Nabl 217

NABL
NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBRATION LABORATORIES
NABL 217
ASSESSMENT FORMS
and CHECKLIST
(Based on ISO 15189: 2007
ISS!E NO : 0" AMEN#MENT NO :02
ISS!E #ATE: 27$0%$2012 AMEN#MENT #ATE: 1%$10$2012

AMEN#MENT SHEET
S& 'a(e
No$
C&a)se
No$
#a*e o+
A,end,en*
A,end,en* Made Reasons S-(na*).e
/O
S-(na*).e
#-.e0*o.
1. 3/83
6/83
--
NAF1
22.08.2012 Laboratory locations Internal audit
finding
2. 16/83 .1.!"i# 16.10.2012 Note$ %esignated
&uality 'anager
s(all .........according to
I)* 1!18+$200,
A-LA. findings
3.
.
!.
6.
,.
8.
+.
10.
Na*-ona& A00.ed-*a*-on Boa.d +o. Tes*-n( and Ca&-1.a*-on La1o.a*o.-es
Doc. No: NABL 217 Assessment Forms and Checklist (Based on ISO 11!": 2##7$
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: #2 Amend Date: 1'.1#.2#12 (a)e No: 1*!&

Con*en*s
S&$ No$ T-*&e 'a(e No$
1. Amendment Sheet 1
2. Contents 2
&. +%ide to %se the NAFs , Checklists and Com-ilation o. the Assessment
/e-ort
&
0. NAF 1 1 Assessment Sched%le '
. NAF1A 1 Attendance Sheet (O-enin)* closin) meetin)$ 7
'. NAF 2 1 Assessor2s O3ser4ation !
7. NAF & 1 5est(s$ 6itnessed 37 the Assessment 5eam "
!. NAF &A 1 Details o. /e85estin) 6itnessed d%rin) Assessment 1#
". NAF 0 1 S%mmar7 on Non8Con.ormities 11
1#. NAF 1 Consolidated Non8Con.ormities 12
11. NAF ' 1 S%mmar7 o. Assessment 1&
12. Checklist 1 1 B7 Lead Assessor 10
1&. Checklist 2 1 5est (s$ 9itness 8 B7 5echnical Assessor #
10. Checklist & 1 For :edical La3orator7 Collection Centres 7!
1. Form 71 1 /ecommended A%thorised Si)natories !1
1'. Form 72 1 /ecommended Sco-e o. Accreditation !2
17. Form 70 1 Declaration o. Im-artialit7 , Con.identialit7 !&
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: 2*!&

2)-de *o )se *3e NABL Assess,en* Fo.,s4 C3e05&-s*s 6 o*3e. Fo.,s 1ased
on ISO 15189: 2007 and Co,7-&a*-on o+ *3e Assess,en* Re7o.*
It is -res%med that the Assessors 6ho ha4e 3een nominated 37 the NABL Secretariat; are .%ll7 a6are o.
the NABL Accreditation -rocess; its o3<ecti4es and the on8site Assessment -roced%re. 5his doc%ment
contains Assessment .orms NAF 1 to '; Checklists 1 and 2 and Forms 71 to 70; 6hich 6ill .orm a -art o.
the Assessment /e-ort. 5he doc%ment shall )%ide the Lead Assessor and the 5echnical Assessor(s$ in
com-letin) 4ario%s .orms , checklists and com-ile the assessment re-ort.
Ro&e o+ Lead Assesso.
Be.ore the start o. Assessment the Lead Assessor sho%ld -re-are an Assessment sched%le in NAF 1
6hich sho%ld incl%de the la3orator7 locations *de-artments* sections* areas* acti4ities to 3e assessed and
assi)nment to 4ario%s Assessors 3ased on their e=-ertise. 5he O3ser4er ((otential Assessor$ sho%ld also
3e )%ided a3o%t the cond%ct o. assessment.
5he Lead Assessor m%st re4ie6 the La3orator72s doc%mented :ana)ement S7stem to 4eri.7 com-liance
6ith the re>%irements o. ISO 11!": 2##7. ?e sho%ld assess that the doc%mented :ana)ement S7stem is
indeed im-lemented , e..ecti4e; as descri3ed and record o3ser4ations in NAF 2. ?e sho%ld also com-lete
Checklist 1 and record concl%sion * comments related to the re>%irements o. res-ecti4e cla%se n%m3er. All
Non8Con.ormities m%st 3e identi.ied and re-orted; se-aratel7 on each sheet in NAF 0. No non con.ormit7
shall 3e closed d%rin) the assessment. La3orator7 shall e4al%ate the root ca%se o. the non con.ormit7 and
-ro-ose correction and correcti4e action. 5he ma=im%m time -eriod )i4en .or a la3orator7 to close the
Noncon.ormit7 is t6o months .rom the date o. assessment.
As a leader o. the Assessment team; he 6o%ld collect the re-orts and doc%ments .rom all 5echnical
Assessors incl%din) his o6n re-ort and com-ile it. A consolidated statement o. Non8Con.ormities raised
d%rin) the Assessment shall 3e listed in NAF . I.; d%rin) S%r4eillance or /e8assessment; a case o. total
s7stem .ail%re and )ross ne)li)ence in technical as-ects is noticed; the Lead Assessor 6ill at the earliest
in.orm NABL and ela3oratel7 3rin) it o%t in the Assessment s%mmar7 (NAF8'$ o. assessment re-ort . ?e
6o%ld .inall7 s%mmarise the cond%ct o. Assessment and record the recommendations in NAF '.
?e m%st )et an endorsement .rom the la3orator7 on NAF ' and hand o4er a -hotoco-7 o. the .orms NAF
0; ; and ' to the La3orator7 to ena3le them to take correcti4e actions. Co-7 o. recommended sco-e;
a%thorised si)natories shall also 3e )i4en to the la3orator7.
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: #1 Amend Date: 22.#!.2#12 (a)e No: &*!&

5he Lead Assessor is also re>%ired to monitor the -er.ormance o. 5echnical Assessor(s$ and the O3ser4er.
?e shall recommend 6hether the O3ser4er is ca-a3le to -er.orm the role o. a 5echnical Assessor in his
ne=t 4isit. ?is comments* ratin) .or each 5echnical Assessor shall 3e enclosed 6ith the re-ort in Form 0.
Ro&e o+ Te03n-0a& Assesso.
5he 5echnical Assessor sho%ld clearl7 %nderstand the areas* acti4ities to 3e assessed 37 him. ?e m%st
re4ie6 the La3orator72s doc%mented s7stem to 4eri.7 com-liance 6ith the re>%irements o. ISO 11!":
2##7 and related NABL S-eci.ic Criteria. ?e sho%ld assess to 4eri.7 that the doc%mented SO(s; test
methods; records are indeed im-lemented , e..ecti4e; as descri3ed and record o3ser4ations in NAF 2. ?e
sho%ld also com-lete Checklist 2 related to the re>%irements o. res-ecti4e cla%se n%m3er and NAF & .or
the 5est(s$ 6itnessed 37 him.
Assessors shall inter4ie6 the La3orator72s A%thorised Si)nator7 .or their com-etence; and recommend in
Form 71. Assessors shall refer NABL 112 for requirements of authorised signatory.
All Non8Con.ormities m%st 3e identi.ied and re-orted; se-aratel7 on each sheet in NAF 0. 5he Sco-e o.
Accreditation to 3e )ranted to the La3orator7 m%st 3e checked thoro%)hl7 6ith necessar7
recommendations on Form 72. An7 deletions or alterations in the sco-e m%st 3e clearl7 3ro%)ht o%t and
si)ned 37 3oth the La3orator7 /e-resentati4e and the Assessor.
5he re-ort sho%ld 3e handed o4er to the Lead Assessor alon)6ith the 5A* DA .orm. 9hen the Lead
Assessor; also -er.orms the <o3 o. a 5echnical Assessor; he sho%ld .ollo6 the a3o4e -roced%re.
Ro&e o+ Te03n-0a& E87e.*
5he role o. 5echnical @=-ert is same as o. 5echnical Assessor; e=ce-t he 6ill seek )%idance o. Lead
Assessor in .illin) the rele4ant .orms; checklist etc.
Ro&e o+ O1se.9e.
5he O3ser4er ((otential Assessor$ 6ill 3e assi)ned to accom-an7 the Lead Assessor and 5echnical
Assessor(s$ as -er the sched%le -ro4ided to him. ?e shall 3e )%ided 37 the Lead Assessor and the
5echnical Assessor(s$. ?e is not re>%ired to s%3mit an7 re-ort ho6e4er his 5A* DA .orm ma7 3e s%3mitted
to the Lead Assessor. ?e is not entitled .or -a7ment o. an7 honorari%m.

Co,7-&a*-on o+ Assess,en* Re7o.*
5he Assessment /e-ort sho%ld consist o. 4ario%s doc%ments in the order as indicated in NAF '. @ach
.orm or checklist sho%ld 3e care.%ll7 .illed in. 5he -a)es sho%ld 3e seriall7 n%m3ered in the 3o= -ro4ided at
the ri)ht to- corner o. each -a)e; startin) .rom NAF '.
5he assessment re-ort sho%ld 3e s%3mitted to the NABL Secretariat 6ithin 1# da7s .rom the com-letion o.
assessment. 5he Lead Assessor sho%ld ret%rn all doc%ments to NABL* la3orator7 6hich ha4e 3een
.or6arded to him .or cond%ctin) the assessment s%ch as La3orator72s A%alit7 :an%al; A--lication .orm etc.
Form 70 1 Declaration o. maintainin) im-artialit7 , con.identialit7 m%st 3e .illed %- 37 the Lead Assessor;
all 5echnical Assessors , O3ser4er and enclosed 6ith the assessment re-ort. 5he 5A* DA .orms o. the
5echnical Assessors and his o6n ma7 also 3e enclosed alon)6ith the assessment re-ort.
BBB
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: *!&

NAF 1
ASSESSMENT SCHE#!LE
La1o.a*o.::
/)a&-*: Mana(e.: #a*e(s o+ ;-s-*:
T:7e o+ ;-s-*: Assessment / 1
st
Surveillance/ Re-Assessment /Supplementary visit
F-e&d : Medical Testing #-s0-7&-ne (s:
Assess,en* S*anda.d: Laboratorys !uality Manual" #S$ 1%1&'( )**+ and Speci,ic -riteria NA.L 11)
Assess,en* T-,-n(s O7en-n(<C&os-n( Mee*-n( Date*5ime #a-&: #e1.-e+-n( Date * 5ime
(at the end o. each da7$
:ornin): A: to (:
A.ternoon: (: to (:
O-enin) :eetin):
Closin) :eetin):
Da7 1:
Da7 2:
Da7 &:
Na,e and E87e.*-se
o+ *3e Assesso.
Sched%le o. Locations *De-artment* Section* Acti4it7 to 3e Assessed (date6ise$
Da7 1 Da7 2 Da7 &
:ornin) A.ternoon :ornin) A.ternoon :ornin) A.ternoon
Lead Assesso.
Assesso. 1
Assesso. 2
Assesso. "
Assesso. =
Assesso. 5
Assesso. %
Assesso. 7
O1se.9e.
(onl7 .or o3ser4ation$
Si)nat%re o. Lead Assessor
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: #1 Amend Date: 22.#!.2#12 (a)e No: '*!&

NAF 1A
ATTEN#ANCE SHEET (O'ENIN2 < CLOSIN2 MEETIN2
Laboratory:
Date & Time :
Type of Visit: Assessment / 1
st
Sl.
Assessors / Lab Personnel
Present
Capacity/ Designation Signature

NAF )
ASSESSOR>S OBSER;ATIONS

La3orator7:
Date: De-artment: Acti4it7 Assessed:
A%ditee: @d%cation: Cears o. @=-erience:
SL OBSER;ATION REMARKS
Si)nat%re , Name o. Assessor
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: !*!&

NAF /
TEST(S ?ITNESSE# B@ THE ASSESSSMENT TEAM
(5o 3e .illed in 37 each 5echnical Assessor$
La3orator7: Date(s$ o. Disit:
Assessor: Disci-line:
Re+$ *o
O1s$ -n
NAF 2
Tes*(s A-*nessed Tes* Me*3od
!sed o. S*anda.d
Re+e..ed
Re,a.5s
Si)nat%re o. Assessor
/emarks 37 Lead Assessor; i. an7
Si)nat%re o. Lead Assessor
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: "*!&

NAF /A
#ETAILS OF REBTESTIN2 ?ITNESSE# #!RIN2 ASSESSMENT
(5o 3e .illed in 37 the 5echnical Assessor$
La3orator7 assessed
Disci-line Date o. Assessment
Test 1 Test 2 Test 3
(rod%ct * :aterial o. 5est
5est 9itnessed
5est :ethod S-eci.ication
%sed
/an)e o. 5estin) *
Limits o. Detection
ECD * *:eas%rement
Fncertaint7 (:F$
1$ ReB*es*-n( o+ Re*a-ned Sa,7&e
Sam-le ID
Date o. @arlier 5estin)
@arlier 5ested 37
@arlier /e-orted /es%lts
/es%lts o. 5est 9itnessed
5est cond%cted 37
(same -erson$
5est cond%cted 37
(di..erent -erson$
2. Testing of CRM / SRM
/e.erence :aterial
S-eci.ied Dal%e
/es%lts o. 5est 9itnessed
Re,a.5s:
De4iations o3ser4ed; i. an7
Concl%sion on the
technical com-etence o.
the la3 .or the test
6itnessed
(En0&ose a&& s)77o.*-n( da*a s3ee*s +o. *es*s A-*nessed
(Si)nat%re , Name o. Assessor$
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: 1#*!&

