TIU CHUN QUC GIA

TCVN 7777-1 : 2008

ISO/IEC GUIDE 43-1 : 1997
TH NGHIM THNH THO BNG SO SNH LIN PHNG TH NGHIM - LN 1: XY DNG V
TRlN KHAI CC CHNG TRNH TH NGHIM THNH THO
Proficiency testing by interlaboratory comparisons- Part 1: Development and operation of proficiency
testing schemes
Li ni u
TCVN 7777-1 : 2008 hon ton tng ng vi ISO/IEC Guide 43-1 : 1997.
TCVN 7777-1 : 2008 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 v Cng ngh
cng b.
TCVN 7777-1 : 2008 l mt phn ca b tiu chun TCVN 7777 (ISO/IEC Guide 43). B tiu chun
ny gm 2 phn c tn chung Th nghim thnh tho bng so snh lin phng th nghim:
- Phn 1: Xy dng v trin khai cc chng trnh th nghim thnh tho.
- Phn 2: La chn v s ng cc chng trnh th nghim thnh tho ca t chc cng nhn
phng th nghim.
Li gii thiu
So snh lin phng th nghim (sau y gi l so snh lin phng) c thc hin vi nhiu mc ch
v c th c s tham gia ca cc phng th nghim v cc bn khc
V d, so snh lin phng c s dng :
a) xc nh vic thc hin ca cc phng th nghim ring l i vi cc php o hoc th nghim c
th v theo di hot ng lin tc ca cc phng th nghim
b) nhn bit cc vn trong cc phng th nghim v c ngay nhng hnh ng khc phc v d
nh lin quan n nhn vin thc hin hay hiu chun thit b;
c) thit lp tnh hiu lc v kh nng so snh ca cc phng php th hay phng php o mi v
tng t nh vy theo di cc phng php c thit lp;
d) cung cp thm bng chng cho khch hng ca phng th nghim;
e) nhn bit s khc nhau gia cc phng th nghim;
f) xc nh cc c im tnh nng ca phng php - thng l th nghim phi hp;
g) n nh gi tr cho mu chun v nh gi s ph hp s dng trong cc quy trnh o lng v
th nghim c th.
Th nghim thnh tho c dng trong so snh lin phng vi mc ch a), ngha l xc nh vic
thc hin hot ng o lng v th nghim ca phng th nghim. Tuy nhin vic trin khai cc
chng trnh th nghim thnh tho cng thng cung cp thng tin cho cc mc ch khc nu
trn.
Vic tham gia vo cc chng trnh th nghim thnh tho cung cp cho cc phng th nghim tin
cy v cc d liu m h a ra vi phng php nh gi v th hin khch quan. Mc d c mt
s loi chng trnh th nghim thnh tho (xem iu 4), nhng phn ln u c c trng chung v
so snh kt qu th nghim, o lng thu c t hai hay nhiu phng th nghim.
Mt trong s cc u im chnh ca cc chng trnh th nghim thnh tho l nh gi nng lc
thc hin php th mt cch thnh tho ca cc phng th nghim. Vic ny c th bao gm vic t
nh gi ca phng th nghim, nh gi ca khch hng hoc ca cc bn khc nh cc t chc
cng nhn, hoc c quan c thm quyn. V vy n s b sung cho cc th tc kim sot cht lng
ni b ca cc phng th nghim thng qua vic cung cp bin php b sung bn ngoi v kh nng
th nghim ca h. Hot ng ny cng nng cao k thut nh gi ti ch phng th nghim ca cc
chuyn gia k thut (thng c s dng bi cc t chc cng nhn phng th nghim). S tin cy

vo kt qu m phng th nghim hay hiu chun t c mt cch nht qun l iu c tm quan

trng ln i vi khch hng s dng dch v th nghim. Nhng khch hng tm kim s m bo
nh vy c th t nh gi cc kt qu th nghim hoc s dng vic nh gi ca cc t chc
khc.
Trong khi tiu chun ny nhn mnh vo vic trin khai hot ng so snh lin phng i vi th
nghim thnh tho, th phn ln cc nguyn tc v hng dn c a ra c th p dng cho vic
trin khai cc so snh lin phng vi nhng mc ch khc.
Trong khi c nhiu t chc cng nhn phng th nghim trin khai cc chng trnh th nghim thnh
tho ca ring h, th cng c mt s lng ng k s dng cc chng trnh th nghim thnh
tho hoc cc phng thc so snh lin phng khc do t chc khc thc hin. Mc ch ca TCVN
7777-2 : 2008 l a ra cc nguyn tc hi ha cho vic la chn phng thc so snh lin phng
ph hp dng lm chng trnh th nghim thnh tho ca cc t chc cng nhn phng th
nghim.
Phn ln cc t chc nh gi nng lc k thut ca phng th nghim yu cu hoc mong i vic
thc hin tho ng cc chng trnh th nghim thnh tho nh l bng chng quan trng v kh
nng a ra cc kt qu tin cy ca phng th nghim (tr trng hp th nghim thnh tho l
khng thch hp).
Tuy nhin cn nhn mnh rng c mt s khc bit ln gia:
a) nh gi nng lc phng th nghim thng qua vic nh gi ton b hot ng da trn cc yu
cu c xc nh, v
b) vic kim tra kt qu tham gia th nghim thnh tho ca phng th nghim ch c th c xem l
cung cp thng tin v nng lc k thut ca phng th nghim mt thi im nht nh trong cc
iu kin c th ca php th (hay cc php th) trong mt chng trnh th nghim thnh tho c
th.
Tiu chun ny c tham kho mt s ti liu hng dn lin quan n th nghim thnh tho ca cc
t chc: ILAC; ISO (TC69); ISO/REMCO; IUPAC; AOAC; ASTM v WECC, WELAC (nay st nhp
thnh EAL).
TH NGHIM THNH THO BNG SO SNH LIN PHNG TH NGHIM - LN 1: XY DNG
V TRlN KHAI CC CHNG TRNH TH NGHIM THNH THO
Proficiency testing by interlaboratory comparisons- Part 1: Development and operation of
proficiency testing schemes
1. Phm vi p dng
Trong khi c nhiu u im ca vic so snh lin phng cng vi s a dng trong thit k v thc
thi, th vn c th quy nh nhng nguyn tc thit yu cn c xem xt khi t chc vic so snh
ny. Tiu chun ny xc nh cc nguyn tc v m t cc yu t tnh n trong t chc v thc hin
cc chng trnh th nghim thnh tho.
TCVN 7777-2 : 2008 m t cch thc m t chc cng nhn phng th nghim nh gi nng lc k
thut ca cc phng th nghim, cn la chn v s dng cc chng trnh th nghim thnh tho.
Tiu chun ny nhm mc ch s dng cho ngi trin khai v ngi s dng chng trnh th
nghim thnh tho nh cc phng th nghim tham gia, t chc cng nhn, c quan c thm quyn
v khch hng ca cc dch v th nghim c nhu cu nh gi nng lc k thut ca phng th
nghim. Tiu chun ny cng c bit hu ch trong vic t nh gi ca cc phng th nghim,
nhng cng phi tha nhn rng th nghim thnh tho ch l mt phng php c th gp phn
vo vic thit lp s tin cy ln nhau gia nhng ngi s dng cc phng th nghim khc nhau.
Hin ti y cng l iu kin ca mt s t chc cng nhn yu cu cc phng th nghim tham gia
thng xuyn vo cc chng trnh th nghim thnh tho m t chc cng nhn chp nhn l
ph hp v mc ch. V vy, iu thit yu l nhng ngi trin khai cc chng trnh th nghim
ny phi tun th cc nguyn tc qun l mt cch chuyn nghip cc chng trnh th nghim
thnh tho trong c yu cu k thut, th tc thng k (xem v d trong Ph lc A) v trong qun l
cht lng (xem hng dn trong Ph lc B).

