo rng chnh sch cht lng

a) ph hp vi mc ch ca t chc,
b) bao gm vic cam kt p ng cc yu cu v ci tin lin tc hiu lc ca h thng
qun l cht lng,
14
ISO TS 16949:2009 (V)

c) cung cp c s cho vic thit lp v xem xt cc mc tiu cht lng,
d) c truyn t v thu hiu trong t chc, v
e) c xem xt lun thch hp.
5.4
Hoch nh
5.4.1 Mc tiu cht lng

5.4
Hoch nh
5.4.1 Mc tiu cht lng

Lnh o cao nht phi m bo rng cc mc tiu cht lng, bao gm c nhng iu cn
thit p ng cc yu cu ca sn phm [xem 7.1 a)], c thit lp ti cc cp v b phn
chc nng lin quan trong t chc. Mc tiu cht lng phi o c v nht qun vi chnh
sch cht lng.
5.4.1.1 Mc tiu cht lng - B sung
Lnh o cao nht phi xc nh cc mc tiu cht lng v cc bin php o lng phi c
bao gm trong k hoch kinh doanh v c s dng trin khai chnh sch cht lng.
Ch thch: Mc tiu cht lng nn th hin cc nhu cu ca khch hng v c th t c trong mt
khong thi gian xc nh.
5.4.2 Hoch nh h thng qun l cht lng

5.4.2 Hoch nh h thng qun l cht lng
Lnh o cao nht phi m bo:
a) tin hnh hoch nh h thng qun l cht lng p ng cc yu cu nu trong
4.1 cng nh cc mc tiu cht lng, v
b) tnh nht qun ca h thng qun l cht lng c duy tr khi cc thay i i vi h
c) thng qun l cht lng c hoch nh v thc hin.
5.5 Trch nhim, quyn hn v trao i thng tin

5.5.1 Trch nhim v quyn hn
5.5
Trch nhim, quyn hn v trao i thng tin
5.5.1 Trch nhim v quyn hn

Lnh o cao nht phi m bo cc trch nhim v quyn hn c xc nh v thng bo
trong t chc.
5.5.1.1 Trch nhim i vi cht lng
Cc lnh o vi trch nhim v quyn hn trong hnh ng khc phc phi c thng bo
ngay v sn phm hoc cc qu trnh khng ph hp vi cc yu cu.
Nhn s chu trch nhim v cht lng sn phm phi c quyn cho dng sn xut khc
phc cc vn v cht lng.
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Phi b tr ngi c trch nhim, hoc c u quyn, bo m cht lng sn phm i vi
hot ng xuyn sut qua nhiu ca
5.5.2 i din ca lnh o
5.5.2 i din ca lnh o
Lnh o cao nht phi ch nh mt thnh vin trong ban lnh o ca t chc, ngoi cc trch
nhim khc, phi c trch nhim v quyn hn sau
a) m bo cc qu trnh cn thit ca h thng qun l cht lng c thit lp, thc
hin v duy tr;
b) bo co cho lnh o cao nht v kt qu hot ng ca h thng qun l cht lng v
v mi nhu cu ci tin, v
c) m bo thc y ton b t chc nhn thc c cc yu cu ca khch hng.
CH THCH: Trch nhim ca i din lnh o v cht lng c th bao gm c quan h vi bn ngoi
v cc vn c lin quan n h thng qun l cht lng.
5.5.2.1 i din khch hng

Lnh o cao nht phi ch nh mt ngi c trch nhim v quyn hn m bo cc yu
cu ca khch hng c cp. iu bao gm vic la chn cc c tnh quan trng, thit
lp cc mc tiu cht lng v kho o to lin quan, cc hnh ng khc phc, thit k v
pht trin sn phm.
5.5.3 Trao i thng tin ni b
5.5.3 Trao i thng tin ni b
Lnh o cao nht phi m bo thit lp cc qu trnh trao i thng tin thch hp trong t
chc v c s trao i thng tin v hiu lc ca h thng qun l cht lng
5.6
Xem xt ca lnh o
5.6.1 Khi qut

5.6
Xem xt ca lnh o
5.6.1 Khi qut

Lnh o cao nht phi nh k xem xt h thng qun l cht lng, m bo n lun thch
hp, tha ng v c hiu lc. Vic xem xt ny phi nh gi c cc c hi ci tin v nhu
cu thay i i vi h thng qun l cht lng, k c chnh sch cht lng v cc mc tiu
cht lng.
H s xem xt ca lnh o phi c duy tr (xem 4.2.4)
5.6.1.1 Thc hin h thng qun l cht lng
Nhng xem xt ny phi bao gm cc yu cu ca h thng qun l cht lng v cc xu
hng thc hin chng nh mt phn c bit ca qu trnh ci tin lin tc.
Mt phn ca xem xt lnh o phI l vic theo di cc mc tiu cht lng, v vic bo co
v nh gi nh k v chi ph do cht lng km (xem 8.4.1 v 8.5.1)
16
ISO TS 16949:2009 (V)

Cc kt qu ny phi c lu h s cung cp, ti thiu l cc bng chng v vic t c:
cc mc tiu cht lng quy nh trong k hoch kinh doanh, v
s tho mn ca khch hng i vi cc sn phm cung cp.
5.6.2 u vo ca vic xem xt

5.6.2 u vo ca vic xem xt
u vo ca vic xem xt ca lnh o phi bao gm thng tin v:
a) kt qu ca cc cuc nh gi,
b) phn hi ca khch hng,
c) vic thc hin cc qu trnh v s ph hp ca sn phm,
d) tnh trng ca cc hnh ng khc phc v phng nga,
e) cc hnh ng tip theo t cc cuc xem xt ca lnh o ln trc,
f)
nhng thay i c th nh hng n h thng qun l cht lng, v
g) cc khuyn ngh v ci tin.

5.6.2.1 u vo ca xem xt - b sung
u vo cho xem xt ca lnh o phi bao gm vic phn tch cc sai li s dng thc t v
tim n, v s nh hng ca chng ti cht lng, an ton hoc mi trng
5.6.3 u ra ca vic xem xt.
5.6.3 u ra ca vic xem xt
u ra ca vic xem xt ca lnh o phi bao gm mi quyt nh v hnh ng lin quan
n
a)
vic ci tin hiu lc ca h thng qun l cht lng v ci tin cc qu trnh ca h

thng,
b) vic ci tin sn phm lin quan n cc yu cu ca khch hng, v

c)
nhu cu v ngun lc.
Qun l ngun lc
6.1 Cung cp ngun lc

6
Qun l ngun lc
6.1
Cung cp ngun lc
T chc phi xc nh v cung cp cc ngun lc cn thit :

a)
thc hin v duy tr h thng qun l cht lng, ci tin lin tc hiu lc ca h thng ,
v
b) nng cao s tho mn khch hng bng cch p ng cc yu cu ca khch hng.

6.2
Ngun nhn lc
17/43
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6.2.1 Khi qut
Nhng ngi thc hin cc cng vic nh hng n s ph hp vi cc yu cu ca sn
phm phi c nng lc trn c s c gio dc, o to, c k nng v kinh nghim thch hp.
CH THCH: S ph hp vi cc yu c u ca sn phm c th b nh hng trc tip hoc
gin tip bi nhng ngi thc hin nhim v bt k trong h thng qun l cht lng.
6.2.2 Nng lc, o to v nhn thc
T chc phi:
a)
xc nh nng lc cn thit ca nhng ngi thc hin cc cng vic nh hng n s

ph hp vi cc yu cu ca sn phm,
b) tin hnh o to hay nhng hnh ng khc t c nng lc cn thit, khi thch
hp,
c)
nh gi hiu lc ca cc hnh ng c thc hin,
d) m bo rng nhn s ca t chc nhn thc c mi lin quan v tm quan trng ca

cc hot ng ca h v h ng gp nh th no i vi vic t c mc tiu cht
lng, v
e)
duy tr h s thch hp v gio dc, o to, k nng v kinh nghim (xem 4.2.4).
6.2.2.1 K nng thit k sn phm

T chc phi m bo rng nhn s chu trch nhim thit k sn phm c nng lc p
ng cc yu cu ca thit k v c k nng ng dng cc cng c v k thut thit k.
T chc phi xc nh cc cng c v k thut c th ng dng c.
6.2.2.2 o to
T chc phi thit lp v duy tr th tc dng vn bn xc nh cc nhu cu o to v cc
nng lc cn t ca tt c cc nhn s thc hin nhng cng vic c nh hng ti cht
lng. Nhn s thc hin cc cng vic c th phi c khng nh nng lc theo yu cu
cn thit, vi s ch trng c bit ti s tha mn cc yu cu ca khch hng.
Ch thch 1 : iu ny c p dng cho tt c cc nhn s c nh hng ti cht lng ti tt c cc
cp ca t chc.
Ch thch 2 : Mt v d v yu cu c bit ca khch hng l vic ng dng c s d liu ton hc c
s ha.
6.2.2.3 o to ti ch (training on the job)

T chc phi cung cp cc kha o to ti ch cho cc nhn s trong bt k mt cng vic
mi hoc cng vic c sa i no c nh hng ti cht lng sn phm, bao gm c cc
nhn vin hp ng hoc nhn vin i l. Nhng ngi m cng vic c nh hng ti cht
lng phi c thng bo v cc hu qa lin quan ti khch hng khi c s khng ph hp
v cc yu cu cht lng.
6.2.2.4 Trao quyn v to ng lc cho nhn vin
T chc phi c qu trnh to ng lc cho cc nhn vin nhm t c cc mc tiu cht
lng, thc hin ci tin lin tc, v to ra mt mi trng thc y s sng to. Qu
trnh ny phi bao gm s thc y nhn thc v cht lng v cng ngh trong ton b t
chc.
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ISO TS 16949:2009 (V)

