trong he thong chat liidng hoac trong cac hoat dong thii nghiem va/hoac hieu chuan co the xay ra tai nhieu ndi khac nhau trong he thong chat liidng... Trudng dai ho[r]
Trang 1Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc
NHLTNG KIEN THITC CO BAN VE QUAN LY
PHONG THI NGHIEM
MUC TIEU HOC TAP• • •
Sau khi hoc xong bdi nay, hoc vien co the:
1 Trinh bay diicic cac yeu cau chung cua phong thi nghiem phu hdp vdi cac chuan miic quoc te
2 Van dung de dinh hudng viec hoan thien va tien t6i xin cong nhan phong thi nghiem tai cd sci
NOI DUNG HOC TAP• • •
I GlCfl THIEU TAl LIEU VE QUAN LY PHONG THI NGHIEM
1 Phan mof dau
Tai lieu nay neu cac yeu cau chinh yeu lien quan he thong quan ly va cac yeu cau ve nang liic ky thuat ma theo do neu mot phong thii nghiem (PTN)
cd kha nang dap iing cho nhiing loai phep thii va/hoac hieu chuan nao do thi
no se dUdc cac to chiic cong nhan thiia nhan nhii la dap iing chuan miic cua viec cdng nhan theo tieu chuan quoc te ISO/IEC17025 ve cac loai phep thii/ hieu chuan tUdng iing do
He thong quan ly neu d day la mot bo phan cua he thong quan ly chung cua to chiic co phong thii nghiem nay hoac ciia chinh phong thii nghiem Noi rieng he thong to chiic quan ly do neu dUdc xay diing theo nhiing chuan muc doi hoi ciia tieu chuan IS09001 thi no co the diidc cac cd quan cong nhan xem nhii thoa man cac yeu cau ve he thong to chiic nhiing dieu do chiia du
de minh chiing no co du kha nang ky thuat de cung cap cac ket qua va dti lieu co gia tri ve mat ky thuat Tham chi vao cuol nam 2000, khi cac tieu chuan IS09001 va ISO 9002 da diidc stia doi, hdp nhat thanh tieu chuan
IS 0 9 0 0 1:2000 mang tinh day dti hdn thi du he thong to chtic quan ly ciia phong thti nghiem hieu chuan co dap ting chuan miic nay, neu muon dUdc cong nhan, no cung phai dap ting cac yeu cau ve mat ky thuat
2 Pham vi ap dung
Tai lieu nay diidc ap dung cho moi to chtic hoac bo phan cua mot to chtic
Trang 2Trudng dai hoc Y te cong cong Quan ly chat lupng san xuat thuoc
co thac hien cac phep thti nghiem/ hieu chuan Nhting yeu cau nay khong phu thuoc vao so' liidng nhan vien, khong phu thuoc vao pham vi va linh viic thti nghiem/hieu chuan Khi mot phong thti nghiem hieu chuan khong thac hien mot hoac nhieu hoat dong co neu trong tai lieu nay thi ho chi c£n tuyen bo' ho khong ap dung cac yeu cau doi vdi nhting pham vi loai trti do
M oi phong thti nghiem/ hieu chuan co the sti dung tai lieu nay nha la mot chi d in de xay diing cho minh mot he thong quan ly hanh chmh, quan
ly ky thuat, quan ly chat lu’dng de hoan thien hon moi tac nghiep cua ho, can nh&c cac yeu cau ky thuat de tu so sanh, xac dinh duoc thuc trang cua minh
so vdi chuan mile nay va tti dd de ra cac giai phap hoan thien thich ting ca ve
to chtic quan ly cua he thong chat liidng lan tinh trang trang thiet bi nang liic Mat khac khach hang cua phong thti nghiem, cd quan cd tham quyen va dac biet cd quan cong nhan co the sti dung tai lieu hudng dan nay nhu la cd
sd de xac nhan hoac thtia nhan nang liic cua phong thti nghiem
3 Ldi ich cua viec ap dung
