1、GII THIEU, CAC YEU CAU va THIET LAP TAI LIEU cua HE THONG QUAN LY CHAT LNG Quality Management Systems Introduction, Requirements, and Establishing Doc.,Que Gia Consultant Team,GII THIEU HE THONG QUAN LY CHAT LNG Quality Management System,1/ The nao la ISO 9000? ISO c viet tat t nhom t: International

2、 Organization for Standardization T Chc Tiu Chun Ho Quc T,2/Dien bien: Tiu chun m bo cht lng ca qun i M Tiu chun quc gia ca nc Anh.(BS 5750) ISO 9000 Phin bn 1 1987 Phin bn 2 1994 Phin bn 3 2008,3/Y ngha ap dung: Tieu chuan he thong ISO 9000 c ap dung theo che o anh gia chng nhan ngi th ba, s dung t

3、heo phng thc nay e anh gia mot cong ty nao o a co s chuan b ay u, chu ao e phuc vu hoac cung cap nhng san pham phu hp theo yeu cau cua khach hang hay khong? Thong qua s cong bang oc lap cua ngi th ba, hn na o la s anh gia giam sat cua To chc anh gia chng nhan chuyen mon, se c ang len danh muc a c ch

4、ng nhan va thong qua o khach hang se can c theo danh muc nay e la chon cac to chc, lam giam bt i s phien phc trong viec tm kiem nha san xuat nh t trc ti nay.,ISO 9001:2008 CAC YEU CAU,4. He thong quan ly chat lng 4.1 Yeu cau chung To chc phai: Thiet lap, viet thanh tai lieu, thc hien, duy tr, quan l

5、y va cai tien lien tuc mot he thong quan ly chat lng phu hp vi cac yeu cau cua tieu chuan ISO 9001:2008 nay.,To chc can phai: Xac nh nhng qua trnh can thiet Xac nh trnh t va s tng tac gia cac qua trnh Xac nh cac chuan mc va phng phap Bao am tnh san co cua cac nguon lc va thong tin Giam sat, o lng va

6、 phan tch cac qua trnh nay Thc hien cac hanh ong can thiet e at c ket qua a a hoach nh va lien tuc cai tien Bao am kiem soat cac qua trnh ben ngoai co anh hng en s phu hp cua san pham so vi cac yeu cau,4. 2 Cac yeu cau van ban 4.2.1 Khai quat Van ban cua he thong chat lng phai bao gom: Chnh sach cha

7、t lng va cac muc tieu chat lng So tay chat lng Cac thu tuc c yeu cau bi tieu chuan quoc te nay Cac van ban can thiet khac cho he thong quan ly chat lng Cac ho s c yeu cau bi tieu chuan quoc te nay,4.2.2 So tay chat lng So tay chat lng phai bao gom: Pham vi ap dung Cac chi tiet va s bien minh cho cac

8、 ngoai le Cac thu tuc hoac vien dan ti chung Moi tng tac gia cac qua trnh,ISO 9001:2008 CAC YEU CAU,4. 2.3 Kiem soat tai lieu Thiet lap mot thu tuc dang van ban: Phe duyet Xem xet, cap nhat va phe duyet lai Xac nh nhng thay oi va tnh trang soat xet hien hanh Phien ban thch hp co san tai ni s dung Ro

9、 rang va de nhan biet Nhan dang va kiem soat s phan phoi cac tai lieu nguyen ban ben ngoai Ngan nga viec s dung khong chu y nhng tai lieu loi thi va nhan dang cho chung,ISO 9001:2008 CAC YEU CAU,4.2.4 Kiem soat ho s Ho s phai: Duy tr theo luat nh De nhan biet Phuc hoi c Thiet lap mot thu tuc ve van

10、ban e: Nhan dang Lu tr Bao quan Phuc hoi Thi gian lu tr Huy,ISO 9001:2008 CAC YEU CAU,5. Trach nhiem lanh ao 5.1 Cam ket lanh ao Chng c ve s cam ket phat trien va thc hien he thong quan ly chat lng va cai tien lien tuc tnh hieu qua cua no, bang cach: Truyen at tam quan trong cua viec thoa man cac ye

11、u cau cua khach hang Truyen at tam quan trong cua viec thoa man cac yeu cau quy nh va nhng yeu cau theo luat nh Thiet lap chnh sach chat lng va muc tieu chat lng Thc hien nhng cuoc xem xet cua lanh ao Bao am san co cac nguon lc can thiet,5.2 nh hng khach hang Nhng yeu cau cua khach hang phai c xac n