T chc phi c qu trnh o lng mc nhn vin nhn thc c v mi lin h v
tm quan trng trong cc cng vic ca h v h ng gp nh th no t c cc yu
cu v cht lng.
6.3 C s h tng
6.3
C s h tng
T chc phi xc nh, cung cp v duy tr c s h tng cn thit t c s ph hp vi

cc yu cu ca sn phm. C s h tng bao gm v d nh:
a) nh ca, khng gian lm vic v cc phng tin km theo,
b) trang thit b qu trnh (c phn cng v phn mm), v
c)
dch v h tr (nh vn chuyn hoc trao i thng tin hay h thng thng tin).
6.3.1 Hoch nh nh xng, phng tin v thit b

T chc phi s dng cch tip cn a chc nng (xem 7.3.3.1) xy dng cc k hoch v
nh xng, phng tin v trang thit b. Thit k nh xng phi ti u ha cho vic di
chuyn nguyn vt liu, xp d v to gi tr gia tng khi s dng cc khong khng gian, v
phi to thun li cho dng vt liu mt cch ng b. Phi xy dng v ng dng cc phng
php nh gi v theo di tnh hiu lc ca cc cng vic hin c.
Ch thch : Nhng yu cu ny nn c nh hng theo cc nguyn tc ca sn xut tinh gn (lean
manufacturing) v lin kt vi tnh hiu lc ca h thng qun l cht lng.
6.3.2 K hoch ng ph vi tnh trng khn cp

T chc phi chun b k hoch ng ph vi tnh trng khn cp tha mn cc yu cu ca
khch hng khi c nhng s c khn cp nh gin on cung cp tin ch, thiu nhn lc, thit
b chnh b hng v hng b tr li.
6.4 Mi trng lm vic

6.4
Mi trng lm vic
T chc phi xc nh v qun l mi trng lm vic cn thit t c s ph hp i

vi cc yu cu ca sn phm.
CH THCH: Thut ng mi trng lm vic lin quan ti cc iu kin tin hnh cng vic, bao gm
cc yu t vt l, mi trng v cc yu t khc (nh ting n, nhit , m, chiu sng hoc thi
tit).
6.4.1 An ton cho nhn s t c cht lng sn phm

An ton ca sn phm v nhng cch thc ti thiu ha cc mi nguy tim n cho nhn s
phi c t chc cp, c bit l trong qu trnh thit k v pht trin v cc hot ng
ca qu trnh sn xut.
6.4.2 V sinh nh xng
T chc phi duy tr nh xng trong tnh trng gn gng, sch s v sa cha tng ng vi
nhu cu ca sn phm v qu trnh sn xut.
19/43
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To sn phm
7.1 Hoch nh vic to sn phm

7
To sn phm
7.1
Hoch nh vic to sn phm
T chc phi lp k hoch v trin khai cc qu trnh cn thit i vi vic to sn phm.

Hoch nh vic to sn phm phi nht qun vi cc yu cu ca cc qu trnh khc ca h
thng qun l cht lng (xem 4.1).
Trong qu trnh hoch nh vic to sn phm, khi thch hp, t chc phi xc nh nhng
iu sau y:
a) cc mc tiu cht lng v cc yu cu i vi sn phm;
b) nhu cu thit lp cc qu trnh v ti liu cng nh vic cung cp cc ngun lc c th
i vi sn phm;
c)
cc hot ng kim tra xc nhn, xc nhn gi tr s dng, cc hot ng theo di, o

lng, kim tra v th nghim c th cn thit i vi sn phm v cc tiu ch chp
nhn sn phm;
d) cc h s cn thit cung cp bng chng rng cc qu trnh thc hin v sn phm

to thnh p ng cc yu cu (xem 4.2.4).
u ra ca vic hoch nh phi c th hin ph hp vi phng php tc nghip ca t
chc.
CH THCH 1: Ti liu quy nh cc qu trnh ca h thng qun l cht lng (bao gm c cc qu
trnh to sn phm) v cc ngun lc c s dng i vi mt sn phm, d n hay hp ng c th
c th c coi nh mt k hoch cht lng.
CH THCH 2: T chc cng c th p dng cc yu cu nu trong 7.3 trin khai qu trnh to sn
phm.
7.1.1 Hoch nh vic to sn phm

Cc yu cu ca khch hng v cc quy nh k thut c tham chiu n phi c bao gm
trong hoch nh vic to sn phm nh mt phn ca k hoch cht lng.
7.1.2 Chun mc chp nhn
Chun mc chp nhn phi c t chc xc nh v, khi c yu cu, c khch hng ph
duyt.
Khi ly mu d liu tng trng, mc chp nhn phi l khng sai hng (zero defects) (xem
8.2.3.1)
7.1.3 Bo mt
T chc phi m bo tnh bo mt ca cc sn phm hp ng vi khch hng v cc d
n ang trin khai v cc thng tin lin quan ti sn phm.
7.1.4 Kim sot thay i
T chc phi c qu trnh kim sot v phn ng vi nhng thay i nh hng ti vic to
sn phm. Cc nh hng ca mi thay i, bao gm c cc thay i c nguyn nhn t nh
cung cp, phi c nh gi, v cc hot ng kim tra xc nhn, xc nhn gi tr s dng
phi c xc nh, nhm m bo s ph hp vi yu cu ca khch hng. Cc thay i phi
c xc nhn gi tr s dng trc khi thc hin.
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i vi cc thit k c s hu ring, nh hng ti hnh dng, lp ghp (fit) v chc nng (bao
gm c tnh nng v/hoc bn) phi c xem xt cng vi khch hng c th nh gi
thch hp mi nh hng.
Khi c yu cu ca khch hng, cc yu cu kim tra xc nhn/nhn dng b sung, nh cc yu
cu gii thiu sn phm mi phi c p ng.
Ch thch 1 : Mi hot ng to sn phm nh hng ti yu cu ca khch hng u cn c s thng
bo ti, v s chp thun t, khch hng.
Ch thch 2 : Yu cu trn y c p dng cho thay i sn phm v thay i qu trnh sn xut.
7.2
Cc qu trnh lin quan n khch hng
7.2.1 Xc nh cc yu cu lin quan n sn phm

7.2
Cc qu trnh lin quan n khch hng
7.2.1 Xc nh cc yu cu lin quan n sn phm

T chc phi xc nh:
a) yu cu do khch hng a ra, gm c yu cu v cc hot ng giao hng v sau giao
hng;
b) yu cu khng c khch hng cng b nhng cn thit cho vic s dng quy nh hoc
s dng d kin, khi bit;
c) yu cu lut nh v ch nh p dng cho sn phm, v
d) mi yu cu b sung c t chc cho l cn thit.
CH THCH: Cc hot ng sau giao nhn bao gm, v d nh, cc hnh ng theo nhng iu khon
bo hnh, ngha v hp ng nh dch v bo tr v cc dch v b tr nh ti ch hoc loi b cui
cng.
7.2.1.1 Cc c tnh quan trng do khch hng ch nh

T chc phi chng t s ph hp vi cc yu cu ca khch hng i vi cc ch nh, ti liu
v kim sot cc c tnh.
7.2 Xem xt cc yu cu lin quan n sn phm
7.2.2 Xem xt cc yu cu lin quan n sn phm
T chc phi xem xt cc yu cu lin quan n sn phm. Vic xem xt ny phi c tin
hnh trc khi t chc cam kt cung cp sn phm cho khch hng (v d nh np n d
thu, chp nhn hp ng hay n t hng, chp nhn s thay i trong hp ng hay n
t hng) v phi m bo rng:
a) yu cu v sn phm c nh r;
b) cc yu cu trong hp ng hoc n t hng khc vi nhng g nu trc phi
c gii quyt; v
c) t chc c kh nng p ng cc yu cu nh.
T chc phi xem xt cc yu cu lin quan n sn phm (xem 4.2.4).
Khi khch hng a ra cc yu cu khng bng vn bn, cc yu cu ca khch hng phi c
t chc khng nh trc khi chp nhn.
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Khi yu cu v sn phm thay i, t chc phi m bo rng cc ti liu lin quan c sa
i v cc c nhn lin quan nhn thc c cc yu cu thay i .
CH THCH: Trong mt s tnh hung, v d nh trong bn hng qua internet, vi mi ln t hng,
vic xem xt mt cch chnh thc l khng thc t. Thay vo , vic xem xt c th c thc hin i
vi cc thng tin lin quan v sn phm nh danh mc cho hng hay ti liu qung co.
7.2.2.1 Xem xt cc yu cu lin quan ti sn phm - b sung

S t chi yu cu mc 7.2.2 i vi vic xem xt chnh thc (xem ch thch) phi c s cho
php ca khch hng.
7.2.2.2 Tnh kh thi sn xut ca t chc
T chc phi kho st, khng nh v vn bn ho tnh kh thi ca sn xut i vi sn phm
d kin trong qu trnh xem xt hp ng, bao gm c vic phn tch cc ri ro.
7.2.3 Trao i thng tin vi khch hng
7.2.3 Trao i thng tin vi khch hng
T chc phi xc nh v sp xp c hiu qu vic trao i thng tin vi khch hng c lin
quan ti:
a) thng tin v sn phm;
b) x l cc yu cu, hp ng hoc n t hng, k c cc sa i, v
c) phn hi ca khch hng, k c cc khiu ni.
7.2.3.1 Trao i thng tin vi khch hng - b sung
T chc phi c kh nng trao i cc thng tin cn thit, bao gm d liu, theo ngn ng v
nh dng ca khch hng (v d nh d liu my tnh h tr thit k, trao i d liu in t)
7.3
Thit k v pht trin
Ch thch: Yu cu 7.3 bao gm thit k v pht trin sn phm v qu trnh sn xut, v nh hng
vo vic phng nga sai li hn l pht hin chng.
7.3.1 Hoch nh thit k v pht trin

