Tcvn

Tiu chun vit nam

Tcvn iso 9001:2000

Sot xt ln 2

H thng qun l cht lng - cc yu cu

H ni - 2000

Mc lc
1 1.1 1.2 2 3 4 4.1 4.2 5 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 7.4 7.5 7.6 8 8.1 8.2 8.3 8.4 8.5 A B Phm vi Khi qut p dng Tiu chun trch dn Thut ng v nh ngha H thng qun l cht lng Cc yu cu chung Yu cu v h thng ti liu Trch nhim ca lnh o Cam kt ca lnh o Hng vo khch hng Chnh sch cht lng Hoch nh Trch nhim quyn hn v trao i thng tin Xem xt ca lnh o Qun l ngun lc Cung cp ngun lc Ngun nhn lc C s h tng Mi trng lm vic To sn phm Hoch nh vic to sn phm Cc qu trnh lin quan n khch hng Thit k v pht trin Mua hng Sn xut v cung cp dch v Kim sot phng tin theo di v o lng o lng, phn tch v ci tin Khi qut Theo di v o lng Kim sot sn phm khng ph hp Phn tch d liu Ci tin Tng ng gia ISO 9001:2000 v ISO 14001:1994 Tng ng gia ISO 9001:2000 v ISO 9001:1994

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1 1 1 1 1 1 1 2 3 3 3 3 4 4 4 5 5 5 5 5 5 5 6 7 8 8 9 10 10 10 11 12 12 13 17 21

Ph lc

Ti liu tham kho

Li ni u
TCVN ISO 9001:2000 thay th TCVN ISO 9001:1996 (ISO 9001:1994); TCVN ISO 9002:1996 (ISO 9002:1994); TCVN ISO 9003:1996 ( ISO 9003:1994). TCVN ISO 9001:2000 hon ton tng ng vi ISO 9001:2000. TCVN ISO 9001:2000 do Ban k thut Tiu chun TCVN/TC 176 Qun l cht lng v m bo cht lng bin son, Tng cc Tiu chun o lng Cht lng ngh, B Khoa hc, Cng ngh v Mi trng ban hnh.

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Li gii thiu
0.1 Khi qut Vic chp nhn mt h thng qun l cht lng cn l mt quyt nh chin lc ca t chc. Vic thit k v p dng h thng qun l cht lng ca mt t chc ph thuc vo cc nhu cu khc nhau, cc mc tiu ring bit, cc sn phm cung cp, cc qu trnh c s dng, quy m v cu trc 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 qui 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 bn ngoi t chc, k c cc t chc chng nhn, nh gi kh nng p ng cc yu cu ca khch hng v cc yu cu ch nh v yu cu ring ca mt t chc. Cc nguyn tc qun l cht lng nu trong TCVN ISO 9000 v TCVN ISO 9004 c xem xt khi xy dng tiu chun ny. 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 nng cao hiu lc ca h thng qun l cht lng, nhm tho mn khch hng qua vic p ng yu cu ca h. vn hnh mt cch c hiu lc, t chc phi xc nh v qun l nhiu hot ng c lin h mt thit vi nhau. Bt c hot ng no 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 s 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 cc tng tc gia cc qu trnh nh vy, v s qun l chng, c th c coi nh cch tip cn theo qu trnh. u th ca cch tip cn theo qu trnh l s kim sot cng vic ang din ra, vic kim sot ny bao trm s kt ni cc qu trnh n l trong h thng cc qu trnh, cng nh bao trm c 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: a- vic hiu v p ng cc yu cu, b- nhu cu xem xt qu trnh trong vn gi tr gia tng, c- c c kt qu v tnh hiu lc v hiu qu ca qu trnh, v d- ci tin lin tc qu trnh trn c s o lng i tng. M hnh h thng qun l cht lng da trn qu trnh nu s 1 minh ho s kt ni ca qu trnh c trnh by trong iu 4 n iu 8. M hnh ny tha nhn rng khch hng ng mt vai tr quan trng trong vic xc nh cc yu cu 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 liu

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cc yu cu ca khch hng c c p ng 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 - Ngoi ra, 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 giao cc kt qu ph hp vi cc yu cu ca khch hng v chnh sch ca t chc. Thc hin: Kim tra: Thc hin cc qu trnh Theo di v o 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 kt qu hot ng ca qu trnh.

Ci tin lin tc h thng qun l cht lng

Trch nhim ca lnh o

Khch hng

Khch hng

Qun l

ngun lc

o lng, phn tch v ci tin

Tho mn

Yu cu

u vo

To sn

u ra Sn h

Ghi ch Hot ng gia tng gi tr Dng thng tin

Hnh 1 - M hnh v mt h thng qun l cht lng da trn qu trnh

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0.3 Mi quan h vi TCVN/ISO 9004

n bn ny ca TCVN ISO 9001 v TCVN ISO 9004 c xy dng nh l mt cp thng nht cc tiu chun v h thng qun l cht lng. Hai tiu chun ny c thit k s dng ng thi, nhng cng c th c s dng mt cch c lp. Mc d hai tiu chun ny c phm vi khc nhau, nhng chng c cu trc tng t thun tin cho vic s dng nh mt cp thng nht. TCVN ISO 9001 qui nh cc yu cu i vi mt h thng qun l cht lng, c th c s dng trong ni b t chc s dng, cho vic chng nhn hoc cho cc mc ch hp ng. Tiu chun tp trung vo hiu qu ca h thng qun l cht lng trong vic tho mn yu cu khch hng.

0.4 S tng thch vi cc h thng qun l khc

Tiu chun ny c lin kt vi TCVN ISO 14001:1996 nhm tng tng thch ca hai tiu chun i vi li ch ca cng ng ngi s dng. 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 v ri ro. Tuy nhin, tiu chun ny gip t chc ho hp v hp nht h thng qun l ca mnh vi cc yu cu ca cc h thng qun l c lin quan. iu ny lm cho 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.