NAF 0
ASSESSOR>S S!MMAR@ ON NONBCONFORMITIES
((lease %se se-arate sheet .or raisin) each Non8Con.ormit7$
La3orator7:
Date: De-artment: Acti4it7 Assessed:
NC No$ /e.erence to O3ser4ation No. in NAF82:
NONBCONFORMITIES (NC RAISE#:
/e.erence to ISO 11!": 2##7 Cla%se No.: Classi.ication o. Non8Con.ormities: MACOR< MINOR
Si)nat%re , Name o. La3orator7 /e-resentati4e Si)nat%re , Name o. Assessor
CORRECTI;E ACTION 'RO'OSE# B@ THE LABORATOR@:
Si)nat%re o. La3orator7 /e-resentati4e
ASSESSOR>S COMMENTS ON CORRECTI;E ACTION 'RO'OSE# B@ THE LABORATOR@:
Si)nat%re o. Assessor
REMARKS B@ LEA# ASSESSOR4 IF AN@:
Si)nat%re , Name o. Lead Assessor

NAF %
CONSOLI#ATE# NONBCONFORMITIES
ISO 15189
C&a)se No$
ISO 15189: 2007 ReD)-.e,en* No$ o+ NonBCon+o.,-*-es .a-sed
d).-n( Assess,en*
MACOR MINOR
= MANA2EMENT RE/!IREMENTS
0.1 Or)anisation , :ana)ement
0.2 A%alit7 :ana)ement S7stem
0.& Doc%ment Control
0.0 /e4ie6 o. Contracts
0. @=amination 37 re.erral la3oratories
0.' @=ternal Ser4ices and S%--lies
0.7 Ad4isor7 Ser4ices
0.! /esol%tion o. Com-laints
0." Identi.ication , controls o. Non8con.ormities
0.1# Correcti4e Action
0.11 (re4enti4e Action
0.12 Contin%al Im-ro4ement
0.1& A%alit7 and 5echnical /ecords
0.10 Internal A%dits
0.1 :ana)ement /e4ie6s
5 TECHNICAL RE/!IREMENTS
.1 (ersonnel
.2 Accommodation and @n4ironmental Conditions
.& La3orator7 @>%i-ment
.0 (re8e=amination (roced%res
. @=amination (roced%res
.' Ass%rin) the A%alit7 o. @=amination -roced%res
.7 (ost 8e=amination (roced%res
.! /e-ortin) o. /es%lts
T1e non-con,ormities raised during t1e assessment are as a result o, limited sampling and t1ere,ore it s1all
not be assumed t1at ot1er non-con,ormities do not e2ist3
S-(na*).e 6 Na,e o+ A)*3o.-sed S-(na*o.: o+ La1 S-(na*).e 6 Na,e o+ Lead Assesso.

NAF 4
S!MMAR@ OF THE ASSESSMENT
La1o.a*o.::
/)a&-*: Mana(e.: #a*e(s o+ ;-s-*:
T:7e o+ ;-s-*: Assessment / 1
st
F-e&d : Medical Testing #-s0-7&-ne (s:
Lead Assesso.: Assesso. 1: Assesso. 2:
Assesso. ": Assesso. =: Assesso. 5:
Assesso. %: Assesso. 7: O1se.9e.:
#a*e o+ ea.&-e. 9-s-*: Non--on,ormities recorded during earlier visit 1ave / 1ave not been disc1arged3
ASSESSMENT S!MMAR@:
Non8Con.ormities raised d%rin) the 4isit
(re.. ISO 11!": 2##7$
MACOR MINOR
RECOMMEN#ATIONS OF ASSESSMENT TEAM:
En0&oB
s).es
NAF
%
NAF
5
NAF
=
NAF
"
NAF
2
NAF
1
C3e05
&-s* 1
C3e05
&-s* 2
C3e05
&-s* "
!n0e.*a-n*:
Ca&0)&a*-on
(#a*as3ee*
A)*3o.-sed
S-(na*o.:
(Fo., 71
Re0o,,$
S0o7e
(Fo., 72
#e0&a.B
a*-on
(Fo., 7=
Assesso.s
Feed1a05
'T<E/AS
s),,a.:
TA<#A
Fo.,s
'a(e
Nos$
(lease enclose NAFs; checklists; other .orms , doc%ments in the a3o4e order and )i4e a contin%o%s -a)e n%m3er
Date 37 6hich the Non8Con.ormities are to 3e dischar)ed 37 the La3orator7: GGGGGGGGGGGGGGGG
5he re>%irements o. NABL 1&& ha4e 3een e=-lained 37 the Lead Assessor and %nderstood 37 the la3orator7.
Ackno6led)ement 37 A%thorised /e-resentati4e o. La3 ,
Date
Si)nat%re o. Lead Assessor , Date
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: 1&*!&

ASSESSOR CHECKLIST 1: (ISO 15189: 2007
(5o 3e .illed in 37 the Lead Assessor$
NABL8Checklist81
5he .ollo6in) -a)es -resent a checklist o. the criteria .rom ISO 11!": 2##7; 6hich is the 3asis .or the
NABL +eneral re>%irements .or accreditation o. :edical la3oratories. 5he la3orator72s -olicies and
-roced%res m%st meet .%ll re>%irements o. ISO 11!": 2##7. T3e a0*)a& s*anda.d ,)s* 1e .e+e..ed
+o. *3e de+-n-*-9e &an()a(e and -n*e.7.e*a*-on$
5he Lead Assessor m%st com-lete this checklist; -%t initials on each -a)e. 5he .ollo6in) s7m3ols
ma7 3e %sed .or com-letin) this checklist.
EE H CO:(LIANC@
E H CO:(LIANC@ 9I5? /@:A/I
A H :AJO/ NON8CO:FO/:I5C
B H :INO/ NON8CO:FO/:I5C
NA H NO5 A((LICABL@
BLANK H NO5 ASS@SS@D
5he Lead Assessor m%st re4ie6 the la3orator72s doc%mented s7stem to 4eri.7 con.ormit7 6ith the
re>%irements o. ISO 11!": 2##7; assess to 4eri.7 that the doc%mented >%alit7 s7stem is indeed
im-lemented as descri3ed; record concl%sion*comments related to an7 re>%irements on the s-ace
-ro4ided or %se the 3ottom o. the -a)e or %se se-arate sheet(s$. All non8con.ormities m%st 3e
identi.ied and re-orted se-aratel7 on each sheet o. NAF80. 5his checklist 3e s%3mitted as a -art o.
the assessment re-ort.
LABO/A5O/C ASS@SS@D
CI5C* 5O9N
ASS@SS:@N5 DA5@ (S$
L@AD ASS@SSO/2S NA:@
SI+NA5F/@

ASSESSOR CHECKLIST 1: (ISO 15189: 2007
(5o 3e .illed in 37 the Lead Assessor$
(a)e 1 o. &
NABL8Checklist81
DOCF:@N5A5ION
I:(L@:@N5A5ION
RE/!IREMENTS OF ISO 15189: 2007
/0'A/1
= MANA2EMENT RE/!IREMENT
=$1 OR2ANISATION 6 MANA2EMENT
0.1.1 5he medical la3orator7 or the or)anisation o. 6hich
the la3orator7 is a -art shall 3e le)all7 identi.ia3le.
0.1.2 :edical la3orator7 ser4ices; incl%din) a--ro-riate
inter-retation and ad4isor7 ser4ices; shall 3e
desi)ned to meet the needs o. -atients and all clinical
-ersonnel res-onsi3le .or -atient care.
0.1.& 5he medical la3orator7 (herea.ter re.erred to as Kthe
La3orator7L$ shall meet the rele4ant re>%irements o.
this International Standard 6hen carr7in) o%t 6ork in
its -ermanent .acilities; or at sites other than the
-ermanent .acilities .or 6hich it is res-onsi3le.
0.1.0 5he res-onsi3ilities o. -ersonnel in the la3orator7 6ith
an in4ol4ement or in.l%ence on the e=amination o.
-rimar7 sam-les shall 3e de.ined in order to identi.7
con.licts o. interest. Financial or -olitical
considerations (e.).; ind%cements$ sho%ld not
in.l%ence testin).
0.1. 5he la3orator7 mana)ement shall ha4e res-onsi3ilit7
.or the desi)n; im-lementation;
maintenance; and im-ro4ement o. the >%alit7
mana)ement s7stem. 5his shall incl%de the .ollo6in):
a mana)ement s%--ort o. all la3orator7 -ersonnel
37 -ro4idin) them 6ith the a--ro-riate a%thorit7
and reso%rces to carr7 o%t their d%tiesM
3 arran)ements to ens%re that its mana)ement
and -ersonnel are .ree .rom an7 %nd%e internal
and e=ternal commercial; .inancial or other
-ress%res and in.l%ences that ma7 ad4ersel7
a..ect the >%alit7 o. their 6orkM
c -olicies and -roced%res .or ens%rin) the
-rotection o. con.idential in.ormationM

(a)e 2 o. &
NABL8Checklist81
DOCF:@N5A5ION
I:(L@:@N5A5ION
/0'A/1
D -olicies and -roced%res .or a4oidin) in4ol4ement
in an7 acti4ities that 6o%ld diminish con.idence in
its com-etence; im-artialit7; <%d)ement; or
o-erational inte)rit7M
@ the or)anisational and mana)ement str%ct%re o.
the la3orator7 and its relationshi- to an7 other
or)anisation 6ith 6hich it ma7 3e associatedM
F s-eci.ied res-onsi3ilities; a%thorit7; and
interrelationshi-s o. all -ersonnelM
+ ade>%ate trainin) o. all sta.. and s%-er4ision
a--ro-riate to their e=-erience and le4el o.
res-onsi3ilit7 37 com-etent -ersons con4ersant
6ith the -%r-ose; -roced%res; and assessment o.
res%lts o. the rele4ant e=amination -roced%resM
? technical mana)ement 6hich has o4erall
res-onsi3ilit7 .or the technical o-erations and the
-ro4ision o. the reso%rces needed to ens%re the
re>%ired >%alit7 o. la3orator7 -roced%resM
I a--ointment o. a >%alit7 mana)er (ho6e4er
named$ 6ith dele)ated res-onsi3ilit7 and
a%thorit7 to o4ersee com-liance 6ith the
re>%irements o. the >%alit7 mana)ement s7stem;
6ho shall re-ort directl7 to the le4el o. la3orator7
mana)ement at 6hich decisions are made on
la3orator7 -olic7 and reso%rcesM
Note$ %esignated &uality 'anager s(all (a2e
attended days training on laboratory 3anage3ent
syste3 according to I)* 1!18+$200,
J a--ointment o. de-%ties .or all ke7 .%nctions;
6hile reco)nisin) that in smaller la3oratories
indi4id%als can ha4e more than one .%nction and
that it co%ld 3e im-ractical to a--oint de-%ties .or
e4er7 .%nction.
0.1.' La3orator7 mana)ement shall ens%re that a--ro-riate
comm%nication -rocesses are esta3lished 6ithin the
la3orator7 and that comm%nication takes -lace
re)ardin) the e..ecti4eness o. the >%alit7
mana)ement s7stem
=$2 /!ALIT@ MANA2EMENT S@STEM
0.2.1 (olicies; -rocesses; -ro)rammes; -roced%res and
instr%ctions shall 3e doc%mented and comm%nicated
to all rele4ant -ersonnel. 5he mana)ement shall
ens%re that the doc%ments are %nderstood and
im-lemented.
0.2.2 5he >%alit7 mana)ement s7stem shall incl%de; 3%t not
3e limited to; internal >%alit7 control and -artici-ation
in or)anised interla3orator7 com-arisons s%ch as
e=ternal >%alit7 assessment schemes.
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: #2 Amend Date: 1'.1#.2#12 (a)e No: 1'*!&

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0.2.& (olicies and o3<ecti4es o. the >%alit7 mana)ement
s7stem shall 3e de.ined in a >%alit7 -olic7 statement
%nder the a%thorit7 o. the la3orator7 director and
doc%mented in a >%alit7 man%al. 5his -olic7 shall 3e
readil7 a4aila3le to a--ro-riate -ersonnel; shall 3e
concise; and shall incl%de the .ollo6in):
a the sco-e o. ser4ice the la3orator7 intends to
-ro4ideM
3 the la3orator7 mana)ement2s statement o. the
la3orator72s standard o. ser4iceM
c the o3<ecti4es o. the >%alit7 mana)ement
s7stemM
d a re>%irement that all -ersonnel concerned 6ith
e=amination acti4ities .amiliarise themsel4es 6ith
the >%alit7 doc%mentation and im-lement the
-olicies and -roced%res at all timesM
e the la3orator72s commitment to )ood -ro.essional
-ractice; the >%alit7 o. its e=aminations; and
com-liance 6ith the >%alit7 mana)ement s7stemM
. the la3orator7 mana)ement2s commitment to
com-liance 6ith this International Standard.
0.2.0 A >%alit7 man%al shall descri3e the >%alit7
mana)ement s7stem and the str%ct%re o. the
doc%mentation %sed in the >%alit7 mana)ement
s7stem. 5he >%alit7 man%al shall incl%de or make
re.erence to the s%--ortin) -roced%res incl%din)
technical -roced%res. It shall o%tline the str%ct%re o.
the doc%mentation in the >%alit7 mana)ement
s7stem. 5he roles and res-onsi3ilities o. technical
mana)ement and the >%alit7 mana)er; incl%din) their
res-onsi3ilit7 .or ens%rin) com-liance 6ith this
International Standard; shall 3e de.ined in the >%alit7
man%al.
All -ersonnel shall 3e instr%cted on the %se and
a--lication o. the >%alit7 man%al and all re.erenced
doc%ments; and o. the re>%irements .or their
im-lementation. 5he >%alit7 man%al shall 3e ke-t %-
to date %nder the a%thorit7 and res-onsi3ilit7 o. an
indi4id%al a--ointed to 3e res-onsi3le .or >%alit7 37
the la3orator7 mana)ement Nsee 0.1. i$O.
5he ta3le o. contents o. a >%alit7 man%al .or a
medical la3orator7 mi)ht 3e as .ollo6s:
a introd%ction.
3 descri-tion o. the medical la3orator7; its le)al
identit7; reso%rces; and main d%ties.