Phng php trin khai trong phm vi cc t chc th nghim thnh tho khc nhau khng nht thit
phi hon ton tng ng v tiu chun ny khng a ra hng dn chi tit cho hot ng trin
khai c th trong so snh lin phng. Ni dung ca tiu chun ch nhm thit lp khun kh chung
trn c s c th sa i cho ph hp vi tng hon cnh c th, bao gm c nhng chng
trnh c s lng ngi tham gia nhiu hay t.
Tiu chun ny khng cp n k thut m cc t chc thng dng nh gi vic thc hin
ca phng th nghim n l thng qua vic giao np mu chun c chng nhn hoc cc mu th
nghim tiu biu khc.
Th mc ti liu tham kho c nu trong Ph lc C.
2. Ti liu vin dn
Cc ti liu vin dn di y rt cn thit cho vic p dng tiu chun ny. i vi cc ti liu ghi
nm cng b th p dng bn c nu. i vi cc ti liu khng ghi nm cng b th p dng bn
mi nht, bao gm c cc sa i.
ISO 3534-1:1993, Statistics - Vocabulary and symbols - Part 1: Probability and general statistical
terms (Thng k - T vng v k hiu - Phn 1: Xc sut v thut ng chung v thng k)
TCVN 6910-1 : 2001 (ISO 5725-1 : 1994), chnh xc ( ng v chm) ca phng php o
v kt qu o - Phn 1: Nguyn tc v nh ngha chung
TCVN 6910-2 : 2001 (ISO 5725-2 : 1994), chnh xc ( ng v chm) ca phng php o
v kt qu o - Phn 2: Phng php c bn xc nh lp li v ti lp ca phng php o
tiu chun
TCVN 6910-4 : 2001 (ISO 5725-4 : 1994), chnh xc ( ng v chm) ca phng php o
V kt qu o - Phn 4: Cc phng php c bn xc nh ng ca phng php o tiu chun
B tiu chun TCVN ISO 9000 v H thng qun l cht lng
TCVN 6450 : 2007 (ISO/IEC Guide 2 : 2004), Tiu chun ho v cc hot ng lin quan - Thut ng
chung
TCVN ISO/IEC 17025 : 2007 (ISO/IEC 17025 : 2005), Yu cu chung v nng lc ca phng th
nghim v hiu chun
TCVN 7777-2 : 2008 (ISO/IEC Guide 43-2 : 1997), Th nghim thnh tho bng so snh lin phng
th nghim - Phn 2: La chn v ng dng chng trnh th nghim thnh tho ca t chc cng
nhn phng th nghim
Guide to Expression of Uncertainty in Measurement: 1993, issued by BIPM; IEC; IFCC; ISO; IUPA;
IUPAP; OIML (Hng dn th hin khng m bo o do BIPM; IEC; IFCC; ISO; IUPAC; IUP/
OIML ban hnh)
International vocabulary of basic and general terms in metrology : 1993, issued by BIPM; IEC; IFCC;
ISO; IUPAP; OIML (T vng quc t v thut ng chung v c bn trong o lng do BIPM- IEC;
IFCC; ISO; IUPAP; OIML ban hnh) [VIM 1993]
The international Harmonized Protocol for the Proficiency Testing of (Chemical) Analytical
Laboratories (Tho thun hi ho quc t v th nghim thnh tho ca Phng th nghim phn tch
(ho hc)).
Evaluation of Matrix Effects: Proposed Guideline, NCCLS Document EP - 14P, National Committee
for Clinical Laboratory Standards, Villanova, PA, 1994 (nh gi nhng nh hng ma trn: Hng
dn xut ca Ban k thut quc gia v cc tiu chun ca Phng th nghim y t)
3. Thut ng v nh ngha
Tiu chun ny p dng cc nh ngha di y. Mt s nh ngha c trch t cc Hng dn
ca ISO v Tiu chun quc t khc.
3.1
Php th (test)
Hot ng k thut bao gm vic xc nh mt hoc nhiu c tnh ca mt sn phm, qu trnh hay
dch v theo mt th tc quy nh.

[TCVN 6450 : 2007 (ISO/IEC Guide 2)]

3.2
Phng th nghim (testing laboratory)
Phng th nghim thc hin cc th nghim
CH THCH: Thut ng phng th nghim c th c dng theo ngha mt thc th php l, k
thut hoc c hai trng hp
[TCVN 6450 : 2007 (ISO/IEC Guide 2)]
3.3
Mu th nghim (test item)
Vt liu hoc mu phng tin o giao np cho phng th nghim tham gia hot ng th nghim
thnh tho.
3.4
Phng php th (test method)
Quy trnh k thut xc nh thc hin th nghim.
[TCVN 6450 : 2007 (ISO/IEC Guide 2)]
3.5
Kt qu th (test result)
Gi tr ca c tnh thu c sau khi thc hin hon chnh mt phng php o xc nh.
[TCVN 6910-1 : 2001 (ISO 5725-1 : 1994)]
3.6
Th nghim thnh tho (phng th nghim) ((laboratory) proficiency testing)
Vic xc nh hot ng th nghim ca phng th nghim bng so snh lin phng.
[TCVN 6450 : 2007 (ISO/IEC Guide 2)]
CH THCH: Vi mc ch ca tiu chun ny, thut ng th nghim thnh tho phng th nghim
c dng vi ngha rng nht v bao gm, v d nh:
a) Chng trnh nh tnh - v d trng hp cc phng th nghim c yu cu xc nh mt thnh
phn ca mu th nghim.
b) Thc hin bin i d liu - v d trng hp cc phng th nghim c cung cp tp d liu v
c yu cu vn dng d liu cung cp thm thng tin.
c) Th nghim mu n - trng hp mt mu c gi ti mt s phng th nghim mt cch lin
tc v tr ngi t chc sau mt khong thi gian.
d) Thc hin mt ln - trng hp phng th nghim c cung cp mu th nghim cho mt thi
im n l.
e) Chng trnh lin tc - trng hp phng th nghim c cung cp u n cc mu th nghim
trn c lin tc.
f) Ly mu - v d khi c nhn hay t chc c yu cu ly mu cho phn tch tip theo.
3.7
So snh lin phng (interlaboratory comparisons)
Vic t chc, thc hin v nh gi cc th nghim trn cng mt mu th nghim hoc mu th
nghim tng t c thc hin bi hai hay nhiu phng th nghim theo cc iu kin xc nh
trc
CH THCH: Trong mt s trng hp, mt trong cc phng th nghim tham gia vo so snh lin
phng c th phng th nghim cung cp gi tr n nh cho mu th nghim.

3.8
Mu chun (RM) (reference material)
Vt liu hoc cht c mt hay nhiu gi tr v tnh cht ca n c xc nh ng nht v tt hiu
chun mt thit b, nh gi mt phng php o hoc n nh cc gi tr ca vt liu.
[TCVN 6165:1996 (VIM:1993), 6.13]
3.9
Mu chun c chng nhn (CRM) (Certified reference material)
Mu chun c km theo giy chng nhn, trong mt hay nhiu gi tr v tnh cht ca n c
chng nhn theo mt th tc nhm thit lp s lin kt vi vic th hin chnh xc n v m theo
cc gi tr v tnh cht c biu th ra v mi gi tr c chng nhn c km theo khng m
bo tng ng mc tin cy quy nh.
[TCVN 6165:1996 (VIM:1993), 6.14]
3.10
Phng th nghim quy chiu (reference laboratory)
Phng th nghim cung cp gi tr quy chiu cho mt mu th nghim.
CH THCH: V d nh Phng hiu chun quc gia.
3.11
Gi tr n nh (assigned value)
Gi tr quy cho mt i lng ring bit v c chp nhn, i khi bng tha c, c khng m
bo ph hp vi mc ch nh.
[TCVN 6165:1996 (VIM:1993), 1.20 v ch thch 1 v 2)
3.12
Tnh lin kt chun (traceability)
Tnh cht ca kt qu o hoc gi tr ca mt chun m nh c th lin h ti nhng chun
nh, thng l chun quc gia hay quc t, thng qua mt chui so snh khng gin on vi
nhng khng m bo nh.
[TCVN 6165:1996 (VIM:1993), 6.10]
3.13
iu phi vin (coordinator)
T chc (hay c nhn) c trch nhim iu phi tt c cc hot ng lin quan trong vic trin khai
mt chng trnh th nghim thnh tho.
3.14
ng (trueness)
Mc gn nhau gia gi tr trung bnh ca mt dy ln cc kt qu th nghim v gi tr quy chiu
c chp nhn.
[ISO 3534-1]
3.15
chm (precision)
Mc gn nhau gia cc kt qu th nghim c lp nhn c trong iu kin quy nh.
[ISO 3534-1]
3.16
Gi tr bt thng (outlier)