TCVN ISO 9001:2000

H thng qun l cht lng - Cc yu cu

1 1.1
a) b)

Phm vi Khi qut

cn chng t kh nng cung cp mt cch n nh sn phm p ng cc yu cu ca khch hng v cc yu cu ch nh thch hp; nhm nng cao s tha mn ca khch hng thng qua vic p dng c hiu lc h thng ny, 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 v yu cu ch nh c p dng.

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

Ch thch: Trong tiu chun ny, thut ng "sn phm" ch p dng cho sn phm nhm cho khch hng hoc khch hng yu cu.

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 yu cu no ca tiu chun ny khng th p dng c do bn cht ca t chc v sn phm ca mnh, c th xem xt yu cu ny nh mt ngoi l. Khi c ngoi l, vic c cng b ph hp vi tiu chun ny khng c chp nhn tr phi cc ngoi l ny c gii hn trong phm vi iu 7, v cc ngoi l ny khng nh hng n kh nng hay trch nhim ca t chc trong vic cung cp cc sn phm p ng cc yu cu ca khch hng v cc yu cu thch hp.

2 3

Tiu chun trch dn Thut ng v nh ngha

TCVN ISO 9000:2000, H thng qun l cht lng - C s v t vng.

Tiu chun ny s dng cc thut ng v nh ngha trong TCVN ISO 9000:2000. Cc thut ng sau, c s dng trong n bn ny ca TCVN ISO 9001 m t chui cung cp, c thay i phn nh t vng c s dng hin hnh: ngi cung ng t chc khch hng Thut ng "t chc" thay th cho thut ng "ngi cung ng" c s dng trc y trong TCVN ISO 9001:1996 (ISO 9001:1994) ch n v p dng tiu chun ny. Thut ng "ngi cung ng" lc ny c s dng thay cho thut ng "ngi thu ph". Trong tiu chun ny, thut ng "sn phm" cng c ngha "dch v".

4 4.1

H thng qun l cht lng Yu cu chung

T chc phi xy dng, lp vn bn, thc hin, duy tr h thng qun l cht lng v thng xuyn nng cao hiu lc ca h thng theo cc yu cu ca tiu chun ny.

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Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

T chc phi: a) b) c) d) e) f) nhn bit cc qu trnh cn thit trong h thng qun l cht lng v p dng chng trong ton b t chc (xem 1.2), 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 vic tc nghip v kim sot cc qu trnh ny c hiu lc, m bo s sn c ca cc ngun lc v thng tin cn thit h tr hot ng tc nghip v theo di cc qu trnh ny, o lng, theo di 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 trnh ny. T chc phi qun l cc qu trnh tun th theo cc yu cu ca tiu chun ny. 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 . Vic kim sot nhng qu trnh do ngun bn ngoi phi c nhn bit trong h thng qun l cht lng.
Ch thch - Cc qu trnh cn thit i vi h thng qun l cht lng nu trn cn bao gm c cc qu trnh v cc hot ng qun l, cung cp ngun lc, to sn phm v o lng.

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) b) c) d) e) cc vn bn cng b v chnh sch cht lng v mc tiu cht lng, s tay cht lng, cc th tc dng vn bn theo yu cu ca tiu chun ny, cc ti liu cn c ca t chc m bo vic hoch nh, tc nghip v kim sot c hiu lc cc qu trnh ca t chc , v cc h s theo yu cu ca tiu chun ny (xem 4.2.4)
dng, lp thnh vn bn, thc hin v duy tr. Ch thch 2 - Mc vn bn ha 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 ca con ngi. Ch thch 3 - H thng ti liu c th bt k dng hoc loi phng tin truyn thng no. Ch thch 1 - Khi thut ng "th tc dng vn bn" xut hin trong tiu chun ny, th th tc phi c xy

4.2.2 S tay cht lng

T chc phi lp v duy tr s tay cht lng trong bao gm: a) b) c) 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), cc th tc dng vn bn c thit lp cho h thng qun l cht lng hoc vin dn n chng v, m t s tng tc gia cc qu trnh trong h thng qun l cht lng.

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Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

4.2.3 Kim sot ti liu

Cc ti liu theo yu cu 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. Phi lp mt th tc dng vn bn xc nh vic kim sot cn thit nhm: a) b) c) d) e) f) g) ph duyt ti liu v s tho ng trc khi ban hnh, xem xt, cp nht khi cn v ph duyt li ti liu, m bo nhn bit c cc thay i v tnh trng sa i hin hnh ca ti liu, m bo cc bn ca cc ti liu thch hp sn c ni s dng, m bo ti liu lun r rng, d nhn bit, m bo cc ti liu c ngun gc bn ngoi c nhn bit v vic phn phi chng c kim sot v ngn nga vic s dng v tnh cc ti liu li thi v p dng cc du hiu nhn bit thch hp nu chng c gi li v mc ch no .

4.2.4 Kim sot h s

Phi lp v duy tr cc h s cung cp bng chng v s ph hp vi cc yu cu v hot ng tc nghip c hiu lc ca h thng qun l cht lng. Cc h s cht lng phi r rng, d nhn bit v d s dng. Phi lp mt th tc bng vn bn xc nh vic kim sot cn thit i vi vic nhn bit, bo qun, bo v, s dng, xc nh thi gian lu gi v hu b cc h s cht lng.

5 5.1

Trch nhim ca lnh o 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 thng xuyn hiu lc ca h thng bng cch a) truyn t cho t chc v tm quan trng ca vic p ng khch hng cng nh cc yu cu ca php lut 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.

5.2

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 tha mn khch hng (xem 7.2.1 v 8.2.1)

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 thng xuyn hiu lc ca h thng qun l cht lng, 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 lun thch hp.