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c >%alit7 -olic7.
d sta.. ed%cation and trainin).
e >%alit7 ass%rance.
. doc%ment control.
) records; maintenance; and archi4in).
h accommodation and en4ironment.
i instr%ments; rea)ents; and*or rele4ant
cons%ma3les mana)ement.
< 4alidation o. e=amination -roced%res.
k sa.et7.
l en4ironmental as-ects NFor e=am-le;
trans-ortation; cons%ma3les; 6aste dis-osal in
addition to; and di..erent .rom h$ and i$O
m research and de4elo-ment (i. a--ro-riate.$.
n list o. e=amination -roced%res.
o re>%est -rotocols; -rimar7 sam-le collection; and
handlin) o. la3orator7 sam-les.
- 4alidation o. res%lts.
> >%alit7 control (incl%din) interla3orator7
com-arisons$.
r la3orator7 in.ormation s7stem.
s re-ortin) o. res%lts.
t remedial actions and handlin) o. com-laints.
% comm%nications and other interactions 6ith
-atients; health -ro.essionals; re.erral
la3oratories and s%--liers.
4 internal A%dits.
6 ethics.
0.2. 5he la3orator7 mana)ement shall esta3lish and
im-lement a -ro)ramme that re)%larl7 monitors and
demonstrates -ro-er cali3ration and .%nction o.
instr%ments; rea)ents; and anal7tical s7stems. It shall
also ha4e a doc%mented and recorded -ro)ramme o.
-re4enti4e maintenance and cali3ration (see .&.2$;
6hich; at a minim%m; .ollo6s man%.act%rer2s
recommendations.
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: 1!*!&

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=$" #OC!MENT CONTROL
0.&.1 5he la3orator7 shall de.ine; doc%ment and maintain
-roced%res to control all doc%ments and in.ormation
(.rom internal and e=ternal so%rces$ that .orm its
>%alit7 doc%mentation. A co-7 o. each o. these
controlled doc%ments shall 3e archi4ed .or later
re.erence and the la3orator7 director shall de.ine a
retention -eriod. 5hese controlled doc%ments ma7 3e
maintained on an7 a--ro-riate medi%m incl%din); or
not; -a-er. National; re)ional and local re)%lations
concernin) doc%ment retention co%ld a--l7.
0.&.2 (roced%res shall 3e ado-ted to ens%re that
a all doc%ments iss%ed to la3orator7 -ersonnel as
-art o. the >%alit7 mana)ement s7stem are
re4ie6ed and a--ro4ed 37 a%thorised -ersonnel
-rior to iss%e;
3 a list; also re.erred to as a doc%ment control lo);
identi.7in) the c%rrent 4alid re4isions and their
distri3%tion is maintained;
c onl7 c%rrentl7 a%thorised 4ersions o. a--ro-riate
doc%ments are a4aila3le .or acti4e %se at
rele4ant locations;
d doc%ments are -eriodicall7 re4ie6ed; re4ised
6hen necessar7; and a--ro4ed 37 a%thorised
-ersonnel;
e in4alid or o3solete doc%ments are -rom-tl7
remo4ed .rom all -oints o. %se; or other6ise
ass%red a)ainst inad4ertent %se;
. retained or archi4ed s%-erseded doc%ments are
a--ro-riatel7 identi.ied to -re4ent their
inad4ertent %se;
) i. the la3orator72s doc%mentation control s7stem
allo6s .or the amendment o. doc%ments 37 hand
-endin) the re8iss%e o. doc%ments; the
-roced%res and a%thorities .or s%ch amendments
are de.ined; 6hile amendments are clearl7
marked; initialled and dated; and a re4ised
doc%ment is .ormall7 re8iss%ed as soon as
-ractica3le;
h -roced%res shall 3e esta3lished to descri3e ho6
chan)es to doc%ments maintained in
com-%terised s7stems are to 3e made and
controlled.
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: 1"*!&

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0.&.& All doc%ments rele4ant to the >%alit7 mana)ement
s7stem shall 3e %ni>%el7 identi.ied; to incl%de:
a 5itle;
3 edition or c%rrent re4ision date; or re4ision
n%m3er; or all these;
c n%m3er o. -a)es (6here a--lica3le$;
d a%thorit7 .or iss%e;
e so%rce identi.ication.
=$= RE;IE? OF CONTRACTS
0.0.1 9here a la3orator7 enters into a contract to -ro4ide
medical la3orator7 ser4ices; it shall esta3lish and
maintain -roced%res .or re4ie6 o. contracts. 5he
-olicies and -roced%res .or these re4ie6s leadin) to a
chan)e in the arran)ements .or e=aminations or
contracts shall ens%re that
a re>%irements; incl%din) the methods to 3e %sed;
are ade>%atel7 de.ined; doc%mented and
%nderstood (see .$M
3 the la3orator7 has the ca-a3ilit7 and reso%rces to
meet the re>%irements; and
c a--ro-riate -roced%res selected are a3le to meet
the contract re>%irements and clinical needs.
(see .$
In re.erence to 3$; the re4ie6 o. ca-a3ilit7 sho%ld
esta3lish that the la3orator7 -ossesses the necessar7
-h7sical; -ersonnel and in.ormation reso%rces; and
that the la3orator72s -ersonnel ha4e the skills and
e=-ertise necessar7; .or the -er.ormance o. the
e=aminations in >%estion. 5he re4ie6 ma7 also
encom-ass res%lts o. earlier -artici-ation in e=ternal
>%alit7 ass%rance schemes %sin) sam-les o. kno6n
4al%e in order to determine %ncertainties o.
meas%rement; limits o. detection; con.idence limits;
etc.
0.0.2 /ecords o. re4ie6s; incl%din) an7 si)ni.icant chan)es
and -ertinent disc%ssions; shall 3e maintained (see
0.1&.&$.
0.0.& 5he re4ie6 shall also co4er an7 6ork re.erred 37 the
la3orator7 (see 0.$.
0.0.0 C%stomers (e.).; clinicians; health care 3odies; health
ins%rance com-anies; -harmace%tical com-anies$
shall 3e in.ormed o. an7 de4iation .rom the contract.

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0.0. I. a contract needs to 3e amended a.ter 6ork has
commenced; the same contract re4ie6 -rocess shall
3e re-eated and an7 amendments shall 3e
comm%nicated to all a..ected -arties.
=$5 EFAMINATION B@ REFERRAL LABORATORIES
0..1 5he la3orator7 shall ha4e an e..ecti4e doc%mented
-roced%re .or e4al%atin) and selectin) re.erral
la3oratories as 6ell as cons%ltants 6ho are to -ro4ide
second o-inions .or histo-atholo)7; c7tolo)7; and
related disci-lines. La3orator7 mana)ement; 6ith the
ad4ice o. %sers o. la3orator7 ser4ices 6here
a--ro-riate; shall 3e res-onsi3le .or selectin) and
monitorin) the >%alit7 o. re.erral la3oratories and
cons%ltants and shall ens%re that the re.erral
la3orator7 or re.erral cons%ltant is com-etent to
-er.orm the re>%ested e=aminations.
0..2 Arran)ements 6ith re.erral la3oratories shall 3e
re4ie6ed -eriodicall7 to ens%re that
a re>%irements; incl%din) the -re8e=amination and
-ost8e=amination -roced%res; are ade>%atel7
de.ined; doc%mented; and %nderstood;
3 the re.erral la3orator7 is a3le to meet the
re>%irements and that there are no con.licts o.
interest;
c selection o. e=amination -roced%res is
a--ro-riate .or the intended %se;
d res-ecti4e res-onsi3ilities .or the inter-retation o.
e=amination res%lts are clearl7 de.ined.
/ecords o. s%ch re4ie6s shall 3e maintained in
accordance 6ith national; re)ional; or local
re>%irements.
0..& 5he la3orator7 shall maintain a re)ister o. all re.erral
la3oratories that it %ses. A re)ister shall 3e ke-t o. all
sam-les that ha4e 3een re.erred to another
la3orator7. 5he name and address o. the la3orator7
res-onsi3le .or the e=amination res%lt shall 3e
-ro4ided to the %ser o. la3orator7 ser4ices. A
d%-licate o. the la3orator7 re-ort shall 3e retained in
3oth the -atient record and in the -ermanent .ile o.
the la3orator7.

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0..0 5he re.errin) la3orator7 and not the re.erral la3orator7
shall 3e res-onsi3le .or ens%rin) that re.erral
la3orator7 e=amination res%lts and .indin)s are
-ro4ided to the -erson makin) the re>%est. I. the
re.errin) la3orator7 -re-ares the re-ort; it shall
incl%de all essential elements o. the res%lts re-orted
37 the re.erral la3orator7; 6itho%t alterations that
co%ld a..ect clinical inter-retation.
National; re)ional and local re)%lations ma7 a--l7.
?o6e4er; this does not re>%ire that the re.errin)
la3orator7 re-ort incl%de e4er7 6ord and ha4e the
e=act .ormat o. the re.erral la3orator7 re-ort; %nless
national*local la6s or re)%lations re>%ire it. 5he
re.errin) la3orator7 director ma7 elect to -ro4ide
additional inter-retati4e remarks to those; i. an7; o.
the re.erral la3orator7; in the conte=t o. the -atient
and the local medical en4ironment. 5he a%thor o.
s%ch added remarks sho%ld 3e clearl7 identi.ied.
=$% EFTERNAL SER;ICES AN# S!''LIES
0.'.1 La3orator7 mana)ement shall de.ine and doc%ment
its -olicies and -roced%res .or the selection and %se
o. -%rchased e=ternal ser4ices; e>%i-ment; and
cons%ma3le s%--lies that a..ect the >%alit7 o. its
ser4ice. (%rchased items shall consistentl7 meet the
la3orator72s >%alit7 re>%irements. National; re)ional;
or local re)%lations ma7 re>%ire records o. -%rchased
items. 5here shall 3e -roced%res and criteria .or
ins-ection; acce-tance* re<ection; and stora)e o.
cons%ma3le materials.
0.'.2 (%rchased e>%i-ment and cons%ma3le s%--lies that
a..ect the >%alit7 o. the ser4ice shall not 3e %sed %ntil
the7 ha4e 3een 4eri.ied as com-l7in) 6ith standard
s-eci.ications or re>%irements de.ined .or the
-roced%res concerned. 5his ma7 3e accom-lished 37
e=aminin) >%alit7 control sam-les and 4eri.7in) that
res%lts are acce-ta3le. Doc%mentation o. the
s%--lier2s con.ormance 6ith its >%alit7 mana)ement
s7stem ma7 also 3e %sed .or 4eri.ication.
0.'.& 5here shall 3e an in4entor7 control s7stem .or
s%--lies. A--ro-riate >%alit7 records o. e=ternal
ser4ices; s%--lies; and -%rchased -rod%cts shall 3e
esta3lished and maintained .or a -eriod o. time; as
de.ined in the >%alit7 mana)ement s7stem. 5his
s7stem shall incl%de the recordin) o. lot n%m3ers o.
all rele4ant rea)ents; control materials; and
cali3rators; the date o. recei-t in the la3orator7; and
the date the material is -laced in ser4ice. All o. these
>%alit7 records shall 3e a4aila3le .or la3orator7
mana)ement re4ie6.