Phn t ca mt tp hp cc gi tr khng ph hp vi cc phn t khc ca tp hp [TCVN

6910-1 : 2001 (ISO 5725-1 : 1994)]
3.17
Kt qu ngoi bin (extreme results)
Gi tr bt thng v cc gi tr khc hon ton khng ph hp vi cc phn t khc ca tp hp ti
liu.
CH THCH: Nhng kt qu ny c th c nh hng ln n thng k tng hp nh lch trung
bnh v lch chun.
3.18
K thut thng k th (robust statistical techniques)
K thut hn ch nh hng ca cc kt qu ngoi bin gy ra cho vic c lng lch trung
bnh v lch chun.
CH THCH: Nhng k thut ny ch gim bt nh hng ca cc kt qu ngoi bin ch khng loi
c chng khi tp hp d liu.
3.19
khng m bo o (uncertainty of measurement)
Thng s gn vi kt qu ca php o, c trng cho s phn tn ca cc gi tr c th quy cho s
lng o mt cch hp l.
[TCVN 6165:1996 (VIM:1993), 3.9]
4. Cc loi th nghim thnh tho
4.1. Khi qut
Cc k thut th nghim thnh tho khc nhau tu thuc vo tnh cht ca mu th nghim, phng
php s dng v s lng phng th nghim tham gia. Phn ln c c trng chung l so snh kt
qa thu c ca mt phng th nghim vi cc kt qu thu c t mt hoc nhiu phng th
nghim khc. Trong mt s chng trnh, mt trong cc phng th nghim tham gia c th c chc
nng kim sot iu phi hoc quy chiu.
Di y l cc loi chng trnh th nghim thnh tho ph bin.
4.2 .Chng trnh so snh o lng
Chng trnh so snh o lng i hi mu th cn o hay hiu chun phi c lun chuyn lin
tip t phng th nghim tham gia ny n phng th nghim k tip. Thng thng c trng ca
cc chng trnh ny l:
a) Gi tr n nh cho mu th nghim do phng th nghim quy chiu cung cp, y c th l c
quan quyn lc cao nht ca quc gia i vi php o lin quan. Mu th nghim c th cn c
kim tra nhng giai on nht nh trong sut qu trnh tin hnh th nghim thnh tho. iu ny
nhm m bo khng c thay i ng k no v gi tr n nh trong sut qu trnh th nghim
thnh tho.
b) hon thnh cc chng trnh ny i hi s tham gia lin tc (trong mt s trng hp cn n
hng nm). iu ny gy nn mt s kh khn nh: m bo n nh ca mu th nghim; theo
di cht ch vic lun chuyn v thi gian cho php i vi php o ca ring cc bn tham gia; v
s cn thit phi cung cp thng tin phn hi v vic thc hin n l cho cc phng th nghim
trong sut qu trnh trin khai chng trnh th nghim ch khng phi ch n khi kt thc. Ngoi
ra, vic so snh kt qu theo nhm s c th kh khn v c th c tng i t phng th nghim c
nng lc o tng xng nhau.
c) Cc kt qu o ring l c so snh vi gi tr quy chiu do phng th nghim quy chiu thit lp.
iu phi vin phi tnh n khng m bo o ca tng phng th nghim tham gia.
d) Cc v d v mu th nghim (mu phng tin o) c dng trong loi th nghim thnh tho
ny bao gm c cc chun chnh (v d in tr, dng v phng tin o)
4.3. Chng trnh th nghim lin phng

Chng trnh th nghim lin phng vi cc mu th c chn ngu nhin t ngun vt liu c
phn phi ng thi cho cc phng th nghim tham gia cng th nghim. i khi k thut ny
cng c s dng cho chng trnh o lin phng. Sau khi hon thnh th nghim, kt qu c
gi tr li c quan iu phi v c so snh vi (cc) gi tr n nh a ra ch s vic thc hin
ca phng th nghim n l v ca ton b nhm.
Cc v d v mu th nghim c dng trong loi th nghim thnh tho ny bao gm thc phm,
cht lu ca c th, nc, t v vt liu mi trng khc. Trong mt vi trng hp, cc phn ring
l ca mu chun c thit lp (chng nhn) trc khi c lun chuyn.
iu thit yu l mi l mu th nghim cung cp cho cc bn tham gia trong mi chu k phi
ng nht bt k kt qu no sau c xc nh l ngoi bin khng c quy cho bt k s
bin i ng k no ca mu th nghim, (xem 5.6.2 v A.4 trong Ph lc A)
Chng trnh th nghim lin phng thng c t chc cng nhn, c quan c thm quyn v
cc chc khc s dng, khi h p dng cc chng trnh trong lnh vc th nghim.
Mt loi chng trnh th nghim lin phng ph bin l thit k "phn cp trong cc mc ca
lng o tng t nhau (nhng khng ng nht) thuc hai mu th nghim ring bit. Thit k ny
c s dng c lng chm ca phng th nghim mt mc xc nh ca i lng o.
iu ny nhm trnh cc vn lin quan n php o lp li trn cng mu th nghim hoc kt
hp mu th nghim ging nhau trong cng mt chu k th nghim thnh tho.
4.4. Chng trnh th nghim vi mu tch
Mt dng th nghim thnh tho c bit thng c khch hng ca cc phng th nghim, bao
gm c cc c quan c thm quyn s dng l k thut th vi mu tch. (Khng nn nhm ln k
thut vi chng trnh phn cp nu trong 4.3).
Thng thng th nghim vi mu tch dng trong so snh d liu c a ra bi nhm nh cho
(phng th nghim (thng ch hai phng th nghim) ang c nh gi l nh cung ng dch v th
nghim tim nng hay lin tc.
So snh lin phng tng t thng c thc hin trong giao dch thng mi khi cc mu th
nghim i din mt hng thng mi c phn chia gia phng th nghim i din cho ngi
cung ng phng th nghim khc i din cho ngi mua. Mu th nghim b sung thng c gi
li cho phng th nghim ca bn th ba kim tra khi cn s phn x trong trng hp c s khc
nhau ng k gia kt qu do phng th nghim pha ngi cung ng v phng th nghim pha
ngi a ra.
Chng trnh th nghim vi mu tch i hi cc mu ca mt sn phm hay vt liu c tch
thnh hai hay nhiu phn vi tng phng th nghim tham gia th nghim mt phn ca tng mu.
Cc chng trnh ny khc vi dng th nghim thnh tho m t 4.3, v thng c rt t phng th
nghim tham gia (thng l hai). Cc ng dng ca loi chng trnh ny bao gm vic nhn bit
..thp, vic m t dc ng nht v xc nhn tnh hiu lc ca hnh ng khc phc.
Cc chng trnh ny thng cn lu vt liu gii quyt mi khc bit nhn bit c gia ...
cc phng th nghim tham gia bng cc phn tch su hn ca cc phng th nghim b sung.
Mt k thut th vi mu tch tng t cng c s dng trong vic gim st phng th nghim y t
mi trng. Thng thng, cc chng trnh ny bao gm kt qu t mt s mu tch ph kho nng
rng c so snh gia mt phng th nghim ring l vi mt hay nhiu phng th nghi m
khc.
Vi nhng chng trnh ny, mt trong s cc phng th nghim c th c coi l hot ng trnh
o lng cao hn (ngha l khng m bo mc thp hn) nh ng dng phng php quy
chiu v thit b hin i hn,... Kt qu ca cc phng th nghim ny c th c coi l gi tr quy
chiu trong cc so snh lin phng ny v c th ng vai tr phng th nghim t vn hay hng
dn i vi cc phng th nghim khc trong vic so snh d liu ca th nghim tch mu vi n.
4.5. Chng trnh nh tnh
nh gi vic thc hin th nghim ca phng th nghim khng nht thit phi tham gia vo so snh
lin phng [(xem im a) trong ch thch ca 3.6], V d mt s chng trnh c thit k nh
gi kh nng ca phng th nghim nhm m t cc thc th c th (v d nh dng aming nhn
dng sinh vt gy bnh c trng,...).
Chng trnh ny c th cn s chun b c bit cc mu th nghim vi s b sung thnh phn
ph thuc ca iu phi vin chng trnh. Nh vy, cc chng trnh ny v bn cht l "nh tnh''