Moi phong thti nghiem co the diing tai lieu nay nhu mot chi dan cho viec xay diing va trien khai cac hoat dong quan ly phu hdp va hieu qua vdi tinh trang thac tai cua minh Hdn the cac phong thti nghiem/hieu chuan ap dung day du cac hudng d in cua tai lieu nay cd the xay diing va minh chting cho cd quan cdng nhan rfing ho cd he thong quan ly va nang liic ky thuat thoa man cac yeu cau cua tieu chuan ISO/IEC17025 Nhting phong thti nghiem/ hieu chuan neu diidc cd quan cong nhan thtia nhan se cd dUdc uy tin va ldi the trong tiep thi, ket qua thti nghiem/hieu chuan cua ho se dUdc Uu tien sti dung cho cac hoat dong danh gia, giam dinh hay phan xti m ang tinh trong tai Nen liiu y rin g , khi cac to chtic cong nhan cua moi nUdc tham gia thoa lidc thtia nhan da phiidng vdi cac to chtic tUdng dudng cua cac quoc gia khac
cd sti dung tieu chuan nay de cdng nhan, thi ket qua thti nghiem va hieu chuan gitia cac phong thi nghiem tuan thu tieu chuan nay se de dang dUdc dong thtia nhan.Viec nay tao dieu kien cho sii phat trien hdp tac thudng mai
va ky thuat, hai hoa cac tieu chuan, thu tuc va se tao dieu kien cho chinh hoat dong va quan he cua mdi phong thti nghiem iuai nay
II NOI DUNG TAI LIEU
De tien cho viec tra ctiu, phan diidi day chting toi se trinh bay mot cach tong quan cac yeu cau ve he thdng to chtic quan ly chat liidng va cac yeu cau
ve nang liic cua phong thti nghiem theo tuan tii cac hang muc chinh da dUdc neu trong IS 017025
1 Ve cd cau to chtic
Phong thti nghiem hoac cd quan chu quan cua PTN phai la mot thiic the
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Trang 3Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc
co kha nang chiu trach nhiem ve mat phap ly, dap iing duoc tat ca cac yeu cau cua tieu chuan nay va thoa man cac yeu cau cua khach hang, cua cac cd quan co tham quyen hoac cac cd quan cong nhan Ngoai kha nang thiic hien cac cong viec tai tru sd, PTN cung phai co kha nang thuc hien cac hoat dong tai hien triidng, tai cac dia diem lien ket tam thdi vdi cd sd hay tren cac phudng tien di dong ma ban chat cong viec doi hoi Neu PTN chi la mot bo phan cua mot to chiic co thiic hien cac hoat dong khac vdi cdng viec thu nghiem va/hoac hieu chuan thi ve cd cau to chiic, phai dinh rd trach nhiem cua moi nhan vien chu chot co lien quan hoac co anh hudng t6i cac hoat dong thii nghiem va/hoac hieu chuan cua PTN de nhan biet cac mau thuan co the
ve quyen ldi Dieu nay nh&m dam bao tinh trach nhiem va khach quan trong hoat dong cua no Cac bo phan co lien quan ve quyen ldi nhii: San xuat kinh doanh, tiep thi hoac tai chinh se khdng gay ra anh hudng bat ldi den sii tuan thu cua PTN theo cac yeu cau cua tieu chuan nay Neu mot PTN mong muon dUdc thiia nhan la PTN cua ben thii ba thi ta phai chiing minh rang PTN dd la khach quan, rang nhan vien cua PTN do khong chiu mot ap liic nao ve thudng mai, tai chinh hay ap liic khac cd the anh hUdng den quyet dinh co tinh ky thuat Phong thii nghiem hoac hieu chuan cua ben thii ba khdng dUdc tham gia bat cii cac hoat dong nao co the ton hai den do tin cay, tinh doc lap ciia cac quyet dinh va tinh trung thiic lien quan den hoat dong thii nghiem hoac hieu chuan ciia no