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0.'.0 5he la3orator7 shall e4al%ate s%--liers o. critical
rea)ents; s%--lies and ser4ices that a..ect the >%alit7
o. e=aminations and shall maintain records o. these
e4al%ations and list those a--ro4ed.
=$7 A#;ISOR@ SER;ICES
A--ro-riate la3orator7 -ro.essional sta.. shall -ro4ide ad4ice
on choice o. e=aminations and %se o. the ser4ices; incl%din)
re-eat .re>%enc7 and re>%ired t7-e o. sam-le. 9here
a--ro-riate; inter-retation o. the res%lts o. e=aminations shall
3e -ro4ided.
5here sho%ld 3e re)%lar doc%mented meetin)s o. -ro.essional
sta.. 6ith the clinical sta.. re)ardin) the %se o. the la3orator7
ser4ices; and .or the -%r-ose o. cons%ltation on scienti.ic
matters. 5he -ro.essional sta.. sho%ld -artici-ate in clinical
ro%nds; ena3lin) ad4ice on e..ecti4eness in )eneral as 6ell as
in indi4id%al cases.
=$8 RESOL!TION OF COM'LAINTS
5he la3orator7 shall ha4e a -olic7 and -roced%res .or the
resol%tion o. com-laints or other .eed3ack recei4ed .rom
clinicians; -atients or other -arties. /ecords o. com-laints and
o. in4esti)ations and correcti4e actions taken 37 the la3orator7
shall 3e maintained; as re>%ired (see 0.1&.&$.
=$9 I#ENTIFICATION AN# CONTROL OF NONBCONFORMITIES
0.".1 La3orator7 mana)ement shall ha4e a -olic7 and
-roced%re to 3e im-lemented 6hen it detects that an7
as-ect o. its e=aminations does not con.orm 6ith its
o6n -roced%res or the a)reed %-on re>%irements o.
its >%alit7 mana)ement s7stem or the re>%estin)
clinician. 5hese shall ens%re that
a -ersonnel res-onsi3le .or -ro3lem resol%tion are
desi)nated;
3 the actions to 3e taken are de.ined;
c the medical si)ni.icance o. the noncon.ormin)
e=aminations is considered; and 6here
a--ro-riate; the re>%estin) clinician in.ormed;
d e=aminations are halted and re-orts 6ithheld as
necessar7;
e correcti4e action is taken immediatel7;
. the res%lts o. noncon.ormin) e=aminations
alread7 released are recalled or a--ro-riatel7
identi.ied; i. necessar7;

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) the res-onsi3ilit7 .or a%thorisation o. the
res%m-tion o. e=aminations is de.ined; and
h each e-isode o. noncon.ormit7 is doc%mented
and recorded; 6ith these records 3ein) re4ie6ed
at re)%lar s-eci.ied inter4als 37 la3orator7
mana)ement to detect trends and initiate
-re4enti4e action.
0.".2 I. it is determined that noncon.ormin) e=aminations
co%ld rec%r or that there is do%3t a3o%t the
la3orator7Ps com-liance 6ith its o6n -olicies or
-roced%res as )i4en in the >%alit7 man%al;
-roced%res to identi.7; doc%ment and eliminate the
root ca%se(s$ shall 3e -rom-tl7 im-lemented (see
0.1#$.
0.".& 5he la3orator7 shall de.ine and im-lement -roced%res
.or the release o. res%lts in the case o.
noncon.ormities; incl%din) the re4ie6 o. s%ch res%lts.
5hese e4ents shall 3e recorded.
=$10 CORRECTI;E ACTION
0.1#.1 (roced%res .or correcti4e action shall incl%de an
in4esti)ation -rocess to determine the %nderl7in)
ca%se or ca%ses o. the -ro3lem. 5hese shall; 6here
a--ro-riate; lead to -re4enti4e actions. Correcti4e
action shall 3e a--ro-riate to the ma)nit%de o. the
-ro3lem and commens%rate 6ith the -ossi3le risks.
0.1#.2 La3orator7 mana)ement shall doc%ment and
im-lement an7 chan)es re>%ired to its o-erational
-roced%res res%ltin) .rom correcti4e action
in4esti)ations.
0.1#.& La3orator7 mana)ement shall monitor the res%lts o.
an7 correcti4e action taken; in order to ens%re that
the7 ha4e 3een e..ecti4e in o4ercomin) the identi.ied
-ro3lems.
0.1#.0 9hen the identi.ication o. non8con.ormit7 or the
correcti4e action in4esti)ation casts do%3t on
com-liance 6ith -olicies and -roced%res or the
>%alit7 mana)ement s7stem; la3orator7 mana)ement
shall ens%re that a--ro-riate areas o. acti4it7 are
a%dited in accordance 6ith 0.10. 5he res%lts o.
correcti4e actions shall 3e s%3mitted .or la3orator7
mana)ement re4ie6.

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=$11 'RE;ENTI;E ACTION
0.11.1 Needed im-ro4ements and -otential so%rces o. non8
con.ormities; either technical or concernin) the >%alit7
mana)ement s7stem; shall 3e identi.ied. I. -re4enti4e
action is re>%ired; action -lans shall 3e de4elo-ed;
im-lemented and monitored to red%ce the likelihood
o. the occ%rrence o. s%ch non8con.ormities and to
take ad4anta)e o. the o--ort%nities .or im-ro4ement.
0.11.2 (roced%res .or -re4enti4e action shall incl%de the
initiation o. s%ch actions and a--lication o. controls to
ens%re that the7 are e..ecti4e.
=$12 CONTIN!AL IM'RO;EMENT
0.12.1 All o-erational -roced%res shall 3e s7stematicall7
re4ie6ed 37 la3orator7 mana)ement at re)%lar
inter4als; as de.ined in the >%alit7 mana)ement
s7stem; in order to identi.7 an7 -otential so%rces o.
non8con.ormit7 or other o--ort%nities .or im-ro4ement
in the >%alit7 mana)ement s7stem or technical
-ractices. Action -lans .or im-ro4ement shall 3e
de4elo-ed; doc%mented and im-lemented; as
a--ro-riate.
0.12.2 A.ter action has 3een taken res%ltin) .rom the re4ie6;
la3orator7 mana)ement shall e4al%ate the
e..ecti4eness o. the action thro%)h a .oc%sed re4ie6
or a%dit o. the area concerned.
0.12.& 5he res%lts o. action .ollo6in) the re4ie6 shall 3e
s%3mitted to la3orator7 mana)ement .or re4ie6 and
im-lementation o. an7 needed chan)es to the >%alit7
mana)ement s7stem.
0.12.0 La3orator7 mana)ement shall im-lement >%alit7
indicators .or s7stematicall7 monitorin) and
e4al%atin) the la3orator7Ps contri3%tion to -atient
care. 9hen this -ro)ramme identi.ies o--ort%nities
.or im-ro4ement; la3orator7 mana)ement shall
address them re)ardless o. 6here the7 occ%r.
La3orator7 mana)ement shall ens%re that the
medical la3orator7 -artici-ates in >%alit7 im-ro4ement
acti4ities that deal 6ith rele4ant areas and o%tcomes
o. -atient care.
0.12. La3orator7 mana)ement shall -ro4ide access to
s%ita3le ed%cational and trainin) o--ort%nities .or all
la3orator7 -ersonnel and rele4ant %sers o. la3orator7
ser4ices.

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=$1" /!ALIT@ AN# TECHNICAL RECOR#S
0.1&.1 5he la3orator7 shall esta3lish and im-lement
-roced%res .or identi.ication; collection; inde=in);
access; stora)e; maintenance and sa.e dis-osal o.
>%alit7 and technical records.
0.1&.2 All records shall 3e le)i3le and stored s%ch that the7
are readil7 retrie4a3le. /ecords ma7 3e stored on an7
a--ro-riate medi%m s%3<ect to national; re)ional; or
local le)al re>%irements. Facilities shall -ro4ide a
s%ita3le en4ironment to -re4ent dama)e;
deterioration; loss; or %na%thorised access.
0.1&.& 5he la3orator7 shall ha4e a -olic7 that de.ines the
len)th o. time 4ario%s records -ertainin) to the >%alit7
mana)ement s7stem and e=amination res%lts are to
3e retained. /etention time shall 3e de.ined 37 the
nat%re o. the e=amination or s-eci.icall7 .or each
record.
National; re)ional and local re)%lations ma7 a--l7.
5hese records ma7 incl%de 3%t are not limited to the
.ollo6in):
a re>%est .orms (incl%din) the -atient chart or
medical record onl7 i. %sed as the re>%est .orm$M
3 e=amination res%lts and re-ortsM
c instr%ment -rinto%tsM
d e=amination -roced%resM
e la3orator7 6ork83ooks or sheetsM
. accession recordsM
) cali3ration .%nctions and con4ersion .actorsM
h >%alit7 control recordsM
i com-laints and action takenM
< records o. internal and e=ternal a%ditsM
k e=ternal >%alit7 assessment records*
interla3orator7 com-arisonsM
l >%alit7 im-ro4ement recordsM
m instr%ment maintenance records; incl%din)
internal and e=ternal cali3ration recordsM
n lot doc%mentation; certi.icates o. s%--lies;
-acka)e insertsM
o incident* accident records and action takenM
- sta.. trainin) and com-etenc7 records.
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: 2'*!&

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=$1= INTERNAL A!#ITS
0.10.1 In order to 4eri.7 that o-erations contin%e to com-l7
6ith the re>%irements o. the >%alit7 mana)ement
s7stem; internal a%dits o. all elements o. the s7stem;
3oth mana)erial and technical; shall 3e cond%cted at
inter4als de.ined 37 the s7stem itsel.. 5he internal
a%dit shall -ro)ressi4el7 address these elements and
em-hasise areas o. criticall7 im-ortant to -atient care.
0.10.2 A%dits shall 3e .ormall7 -lanned; or)anised; and
carried o%t 37 the >%alit7 mana)er or desi)nated
>%ali.ied -ersonnel. (ersonnel shall not a%dit their
o6n acti4ities. 5he -roced%res .or internal a%dits shall
3e de.ined and doc%mented and incl%de the t7-es o.
a%dit; .re>%encies; methodolo)ies; and re>%ired
doc%mentation. 9hen de.iciencies or o--ort%nities .or
im-ro4ement are noted; the la3orator7 shall
%ndertake a--ro-riate correcti4e or -re4enti4e
actions; 6hich shall 3e doc%mented and carried o%t
6ithin an a)reed %-on time.
5he main elements o. the >%alit7 s7stem sho%ld
normall7 3e s%3<ect to internal a%dit once e4er7
t6el4e months.
0.10.& 5he res%lts o. internal a%dits shall 3e s%3mitted to
la3orator7 mana)ement .or re4ie6.
=$15 MANA2EMENT RE;IE?
0.1.1 In order to ens%re their contin%in) s%ita3ilit7 and
e..ecti4eness in s%--ort o. -atient care and to
introd%ce an7 necessar7 chan)es or im-ro4ements;
la3orator7 mana)ement shall re4ie6 the la3orator72s
>%alit7 mana)ement s7stem and all its medical
ser4ices; incl%din) e=amination and ad4isor7
acti4ities. 5he res%lts o. the re4ie6 shall 3e
incor-orated into a -lan that incl%des )oals;
o3<ecti4es; and action -lans. A t7-ical -eriod .or
cond%ctin) a mana)ement re4ie6 is once e4er7
t6el4e months.
0.1.2 :ana)ement re4ie6 shall take acco%nt o.; 3%t not 3e
limited to:
a .ollo68%- o. -re4io%s mana)ement re4ie6s;
3 stat%s o. correcti4e actions taken and re>%ired
-re4enti4e action;
c re-orts .rom mana)erial and s%-er4isor7
-ersonnel;
d the o%tcome o. recent internal a%dits;

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e assessment 37 e=ternal 3odies;
. the o%tcome o. e=ternal >%alit7 assessment and
other .orms o. interla3orator7 com-arison;
) an7 chan)es in the 4ol%me and t7-e o. 6ork
%ndertaken;
h .eed3ack; incl%din) com-laints and other
rele4ant .actors; .rom clinicians; -atients and
other -arties;
i >%alit7 indicators .or monitorin) the la3orator72s
contri3%tion to -atient care;
< noncon.ormities;
k monitorin) o. t%rnaro%nd time;
l res%lts o. contin%o%s im-ro4ement -rocesses;
and
m e4al%ation o. s%--liers.
Shorter inter4als 3et6een re4ie6s sho%ld 3e ado-ted
6hen a >%alit7 mana)ement s7stem is 3ein)
esta3lished. 5his 6ill allo6 earl7 action to 3e taken in
res-onse to those areas identi.ied as re>%irin)
amendment o. the >%alit7 mana)ement s7stem or
other -ractices.
0.1.& 5he >%alit7 and a--ro-riateness o. the la3orator7Ps
contri3%tion to -atient care shall; to the e=tent
-ossi3le; 3e monitored and e4al%ated o3<ecti4el7.
0.1.0 Findin)s and the actions that arise .rom mana)ement
re4ie6s shall 3e recorded; and la3orator7 sta.. shall
3e in.ormed o. these .indin)s and the decisions made
as a res%lt o. the re4ie6. La3orator7 mana)ement
shall ens%re that arisin) actions are dischar)ed 6ithin
an a--ro-riate and a)reed8%-on time


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5$1 'ERSONNEL
.1.1 La3orator7 mana)ement shall ha4e an or)anisational
-lan; -ersonnel -olicies; and <o3 descri-tions that
de.ine >%ali.ications and d%ties .or all -ersonnel.
.1.2 5he la3orator7 mana)ement shall maintain records o.
the rele4ant ed%cational and -ro.essional
>%ali.ications; trainin) and e=-erience; and
com-etence o. all -ersonnel. 5his in.ormation shall
3e readil7 a4aila3le to rele4ant -ersonnel and ma7
incl%de:
a certi.ication or license; i. re>%ired;
3 re.erences .rom -re4io%s em-lo7ment;
c <o3 descri-tions;
d records o. contin%in) ed%cation and
achie4ements;
e com-etenc7 e4al%ations; and
. -ro4ision .or %nto6ard incident or accident
re-orts.
Other records a4aila3le to a%thorised -ersons relatin) to
-ersonnel health ma7 incl%de records o. e=-os%re to
occ%-ational haQards and records o. imm%nisation stat%s.
.1.& 5he la3orator7 shall 3e directed 37 a -erson or
-ersons ha4in) e=ec%ti4e res-onsi3ilit7 and the
com-etence to ass%me res-onsi3ilit7 .or the ser4ices
-ro4ided.
.1.0 5he res-onsi3ilities o. the la3orator7 director or
desi)nees shall incl%de -ro.essional; scienti.ic;
cons%ltati4e or ad4isor7 or)anisational; administrati4e
and ed%cational matters. 5hese shall 3e rele4ant to
the ser4ices o..ered 37 the la3orator7.
5he la3orator7 director or desi)nees .or each task
sho%ld ha4e the a--ro-riate trainin) and 3ack)ro%nd
to 3e a3le to dischar)e the .ollo6in) res-onsi3ilities:
a -ro4ide ad4ice to those re>%estin) in.ormation
a3o%t the choice o. tests; the %se o. the
la3orator7 ser4ice and the inter-retation o.
la3orator7 dataM

