ISO 9001:2015

ISO 9001:2015
H THNG QUN L CHT LNG
CC YU CU S DNG
ENVIRONMENTAL MANAGEMENT SYSTEMS
REQUIREMENTS

ISO 9001:2015

H thng qun l cht lng Cc yu cu ISO 9001:2015 (V)

4. Bi cnh ca t chc
4.1 Nhn thc v t chc v bi cnh ca t chc
T chc phi xc nh cc vn ni b v bn ngoi c lin quan n mc ch v
nh hng chin lc ca t chc v iu nh hng n kh nng ca t chc nhm t
c (cc) kt qu d kin ca h thng qun l cht lng ca t chc
T chc phi theo di v xem xt cc thng tin v nhng vn ni b v bn ngoi.
CH THCH 1 Vn c th bao gm cc yu t tch cc v tiu cc hoc iu kin xem xt.
CH THCH 2 Hiu bit v bi cnh bn ngoi c th c to iu kin thun li bng cch xem
xt cc vn pht sinh t mi trng php l, cng ngh, cnh tranh, th trng, vn ha, x hi
v kinh t, d phm vi quc t, quc gia, khu vc v a phng
CH THCH 3 Hiu bit v bi cnh ni b c th c thun li bng cch xem xt cc vn
lin quan n gi tr, kin thc vn ha v hiu sut ca t chc

4.2 Nhn thc v nhu cu v mong i ca cc bn hu quan

Do nh hng hay tc ng tim n v kh nng ca t chc lun cung cp sn
phm v dch v p ng cc yu cu ca khch hng v cc yu cu lut nh, ch nh thch
hp quy nh hin hnh, t chc phi xc nh:
a) Cc bn hu quan c quan tm n h thng qun l cht lng;
b) Cc yu cu ca cc bn hu quan c quan tm n h thng qun l cht lng
T chc phi theo di v xem xt cc thng tin v cc bn hu quan v cc yu cu
quan tm ca h.
4.3 Xc nh phm vi ca h thng qun l cht lng
T chc phi xc nh gii hn v kh nng p dng h thng qun l cht lng
thit lp phm vi ca h thng
Khi xc nh phm vi ny, t chc phi xem xt:
a) Cc vn ni b v bn ngoi c cp trong 4.1;
b) Cc yu cu ca cc bn hu quan c cp trong 4.2;
c) Cc sn phm v dch v ca t chc.
T chc phi p dng tt c cc yu cu ca tiu chun ny nu cc yu cu ny
c p dng trong phm vi xc nh ca cc h thng qun l cht lng ca t chc
Phm vi ca h thng qun l cht lng ca t chc phi sn c v c duy
tr nh thng tin dng vn bn. Phm vi phi nu r cc loi sn phm v bao gm c

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dch v, v cung cp bng chng chng minh l ng cho bt k yu cu no ca tiu

chun ny m t chc xc nh l khng p dng i vi cc phm vi ca h
thng qun l cht lng ca t chc
S ph hp vi tiu chun quc t ny ch c th c khng nh nu cc yu cu
xc nh nh khng p dng th khng nh hng n kh nng v trch nhim ca t
chc, nhm m bo s ph hp ca sn phm v dch v ca t chc v nng cao s
tha mn ca khch hng
4.4 H thng qun l cht lng v cc qu trnh
4.4.1 T chc phi xy dng, thc hin, duy tr v ci tin thng xuyn h thng qun l
cht lng, bao gm cc qu trnh cn thit v mi tng tc ca cc qu trnh, ph hp vi
cc yu cu ca tiu chun ny
T chc phi xc nh cc qu trnh cn thit trong h thng qun l cht lng v p
dng chng trong ton b t chc v phi :
a) Xc nh cc yu t u vo cn thit v kt qu mong i t cc qu trnh ny;
b) Xc nh trnh t v mi tng tc ca cc qu trnh ny;
c) Xc nh v p dng cc chun mc, phng php (bao gm theo di, o lng v ch s
hot ng lin quan cn thit m bo tnh hiu lc trong vn hnh v kim sot cc
qu trnh ny;
d) Xc nh cc ngun lc cn thit i vi cc qu trnh ny v m bo sn c cc ngun
lc ;
e) Phn cng trch nhim v quyn hn i vi cc qu trnh ny;
f) Gii quyt nhng ri ro v c hi nh xc nh ph hp vi nhng yu cu ca iu
6.1;
g) nh gi cc qu trnh ny v thc hin bt k thay i cn thit no m bo rng
cc qu trnh t c kt qu d kin ca t chc ;
h) Ci tin cc qu trnh v h thng qun l cht lng.
T chc phi duy tr thng tin dng vn bn trong mc cn thit h tr vn hnh
cc qu trnh v lu gi thng tin dng vn bn trong mc cn thit c s tin tng
rng cc qu trnh ang c tin hnh theo d nh.
4.4.2 n mc cn thit, t chc phi c trch nhim:
a) Duy tr thng tin dng vn bn h tr cc hot ng ca cc qu trnh;
b) Lu gi thng tin dng vn bn tin tng rng cc tin trnh ang c thc hin theo
k hoch.