PTN phai xac dinh cd cau to chiic va vi tri ciia no trong to chiic chii quan va cac moi quan he giiia quan ly chat liidng, hoat dong ky thuat va dich vu ho trd Phai quy dinh trach nhiem, quyen han va moi quan he qua lai ciia tat ca cac nhan vien quan ly, thiic hien hoac kiem tra cong viec co anh hudng den chat ludng ciia phep thii nghiem va/hoac hieu chuan Phong cung phai giam sat mot cach thich hdp trinh do ky nang va thao tac ciia cac nhan vien thii nghiem va hieu chuan, bao gom ca cac nhan vien dang tap sii De lam viec nay, chang han can co can bo quan ly ky thuat chiu trach nhiem toan bo cac hoat dong ky thuat NgUdi nay phai dUdc cung cap cac nguon liic can thiet de dam bao chat liidng cac hoat dong ciia PTN Phong se phai bo nhiem dich danh mot can bo giii vai trd quan ly chat liidng, ngoai cac nhiem vu va cac trach nhiem khac, ngUdi nay co trach nhiem va quyen han rd rang dam bao sao cho he thong chat liidng luon du'dc thiic hien va tuan thu, diidc phep lien he triic tiep v6i cap quan ly cao nhat co tham quyen diia ra cac quyet dinh ve chinh sach va nguon liic ciia PTN Phong phai xem xet viec bo nhiem cac cap pho thay the ngiidi phu trach quan ly chii chot khi ho di vang
2 He thong chat lu’dng
Nhii da neu he thong chat liidng la cd cau to chiic, thu tuc, qua trinh va nguon liic can thiet de thiic hien cong tac quan ly chat liidng He thong nay
Trang 4Trudng dai hoc Y te cdng cong Quan ly chat luong san xuat thuoc
la mot phan cau thanh trong he thong quan ly chung cua ban than phong thii nghiem va luan diem xay diing cua he thong chat lifdng trong phong thii nghiem cung tuan thu 8 nguyen tac:
1 D inh hudng khach hang va thi trUdng
2 Vai tro lanh dao
3 Su tham gia cua moi thanh vien
4 Phudng phap qua trinh
5 Phudng thiic tiep can mang tinh he thong
6 Cai tien lien tuc
7 Quyet dinh diia tren sii kien
8 Phat trien quan he hdp tac
PTN phai thiet lap, thiic hien va duy tri mot he thong chat liidng phu hdp v6i quy md hoat dong cua no Phong phai lap thanh van ban cac chinh sach, he thong, chUdng trinh, thu tuc, hucfng dan trong pham vi can thiet de dam bao chat lifdng cho ket qua thii nghiem va/hoac hieu chuan Cac chinh sach va muc tieu ve chat lifdng ciia PTN phai dUdc xac dinh trong so tay chat lifdng va phai dUdc lanh dao cam ket Moi tai lieu sii dung trong he thong chat lifdng phai dUdc pho bien, hieu rd, luon san co va dUdc cac nhan vien co trinh do thich iing sii dung
3 Kiem soat tai lieu
PTN phai thiet lap va duy tri cac thii tuc kiem soat tat ca cac tai lieu cua
he thong chat lifdng (cac tai lieu noi bo hoac co nguon goc tii ben ngoai) nhif: Cac quy dinh, tieu chuan, tai lieu tieu chuan khac, phudng phap thii va/hoac hieu chuan cung nhif cac ban ve, phan mem, qui dinh ky thuat, hu6ng d in
va so tay
Tat ca cac tai lieu phai difdc bien soan, xem xet, phe chuan ca ve noi dung chuyen mon cung nhu cach trinh bay dinh dang thong nhat trifdc khi sii dung V iec ban hanh, phan phoi, cap nhat, siia doi, thu hoi, thay the hay loai bo moi tai lieu loi thdi deu phai theo mot thii tuc da dinh
N hiing dieu nay cung difdc ap dung cho cac tai lieu dUdc liiu giuf trong he thong m ay tinh
4 Xem xet cac yeu cau, de nghi va hdp dong
Phan nay de cap viec PTN co lap va duy tri thu tuc xem xet cac yeu cau,
de nghi va hdp dong ciia khach hang qua dd dam bao hieu dung cac yeu cau ciia khach hang, co kha nang va chuan bi day du cac dieu kien de dap iing cac yeu c iu do Vi du nang liic va nguon liic, phudng phap thu va/hdac hieu chuan thich hdp difdc liia chon va co kha nang dap iing yeu cau ciia khach hang Yeu cau nay cung k h in g dinh r in g bat cii sii khac biet nao giiia yeu