7.3
Thit k v pht trin
7.3.1 Hoch nh thit k v pht trin

T chc phi lp k hoch v kim sot vic thit k v pht trin sn phm. Trong qu trnh
hoch nh thit k v pht trin t chc phi xc nh:
a) cc giai on ca thit k v pht trin,
b) vic xem xt, kim tra xc nhn v xc nhn gi tr s dng thch hp cho mi giai on
thit k v pht trin, v
c) trch nhim v quyn hn i vi cc hot ng thit k v pht trin.
T chc phi qun l s tng giao gia cc nhm khc nhau tham d vo vic thit k v
pht trin nhm m bo s trao i thng tin c hiu qu v phn cng trch nhim r rng.
Kt qu hoch nh phi c cp nht mt cch thch hp trong qu trnh thit k v pht
trin.
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ISO TS 16949:2009 (V)

CH THCH: Vic xem xt, kim tra xc nhn v xc nhn gi tr s dng ca thit k v pht trin c
cc mc ch ring bit. C th tin hnh v lp h s ring r hoc kt hp cc hot ng ny sao cho
ph hp vi sn phm v t chc.
7.3.1.1 Tip cn a chc nng (multidisciplinary approach)

T chc phi s dng cch tip cn a chc nng chun b cho vic to sn phm, bao gm:
pht trin/hon thnh v theo di cc c tnh quan trng,
pht trin v xem xt theo FMEA, bao gm cc hnh ng lm gim cc mi nguy tim
n, v
pht trin v xem xt cc k hoch cht lng.
Ch thch : Mt s tip cn a chc nng c trng bao gm nhn s thit k, ch to, k thut, cht
lng, sn xut v nhn s thch hp khc.
7.3.2 u vo ca thit k v pht trin

7.3.2 u vo ca thit k v pht trin
u vo lin quan n cc yu cu i vi sn phm phi c xc nh v duy tr h s (xem
4.2.4). u vo phi bao gm:
a) yu cu v chc nng v cng dng,
b) yu cu lut nh v ch nh thch hp,
c) khi thch hp thng tin nhn c t cc thit k tng t trc , v
d) cc yu cu thit yu khc cho thit k v pht trin.
u vo ny phi c xem xt v s tha ng. Cc yu cu phi y , r rng v khng
mu thun vi nhau.
7.3.2.1 u vo ca thit k sn phm
T chc phi xc nh, lp thnh vn bn v xem xt cc yu cu u vo ca thit k sn
phm, bao gm nhng iu sau y :
yu cu ca khch hng (xem xt hp ng) nh cc c tnh c bit (xem 7.3.2.3),
nhn dng, truy tm ngun gc v bao gi;

s dng thng tin : t chc phi c qu trnh trin khai cc thng tin thu c t cc
d n thit k trc , phn tch cnh tranh, phn hi ca khch hng, u vo ni b,

d liu th trng v cc ngun khc, cho cc d n hin ti, tng lai hoc cng bn
cht;
mc ch i vi cht lng sn phm, vng i, tin cy, bn, kh nng bo
dng, thi gian v gi c.
7.3.2.2 u vo ca thit k qu trnh sn xut

T chc phi xc nh, lp thnh vn bn v xem xt cc yu cu u vo ca vic thit k qu
trnh sn xut, bao gm:
d liu u ra ca thit k sn phm,
ch tiu nng sut, nng lc qu trnh v gi thnh,
yu cu ca khch hng, nu c, v
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kinh nghim t cc qu trnh pht trin trc
Ch thch. Thit k qu trnh sn xut bao gm vic s dng phng php chng sai li (errorproofing) cp ph hp vi mc nghim trng ca vn v tng xng vi ri ro gp phi.
7.3.2.3 c tnh quan trng

T chc phi xc nh cc c tnh quan trng (xem 7.3.3.d) v
bao gm tt c cc c tnh trong k hoch kim sot,
ph hp vi cc quy nh v k hiu ring ca khch hng, v
xc nh qu trnh kim sot ti liu bao gm bn v, FMEA, k hoch kim sot, hng
dn cng vic vi k hiu c tnh quan trng ca khch hng hoc k hiu tng
ng ca t chc hoc lu a vo cc bc ca qu trnh c nh hng ti cc
c tnh quan trng.
Ch thch: c tnh quan trng c th bao gm cc c tnh ca sn phm v thng s ca qu trnh
7.3.3 u ra ca thit k v pht trin

7.3.3 u ra ca thit k v pht trin
u ra ca thit k v pht trin phi dng thch hp kim tra xc nhn theo u vo ca
thit k v pht trin v phi c ph duyt trc khi ban hnh.
u ra ca thit k v pht trin phi:
a) p ng cc yu cu u vo ca thit k v pht trin,
b) cung cp cc thng tin thch hp cho vic mua hng, sn xut v cung cp dch v,
c) bao gm hoc vin dn ti cc chun mc chp nhn ca sn phm, v
d) xc nh cc c tnh ct yu cho an ton v s dng ng ca sn phm.
CH THCH: Thng tin cho qu trnh sn xut v cung cp dch v c th bao gm chi tit v vic bo
ton sn phm.
7.3.3.1 u ra ca thit k sn phm - b sung

u ra ca thit k sn phm phi dng sao cho c th kim tra v xc nhn theo cc yu cu
u vo ca thit k sn phm. u ra ca thit k sn phm phi bao gm:
FMEA thit k, tin cy ca kt qu,
c tnh c trng ca sn phm v quy cch k thut,
chng sai li (error-proofing) sn phm, khi thch hp,
nh dng sn phm bao gm bn v v c s d liu ton hc,
kt qu xem xt thit k sn phm, v
cc bn thuyt minh, nu c th.
7.3.3.2 u ra ca thit k qu trnh sn xut

u ra ca thit k qu trnh phi dng sao cho c th kim tra v xc nhn theo cc yu cu
u vo ca thit k qu trnh. u ra ca thit k qu trnh phi bao gm:
quy cch k thut v bn v,
lu /cch b tr qu trnh sn xut,
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ISO TS 16949:2009 (V)

FMEA qu trnh,
k hoch kim sot (xem 7.5.1.1),
hng dn cng vic,
tiu chun chp nhn ph duyt qu trnh,
d liu v cht lng, tin cy, kh nng bo tr v o lng,
phng php nhanh pht hin v phn hi v sn phm/qu trnh khng ph hp.
7.3.4 Xem xt thit k v pht trin

7.3.4 Xem xt thit k v pht trin
Ti nhng giai on thch hp, vic xem xt thit k v pht trin mt cch c h thng phi
c thc hin theo hoch nh (xem 7.3.1) :
a) nh gi kh nng p ng cc yu cu ca cc kt qu thit k v pht trin, v
b) nhn bit mi vn trc trc v xut cc hnh ng cn thit.
Nhng ngi tham gia vo vic xem xt phi bao gm i din ca tt c cc b phn chc
nng lin quan ti (cc) giai on thit k v pht trin ang c xem xt. Phi duy tr h s
v cc kt qu xem xt v mi hnh ng cn thit (xem 4.2.4).
Ch thch : Vic xem xt ny thng c phi hp vi cc giai on ca thit k v bao gm c thit
k v pht trin qu trnh sn xut.
7.3.4.1 Theo di
Vic o lng ti cc giai on c th ca thit k v pht trin phi c xc nh, phn tch
v bo co vi cc kt qu tm tt c xem nh d liu u vo ca Xem xt ca Lnh o
Ch thch : Vic o lng ny bao gm cc mi nguy v cht lng, gi thnh, thi gian ra mt sn
phm (lead-time), hnh trnh ti thiu (critical paths), v nhng yu t khc khi thch hp
7.3.5 Kim tra xc nhn thit k v pht trin

7.3.5 Kim tra xc nhn thit k v pht trin
Vic kim tra xc nhn phi c thc hin theo cc b tr hoch nh (xem 7.3.1) m
bo rng u ra thit k v pht trin p ng cc yu cu u vo ca thit k v pht trin.
Phi duy tr h s cc kt qu kim tra xc nhn v mi hnh ng cn thit (xem 4.2.4).
7.3.6 Xc nhn gi tr s dng ca thit k v pht trin
7.3.6 Xc nhn gi tr s dng ca thit k v pht trin
Xc nhn gi tr s dng ca thit k v pht trin phi c tin hnh theo cc b tr
hoch nh (xem 7.3.1) m bo rng sn phm to ra c kh nng p ng cc yu cu s
dng d kin hay cc ng dng quy nh khi bit. Khi c th, phi tin hnh xc nhn gi tr
s dng trc khi chuyn giao hay s dng sn phm. Phi duy tr h s cc kt qu ca vic
xc nhn gi tr s dng v mi hnh ng cn thit (xem 4.2.4).
Ch thch 1 : Qu trnh xc nhn gi tr s dng ca thit k thng bao gm mt bo co phn tch th
trng i vi sn phm tng t.
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Ch thch 2 : Yu cu 7.3.5 v 7.3.6 trn y p dng cho c sn phm v qu trnh sn xut
7.3.6.1 Xc nhn gi tr s dng ca thit k v pht trin - b sung

