B TIU CHUN ISO 9000 : 2008 H thng qun tr cht lng QMSThS NG GIA LNG

CAC LNH VC QUAN LY TRONG TO CHC1. QUAN LY KY THUAT

2. QUAN LY TAI CHNH va RUI RO

(SSOP, GMP, HACCP, ISO 22000, SQF An toan dc pham, thc pham, my pham Phac o ieu tr trong benh vien, An toan ng bien, hang khong)

He thong quan ly ky thuat -TMS

He thong quan ly tai chnh FMS He thong quan ly chat lng QMSGia ca kham cha benh, Bao hiem y te

3. QUAN LY CHAT LNG

(ISO 9001:2008, TQM, Giai thng Chat lng Viet nam, Tieu chuan benh vien xuat sac, benh vien tnh thng, Y c cua Viet nam)

4. QUAN LY MOI TRNG

5. QUAN LY AN SINH XA HOI

(ISO 14001:2004, an toan moi trng t nhien, chong nhiem khuan benh vien, ) (SA 8000:2005, OHSAS 18001:2003, cac luat ve lao ong, an toan va sc khoe nghe nghiep, quan ly nguon nhan lc)

He thong quan ly moi trng EMS

He thong quan ly an sinh xa hoi SSMS

CAC LNH VC QUAN LY TRONG TO CHC

SSOP: Qui trnh thc hien tieu chuan ve sinh (Sanitation Standard Operating Procedure) GMP: Thc hanh san xuat tot (Good Manufacturing Practices) HACCP: Phan tch moi nguy va iem kiem soat ti han ve ve sinh (Hazard Analysis and Critical Control Point) ISO 22000 - He thong quan ly an toan thc pham (Food Safety Management System) ISO 17025 Yeu cau chung ve nang lc phong th nghiem va hieu chuan (General Requirements for the competence of Testing and Calibration Labaratories) ISO 13485:2003 H thng qun l cht lng cc thit b y t (Medical Devices Quality Manangement Systems) TQM: Quan ly Chat lng toan dien (Total Quality Mannagement)

SA -Trach nhiem xa hoi (Social Accountability) - ISO 27000:2009OHSAS -He thong anh gia an toan va sc khoe nghe nghiep (Occupational Health and Safety Assessment Series) SQF Thc pham chat lng an toan (Safe Quality Food) ISO: To chc quoc te ve tieu chuan hoa (International Orgranization for Standardization)

GHI CHU: Cac tieu chuan ve he thong quan ly ke tren thuoc RAO CAN PHI THUE QUAN hay RAO CAN KY THUAT TRONG THNG MAI (TBT) trong qua trnh hoi nhap kinh te toan cau.

CAC LNH VC QUAN LY TRONG TO CHC

QMS nham thoa man yeu cau nhu cau & mong i cua khach hang (KH) va cac ben quan tam (BQT) MTCL bo sung cho cac muc tieu khac nh: li nhuan, moi trng, sc khoe, an toan nghe nghiep Cac he thong quan ly trong to chc co the hp nhat hoa thanh mot he thong quan ly duy nhat. o la he thong quan ly tch hp (Integrated Management system IMS)

ISO 9001

QMSISO 14001

EMS

SSMS

SA 8000, OHSAS 18001

ISO 13485 SSOP GMP, HACCP, ISO 22000, SQF

IMSTMS FMS

Cac he thong quan ly tren cung co the c anh gia theo nhng yeu cau cua ISO 9001 & ISO 14001 (anh gia rieng re hay ket hp eu c)

ISO 9000 L G ?9000 : B tiu chun quc t v H thng qun tr cht lng do T chc Quc t v tiu chun ha (ISO International Organization for Standardization) ban hnh Tiu chun p dng cho mi lnh vc kinh doanh, sn xut v dch v ISO ting Hy Lp isos c ngha tng ng ISO

VAI TR CA ISO 9000 To

ra mi quan h gia cht lng qun tr vi qu trnh ct li ca t chc Cht lng sn phm do cht lng qun tr quyt nh v cht lng qun tr chnh l ni dung ch yu ca qun tr cht lng Ci tin cht lng trong t chc vi phng chm chin lc l lm ng ngay t u (do right the first time), ly phng nga lm phng chm chnh (prevention) Gia tng s hi lng ca khch hng

NGHA CA ISO 9000 p

dng ISO 9000 l mt i hi khch quan ca qu trnh pht trin, hp tc kinh t , thng mi quc t v l c s hng ha c th trao i vi nhau mt cch d dng, khc phc c nhng khc nhau gia cc tiu chun ca cc quc gia v khu vc Chng nhn ISO 9000 l chng minh th trong giao thng quc t hng ha c th vt qua ro cn k thut trong thng mi quc t (TBT- Technical Barriers to Trade) To ra h thng mua bn tin cy