v khng cn s tham gia ca nhiu phng th nghim hay so snh lin phng nh gi vic thc
hin th nghim ca phng th nghim.
4.6. Chng trnh cho trc gi tr
Mt dng chng trnh th nghim thnh tho c bit khc c th i hi phi chun b cc mu th
nghim vi s lng bit ca i lng o c th. Sau c th nh gi kh nng ca phng
th nghim ring l trong vic th nghim cc mu v cung cp kt qu bng s so snh vi gi tr
n nh. Loi chng trnh ny cng khng cn s tham gia ca nhiu phng th nghim.
4.7. Chng trnh thc hin tng phn qu trnh
Cc dng c bit ca th nghim thnh tho i hi vic nh gi nng lc ca phng th nghim
thc hin cc phn ca qu trnh th nghim hoc o lng tng th. V d, mt vi chng trnh
hin c nh gi nng lc ca phng th nghim trong vic bin i v bo co mt tp hp d liu
cho trc (thay v tin hnh php th hoc php o thc) hoc ly mu v chun b mu hay b mu
theo quy nh k thut.
5. T chc v thit k
5.1. Phm vi
5.1.1. Giai on thit k ca bt k chng trnh th nghim thnh tho no u i hi s tham gia
ca chuyn gia k thut, thng k vin v iu phi vin chng trnh nhm m bo s thnh cng
v vic trin khai mt cch sun s.
5.1.2. iu phi vin, thng qua vic trao i vi nhng ngi khc, cn xy dng chng trnh ph
hp vi th nghim thnh tho c th. Mt chng trnh th nghim thnh tho cn c thit k
nhm trnh bt k s nhm ln no v mc ch ca n. K hoch cn c thng nht v lp thnh
vn bn (xem Ph lc B) trc khi bt u chng trnh v thng bao gm cc thng tin sau:
a) tn v a ch ca t chc tin hnh chng trnh thnh tho;
b) tn v a ch ca iu phi vin v nhng ngi khc tham gia vo vic thit k v trin khai
chng trnh thnh tho;
c) bn cht v mc ch ca chng trnh thnh tho;
d) th tc v cch thc la chn ngi tham gia, khi thch hp, hoc cc tiu ch cn p ng trc
c php tham gia;
e) tn v a ch ca phng th nghim hay cc phng th nghim thc hin (nhng phn ca) chng
trnh (v d ly mu, x l mu, th nghim tnh ng nht v n nh gi tr) v s lng ngi tham
gia d kin;
f) bn cht ca (cc) mu th nghim v (cc) php th c la chn cng nh bn m t tm tt
vic xem xt u tin cc la chn;
g) bn m t v cch thc nhn, x l, kim tra v vn chuyn mu th nghim;
h) bn m t cc thng tin cung cp cho ngi tham gia vo giai on thng bo ny v k hoch
thi gian cho cc giai on khc nhau ca th nghim thnh tho;
i) k hn hay thi hn bt u v kt thc d kin ca chng trnh thnh tho bao gm c thi hn
cho ngi tham gia thc hin th nghim;
j) tn sut phn phi mu th nghim vi nhng chng trnh lin tip;
k) thng tin v phng php hay th tc m ngi tham gia c th cn s dng thc hin cc
phng th hay php o (thng l th tc thng thng);
l) bn s lc v phn tch thng k cn s dng, bao gm vic xc nh cc gi tr n nh v bt k
k thut pht hin gi tr bt thng no;
m) bn m t thng tin hoc d liu c gi tr li cho ngi tham gia;
n) c s ca k thut nh gi vic thc hin;
o) bn m t phm vi cng khai kt qu php th v kt lun da trn kt qu th nghim thnh tho
5.2. Nhn vin

Nhn vin tham gia vo vic cung cp chng trnh cn c, hoc cng tc cht ch vi ngi
nng lc v kinh nghim trong thit k, trin khai v lp bo co v cc so snh lin phng cng cn
c c cc k nng v k thut, thng k v qun tr thch hp.
5.2.2. Nh nu trong 5.1.1, vic trin khai so snh lin phng c th cng i hi ch dn ca
ngi am hiu chi tit v k thut v c kinh nghim v phng php v th tc th nghim lin
quan. Vi mc ch ny, iu phi vin c th cn tuyn chn mt hay nhiu c nhn thch hp
lm vic nh nhm t vn, v d c ly ra t c quan chuyn ngnh, phng th nghim thu (nu
c), nhng ngi tham gia chng trnh hay ngi s dng d liu.
5.2.3. Chc nng ca nhm t vn ny c th bao gm:
a) xy dng v sot xt cc th tc cho vic hoch nh, thc hin, phn tch, bo co v tnh hiu
lc ca chng trnh th nghim thnh tho;
b) nhn bit v nh gi so snh lin phng c t chc bi cc c quan khc;
c) nh gi kt qu th nghim thnh tho lin quan vic thc hin ca cc phng th nghim tham
gia;
d) cung cp ch dn cho bt k c quan nh gi nng lc k thut ca phng th nghim tham gia
no v kt qu t c trong sut chng trnh th nghim thnh tho cng nh cch s dng kt
qu ny vi cc kha cnh khc ca nh gi phng th nghim;
e) cung cp ch dn cho ngi tham gia v cc vn kinh nghim r rng; v
f) gii quyt bt k bt ng no gia iu phi vin v ngi tham gia.
5.3. Thit b x l d liu
Bt k thit b no c s dng u cn phi ph hp tin hnh nhp tt c d liu cn thit
cng nh phn tch thng k v a ra cc kt qu kp thi, c gi tr. Cc th tc kim tra d liu
u vo cn phi c tin hnh, cc phn mm cn phi c kim tra xc nhn, h tr v sao lu.
Cn phi kim sot vic lu tr v bo mt cc tp tin d liu.
5.4. Thit k thng k
5.4.1. M hnh thng k v cc k thut phn tch d liu s dng cn phi c lp thnh vn bn
cng vi mt bn m t tm tt v c s la chn. Chi tit hn v cc th tc thng k ph bin v
vic x l d liu th nghim thnh tho c nu trong Ph lc A.
5.4.2. Thit k thng k ph hp ca chng trnh th nghim thnh tho l thit yu. Cn xem xt
k lng cc vn sau v s tng tc ca chng:
a) chm v ng ca cc php th lin quan;
b) khc bit nh nht gia cc phng th nghim tham gia cn c pht hin mc tin cy yu
cu;
c) s lng phng th nghim tham gia;
d) s lng mu cn th v s ln lp li php th hoc php o cn thc hin trn mi mu th
nghim;
e) quy trnh dng c lng gi tr n nh;
f) th tc s dng xc nh gi tr bt thng.
5.4.3. Khi thiu thng tin tin cy lin quan n im a), th trong mt s trng hp cn t chc snh
lin phng th im (th nghim cng tc) t c yu cu ny.
5.5. Chun b mu th nghim
5.5.1. Vic chun b mu th nghim cng c th c iu phi vin cho thu hoc m nhn. V t
chc chun b mu th nghim cn th hin nng lc lm vic ny.
5.5.2. Bt k iu kin no lin quan n mu th nghim c th nh hng n tnh ton vn ca so
snh lin phng, nh tnh ng nht, vic ly mu, n nh, kh nng h hi dc ng v nhng
nh hng ca iu kin xung quanh u cn c xem xt (xem 5.6).
5.5.3. Mu th nghim hoc vt liu th nghim c phn phi trong chng trnh ni chung ging
nhau v bn cht vi cc loi thng thng c th nghim bi cc phng th nghim tham gia

CH THCH: V d v tho thun cho vic thit lp s tng ng c nu trong ti liu NCCLS
EP-14P do ban quc gia v tiu chun phng th nghim y t Villanova, PA, xut bn nm 1994.
5.5.4. S mu th nghim c phn phi c th ph thuc vo vic c hay khng c yu cu tng
qut tp hp cc thnh phn cu to.
5.5.5. (Cc) gi tr n nh khng cn phi cng b cho nhng ngi tham gia cho ti sau khi kt qu
c i chiu. Tuy nhin, trong mt vi trng hp c th ch dn cc phm vi mc tiu trc khi
th nghim.
5.5.6. Vic chun b mu th nghim b sung khc ngoi cc mu cn thit cho chng trnh th
nghim thnh tho cn c a ra xem xt. Cc mu th nghim d c th hu ch lm mu
chun, mu kim sot cht lng hay h tr o to cho cc phng th nghim sau khi kt qu
nhng ngi tham gia c nh gi.
5.6. Qun l mu th nghim
5.6.1. Th tc ly mu, ly mu ngu nhin, vn chuyn, tip nhn, nhn dng, ghi nhn lu kho v
x l hng mc th nghim cn c lp thnh vn bn.
5.6.2. Trong trng hp vt liu khi lng ln c chun b cho th nghim thnh tho chng cn
ng nht hon ton i vi tng tham s th nghim tt c cc phng th nghim nhn c
mu th nghim khng c khc bit ng k v tham s c o. iu phi vin cn lp thnh vn
bn th tc s dng thit lp tnh ng nht ca mu th nghim (xem A.4 trong Ph lc A). Khi c
th cn tin hnh th nghim tnh ng nht trc khi gi mu th nghim cho cc phng th nghim
tham gia. Mc ng nht cn t n mc m s khc bit gia cc mu th nghim khng gy
nh hng ng k n vic nh gi kt qu ca ngi tham gia.
5.6.3. Khi c th, iu phi vin cng cn cung cp bng chng chng t mu th nghim l n
nh m bo chng c th chu c bt k thay i ng k no trong sut qu trnh tin hnh
th nghim thnh tho. Khi cc i lng o khng n nh cn c nh gi, t chc iu phi c
th cn quy nh thi gian hon thnh th nghim v cc th tc cn thit c bit trc th nghim.
5.6.4. iu phi vin cn xem xt n bt k mi nguy no m mu th nghim c th gy ra v a
ra ch dn thch hp cho cc bn c th b ri ro bi cc mi nguy tim n (v d ngi phn phi vt
liu th nghim, phng th nghim,...).
5.7. La chn phng php/th tc
5.7.1. Thng thng cc bn tham gia c th s dng phng php h la chn ph hp vi th tc
thng thng c dng trong cc phng th nghim. Tuy nhin, trong cc trng hp nht nh,
iu phi vin c th hng dn ngi tham gia s dng mt phng php quy nh. Phng php
ny thng l phng php tiu chun c tha nhn cp quc gia hoc quc t v c xc
nhn gi tr s dng bng mt th tc thch hp (v d th nghim cng tc).
5.7.2. Khi s dng th tc hiu chun, gi tr n nh thng l gi tr quy chiu t c t php o
do phng hiu chun cp cao thc hin (thng l Phng th nghim chun quc gia) s dng cc
th tc c xc nh r v c chp nhn. Cc phng th nghim tham gia cn s dng cng th
tc hoc s dng cc th tc tng t nhau nhng vi cc phng hiu chun th khng phi khi no
cng t c iu ny.
5.7.3. Trong trng hp cc bn tham gia c t do s dng phng php h la chn, iu phi
vin cn yu cu thng tin chi tit v phng php cho php so snh cc kt qu ca cc bn
tham gia v gp v phng php khi thch hp.
5.8. S tin trin ca cc chng trnh th nghim thnh tho
Nhm m bo chng trnh th nghim thnh tho thch hp vi s pht trin ca khoa hc v k
thut cn c cc loi mu mi, phng php hay th tc mi. Cc kt lun ban u t kt qu thc
hin ca cc phng th nghim ring l ca nhng chng trnh ny cn c a ra mt cch thn
trng. (Xem 6.4.3)
6. Trin khai v lp bo co
6.1. Vic iu phi v vn bn ha