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5. Lnh o
5.1. Lnh o v cam kt
5.1.1 Khi qut
Lnh o cao nht phi chng t s lnh o v cam kt i vi h thng qun l
cht lng bng cch:
a) C trch nhim gii trnh v tnh hiu lc ca h thng qun l cht lng;
b) m bo rng chnh sch cht lng v cc mc tiu cht lng c thit lp trong
h thng qun l cht lng v ph hp vi bi cnh v nh hng chin lc ca t chc;
c) m bo s tch hp cc yu cu ca h thng qun l cht lng vo cc qu trnh
kinh doanh ca t chc;
d) Thc y s dng cch tip cn qu trnh v t duy da trn ri ro;
e) m bo sn c cc ngun lc cn thit i vi h thng qun l cht lng;
f) Truyn t tm quan trng v tnh hiu lc ca qun l cht lng v s ph hp vi
cc yu cu ca h thng qun l cht lng;
g) m bo rng h thng qun l cht lng t c cc kt qu d kin;
h) Tham gia, ch o v h tr nhng nhn s ng gp vo hiu lc ca h thng qun l
cht lng;
i) Thc y ci tin;
j) H tr vai tr lnh o khc c lin quan chng t s lnh o ca h khi h thng p
dng cho khu vc thuc trch nhim ca h.
CH THCH Thut ng "kinh doanh" trong tiu chun ny c th c hiu mt cch rng ri ch
nhng hot ng mang tnh ct li cho mc ch tn ti ca t chc; cho d t chc ny l nh nc,
t nhn, v li nhun hay phi li nhun

5.1.2 Hng vo khch hng

Lnh o cao nht phi chng t s lnh o v cam kt i vi chnh sch hng
vo khch hng bng cch m bo rng:
a) Cc yu cu ca khch hng v cc yu cu ca lut nh v ch nh thch hp c xc
nh, c thu hiu v lun c p ng;
b) Nhng ri ro v nhng c hi c th nh hng n s ph hp ca sn phm, dch
v v kh nng nng cao s tha mn ca khch hng c xc nh v c gii
quyt;
c) Hng vo khch hng nhm nng cao s tha mn ca khch hng c duy tr.

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5.2 Chnh sch

5.2.1 Trin khai chnh sch cht lng
Lnh o cao nht phi thit lp, thc hin v duy tr chnh sch cht lng:
a) Ph hp vi mc ch v bi cnh ca t chc v h tr cc nh hng chin lc
ca t chc;
b) Cung cp c s cho vic thit lp cc mc tiu cht lng;
c) Bao gm vic cam kt nhm tha mn cc yu cu sn c;
d) Bao gm cam kt ci tin thng xuyn h thng qun l cht lng.
5.2.2 Truyn t chnh sch cht lng
Chnh sch cht lng phi:
a) c sn c v c duy tr nh l thng tin dng vn bn;
b) c truyn t, c thu hiu v c p dng trong t chc;
c) c sn c cho cc bn hu quan c quan tm, khi thch hp.
5.3 Vai tr, trch nhim v quyn hn ca t chc
Lnh o cao nht phi m bo cc trch nhim v quyn hn i vi cc vai tr
c lin quan c phn cng, c truyn t v c thu hiu trong ton b t chc.
Lnh o cao nht phi phn cng trch nhim v quyn hn i vi :
a) Vic m bo rng h thng qun l cht lng ph hp vi cc yu cu ca tiu
chun ny;
b) Vic m bo rng cc qu trnh cung cp kt qu u ra nh d nh;
c) B o co vic thc hin h thng qun l cht lng, v c hi ci tin n lnh o
cao nht;
d) m bo thc y hng v khch hng trong ton t chc;
e) m bo duy tr tnh nht qun ca h thng qun l cht lng khi cc thay i i vi h
thng qun l cht lng c hoch nh v thc hin.
6. Hoch nh
6.1 Hnh ng gii quyt cc ri ro v c hi
6.1.1 Khi hoch nh h thng qun l cht lng, t chc phi xem xt cc vn c nu
trong 4.1 v cc yu cu nu trong 4.2 v xc nh cc ri ro v c hi cn c gii
quyt :
a) m bo rng h thng qun l cht lng c th t c (cc) kt qu d kin
b) Tng cng cc tc ng qu mong mun;
c) Ngn nga, hoc gim thiu, cc tc ng khng mong mun;

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d) t c ci tin.
6.1.2 T chc phi lp k hoch:
a) Cc hnh ng gii quyt cc ri ro v c hi;
b) Cch thc :
- Tch hp v thc hin cc hnh ng vo cc qu trnh h thng qun l cht lng
(xem 4.4);
- nh gi hiu lc ca nhng hnh ng ny
Cc hnh ng c thc hin nhm gii quyt cc ri ro v c hi phi tng ng vi
tc ng tim n v s ph hp ca sn phm v dch v
CH THCH 1 Phng n gii quyt cc ri ro c th bao gm vic trnh ri ro, chp nhn ri ro
theo ui mt c hi, loi b ngun ri ro, thay i kh nng xy ra hoc hu qu,s chia ri ro, hoc
lu gi li ri ro bng cch quyt nh c hiu bit.
CH THCH 2 C hi c th dn n vic p dng cc phng php mi, tung ra sn phm mi,
m th trng mi, gii quyt cc khch hng mi, xy dng quan h i tc, s dng cng ngh mi
v kh nng mong mun v kh thi khc gii quyt cc nhu cu ca t chc hoc khch hng
ca t chc.

6.2 Mc tiu cht lng v hoch nh t c mc tiu cht lng

6.2.1 T chc phi thit lp cc mc tiu cht lng ti cc cp v b phn chc nng v cc
qu trnh lin quan cn thit ca h thng qun l cht lng
Cc mc tiu cht lng phi:
a) Nht qun vi chnh sch cht lng;
b) o c;
c) Xem xt n cc cc yu cu thch hp;
d) Lin quan n s ph hp ca sn phm, dch v v nng cao s tha mn ca khch
hng;
e) c theo di;
f) c truyn t
g) c cp nht khi thch hp
T chc phi lu gi li thng tin dng vn bn v cc mc tiu cht lng.
6.2.2 Khi hoch nh cch thc t c mc tiu cht lng, t chc phi xc nh:
a) Nhng g s c thc hin; (What)
b) Nhng ngun lc cn thit; (What)
c) Ai chu trch nhim;

(Who)

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d) Khi no hon thnh;