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Trang 5Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc
cau hoac de nghi va hop dong phai duoc giai quyet trudc khi b i t dau cong viec Moi hdp dong phai diidc ca hai ben PTN va khach hang chap nhan Phong thii nghiem phai bao cho khach hang ve moi thay doi neu co cua hdp dong Tham chi neu hdp dong can thay doi sau khi cdng viec da b it dau thiic hien thi phai lap lai qua trinh xem xet hdp dong nhu trudc dd va moi thay doi phai dUdc thong bao cho tat ca cac nhan vien lien quan
5 Ho?p dong phu ve thvf nghiem va hieu chuan
Trudng hdp cd bat cii cong viec nao do ngUdi thau phu cua PTN tien hanh, phong thii nghiem cung phai ap dung viec xem xet nay doi vdi ho va phai bao b in g van ban cho khach hang ve viec dd cung nhu phai dUdc sii dong y cua khach hang ve viec nay PTN chiu trach nhiem doi vdi khach hang ve cong viec ciia nha thau phu ngoai tru: trudng hdp khi khach hang hoac cO quan cd tham quyen chi dinh nha thau phu can dUdc sii dung
PTN phai cd mot so dang ky tat ca cac nha thau phu sii dung cho cac phep thii va/hoac hieu chuan va phai cd ho sd chiing m inh cac nha thau phu phu hdp vdi tieu chuan nay doi vdi cong viec dUdc yeu c iu
6 Dich vu mua sam va nguon cung cap
PTN phai cd chinh sach, thii tuc ve liia chon va sii dung dich vu mua
s im dung cu, thiet bi, thuoc thii va cac hoa chat, vat lieu can sii dung co lien quan den hoat dong thii nghiem va hieu chuan PTN phai dam bao
r in g cac nha cung iing, cac thuoc thii va vat lieu tieu thu dude mua cd anh hiidng tdi chat liidng ciia cac phep thii va/hoac hieu chuan se khdng diidc sii dung cho den khi chung diidc kiem tra va hieu chuan hoac phai dUdc xac nhan la da phu hdp vdi quy dinh ky thuat tieu chuan hoac cac yeu cau diidc quy dinh trong cac phudng phap thii nghiem va/hoac hieu chuan lien quan Cac dich vu va hang cung cap diidc sii dung phai tuan thii theo yeu cau da qui dinh Phai cd va liiu giii ho sd m inh chiing ve hoat dong kiem tra sii phu hdp nay
Tai lieu mua s im ndi chung hay cac ddn dat hang cu the cho nhiing hang muc cd anh hudng tdi chat lifdng thu nghiem hieu chuan phai md ta rd, chang han chiing loai, cap, hang, nhan dang chinh xac, qui dinh ky thuat,
hudng dan kiem tra, so lieu ky thuat khac bao gom viec chap nhan cac ket
qua thii nghiem, chat liidng yeu cau va chuan miic he thong chat lifdng cua
cd sd san xuat cung cap cac san pham dd
PTN phai danh gia nang liic cac nha cung cap vat tu, dich vu chu yeu
cd anh hudng den chat lifdng ciia thii nghiem va hieu chuan va phai duy tri, cap nhat cac ho sd danh gia, danh sach nha cung cap dUdc phe chuan nay
Trang 6Trudng dai hoc Y te cdng cong Quan ly chat li/png san xuat thuoc
7 Dich vu doi vdi khach hang
PTN phai tao dieu kien cho khach hang hoac dai dien cua khach hang co dieu kien hdp tac de lam rd cac yeu cau cua khach hang va de theo ddi hoat dong cua PTN n h im dam bao dUdc tmh bao mat doi vdi khach hang khac Sii hdp tac nay co the the hien qua viec:
Tao dieu kien cho khach hang hoac dai dien cua khach hang tiep can mot cach hdp ly vdi cac llnh vUc lien quan cua PTN de chiing kien thuc hien cac phep thii va/hoac hieu chuan cho khach hang, chiing kien viec chuan bi, dong goi va giii cac mau thii va/hoac hieu chuan do khach hang yeu cau vi muc dich tham tra;
