Quy trinh phan loại ttbyt

cqI{G IroA xA HQr cr{u NGr{iA viEr.r{.,rM

TRU'ONG CDN KY THUAT
THIET BI Y TE

DQc l4p -

W

TRUNG TAM DICH

KTTBYT

Tg'do - Flanh phric
Hd Noi, ngdt'\frhang

I

nam 2017

QUY TRINH

TIEr NHAN Ho so va rnA KET euA psars LOAr r'l'Byl( Ban

hdnh kem theo Phieu ti€p nhdn Ho so cong bo dtt dieu kiin phcin locri

: ,-^^

sri.170000010/PCBPL-BYT c'ua Bo y te ngd.t'29,t3i'2017

trcutg,

thitt bi r tti

1

1. MUC DiCH VA PI{AM VI AP DIJNG:

-

Vdr.r bAn ndy

quy dinh trinh tu vd c6ch thirc thuc hi6n cdng t6c ti€p nhdn ho so vd trA k6t

,1

quA cho cac t6 chuc/don
vr,r

-

k!

vi c6 nhu cAr"r ddng hy phAn loai trang thiet bi y t€ tai Trung

tArn dich

thi6t bi y t6 - Truong Cao ding nghd k! thLrAt thi6t bi y t€ (goi tdt ld -l-rr-rrrg tAm).

thr,rAt

Vdn bAn ndy duo-c 6p clung cho c6ng tiic ti6p nhdn hd so' vd trA k6t

qLrA phAn

loai trang

thiet bi y t6 do bQ phan ti6p nh6n vd giao tr6 hd so cta Trung tAm thLrc hi0n.

DIM{ NGHIA, Ttl\fIET rAr Va TAr LIEU LrEN QUAN:
2.1. Einh nghia, til vi6t tit:
2.

-

Cfn

bQ

ti6p nhfln: ld bd phdn ti6p nhdn

cua Trung tdrn dich vLr

-

Chc

k!

thLrAt

116

so

vdr

tra h€t qua phAn loai theo su phAn ci,rrg

thi6t bi y t€, trr.Ldrrg Cao ding nghe f;., thLrdt'I'hier bi Y

thuit ngir, clinh nghia c6 li€n quan du'o-c sil dung

rC.

theo TieLr clruan TCVN ISO

9000:2000.

2.2.Titl li6u li6n quan:

-

Xem Phg lgc 1: "Danh mgc

tii

liQu li6n quan".

3. NQr DUNG:

3.1. Luu cI6 qud
Co sd y6u

trinh:

clu phin loai

BQ phQn

TTBYT

Xir

ti6p nhin

BAt deu

so phan ioai
TTBYT

t1i trO

T6 chuydn nron li6p Irhan. ru ri
va lap bi6n ban phan lo?i TTBYT

I

Nop h6 sq y6u ciiu
phen lo?i TTBYT
Giam dt,c TTDV kV

phan loai TTBYT

l

Tidp nh,n,

huing

dan

Xec nhan

bi:rn

<-

Ycu cdu ho*n

thi6n lai

hO

so

I

Luu ho so'
va heu kiom

Ki6m tr6

Lu,u hd so

Xec nh?n

-

Thu h6i kdl Oua
ph,'n loai TTBYT

!
Nhan k5t qui phan
loai TTBYT

I

f

xilt tnuc
Ltrxil:
\!rbsir:
Plnr.r:

cn!(r.rd\.r'snriil..!nl
trcFrrll'icrb!]l(.r(i!.!nl

09!J.S23.lll/'tll!.i9i-l?t

LAp lai ban phan loai
TTBYT

3.2. Ti6p nhiin hd so:

-

C6c td chfic/don vi c6 nhu cAu ddng ky phAn loai trang thi6t bi y t6 cAn nOp ho str cho

c6n b6 ti6p nhAn h6 so cira trung

tArr-r.

-

Hd so dd nghi phAn loai c6 th6 dtLo-c n6p trurc ti6p tai Trr.rng tAm. qua clLlong buLr cliOrr.

hodc

qr-ra

Ernail theo dia chi: I'rung

tim Dich vq Ky thu4t [hi61 bi Y t6

Ngudi nh$n: C6. Nguy6n I'hi Binh / Mobile: 0984.823.034
Dia chi: 56 1, ngd tl9, LLrong Dinh Cira, P. Phuong Mai, Q. Ddng Ea, TP. I Ia Ndi
Di€n tlroai: 043.51 6.3450

F'ax: 043.576.0ti71

Email:

-

C6n b6 ti6p nhAn s0 c6 trdch nhi€m trao ddi, ldrn ho-p dong vo'i t6 chrLc/do'n vi dang ky

phAn loai, trinh gi6rn cl6c trung tArn ph€ duydt, sau d6 se chuy6n h6 so cho t6 chuy€n rn6n
phAn

loaivd tra k6t

qr-rA

cirng nhr-rthanh ly

ho.

p ddng cho t6 chfLc/cfo'n

vi darrg

l
3.3. Ki0m 1ra, xem x61h6 so:

-

Cdn

.:

cfiNghi dinh s6 3612016ND-CP ngdy l5 thang 5 rram 2016

cLra

Chinh phLr. can b0

..,1

tiep nlrdn kiern tra va hr-r6ng d6n hodn thi6n ddy dt vd hop l0 cira bd h6 so.

-

I(hi h6 so dd dat y€u cAr,r, cAn b0 tiep nhAn lAp Phi6u ti6p nhAn h6 so (theo

rn6Lr

PL - 0l)

-: trung tAm dC ky kdt ho-p d6ng kinh te, x6c dinh thoi gian trA kdt qLrh voi td
vd trinh gidm doc

\
; TA;\
i rHuir).'
IY
rt'/^; .

g

chilc/don vi nOp h6 so. Ho-p ddng kinh t6 l6p thdnh b6n bAn, m6i ben giil hai bdn.