(When)

e) Cch thc nh gi kt qu

(How)

6.3 Hoch nh vic thay i

Khi t chc xc nh nhu cu thay i i vi h thng qun l cht lng (xem 4.4) th
vic thay i phi c tin hnh mt cch c k hoch v h thng.
T chc phi xem xt:
a) Mc ch ca vic thay i v hu qu tim n ca n;
b) Tnh nht qun ca h thng qun l cht lng;
c) Sn c cc ngun lc;
d) Vic phn b hoc phn b li trch nhim v quyn hn.
7. H tr
7.1 Ngun lc
7.1.1 Khi qut
T chc phi xc nh v cung cp cc ngun lc cn thit thit lp, thc hin,
duy tr v ci tin thng xuyn h thng qun l cht lng.
T chc phi xem xt:
a) Nng lc v nhng hn ch ca cc ni ti hin c;
b) Nhng nhu cu cn t c t cc nh cung cp bn ngoi.
7.1.2 Nhn s
T chc phi xc nh v cung cp cho nhn s cn thit thc hin tnh hiu lc ca
h thng qun l cht lng v vn hnh v kim sot cc qu trnh ca t chc
7.1.3 C s h tng
T chc phi xc nh, cung cp v duy tr c s h tng cho hot ng ca cc qu
trnh t c s ph hp ca sn phm v dch v.
CH THCH
C s h tng c th bao gm:
a) N h ca v cc phng tin km theo;
b) Thit b bao gm c phn cng v phn mm;
c) Vn chuyn;
d) Thng tin v cng ngh truyn thng

7.1.4 Mi trng cho hot ng ca cc qu trnh

T chc phi xc inh, cung cp v duy tr mi trng cn thit i vi hot ng ca
cc qu trnh v t c s ph hp i vi cc sn phm v dch v.

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CH THCH
Mi trng thch hp c th l mt s kt hp ca yu t con ngi v yu t vt l, chng hn
nh:
a) Yu t x hi (v d nh khng phn bit i x,
bnh tnh, khng i u);
b) Yu t tm l (v d nh gim cng thng, phng nga kit sc, xc ng);
c) Y u t vt l (v d nh nhit , nhit , m, nh sng, lung khng kh, v sinh, ting n).
Nhng yu t ny c th khc nhau ng k ty thuc vo cc sn phm v dch v cung cp

7.1.5 Theo di v o lng cc ngun lc

7.1.5.1 Khi qut
T chc phi xc nh v cung cp cc ngun lc cn thit m bo kt qu c gi
tr v ng tin cy khi theo di hoc o lng c s dng kim tra xc nhn s ph hp
ca sn phm v dch v i vi cc yu cu.
T chc phi m bo cc ngun lc c cung cp:
a) Thch hp cho cc loi hnh c th cho hot ng theo di v o lng c thc
hin;
b) c duy tr m bo tip tc ph hp vi mc ch ca chng.
T chc lu gi li thong tin dng vn bn thch hp nh l bng chng v s ph hp
cho mc ch theo di v o lng cc ngun lc
7.1.5.2 Lin kt chun o lng
Khi lin kt chun o lng l mt yu cu hoc c t chc xem xt l
mt phn thit yu ca vic cung cp mc tin cy vo gi tr php l ca kt qu o,
thit b o phi:
a) c kim nh hoc hiu chun hay c hai trong khong thi gian quy nh
hoc trc khi s dng i vi cc chun o lng quc t hay quc gia. Khi khng c
cc chun ny th cn c c s dng hiu chun hoc kim nh phi c lu gi di
dng thng tin dng vn bn;
b) c nhn bit nhm xc nh tnh trng;
c) c bo v trnh b iu chnh, h hng hoc xung cp, suy gim lm mt hiu lc cc
trng thi hiu chun v cc kt qu o lng tip theo.
T chc phi xc nh tnh xc nhn gi tr s dng ca cc kt qu o trc b
nh hng bt li khi thit b o c pht hin c sai st khng thch hp cho mc ch d
kin v phi c hnh ng thch hp khi cn thit.

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7.1.6 Kin thc ca t chc

T chc phi xc nh kin thc cn thit cho hot ng ca cc qu trnh ca t
chc v t c s ph hp ca sn phm v dch v. Nhng kin thc ny phi c duy
tr, v sn c mc cn thit.
Khi gii quyt cc nhu cu v xu hng thay i, t chc phi xem xt kin thc
hin ti v xc nh cch thc c c hoc tip cn nhng kin thc b sung cn thit v
nhng cp nht i hi.
CH THCH 1 Kin thc t chc l kin thc c th i vi t chc; n t c bng kinh nghim.
l thng tin c s dng v c s chia t c
cc mc tiu ca t chc.
CH THCH 2

Kin thc t chc c th c da vo :

a) cc ngun ni lc (v d nh s hu tr tu, kin thc thu c t kinh nghim; bi hc

kinh nghim t nhng tht bi v thnh cng cc d n; thu ht v s chia kin thc v kinh
nghim, kt qu ca nhng ci tin cc qu trnh, sn phm v dch v);
b) cc ngun lc bn ngoi (v d nh cc tiu chun; gii hc vin; hi ngh; thu thp kin
thc t khch hng hoc cc nh cung cp bn ngoi).
7.2

Nng lc

Cc t chc phi :
a) Xc nh nng lc cn thit ca nhng ngi lm vic di s kim sot ca t chc c
nh hng n vic thc hin v tnh hiu lc ca h thng qun l cht lng;
b) m bo rng nhng ngi ny c nng lc trn c s c gio dc, o to, hoc kinh
nghim thch hp;
c) Tin hnh nhng hnh ng t c nng lc cn thit, v nh gi hiu lc ca
cc hnh ng c thc hin, khi cn;
d) lu gi thng tin dng vn bn thch hp nh l bng chng v nng lc.
CH THCH Vic p dng c th bao gm, v d nh: cung cp o to, c vn, hoc ti phn
cng cng vic ca cc nhn vin hin ang lm vic; hoc thu mn hay k hp ng vi
nhng ngi c nng lc.