Xc nhn gi tr s dng ca thit k v pht trin phi thc hin theo yu cu ca khch hng
bao gm c thi gian biu
7.3.6.2 Chng trnh sn phm mu (prototype programme)
Khi khch hng yu cu, t chc phi c mt chng trnh sn xut th v k hoch kim sot.
T chc phi s dng, khi c th, cng mt nh cung cp, cng c, cc qu trnh sn xut nh
s c s dng trong sn xut.
Tt c cc hot ng th nghim phi c theo di hon thnh ng thi gian v ph hp
vi cc yu cu.
Nu s dng cc dch v bn ngoi, t chc phi chu trch nhim v nhng dch v bn ngoi
, bao gm c vic qun l k thut.
7.3.6.3 Qu trnh ph duyt sn phm
T chc phi tun theo quy trnh ph duyt sn phm v qu trnh sn xut c tha
nhn bi khch hng.
Ch thch: Ph duyt sn phm nn c thc hin tip sau vic kim tra xc nhn qu trnh sn xut
Quy trnh ph duyt sn phm v qu trnh sn xut cng phi c p dng i vi cc nh

cung cp.
7.3.7 Kim sot thay i thit k v pht trin
7.3.7 Kim sot thay i thit k v pht trin
Cc thay i ca thit k v pht trin phi c nh n bit v duy tr h s. Nhng thay i
ny phi c xem xt, kim tra xc nhn v xc nhn gi tr s dng mt cch thch hp v
c ph duyt trc khi thc hin. Vic xem xt cc thay i thit k v pht trin phi bao
gm vic nh gi tc ng ca s thay i ln cc b phn cu thnh v sn phm c
chuyn giao. Phi duy tr h s cc kt qu ca vic xem xt cc thay i v hnh ng cn
thit (xem 4.2.4).
Ch thch: Thay i ca thit k v pht trin bao gm cc thay i trong tui th chng trnh sn
phm (xem 7.1.4)
7.4 Mua hng

7.4.1 Qu trnh mua hng
7.4
Mua hng
7.4.1 Qu trnh mua hng

T chc phi m bo sn phm mua vo ph h p vi cc yu cu mua sn phm quy nh.
Cch thc v mc kim sot p dng cho ng i cung ng v sn phm mua vo ph thuc
vo s tc ng ca sn phm mua vo i vi vic to ra sn phm tip theo hay thnh phm.
T chc phi nh gi v la chn ngi cung ng da trn kh nng cung cp sn phm ph
hp vi cc yu cu ca t chc. Phi xc nh cc tiu ch la chn, nh gi v nh gi li.
Phi duy tr h s cc kt qu ca vic nh gi v mi hnh ng cn thit ny sinh t vic
nh gi (xem 4.2.4).
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ISO TS 16949:2009 (V)

Ch thch 1: Sn phm mua vo nu trn bao gm tt c cc sn phm v dch v c nh hng ti
cc yu cu ca khch hng, nh thu ph lp rp, sp xp, phn loi, sa cha hoc dch v hiu
chun.
Ch thch 2: Khi c s sp nhp, thu nhn hoc lin kt lin quan ti cc nh cung ng, t chc cn
kim tra tnh lin tc h thng qun l cht lng ca nh cung ng v tnh hiu lc ca h thng .
7.4.1.1 S ph hp vi cc quy nh
Tt c cc sn phm mua vo hoc nguyn liu s dng trong sn phm phi ph hp vi yu
cu ca cc quy nh hin hnh.
7.4.1.2 Pht trin h thng qun l cht lng ca nh cung ng
T chc phi tin hnh pht trin h thng qun l cht lng ca nh cung ng vi mc ch
cc nh cung ng cng ph hp vi Quy nh k thut ny. Ph hp vi ISO 9001:2008 l
bc u tin t c mc ch ny.
Ch thch Vic u tin chn nh cung ng pht trin ph thuc trc ht vo, v d, kt qu
thc hin cht lng v mc quan trng ca sn phm cung ng.
Tr phi c cc yu cu khc ca khch hng, nh cung ng ca t chc phi c chng nhn
theo ISO 9001:2008 bi mt t chc chng nhn bn th ba c cng nhn.
7.4.1.3 Ngun do khch hng ph duyt
Khi c quy nh trong hp ng (v d bn v hoc cc quy nh k thut ca khch hng), t
chc phi mua sn phm, nguyn liu hoc dch v t nhng ngun c ph duyt.
Vic s dng cc ngun do khch hng ch nh, bao gm c cc nh cung ng dng c/ g,
khng lm gim trch nhim ca t chc v vic m bo cht lng ca sn phm mua vo.
7.4.2 Thng tin mua hng
7.4.2 Thng tin mua hng
Thng tin mua hng phi miu t sn phm c mua, nu thch hp c th bao gm:
a) yu cu v ph duyt sn phm, cc th tc, qu trnh v thit b,
b) yu cu v trnh con ngi, v
c) yu cu v h thng qun l cht lng.
T chc phi m bo s tha ng ca cc yu cu mua hng quy nh trc khi thng
bo cho ngi cung ng.
7.4.3 Kim tra xc nhn sn phm mua vo
7.4.3 Kim tra xc nhn sn phm mua vo
T chc phi lp v thc hin cc hot ng kim tra hoc cc hot ng khc cn thit
m bo rng sn phm mua vo p ng cc yu cu mua hng quy nh.
Khi t chc hoc khch hng c nh thc hi n cc hot ng kim tra xc nhn ti c s ca
ngi cung ng, t chc phi cng b vic sp xp kim tra xc nhn d kin v phng php
thng qua sn phm trong thng tin mua hng.
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7.4.3.1 Cht lng sn phm u vo
T chc phi c qu trnh bo m cht lng hng mua vo (xem 7.4.3) s dng mt hoc
nhiu cch sau y:
tip nhn v nh gi cc d liu thng k bi t chc;
kim tra v/hoc th nghim khi nhn v d nh kim tra ly mu da trn vic thc
hin;
gim st hoc nh gi bn th hai hoc bn th ba ti a im ca nh cung ng, km
vi h s chp nhn cht lng ca sn phm giao;
xem xt nh gi cc chi tit b phn bi mt phng th nghim c ch nh;

cc bin php khc thng nht vi khch hng.
7.4.3.2 Theo di nh cung ng

Vic thc hin ca nh cung ng phi c theo di bng cc ch s sau y:
cht lng ca sn phm giao;
s gin on ca khch hng bao gm c hng tr v t hin trng;
thc hin giao hng theo k hoch (bao gm c cc s c v tng chi ph vn chuyn
hng ho);
cc thng bo ca khch hng v tnh trng c bit lin quan ti cht lng hoc giao
hng.
T chc phi thc y vic theo di ca nh cung ng i vi kt qu thc hin cc qu trnh

sn xut ca h.
7.5 Sn xut v cung cp dch v
7.5.1 Kim sot sn xut v cung cp dch v
7.5
Sn xut v cung cp dch v
7.5.1 Kim sot sn xut v cung cp dch v

T chc phi lp k hoch, tin hnh sn xut v cung cp dch v trong iu kin c kim
sot. Khi c th, cc iu kin c kim sot phi bao gm:
a) s sn c thng tin m t cc c tnh ca sn phm,
b) s sn c cc hng dn cng vic khi cn,
c) vic s dng cc thit b thch hp,
d) s sn c v vic s dng cc thit b theo di v o lng,
e) thc hin vic theo di v o lng, v
f)
thc hin cc hot ng thng qua sn phm, giao hng v sau giao hng
7.5.1.1 K hoch kim sot

T chc phi:
xy dng cc k hoch kim sot (xem ph lc A) trong h thng, h thng ph, cc
thnh phn v/hoc mc vt liu i vi sn phm cung ng, bao gm cc k hoch

kim sot i vi qu trnh sn xut ra vt liu ri cng nh cc chi tit, b phn, v
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ISO TS 16949:2009 (V)

c k hoch kim sot cho sn xut th v sn xut, c xt n u ra ca FMEA thit
k v ca FMEA qu trnh sn xut.

K hoch kim sot phi:
lit k nhng s kim sot c s dng kim sot qu trnh sn xut;
bao gm cc bin php theo di cc kim sot c tin hnh i vi cc c tnh
c bit (xem 7.3.2.3) c xc nh bi c t chc v khch hng,

bao gm cc thng tin do khch hng yu cu, nu c, v
xut mt k hoch hnh ng c bit (xem 8.2.3.1) khi qu trnh tr nn mt n
nh hoc khng c nng lc v thng k.
Cc k hoch kim sot phi c xem xt v cp nht khi c bt k s thay i no nh

hng ti sn phm, qu trnh sn xut, o lng, tip vn, cung ng ngun lc hoc FMEA
(xem 7.1.4)
Ch thch: C th cn c s ph duyt ca khch hng sau khi xem xt hoc cp nht k hoch kim
sot.
7.5.1.2 Hng dn cng vic

T chc phi chun b cc hng dn cng vic bng vn bn cho tt c cc nhn s c trch
nhim trong s vn hnh cc qu trnh c nh hng ti cht lng sn phm. Nhng hng
dn ny phi sn c s dng ti ni lm vic.
Nhng hng dn ny phi c xy dng t cc ngun nh k hoch cht lng, k hoch
kim sot v qu trnh to sn phm
7.5.1.3 Kim tra xc nhn vic sp xp cng vic
Phi kim tra xc nhn vic sp xp cng vic khi thc hin, v d nh chy th cng vic, thay
g lp hay thay i cng vic.
Cc nhn vin sp t phi c hng dn cng vic. T chc phi s dng cc phng php
thng k khi c th.
Ch thch: Cn so snh cc chi tit c sn xut cui cng.
7.5.1.4 Bo tr phng nga v tin liu

T chc phi nhn bit thit b qa trnh trng yu v cung cp ngun lc cho vic bo tr my
mc thit b v xy dng mt h thng bo tr phng nga tng th c k hoch c hiu lc.
Ti thiu, h thng ny phi bao gm:
cc hot ng bo tr c k hoch;
bao gi v bo qun cc thit b, trang b v dng;
sn c cc chi tit thay th cho cc thit b sn xut ct yu;
lp vn bn, nh gi v ci tin cc mc tiu bo dng .
T chc phi s dng cc phng php bo tr tin liu ci tin lin tc hiu lc v hiu qu
ca cc thit b sn xut.
7.5.1.5 Qun l trang b sn xut
T chc phi cung cp ngun lc thit k, sn xut v kim tra xc nhn trang b v dng.
T chc phi thit lp v p dng mt h thng qun l trang b sn xut bao gm:
cc phng tin v nhn s bo tr v sa cha;
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bo qun v khi phc;
lp t ;
cc chng trnh thay i trang b cho cc trang b chng hng;
h thng ti liu v sa i thit k trang b, bao gm c mc thay i cng ngh;
cc sa i v sot xt trang b c lp vn bn;
nhn bit trang b, xc nh trng thi, v d nh sn xut, sa cha hay hy.
T chc phi p dng mt h thng theo di cc hot ng ny nu c thu ngoi.