Thong bao cho khach hang bat cii sii cham tre nao hoac co thay doi ldn lien quan tdi cong viec thii nghiem va/hoac hieu chuan
Quan tam moi thdng tin phan hoi ciia khach hang, ke ca thong tin tich ciic va tieu ciic va sii dung cac thong tin nay de cai tien he thong chat liidng, cac hoat dong thu nghiem va hieu chuan cung nhii cung cach phuc
vu khach hang
8 Khieu nai
PTN phai co chinh sach va thii tuc de giai quyet cac khieu nai cua khach hang hoac cac ben khac PTN phai lUu giut ho sd cua tat ca cac khieu nai, cac lan dieu tra cung nhu ket qua ciia cac hanh dong khac phuc doi vdi cac khieu nai
9 Kiem soat cong viec thii nghiem va/ hoac hieu chuan khong phu hdp
PTN phai co chinh sach va thii tuc de ap dung khi co bat cii cong viec thii nghiem va/hoac hieu chuan ciia PTN hoac ket qua ciia cong viec khong phu hdp vdi cac thii tuc ciia PTN hoac cac yeu cau da thoa thuan vo'i khach hang Chinh sach va thu tuc nay phai dam bao rin g:
a Xac dinh trach nhiem va quyen han de quan ly cong viec khong phu hdp nha tam ngiing cong viec, tut chol khdng lam bao cao thu nghiem, tam ngu'ng cap chung chi hieu chuan khi can thiet
b Danh gia muc do va tinh nghiem trong ciia cong viec khdng phu hdp
c Phai cd hanh dong k h ic phuc dUdc thuc hien ngay lap tiic cung vdi moi quyet dinh ve kha nang chap nhan cdng viec khdng phii hdp
d Khi can thiet PTN phai thdng bao cho khach hang va thu hoi lai ket qua cdng viec khdng phu hdp;
e. Dinh rd du'dc trach nhiem ve quyen han cho phep tiep tuc cdng viec Cac cdng viec khdng phu ho'p hoac cac van de khdng phu hdp phat sinh
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Trang 7Trudng dai hoc Y te cdng cong Quan ly chat luong san xuat thuoc
trong he thong chat liidng hoac trong cac hoat dong thii nghiem va/hoac hieu chuan co the xay ra tai nhieu ndi khac nhau trong he thong chat liidng Vf du: Khieu nai cua khach hang, viec kiem soat chat liidng, hieu chuan thiet
bi, kiem tra cac vat lieu tieu thu, giam sat nhan vien, thanh tra, bien ban va viec kiem tra giay chiing nhan, viec xem xet ciia lanh dao va cac cuoc danh gia noi bo hoac ben ngoai Khi viec danh gia chi ra r in g cdng viec khdng phu hdp co the lai xay ra hoac co nghi ngd ve sii phu hdp so v6i cac chinh sach va cac thii tuc cua PTN thi phong thii nghiem can ap dung ngay thu tuc hanh dong k h ic phuc du6i day
10 Hanh dong khac phuc
PTN phai xay diing chm h sach, thii tuc va phai phan cong cac trach nhiem thich hdp de thiic hien hanh dong k h ic phuc (la hanh dong dUdc tien
hanh de loai bo cac nguyen nhan gay ra tinh trang khdng phu hdp von di
dang ton tai, dong thdi de ngan chan sii tai d iin tinh trang khong phu hdp do) khi xac dinh dUdc cong viec khdng phu hdp hoac cac sai khac so v6i chinh sach va thu tuc trong he thong chat liidng hoac cac hoat dong ky thuat V6i nhiing sii khdng phu hdp ma nguyen nhan ciia no da rd ta co the tien hanh ngay cac hanh dong khac phuc nhung vdi cac trUdng hdp nguyen nhan cua