7.3 Nhn thc

T chc phi m bo nhng ngi c lin quan lm vic di s kim sot ca t
chc nhn thc c:
a) chnh sch cht lng;
b) nhng mc tiu cht lng lin quan;
c) ng gp ca h i vi tnh hiu lc ca h thng qun l cht lng, k c nhng li

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ch ca vic ci tin hot ng;

d) Nhng tc ng ca s khng ph hp vi cc yu cu h thng qun l cht lng
7.4

Trao i thng tin

T chc phi xc nh cc trao i thng tin ni b v bn ngoi c lin quan n h

thng qun l cht lng, bao gm:

a) Nhng g s trao i, truyn t;
b) Khi no trao i thng tin;
c) Trao i thng tin vi ai;
d) Cch thc trao i thng tin;
e) Ngi trao i, truyn t
Thng tin dng vn bn

7.5
7.5.1

Khi qut
H thng qun l cht lng ca t chc phi bao gm:

a) Thng tin dng vn bn theo yu cu ca tiu chun ny;

b) T hng tin dng vn bn c t chc xc nh l c thit i vi hiu lc ca h thng
qun l cht lng.
CH THCH : Mc thng tin dng vn bn i vi h thng qun l cht lng c th khc
nhau t t chc ny n t chc khc do:
- Quy m, loi hnh hot ng, quy trnh, sn phm v dch v ca t chc;
- Tnh phc tp ca cc qu trnh v s tng tc ca chng;
- Nng lc ca nhn vin

7.5.2 To v cp nht
Khi to ra v cp nht thng tin dng vn bn, t chc phi m bo thch hp:
a) Nhn bit v m t (v d: tiu , ngy thng, tc gi hay s tham kho);
b) nh dng (v d: ngn ng, phin bn phn mm, ha) v phng tin (v d: giy,
in t);
c) Xem xt v ph duyt v tnh ph hp v y
7.5.3 Kim sot thng tin dng vn bn
7.5.3.1 Thng tin dng vn bn theo yu cu ca h thng qun l cht lng v tiu chun
ny phi c kim sot m bo:
a) Sn c v thch hp s dng, ni lu gi v s dng khi cn;
b) c bo v y (v d: khng mt tnh bo mt, s dng khng ng, hoc mt tnh
ton vn).

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7.5.3.2 kim sot thng tin dng vn bn, t chc phi gii quyt cc hot ng sau y,
khi c th:
a) Phn phi, truy cp, thu hi v s dng;
b) Lu tr, bo qun, bao gm bo qun mc d c ti liu;
c) Kim sot cc thay i (v d kim sot phin bn ti liu);
d) Lu gi v sp xp ti liu.
Thng tin dng vn bn c ngun gc bn ngoi c t chc xc nh l cn thit cho
hoch nh v vn hnh ca h thng qun l cht lng phi c nhn bit khi thch hp, v
c kim sot.
Thng tin dng vn bn c lu gi nh bng chng v s ph hp phi c bo
v t s sa i ngoi mun.
CH THCH Vic truy cp c th bao hm quyt nh lin quan n vic ch cho php xem cc thng
tin dng vn bn, hoc cho php v thm quyn xem v thay i thng tin dng vn bn.

8.1

Hoch nh v kim sot vn hnh

T chc phi lp k hoch, thc hin v kim sot cc qu trnh cn thit (xem 4.4)

p ng cc yu cu i vi vic cung cp cc sn phm v dch v, v thc hin cc

hnh ng c xc nh ti iu 6, bng cch:
a) Xc nh cc yu cu i vi cc sn phm v dch v;
b) Thit lp chun mc cho:
- Cc qu trnh;
- Chp nhn cho sn phm v dch v;
c) Xc nh cc ngun lc cn thit t c s ph hp vi cc yu cu v sn phm v
dch v;
d) Thc hin kim sot cc qu trnh ph hp vi cc chun mc;
e) Xc nh v gi gn thng tin dng vn bn n mc cn thit:
- Tin tng rng cc qu trnh c tin hnh nh hoch nh;
- chng t s ph hp ca sn phm v dch v i vi cc yu cu;
CH THCH "Gi gn" hm c vic duy tr v gi li cc thng tin dng vn bn
u ra ca hoch nh ny phi thch hp cho cc hot ng ca t chc.
T chc phi kim sot nhng thay i k hoch v xem xt cc hu qu ca nhng thay i ngoi
mun, tin hnh hnh ng gim thiu bt k tc dng ph, khi cn.
T chc phi m bo rng cc qu trnh gia cng c kim sot (xem 8.4)

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8.2 Yu cu i vi sn phm v dch v