Ch thch: Yu cu ny cng p dng cho vic sn c cc trang b cho cc chi tit dch v v xe c.
7.5.1.6 Lp tin sn xut

Phi lp tin sn xut p ng yu cu ca khch hng, v d nh va ng lc (just-intime) c h tr bi mt h thng thng tin cho php tip cn thng tin sn xut ti cc giai
on ch cht ca qu trnh v c dn hng c th t.
7.5.1.7 Phn hi thng tin t dch v
Phi thit lp v duy tr mt qu trnh trao i thng tin v dch v c lin quan n cc hot
ng sn xut, k thut, thit k v bo tr.
Ch thch Vic thm dch v c lin quan vo mc ny m bo rng t chc nhn thc
c s khng ph hp xy ra bn ngoi t chc.
7.5.1.8 Tha thun dch v vi khch hng
Khi c s tha thun dch v vi khch hng, t chc phi kim tra xc nhn hiu lc ca:
cc trung tm dch v ca t chc,
cc trang b s dng vo mc ch bt k hay thit b o lng, v
hun luyt nhn s v dch v.
7.5.2 Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v

7.5.2 Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v
T chc phi xc nh n gi tr s dng ca mi qu trnh sn xut v cung cp dch v c kt
qu u ra khng th kim tra xc nhn bng cch theo di hoc o lng sau v v vy
nhng sai st ch c th tr nn r rng sau khi sn phm c s dng hoc dch v c
chuyn giao.
Vic xc nhn gi tr s dng phi chng t kh nng ca cc qu trnh t c kt qu
hoch nh.
i vi cc qu trnh ny, khi c th, t chc phi sp xp nhng iu sau:
a) cc chun mc nh xem xt v ph duyt cc qu trnh,
b) ph duyt thit b v trnh con ngi,
c) s dng cc phng php v th tc c th,
d) cc yu cu v h s (xem 4.2.4); v
e) ti xc nhn gi tr s dng.
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7.5.2.1 Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v - B sung
Yu cu 7.5.2 phi c p dng i vi tt c cc qu trnh sn xut v cung cp dch v
7.5.3 Nhn bit v xc nh ngun gc
7.5.3 Nhn bit v xc nh ngun gc
Khi thch hp, t chc phi nhn bit sn phm bng cc bin php thch hp trong sut qu
trnh to sn phm.
T chc phi nhn bit c trng thi ca sn phm tng ng vi cc yu cu theo di v
o lng trong sut qu trnh to sn phm.
T chc phi kim sot vic nhn bit duy nht sn phm v duy tr h s (xem 4.2.4) khi vic
xc nh ngun gc l mt yu cu.
CH THCH: Trong mt s lnh vc cng nghip, qun l cu hnh l phng php duy tr vic nhn
bit v xc nh ngun gc.
Ch thch: Trng thi kim tra v th nghim khng nhn bit bi v tr trn dng lu chuyn ca sn
phm tr khi c nhn bit hin nhin, chng hn nguyn vt liu trong qu trnh sn xut t ng.
Cc hnh thc nhn bit thay th s c cho php nu tnh trng sn phm c nhn bit mt cch
r rng, c vn bn ho v t c nhng mc ch nh
7.5.3.1 Nhn bit v xc nh ngun gc

Cm t khi thch hp trong mc 7.5.3 s khng c p dng
7.5.4 Ti sn ca khch hng
7.5.4 Ti sn ca khch hng
T chc phi gi gn ti sn ca khch hng khi chng thuc s kim sot ca t chc hay
c t chc s dng. T chc phi nhn bit, kim tra xc nhn, bo v ti sn do khch hng
cung cp s dng hoc hp thnh sn phm. Khi c bt k ti sn no ca khch hng b
mt mt, h hng hoc c pht hin khng ph hp cho vic s dng, t chc u phi
thng bo cho khch hng v phi duy tr h s (xem 4.2.4).
CH THCH: Ti sn ca khch hng c th bao gm c s hu tr tu v d liu c nhn.
Ch thch: Bao b c th tr li cho khch hng cng bao gm trong iu khon ny
7.5.4.1 Cng c sn xut thuc s hu khch hng

Nhng cng c s dng trong kim tra, th nghim, sn xut thuc s hu ca khch hng
phi c nh du sao cho c th nhn thy v xc nh c
7.5.5 Bo ton sn phm
7.5.5 Bo ton sn phm
T chc phi b o ton sn phm trong qu trnh x l ni b v giao hng n v tr d kin
nhm duy tr s ph hp vi cc yu cu. Khi thch hp, vic bo ton phi bao gm nhn bit,
xp d (di chuyn), bao gi, lu gi v bo qun. Vic bo ton cng phi p dng vi cc b
phn cu thnh ca sn phm.
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7.5.5.1 Lu kho v kim k
Nhm pht hin cc h hao, iu kin ca sn phm lu kho s c nh gi nh k.
T chc phi s dng h thng qun l kho ti u ho thi gian quay vng v m bo vic
o kho v d nh nhp trc - xut trc. Sn phm qu hn c kim sot nh sn phm
khng ph hp.
7.6 Kim sot thit b theo di v o lng

7.6
Kim sot thit b theo di v o lng
T chc phi xc nh vic theo di v o lng cn thc hin v cc thit b theo di, o
lng cn thit cung cp bng chng v s ph hp ca sn phm vi cc yu cu xc
nh.
T chc phi thit lp cc qu trnh m bo rng vic theo di v o lng c th tin
hnh v c tin hnh mt cch nht qun vi cc yu cu theo di v o lng.
Khi cn m bo kt qu ng, thit b o lng phi:
a) c hiu chun hoc kim tra xc nhn, hoc c hai, nh k hoc trc khi s dng, da
trn cc chun o lng c lin kt vi chun o lng quc gia hay quc t; khi khng
c cc chun ny th cn c c s dng hiu chun hoc kim tra xc nhn phi c
lu h s (xem 4.2.4);
b) c hiu chnh hoc hiu chnh li, khi cn;
c) c du hiu nhn bit xc nh tnh trng hiu chun;
d) c gi gn trnh b hiu chnh lm mt tnh ng n ca cc kt qu o;
e) c bo v trnh h hng hoc suy gim cht lng trong khi di chuyn, bo dng
v lu gi.
Ngoi ra, t chc phi nh gi v ghi nhn gi tr hiu lc ca cc kt qu o lng trc
khi thit b c pht hin khng ph hp vi yu cu. T chc phi tin hnh hnh ng
thch hp i vi thit b v bt k sn phm no b nh hng.
Phi duy tr h s (xem 4.2.4) v kt qu hiu chun v kim tra xc nhn.
Khi s dng phn mm my tnh theo di v o lng cc yu cu quy nh, phi khng
nh kh nng tho mn vic ng dng d kin. Vic ny phi c tin hnh trc ln s
dng u tin v c xc nhn li khi cn.
CH THCH: Vic xc nhn kh nng p ng ng dng d kin ca phn mm my tnh thng bao
gm vic kim tra xc nhn v qun l cu hnh duy tr tnh thch hp s dng ca phn mm .
Ch thch: Mt ch s hay mt du hiu nhn bit khc, kt ni vi h s hiu chun thit b p ng
c yu cu ca phn c) trn
7.6.1 Phn tch h thng o

Phi thc hin k thut thng k phn tch nhng bin ng trong cc php o v h thng
thit b th nghim. Yu cu ny phi c p dng i vi cc h thng o vin dn trong k
hoch kim sot. Phng php phn tch v tiu chun chp nhn s dng phi ph hp vi
nhng s tay vin dn ca khch hng v phn tch h thng o lng. Cc phng php phn
tch v chun mc chp nhn khc c th c s dng nu c khch hng ph duyt.
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ISO TS 16949:2009 (V)

7.6.2 H s hiu chun/kim tra xc nhn
H s hiu chun/kim tra xc nhn ca dng mu, thit b o lng v th nghim dng
chng t s ph hp ca sn phm vi cc yu cu nh, bao gm thit b c s dng v
thit b thuc s hu ca khch hng, phi bao gm:
nhn dng thit b, bao gm c chun o lng s dng hiu chun thit b;
cc sot xt tip theo nhng ln thay i k thut;
bt c nhng kt qu ngoi phm vi cho php c ghi nhn khi hiu chun/kim tra
xc nhn.
nh gi v tc ng ca tnh trng nm ngoi phm vi cho php.

cng b v s ph hp vi yu cu sau khi hiu chun/kim tra xc nhn.
thng bo vi khch hng nu c nghi ng vi nhng sn phm hay vt liu chuyn
giao
7.6.3 Nhng yu cu v phng th nghim