12、h va c ap ng vi muc tieu,ISO 9001:2008 CAC YEU CAU,5.3 Chnh sach chat lng Lanh ao cao nhat phai am bao rang chnh sach chat lng: Phu hp vi muc ch cua to chc.,5.4 Hoach nh 5.4.1 Muc tieu chat lng Muc tieu chat lng phai c o va nhat quan vi chnh sach chat lng.,5.4.2 Hoach nh he thong quan ly chat lng La

13、nh ao cao nhat phai am bao: Tien hanh hoach nh he thong quan ly chat lng e ap ng cac yeu cau He thong quan ly chat lng c duy tr.,5.5 Trach nhiem, quyen han va trao oi thong tin 5.5.1 Trach nhiem va quyen han Lanh ao cao nhat phai am bao cac trach nhiem, quyen han va moi quan he cua chung c xac nh va

14、 thong bao trong to chc,5.5.2 ai dien cua lanh ao Lanh ao cao nhat phai ch nh mot thanh vien trong ban lanh ao,5.5.3 Trao oi thong tin noi bo Lanh ao cao nhat phai am bao thiet lap cac qua trnh trao oi thong tin thch hp trong to chc va co s trao oi thong tin ve hieu qua cua he thong quan ly chat lng

15、.,5.6 Xem xet cua lanh ao 5.6.1 Khai quat Tai nhng thi iem c hoach nh Bao am tnh lien tuc thch hp, phu hp vi van ban va hieu qua anh gia c hoi e cai tien va cac nhu cau thay oi bao gom chnh sach chat lng va cac muc tieu chat lng,5.6.2 D lieu xem xet Phai bao gom cac thong ve: Cac ket qua anh gia Pha

16、n hoi cua khach hang Thc hien qua trnh va san xuat san pham Tnh trang cua cac hanh ong phong nga va khac phuc Nhng hanh ong theo doi t nhng xem xet lan trc Nhng thay oi co anh hng en he thong quan ly chat lng Khuyen cao cai tien,ISO 9001:2008 CAC YEU CAU,5.6.3 Ket qua xem xet Phai bao gom cac quyet

17、nh va hanh ong lien quan ti: Nhng cai tien s hieu qua cua he thong quan ly chat lng va nhng qua trnh cua no Cai tien san pham lien quan en cac yeu cau cua khach hang Cac nguon lc can thiet,6. Quan ly nguon lc 6.1 Cung cap nguon lc Phai xac nh va cung cap nhng nguon lc can thiet e: Thc hien va duy tr

18、 he thong quan ly chat lng va cai tien lien tuc s hieu qua cua no Nang cao s thoa man cua khach hang,6.2 Nguon nhan lc 6.2.1 Khai quat Co u trnh o tren c s cua: Giao duc thch hp ao tao Ky nang Kinh nghiem,ISO 9001:2008 CAC YEU CAU,6.2.2 Kha nang, nhan thc va ao tao Xac nh nang lc can thiet va cung c

19、ap viec ao tao hoac cac hoat ong khac anh gia tnh hieu qua Nhan s phai nhan thc s lien quan va tam quan trong cua cac hoat ong nay Nhan s phai ong gop vao viec at c cac muc tieu chat lng Lu tr ho s,6.3 C s vat chat Nham at c s phu hp cua san pham Bao gom: Ni lam viec va cac thiet b lien quan Thiet b

20、 qua trnh (phan cng va phan mem) Cac dch vu ho tr,6.4 Moi trng lam viec To chc phai xac nh va quan ly moi trng lam viec can thiet e at c s phu hp cua san pham,ISO 9001:2008 CAC YEU CAU,7. Thc hien san pham 7.1 Lap ke hoach thc hien san pham Lap ke hoach va phat trien cac qua trnh can thiet Nhat quan

21、 vi cac yeu cau cua cac qua trnh khac Xac nh nhng ieu sau: Nhng muc tieu chat lng va cac yeu cau oi vi san pham Nhu cau thiet lap cac qua trnh, tai lieu va cung cap cac nguon lc Xac nhan, tham nh gia tr, giam sat, kiem tra va th nghiem Lu tr ho s Lu tr san pham pham phu hp S dung bieu mau phu hp cho

22、 viec hoach nh au ra,7.2 Cac qua trnh lien he khach hang 7.2.1 xac nh cac yeu cau lien quan en san pham Cac hoat ong giao hang va giao hang Khong quy nh bi khach hang nhng can thiet cho viec s dung cu the hoac d nh Quy nh hoac luat nh lien quan en san pham Them vao bi to chc,ISO 9001:2008 CAC YEU CA