no chua rd hoac cd the co nhieu nguyen nhan thi van de phan tich tim ra va xac dinh miic do quan trong cua chung de de ra bien phap khac phuc lai la mot dieu rat can thiet va kho khan Thdng thiidng thu tuc ve hanh dong khac phuc phai dUdc b it dau bang mot cuoc dieu tra de xac dinh cac nguyen nhan chinh ciia van de Do cac nguyen nhan chinh lai khdng rd rang nen viec nay doi hoi can phan tich can than tat ca cac nguyen nhan tiem an co the xay ra Cac nguyen nhan tiem an co the bao gom: Viec lay, xii ly, liiu mau, cac yeu cau cua khach hang, qui dinh ky thuat cua m lu , phudng phap
va thii tuc, tay nghe va dao tao nhan vien, chiing loai chat liidng vat lieu tieu thu hoac thiet bi va viec hieu chuan thiet bi Phong thu nghiem phai xac dinh hanh dong k h ic phuc va phai liia chon, thiic hien hanh dong kh ic phuc co the thiic hien d§ nhat de loai trii van de va ngan chan no tai dien Vi
ly do nay cac hanh dong k h ic phuc phai diidc xem xet sao cho tiidng xiing v6i miic do quan trong va sii nguy hiem cua van de Sau khi thiic hien cac hanh dong k h ic phuc neu co nhiing thay doi nay sinh tii viec dieu tra nghien ciiu ve hanh dong k h ic phuc thi PTN phai lap van ban de thong bao va cho
ap dung nhiing thay doi do
V6i nhiing giai phap k h ic phuc da neu PTN phai kiem soat ket qua de dam bao hanh dong khac phuc da thiic hien la co hieu qua Trong trUdng hdp can thiet hoac khi phat hien co sii khdng phu hdp hoac sai khac gay nghi ngd ve sii phu hdp ciia PTN thi PTN phai dam bao r in g tai cac linh viic
co nghi ngd do se dUdc danh gia xem xet bo sung kip thdi
Trang 8Trudng dai hoc Y te cdng cdng Quan ly chat luong san xuS't thudc
11 Hanh dong phong ngvfa
Khong chi vdi nhting si1 khong phu hdp da xay ra, phong thu nghiem
phai xac dinh nhiing cai tien can thiet cho nhiing sii khdng phu hdp tiem an
ca ve mat ky thuat lin he thong chat liidng, nghia la phai xac dinh cac hanh dong phong ngiia de loai bo mot sd" nguyen nhan cd kha nang gay ra sii khdng phu hdp, xay dting ke hoach hanh dong, thtic hien va kiem soat hanh dong dd; so v6i hanh dong khac phuc Hanh dong phong ngiia la mot qua trinh "cd xu the chu dong" de xac dinh cac cd hoi cai tien hdn la mot phan iing ddi pho n iy sinh tii viec xac nhan van de da phat sinh hoac khieu nai
12 Kiem soat ho sd
Ho sd cd the la d bat cii hinh thiic nao vi du ban in may tinh hoac ban lUu dien tii Ho sd la chiing cd minh chiing cho cac hoat dong cua phong thii
nghiem do dd PTN phai thiet lap va duy tri cac thii tuc de ma hoa, tap hdp,
danh so, truy cap, lu'u trii, duy tri va thanh ly cac ho sd chat liidng va ky
thuat sao cho cd the de dang truy tim va dUdc liiu giuc trong mot mdi triidng thich hdp de ngan chan hu hong hoac xuong cap cung nhu phong ngiia mat mat Thdi gian lUu giii tiing loai ho sd phai dUdc quy dinh cho phu hdp v6i nhu c iu sii dung hoac cac yeu cau phap ly Tat ca cac ho sd phai diidc liiu giii an toan va dam bao tinh bao mat Vdi cac loai ho sd diidc lUu giii trong may tinh, PTN phai co cac thii tuc de bao ve va sao lai sd" lieu va ngan ngiia viec tiep can khdng diidc phep hoac tinh trang sUa doi dii lieu
Vdi cac loai ho sd lien quan dac tinh ky thuat, nhu tap hdp dii lieu va thdng tin co du'dc khi thiic hien cac phep thii va/hoac hieu chuan va chi ra so" lieu thdng so" ciia qua trinh va chat liidng qui dinh cd dat diidc hay khdng
Ho sd ky thuat co the bao gom cac bieu mau, hdp dong, phieu lam viec, so ghi chep td rdi kiem tra, sd ghi chep cdng viec, do thi kiem soat, bien ban va giay chiing nhan hieu chuan noi bo va ben ngoai, thdng bao ciia khach hang