8.2.1 Trao i thng tin vi khch hng
Trao i thng tin vi khch hng phi bao gm:
a) Cung cp thng tin lin quan n sn phm v dch v;
b) X l cc yu cu, hp ng hoc n t hng, bao gm c nhng thay i;
c) Thu thp thng tin phn hi ca khch hng lin quan n cc sn phm v dch v, bao
gm c cc khiu ni ca khch hng;
d) X l hoc kim sot ti sn ca khch hng;
e) Thit lp cc yu cu c th i vi cc hnh ng d phng, khi c lin quan
8.2.2 Xc nh cc yu cu lin quan n sn phm v dch v
Khi xc nh cc yu cu i vi cc sn phm v dch v c cung cp cho khch
hng, t chc phi m bo rng:
a) Cc yu cu i vi cc sn phm v dch v c xc nh, bao gm:
- Bt k yu cu lut nh v ch nh p dng cho sn phm v dch v;
- nhng yu cu c t chc cho l cn thit;
b) T chc c th p ng cc cng b v cc sn phm v dch v m t chc cung cp
8.2.3 Xem xt cc yu cu lin quan n sn phm v dch v
8.2.3.1 T chc phi m bo rng t chc c kh nng p ng cc yu cu i vi cc sn
phm v dch v c cung cp cho khch hng. T chc phi tin hnh xem xt trc
khi cam kt cung cp sn phm v dch v cho khch hng, bao gm:
a) Yu cu do khch hng a ra, bao 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) Y u cu theo quy nh ca t chc;
d) Yu cu lut nh v ch nh p dng cho sn phm v dch v;
e) Cc yu cu trong hp ng hoc n t hng khc vi nhng g nu trc .
T chc phi m bo rng cc yu cu trong hp ng hoc n t hng khc vi
nhng g nu trc c gii quyt.
Khi khch hng a ra cc yu cu khng bng vn bn, cc yu cu ny ca khch
hng phi c t chc khng nh trc khi chp nhn.
8.2.3.2 T chc phi lu gi thng tin dng vn bn, khi thch hp :
a) Vo kt qu xem xt;

ISO 9001:2015

b) Vo bt k yu cu mi i vi sn phm v dch v.
8.2.4 Thay i cc yu cu i vi sn phm v dch v
T chc phi m bo rng cc thng tin dng vn bn lin quan c sa i, v
rng nhng nhn s c lin quan nhn thc c cc yu cu thay i , khi cc yu cu i
vi cc sn phm v dch v c thay i.
8,3 Thit k v pht trin sn phm v dch v
8.3.1 Khi qut
T chc phi thit lp, thc hin v duy tr mt qu trnh thit k v pht trin
thch hp m bo cung cp tip theo sn phm v dch v.
8.3.2 Hoch nh thit k v pht trin
Khi xc nh cc giai on v kim sot i vi thit k v pht trin, t chc phi
xem xt:
a) Bn cht, thi gian v tnh phc tp ca cc hot ng thit k v pht trin;
b) Cc giai on qu trnh yu cu, bao gm c xem xt thit k v pht trin;
c) Hot ng kim tra xc nhn v xc nhn gi tr s dng ca thit k v pht trin;
d) Trch nhim v quyn hn tham gia vo qu trnh thit k v pht trin;
e) Cc ngun lc ni b v bn ngoi cn cho vic thit k v pht trin sn phm v dch v;
f) S cn thit kim sot cc tng giao gia ngi tham gia vo qu trnh thit k v
pht trin;
g) S cn thit tham gia ca khch hng v ngi s dng trong qu trnh thit k v
pht trin;
h) Cc yu cu i vi vic cung cp tip theo ca sn phm v dch v;
i) Mc kim sot d kin i vi thit k v pht trin ca cc khch hng v cc bn
quan tm khc c lin quan;
j) Cc thng tin dng vn bn cn thit chng t rng cc yu cu ca thit k v pht
trin c p ng.
8.3.3 u vo ca thit k v pht trin
T chc phi xc nh cc yu cu thit yu cho cc loi hnh c th ca sn phm v
dch v c thit k v pht trin. T chc phi xem xt:
a) Y u cu chc nng v cng dng;
b) Thng tin nhn c t cc hot ng thit k v pht trin tng t trc ;
c) Yu cu lut nh v ch nh;
d) Tiu chun hoc quy phm thc hnh m t chc cam kt thc hin;

ISO 9001:2015

e) Hu qu tim n t tht bi do tnh cht ca sn phm v dch v.

u vo phi c tha ng cho mc ch thit k v pht trin, y v r rng.
Mu thun gia cc yu t u vo thit k v pht trin phi c gii quyt.
T chc phi lu gi cc thng tin dng vn bn v u vo thit k v pht trin
8.3.4 Kim sot thit k v pht trin
T chc phi p dng kim sot i vi qu trnh thit k v pht trin m bo
rng:
a) C c kt qu t c c xc nh;
b) Tin hnh xem xt nh gi kh nng p ng cc yu cu ca cc kt qu thit k v
pht trin;
c) Tin hnh cc hot ng kim tra xc nhn m bo rng u ra ca thit k v pht
trin p ng cc yu cu u vo ca thit k v pht trin;
d) Tin hnh cc hot ng xc nhn gi tr s dng m bo rng sn phm v dch v
to ra p ng cc yu cu s dng d kin hay cc ng dng quy nh;
e) Thc hin bt k hnh ng cn thit v nhng vn c xc nh trong sut qu
trnh xem xt, hoc kim tra xc nhn v xc nhn gi tr s dng;
f) Thng tin dng vn bn i vi cc hot ng xem xt, hoc kim tra xc nhn v xc nhn
gi tr s dng c lu gi.
CH THCH Cc hot ng xem xt, hoc kim tra xc nhn v xc nhn gi tr s dng thit k v
pht trin c mc ch ring bit. Cc hot ng ny c th c tin hnh ring r hoc kt hp,
khi thch hp cho cc sn phm v dch v ca t chc.

8.3.5 u ra ca thit k v pht trin

T chc phi m bo u ra ca thit k v pht trin:
a) p ng yu cu u vo;
b) Tha ng cho cc qu trnh tip theo nhm cung cp sn phm v dch v;
c) Bao gm hoc vin dn ti cc yu cu theo di v o lng, khi thch hp, v cc chun
mc chp nhn;
d) Xc nh cc c tnh ct yu cho mc ch d kin, cho an ton v cung cp ng ca
sn phm v dch v.
8.3.5 u ra ca thit k v pht trin
T chc phi nhn bit, xem xt v kim sot nhng thay i c thc hin trong sut
qu trnh thit k v pht trin sn phm v dch v, hoc tip sau , ti mc cn thit
m bo khng c tc ng xu n s ph hp vi cc yu cu..