23、U,7.2.2 Xem xet cac yeu cau lien quan en san pham Cac yeu cau ve san pham Cac yeu cau c to chc them vao Giai quyet s khac biet Kha nang ap ng cac yeu cau Lu tr ket qua Khi yeu cau ve san pham c thay oi th phai bao am nhng tai lieu c sa oi va nhng ngi lien quan nhan biet,7.2.3 Lien lac khach hang Nhn

24、g sap at hieu qua cho viec lien lac vi khach hang phai c xac nh va thc hien bao gom: Thong tin ve san pham Cac yeu cau, x ly hp ong hay n hang, bao gom nhng sa oi Phan hoi cua khach hang bao gom ca nhng khieu nai cua khach hang,ISO 9001:2008 CAC YEU CAU,7.3 Thiet ke va phat trien 7.3.1 Lap ke hoach

25、thiet ke va phat trien Lap ke hoach va kiem soat Xac nh: Cac giai oan Xem xet, xac nhan va tham nh gia tr Trach nhiem va quyen han Quan ly moi tng giao gia cac nhom khac nhau Ket qua hoach nh phai c cap nhat,7.3.2 D lieu thiet ke va phat trien Bao gom cac yeu cau ve chc nang va thc hien sau: Cac yeu

26、 cau quy nh va luat nh Thong tin rut ra t thiet ke tng t trc o Cac yeu cau khac c xem xet Lu tr ho s,ISO 9001:2008 CAC YEU CAU,7.3.3 Ket qua thiet ke va trien khai Di dang co the kiem tra xac nhan theo cac d lieu ap ng cac yeu cau d lieu au vao Cung cap thong tin Bao gom hoac tham khao tieu chuan ch

27、ap nhan Quy nh cac ac tnh cua san pham,7.3.4 Xem xet thiet ke va phat trien Tai cac giai oan thch hp Phu hp vi cac sap at a c hoach nh anh gia kha nang ap ng hoan toan cac yeu cau Nhan dang cac van e va e xuat cac hanh ong tiep theo Lu tr ho s,7.3.5 Xac nhan thiet ke va phat trien Phu hp vi cac sap

28、at a c hoach nh Bao am rang ket qua ap ng cac yeu cau d lieu au vao Lu tr ho s,ISO 9001:2008 CAC YEU CAU,7.3.6 Tham nh gia tr thiet ke va phat trien Phu hp vi cac sap at a c hoach nh San pham c tao ra co kha nang ap ng cac yeu cau oi vi viec s dung cu the hoac hoach nh c hoan thanh trc khi giao hang

29、 hoac san xuat san pham Lu tr ho s,7.3.7 Kiem soat s thay oi cua thiet ke va phat trien c nhan dang va ho s c duy tr c xem xet, xac nhan, tham nh gia tr mot cach thch hp c phen duyet trc khi thc hien anh gia anh hng cua cac thay oi en cac bo phan cau thanh va san pham giao hang Lu tr ho s,ISO 9001:2

30、008 CAC YEU CAU,7.4 Mua hang 7.4.1 Qua trnh mua hang San pham mua phu hp vi cac yeu cau mua cu the Loai va mc o kiem soat phai tuy theo anh hng cua san pham mua vao oi vi san xuat hoac san pham cuoi anh gia va chon nha cung cap Thiet lap tieu chuan e la chon, anh gia va tai anh gia Lu tr ho s,7.4.2

31、Thong tin mua hang Cac yeu cau phe duyet san pham, quy trnh, qua trnh va thiet b Cac yeu cau ve nang lc nhan s Cac yeu cau ve he thong quan ly chat lng Bao am s phu hp ve van ban cua cac yeu cau,7.4.3 Xac nhan san pham mua Kiem tra hoac cac hoat ong khac nham bao am san pham mua ap ng cac yeu cau Xa

32、c nhan tai c s nha cung cap cong bo viec sap xep kiem tra xac nhan va phng phap giai toa san pham trong thong tin mua hang,ISO 9001:2008 CAC YEU CAU,7.5. San xuat va cung ng dch vu 7.5.1 Kiem soat san pham va cung ng dch vu Di nhng ieu kien c kiem soat Thong tin mo ta cac ac tnh san pham Cac hng dan

33、 cong viec khi can thiet Thiet b thch hp Cac thiet b giam sat va o lng Giam sat va o lng Giai toa, giao hang va hau giao hang,7.5.2 Tham nh gia tr qua trnh san xuat va cung ng dch vu Chng minh nang lc cua qua trnh nay la at c cac ket qua a hoach nh Cac sap at bao gom: Chuan chap nhan e xem xet va ph