7.6.3.1 Phng th nghim ni b
Phm vi v kh nng ca phng th nghim ni b phi c xc nh, bao gm nng lc thc
hin nhng cng vic hiu chun, th nghim v kim tra nh. Phm vi ny phi c
cp trong ti liu ca h thng qun l cht lng. Phng th nghim ti thiu phi xc nh v
p dng nhng yu cu k thut v:
s y ca cc quy trnh trong phng th nghim,
nng lc ca nhng ngi trong phng th nghim,
th nghim sn phm,
kh nng thc hin nhng cng vic ny mt cch chnh xc, c th truy vt ti nhng
tiu chun x l tng ng. (nh l ASTN, EN...), v

xem xt cc h s tng ng.
Ch thch: Cng nhn theo ISO/IEC 17025 cng c th c s dng chng t s ph hp ca
phng th nghim ca nh cung cp i vi yu cu ny, nhng khng bt buc.
7.6.3.2 Phng th nghim bn ngoi

Cc phng th nghim bn ngoi c t chc s dng kim tra, th nghim v hiu chun
phi c phm vi c xc nh, bao gm kh nng thc hin vic hiu chun, th nghim v
kim tra nh, v
c bng chng rng phng th nghim bn ngoi c khch hng chp thun, hoc
c cng nhn theo ISO/IEC 17025 hay tiu chun quc gia tng ng.
Ch thch 1: Bng chng nh vy c th c chng thc bi nh gi ca khch hng hay bi nh
gi ca bn thc hai c khch hng ph duyt rng phng th nghim p ng yu cu ca tiu
chun ISO/TS 17025 hoc tng ng.
Ch thch 2: Khi khng c nhng phng th nghim c cng nhn, dch v hiu chun c th c
thc hin bi nh ch to thit b. Trong nhng trng hp nh vy, t chc phi bo m rng nhng
yu cu trong mc 7.6.3.1 c p ng.
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o lng, phn tch v ci tin
8.1 Khi qut

8
o lng, phn tch v ci tin
8.1
Khi qut
T chc phi hoch nh v trin khai cc qu trnh theo di, o lng, phn tch v ci tin
cn thit :
a) chng t s ph hp vi cc yu cu ca sn phm,
b) m bo s ph hp ca h thng qun l cht lng, v
c)
ci tin lin tc hiu lc ca h thng qun l cht lng.
iu ny phi bao gm vic xc nh cc phng php c th p dng, k c cc k thut thng

k, v mc s dng chng.
8.1.1 Xc nh nhng cng c thng k
Nhng cng c thng k thch hp cho mi qu trnh s c xc nh trong k hoch cht
lng v trong k hoch kim sot
8.1.2 Hiu bit v nhng khi nim thng k c bn
Nhng khi nim thng k c bn nh l bin ng, kim sot (s n nh), nng lc ca qu
trnh v iu chnh qu mc phi c hiu v vn dng trong ton t chc.
8.2 Theo di v o lng

8.2.1 S tho mn ca khch hng
8.2
Theo di v o lng
8.2.1 S tho mn ca khch hng

T chc phi theo di cc thng tin lin quan n s chp nhn ca khch hng v vic t chc
c p ng yu cu ca khch hng hay khng, coi nh mt trong nhng thc o mc
thc hin ca h thng qun l cht lng. Phi xc nh cc phng php thu thp v s
dng cc thng tin ny.
CH THCH: Theo di cm nhn ca khch hng c th bao gm vic thu thp u vo t cc ngun
nh kho st v s tha mn ca khch hng, d liu khch hng v cht lng sn phm giao nhn,
kho st kin ngi s dng, phn tch thua l kinh doanh, nhng khen ngi, cc yu cu bo hnh v
bo co ca i l.
Ch thch : Nn cn nhc xem xt c khch hng ni b v khch hng bn ngoi.
8.2.1.1 S tho mn ca khch hng - B sung

S tho mn ca khch hng i vi t chc phi c theo di thng qua nh gi thng
xuyn vic thc hin cc qu trnh. Ch s theo di s da trn nhng d liu khch quan v t
nht phi bao gm:
thc hin c cht lng vic giao hng,
s nh tr ca khch hng, bao gm hng tr li,
thc hin tin giao hng (bao gm c s c chi ph vn chuyn ph tri), v
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ISO TS 16949:2009 (V)

nhng thng bo ca khch hng lin quan n vn giao hng v cht lng.
T chc phi theo di vic thc hin ca cc qu trnh sn xut chng t s ph hp vi cc

yu cu ca khch hng v cht lng sn phm v hiu qu ca qu trnh.
8.2.2 nh gi ni b
8.2.2 nh gi ni b
T chc phi tin hnh nh gi ni b nh k theo k hoch xc nh h thng qun l
cht lng:
a) c ph hp vi cc b tr sp xp c hoch nh (xem 7.1), i vi cc yu cu ca
tiu chun ny v vi cc yu cu ca h thng qun l cht lng c t chc thit
lp, v
b) c c thc hin v duy tr mt cch hiu lc.
T chc phi hoch nh chng trnh nh gi, c ch n tnh trng v tm quan trng
ca cc qu trnh v cc khu vc c nh gi, cng nh kt qu ca cc cuc nh gi trc.
Chun mc, phm vi, tn sut v phng php nh gi phi c xc nh. Vic la chn cc
chuyn gia nh gi v tin hnh nh gi phi m bo c tnh khch quan v cng bng
ca qu trnh nh gi. Cc chuyn gia nh gi khng c nh gi cng vic ca mnh.
Phi thit lp mt th tc dng vn bn xc nh trch nhim v yu cu i vi vic hoch
nh v tin hnh nh gi, lp h s v bo co kt qu.
Phi duy tr h s nh gi v cc kt qu nh gi (xem 4.2.4).
Lnh o chu trch nhim v khu vc c nh gi phi m bo tin hnh khng chm tr
mi s khc phc cng nh cc hnh ng khc phc cn thit loi b s khng ph hp
c pht hin v nguyn nhn ca chng. Cc hot ng tip theo phi bao gm vic kim tra
xc nhn cc hnh ng c tin hnh v bo co kt qu kim tra xc nhn (xem 8.5.2).
CH THCH: Xem hng dn trong ISO 19011
8.2.2.1 nh gi h thng qun l cht lng

T chc phi nh gi h thng qun l cht lng ca mnh kim tra s tun th vi tiu
chun ny v bt c nhng yu cu b sung no khc ca h thng qun l cht lng.
8.2.2.2 nh gi qu trnh sn xut
T chc phi nh gi mi qu trnh sn xut xc nh tnh hiu lc ca chng.
8.2.2.3 nh gi sn phm
T chc phi tin hnh nh gi sn phm ti cc giai on thch hp ca qu trnh sn xut v
giao hng chng t s ph hp vi tt c cc yu cu nh, nh l kch thc ca sn
phm, tnh nng, bao gi v nhn mc, vi tn sut xc nh.
8.2.2.4 K hoch nh gi ni b
nh gi ni b phi bao trm ton b cc ca sn xut, cc hot ng v cc qu trnh lin
quan ti qun l cht lng v phi c ln lch trnh theo k hoch hng nm.
Khi ny sinh cc s khng ph hp do nh gi ni b/nh gi bn ngoi hay khiu ni ca
khch hng, tn sut ca nh gi phi tng ln mt cch thch hp.
Ch thch: Danh mc nh gi nn c s dng cho mi cuc nh gi.
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8.2.2.5 Trnh ca cc chuyn gia nh gi ni b
T chc phi c cc chuyn gia nh gi c trnh nh gi cc yu cu ca tiu chun
ny (xem 6.2.2.2).
8.2.3 Theo di v o lng cc qu trnh
8.2.3 Theo di v o lng cc qu trnh
T chc phi p dng cc phng php thch hp cho vic theo di v, khi c th, o lng cc
qu trnh ca h thng qun l cht lng. Cc phng php ny phi chng t kh nng ca
cc qu trnh t c cc kt qu hoch nh. Khi khng t c cc kt qu theo
hoch nh, phi tin hnh vic khc phc v hnh ng khc phc thch hp.
CH THCH: xc nh cc phng php thch hp, t chc nn xem xt loi v phm vi theo di
hoc o lng thch hp vi mi qu trnh trong mi tng quan vi nh hng ca nhng qu trnh
ny ti s ph hp vi cc yu cu ca sn phm cng nh hiu lc ca h thng qun l cht lng.
8.2.3.1 Theo di v o lng qu trnh sn xut.