va thdng tin phan hoi v.v PTN phai liiu giii ho so ciia cac quan trie goc, so" lieu da truyen d in va thong tin can thiet de thiet lap mot cuoc danh gia, ho
sd hieu chuan ho sd nhan vien va mot ban sao cua mdi bao cao thii nghiem hoac chiing chi hieu chuan da ban hanh trong mot thdi gian nhat dinh Ho so' doi vo'i moi phep thu' hoac hieu chuan phai liiu giu day dii cac thong tin de tao dieu kien xac dinh cac yeu td" anh hudng den do khdng dam bao do neu
co the va de tao dieu kien cho cac phep thu va hieu chuan diidc lap lai du6i dieu kien gan vdi dieu kien ban dau nhat Cac ho sd phai bao gom ca viec xac dinh ngudi chiu trach nhiem lay m lu , thtic hien tiing phep thii va/hoac hieu chuan va ngudi kiem tra ket qua
Khi trong cac ho sd co sai loi, phai diidc gach ngay len sai loi do, khong du'oc tay xoa, lam cho kho doc hoac phai xoa bo va phai ghi thong tin dung
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Trang 9Truong dai hoc Y te cong cong Quan ly chat lupng san xuat thuoc
ben canh Tat ca cac thay doi trong cac ho so phai difdc chinh ngiidi sUa chiia
ky xac nhan hoac viet t a t ten Trong triidng hdp ho sd diidc liiu giii trong may tinh, phai co bien phap tUdng xting de tranh mat mat hoac thay doi so" lieu goc
13 Danh gia noi bo
PTN phai dinh ky tuan thu mot ke hoach va thu tuc da xac dinh thiic hien danh gia noi bo cac hoat dong cua PTN nham tham tra xem cac hoat dong cua PTN con tiep tuc tuan thu cac yeu cau cua he thong chat lifdng hay khdng ChUdng trinh danh gia noi bo phai chi rd tat ca cac yeu td" cua he thong cha"t lifdng, bao gom cac hoat dong thu nghiem va/hoac hieu chuan Phu trach cha"t lifdng co trach nhiem lap ke" hoach va td chiic danh gia theo ke" hoach va theo yeu c iu cua lanh dao Viec danh gia nay phai dtidc nhiing ngtidi da qua dao tao va co trinh do chuyen mon, co cac nguon liic cho phep, doc lap vdi linh viic hoac pham vi hoat dong diidc danh gia thiic hien Tai cac phong thii nghiem 16n, yeu c lu nay thuan ldi hdn vi nhiing ngtidi da dtidc dao tao tai cac bo phan khac nhau co the thtic hien cac cuoc danh gia cheo cho nhau va nhti vay co the dam bao tinh khach quan doc lap Tai cac phong thii nghiem nho, viec nay co the dtidc thtic hien theo cach linh dong hdn, chang han bd" tri cac trtidng nhom, trtidng cac bo phan danh gia lan nhau Dieu quan trong la nhting ngtidi danh gia phai am hieu ve cac thu tuc, cac hti6ng dan ma bo phan bi danh gia dang ap dung de tti dd phat hien ra nhting dieu khdng phti hdp, giup ho hoan thien cong viec hdn
14 Xem xet cua lanh dao
Xem xet cua lanh dao ve chat lifdng la cuoc hop do ban lanh dao to chtic
de kiem tra viec tuan thii qui dinh trong he thong chat liidng HTCL, sti phti hdp cua HTCL da xay dting do"i v6i yeu cau thtic tien, tinh hieu qua cua viec
ap dung he thong chat lifdng hien hanh va cac van de lien quan cac yeu cau
ve cha"t lu’dng trong hoat dong kiem tra thti nghiem hieu chuan Sau hay mtidi hai thang mot lan, lanh dao PTN phai dinh ky thtic hien mot cuoc xem xet he thong cha"t ltidng nhti vay Cuoc xem xet nay phai de cap t6i:
- Sti phu hdp ciia chinh sach va cac thu tuc
- Cac bao cao ciia ngtidi quan ly va giam sat
- Ket qua cua danh gia noi bo gan day
- Hanh dong khac phuc va phong ngtia
- Cac cuoc danh gia cua cac td chtic ben ngoai.