ISO 9001:2015

T chc phi lu gi cc thng tin dng vn bn v:

a) Thay i thit k v pht trin;
b) Kt qu ca vic xem xt ;
c) Quyn hn v vic thay i;
d) Thc hin cc hnh ng phng nga nhng tc ng bt li
8.4 Kim sot qu trnh, sn phm v dch v c cung cp t bn ngoi
8.4.1 Khi qut
T chc phi m bo cc qu trnh, sn phm v dch v c cung cp t bn ngoi
ph hp vi cc yu cu.
T chc phi xc nh vic kim sot p dng i vi cc qu trnh, sn phm
v dch v c cung cp t bn ngoi khi:
a) Sn phm v dch v c cung cp t cc nh cung cp bn ngoi nhm cu thnh cc
sn phm v dch v ring ca t chc;
b) Sn phm v dch v c cung cp trc tip cho khch hng bi cc nh cung cp bn
ngoi i din cho t chc;
c) Mt qu trnh hoc mt phn ca qu trnh c cung cp bi nh cung cp bn ngoi
theo quyt nh ca t chc.
T chc phi xc nh v p dng cc tiu ch nh gi, la chn, theo di thc hin v
nh gi li cc nh cung cp bn ngoi da trn kh nng cung cp qu trnh hoc
sn phm v dch v ph hp vi cc yu cu. T chc phi lu gi thng tin dng vn
bn cc hot ng ny v mi hnh ng cn thit pht sinh t vic nh gi
8.4.2 Loi v mc kim sot
T chc phi m bo qu trnh, sn phm v dch v c cung cp t bn ngoi
khng nh hng xu n kh nng ca t chc cung cp sn phm v dch v ph hp cho
khch hng ca mnh mt cch nht qun
T chc phi:
a) m bo rng cc qu trnh bn ngoi cung cp vn trong vng kim sot ca h thng
qun l cht lng ca mnh;
b) Xc nh c cc kim sot m t chc nh p dng i vi nh cung cp bn ngoi v
nhng d nh p dng vi kt qu u ra;
c) Thc hin xem xt:
- T c ng tim n ca cc qu trnh, sn phm v dch v cung cp bn ngoi i
vi kh nng ca t chc nhm lun p ng cc yu cu ca khch hng v cc yu

ISO 9001:2015

cu lut nh v ch nh p dng;
- Tnh hiu lc ca vic kim sot c pdng bi nh cung cp bn ngoi.
d) Xc nh vic kim tra xc nhn, hoc cc hot ng khc, cn thit m bo cc
qu trnh, sn phm v dch v bn ngoi cung cp p ng yu cu.
8.4.3 Thng tin cho nh cung cp bn ngoi
T chc phi m bo y cc yu cu trc khi thng bo cho nh cung cp bn
ngoi.
T chc phi trao i thng tin vi cc nh cung cp bn ngoi cc yu cu ca h v:
a) Qu trnh, sn phm v dch v cung cp;
b) Ph duyt :
- Cc sn phm v dch v;
- Cc phng php, qu trnh v thit b;
- Thng qua sn phm v dch v;
c) Nng lc, bao gm c trnh chuyn mn c yu cu i vi nhn s;
d) Mi tng tc ca nh cung cp bn ngoi vi t chc;
e) T chc kim sot v theo di kt qu hot ng ca cc nh cung cp bn
ngoi;
f) Cc hot ng kim tra xc nhn v xc nhn gi tr s dng m t chc, hoc khch hng
ca mnh d nh s thc hin ti c s ca cc nh cung cp dch v bn ngoi
Sn xut v cung cp dch v

8.5
8.5.1

Kim sot sn xut v cung cp dch v

T chc phi tin hnh sn xut v cung ng dch v theo cc iu kin c kim sot.

iu kin c kim sot phi bao gm, khi thch hp:

a) s sn c ca cc thng tin dng vn bn c xc nh :
- Cc c tnh ca sn phm c sn xut, cc dch v c cung cp, hoc cc
hot ng c thc hin;
- Cc kt qu t c;
b) S sn c v s dng cc ngun lc thch hp theo di v o lng;
c) Thc hin cc hot ng theo di v o lng nhng giai on thch hp kim
tra xc nhn cc tiu ch kim sot qu trnh hay u ra ca qu trnh v tiu ch chp
nhn cho cc sn phm v dch v, c p ng;
d) S dng c s h tng v mi trng thch hp cho vn hnh qu trnh;
e) Vic b nhim ngi c nng lc, bao gm bt k trnh chuyn mn c yu cu;

ISO 9001:2015

f) Xc nhn ga tr s dng, v ti xc nhn ga tr s dng nh k, v kh nng t c kt

qu hoch nh ca bt k qu trnh sn xut v cung cp dch v m kt qu u ra
khng th kim tra xc nhn bng cch theo di hoc o lng sau ;
g) Thc hin cc hnh ng ngn chn li ca con ngi;
h) Vic thc hin cc hot ng thng qua giao hng v sau giao hng
8.5.2 Nhn bit v xc nh ngun gc
T chc phi s dng phng tin thch hp nhn bit c kt qu u ra khi n l
cn thit m bo s ph hp ca sn phm v dch v.
T chc phi nhn bit c trng thi ca cc kt qu u ra tng ng vi cc yu
cu theo di v o lng yu cu trong sut qu trnh sn xut v cung cp dch v.
T chc phi kim sot vic nhn bit duy nht kt qu u ra khi vic xc nh
ngun gc l mt yu cu, v phi lu gi cc thng tin dng vn bn cn thit xc
nh ngun gc
8.5.3 Ti sn ca khch hng hoc nh cung cp bn ngoi
T chc phi gi gn ti sn ca khch hng

hoc

nh

cung

cp

bn

ngoi 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 hoc nh cung cp bn
ngoi cung cp s dng hoc hp thnh sn phm v dch v.
Khi ti sn ca khch hng hoc cc nh cung cp bn ngoi 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
hoc nh cung cp bn ngoi v lu gi thng tin dng vn bn v nhng g xy ra.
CH THCH: Ti sn ca khch hng hoc nh cung cp bn ngoi c th bao gm vt liu, linh kin,
dng c v trang thit b, c s khch hng,s hu tr tu v d liu c nhn.