Vic trin khai chng trnh thng ngy cn do mt iu phi vin chu trch nhim. Tt c cc hot
ng v th tc cn c lp thnh vn bn. Cc ti liu ny c th bao gm, hoc c b sung
trong s tay cht lng. (Xem Ph lc B)
6.2. Hng dn
6.2.1. Cn phi cung cp cc hng dn chi tit cho ton b cc kha cnh ca chng trnh m cc
phng th nghim tham gia chp thun. V d cc hng dn ny c th c cung cp nh l mt
phn tch hp ca tho thun chng trnh.
6.2.2. Hng dn c th bao gm cc chi tit lin quan n cc yu t c th nh hng n vic th
nghim cc mu hay vt liu th nghim c cung cp. Cc yu t ny c th bao gm: ngi trin
khai, tnh cht ca mu hoc vt liu, tnh trng thit b, vic la chn quy trnh th v thi gian th
nghim.
6.2.3. Hng dn c th v lp h s v bo co kt qu th nghim, hoc hiu chun cng c
c cung cp (v d n v, mt s con s quan trng, c s bo co, thi hn ca kt qu,...).
6.2.4. Ngi tham gia cn c thng bo x l mu th nghim thnh tho nh l thc hin
( php th thng thng (tr khi c cc yu cu c bit v thit k ca th nghim thnh tho c
yu cu lch vi nguyn tc ny).
6.3. Bao gi v vn chuyn
iu phi vin ca chng trnh cn xem xt cc kha cnh di y lin quan n vic phn phi
mu th nghim hoc o. Vic bao gi v phung thc vn chuyn phi thch hp v c th bo v
c nh v cc c tnh ca mu th nghim. C th c mt s hn ch nht nh trong vn
chuyn ca cc quy nh v hng ho nguy him hay cc yu cu hi quan. Trong mt s trng
hp, cc phng th nghim cn t chu trch nhim v vic vn chuyn mu, c bit trong cc
chng trnh so snh o lng lin tip.
iu phi vin cn hon thin tt c cc mu khai bo hi quan ph hp nhm m bo gim thiu
s chm tr trong vic thng quan. Chng trnh cn tun th cc quy nh ca quc gia v quc t
p dng cho vic vn chuyn mu th nghim.
6.4. Phn tch d liu v h s
6.4.1. Kt qu nhn c t cc phng th nghim tham gia cn c nhp v phn tch sau
c bo co tr li ngay khi c th. iu thit yu l phi vn dng cc th tc kim tra hiu lc
ca d liu nhp, truyn v phn tch thng k sau (xem 5.3). Lu rng cc bng d liu, cc
tp tin sao lu trong my tnh, d liu in ra, biu ,... phi c lu trong mt khong thi gian xc
nh.
6.4.2. Phn tch d liu cn to ra cc thc o tng hp, cc thng k c trng v thng tin km
theo ph hp vi m hnh thng k v cc mc tiu ca chng trnh, cn gim thiu nh hng ca
cc kt qu ngoi bin n thng k tng hp bng vic p dng cc php th pht hin gi tr bt
thng nhm xc nh v sau loi b chng hoc tt nht l thng qua vic s dng k thut
thng k th. Ph lc A nu cc hng dn khi qut cho vic nh gi thng k.
6.4.3. iu phi vin chng trnh cn c cc tiu ch bng vn bn x l cc kt qu th khng
thch hp vi vic nh gi thnh tho. V d, khuyn ngh rng i vi cc i lng o m vt liu
th nghim chng t l khng ng nht v n nh th nghim thnh tho th khng cn phn
cp hay cho im.
6.5. Bo co chng trnh
6.5.1. Ni dung ca bo co chng trnh s khc nhau tu thuc vo mc ch ca chng trnh c
th, nhng cn r rng, d hiu v bao gm d liu v vic phn phi kt qu t tt c cc phng th
nghim ng thi ch ra vic thc hin ca mi bn tham gia (xem 6.6).
6.5.2. Thng thng trong bo co chng trnh thnh tho cn c cc thng tin sau y:
a) tn v a ch ca t chc tin hnh hoc iu phi chng trnh;
b) tn v cc chi nhnh ca t chc tham gia vo vic thit k v thc hin chng trnh (xem 5.2);
c) ngy pht hnh bo co;
d) s bo co v vic nhn dng r rng chng trnh;

e) m t r mu hay vt liu s dng, bao gm c chi tit v vic chun b mu v th nghim tnh
ng nht;
f) m tham gia ca phng th nghim v cc kt qu th;
g) d liu thng k v cc bn tm tt, bao gm c gi tr n nh cng nh phm vi cc kt qu c
th chp nhn;
h) th tc dng thit lp bt k gi tr n nh no;
i) chi tit ca vic lin kt chun v khng m bo ca mi gi tr n nh;
j) cc gi tr n nh v cc thng k tng hp v cc th tc/phng php th c s dng bi cc
phng th nghim tham gia khc (nu cc phng php khc nhau c s dng bi cc phng th
nghim khc nhau);
k) cc kin ca iu phi vin hay t vn k thut v vic thc hin ca phng th nghim (xem 6.6)
I) th tc c s dng trong thit k, trin khai chng trnh (c th bao gm tham chiu n tha
thun chng trnh);
m) th tc dng trong phn tch thng k d liu (xem Ph lc A);
n) ch dn v vic gii thch phn tch thng k, nu thch hp.
6.5.3. Vi cc chng trnh c trin khai thng xuyn, cc bo co c th n gin hn ti mc
nhiu yu t khuyn co trong 6.5.2 khng cn nu trong cc bo co hng ngy, tuy nhin vn c
trong cc bo co tm tt nh k v khi c yu cu ca bn tham gia.
6.5.4. Cc bo co cn nhanh chng sn c trong khong thi gian quy nh. Mc d vic tt c cc
d liu gc c cung cp cn c bo co cho ngi tham gia l l tng nhng trong mt s
chng trnh c phm vi rt rng th c th khng lm c iu ny. Cc bn tham gia t nht cng
nhn c kt qu tm tt ca tt c cc phng th nghim (v d dng biu ). Trong mt vi
chng trnh nh chng trnh so snh o lng ko di cc bo co tm thi cn c pht hnh
cho cc bn tham gia ring l.
6.6. nh gi vic thc hin
6.6.1. Trong trng hp cn nh gi vic thc hin, iu phi vin cn chu trch nhim m bo
thch hp ca phng php nh gi nhm duy tr tin cy ca chng trnh.
6.6.2. iu phi vin c th nh s tr gip ca chuyn gia t vn k thut a ra cc kin chuyn
mn v vic thc hin lin quan n:
a) vic thc hin tng th so vi cc mong i trc (tnh n khng m bo);
b) s khc nhau trong v gia cc phng th nghim (v so snh vi bt k chng trnh no trc
hay d liu chnh xc c cng b);
c) s khc nhau gia cc phng php hay th tc, nu c th;
d) nguyn nhn gy sai s (lin quan n gi tr ngoi bin) v cc gi ci tin vic thc hin;
e) cc gi , khuyn co hay kin chung khc;
f) kt lun.
6.6.3. C th cn phi nh k cung cp cc bng tm tt ring l cho cc bn tham gia trong sut
hoc sau mt chng trnh c th. Chng c th bao gm bn tm tt c cp nht vic thc hin
ca cc phng th nghim ring l cc chu trnh khc nhau ca mt chng trnh lin tc. Nhng
bn tm tt ny c th phn tch chi tit hn v nu bt xu hng nu cn.
6.6.4. C nhiu th tc khc nhau nh gi vic thc hin ca cc bn tham gia, c chng trnh
thc hin mt ln v sau cc chu trnh lin tip ca chng trnh lin tc. Mt s v d v cc th tc
c a ra trong Ph lc A.
6.6.5. Bo co vic thc hin bng cch phn cp cc phng th nghim thnh bng theo vic thc
hin ca h khng c khuyn ngh trong th nghim thnh tho. V vy, vic phn cp ch nn s
dng vi s thn trng c bit v n c th lm sai lch v dn n gii thch sai.
6.7. Trao i thng tin vi cc bn tham gia