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Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

5.4

Hoch nh

5.4.1 Mc tiu cht lng

Lnh o cao nht phi m bo rng 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 mi cp v tng b phn chc nng thch hp trong t chc. Mc tiu cht lng phi o c v nht qun vi chnh sch 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 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

Lnh o cao nht phi m bo cc trch nhim, quyn hn v mi quan h ca chng c xc nh v thng bo trong t chc.

5.5.2 i din ca lnh o

Lnh o cao nht phi ch nh mt thnh vin trong ban lnh o, ngoi cc trch nhim khc, c trch nhim v quyn hn bao gm 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.

5.5.3 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

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 c hi ci tin v nhu cu thay i i vi h thng qun l cht lng ca t chc, 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)

5.6.2 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.
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Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

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 nng cao tnh hiu lc ca h thng qun l cht lng v ci tin cc qu trnh ca h thng, b) vic ci tin cc sn phm lin quan n yu cu ca khch hng, v c) nhu cu v ngun lc .

6 6.1

Qun l ngun lc 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 v thng xuyn nng cao hiu lc ca h thng , v b) tng s tha mn khch hng bng cch p ng cc yu cu ca khch hng.

6.2

Ngun nhn lc

6.2.1 Khi qut

Nhng ngi thc hin cc cng vic nh hng n cht lng sn phm phi c nng lc trn c s c gio dc, o to, c k nng v kinh nghim thch hp.

6.2.2 Nng lc, nhn thc v o to

T chc phi a) xc nh nng lc cn thit ca nhng ngi thc hin cc cng vic nh hng n cht lng sn phm, b) tin hnh o to hay nhng hnh ng khc p ng cc nhu cu ny, c) nh gi hiu lc ca cc hnh ng c thc hin, d) m bo rng ngi lao ng 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 chuyn mn (xem 4.2.4).

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 i vi cc yu cu v 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 (c phn cng v phn mm) v c) dch v h tr (nh vn chuyn hoc trao i thng tin).

6.4

Mi trng lm vic

T chc phi xc nh v qun l mi trng lm vc cn thit t c s ph hp i vi cc yu cu ca sn phm.

7 7.1

To sn phm 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:

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Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

a) b) c) d)

cc mc tiu cht lng v cc yu cu i vi sn phm; nhu cu thit lp cc qu trnh, ti liu v vic cung cp cc ngun lc c th i vi sn phm; cc hot ng kim tra xc nhn, xc nhn gi tr s dng, cc hot ng theo di, kim tra v th nghim c th cn thit i vi sn phm v cc chun mc chp nhn sn phm; 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 qui 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 phi p dng cc yu cu nu trong 7.3 trin khai qu trnh to 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) b) c) d) yu cu do khch hng a ra, gm c cc yu cu v cc hot ng giao hng v sau giao hng; yu cu khng c khch hng cng b nhng cn thit cho vic s dng c th hoc s dng d kin khi bit; yu cu ch nh v php lut lin quan n sn phm, v mi yu cu b sung do t chc xc nh.

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) b) yu cu v sn phm c nh r; cc yu cu trong hp ng hoc n t hng khc vi nhng g nu trc phi c gii quyt; v t chc c kh nng p ng cc yu cu nh.

c)

Phi duy tr h s cc kt qu ca vic xem xt v cc hnh ng ny sinh t vic xem xt (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. Khi yu cu v sn phm thay i, t chc phi m bo rng cc vn bn tng ng 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 thch hp v sn phm nh danh mc cho hng hay ti liu qung co.

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;

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Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

b) c)

x l cc yu cu, hp ng hoc n t hng, k c cc sa i, v phn hi ca khch hng, k c cc khiu ni.

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.

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 ch nh v lut php thch hp, c) thng tin c th p dng nhn c t cc thit k tng t trc , v d) cc yu cu khc ct yu cho thit k v pht trin. Nhng u vo ny phi c xem xt v s thch ng. Nhng yu cu ny phi y , khng m h v khng mu thun vi nhau.

7.3.3 u ra ca thit k v pht trin

u ra ca thit k v pht trin phi dng sao cho c th 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) b) c) d) p ng cc yu cu u vo ca thit k v pht trin, cung cp cc thng tin thch hp cho vic mua hng, sn xut v cung cp dch v, bao gm hoc vin dn ti cc chun mc chp nhn ca sn phm, v xc nh cc c tnh ct yu cho an ton v s dng ng ca sn phm.

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 a) b) nh gi kh nng p ng cc yu cu ca cc kt qu thit k v pht trin, v nhn bit mi vn trc trc v xut cc hnh ng cn thit.

Nhng ngi tham d 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).

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 duy tr mi hot ng cn thit (xem 4.2.4).

7
Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

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) bo m rng sn phm to ra c kh nng p ng cc yu cu s dng d kin hay cc ng dng qui 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)

7.3.7 Kim sot thay i thit k v pht trin

Nhng thay i ca thit k v pht trin phi c nhn 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).

7.4

Mua hng

7.4.1 Qu trnh mua hng

T chc phi m bo sn phm mua vo ph hp vi cc yu cu mua sn phm qui nh. Cch thc v mc kim sot p dng cho ngi 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 chun mc 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).

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 tho ng ca cc yu cu mua hng qui nh trc khi thng bo cho ngi cung ng.

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 qui nh. Khi t chc hoc khch hng c nh thc hin cc hot ng kim tra xc nhn ti c s ca nh cung ng, t chc phi cng b vic sp xp kim tra xc nhn d kin v phng php thng qua sn phm trong cc thng tin mua hng.