T chc phi thc hin nghin cu qu trnh ti tt c cc qu trnh sn xut mi (bao gm lp
rp v trnh t) kim tra xc nhn nng lc ca qu trnh v cung cp thm u vo cho
kim sot qu trnh. Kt qu ca nghin cu qu trnh phi c vn bn ho vi cc qui nh,
khi c th c, ng vi cc phng thc sn xut, o lng v th nghim, v hng dn
duy tr. Nhng ti liu ny phi bao gm cc mc tiu cho nng lc ca qu trnh sn xut,
tin cy, tnh duy tr v tnh sn c, cng nh cc chun mc chp nhn.
T chc phi duy tr nng lc ca qu trnh sn xut hay thc hin theo cc yu cu ca khch
hng v qu trnh ph duyt chi tit sn phm. T chc phi m bo rng k hoch kim sot
v lu sn xut c p dng, c km theo:
k thut o lng c th,
k hoch ly mu,
chun mc chp nhn, v
k hoch hnh ng khi tiu chun khng c p ng.
Nhng s kin qu trnh c ngha ng k, nh l thay i cng c hay sa my, phi c

lu h s.
T chc phi a ra k hoch hnh ng trong k hoch kim sot vi cc c tnh m qua
vic thng k thy khng p ng nng lc hoc khng n nh. Nhng k hoch hnh ng
ny phi bao gm vic kim sot sn phm v kim tra 100% khi thch hp. T chc phi hon
thnh k hoch v hnh ng khc phc, ch r thi gian v nhn s chu trch nhim m
bo rng qu trnh c th n nh v c kim sot. Khi c yu cu, nhng k hoch nh vy
phi c xem xt v ph duyt bi khch hng.
T chc phi lu h s v ngy hiu lc v nhng thay i ca qu trnh.
8.2.4 Theo di v o lng sn phm
8.2.4 Theo di v o lng sn phm
T chc phi theo di v o lng cc c tnh ca sn phm kim tra xc nhn rng cc
yu cu v sn ph m c p ng. Vic ny phi c tin hnh nhng giai on thch
36
ISO TS 16949:2009 (V)

hp ca qu trnh to sn phm theo cc sp xp hoch nh (xem 7.1). Phi duy tr bng
chng v s ph hp vi tiu ch chp nhn.
H s phi ch ra (nhng) ngi c quyn thng qua sn phm giao cho khch hng (xem
4.2.4).
Vic thng qua sn phm v chuyn giao dch v cho khch hng ch c tin hnh sau khi
hon thnh tho ng cc hot ng theo hoch nh (xem 7.1), nu khng th phi c s
ph duyt ca ngi c thm quyn v, nu c th, ca khch hng.
Ch thch: Khi la chn nhng thng s ca sn phm theo di s ph hp i vi nhng yu cu
nh ca ni b v bn ngoi, t chc xc nh loi c tnh ca sn phm, t xc nh:
dng o lng thch hp,
thit b o ph hp, v
yu cu v nng lc v k nng.
8.2.4.1 Kim tra kch thc v th nghim chc nng

Vic kim tra kch thc v kim tra xc nhn chc nng theo tiu chun c th p dng c
ca khch hng v vt liu ch to v tnh nng phi c thc hin i vi mi sn phm
c xc nh trong k hoch kim sot. Kt qu phi sn c khch hng xem xt.
Ch thch: Kim tra kch thc l vic o lng tt c cc kch thc ca sn phm th hin
trong h s thit k.
8.2.4.2 Ngoi quan
Nhng t chc sn xut ph tng c khch hng ch nh l sn phm ngoi quan phi
cung cp:
ngun lc ph hp bao gm c ngun chiu sng nh gi
mu chun v mu sc, mn, bng, pht sng kim loi, cht liu, khc bit
hnh nh (DOI), khi thch hp
bo dng v kim sot nhng mu chun v ngoi quan v thit b nh gi, v

xc nhn rng nhn s thc hin nh gi ngoi quan c nng lc v trnh
thc hin cng vic ny.
8.3 Kim sot sn phm khng ph hp

8.3
Kim sot sn phm khng ph hp
T chc phi m bo rng sn phm khng ph hp vi cc yu c u c nhn bit v kim

sot phng nga vic s dng hoc chuyn giao ngoi d kin. Phi thit lp mt th tc
dng vn bn xc nh vic kim sot v trch nhim, quyn hn c lin quan i vi vic
x l sn phm khng ph hp.
Khi thch hp, t chc phi x l sn phm khng ph hp bng mt hoc mt s cch sau:
a) tin hnh loi b s khng ph hp c pht hin;
b) cho php s dng, thng qua hoc chp nhn c nhn nhng bi ngi c thm
quyn v, khi c th, bi khch hng;
c)
tin hnh loi b khi vic s dng hoc p dng d kin ban u.
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d) tin hnh hnh ng thch hp vi nhng tc ng hoc hu qu tim n ca s khng
ph hp nu sn phm khng ph hp c pht hin sau khi chuyn giao hoc bt
u s dng.
Khi sn phm khng ph hp c khc phc, chng phi c kim tra xc nhn li
chng t s ph hp vi cc yu cu.
Phi duy tr h s (xem 4.2.4) v bn cht ca s khng ph hp v bt k hnh ng tip theo
no c tin hnh, k c cc nhn nhng c c.
8.3.1 Kim sot sn phm khng ph hp b sung
Sn phm c tnh trng khng c nhn bit hay nghi ng phi c coi nh l sn phm
khng ph hp (xem 7.5.3)
8.3.2 Kim sot sn phm c lm li
Nhng hng dn cho vic lm li, gm c nhng yu cu ti kim tra, phi truy cp c v
c s dng bi nhn s tng ng
8.3.3 Thng tin cho khch hng
Khch hng phi c thng bo ngay lp tc khi sn phm khng ph hp c chuyn
giao.
8.3.4 S khc t ca khch hng
Bt c khi no sn phm hay qu trnh sn xut khc bit so vi s ph duyt trc , t
chc phi c c s nhn nhng hay cho php ca khch hng trc khi a ra bt k x l
tip theo no.
T chc phi duy tr h s v ngy ht hn hoc s lng cho php. T chc phi m bo s
ph hp vi nhng qui nh v yu cu gc v thay th khi s cho php ht hiu lc. Nguyn
liu chuyn giao di s nhn nhng phi c nhn bit chnh xc cho mi ln giao hng.
iu ny p dng tng t vi sn phm mua vo. T chc phi ph duyt mi yu cu t nh
cung cp trc khi trnh cho khch hng.
8.4 Phn tch d liu

8.4
Phn tch d liu
T chc phi xc nh, thu thp v phn tch cc d liu thch hp chng t s ph hp v
tnh hiu lc ca h thng qun l cht lng v nh gi xem vic ci tin lin tc hiu lc
ca h thng qun l cht lng c th tin hnh u. iu ny bao gm c cc d liu c
to ra do kt qu ca vic theo di, o lng v t cc ngun thch hp khc.
Vic phn tch d liu phi cung cp thng tin v:
a) s tho mn khch hng (xem 8.2.1);
b) s ph hp vi cc yu cu v sn phm (xem 8.2.4);
c) c tnh v xu hng ca cc qu trnh v sn phm, k c cc c hi cho hnh ng
phng nga (xem 8.2.3 v 8.2.4), v
d) ngi cung ng (xem 7.4).
38
ISO TS 16949:2009 (V)

8.4.1 Phn tch v s dng d liu
Xu hng v cht lng v kt qu hot ng tc nghip phi c so vi tin trnh tin n
cc mc tiu v dn ti hnh ng h tr nhng hot ng sau:
trin khai nhng gii php u tin cho nhng vn lin quan ti khch hng
xc nh nhng xu hng v quan h lin quan ti khch hng ch yu xem xt tnh
trng, ra quyt nh v hoch nh di hn.

h thng thng tin bo co kp thi thng tin ca sn phm ny sinh t qu trnh s
dng.
Ch thch: D liu nn c so vi cc i th cnh tranh v hoc so snh vi i chun thch hp
8.5 Ci tin
8.5.1 Ci tin lin tc
8.5
Ci tin
8.5.1 Ci tin lin tc
T chc phi ci tin lin tc hiu lc ca h thng qun l cht lng thng qua vic s dng
chnh sch cht lng, mc tiu cht lng, kt qu nh gi, phn tch d liu, hnh ng
khc phc, phng nga v s xem xt ca lnh o.
8.5.1.1 Ci tin thng xuyn ca T chc
T chc phi xc nh mt qu trnh ci tin thng xuyn (xem v d trong ph lc B ca ISO
9004:2007)
8.5.1.2 Ci tin qu trnh sn xut
Ci tin qu trnh sn xut phi tp trung lin tc vo kim sot v gim cc bin ng v c
trng k thut ca sn phm v thng s ca qu trnh sn xut.
Ch thch 1: Cc c trng c kim sot phi c vn bn ho v a vo k hoch kim sot
Ch thch 2: Ci tin thng xuyn c p dng khi qu trnh sn xut c nng lc v n nh, hoc
c tnh ca sn phm c th tin on c v ph hp cc yu cu ca khch hng.
8.5.2 Hnh ng khc phc

8.5.2 Hnh ng khc phc
T chc phi thc hin hnh ng nhm loi b nhng nguyn nhn ca s khng ph hp
ngn nga vic ti din. Hnh ng khc phc phi tng ng vi tc ng ca s khng ph
hp gp phi.
Phi lp mt th tc dng vn bn xc nh cc yu cu i vi:
a) vic xem xt s khng ph hp (k c cc khiu ni ca khch hng),
b) vic xc nh nguyn nhn ca s khng ph hp,
c) vic nh gi nhu cu thc hin cc hnh ng m bo rng s khng ph hp
khng ti din,
d) vic xc nh v thc hin cc hnh ng cn thit,
e) vic lu h s cc kt qu ca hnh ng c thc hin (xem 4.2.4), v
f)
vic xem xt hiu lc ca cc hnh ng khc phc thc hin.
39/43
ISO TS 16949:2009 (V)

8.5.2.1 Gii quyt vn
T chc phi xc nh mt qu trnh gii quyt vn nhn bit v loi b nguyn nhn su
xa
Nu khch hng a ra biu mu v nguyn tc gii quyt vn , t chc phi p dng biu
mu ny trong vic gii quyt cc vn
8.5.2.2 Chng sai li (Error proofing)
T chc phi p dng cc k thut chng sai li trong qu trnh hnh ng khc phc ca
mnh.
8.5.2.3 Tc ng ca hnh ng khc phc
T chc phi p dng hnh ng khc phc vi cc sn phm v qu trnh tng t khc, v
kim sot vic p dng loi b nguyn nhn ca s khng ph hp
8.5.2.4 Phn tch / th nghim sn phm b loi
T chc phi thc hin phn tch cc linh kin do khch hng, trang thit b k thut v cc
nh phn phi loi b. Qu trnh ny phi c thc hin mt cch nhanh nht. H s ca
nhng phn tch ny phi c lu li v sn c khi c yu cu. T chc phi tin hnh
phn tch v xut cc hnh ng khc phc ngn nga s ti din.
Ch thch: Thi gian dnh cho phn tch sn phm b loi phi nht qun vi vic xc nh nguyn nhn
su xa, hnh ng khc phc v theo di hiu lc ca cc hnh ng c thc hin.
8.5.3 Hnh ng phng nga