8.5.4 Bo ton
T chc phi bo ton kt qu u ra trong qu trnh sn xut v cung cp dch v,
n mc cn thit nhm m bo ph hp vi cc yu cu.
CH THCH: Vic bo ton c th bao gm nhn bit, xp d (di chuyn), bao gi, lu gi, truyn
ti,vn chuyn v bo qun

8.5.5 Cc hot ng sau giao hng

T chc phi p ng cc yu cu cho cc hot ng sau giao hng lin quan sn phm
v dch v.
Khi xc nh mc ca cc hot ng sau giao hng c yu cu, t chc phi
xem xt:

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a) Yu cu ca lut nh v ch nh;
b) Nhng hu qu tim n khng mong mun lin quan vi cc sn phm v dch v;
c) Tnh cht, s dng v tui th ca sn phm v dch v;
d) Yu cu ca khch hng;
e) Phn hi ca khch hng.
CH THCH: Cc hot ng sau giao hng c th bao gm cc hot ng theo quy nh bo
hnh, ngha v hp ng nh dch v bo tr v cc dch v b tr nh ti ch hoc x l cui cng

8.5.6 Kim sot vic thay i

T chc phi xem xt v kim sot cc thay i cho sn xut, cung ng dch v ti
mc cn thit m bo tip tc ph hp vi cc yu cu.
T chc phi lu gi thng tin dng vn bn m t cc kt qu ca vic xem xt cc
thay i, ngi c quyn thay i, v mi hnh ng cn thit ny sinh t vic xem xt
8.6 Thng qua sn phm v dch v
T chc phi thc hin cc sp xp theo hoch nh nhng giai on thch hp
kim tra xc nhn rng cc yu cu sn phm v dch v c p ng.
Vic thng qua cc sn phm v dch v cho cc khch hng ch c tin hnh sau
hon thnh tha ng cc sp xp theo hoch nh, nu khng th phi c s ph
duyt ca ngi c thm quyn v nu c th, ca khch hng.
T c hc phi lu gi thng tin dng vn bn v vic thng qua sn phm v dch v. Cc
thng tin dng vn bn bao gm:
a) Bng chng v s ph hp vi tiu ch chp nhn;
b) Xc nh ngun gc n ngi c quyn thng qua
8.7 Kim sot u ra khng ph hp
8.7.1 T chc phi m bo rng cc kt qu u ra m khng ph hp vi yu cu ca h
c nhn bit v c kim sot phng nga vic s dng hoc chuyn giao ngoi d kin.
T chc phi c hnh ng thch hp da vo bn cht ca s khng ph hp v nh
hng v s ph hp ca sn phm v dch v. iu ny cng phi p dng i vi cc sn
phm v dch v khng ph hp c pht hin sau khi chuyn giao sn phm, trong hoc
sau khi cung cp dch v.
T chc phi x l u ra khng ph hp ca qu trnh bng mt hoc mt s cch sau :
a) Khc phc;
b) Chia tch, ngn chn, tr li hoc ngng cung cp cc sn phm v dch v;
c) Thng bo cho khch hng;

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d) Cho php chp nhn c nhn nhng.

Khi kt qu u ra khng ph hp c khc phc, s ph hp vi cc yu cu phi
c kim tra xc nhn.
8.7.2 T chc phi lu gi thng tin dng vn bn
a) M t s khng ph hp;
b) M t cc hnh ng c thc hin;
c) M t cc nhn nhng t c;
d) Nhn bit ngi c thm quyn quyt nh hnh ng lin quan n s khng ph
hp
9. nh gi kt qu hot ng
9.1 Theo di, o lng, phn tch v nh gi
9.1.1 Khi qut
a) Nhng g cn phi c theo di v o lng;
b) Cc phng php theo di, o lng, phn tch v nh gi cn thit m bo cc kt qu
hp l
c) Khi no vic theo di v o lng c thc hin
d) Khi cc kt qu t theo di v o lng phi c phn tch v nh gi. T chc phi
nh gi kt qu hot ng v tnh hiu lc ca h thng qun l cht lng. T chc
phi lu gi cc thng tin dng vn bn thch hp nh l bng chng ca kt qu t theo
di v o lng.
9.1.2 S tha mn ca khch hng
T chc phi theo di mc chp nhn ca khch hng i vi cc nhu cu v
mong i ca khch hng c p ng hay khng. T chc phi xc nh cc
phng php cho vic thu thp, theo di v xem xt thng tin ny
CH THCH V d v theo di chp nhn ca khch hng c th bao gm iu tra khch hng, phn
hi ca khch hng v chuyn giao sn phm hoc dch v, hi ngh khch hng, phn tch th trng,
gp khen ngi, yu cu bo hnh v bo co i l.