6.7.1. Cc bn tham gia cn c cung cp tp hp cc thng tin chi tit v vic tham gia chng
trnh th nghim thnh tho, nh tho thun chng trnh chnh thc. Sau , vic trao i thng tin
vi cc bn tham gia c th thng qua th, bn tin v/hoc bo co, cng vi cc cuc hp m rng
nh k. Cc bn tham gia cn c ch dn ngay v mi thay i lin quan n thit k hay trin khai
chng trnh.
6.7.2. Bn tham gia cn c kh nng lin h vi iu phi vin nu nhn thy li trong vic nh gi
hot ng th nghim thnh tho.
6.7.3. Cn khuyn khch vic phn hi t cc phng th nghim cc bn tham gia ng gp tch
cc vo s pht trin ca chng trnh.
6.7.4. Th tc lin quan n hnh ng khc phc ca cc bn tham gia (c bit lin quan n phn
hi ti t chc cng nhn) c nu trong TCVN 7777-2 : 2008 (ISO/IEC Guide 43-2).
7. Xem xt tnh bo mt v o c ngh nghip
7.1. Bo mt h s
Thng thng, chnh sch ca phn ln cc chng trnh l duy tr tnh bo mt trong vic nhn
dng cc bn tham gia ring. Vic nhn dng cc bn tham gia ch c mt s t ngi tham gia vo
iu phi chng trnh bit, v iu ny cn m rng ti tt c cc hng dn hay cc hnh ng
iu chnh tip sau p dng i vi phng th nghim th hin nng lc thc hin yu km. Trong
mt s trng hp, c quan iu phi c th c yu cu bo co v vic thc hin yu km cho
c quan c thm quyn c th, nhng nhng ngi tham gia cn c thng bo trc v kh nng
ny khi ng tham gia chng trnh.
Mt nhm cc bn tham gia c th quyt nh t b vic bo mt trong phm vi nhm vi mc ch
trao i v h tr ln nhau cng tin b.
7.2. S thng ng v lm sai lch kt qu
Mc d cc chng trnh th nghim thnh tho trc ht l nhm gip cc bn tham gia nng cao
nng lc thc hin ca h, nhng gia mt s bn tham gia vn c chiu hng to n tng lc
quan sai v nng lc ca h. V d vic thng ng c th xy ra gia cc phng th nghim
khng a ra d liu xc thc c lp. Cc phng th nghim cng c th to n tng sai v vic
thc hin khi trin khai cc phn tch c lp thng thng nhng bo co trung gian vic xc nh
sao chp v cc mu th nghim thnh tho hoc tin hnh sao chp thm cc mu quy nh cho
chng trnh c th. Khi c th, cc chng trnh th nghim thnh tho cn c thit k m
bo rng kh nng thng ng v lm sai lch kt qu l t nht.
Mc d iu phi vin cn thc hin tt c cc bin php hp l trnh vic thng ng, nhng
cng cn hiu ng rng trch nhim ca cc phng th nghim tham gia l trnh xy ra iu ny.
Ph lc A
(tham kho)
Cc v d v phng php thng k dng trong x l d liu th nghim thnh tho
Cc kt qu th nghim thnh tho c th th hin di nhiu hnh thc, bao trm mt tp hp ln
cc loi d liu v lm c s cho cc phn b thng k. K thut thng k s dng phn tch kt
qu cn ph hp vi tng tnh hung v li qu a dng quy nh.
Tuy nhin, c ba bc ph bin i vi th nghim thnh tho khi nh gi kt qu ca cc bn tham
gia:
a) xc nh gi tr n nh;
b) tnh ton cc thng k c trng;
c) nh gi vic thc hin; v trong mt s trng hp,
d) xc nh s b tnh ng nht v n nh ca mu th nghim.
Ph lc ny a ra tiu ch chung i vi cc k thut thng k c th s dng khi cn hng dn
cho cc ng dng c th.

Vi nhng chng trnh so snh lin phng mi, tho thun ban u thng rt s si v c nhiu
vn mi, biu mu mi, mu th nghim nhn to, tho thun v phng php s si, hoc cc
th tc th nghim a dng. iu phi vin c th phi s dng cc bin php th cho vic thc hin
lin quan (nh gi tr phn trm) cho ti khi tho thun c ci thin. Cc k thut thng k c th
cn c sng lc khi tho thun lin phng c ci thin v th nghim thnh tho c thit lp
ph hp.
Ph lc ny khng xt n cc k thut thng k i vi cc nghin cu phn tch ngoi x l d liu
th nghim thnh tho. Cc k thut khc nhau cng c th cn thit thc hin cc mc ch khc
ca d liu trong so snh lin phng c nu trong li gii thiu.
CH THCH: Ban k thut ISO/TC 69 hin ang son tho ti liu cung cp thng tin chi tit v cc
phng php thng k nu trong ph lc ny.
A.1 Xc nh gi tr n nh v khng m bo ca cc gi tr ny
A.1.1 C nhiu th tc thit lp gi tr n nh khc nhau. Cc th tc ph bin nht c nu
di y theo mt trt t m trong nhiu trng hp s lm tng khng m bo ca gi tr n
nh. Cc th tc ny cn s dng:
a) Cc gi tr cho trc - vi kt qu xc nh bng cng thc ca mu th nghim c th (v d
sn xut hoc iu ch).
b) Gi tr quy chiu c chng nhn - nh xc nh bng phng php cui cng (i vi cc
php th nh lng).
c) Gi tr quy chiu - nh xc nh bng phn tch, o hoc so snh mu th nghim theo mu
chun hay chun chnh c kh nng lin kt vi chun quc gia hoc quc t.
d) Gi tr ng thun t cc phng th nghim chuyn nghip - cc phng th nghim chuyn
nghip cn c nng lc c th hin trong vic xc nh (cc) i lng o cn th, s dng cc
phng php c xc nhn gi tr s dng c chm, chnh xc cao, v c th so snh
c vi nhng phng php thng s dng. Trong mt s trng hp, cc phng th nghim c
th l Phng th nghim quy chiu.
e) Gi tr ng thun t cc phng th nghim tham gia - s dng k thut thng k m t trong
A.1.3 vi vic xem xt nh hng ca cc gi tr ngoi bin.
A.1.2 Gi tr n nh cn c xc nh nh gi cng bng cc bn tham gia, thc y hn na
tho thun lin phng v lin phng php. Vic ny c thc hin thng qua vic la chn cc
nhm so snh chung, v vic s dng gi tr n nh chung khi c th.
A.1.3 Cc thng k sau y c th ph hp khi gi tr n nh c xc nh bng phng php
ng thun:
a) gi tr nh tnh - s ng thun ca t l phn ln c xc nh trc (thng c th hin
theo thang o danh ngha hoc th t);
b) gi tr nh lng - "gi tr trung bnh i vi nhm so snh ph hp nh l:
i) gi tr trung bnh c th c ly trng s hay chuyn i (v d trung bnh rt gn hoc trung bnh
nhn),
ii) trung v, mt (mode) hoc php o th khc.
A.1.4 khng m bo ca gi tr n nh cn c xc nh bng cch s dng cc th tc m t
trong Hng dn th hin khng m bo o khi thch hp.
A.1.5 Cc kt qu ngoi bin c x l nh di y.
a) Khi kt qu ca cc bn tham gia c dng xc nh gi tr n nh, cc k thut cn thch hp
hn ch ti a nh hng ca kt qu ngoi bin. Vic ny cn c thc hin cng phng
php thng k th hoc bng cch loi b cc gi tr bt thng trc khi tnh ton (xem ISO 57252). Trong cc chng trnh ln hn hoc chng trnh thng thng, c th c bng hin th gi tr
bt thng t ng.
b) Nu cc kt qu c loi b nh cc gi tr bt thng, th ch nn loi b cho vic tnh ton
thng k tng hp. Cc kt qu ny vn cn c nh gi trong chng trnh thnh tho v phi
c a ra phn loi thc hin thch hp.