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3 ser4e as an acti4e mem3er(s$ o. the medical sta..
.or those .acilities ser4ed; i. a--lica3le and
a--ro-riateM
c relate and .%nction e..ecti4el7(incl%din)
contract%al arran)ements; i. necessar7$; 6ith
1 a--lica3le accreditin) and re)%lator7
a)encies;
2 a--ro-riate administrati4e o..icials;
& the healthcare comm%nit7; and
0 the -atient -o-%lation ser4edM
d de.ine; im-lement; and monitor standards o.
-er.ormance and >%alit7 im-ro4ement o. the
medical la3orator7 ser4ice or ser4icesM
e im-lement the >%alit7 mana)ement s7stem (the
la3orator7 director and -ro.essional la3orator7
-ersonnel sho%ld -artici-ate as mem3ers o. the
4ario%s >%alit7 im-ro4ement committees o. the
instit%tion; i. a--lica3le$M
. monitor all 6ork -er.ormed in the la3orator7 to
determine that relia3le data are 3ein) )eneratedM
) ens%re that there are s%..icient >%ali.ied
-ersonnel 6ith ade>%ate doc%mented trainin)
and e=-erience to meet the needs o. the
la3orator7M
h -lan; set )oals; de4elo- and allocate reso%rces
a--ro-riate to the medical
en4ironmentM
i -ro4ide e..ecti4e and e..icient administration o.
the medical la3orator7 ser4ice; incl%din) 3%d)et
-lannin) and control 6ith res-onsi3le .inancial
mana)ement; in accordance 6ith instit%tional
assi)nment o. s%ch res-onsi3ilitiesM
< -ro4ide ed%cational -ro)rams .or the medical
and la3orator7 sta.. and -artici-ate in ed%cational
-ro)rams o. the instit%tionM
k -lan and direct research and de4elo-ment
a--ro-riate to the .acilit7M
l select and monitor all re.erral la3oratories .or
>%alit7 o. ser4iceM
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: &#*!&

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m im-lement a sa.e la3orator7 en4ironment in
com-liance 6ith )ood -ractice and a--lica3le
re)%lationsM
n address an7 com-laint; re>%est; or s%))estion
.rom %sers o. la3orator7 ser4icesM
o ens%re )ood sta.. morale.
5he la3orator7 director need not -er.orm all
res-onsi3ilities -ersonall7. ?o6e4er; it is the
la3orator7 director 6ho remains res-onsi3le .or the
o4erall o-eration and administration o. the la3orator7;
to ens%re that >%alit7 ser4ices are -ro4ided .or
-atients.
.1. 5here shall 3e sta.. reso%rces ade>%ate to the
%ndertakin) o. the 6ork re>%ired and the carr7in) o%t
o. other .%nctions o. the >%alit7 mana)ement s7stem.
.1.' (ersonnel shall ha4e trainin) s-eci.ic to >%alit7
ass%rance and >%alit7 mana)ement .or ser4ices
o..ered.
.1.7 La3orator7 mana)ement shall a%thorise -ersonnel to
-er.orm -artic%lar tasks s%ch as sam-lin);
e=amination and o-eration o. -artic%lar t7-es o.
e>%i-ment; incl%din) %se o. com-%ters in the
la3orator7 in.ormation s7stem.
.1.! (olicies shall 3e esta3lished 6hich de.ine 6ho ma7
%se the com-%ter s7stem; 6ho ma7 access -atient
data and 6ho is a%thorised to enter and chan)e
-atient res%lts; correct 3illin) or modi.7 com-%ter
-ro)rams.
.1." 5here shall 3e a contin%in) ed%cation -ro)ram
a4aila3le to sta.. at all le4els.
.1.1# @m-lo7ees shall 3e trained to -re4ent or contain the
e..ects o. ad4erse incidents.
.1.11 5he com-etenc7 o. each -erson to -er.orm assi)ned
tasks shall 3e assessed .ollo6in) trainin) and
-eriodicall7 therea.ter. /etrainin) and reassessment
shall occ%r 6hen necessar7.
.1.12 5he -ersonnel makin) -ro.essional <%d)ements 6ith
re.erence to e=aminations shall ha4e the a--lica3le
theoretical and -ractical 3ack)ro%nd as 6ell as recent
e=-erience. (ro.essional <%d)ements can 3e
e=-ressed as o-inions; inter-retations; -redictions;
sim%lations and models and 4al%es and sho%ld 3e in
accordance 6ith national; re)ional; and local
re)%lations.
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(ersonnel shall take -art in re)%lar -ro.essional
de4elo-ment or other -ro.essional liaison.
.1.1& Con.identialit7 o. in.ormation re)ardin) -atients shall
3e maintained 37 all -ersonnel.
5$2 ACCOMMO#ATION AN# EN;IRONMENTAL CON#ITIONS
.2.1 5he la3orator7 shall ha4e s-ace allocated so that its
6orkload can 3e -er.ormed 6itho%t com-romisin)
the >%alit7 o. 6ork; >%alit7 control -roced%res; sa.et7
o. -ersonnel or -atient care ser4ices. 5he la3orator7
director shall determine the ade>%ac7 o. this s-ace.
5he reso%rces shall 3e o. a de)ree necessar7 to
s%--ort the acti4ities o. the la3orator7. La3orator7
reso%rces shall 3e maintained in a .%nctional and
relia3le condition. Similar -ro4isions sho%ld 3e made
.or -rimar7 sam-le collection and e=aminations at
sites other than the -ermanent la3orator7 .acilit7.
.2.2 5he la3orator7 shall 3e desi)ned .or the e..icienc7 o.
its o-eration; to o-timise the com.ort o. its occ%-ants
and to minimise the risk o. in<%r7 and occ%-ational
illness. (atients; em-lo7ees and 4isitors shall 3e
-rotected .rom reco)nised haQards.
.2.& 9hen -rimar7 sam-le collection .acilities are
-ro4ided; consideration shall 3e )i4en to the
accommodation o. -atient disa3ilities; com.ort and
-ri4ac7; in addition to the o-timisation o. collection
conditions.
.2.0 5he la3orator7 desi)n and en4ironment shall 3e
s%ita3le .or the tasks carried o%t therein. 5he
en4ironment in 6hich the -rimar7 sam-le collection
or e=aminations or 3oth are %ndertaken shall not
in4alidate the res%lts; or ad4ersel7 a..ect the re>%ired
>%alit7 o. an7 meas%rement.
La3orator7 .acilities .or e=amination sho%ld -ermit
correct -er.ormance o. e=aminations. 5hese incl%de;
3%t are not limited to; ener)7 so%rces; li)htin);
4entilation; 6ater; 6aste and re.%se dis-osal; and
en4ironmental conditions. 5he la3orator7 sho%ld
ha4e -roced%res .or checkin) that the en4ironment
does not ad4ersel7 a..ect the -er.ormance o.
s-ecimen collection and e>%i-ment.

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.2. 5he la3orator7 shall monitor; control and record
en4ironmental conditions; as re>%ired 37 rele4ant
s-eci.ications or 6here the7 ma7 in.l%ence the >%alit7
o. the res%lts. Attention sho%ld 3e -aid to sterilit7;
d%st; electroma)netic inter.erence; radiation;
h%midit7; electrical s%--l7; tem-erat%re and so%nd
and 4i3ration le4els; as a--ro-riate to the technical
acti4ities concerned.
.2.' 5here shall 3e e..ecti4e se-aration 3et6een ad<acent
la3orator7 sections in 6hich there are incom-ati3le
acti4ities. :eas%res shall 3e taken to -re4ent cross8
contamination.
.2.7 Access to; and %se o.; areas a..ectin) the >%alit7 o.
the e=aminations shall 3e controlled. A--ro-riate
meas%res shall 3e taken to sa.e)%ard sam-les and
reso%rces .rom %na%thorised access.
.2.! Comm%nication s7stems 6ithin the la3orator7 shall 3e
those a--ro-riate to the siQe and com-le=it7 o. the
.acilit7 and the e..icient trans.er o. messa)es.
.2." /ele4ant stora)e s-ace and conditions shall 3e
-ro4ided to ens%re the contin%in) inte)rit7 o.
sam-les; slides; histolo)7 3locks; retained micro8
or)anisms; doc%ments; .iles; man%als; e>%i-ment;
rea)ents; la3orator7 s%--lies; records and res%lts.
.2.1# 9ork areas shall 3e clean and 6ell maintained.
Stora)e and dis-osal o. dan)ero%s materials shall 3e
those s-eci.ied 37 rele4ant re)%lations.
:eas%res shall 3e taken to ens%re )ood
ho%sekee-in) in the la3orator7. S-ecial -roced%res
and trainin) .or -ersonnel ma7 3e necessar7 to that
end.
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5$" LABORATOR@ E/!I'MENT
.&.1 5he la3orator7 shall 3e .%rnished 6ith all items o.
e>%i-ment re>%ired .or the -ro4ision o. ser4ices
(incl%din) -rimar7 sam-le collection; and sam-le
-re-aration and -rocessin); e=amination and
stora)e$. In those cases 6here the la3orator7 needs
to %se e>%i-ment o%tside its -ermanent control; the
la3orator7 mana)ement shall ens%re that the
re>%irements o. this International Standard are met.
9hen selectin) e>%i-ment; acco%nt sho%ld 3e taken
o. the %se o. ener)7 and .%t%re dis-osal (care o. the
en4ironment$.
.&.2 @>%i-ment shall 3e sho6n (%-on installation and in
ro%tine %se$ to 3e ca-a3le o. achie4in) the
-er.ormance re>%ired and shall com-l7 6ith
s-eci.ications rele4ant to the e=aminations
concerned.
La3orator7 mana)ement shall esta3lish a -ro)ramme
that re)%larl7 monitors and demonstrates -ro-er
cali3ration and .%nction o. instr%ments; rea)ents; and
anal7tical s7stems. It shall also ha4e a doc%mented
and recorded -ro)ramme o. -re4enti4e maintenance
(c.. 0.2.$; 6hich; at a minim%m; .ollo6s the
man%.act%rer2s recommendations.
9hen man%.act%rer2s instr%ctions; o-erator2s
man%als; or other doc%mentation are a4aila3le; the7
ma7 3e %sed to esta3lish re>%irements; .or
com-liance 6ith rele4ant standards or to s-eci.7
re>%irements .or -eriodic cali3ration; as a--ro-riate;
to .%l.il -art or all o. this re>%irement.
.&.& @ach item o. e>%i-ment shall 3e %ni>%el7 la3elled;
marked; or other6ise identi.ied.
.&.0 /ecords shall 3e maintained .or each item o.
e>%i-ment contri3%tin) to the -er.ormance o.
e=aminations. 5hese records shall incl%de at least
the .ollo6in):
a identit7 o. the e>%i-mentM
3 man%.act%rer2s name; t7-e identi.ication and
serial n%m3er or other %ni>%e identi.icationM
c man%.act%rer2s contact -erson and tele-hone
n%m3er; as a--ro-riateM
d date o. recei4in) and date o. -%ttin) into ser4iceM