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 cc 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 phng tin theo di v o lng, e) thc hin vic o lng v theo di, v f) thc hin cc hot ng thng qua, giao hng v cc hot ng sau giao hng.
8
Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

7.5.2 Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v

T chc phi xc nhn gi tr s dng i vi 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 . iu ny bao gm mi qu trnh m s 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 , khi c th, t chc phi sp xp nhng iu sau: a) b) c) d) e) cc chun mc nh xem xt v ph duyt cc qu trnh, ph duyt thit b v trnh con ngi, s dng cc phng php v th tc c th, cc yu cu v h s (xem 4.2.4); v ti xc nhn gi tr s dng.

7.5.3 Nhn bit v xc nh ngun gc

Khi cn thit, 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 T chc phi kim sot v lu h s vic nhn bit duy nht sn phm khi vic xc nh ngun gc l mt yu cu (xem 4.2.4).
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.

7.5.4 Ti sn ca khch hng

T chc phi gn gi 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. Bt k ti sn no ca khch hng b mt mt, h hng hoc c pht hin khng ph hp cho vic s dng u phi c thng bo cho khch hng v cc h s phi c duy tr (xem 4.2.4).
Ch thch - Ti sn khch hng c th bao gm c s hu tr tu.

7.5.5 Bo ton sn phm

T chc phi bo ton s ph hp ca sn phm trong sut cc qu trnh ni b v giao hng n v tr nh. Vic bo ton ny phi bao gm nhn bit, xp d (di chuyn), bao gi, lu gi, bo qun. Vic bo ton cng phi p dng vi cc b phn cu thnh ca sn phm .

7.6

Kim sot phng tin theo di v o lng

T chc phi xc nh vic theo di v o lng cn thc hin v cc phng tin theo di v o lng cn thit cung cp bng chng v s ph hp ca sn phm vi cc yu cu xc nh (xem 7.2.1).

9
Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

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 thit m bo kt qu ng, thit b o lng phi a) c hiu chun hoc kim tra xc nhn nh k, hoc trc khi s dng, da trn cc chun o lng c lin kt c 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; b) c) d) e) c hiu chnh hoc hiu chnh li, khi cn thit; c nhn bit gip xc nh trng thi hiu chun; c gi gn trnh b hiu chnh lm mt tnh ng n ca cc kt qu o; 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 cc 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) ca cc kt qu hiu chun v kim tra xc nhn. Khi s dng phn mm my tnh theo di v o lng cc yu cu qui nh, phi khng nh kh nng tha mn vic p dng nhm ti ca chng. Vic ny phi c tin hnh trc ln s dng u tin v c xc nhn li khi cn thit.
Ch thch - Xem hng dn trong ISO 10012-1 v ISO 10012-2

8 8.1
a) b) c)

o lng, phn tch v ci tin Khi qut

T chc phi hoch nh v trin khai cc qu trnh theo di, o lng, phn tch v ci tin cn thit

chng t s ph hp ca sn phm, m bo s ph hp ca h thng qun l cht lng, v thng xuyn nng cao tnh 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 ca chng.

8.2

Theo di v o lng

8.2.1 S tha mn ca khch hng

T chc phi theo di cc thng tin v 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.

8.2.2 nh gi ni b
T chc phi tin hnh nh gi ni b nh k theo k hoch xc nh xem 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 cht lng c t chc thit lp, v
10
Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

b) c c p dng mt cch hiu lc v c duy tr 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 v t ca qu trnh nh gi. Cc chuyn gia nh gi khng c nh gi cng vic ca mnh. Trch nhim v cc yu cu v vic hoch nh v tin hnh cc nh gi, v vic bo co kt qu v duy tr h s (xem 4.2.4) phi c xc nh trong mt th tc dng vn bn. Lnh o chu trch nhim v khu vc c nh gi phi m bo tin hnh khng chm tr cc hnh ng loi b s khng ph hp c pht hin trong khi nh gi v nguyn nhn ca chng. Cc hnh 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 10011-1, ISO 10011-2 v ISO 10011-3

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 mt cch thch hp m bo s ph hp ca 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 phm c p ng. Vic ny phi c tin hnh ti nhng giai on thch hp ca qu trnh to sn phm theo cc sp xp hoch nh (xem 7.1). Bng chng ca s ph hp vi cc chun mc chp nhn phi c duy tr. H s phi ch ra ngi c quyn hn trong vic thng qua sn phm (xem 4.2.4). Ch c thng qua sn phm v chuyn giao dch v khi hon thnh tho ng cc hot ng theo hoch nh (xem 7.1), nu khng phi c s ph duyt ca ngi c thm quyn v, nu c th, ca khch hng.

8.3

Kim sot sn phm khng ph hp

T chc phi m bo rng sn phm khng ph hp vi cc yu cu c nhn bit v kim sot phng nga vic s dng hoc chuyn giao v tnh. Phi xc nh trong mt th tc dng vn bn vic kim sot, cc trch nhim v quyn hn c lin quan i vi sn phm khng ph hp. T chc phi x l sn phm khng ph hp bng mt hoc mt s cch sau: a) b) c) tin hnh loi b s khng ph hp c pht hin; cho php s dng, thng qua hoc chp nhn s nhn nhng bi ngi c thm quyn v, khi c th, bi khch hng; tin hnh loi b khi vic s dng hoc p dng d kin ban u. Phi duy tr h s (xem 4.2.4) v bn cht cc s khng ph hp v bt k hnh ng tip theo no c tin hnh, k c cc nhn nhng c c. 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.

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Ghi ch: nh my li t TCVN ISO 9001:2000

TCVN ISO 9001:2000

Khi sn phm khng ph hp c pht hin sau khi chuyn giao hoc bt u s dng, t chc phi c cc hnh ng thch hp i vi cc tc ng hoc hu qu tim n ca s khng ph hp.