HIP NH CA T CHC WTO V RO CN K THUT TRONG THNG MI TBTp dng cho cc nc ang pht trinNC A NC B

Thut ng Biu tng Nhn hiu Dn nhn Bao gi

RO CN THU QUAN

Cc tiu chun Cc quy nh Cc iu kin k thut Cc qu trnh v pp sn xut Kim tra Th nghim Chng nhn sn phm Chng nhn h thng

Cc tiu chun Cc quy nh Cc iu kin k thut Cc qu trnh v pp sn xut Kim tra Th nghim Chng nhn sn phm Chng nhn h thng Thut ng Biu tng Nhn hiu Dn nhn Bao gi

Cc yu cu khc

Cc yu cu khc

Hip nh TBT to ra c ch gim hoc loi b TBT

H THNG MUA BN TIN CYVIT NAM EU

DOANH NGHIPXUT KHU

SN PHM DCH V Y THC KIM TRA

DOANH NGHIPNHP KHU

A

TIN CY KHI MUA - BN KHNG CN KIM TRA

B

LI CH CA VIC P DNG ISO 9000A. LI CH BN TRONG Thc hin cc yu cu v cht lng mt cch hiu qu v tit kim nht nng cao kh nng cnh tranh a ra bin php lm vic ng ngay t u, xc nh ng nhim v v ch ra cch thc hin m bo cht lng t nguyn vt liu qua p dng ISO 9000 ngay c i vi nh cung cp Ci tin nng sut v cht lng sn phm Ci thin truyn thng bn trong

LI CH CA VIC P DNG ISO 9000B. LI CH BN NGOI Khch hng chc chn c m bo cung cp sn phm ng yu cu To sn phm cht lng cho th trng vi thi gian nhanh hn To H thng mua bn tin cy t khch hng, gim vic thm nh nhiu ln v chi ph cho vic nh gi Khch hng hi lng hn v gia tng th phn

LI CH CA VIC P DNG ISO 9000

C. LI CH I VI NHN VIN Nhn vin hiu r vai tr v nhim v ca mnh qua h thng ti liu th tc Nhn vin mi c th hc hi cch lm vic ngay v mi ch dn u c ghi thnh vn bn To H thng mua bn tin cy t khch hng, gim vic thm nh nhiu ln v chi ph cho vic nh gi

LC S HNH THNH ISO 9000

1959, B Quc phng M thit lp h thng MIL-Q9858 1968, NATO chp nhn MIL-Q9858 m bo cht lng nh thu ph : AQUAP-1 Allied Quality Assurance Publication I 1970, B Quc phng Anh chp nhn AQUAP-1 trong chng trnh qun l quc phng thnh DEFSTAN 05-8 1979, Vin tiu chun Anh pht trin BS 5750 H thng tiu chun cht lng qun tr u tin trong thng mi 1987, T chc ISO ban hnh ISO 9000 phin bn 1, chp nhn hu ht cc tiu chun ca BS 5750 1994, sot xt, chnh l, b sung (phin bn 2) 2000, ISO 9000 phin bn 2000 c ban hnh (phin bn 3) 1996, Vit Nam chp nhn v ban hnh ISO 9000 k hiu TCVN ISO 9000 2008 : Phin bn 4 (ISO 9000: 2008)

B TIU CHUN ISO 9000 CC NCTN NCAustralia Belgium Canada Denmark European U France Germany Hungary India

K HiUAS 3900 NBNX 50 CZAZ 299 DS/ EN 29000 EN 29000 NFX 50 DIN ISO 9000 MI 18990 IS 10210

TN NCIreland Netherlands New Zealand Norway South Africa Spain Sweden United K Vietnam

K HiUIS 300 NEN ISO 9000 NZS 5600 NS 5600 SABS 0157 UNE 66900 SS ISO 9000 BS 5750 TCVN ISO 9000

8 NGUYN TC QTCL THEO ISO 90001.

2.3. 4. 5. 6.

7.8.

Hng vo khch hng S lnh o S tham gia ca mi ngi Cch tip cn theo qu trnh Cch tip cn theo h thng i vi qun l Ci tin lin tc Quyt nh da trn s kin Quan h hp tc cng c li vi ngi cung ng

nh hng khch hngT chc ph thuc vo khch hng Xc nh nhu cu khch hng & K vng

Xc nh nhu cu hin ti v tng lai ca khch hng p ng yu cu v cao hnXc nh cc phng php o lng s tha mn ca khch hng

Cc yu cu

Tha mn khch hng

Nguyn tc 1

Lnh o Lnh o thit lp phng hng v mc tiu ca t chc, to iu kin thun li duy tr mi trng ni b thun li mi ngi c th tham gia nhm hon thnh mc tiu. Lnh o xem xt nhu cu ca khch hng, ch u t, CBCNV, ca cng ng x hi t ra mc tiu trong tng lai v chng trnh hnh ng