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e c%rrent location; 6here a--ro-riateM
. condition 6hen recei4ed (e.).; ne6; %sed or
reconditioned$M
) man%.act%rerPs instr%ctions; i. a4aila3le; or
re.erence to their retentionM
h e>%i-ment -er.ormance records that con.irm
e>%i-ment2s s%ita3ilit7 .or %seM
i maintenance carried o%t and that -lanned .or the
.%t%reM
< dama)e to; or mal.%nction; modi.ication or re-air
o. the e>%i-mentM
k -redicted re-lacement date; i. -ossi3le.
5he -er.ormance records re.erred to in h$ sho%ld
incl%de co-ies o. re-orts* certi.icates o. all
cali3rations and*or 4eri.ications incl%din) dates; time
and res%lts; ad<%stments; the acce-tance criteria and
d%e date o. the ne=t cali3ration and* or 4eri.ication;
to)ether 6ith the .re>%enc7 o. checks carried o%t
3et6een maintenance* cali3ration; as a--ro-riate; to
.%l.il -art or all o. this re>%irement. :an%.act%rer2s
instr%ctions ma7 3e %sed to esta3lish acce-tance
criteria; -roced%res and .re>%enc7 o. 4eri.ication .or
maintenance or cali3ration or 3oth; as a--ro-riate; to
.%l.il -art or all o. this re>%irement.
5hese records shall 3e maintained and shall 3e
readil7 a4aila3le .or the li.e s-an o. the e>%i-ment or
.or an7 time -eriod re>%ired 37 national; re)ional and
local re)%lations.
.&. @>%i-ment shall 3e o-erated 37 a%thorised -ersonnel
onl7. F-8to8date instr%ctions on the %se and
maintenance o. e>%i-ment (incl%din) an7 rele4ant
man%als and directions .or %se -ro4ided 37 the
man%.act%rer o. the e>%i-ment$ shall 3e readil7
a4aila3le to la3orator7 -ersonnel.
.&.' @>%i-ment shall 3e maintained in a sa.e 6orkin)
condition. 5his shall incl%de e=amination o. electrical
sa.et7; emer)enc7 sto- de4ices and the sa.e handlin)
and dis-osal o. chemical; radioacti4e and 3iolo)ical
materials 37 a%thorised -ersons. :an%.act%rer2s
s-eci.ications or instr%ctions or 3oth shall 3e %sed; as
a--ro-riate.
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.&.7 9hene4er e>%i-ment is .o%nd to 3e de.ecti4e; it shall
3e taken o%t o. ser4ice; clearl7 la3elled and
a--ro-riatel7 stored %ntil it has 3een re-aired and
sho6n 37 cali3ration; 4eri.ication or testin) to meet
s-eci.ied acce-tance criteria. 5he la3orator7 shall
e=amine the e..ect o. this de.ect on -re4io%s
e=aminations and instit%te the -roced%re )i4en in 0.".
5he la3orator7 shall take reasona3le meas%res to
decontaminate e>%i-ment -rior to ser4ice; re-air or
decommissionin).
.&.! A list o. the meas%res taken to red%ce contamination
shall 3e -ro4ided to the -erson 6orkin) on the
e>%i-ment. 5he la3orator7 shall -ro4ide s%ita3le
s-ace .or re-airs and a--ro-riate -ersonal -rotecti4e
e>%i-ment.
.&." 9hene4er -ractica3le; e>%i-ment %nder the control o.
the la3orator7 6hich re>%ires cali3ration or
4eri.ication shall 3e la3elled or other6ise coded to
indicate the stat%s o. cali3ration or 4eri.ication and the
date 6hen recali3ration or re4eri.ication is d%e.
.&.1# 9hen e>%i-ment is remo4ed .rom the direct control o.
the la3orator7 or is re-aired or ser4iced; the
la3orator7 shall ens%re that it is checked and sho6n
to 3e .%nctionin) satis.actoril7 3e.ore 3ein) ret%rned
to la3orator7 %se.
.&.11 9hen com-%ters or a%tomated e=amination
e>%i-ment are %sed .or the collection; -rocessin);
recordin); re-ortin); stora)e or retrie4al o.
e=amination data; the la3orator7 shall ens%re that
a com-%ter so.t6are; incl%din) that 3%ilt into
e>%i-ment; is doc%mented and s%ita3l7 4alidated
as ade>%ate .or %se in the .acilit7;
3 -roced%res are esta3lished and im-lemented .or
-rotectin) the inte)rit7 o. data at all times;
c com-%ters and a%tomated e>%i-ment are
maintained to ens%re -ro-er .%nctionin) and
-ro4ided 6ith en4ironmental and o-eratin)
conditions necessar7 .or maintainin) the inte)rit7
o. data; and
d com-%ter -ro)rammes and ro%tines are
ade>%atel7 -rotected to -re4ent access;
alteration; or destr%ction 37 cas%al or
%na%thorised -ersons.
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: &'*!&

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.&.12 5he la3orator7 shall ha4e -roced%res .or sa.e
handlin); trans-ort; stora)e and %se o. e>%i-ment to
-re4ent its contamination or deterioration.
.&.1& 9here cali3rations )i4e rise to a set o. correction
.actors; the la3orator7 shall ha4e -roced%res .or
ens%rin) that co-ies o. -rior correction .actors are
correctl7 %-dated.
.&.10 @>%i-ment; incl%din) hard6are; so.t6are; re.erence
materials; cons%ma3les; rea)ents; and anal7tical
s7stems shall 3e sa.e)%arded .rom ad<%stments or
tam-erin) that mi)ht in4alidate e=amination res%lts.
5$= 'REBEFAMINATION 'ROCE#!RES
.0.1 5he re>%est .orm shall contain in.ormation s%..icient
to identi.7the -atient and the a%thorised re>%ester; as
6ell as -ro4idin) -ertinent clinical data. National;
re)ional or local re>%irements shall a--l7.
5he re>%est .orm or an electronic e>%i4alent sho%ld
allo6 s-ace .or the incl%sion o.; 3%t not 3e limited to;
the .ollo6in):
a %ni>%e identi.ication o. the -atientM
3 name or other %ni>%e identi.ier o. -h7sician or
other -erson le)all7 a%thorised to re>%est
e=aminations or %se medical in.ormation
to)ether 6ith the destination .or the re-ort. 5he
re>%estin) clinician2s address sho%ld 3e -ro4ided
as -art o. the re>%est .orm in.ormation 6hen it is
di..erent .rom that o. the recei4in) la3orator7.
c t7-e o. -rimar7 sam-le and the anatomic site o.
ori)in; 6here a--ro-riateM
d e=aminations re>%estedM
e clinical in.ormation rele4ant to the -atient; 6hich
sho%ld incl%de )ender and date o. 3irth; as a
minim%m; .or inter-retation -%r-osesM
. date and time o. -rimar7 sam-le collectionM
) date and time o. recei-t o. sam-les 37 the
la3orator7.
5he .ormat o. the re>%est .orm (e.).; electronic or
-a-er$ and the manner in 6hich re>%ests are to 3e
comm%nicated to the la3orator7 sho%ld 3e
determined in disc%ssion 6ith the %sers o. la3orator7
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.0.2 S-eci.ic instr%ctions .or the -ro-er collection and
handlin) o. -rimar7 sam-les shall 3e doc%mented
and im-lemented 37 la3orator7 mana)ement (see
0.2.0$ and made a4aila3le to those res-onsi3le .or
-rimar7 sam-le collection. 5hese instr%ctions shall 3e
contained in a -rimar7 sam-le collection man%al.
.0.& 5he -rimar7 sam-le collection man%al shall incl%de
the .ollo6in):
a co-ies o. or re.erences to
1 lists o. a4aila3le la3orator7 e=aminations
o..ered;
2 consent .orms; 6hen a--lica3le;
& in.ormation and instr%ctions -ro4ided to
-atients in relation to their o6n -re-aration
3e.ore -rimar7 sam-le collection;
0 in.ormation .or %sers o. la3orator7 ser4ices
on medical indications and a--ro-riate
selection o. a4aila3le -roced%resM
3 -roced%res .or:
1 -re-aration o. the -atient (e.).; instr%ctions
to care)i4ers and -hle3otomists$;
2 identi.ication o. -rimar7 sam-le;
& -rimar7 sam-le collection (e.).; -hle3otom7;
skin -%nct%re; 3lood; %rine and other 3od7
.l%ids$; 6ith descri-tions o. the -rimar7
sam-le containers and an7 necessar7
additi4esM
c instr%ctions .or
1 com-letion o. re>%est .orm or electronic
re>%est;
2 t7-e and amo%nt o. the -rimar7 sam-le to
3e collected;
& s-ecial timin) o. collection; i. re>%ired;
0 an7 s-ecial handlin) needs 3et6een time o.
collection and time recei4ed 37 the
la3orator7 (trans-ort re>%irements;
re.ri)eration; 6armin); immediate deli4er7;
etc.$;
la3ellin) o. -rimar7 sam-les;
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: &!*!&

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' clinical in.ormation (e.).; histor7 o.
administration o. dr%)s$;
7 -ositi4e identi.ication; in detail; o. the -atient
.rom 6hom a -rimar7 sam-le is collected;
! recordin) the identit7 o. the -erson collectin)
the -rimar7 sam-le;
" sa.e dis-osal o. materials %sed in the
collectionM
d instr%ctions .or
1 stora)e o. e=amined sam-les;
2 time limits .or re>%estin) additional
e=aminations;
& additional e=aminations;
0 re-eat e=amination d%e to anal7tical .ail%re
or .%rther e=aminations o. same -rimar7
sam-leM
.0.0 5he -rimar7 sam-le collection man%al shall 3e -art o.
the doc%ment control s7stem (see 0.&.1$.
.0. (rimar7 sam-les shall 3e tracea3le; normall7 37 a
re>%est .orm; to an identi.ied indi4id%al. (rimar7
sam-les lackin) -ro-er identi.ication shall not 3e
acce-ted or -rocessed 37 the la3orator7.
9here there is %ncertaint7 in the identi.ication o. the
-rimar7 sam-le or insta3ilit7 o. the anal7tes in the
-rimar7 sam-le (cere3ros-inal .l%id; 3io-s7; etc.$; and
the -rimar7 sam-le is irre-lacea3le or critical; the
la3orator7 ma7 choose initiall7 to -rocess the sam-le
3%t not release the res%lts %ntil the re>%estin)
-h7sician or -erson res-onsi3le .or the -rimar7
sam-le collection takes res-onsi3ilit7 .or identi.7in)
and acce-tin) the sam-le; or .or -ro4idin) -ro-er
in.ormation; or all these. In s%ch an instance; the
si)nat%re o. that -erson takin) res-onsi3ilit7 .or the
-rimar7 sam-le identi.ication sho%ld 3e recorded on;
or tracea3le to; the re>%est .orm. I. this re>%irement is
not met .or an7 reason; the -erson res-onsi3le
sho%ld 3e identi.ied in the re-ort i. the e=amination is
carried o%t. Sam-les to 3e set aside .or .%t%re
e=amination (e.).; 4iral anti3odies; meta3olites
rele4ant to the clinical s7ndrome$ sho%ld also 3e
identi.ia3le.
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: &"*!&

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.0.' 5he la3orator7 shall monitor the trans-ortation o.
sam-les to the la3orator7 s%ch that the7 are
trans-orted
a 6ithin a time .rame a--ro-riate to the nat%re o.
the re>%ested e=aminations and the la3orator7
disci-line concerned;
3 6ithin a tem-erat%re inter4al s-eci.ied in the
-rimar7 sam-le collection man%al and 6ith the
desi)nated -reser4ati4es to ens%re the inte)rit7
o. sam-les; and
c in a manner that ens%res sa.et7 .or the carrier;
the )eneral -%3lic and the recei4in) la3orator7; in
com-liance 6ith national; re)ional; or local
re)%lator7 re>%irements.
.0.7 All -rimar7 sam-les recei4ed shall 3e recorded in an
accession 3ook; 6orksheet; com-%ter or other
com-ara3le s7stem. 5he date and time o. recei-t o.
sam-les; as 6ell as the identit7 o. the recei4in)
o..icer; shall 3e recorded.
.0.! Criteria shall 3e de4elo-ed and doc%mented .or
acce-tance or re<ection o. -rimar7 sam-les. I.
com-romised -rimar7 sam-les are acce-ted; the .inal
re-ort shall indicate the nat%re o. the -ro3lem and; i.
a--lica3le; that ca%tion is re>%ired 6hen inter-retin)
the res%lt.
.0." 5he la3orator7 shall -eriodicall7 re4ie6 its sam-le
4ol%me re>%irements .or -hle3otom7 (and other
sam-les s%ch as cere3ros-inal .l%id$ to ens%re that
neither ins%..icient nor e=cessi4e amo%nts o. sam-le
are collected.
.0.1# A%thoriQed -ersonnel shall s7stematicall7 re4ie6
re>%ests and sam-les and decide 6hich
e=aminations are to 3e -er.ormed and the methods to
3e %sed in -er.ormin) them.
.0.11 5he la3orator7 shall; i. rele4ant; ha4e a doc%mented
-roced%re .or the recei-t; la3ellin); -rocessin) and
re-ortin) o. those -rimar7 sam-les recei4ed 37 the
la3orator7 and s-eci.icall7 marked as %r)ent. 5he
-roced%re shall incl%de details o. an7 s-ecial la3ellin)
o. the re>%est .orm and -rimar7 sam-le; the
mechanism o. trans.er o. the -rimar7 sam-le to the
e=amination area o. the la3orator7; an7 ra-id
-rocessin) mode to 3e %sed and
an7 s-ecial re-ortin) criteria to 3e .ollo6ed.