8.4

Phn tch d liu

T chc phi xc nh, thu thp v phn tch cc d liu tng ng chng t s thch hp v tnh hiu lc ca h thng qun l cht lng v nh gi xem s ci tin thng xuyn hiu lc ca h thng 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) b) c) s tha mn khch hng (xem 8.2.1); s ph hp vi cc yu cu v sn phm (xem 7.2.1); c tnh v xu hng ca cc qu trnh v sn phm, k c cc c hi cho hnh ng phng nga, v d) ngi cung ng.

8.5

Ci tin

8.5.1 Ci tin thng xuyn

T chc phi thng xuyn nng cao tnh 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, vic phn tch d liu, hnh ng khc phc v phng nga v s xem xt ca lnh o.

8.5.2 Hnh ng khc phc

T chc phi thc hin hnh ng nhm loi b nguyn nhn ca s khng ph hp ngn nga s 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 v a) b) c) d) e) f) vic xem xt s khng ph hp (k c cc khiu ni ca khch hng), vic xc nh nguyn nhn ca s khng ph hp, vic nh gi cn c cc hnh ng m bo rng s khng ph hp khng ti din, vic xc nh v thc hin cc hnh ng cn thit, vic lu h s cc kt qu ca hnh ng c thc hin (xem 4.2.4), v vic xem xt cc hnh ng khc phc thc hin.

8.5.3 Hnh ng phng nga

T chc phi xc nh cc 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) b) c) d) e) vic xc nh s khng ph hp tim n v cc nguyn nhn ca chng, vic nh gi nhu cu thc hin cc hnh ng phng nga vic xut hin s khng ph hp, vic xc nh v thc hin cc hnh ng cn thit, h s cc kt qu ca hnh ng c thc hin (xem 4.2.4), v vic xem xt cc hnh ng phng nga c thc hin.
12
Ghi ch: nh my li t TCVN ISO 9001:2000

Ph lc A
(tham kho)

Tng ng gia tcvn iso 9001:2000 v tcvn iso 14001:1996

Bng A.1 Tng ng gia tcvn iso 9001:2000 v tcvn iso 14001:1996
Tcvn iso 9001:2000 Li gii thiu Khi qut Cch tip cn theo qu trnh Quan h vi TCVN ISO 9004 S tng thch vi cc h thng qun l khc Phm vi Khi qut p dng Tiu chun vin dn Thut ng v nh ngha H thng qun l cht lng Yu cu chung Yu cu v h thng ti liu Khi qut S tay cht lng Kim sot ti liu Kim sot h s Trch nhim ca lnh o Cam kt ca lnh o Hng vo khch hng Chnh sch cht lng Hoch nh Mc tiu cht lng Hoch nh h thng qun l cht lng Trch nhim, quyn hn v trao i thng tin Trch nhim v quyn hn i din ca lnh o Trao i thng tin ni b Xem xt ca lnh o Khi qut u vo ca vic xem xt u ra ca vic xem xt Qun l ngun lc Cung cp ngun lc Ngun nhn lc (ch c tiu ) Khi qut Nng lc nhn thc v o to C s h tng Mi trng lm vic tcvn iso 14001:1996 Gii thiu 0.1 0.2 0.3 0.4 1 1.1 1.2 2 3 4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 5 5.1 5.2 5.3 5.4 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3 6 6.1 6.2 6.2.1 6.2.2 6.3 6.4
13

Phm vi

2 3 4 4.1 4.4.4 4.4.4 4.4.5 4.5.3 4.4.1 4.2 4.4.1 4.3.1 4.3.2 4.2 4.3 4.3.3 4.3.4 4.1 4.4.1 4.4.3 4.6

Tiu chun trch dn nh ngha Cc yu cu ca H thng qun l mi trng Cc yu cu chung T liu ca h thng qun l mi trng T liu ca h thng qun l mi trng Kim sot ti liu H s C cu v trch nhim Chnh sch mi trng C cu v trch nhim Kha cnh mi trng Yu cu v php lut v yu cu khc Chnh sch mi trng Lp k hoch Mc tiu v ch tiu Chng trnh qun l mi trng Cc yu cu chung C cu v trch nhim Thng tin lin lc Xem xt li ca ban lnh o

4.4.1

C cu v trch nhim

4.4.2 4.4.1

o to, nhn thc v nng lc C cu v trch nhim

Bng A.1 Tng ng gia tcvn iso 9001:2000 v tcvn iso 14001:1996 (kt thc)
Tcvn iso 9001:2000 To sn phm Hoch nh vic to sn phm Cc qu trnh lin quan n khch hng Xc nh cc yu cu lin quan n sn phm tcvn iso 14001:1996 Thc hin v iu hnh Kim sot iu hnh Kim sot iu hnh

7 7.1 7.2 7.2.1

4.4 4.4.6 4.4.6 4.3.1 4.3.2 4.4.6 4.4.6 4.3.1 4.4.3 4.4.6

Xem xt cc yu cu lin quan n sn phm Trao i thng tin vi khch hng Thit k v pht trin Hoch nh thit k v pht trin u vo ca thit k v pht trin u ra ca thit k v pht trin Xem xt thit k v pht trin Kim tra xc nhn thit k v pht trin Xc nhn gi tr s dng ca thit k v pht trin Kim sot thay i thit k v pht trin Mua hng Qu trnh mua hng Thng tin mua hng Kim tra xc nhn sn phm mua vo Sn xut v cung cp dch v Kim sot sn xut v cung cp dch v Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v Nhn bit v xc nh ngun gc Ti sn ca khch hng Bo ton sn phm Kim sot phng tin theo di v o lng o lng, phn tch v ci tin Khi qut Theo di v o lng S tho mn ca khch hng nh gi ni b Theo di v o lng cc qu trnh Theo di v o lng sn phm Kim sot sn phm khng ph hp

7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4 7.4.1 7.4.2 7.4.3 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 8 8.1 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.3