Nguyn tc 2

S tham gia ca mi ngi

Con ngi l ct yu ca t chc Cc thnh vin mi cp tham gia hot ng ca t chc gip pht huy kh nng ca c nhn v t chc phc v li ch chung S tham gia ca mi ngi to sc mnh tng hp v nhiu sng to, chm lo cho kt qu tt hn v t ho v kt qu t c

Nguyn tc 3

Tip cn theo qu trnh Tip cn theo qu trnh th kt qu c th d on trc c kh chnh xc v cng d xp u tin cc c hi ci tin T chc cn xc nh cc qu trnh v cc tng tc gia chng c bin php thch hp m bo phi hp v pht huy tt nht cc qu trnh m bo cht lng

Nguyn tc 4

Tip cn qu trnh

Cu trc mi Quen

thuc vi 20 yu cu xc nh Cu trc mi da trn nn tng qu trnh mang tnh khi qut hn Da

trn chu trnh Plan - Do - Check Act Nhng yu cu chnh : Trch

nhim ca Lnh o Qun l ngun lc To sn phm o lng, phn tch v ci tin

Tip cn qu trnhH thng qun tr cht lng Ci tin lin tc C C Y U C U Trch nhim lnh o T H A M N

K H C H H N G

K H C H H N G

Qun l ngun lc

o lng, phn tch v ci tin

u vo

To sn phm

Sn phm

u ra

Tip cn h thng Xc nh, hiu v qun l cc qu trnh c tng quan nh tng b phn trong tng th ca h thng Cn xy dng h thng t mc tiu theo hng hiu qu nht Xc nh cch vn hnh ca cc hot ng trong h thng

Nguyn tc 5

Ci tin lin tcCi tin lin tc phi xem l mc tiu thng trc p ng nhng thay i ca th trng, yu cu ngy cng cao ca khch hng

Ci tin lin tc:Mt phn trong qun tr cht lng tp trung vo nng cao hiu qu v kt qu(ISO 9000:2000)

Nguyn tc 6

Quyt nh da trn s kin

Vic ra quyt nh da trn phn tch d liu v thng tin m bo c y d liu, thng tin ng tin cy to c s cho vic ra quyt nh thch ng

Nguyn tc 7

Quan h hp tc cng c li vi ngi cung ng

Doanh nghip v ngi cung ng hot ng c lp v quan h cng c li s tng kh nng c hai bn u to ra gi trNguyn tc 8

U IM CA ISO 9000 : 2008H thng QTCL ISO 9000 c xy dng nhm mc ch tha mn khch hng bng cch phng nga nhng s khng ph hp theo yu cu 1. B tiu chun ISO 9000 phin bn 2008 nng cao tm quan trng vn tip cn theo qu trnh ph hp vi xu th ca QTCL hin i 2. S tha mn khch hng c cao v tr thnh mc tiu chnh, qua t chc c c hi pht trin

U IM CA ISO 9000 : 20083. cao vai tr ca thng tin mt cch r rt, cc b phn trong doanh nghip c mi lin h cht ch, thng tin xuyn sut t marketing, thit k, sn xut, kho n ti chnh v tt c chu s gim st phi hp, ch o ca lnh o 4. Ci tin lin tc mt c tnh quan trng ca TQM - c cao, ci thin thnh qu tin n s hon thin cho doanh nghip 5. B tiu chun ISO 9000 tng thch cao vi cc H thng tiu chun khc, c bit l ISO 14000

CU TRC CA B TIU CHUN ISO 9000: 2008

ISO 9000:2005 H THNG QUN TR CHT LNG C S V T VNG

ISO 9004:2009H THNG QUN TR CHT LNG HNG DN CI TIN HIU QA

ISO 9001:2008H THNG QUN TR CHT LNG CC YU CUISO 19011:2002 HNG DN NH GI H THNG QUN TR CHT LNG

CU TRC CC YU CU CA TIU CHUN ISO 9001: 20085. TRCH NHIM CA LNH O5.1. Cam kt ca lnh o 5.2. Tp trung vo khch hng 5.3. Chnh sch cht lng 5.4. Hoch nh 5.5. Trch nhim, quyn hn & truyn thng 5.6. Xem xt ca lnh o

4. H THNG TI LIU CHT LNG4.1. Yu cu tng qut 4.2. Yu cu ti liu cht lng

8. O LNG, PHN TCH & CI TIN8.1. Tng qut 8.2. Gim st v o lng 8.3. Kim sot sn phm khng ph hp 8.4. Phn tch gi liu 8.5. Ci tin

7. TO SN PHM7.1. Hoch nh vic to sn phm 7.2. Quy trnh lin quan n khch hng 7.3. Thit k v pht trin 7.4. Mua hng 7.5. Sn xut v dch v 7.6. Kim sot thit b gim st & o lng

6. QUN L NGUN LC6.1. Cung ng ngun lc 6.2. Ngun nhn lc 6.3. C s h tng 6.4. Mi trng