34、e duyet Phe duyet thiet b va nang lc nhan vien Cac phng phap va cac quy trnh cu the Cac yeu cau ve ho s,ISO 9001:2008 CAC YEU CAU,7.5.3 Nhan dang va truy tm Nhan dang san pham bang cach phng tien thch hp Nhan dang tnh trang san pham theo yeu cau giam sat va o lng Kiem soat va lu ho s viec nhan dang

35、thong nhat, khi truy tm la mot yeu cau,7.5.4 Tai san cua khach hang Cham soc Nhan dang, xac nhan, ngan nga va canh gi Bao cao cho khach hang va duy tr ho s cac tai san mat mat, h hong hoac khong thch hp vi muc ch s dung,7.5.5 Bao quan san pham Suot qua trnh ben trong va giao hang en ni a d nh Nhan d

36、ang, boc xep, bao goi, lu tr va ngan nga Ke ca cac bo phan cau thanh san pham,ISO 9001:2008 CAC YEU CAU,7.6 kiem soat cac thiet b giam sat va o lng Xac nh cac phep giam sat va o lng va cac thiet b giam sat va o lng can thiet e cung cap bang chng ve s phu hp cua san pham vi cac yeu cau a xac nh Qua t

37、rnh giam sat va o lng phai theo cach thc nhat quan vi cac yeu cau Khi can bao am la cac ket qua co gia tr, cac thiet b o phai: c hieu chuan hay kiem tra xac nhan chuan quoc te hay quoc gia hay dung c s khac th phai co ho s c ieu chnh hay tai ieu chnh Co tnh trang hieu chuan c an toan tranh s ieu chn

38、h vo tnh c ngan nga khoi h hong va suy giam chat lng,ISO 9001:2008 CAC YEU CAU,8. o lng, phan tch va cai tien 8.1 Khai quat Cac qua trnh can thiet e Chng minh s phu hp cua san pham Bao am s phu hp cua he thong Cai tien lien tuc s hieu qua cua he thong Phai c hoach nh va thc hien Xac nh cac phng phap

39、 o lng bao gom cac ky thuat thong ke,8.2 Giam sat va o lng 8.2.1 S thoa man cua khach hang Giam sat cac thong tin lien quan en nhan thc cua khach hang To chc co ap ng cac yeu cau cua khach hang khong Xac nh cac phng phap e nhan c va s dung cac thong tin nay,ISO 9001:2008 CAC YEU CAU,8.2.2 anh gia no

40、i bo Phai co quy trnh bang van ban c thc hien tai nhng thi iem c hoach nh Nham xac nh xem he thong co phu hp vi Nhng sap xep a hoach nh Nhng yeu cau cua tieu chuan quoc te nay va nhng yeu cau cua he thong QLCL Nham xac nh xem he thong co c thc hien va duy tr hieu qua Phai xac nh tieu chuan, pham vi,

41、 tan suat va phng phap cho cac anh gia Lu tr ho s,8.2.3 Giam sat va o lng cac qua trnh Ap dung cac phng phap thch hp e giam sat va khi thch hp phai o lng Cac phng phap nay phai chng minh nang lc cua qua trnh trong viec at c cac ket qua a hoach nh Khi cac ket qua nay khong at c th phai ap dung viec s

42、a cha va khac phuc,ISO 9001:2008 CAC YEU CAU,8.2.4 Giam sat va o lng san pham Cac ac tnh cua san pham Tai cac giai oan thch hp cua qua trnh san xuat Duy tr chng c cua s phu hp vi chuan chap nhan Ho s ch ro ngi co tham quyen giai to san pham S sap xep a hoach nh phai c hoan tat va thoa man,8.3 Kiem s

43、oat san pham khong phu hp Nhan dang va kiem soat nham ngan nga viec s dung vo tnh Xac nh trach nhiem va them quyen x ly san pham khong phu hp X ly san pham khong phu hp bang cach: Loai bo loi Giai toa hoac chap nhan co nhan nhng (tham quyen thch hp, khach hang) Khong s dung theo muc ch ban au,ISO 90

44、01:2008 CAC YEU CAU,8.4 Phan tch d lieu Xac nh, thu thap va phan tch cac d lieu thch hp Chng minh s thch hp va hieu qua cua he thong QLCL anh gia c hoi cai tien lien tuc co the thc hien au D lieu co c la ket qua cua viec giam sat va o lng t cac nguon thch hp khac D lieu phai cung cap thong tin lien quan ti S thoa man cua khach hang, s phu hp vi cac yeu cau ve san pham, nha cung cap. ac tnh va khuynh hng cua cac qua trnh va san pham,8.5 Cai tien 8.5.1 Cai tien lien tuc Thong qua viec s dung Chnh sach chat lng Muc t