A.1.6 Cc xem xt khc c tin hnh nh di y:

a) L tng l xc nh gi tr n nh bng cch quy chiu hoc s ng thun ca cc bn tham
gia, iu phi vin cn c th tc xc nh ng ca gi tr n nh v xem xt vic phn b d
liu.
b) iu phi vin cn c tiu ch chp nhn gi tr n nh theo khng m bo ca n.
A.2 Tnh ton thng k c trng
A.2.1 Thc hin trn mu th nghim n l
A.2.1.1 Kt qu th nghim thnh tho thng cn phi chuyn i sang mt thng k c trng
h tr vic gii thch v cho php so snh vi mc tiu xc nh. Mc ch l o lch so vi gi tr
n nh theo cch cho php so snh vi tiu ch c trng. Cc k thut c th t khng yu cu x
l n cc chuyn i thng k phc tp.
A.2.1.2 Cc bin php thc hin cn c ngha i vi cc bn tham gia chng trnh. V vy, cc
thc o cn lin quan n nhu cu ng dng ca php th v c thu hiu hoc c tnh truyn
thng trong mt lhh vc c th.
A.2.1.3 Cc thc o s thay i thng c s dng tnh ton thng k c trng v trong bo
co tm tt chng trnh th nghim thnh tho. V d ph bin v cc thc o s thay i i vi
nhm so snh thch hp bao gm:
a) lch chun (SD);
b) h s bin thin (CV) hoc lch chun tng i (RSD);
c) cc phn v, lch tuyt i ca trung v hoc cc thc o th khc.
A.2.1.4 i vi cc kt qu nh tnh, vic tnh ton thng khng cn thit.
Cc thng k thng c s dng cho nhng kt qu nh lng c lit k di y theo mc
bin i kt qu tng dn ca cc bn tham gia.
a) Hiu s (x-X), trong "x" l kt qu ca bn tham gia v "X" l gi tr n nh.
b) Chnh lch theo phn trm,

x X x 100
X

c) Phn v hoc dy
d) T s z, trong
z=

xX
s

v s l bin c lng/thc o thch hp ca s thay i c chn ph hp vi cc yu cu ca

chng trnh. Cng thc ny c th c s dng trong cc trng hp khi X v s c c t kt
qu ca cc bn tham gia hay khi X v s khng c c t (tt c) cc kt qu ca bn tham gia. [V
d khi gi tr n nh v s thay i c quy nh; tham kho 4.2 ca Tho thun hi ho quc t v
th nghim thnh tho ca Phng th nghim phn tch (ho hc)]
e) S En (thng s dng c th trong chng trnh so snh o lng), trong

v Ulab l khng m bo ca kt qu ca bn tham gia v Uref l khng m bo ca gi tr n

nh ca phng th nghim quy chiu.
A.2.1.5 Cc xem xt nh nu di y.

a) S khc bit khng ng k gia kt qu ca bn tham gia v gi tr n nh c th thch hp

xc nh c trng v c ngi tham gia hiu mt cch d dng nht. Tr s (x-X) trong TCVN
6910-4 : 2001 (ISO 5725-4) c gi l c lng chch phng th nghim".
b) Cc iu chnh phn trm chnh lch i vi nng v c cc bn tham gia thu hiu.
c) Cc phn v hoc dy l hu ch vi cc kt qu phn tn cao hoc kt qu lch, cc p ng theo
th t hoc khi c mt s gii hn cc p ng khc nhau. K thut ny cn c s dng thn
trng (xem 6.6.5).
d) Kt qu chuyn i c th c u tin, hoc cn thit, tu thuc vo bn cht ca php th. V
d cc kt qu da trn s pha long l mt dng ca thang hnh hc, c th chuyn i theo logarit.
e) Nu s dng tiu ch thng k (v d t s z), c lng ca s thay i phi ng tin cy; l
trn c s cc quan trc y nhm lm gim nh hng ca cc gi tr ngoi bin v t c
khng m bo thp.
A.2.2 T s c trng phi hp
A.2.2.1 c trng c th c nh gi trn c s nhiu hn mt kt qu trong mt chu trnh th
nghim thnh tho n l. iu ny xy ra khi c nhiu hn mt mu th nghim cho mt i lng
o c th, hoc mt h i lng o lin quan. Vic ny c thc hin a ra nh gi c
trng ton din hn.
Cc phng php th nh Biu Youden hay th biu din thng k h ca Mandel l cc k
thut hiu qu din t c trng (xem TCVN 6910-2:2001 (ISO 5725-2)).
Cc v d c nu di y:
a) T s kt hp i vi cng mt i lng o:
- s lng kt qu tho mn;
- t s z trung bnh hoc tng cng;
- hiu s tuyt i trung bnh (theo n v hoc phn trm);
- hiu s tuyt i tng (hay hiu bnh phng);
b) T s kt hp i vi cc i lng o khc nhau:
- s lng (hoc phn trm) kt qu tho mn;
- t s z trung bnh tuyt i;
- hiu tuyt i trung bnh so vi gii hn nh gi.
A.2.2.2 Cc xem xt nh nu di y:
a) T s c th c chuyn i (nu cn) tt c cng theo mt phn b gi nh (v d phn b
Gau-x cho t s z hay X2 cho hiu bnh phng).
b) Cn kim tra gi tr ngoi bin c th c nh hng ln ti t s kt hp nh lng.
A.3 nh gi vic thc hin
A.3.1 Thc hin ban u
Tiu ch nh gi vic thc hin cn c thit lp sau khi xem xt cc thc o hot ng c lin
quan n cc c trng nht nh hay khng.
A.3.1.1 Cc c trng ny nh sau:
a) S ng thun chuyn mn: khi nhm t vn hoc cc chuyn gia lnh ngh khc quyt nh
trc tip vic kt qu bo co c ph hp vi mc ch hay khng. S ng thun chuyn mn l
cch thc in hnh nh gi kt qu ca cc php th nh tnh.
b) Tnh ph hp vi mc ch: v d, xem xt cc quy nh v thc hin phng php v trnh
iu hnh c cng nhn ca cc bn tham gia.
c) Xc nh t s bng thng k: trong cc tiu ch cn ph hp vi tng t s. V d ph bin v
ng dng t s l:
i) vi t s z:

|z|< 2 = tho mn
2<|z|<3 = nghi vn
|z| 3 = khng tho mn
ii) vi s En:
| En l 1 = tho mn
| En l > 1 = khng tho mn
d) S ng thun ca cc bn tham gia: phm vi cc t s hay kt qu c s dng bi mt t l
phn trm cc bn tham gia, hay t mt nhm quy chiu, nh;
- t l phn trm trung tm tho mn (80 %, 90 % hay 95 %), hoc
- t l phn trm mt pha tho mn (t nht 90%).
A.3.1.2 i vi thit k mu tch, mc tiu c th l nhn bit vic hiu chun khng y
v/hoc s bin ng ngu nhin ln trong kt qu. Trong trng hp ny vic nh gi cn da
trn s lng kt qu ph hp v bao trm phm vi tp trung rng. K thut th rt c ch cho vic
nhn bit v m t cc vn ny, c bit, cc biu th hin s khc bit gia cc phng th
nghim c v theo gi tr trung bnh tng ng. Cc kt qu c th c so snh bng phn tch
hi quy v phn tch s d vi k thut tham s hoc phi tham s thch hp.
A.3.1.3 th cn c s dng khi c th biu din vic thc hin (v d biu ct, biu li,
biu th t t s z). Cc biu ny c th dng th hin:
a) phn b cc gi tr tham gia;
b) mi quan h gia cc kt qu trn mu th bi; v
c) phn b so snh cho cc phng php khc nhau.
A.3.2 Gim st vic thc hin theo thi gian
A.3.2.1 Chng trnh th nghim thnh tho c th bao gm k thut gim st vic thc hin theo
thi gian. K thut thng k cn cho php cc bn tham gia thy c s bin i trong vic thc
hin ca h; c hay khng nhng xu hng hay s khng nht qun chung, v khi no vic thc hin
bin i mt cch ngu nhin.
A.3.2.2 Phng php th cn c s dng to thun li cho vic thng hiu ca nhiu ngi
c khc nhau. Biu kim sot Shewhart" truyn thng rt hu ch, c bit cho mc ch t ci
tin. Lit k d liu v cc thng k s b cho php xem xt chi tit hn. Cc thng k dng nh
gi vic thc hin cn s dng cc th v bng biu ny.
A.4 Xc nh s b tnh ng nht ca mu th nghim
Cn s dng k thut thng k ph hp nh gi d liu t vic th nghim tnh ng nht ca
mu th. Mt cch tip cn thch hp c m t trong Tho thun hi ho quc t v th nghim
thnh tho ca cc Phng th nghim phn tch (ho hc). Xem Ph lc II: Th tc khuyn ngh v vt
liu th nghim c tnh ng nht thch hp.
Ph lc B
(tham kho)
Qun l cht lng chng trnh th nghim thnh tho
Khuyn ngh nn thit lp v duy tr mt h thng cht lng. H thng ny cn c lp thnh vn
bn, v d m t trong s tay cht lng. N cn phc tho cc chnh sch v th tc m bo cht
lng ca cc chng trnh th nghim thnh tho, mang li s tin cy ca c cc bn tham gia v
ngi s dng d liu.T chc tin hnh chng trnh nn p ng cc yu cu ca h thng qun
l cht lng v nng lc k thut da vo cc phn thch hp ca b tiu chun TCVN ISO 9000 v
TCVN ISO/IEC 17025 chng t bng vic chng nhn v/hoc cng nhn ca mt t chc c
tha nhn.
H thng ti liu cht lng ny cn bao gm cc ni dung di y:

a) Chnh sch cht lng

b) T chc ca c quan iu phi
c) o to v nng lc nhn vin
d) Vai tr v trch nhim ca nhn vin
e) Kim sot ti liu
f) Th tc nh gi v xem xt
g) Mc ch, phm vi, thit k thng k v nh dng chng trnh th nghim thnh tho
h) Th tc thc hin
- chun b mu
- th nghim tnh ng nht ca mu
- thit b
- th tc thit lp gi tr n nh
- ngi cung ng, bao gm c nh thu ph
- hu cn
- phn tch d liu
i) Son tho v pht hnh cc bo co
j) Hnh ng v phn hi ca cc bn tham gia
k) H thng ti liu v lu tr h s
k) Th tc x l khiu ni
m) Chnh sch v tnh bo mt v th tc quy nh v o c
n) Thng tin s dng my tnh
o) An ton v cc yu t mi trng khc
p) Nh thu ph
q) Ph tham gia
r) Phm vi hiu lc ca chng trnh
s) Chnh sch chung v s tham gia v vic s dng kt qu ca chng trnh
Ph lc C
(tham kho)
Th mc ti liu tham kho
[1] WECC Doc. 15-1992, WECC Interlaboratory Comparisons. Western European Calibration
Cooperation (now EAL) ( So snh lin phng th nghim)
[2] EAL-G6-1993, WELAC Criteria for Proficiency Testing in Accreditation. European Cooperation for
Accreditation of Laboratories (EAL) (Tiu chun th nghim thnh tho trong Cng nhn).
[3] APLAC, Interlaboratory Comparisons (So snh lin phng)
Doc. 1 - Calibration & Measurement Proficiency Programs (Chng trnh hiu chun v o lng
thnh tho)
Doc. 2 - Testing Programs (Chng trnh th nghim)
Asia-Pacific Laboratory Accreditation Cooperation, 1996.

[4] ASTM E 1301-1995, StandardGuide for the Development and Operation of Laboratory Proficiency
Testing Programs (Hng dn tiu chun cho vic xy dng v trin khai chng trnh th nghim
thnh tho phng th nghim).
[5] ISO Guide 30: 1992, Terms and definitions used in connection with reference materials (Thut ng
v nh ngha dng cng vi mu chun).
[6] HORWITZ W., Nomenclature of interlaboratory analytical studies. PureAppl. Chem., 66(9), 1994,
pp. 1903- 1911 (Thut ng trong nghin cu phn tch lin phng th nghim).
[7] SWEETS J. A. and PICKET R. M., Evaluation of Diagnostic Systems - Methods from Signal
Detection Theory. Academic Press, New York, London, 1982 (nh gi h thng chn on - Cc
phng php t l thuyt tch tn hiu).
[8] YOUDEN W. J., Statistical Techniques for Collaborative Tests. Association of Official Analytical
Chemists, Arlington, VA, 1967 (K thut thng k cho th nghim lin kt).
[9] MANDEL J., Analysis of Two - Way Layouts. Chapman & Hall, New York, NY, 1996, pp. 65-79
(Phn tch hin th hai chiu).
[10] THOLEN D. w., A Statistical Procedure for Measuring and Evaluating Performance in
Interlaboratory Comparison Programs. Arch. Pathol. Lab. Med., 112, 1988, pp. 462-470 (Th tc
thng k i vi o lng v nh gi vic thc hin trong chng trnh so snh lin phng).
[11] KAFADAR K., A Biweight Approach to the One - Sample Problem. Amer. Statistical Assoc.,
77(378), 1982, pp. 416-424 (Phng php Biweight i vi vn mu th nghim mt ln).
[12] Royal Society of Chemistry, Robust Statistics - How not to Reject Outliers, Part 1, Basic
Concepts, and Part 2, Interlaboratory Trials. (Analytical Methods Committee, Royal Society of
Chemistry). Analyst, 114, 1989 pp. 1693-1702 (Thng k th - Cch loi b cc gi tr bt thng,
Phn 1: Khi nim c bn :Phn 2: Th nghim lin phng).
[13] THOLEN D. W., Reference Values and Participant Means as Targets in Proficiency Testing. Arch.
Pathol. Lab. Med., 117, 1993, pp. 885-889 (Gi tr quy chiu v phng thc tham gia vi cc mc
tiu th nghim thnh tho).
[14] ROSS J. W., Evolution of Evaluation Criteria in the College of American Pathologists Surveys
Arch. Pathol. Lab. Med., 112, 1988, pp. 334-339 (Pht trin tiu chun nh gi trong iu tra ca
trng i hc bnh hc M).
[15] HOELTGE G. A. and DUCKWORTH J. K., Review of Proficiency Testing Performance of
Laboratories Accredited by the College of American Pathologists. Arch. Pathol. Lab. Med., 111, 1987,
pp. 101 1-1014 (Xem xt vic tin hnh th nghim thnh tho ca Phng th nghim c cng
nhn bi Trng H bnh hc M).
[16] JENNY R. W. and JACKSON K. Y., Proficiency Test Performance as a Predictor of Accuracy of
Routine Patient Testing for Theophylline. Clin. Chem., 39(1), 1993, pp. 76-81.
MC LC
Li ni u
Li gii thiu
1. Phm vi p dng
2. Ti liu vin dn
3. Thut ng v nh ngha
4. Cc dng th nghim thnh tho
4.1. Khi qut
4.2. Chng trnh so snh o lng
4.3. Chng trnh th nghim lin phng
4.4. Chng trnh th nghim vi mu tch

4.5. Chng trnh th nghim nh tnh

4.6. Chng trnh cho trc gi tr
4.7. Chng trnh thc hin tng phn qu trnh
5. T chc v thit k
5.1. Phm vi
5.2. Nhn vin
5.3. Thit b x l d liu
5.4. Thit k thng k
5.5. Chun b mu th nghim
5.6. Qun l mu th nghim
5.7. La chn phng php/th tc
5.8. Ci tin chng trnh th nghim thnh tho
6. Trin khai v lp bo co
6.1. iu phi v h thng vn bn
6.2. Ch dn
6.3. Bao gi v vn chuyn
6.4. Phn tch d liu v h s
6.5. Bo co chng trnh
6.6. nh gi vic thc hin
6.7. Trao i thng tin vi cc bn tham gia
7. Xem xt tnh bo mt/o c ngh nghip
7.1. Bo mt h s
7.2. S thng ng v lm sai lch kt qu
Ph lc A (tham kho) Cc v d v phng php thit k dng trong x l d liu th nghim thnh
tho
Ph lc B (tham kho) Qun l cht lng chng trnh th nghim thnh tho
Ph lc C Th mc ti liu tham kho