Kim sot iu hnh Kim sot iu hnh

Kim sot iu hnh

4.4.6

Kim sot iu hnh

4.4.6

Kim sot iu hnh

4.5.1 4.5 4.5.1

Gim st (monotoring) v o Kim tra v hnh ng khc phc Gim st (monotoring) v o

4.5.4 4.5.1 4.5.2 4.4.7

nh gi h thng qun l mi trng Gim st (monotoring) v o S khng ph hp v hnh ng khc phc, phng nga S chun b sn sng v p ng vi tnh trng khn cp Gim st (monotoring) v o Chnh sch mi trng Chng trnh qun l mi trng S khng ph hp v hnh ng khc phc, phng nga

Phn tch d liu Ci tin Ci tin thng xuyn Hnh ng khc phc Hnh ng phng nga

8.4 8.5 8.5.1 8.5.2 8.5.3

4.5.1 4.2 4.3.4 4.5.2

14

Bng A.2: Tng ng gia TCVN ISO 14001:1996 v TCVN ISO 9001:2000

Tcvn iso 14001:1996 0 0.1 0.2 0.3 0.4 Phm vi 1 1 1.1 1.2 2 3 4 4.1 5.5 5.5.1 5.1 5.3 8.5 5.4 5.2 7.2.1 7.2.2 Yu cu v php lut v yu cu khc 4.3.2 5.2 7.2.1 5.4.1 5.4.2 8.5.1 7 7.1 5 5.1 5.5.1 5.5.2 6 6.1 6.2 6.2.1 6.3 6.4 6.2.2 5.5.3 7.2.3 4.2 4.2.1 4.2.2
15

Tiu chun trch dn nh ngha Cc yu cu ca H thng qun l mi trng Cc yu cu chung

2 3 4 4.1

Tcvn iso 9001:2000 M u Khi qut Cch tip cn theo qu trnh Quan h vi TCVN ISO 9004 S tng thch vi cc h thng qun l khc Phm vi Khi qut p dng Tiu chun vin dn Thut ng v nh ngha H thng qun l cht lng Yu cu chung Trch nhim, quyn hn v trao i thng tin Trch nhim v quyn hn Cam kt ca lnh o Chnh sch cht lng Ci tin Hoch nh Hng vo khch hng Xc nh cc yu cu lin quan n sn phm Xem xt cc yu cu lin quan n sn phm Hng vo khch hng Xc nh cc yu cu lin quan n sn phm Mc tiu cht lng Hoch nh h thng qun l cht lng To sn phm Hoch nh vic to sn phm Trch nhim ca lnh o Cam kt ca lnh o Trch nhim v quyn hn i din ca lnh o Qun l ngun lc Cung cp cc ngun lc Ngun nhn lc Khi qut C s h tng Mi trng lm vic Nng lc, nhn thc v o to Trao i thng tin ni b Trao i thng tin vi khch hng Yu cu v h thng ti liu Khi qut S tay cht lng

Chnh sch mi trng

4.2

Lp k hoch Kha cnh mi trng

4.3 4.3.1

Mc tiu v ch tiu Chng trnh qun l mi trng Thc hin v iu hnh C cu v trch nhim

4.3.3 4.3.4 4.4 4.4.1

o to, nhn thc v nng lc Thng tin lin lc T liu ca h thng qun l mi trng

4.4.2 4.4.3 4.4.4

Bng A.2: Tng ng gia TCVN ISO 14001:1996 v TCVN ISO 9001:2000 (kt thc)
Iso 14001:1996 Kim sot ti liu Kim sot iu hnh Iso 9001:2000 Kim sot ti liu To sn phm Hoch nh vic to sn phm Cc qu trnh lin quan n khch hng Xc nh cc yu cu lin quan n khch hng Xem xt cc yu cu lin quan n khch hng Thit k v pht trin Hoch nh thit k v pht trin u vo ca thit k v pht trin u ra ca thit k v pht trin Xem xt thit k v pht trin Kim tra xc nhn thit k v pht trin Xc nhn gi tr s dng ca thit k v pht trin Kim sot thay i thit k v pht trin Mua hng Qu trnh mua hng Thng tin mua hng Kim tra xc nhn sn phm mua vo Sn xut v cung cp dch v Kim sot sn xut v cung cp dch v Nhn bit v xc nh ngun gc Ti sn ca khch hng Bo ton sn phm Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v

4.4.5 4.4.6

4.2.3 7 7.1 7.2 7.2.1 7.2.2 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4 7.4.1 7.4.2 7.4.3 7.5 7.5.1 7.5.3 7.5.4 7.5.5 7.5.2

S chun b sn sng v p ng vi tnh trng khn cp Kim tra v hnh ng khc phc Gim st (monitoring) v o

4.4.7 4.5 4.5.1

8.3 8 7.6 8.1 8.2 8.2.1 8.2.3 8.2.4 8.4 8.3 8.5.2 8.5.3 4.2.4 8.2.2 5.6 5.6.1 5.6.2 5.6.3
16

o lng, phn tch v ci tin Khi qut Theo di v o lng S tho mn ca khch hng Theo di v o lng cc qu trnh Theo di v o lng sn phm Phn tch d liu Kim sot sn phm khng ph hp Hnh ng khc phc Hnh ng phng nga nh gi ni b Xem xt ca lnh o Khi qut u vo ca vic xem xt u ra ca vic xem xt

H s nh gi h thng qun l mi trng Xem xt li ca ban lnh o

4.5.3 4.5.4 4.6

ph lc B
(Tham kho)