ISO 9001:2008, H thng qun l cht lng Ca c ye u cau
8.5.3 Hnh ng phng nga
T chc phi xc nh hnh ng nhm loi b nguyn nhn ca s khng ph hp tim n
ngn chn s xut hin ca chng. Cc hnh ng phng nga c tin hnh phi tng ng
vi tc ng ca cc vn tim n.
Phi lp mt th tc dng vn bn xc nh cc yu cu i vi:
a) vic xc nh s khng ph hp tim n v cc nguyn nhn ca chng,
b) vic nh gi nhu cu thc hin cc hnh ng phng nga vic xut hin s khng
ph hp,
c) vic xc nh v thc hin cc hnh ng cn thit,
d) h s cc kt qu ca hnh ng c thc hin (xem 4.2.4), v
e) vic xem xt hiu lc ca cc hnh ng phng nga thc hin.
40
ISO TS 16949:2009 (V)
Ph lc A
(c tnh quy chun)
K hoch kim sot

A.1 Cc giai on ca k hoch kim sot
K hoch kim sot phi cp ba giai on mt cch thch hp
a) Sn phm mu (prototype): bn m t cc php o kch thc, cc php th vt liu v
tnh nng xy ra trong khi lm sn phm mu. T chc phi c k hoch kim sot
prototype nu khch hng yu cu.
b) Chun b sn xut (Pre-launch): bn m t cc php o kch thc, cc php th vt
liu v tnh nng tin hnh sau khi lm sn phm mu v trc khi sn xut hng lot.
Chun b sn xut c xc nh l mt giai on sn xut trong qu trnh to sn
phm v c th c yu cu sau khi lm sn phm mu .
c) Sn xut: H thng ti liu v cc c tnh sn phm/qu trnh, kim sot qu trnh, h
thng th nghim v o lng trong qu trnh sn xut hng lot
Mi chi tit phi c k hoch kim sot nhng trong nhiu trng hp cc k hoch kim sot
h chi tit c th bao trm cc chi tit tng t c sn xut c s dng mt qu trnh chung.
K hoch kim sot l mt u ra ca k hoch cht lng
A.2 Cc yu t ca k hoch kim sot
T chc phi xy dng mt k hoch kim sot ti thiu bao gm ni dung sau:
a) D liu chung
s hiu k hoch kim sot,
ngy ban hnh, sot xt, nu c,
thng tin ca khch hng (xem yu cu ca khch hng)
tn t chc/chc nng hin trng
s hiu chi tit
tn/m t chi tit
mc thay i k thut
giai on (prototype, pre-launch, sn xut),
ngi tip xc ch cht,
s hiu bc ca chi tit/qu trnh,
m t tn/thao tc qu trnh.
b) Kim sot sn phm

c trng c bit lin quan n sn phm,
cc c trng khc kim sot (s hiu, sn phm hay qu trnh),
qui nh, dung sai
c) Kim sot qu trnh

cc thng s qu trnh
cc thng s c th lin quan n qu trnh
41/43
ISO TS 16949:2009 (V)

my mc, g, vt c nh, cng c sn xut .
d) Phng php
k thut o lng nh gi,
chng sai li (error-proofing),
c mu v tn s ly mu,
phng php kim sot.
e) K hoch x l v hnh ng khc phc

k hoch x l (bao gm hay vin dn),
hnh ng khc phc.
42
ISO TS 16949:2009 (V)
Ti liu tham kho

[1]
ISO 9004: 1), Managing for the sustained success of an organization A quality management approach
[2]
ISO 10001:2007, Quality management Customer satisfaction Guidelines for codes of conduct for
organizations
[3]
ISO 10002:2004, Quality management Customer satisfaction Guidelines for complaints handling in
organizations
[4]
ISO 10003:2007, Quality management Customer satisfaction Guidelines for dispute resolution
external to organizations
[5]
ISO 10005:2005, Quality management systems Guidelines for quality plans
[6]
ISO 10006:2003, Quality management systems Guidelines for quality management in projects
[7]
ISO 10007:2003, Quality management systems Guidelines for configuration management
[8]
ISO 10012:2003, Measurement management systems Requirements for measurement processes and
measuring equipment
[9]
ISO/TR 10013:2001, Guidelines for quality management system documentation
[10]
ISO 10014:2006, Quality management Guidelines for realizing financial and economic benefits
[11]
ISO 10015:1999, Quality management Guidelines for training
[12]
ISO/TR 10017:2003, Guidance on statistical techniques for ISO 9001:2000
[13]
ISO 10019:2005, Guidelines for the selection of quality management system consultants and use of
their services
[14]
ISO 14001:2004, Environmental management systems Requirements with guidance for use
[15]
ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
[16]
IEC 60300-1:2003, Dependability management Part 1: Dependability programme management.

systems
[17]
IEC 61160:2006, Design review
[18]
ISO/IEC 90003:2004, Software engineering Guidelines for the application of ISO 9001:2000 to
computer software
[19]
Quality management principles 2), ISO, 2001
[20]
ISO Management Systems3)
[21]
ISO 9000 Selection and use, ISO, 2008
[22]
ISO 9001 for small business What to do; Advice from ISO/TC176, ISO, 20024)
Reference websites:
1)
To be published. (Revision of 9004:2000)
2)
Available from website: http://www.iso.org.
3)
A bimonthly publication which provides comprehensive coverage of international developments

relating to ISO's management system standards, including news of their implementation by diverse
organizations around the world.
Available from ISO Central Secretariat (sales@iso.org).
4)
To be updated and aligned with ISO 9001:2008
43/43

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QUY NH

Ti liu ch dng cho mc ch nghin cu v o to

H thng qun l cht lng

ISO TS 16949:2009 (V)

Li gii thiu ................................................................................................................................................6

ISO TS 16949:2009 (V)

ISO TS 16949:2009 (V)

ISO TS 16949:2009 (V)

Cng ty IMC - Nh A1B / 25 Lng H - Ba nh - H Ni

ISO TS 16949:2009 (V)

mi trng ca t chc, cc thay i v nhng ri ro trong mi trng ,

b) cc nhu cu khc nhau,

cc mc tiu ring bit,

d) cc sn phm cung cp,

Mc ch ca tiu chun ny khng nhm dn n s ng nht v cu trc ca cc h thng

0.2 Cch tip cn theo qu trnh

ISO TS 16949:2009 (V)

vic hiu v p ng cc yu cu,

b) nhu cu xem xt qu trnh v mt gi tr gia tng,

c c kt qu v vic thc hin v hiu lc ca qu trnh, v

d) ci tin lin tc qu trnh trn c s o lng khch quan.

Hnh 1: M hnh v H thng qun l cht lng da trn qu trnh

ISO TS 16949:2009 (V)

0.3 Mi quan h vi TCVN/ISO 9004

0.4 S tng thch vi cc h thng qun l khc

0.5 Mc ch ca quy nh k thut ny

Cng ty IMC - Nh A1B / 25 Lng H - Ba nh - H Ni

ISO TS 16949:2009 (V)

H thng qun l cht lng - Cc yu cu ring khi p dng ISO 9001:2008

1.1 Khi qut

Tiu chun ny quy nh cc yu cu i vi h thng qun l cht lng khi mt t chc:

Quy nh k thut ny, lin kt vi ISO 9001:2008, xc nh cc yu cu ca h thng qun l

ISO TS 16949:2009 (V)

ISO 9001:2008, H thng qun l cht lng Cc yu cu

ISO 9001:2008, H thng qun l cht lng Cc yu cu

3.1 Thut ng v nh ngha trong ngnh t.

K hoch kim sot (control plan)

T chc chu trch nhim thit k

T chc c thm quyn lp quy nh sn phm mi hay thay i chng.

Chng sai li (error proofing)

Ti liu c kim sot cha:

Qu trnh lm hay ch to:

ISO TS 16949:2009 (V)

Bo tr tin liu (predictive maintenance)

Hot ng da trn d liu qu trnh nhm trnh cc vn khi bo tr bng cch d on

Hnh ng c k hoch loi b nguyn nhn hng hc ca thit b v gin on khng c

Chi ph vn chuyn ph tri (premium freight)

Chi ph ph tri do giao hng khng ng k hoch hay mun,

3.1.10 V tr xa (remote location)

H thng qun l cht lng

H thng qun l cht lng

b) xc nh trnh t v mi tng tc ca cc qu trnh ny,

xc nh cc chun mc v phng php cn thit m bo vn hnh v kim sot cc

d) m bo sn c cc ngun lc v thng tin cn thit h tr vic vn hnh v theo di

theo di, o lng khi thch hp v phn tch cc qu trnh ny, v

thc hin cc hnh ng cn thit t c kt qu d nh v ci tin lin tc cc qu

T chc phi qun l cc qu trnh theo cc yu cu ca tiu chun ny.

ISO TS 16949:2009 (V)

4.1.1 Cc yu cu chung - b sung

4.2 Yu cu v h thng ti liu

4.2.1 Khi qut

cc vn bn cng b v chnh sch cht lng v mc tiu cht lng,

b) s tay cht lng,