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.0.12 Sam-le -ortions shall also 3e tracea3le to the ori)inal
-rimar7 sam-le.
.0.1& 5he la3orator7 shall ha4e a 6ritten -olic7 concernin)
4er3al re>%ests .or sam-le e=aminations
.0.10 Sam-les shall 3e stored .or a s-eci.ied time; %nder
conditions that ens%rin) sta3ilit7 o. sam-le -ro-erties;
to ena3le re-etition o. the e=amination a.ter re-ortin)
o. the res%lt or .or additional e=aminations.
5$5 EFAMINATION 'ROCE#!RES
..1 5he la3orator7 shall %se e=amination -roced%res;
incl%din) those .or selectin)* takin) sam-le -ortions;
6hich meet the needs o. the %sers o. la3orator7
ser4ices and are a--ro-riate .or the e=aminations.
(re.erred -roced%res are those that ha4e 3een
-%3lished in esta3lished*a%thoritati4e te=t3ooks; -eer8
re4ie6ed te=ts or <o%rnals; or in international; national
or re)ional )%idelines. I. in8ho%se -roced%res are
%sed; the7 shall 3e a--ro-riatel7 4alidated .or their
intended %se and .%ll7 doc%mented.
..2 5he la3orator7 shall %se onl7 4alidated -roced%res .or
con.irmin) that the e=amination -roced%res are
s%ita3le .or the intended %se. 5he 4alidations shall 3e
as e=tensi4e as are necessar7 to meet the needs in
the )i4en a--lication or .ield o. a--lication. 5he
la3orator7 shall record the res%lts o3tained and the
-roced%re %sed .or the 4alidation.
5he methods and -roced%res selected .or %se shall
3e e4al%ated and .o%nd to )i4e satis.actor7 res%lts
3e.ore 3ein) %sed .or medical e=aminations. A re4ie6
o. -roced%res 37 the la3orator7 director or desi)nated
-erson shall 3e %ndertaken initiall7 and at de.ined
inter4als. S%ch a re4ie6 is normall7 carried o%t
ann%all7. 5hese re4ie6s shall 3e doc%mented.
..& All -roced%res shall 3e doc%mented and 3e a4aila3le
at the 6orkstation .or rele4ant sta... Doc%mented
-roced%res and necessar7 instr%ctions shall 3e
a4aila3le in a lan)%a)e commonl7 %nderstood 37 the
sta.. in the la3orator7.
Card .iles or similar s7stems that s%mmarise ke7
in.ormation are acce-ta3le .or %se as a >%ick
re.erence at the 6ork3ench; -ro4ided that a com-lete
man%al is a4aila3le .or re.erence. 5he card .ile or
similar s7stems shall corres-ond to the com-lete
man%al. An7 s%ch a3rid)ed -roced%res shall 3e -art
o. the doc%ment control s7stem

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5he -roced%re shall 3e 3ased in 6hole or in -art on
the instr%ctions .or %se (e.). -acka)e insert$ 6ritten
37 the man%.act%rer; -ro4ided that the7 are in
accordance 6ith ..1 and ..2 and that the7
descri3e the -roced%re as it is -er.ormed in the
la3orator7 and are 6ritten in a lan)%a)e commonl7
%nderstood 37 the sta.. o. the la3orator7. An7
de4iation shall 3e re4ie6ed and doc%mented.
Additional in.ormation that co%ld 3e re>%ired
to -er.orm the e=amination shall also 3e doc%mented.
@ach ne6 4ersion o. e=amination kits 6ith ma<or
chan)es in rea)ents or -roced%re shall 3e checked
.or -er.ormance and s%ita3ilit7 .or intended %se. An7
-roced%ral chan)es shall 3e dated and a%thorised as
.or other -roced%res.
In addition to doc%ment control identi.iers;
doc%mentation sho%ld incl%de; 6hen a--lica3le; the
.ollo6in):
a -%r-ose o. the e=aminationM
3 -rinci-le o. the -roced%re %sed .or e=aminationsM
c -er.ormance s-eci.ications (e.). linearit7;
-recision; acc%rac7 e=-ressed as %ncertaint7 o.
meas%rement; detection limit; meas%rin) inter4al;
tr%eness o. meas%rement; sensiti4it7 and
s-eci.icit7$M
d -rimar7 sam-le s7stem (e.). -lasma; ser%m;
%rine$M
e t7-e o. container and additi4eM
. re>%ired e>%i-ment and rea)entsM
) cali3ration -roced%res (metrolo)ical tracea3ilit7$M
h -roced%ral ste-sM
i >%alit7 control -roced%resM
< inter.erences (e.). li-emia; hemol7sis;
3ilir%3inemia$ and cross reactionsM
k -rinci-le o. -roced%re .or calc%latin) res%lts;
incl%din) meas%rement %ncertaint7M
l 3iolo)ical re.erence inter4alsM
m re-orta3le inter4al o. -atient e=amination res%ltsM
n alert* critical 4al%es; 6here a--ro-riateM

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o la3orator7 inter-retationM
- sa.et7 -reca%tionsM
> -otential so%rces o. 4aria3ilit7.
@lectronic man%als are acce-ta3le -ro4ided that the
a3o4e8s-eci.ied in.ormation is incl%ded. 5he same
re>%irements .or doc%ment control sho%ld also a--l7
to electronic man%als.
5he la3orator7 director shall 3e res-onsi3le .or
ens%rin) that the contents o. e=amination -roced%res
are com-lete; c%rrent; and has 3een thoro%)hl7
re4ie6ed.
..0 (er.ormance s-eci.ications .or each -roced%re %sed
in an e=amination shall relate to the intended %se o.
that -roced%re.
.. Biolo)ical re.erence inter4als shall 3e -eriodicall7
re4ie6ed. I. the la3orator7 has reason to 3elie4e that
a -artic%lar inter4al is no lon)er a--ro-riate .or the
re.erence -o-%lation; then an in4esti)ation shall 3e
%ndertaken; .ollo6ed; i. necessar7; 37 correcti4e
action. A re4ie6 o. 3iolo)ical re.erence inter4als shall
also take -lace 6hen the la3orator7 chan)es an
e=amination -roced%re or -re8e=amination -roced%re;
i. a--ro-riate.
..' F-on re>%est; the la3orator7 shall make its list o.
c%rrent e=amination -roced%res; incl%din) -rimar7
sam-le re>%irements and rele4ant -er.ormance
s-eci.ications and re>%irements; a4aila3le to %sers o.
la3orator7 ser4ices
..7 I. the la3orator7 intends to chan)e an e=amination
-roced%re s%ch that res%lts or their inter-retations
co%ld 3e si)ni.icantl7 di..erent; the im-lications shall
3e e=-lained to %sers o. the la3orator7 ser4ices in
6ritin) -rior to the introd%ction o. the chan)e.
5$% ASS!RIN2 /!ALIT@ OF EFAMINATION 'ROCE#!RES
.'.1 5he la3orator7 shall desi)n internal >%alit7 control
s7stems that 4eri.7 the attainment o. the intended
>%alit7 o. res%lts. It is im-ortant that the control
s7stem -ro4ide sta.. mem3ers 6ith clear and easil7
%nderstood in.ormation on 6hich to 3ase technical
and medical decisions. S-ecial attention sho%ld 3e
-aid to the elimination o. mistakes in the -rocess o.
handlin) sam-les; re>%ests; e=aminations; re-orts;
etc.

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.'.2 5he la3orator7 shall determine the %ncertaint7 o.
res%lts; 6here rele4ant and -ossi3le. Fncertaint7
com-onents 6hich are o. im-ortance shall 3e taken
into acco%nt. So%rces that contri3%te to %ncertaint7
ma7 incl%de sam-lin); sam-le -re-aration; sam-le
-ortion selection; cali3rators; re.erence materials;
in-%t >%antities; e>%i-ment %sed; en4ironmental
conditions; condition o. the sam-le; and chan)es o.
o-erator.
.'.& A -ro)ramme .or cali3ration o. meas%rin) s7stems
and 4eri.ication o. tr%eness shall 3e desi)ned and
-er.ormed so as to ens%re that res%lts are tracea3le
to SI %nits or 37 re.erence to a nat%ral constant or
other stated re.erence. 9here none o. these are
-ossi3le or rele4ant; other means .or -ro4idin)
con.idence in the res%lts shall 3e a--lied incl%din)
3%t not limited to the .ollo6in):
a -artici-ation in a s%ita3le -ro)ramme o.
Interla3orator7 com-arisonsM
3 %se o. s%ita3le re.erence materials; certi.ied to
indicate the characterisation o. the materialM
c e=amination or cali3ration 37 another -roced%reM
d ratio or reci-rocit78t7-e meas%rementsM
e m%t%al consent standards or methods 6hich are
clearl7 esta3lished; s-eci.ied; characterised and
m%t%all7 a)reed %-on 37 all -arties concernedM
. doc%mentation o. statements re)ardin) rea)ents;
-roced%res or the e=amination s7stem 6hen
tracea3ilit7 is -ro4ided 37 the s%--lier or
man%.act%rer.
.'.0 5he la3orator7 shall -artici-ate in interla3orator7
com-arisons s%ch as those or)anised 37 e=ternal
>%alit7 assessment schemes. La3orator7
mana)ement shall monitor the res%lts o. e=ternal
>%alit7 assessment and -artici-ate in the
im-lementation o. correcti4e actions 6hen control
criteria are not .%l.illed. Interla3orator7 com-arison
-ro)rams shall 3e in s%3stantial a)reement 6ith ISO*
I@C +%ide 0&81.
@=ternal >%alit7 assessment -ro)rammes sho%ld; as
.ar as -ossi3le; -ro4ide clinicall7 rele4ant challen)es
that mimic -atient sam-les and ha4e the e..ect o.
checkin) the entire e=amination -rocess; incl%din)
-re8 and -ost8e=amination -roced%res.

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.'. 9hene4er a .ormal interla3orator7 com-arison
-ro)ramme is not a4aila3le; the la3orator7 shall
de4elo- a mechanism .or determinin) the
acce-ta3ilit7 o. -roced%res not other6ise e4al%ated.
9hene4er -ossi3le; this mechanism shall %tilise
e=ternall7 deri4ed challen)e materials s%ch as
e=chan)e o. sam-les 6ith other la3oratories.
La3orator7 mana)ement shall monitor the res%lts o.
this mechanism o. inter la3orator7 com-arison and
-artici-ate in the im-lementation and recordin) o.
correcti4e actions.
.'.' For those e=aminations -er.ormed %sin) di..erent
-roced%res or e>%i-ment or at di..erent sites; or all
these; there shall 3e a de.ined mechanism .or
4eri.7in) the com-ara3ilit7 o. res%lts thro%)ho%t the
clinicall7 a--ro-riate inter4als. S%ch 4eri.ication shall
3e -er.ormed at de.ined -eriods o. time a--ro-riate
to the characteristics o. the -roced%re or instr%ment.
.'.7 5he la3orator7 shall doc%ment; record and; as
a--ro-riate; e=-editio%sl7 act %-on res%lts .rom these
com-arisons. (ro3lems or de.iciencies identi.ied shall
3e acted %-on and records o. actions retained.
5$7 'OSTBEFAMINATION 'ROCE#!RES
.7.1 A%thorised -ersonnel shall s7stematicall7 re4ie6 the
res%lts o. e=aminations; e4al%ate them in con.ormit7
6ith the clinical in.ormation a4aila3le re)ardin) the
-atient and a%thorise the release o. the res%lts.
.7.2 Stora)e o. the -rimar7 sam-le and other la3orator7
sam-les shall 3e in accordance 6ith a--ro4ed -olic7.
.7.& Sa.e dis-osal o. sam-les no lon)er re>%ired .or
e=amination shall 3e carried o%t in accordance 6ith
local re)%lations or recommendations .or 6aste
mana)ement.
5$8 RE'ORTIN2 OF RES!LTS
.!.1 La3orator7 mana)ement shall 3e res-onsi3le .or
.ormattin) re-orts. 5he .ormat o. the re-ort .orm (i.e.
electronic or -a-er$ and the manner in 6hich it is to
3e comm%nicated .rom the la3orator7 sho%ld 3e
ser4ices.
.!.2 La3orator7 mana)ement shares res-onsi3ilit7 6ith
the re>%ester .or ens%rin) that re-orts are recei4ed
37 the a--ro-riate indi4id%als 6ithin an a)reed8%-on
time inter4al.

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.!.& /es%lts shall 3e le)i3le; 6itho%t mistakes in
transcri-tion and re-orted to -ersons a%thorised to
recei4e and %se medical in.ormation. 5he re-ort shall
also incl%de; 3%t not 3e limited to; the .ollo6in):
a Clear; %nam3i)%o%s identi.ication o. the
e=amination incl%din); 6here a--ro-riate; the
meas%rement -roced%reM
3 the identi.ication o. the la3orator7 that iss%ed the
re-ortM
c %ni>%e identi.ication and location o. the -atient;
6here -ossi3le; and destination o. the re-ortM
d name or other %ni>%e identi.ier o. the re>%ester
and the re>%ester2s addressM
e date and time o. -rimar7 sam-le collection; 6hen
a4aila3le and rele4ant to -atient care; and time o.
recei-t 37 the la3orator7M
. date and time o. release o. re-ort; 6hich; i. not
on the re-ort; shall 3e readil7 accessi3le 6hen
neededM
) so%rce and s7stem (or -rimar7 sam-le t7-e$M
h res%lts o. the e=amination re-orted in SI %nits or
%nits tracea3le to SI %nits (see ISO +%ide &1$;
6here a--lica3leM
i 3iolo)ical re.erence inter4als; 6here a--lica3leM
< inter-retation o. res%lts; 6here a--ro-riateM
k other comments (e.).; >%alit7 or ade>%ac7 o.
-rimar7 sam-le 6hich ma7 ha4e com-romised
the res%lt; res%lts*inter-retations .rom re.erral
la3oratories; %se o. de4elo-mental -roced%re$M
the re-ort sho%ld identi.7 e=aminations
%ndertaken as -art o. a de4elo-ment -ro)ramme
and .or 6hich no s-eci.ic claims on meas%rement
-er.ormance are made; and; 6here a--lica3le;
in.ormation on detection limit and %ncertaint7 o.
meas%rement sho%ld 3e -ro4ided %-on re>%est.
l identi.ication o. the -erson a%thorisin) the
release o. the re-ortM
m i. rele4ant; ori)inal and corrected res%ltsM
n si)nat%re or a%thorisation o. the -erson checkin)
or releasin) the re-ort; 6here -ossi3le.