Tng ng gia tcvn iso 9001:2000 v tcvn iso 9001:1994

Bng B.1: Tng ng gia TCVN ISO 9001:1994 v TCVN ISO 9001:2000
TCVN ISO 9001:1994 1. Phm vi 2. Tiu chun trch dn 3. nh ngha 4. Cc yu cu ca h thng cht lng (ch c tiu ) 4.1 Trch nhim ca lnh o (ch c tiu ) 4.1.1 Chnh sch cht lng 4.1.2 T chc (ch c tiu ) 4.1.2.1 Trch nhim v quyn hn 4.1.2.2 Ngun lc 4.1.2.3 i din ca lnh o 4.1.3 Xem xt ca lnh o 4.2 H thng cht lng (ch c tiu ) 4.2.1 Khi qut 4.2.2 Cc th tc ca h thng cht lng 4.2.3 Hoch nh cht lng 4.3 Xem xt hp ng (ch c tiu ) 4.3.1 Khi qut 4.3.2 Xem xt 4.3.3 Sa i hp ng 4.3.4 H s 4.4 Kim sot thit k (ch c tiu ) 4.4.1 Khi qut 4.4.2 Hoch nh thit k v pht trin 4.2.3 Tng giao v t chc v k thut 4.4.4 u vo ca thit k 4.4.5 u ra ca thit k 4..4.6 Xem xt thit k 4.4.7 Kim tra xc nhn thit k 4.4.8 Xc nhn gi tr s dng ca thit k 4.4.9 Sa i thit k 4.5 Kim sot ti liu v d liu (ch c tiu ) 4.5.1 Khi qut 4.5.2 Ph chun v ban hnh ti liu v d liu 4.5.3 Thay i ti liu v d liu 4.2.3 4.2.3 4.2.3 7.3.1 7.3.1 7.2.1 + 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 5.2 + 7.2.1 + 7.2.2 + 7.2.3 7.2.2 7.2.2 4.1 + 4.2.2 4.2.1 5.4.2 + 7.1 5.5.1 6.1 + 6.2.1 5.5.2 5.6.1 + 8.5.1 5.1 + 5.3 + 5.4.1 1 2 3 ISO 9001:2000

17

Bng B.1: Tng ng gia TCVN ISO 9001:1994 v TCVN ISO 9001:2000 (kt thc)
TCVN ISO 9001:1994 4.6 Mua sn phm (ch c tiu ) 4.6.1 Khi qut 4.6.2 nh gi ngi thu ph 4.6.3 D liu mua hng 4.6.4 Kim tra xc nhn sn phm mua 4.7 Kim sot sn phm do khch hng cung cp 4.8 Nhn bit v xc nh ngun gc sn phm 4.9 Kim sot qu trnh 4.10 Kim tra v th nghim (ch c tiu ) 4.10.1 Khi qut 4.10.2 Kim tra v th nghim khi nhn 4.10.3 Kim tra v th nghim trong qu trnh 4.10.4 Kim tra v th nghim cui cng 4.10.5 H s kim tra v th nghim 4.11 Kim sot thit b kim tra, o lng v TN (ch c tiu ) 4.11.1 Khi qut 4.11.2 Kim sot sn phm 4.12 Trng thi kim tra v th nghim 4.13 Kim sot sn phm khng ph hp (ch c tiu ) 4.13.1 Khi qut 4.13.2 Xem xt v thanh l sn phm khng ph hp 4.14 Hnh ng khc phc v phng nga [ch c tiu ] 4.14.1 Khi qut 4.14.2 Hnh ng khc phc 4.14.3 Hnh ng phng nga 4.15 Xp d, lu kho, giao hng (ch c tiu ) 4.15.1 Khi qut 4.15.2 Xp d 4.15.3 Lu kho 4.15.4 Bao b 4.15.5 Bo qun 4.15.6 Giao hng 4.16 Kim sot h s cht lng 4.17 nh gi cht lng ni b 4.18 o to 4.19 Dch v k thut 4.20 K thut thng k (ch c tiu ) 4.20.1 Nhn bit nhu cu 4.20.2 Th tc
18

TCVN ISO 9001:2000

7.4.1 7.4.2 7.4.3 7.5.4 7.5.3 6.3 + 6.4 + 7.5.1 + 7.5.2 7.1 + 8.1 7.4.3 + 8.2.4 8.2.4 8.2.4 7.5.3 + 8.2.4 7.6 7.6 7.5.3 8.3 8.3 8.5.2 + 8.5.3 8.5.2 8.5.3

7.5.5 7.5.5 7.5.5 7.5.5 7.5.1 4.2.4 8.2.2 + 8.2.3 6.2.2 7.5.1 8.1 + 8.2.3 + 8.2.4 + 8.4 8.1 + 8.2.3 + 8.2.4 + 8.4

Bng B2: Tng ng gia TCVN ISO 9001:2000 v TCVN ISO 9001: 1994
TCVN ISO 9001:2000 1 Phm vi 1.1 Khi qut 1.2 ng dng 2 Tiu chun vin dn
3 Thut ng v nh ngha

TCVN ISO 9001:1994 1

2 3 4.2.1 4.2.2 4.2.1 4.5.1 + 4.5.2 + 4.5.3 4.16 4.1.1 4.3.2 4.1.1 4.1.1 4.2.3 4.1.2.1 4.1.2.3