9.1.3 Phn tch v nh gi

T chc phi phn tch v nh gi cc d liu v thng tin thch hp ny sinh t vic
theo di o lng.
Kt qu ca phn tch ph i c s dng nh gi:
a) S ph hp ca sn phm v dch v;
b) Mc tha mn ca khch hng;

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c) Kt qu hot ng v tnh hiu lc ca h thng qun l cht lng;

d) n h gi nh hoch nh c trin khai thc hin c hiu qu;
e) Tnh hiu lc ca cc hnh ng c thc hin gii quyt cc ri ro v c hi;
f) Kt qu hot ng ca cc nh cung cp bn ngoi;
g) N hu cu ci tin h thng qun l cht lng
CH THCH Phng php phn tch d liu c th bao gm cc k thut thng k

nh gi ni b

9.2

9.2.1 T chc phi tin hnh nh gi ni b nh k theo k hoch cung cp thng tin
liu h thng qun l cht lng c hay khng:
a) Ph hp vi:
- Y u cu ring ca t chc v h thng qun l cht lng;
- Cc yu cu ca tiu chun ny;
b) C c thc hin v duy tr mt cch hiu lc
9.2.2 T chc phi :
a) Lp k hoch, thit lp, thc hin v duy tr chng trnh nh gi bao gm tn sut,
phng php, trch nhim, yu cu hoch nh v bo co, phi ch n tm
quan trng ca cc qu trnh c lin quan, cc thay i nh hng n t chc v kt
qu ca cc cuc nh gi trc;
b) Xc nh chun mc nh gi v phm vi cho mi cuc nh gi;
c) La chn chuyn gia nh gi v tin hnh nh gi m bo tnh khch quan v
cng bng ca qu trnh nh gi;
d) m bo cc kt qu nh gi c bo co cho cp qun l c lin quan;
e) Thc hin khc phc v hnh ng khc phc thch hp khng chm tr;
f) Lu gi thng tin dng vn bn nh bng chng v thc hin cc chng trnh nh
gi v kt qu nh gi.
CH THCH Xem hng dn ca ISO 19011.
9.3 Xem xt ca lnh o
9.3.1

Khi qut
Lnh o cao nht phi nh k xem xt h thng qun l cht lng, m bo

n lun thch hp, y , v c hiu lc v s lin kt ca n vi nh hng chin lc ca

t chc.
9.3.2

u vo ca vic xem xt lnh o

Xem xt ca lnh o ph i c lp k hoch v thc hin c tnh n:

ISO 9001:2015

a) Tnh trng cc hnh ng t cuc xem xt ca lnh o ln trc;

b) Nhng thay i trong cc vn bn ngoi v ni b c lin quan n h thng qun l
cht lng;
c) Thng tin v kt qu hot ng v tnh hiu lc ca h thng qun l cht lng, bao
gm xu hng v:
1. S tha mn ca khch hng v phn hi t cc bn hu quan;
2. Mc m cc mc tiu cht lng p ng;
3. Kt qu hot ng v s ph hp ca sn phm v dch v;
4. S khng ph hp v cc hnh ng khc phc;
5. Cc kt qu theo di v o lng;
6. cc kt qu nh gi;
7. kt qu hot ng ca nh cung cp bn ngoi;
d) Ngun lc y ;
e) Tnh hiu lc ca cc hnh ng c thc hin gii quyt ri ro v c hi (xem 6.1)
f) C hi ci tin
9.3.2

u ra ca vic xem xt lnh o

u ra ca vic xem xt ca lnh o phi bao gm cc quyt nh v hnh ng lin

quan n:
a) Cc c hi ci tin;
b) Mi nhu cu thay i n h thng qun l cht lng;
c) Nhu cu v ngun lc.
T chc phi lu gi thng tin dng vn bn nh l bng chng v kt qu xem xt
ca lnh o
10.1

Khi qut
T chc phi xc nh v la chn c hi ci tin v thc hin mi hnh ng cn

thit p ng yu cu ca khch hng v nng cao s tha mn ca khch hng.

iu ny phi bao gm:
a) Ci tin sn phm v dch v p ng cc yu cu cng nh gii quyt nhu cu
v mong i trong tng lai;
b) Khc phc, phng nga hoc gim tc ng khng mong mun;
c) Ci tin kt qu hot ng v tnh hiu lc ca h thng qun l cht lng
CH THCH V d: ci tin c th bao gm khc phc (sa sai), hnh ng khc phc, ci tin
lin tc, thay i mang tnh t ph, i mi v ti t chc

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10.2 S khng ph hp v hnh ng khc phc

10.2.1 Khi xy ra s khng ph hp, bao gm c s khng ph hp ny sinh t khiu ni,
t chc phi:
a) Tc ng li vi s khng ph hp, v khi c th:
- Thc hin hnh ng kim sot v sa cha s khng ph hp;
- ng ph vi cc hu qu;
b) nh gi nhu cu thc hin cc hnh ng loi b nguyn nhn ca s khng ph
hp, khng ti din hay xy ra nhng ni khc, bng cch:
- Xem xt v phn tch s khng ph hp;
- Xc nh nguyn nhn ca s khng ph hp;
- Xc nh liu hin hu s khng ph hp tng t, hoc c kh nng xy ra;
c) Thc hin mi hnh ng cn thit;
d) Xem xt tnh hiu lc ca mi hnh ng khc phc c thc hin;
e) Cp nht ri ro v c hi xc nh trong hoch nh, nu cn thit;
f) Tin hnh thay i h thng qun l cht lng, nu cn thit.
Hnh ng khc phc ph i tng ng vi tc ng ca s khng ph hp gp phi
10.2.2 T chc phi lu gi thng tin dng vn bn nh l bng chng v:
a) Tnh cht ca s khng ph hp v mi hnh ng c thc hin tip theo;
b) Kt qu ca bt k hnh ng khc phc
10.3 Ci tin thng xuyn
T chc phi ci tin thng xuyn s ph hp, y v hiu lc ca h thng qun
l cht lng.
T chc phi xem xt cc kt qu phn tch v nh gi, v cc kt qu t xem xt
ca lnh o, xc nh liu c nhu cu hay cc c hi phi c gii quyt nh mt
phn ca ci tin thng xuyn