- Sau khi hodn thdnh ho-p dong, c6n bQ ti6p nhAn cAp nhAt h6 so vdo Sd theo d6i giai qu,-5t
':ho so cua trung tarrr (bietr rnAu Pl. - 02).
3.4. Birn giao hd so cho td chuy6n mdn

-

giii quy6t:

Sau khi ti€p nhAn hd so', cdn cir y6u cAu cira bd hd so, crin bd ti6p nhdrr cci tr6ch rrlri6m

. .:

ban giao ho so ngay trong ngdry cho t6 chr-ryOn rn6n phu tr6ch llrrh vuc ctuo-c phAn c6ng de ti0n
hdnh phan loai, trong trr-rd'ng ho-p h6 so clu'o'c nhdn vdo cu6i gio'chi6r-r ldrn vi€c thi biur giao ho

.

,).

so vao dau gio larn vi€c cira ngdy h6m sau. Khi giao nhAn ho so, t0 tritdng td chuvcn mon
ki€rn tra vd ky nhAn vdo Phi5u ti6p nhAn hd so (bi6Lr rnALrI'L - 01).

-

_i

,

:

To trurong td chuy€n mdn c6 tr6ch nhi€rn xem xdt h6 so'vd phAn c6ng t6 vi€rr ti6n hdnh

Ph6n loai trang thi6t b! y t6.

-

fet

qLrA phAn

loai clo t6 vi€n thuc hi€n, dLlo-c t6 chr.rydn mdn thdng nhAt, lQp thdnh biOn

bdn phAn loai TTBYT, trinh gi6rn d6c Trung tArn phd dLrydt.

-

Trong qu6 trirrh gidi quy6t,

chiLc/don

vi

n6Lr

nOp h6 so, c6c th6ng

c6 y€u

tin trao

cALr

trao d6i th6ng tin giLla t6 chuyer-r morr rtii ttl

OOi lUao

g6m

vin

ban di vd vdn bAn d6n) pliai thong

':

qua can bo trep rll-lan.

3.5.

Tri

-

C6n bQ ti6p nhAn ld dAu rnOi nhdn k5t quA phArr loai

k6t qui vir luu hd so:

Trung tArn phd duydt.

cr,ra 1o chLrye

n rndn. trinh giiirl

el6c


-

Tru'dng hop hhong th€ gi6i quy€t ho so'theo dirng thd'i gian qr,ry dinh nhLr cl6 hen thi c6n

b0 ti6p nhdn c6 tr6ch nhi€m thdng bao cho t6 chfic/don vi bi6t ly
';
-

Ket qua.
Sau

khi nhAn k6t qu6 phdn loai, cdn cf'vdo tho'i gian hen trA hd so'trong gi6y biOn

nhAn,

: ,^
can bd ti€p nhdn ban giao kdt qua phAn loai vd thanh l1i ho. p ddng cho b€n ndp hd so.
-

Khi tri k6t quA, c6n bd ti6p y6r-r cAr-r t6 chirc/clon vi n6p h6 so
r , :. .,..r. :
quyet ho so (bidu rnau PL - 02).

-

l<1,,

nhdn vao s6 tlrco cldi giai

Circ bQ phAn chuydn m6n c6 triich nhidrn lLlu hd scr vd k6t qua phAn loar theo cluy ciinh tai

c6c quy trinh li€n qr"ran.

4.I{O

SO:

TT

I
2

Don vi

H6 so gdm

quin lf

Cfch luu

Thcri gian
lu'u

Phi6u ti6p nhAn ho so

05 nitrn

So rheo doi giai quy€t ho so

Li€n

Tai lieu k! thu6t rnd tA torn

tit k!

tr,rc

thuar trang thiet bi

05 rram

yt6

bd Theo trinh tr"t
tiep nltan thot gtan
C6n

4o
,7

4

IHIE

i

I

)

,

'5.-sScrre.

:

05 nlirn

v6t li6u ki6m so6t in vitro

TRUI{
lCH VU

Tai li€u kV thudt O6i vOi thuoc thu. chdr hieu chtrarr. .:

6

Tdi lieu rno ta rom tat diI lieu thLr ltirn:arrg trarrg tlriit
b!

05 nAm

ytd

B6n phdn loaiTTBYT

s. PHV

LUC

:

1:

5.1. Phu lgc

05 ndrn

Danh rnuc tdi li€u li€n quan

Tdn tdri li6u

xgt i Or"-ni6

:OZzO t

O,,i.lo-Cp

qr*

l)t

tmg tnifUiy

te

Danh s6ch t6 chuy€n m6n thuc hi6n PI-TTBYT

5.2. Phu lgc 2: C6c bi€u m6u, bao gdrn

.I'T

'l'en bieu miu

Kf

hiQu

l

Phi€u ti6p nhAn hd so'

PI, .0l/TT'I)V

2

So theo doi giai quyet ho so

^: ,

PI, - O2II'TDV

-l

Ho-p ddng

4

Ban phAn loai TTBYT

PI, - O4/'T'I'I)V

5

Thanh ly

PL,

6

Bi€n b6n Ph0n loai c0a Td chuy€n m6n TTBYT

,:.

PLTTBYT

ho.

p ddng

PI, _ O3/TTDV

Os/T"I'DV

PL - O6/TTDV


7

Md td tom tdt

o
o

Tdri lieLr

o

Thu

li!

thLrdt trarrg

PI - il7l't"['t)\

thi€t bi 1't€

PL .08/T'I'DV

li.j thuat irr r itlo

PL - Og/TTDV

lArrr sdng

GIAM DOC
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