4 H thng qun l cht lng (ch c tiu ) 4.1 Cc yu cu chung 4.2 Cc yu cu chung v ti liu (ch c tiu ) 4.2.1 Khi qut 4.2.2 S tay cht lng 4.2.3 Kim sot ti liu 4.2.4 Kim sot h s cht lng 5 Trch nhim ca lnh o (ch c tiu ) 5.1 Cam kt ca lnh o 5.2 nh hng bi khch hng 5.3 Chnh sch cht lng 5.4 Hoch nh (ch c tiu ) 5.4.1 Mc tiu cht lng 5.4.2 Hoch nh h thng qun l cht lng 5.5 Trch nhim, quyn hn v thng tin lin lc (ch c tiu ) 5.5.1 Trch nhim v quyn hn 5.5.2 i din ca lnh o 5.5.4 Thng tin ni b 5.6 Xem xt ca lnh o (ch c tiu ) 5.6.1 Khi qut 5.6.2 u vo ca xem xt 5.6.3 Kt qu ca xem xt 6 Qun l ngun lc (ch c tiu ) 6.1 Cung cp cc ngun lc 6.2 Ngun nhn lc (ch c tiu ) 6.2.1 Khi qut 6.2.2 ao to, nhn thc v nng lc 6.3 C s vt cht 6.4 Mi trng lm vic 7 To sn phm (ch c tiu ) 7.1 Hoch nh cc qu trnh to sn phm 7.2 Cc qu trnh lin quan n khch hng (ch c tiu ) 7.2.1 Xc nh cc yu cu lin quan n sn phm 7.2.2 Xem xt cc yu cu lin quan n sn phm 7.2.3 Lin lc vi khch hng 7.3 Thit k v pht trin (ch c tiu ) 7.3.1 Hoch nh thit k v pht trin 7.3.2 u vo ca thit k v pht trin
19

4.1.3

4.1.2.2 4.1.2.2 4.18 4.9 4.9 4.2.3 + 4.10.1 4.3.2 + 4.4.4 4.3.2 + 4.3.3 + 4.3.4 4.3.2 4.4.2 + 4.4.3 4.4.4

Bng B.2: Tng ng gia TCVN ISO 9001:2000 v TCVN ISO 9001: 1994 (kt thc)
7.3.3 u ra ca thit k v pht trin 7.3.4 Xem xt thit k v pht trin 7.3.5 Kim tra xc nhn thit k v pht trin 7.3.6 Xc nhn gi tr s dng ca thit k v pht trin 7.3.7 Kim sot thay i thit k v pht trin 7.4 Mua hng (ch c tiu ) 7.4.1 Qu trnh mua hng 7.4.2 Thng tin mua hng 7.4.3 Kim tra xc nhn sn phm mua vo 7.5 Sn xut v cung cp dch v (ch c tiu ) 7.5.1 Kim sot hot ng sn xut v cung cp dch v 4.9 + 4.15.6 + 4.19 7.5.2 Xc nhn gi tr s dng cc qu trnh sn xut v cung cp 4.9 dch v 7.5.3 Nhn bit v xc nh ngun gc 7.5.4 Ti sn ca khch hng 7.5.5 Bo ton sn phm 7.6 Kim sot phng tin theo di v o lng 8 o lng, phn tch v ci tin (ch c tiu ) 8.1 Khi qut 8.2 Theo di v o lng (ch c tiu ) 8.2.1 S tho mn ca khch hng 8.2.2 nh gi ni b 8.2.3 Theo di v o lng cc qu trnh 8.2.4 Theo di v o lng sn phm 8.3 Kim sot sn phm khng ph hp 8.4 Phn tch d liu 8.5 Ci tin (ch c tiu ) 8.5.1 Ci tin thng xuyn 8.5.2 Hnh ng khc phc 8.5.3 Hnh ng phng nga 4.1.3 4.14.1 + 4.14.2 4.14.1 + 4.14.3 4.17 4.17 + 4.20.1 + 4.20.2 4.10.2 + 4.10.3 + 4.10.4 + 4.10.5 + 4.20.1 + 4.20.2 4.13.1 + 4.13.2 4.20.1 + 4.20.2 4.10.1 + 4.20.1 + 4.20.2 4.8 + 4.10.5 + 4.12 4.7 4.15.2 + 4.15.3 + 4.15.4 + 4.15.5 4.11.1 + 4.11.2 4.6.2 4.6.3 4.6.4 + 4.10.2 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9

20

Ti liu tham kho

[1]

ISO 90003:1997, Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software. ISO 9004:2000, Quality management systems - Guidelines for performance improvements. ISO 10005:1995, Quality management - Guidelines for quality plans. ISO 10006:1997, Quality management - Guidelines to quality in project management. ISO 10007:1995, Quality management - Guidelines for configuration management. ISO 10011-1:1990, Guidelines for auditing quality systems Part 1:Auditing
1)

[2] [3] [4] [5] [6] [7] [8] [9]

ISO 10011-2:1991, Guidelines for auditing quality systems Part 2:Qualification criteria for quality 1) systems auditor ISO 10011-3:1991, Guidelines for auditing quality systems Part 3:Management of audit 1) programes ISO 10012-1:1992, Quality assurances requirements for 1:Metrological confirmation system for measuring equipment. measuring equipment Part

[10] ISO 10012-2:1997, Quality assurance for measuring equipment Part 2:Guidelines for control of measurement processes. [11] ISO 10013:1995, Guidelines for developing quality manuals. [12] ISO/TR 10014:1998, Guidelines for managing the economics of quality. [13] ISO 10015:1999, Quality management Guidelines for training. [14] ISO/TR 10017:1999, Guidance on statistical techniques for ISO 9001:1994. [15] ISO 10014:1996, Environmental management systems Specification with guidance for use. [16] IEC 60300-1: , Dependability management Part 1:Dependability programme management. [17] Quality Management Principles Brochure
3) 2)

[18] ISO 9000 + ISO 14000 News (a bimonthly publication which provides comprehensive coverage of international developments relating to ISOs management system standards, including news of their 4) implementation by diverse organizations around the world) [19] Reference websites: http://www.iso.ch http://www.bsi.org.uk/iso-tc176-sc2 ____________
1) 2) 3) 3) To be revised as ISO 19011, Guidelines on quality and/or environmental management systems auditing. To be published. (Revision of ISO 9000-4:1993) Available from Website: http://www.iso.ch Available from ISO Central Secretariat (sales@iso.ch)

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