- Ket qua so sanh lien phong hoac thii nghiem thanh thao
- Cac thay doi ve khoi ltidng, pham vi cong viec
Trang 10Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc
- Thong tin phan hoi tu! khach hang.
- Khieu nai
- Cac yeu to' lien quan khac nhu: Cac hoat dong kiem soat chat ltidng, nguon ltic va dao tao nhan vien
Phai cd ho sd ghi lai moi phat hien tti cuoc xem xet cua lanh dao va cac hoat dong phat sinh tti cuoc xem xet nay Lanh dao phai dam bao sao cho cac hoat dong nay thtic hien trong khoang thdi gian thi'ch hdp nhti da thoa thuan
III CAC YEU CAU VE NANG Ll/C KY THUAT
1 Yeu cau chung
Co nhieu yeu to' xac dinh mtic do chinh xac va do tin cay cua phep thti va/hoac hieu chuan do PTN thtic hien Chang han yeu to' con ngtidi; dieu kien tien nghi va mdi trtidng; phtiong phap thti, hieu chuan va hieu ltic cua phuong phap; thiet bi; tinh trang dan xuat chuan do ltidng; cac van de lien quan thu tuc lay mau; cac van de quan ly mau thti nghiem va hieu chuan.v.v Mtic do ma cac yeu to" ndi tren gop phan gay ra do khdng dam bao chung cho cac ket qua thti nghiem, hieu chuan cd sti khac nhau dang ke gitia cac loai phep thu va cac hinh thtic hieu chuan PTN phai tinh den cac yeu to' nay khi xay dting cac phtidng phap va thu tuc thti nghiem va/hoac hieu chuan, cac yeu to' dao tao va trinh do cua nhan vien cung nhti yeu to' ltia chon, hieu chuan thiet bi ma PTN dang sti dung
Lanh dao PTN phai dam bao de tat ca nhting ngtidi thao tac cac thiet bi
cu the nhting ngtidi thtic hien thti nghiem, hieu chuan, danh gia ket qua phai co trinh do ky nang thich ting Neu co sti dung nhan vien dang dtidc dao tao thi phai cd su giam sat thich hdp ciia nhting ngu'di da cd kinh nghiem Cac nhan vien thtic hien cac nhiem vu cu the phai la ngtidi co trinh do, cd cd
sd ve trinh do giao due dao tao, kinh nghiem thich hdp va/hoac cac ky nang
co the chting minh dude khi dude yeu cau Chang han trong mot so' linh vtic nhti thii nghiem khong pha huy, nhting ngtidi thtic hien cac nhiem vu cu the phai la nhting nguoi co chting nhan hanh nghe PTN phai chiu trach nhiem dap ting cac yeu cau ve chting nhan hanh nghe Cac yeu cau ve chting nhan hanh nghe cd the la qui dinh hoac cd the bao gom cac tieu chuan ve linh vtic
ky thuat cu the hoac do khach hang yeu cau
Nhan vien chiu trach nhiem nhan xet va dien giai trong bao cao thti nghiem phai co trinh do, dtidc dao tao, co kinh nghiem phu hdp va co kien thtic thich hop ve phep thii dtidc thtic hien Chang han:
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