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.!.0 As a--ro-riate; the descri-tion o. e=aminations
-er.ormed and their res%lts sho%ld .ollo6 the
4oca3%lar7 and s7nta= recommended 37 one or more
o. the .ollo6in) or)anisations:
8 International Co%ncil .or StandardiQation in
?aematolo)7 (ICS?$M
8 International Societ7 o. ?aematolo)7 (IS?$M
8 International Federation o. Clinical Chemistr7
and La3orator7 :edicine (IFCC$M
8 International Fnion o. (%re and A--lied
Chemistr7 (IF(AC$M
8 International Societ7 o. 5hrom3osis and
?aemostasis (IS5?$M
8 @%ro-ean Committee .or Standardisation (C@N$M
As a--ro-riate; the descri-tion and res%lts sho%ld
.ollo6 the nomenclat%re recommended 37 one or
more o. the .ollo6in) or)anisations:
8 International Fnion o. Biochemistr7 and
:olec%lar Biolo)7 (IFB:B$M
8 International Fnion o. :icro3iolo)ical Societies
(IF:S$M
8 International Fnion o. Imm%nolo)ical Societies
(IFIS$M
8 SNO:@D International (Colle)e o. American
(atholo)ists$M
8 9orld ?ealth Or)aniQation (9?O$.
.!. 5he re-ort shall indicate i. the >%alit7 o. the -rimar7
sam-le recei4ed 6as %ns%ita3le .or e=amination or
co%ld ha4e com-romised the res%lt.
.!.' Co-ies or .iles o. re-orted res%lts shall 3e retained 37
the la3orator7 s%ch that -rom-t retrie4al o. the
in.ormation is -ossi3le. 5he len)th o. time that
re-orted data are retained ma7 4ar7M ho6e4er; the
re-orted res%lts shall 3e retrie4a3le .or as lon) as
medicall7 rele4ant or as re>%ired 37 national;
re)ional; or local re>%irements.

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.!.7 5he la3orator7 shall ha4e -roced%res .or immediate
noti.ication o. a -h7sician (or other clinical -ersonnel
res-onsi3le .or -atient care$ 6hen e=amination
res%lts .or critical -ro-erties .all 6ithin esta3lished
RalertR or RcriticalR inter4als. 5his incl%des res%lts
recei4ed on sam-les sent to re.erral la3oratories .or
e=amination.
.!.! In order that local clinical needs can 3e ser4ed; the
la3orator7 shall determine the critical -ro-erties and
their Ralert* criticalR inter4als; in a)reement 6ith the
clinicians %sin) the la3orator7. 5his a--lies to all
e=aminations; incl%din) nominal and ordinal
-ro-erties.
.!." For res%lts transmitted as an interim re-ort; the .inal
re-ort shall al6a7s 3e .or6arded to the re>%ester.
.!.1# /ecords o. actions taken in res-onse to res%lts in the
critical inter4als shall 3e maintained. 5hese shall
incl%de date; time; res-onsi3le la3orator7 sta..
mem3er; -erson noti.ied; and e=amination res%lts.
An7 di..ic%lt7 enco%ntered in meetin) this re>%irement
shall 3e recorded and re4ie6ed d%rin) a%dits.
.!.11 La3orator7 mana)ement; in cons%ltation 6ith the
re>%esters; shall esta3lish t%rnaro%nd times .or each
o. its e=aminations. A t%rnaro%nd time shall re.lect the
clinical needs.
5here shall 3e a -olic7 .or noti.7in) the re>%ester
6hen an e=amination is dela7ed. 5%rnaro%nd times
as 6ell as an7 .eed3ack .rom clinicians in relation to it
shall 3e monitored; recorded; and re4ie6ed 37
la3orator7 mana)ement. 9here necessar7; correcti4e
action shall 3e taken to address an7 -ro3lems so
identi.ied.
5his does not mean that the clinical -ersonnel are to
3e noti.ied o. all dela7s in e=amination; 3%t onl7 in
those sit%ations 6here the dela7 co%ld com-romise
-atient care. 5his -roced%re sho%ld 3e de4elo-ed in
colla3oration 3et6een clinical and la3orator7
-ersonnel.
.!.12 9hen e=amination res%lts .rom a re.erral la3orator7
need to 3e transcri3ed 37 the re.errin) la3orator7;
-roced%res .or 4eri.7in) the correctness o. all
transcri-tions shall 3e in -lace.
.!.1& 5he la3orator7 shall ha4e clearl7 doc%mented
-roced%res .or the release o. e=amination res%lts;
incl%din) details o. 6ho ma7 release res%lts and to
6hom. 5he -roced%res shall also incl%de )%idelines
.or the release o. res%lts directl7 to -atients.

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.!.10 5he la3orator7 shall esta3lish -olicies and -ractices
.or ens%rin) that res%lts distri3%ted 37 tele-hone or
other electronic means reach onl7 a%thorised
recei4ers. /es%lts -ro4ided 4er3all7 shall 3e .ollo6ed
37 a -ro-erl7 recorded re-ort.
.!.1 5he la3orator7 shall ha4e 6ritten -olicies and
-roced%res re)ardin) the alteration o. re-orts.
9hen altered; the record m%st sho6 the time; date;
and name o. the -erson res-onsi3le .or the chan)e.
Ori)inal entries shall remain le)i3le 6hen alterations
are made.
Ori)inal electronic records shall 3e retained and
alterations added to the record thro%)h a--ro-riate
editin) -roced%res so that re-orts clearl7 indicate the
alteration.
.!.1' /es%lts that ha4e 3een a4aila3le .or clinical decision8
makin) and re4ised shall 3e retained in s%3se>%ent
c%m%lati4e re-orts and 3e clearl7 identi.ied as ha4in)
3een re4ised. I. the re-ortin) s7stem cannot ca-t%re
amendments; chan)es or alterations; an a%dit lo)
shall 3e %sed.


TEST(S ?ITNESS CHECKLIST 2: (ISO 15189: 2007
NABL8Checklist82
5he .ollo6in) -a)es -resent a checklist o. a .e6 criteria .rom ISO 11!": 2##7; 6hich is the 3asis .or
the NABL +eneral re>%irements .or accreditation o. la3oratories. 5he la3orator72s -olicies and
-roced%res m%st meet these re>%irements o. ISO 11!": 2##7. T3e a0*)a& s*anda.d ,)s* 1e
.e+e..ed +o. *3e de+-n-*-9e &an()a(e and -n*e.7.e*a*-on$
5he Assessor m%st com-lete this checklist; -%t initials on each -a)e. 5he .ollo6in) s7m3ols ma7 3e
%sed .or com-letin) this checklist.
EE H CO:(LIANC@
E H CO:(LIANC@ 9I5? /@:A/I
A H :AJO/ NON8CONFO/:I5C
B H :INO/ NON8CONFO/:I5C
NA H NO5 A((LICABL@
BLANK H NO5 ASS@SS@D
5he Assessor m%st re4ie6 the la3orator72s doc%mented s7stem to 4eri.7 con.ormit7 6ith the
re>%irements o. ISO 11!": 2##7M assess to 4eri.7 that the doc%mented SO(s; test methods; records
etc. is indeed im-lemented as descri3ed; assess the la3oratories technical com-etence to -er.orm
s-eci.ic test or s-eci.ic t7-es o. test; record concl%sion*comments related to tests or test method on
se-arate sheet(s$. All non con.ormities m%st 3e identi.ied and re-orted se-aratel7 on each sheet in
NAF80. 5his checklist 3e s%3mitted as a -art o. the assessment re-ort.
5he .ollo6in) s7m3ols ha4e 3een %sed in the Checklist:
#o0 5
Doc%mentation contains 6ork instr%ction; -roced%res etc.
O7. H O-eration 3ein) -racticed
LABO/A5O/C ASS@SS@D
CI5C*5O9N
ASS@SS:@N5 DA5@ (S$
ASS@SSO/2S NA:@
SI+NA5F/@
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: #*!&

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= MANA2EMENT RE/!IREMENT
=$5 EFAMINATION B@ REFERRAL LABORATORIES
.!.1 5he la3orator7 shall ha4e an e..ecti4e
doc%mented -roced%re .or e4al%atin) and
selectin) re.erral la3oratories as 6ell as
cons%ltants 6ho are to -ro4ide second
o-inions .or histo-atholo)7; c7tolo)7; and
related disci-lines. La3orator7 mana)ement;
6ith the ad4ice o. %sers o. la3orator7
ser4ices 6here a--ro-riate; shall 3e
res-onsi3le .or selectin) and monitorin) the
>%alit7 o. re.erral la3oratories and
cons%ltants and shall ens%re that the re.erral
la3orator7 or re.erral cons%ltant is
com-etent to -er.orm the re>%ested
e=aminations.
.!.2 Arran)ements 6ith re.erral la3oratories shall
3e re4ie6ed -eriodicall7 to ens%re that
a re>%irements; incl%din) the -re8
e=amination and -ost8e=amination
-roced%res; are ade>%atel7 de.ined;
doc%mented; and %nderstood;
3 the re.erral la3orator7 is a3le to meet
the re>%irements and that there are no
con.licts o. interest;
c selection o. e=amination -roced%res is
a--ro-riate .or the intended %se;
d res-ecti4e res-onsi3ilities .or the
inter-retation o. e=amination res%lts are
clearl7 de.ined.
/ecords o. s%ch re4ie6s shall 3e maintained
in accordance 6ith national; re)ional; or
local re>%irements.

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0..& 5he la3orator7 shall maintain a re)ister o. all
re.erral la3oratories that it %ses. A re)ister
shall 3e ke-t o. all sam-les that ha4e 3een
re.erred to another la3orator7. 5he name
and address o. the la3orator7 res-onsi3le
.or the e=amination res%lt shall 3e -ro4ided
to the %ser o. la3orator7 ser4ices. A
d%-licate o. the la3orator7 re-ort shall 3e
retained in 3oth the -atient record and in the
-ermanent .ile o. the la3orator7.
0..0 5he re.errin) la3orator7 and not the re.erral
la3orator7 shall 3e res-onsi3le .or ens%rin)
that re.erral la3orator7 e=amination res%lts
and .indin)s are -ro4ided to the -erson
makin) the re>%est. I. the re.errin)
la3orator7 -re-ares the re-ort; it shall
incl%de all essential elements o. the res%lts
re-orted 37 the re.erral la3orator7; 6itho%t
alterations that co%ld a..ect clinical
inter-retation.
National; re)ional and local re)%lations ma7
a--l7.
?o6e4er; this does not re>%ire that the
re.errin) la3orator7 re-ort incl%de e4er7
6ord and ha4e the e=act .ormat o. the
re.erral la3orator7 re-ort; %nless
national*local la6s or re)%lations re>%ire it.
5he re.errin) la3orator7 director ma7 elect to
-ro4ide additional inter-retati4e remarks to
those; i. an7; o. the re.erral la3orator7; in the
conte=t o. the -atient and the local medical
en4ironment. 5he a%thor o. s%ch added
remarks sho%ld 3e clearl7 identi.ied.
=$% EFTERNAL SER;ICES AN# S!''LIES
0.'.1 La3orator7 mana)ement shall de.ine and
doc%ment its -olicies and -roced%res .or the
selection and %se o. -%rchased e=ternal
ser4ices; e>%i-ment; and cons%ma3le
s%--lies that a..ect the >%alit7 o. its ser4ice.
(%rchased items shall consistentl7 meet the
la3orator72s >%alit7 re>%irements. National;
re)ional; or local re)%lations ma7 re>%ire
records o. -%rchased items. 5here shall 3e
-roced%res and criteria .or ins-ection;
acce-tance* re<ection; and stora)e o.
cons%ma3le materials.

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0.'.2 (%rchased e>%i-ment and cons%ma3le
s%--lies that a..ect the >%alit7 o. the ser4ice
shall not 3e %sed %ntil the7 ha4e 3een
4eri.ied as com-l7in) 6ith standard
s-eci.ications or re>%irements de.ined .or
the -roced%res concerned. 5his ma7 3e
accom-lished 37 e=aminin) >%alit7 control
sam-les and 4eri.7in) that res%lts are
acce-ta3le. Doc%mentation o. the s%--lier2s
con.ormance 6ith its >%alit7 mana)ement
s7stem ma7 also 3e %sed .or 4eri.ication.
0.'.& 5here shall 3e an in4entor7 control s7stem
.or s%--lies. A--ro-riate >%alit7 records o.
e=ternal ser4ices; s%--lies; and -%rchased
-rod%cts shall 3e esta3lished and
maintained .or a -eriod o. time; as de.ined in
the >%alit7 mana)ement s7stem. 5his
s7stem sho%ld incl%de the recordin) o. lot
n%m3ers o. all rele4ant rea)ents; control
materials; and cali3rators; the date o. recei-t
in the la3orator7; and the date the material is
-laced in ser4ice. All o. these >%alit7 records
shall 3e a4aila3le .or la3orator7
mana)ement re4ie6.
0.'.0 5he la3orator7 shall e4al%ate s%--liers o.
critical rea)ents; s%--lies and ser4ices that
a..ect the >%alit7 o. e=aminations and shall
maintain records o. these e4al%ations and
list those a--ro4ed.
=$7 A#;ISOR@ SER;ICES
A--ro-riate la3orator7 -ro.essional sta.. shall
-ro4ide ad4ice on choice o. e=aminations and %se
o. the ser4ices; incl%din) re-eat .re>%enc7 and
re>%ired t7-e o. sam-le. 9here a--ro-riate;
inter-retation o. the res%lts o. e=aminations shall
3e -ro4ided.
5here sho%ld 3e re)%lar doc%mented meetin)s o.
-ro.essional sta.. 6ith the clinical sta.. re)ardin)
the %se o. the la3orator7 ser4ices; and .or the
-%r-ose o. cons%ltation on scienti.ic matters. 5he
-ro.essional sta.. sho%ld -artici-ate in clinical
ro%nds; ena3lin) ad4ice on e..ecti4eness in )eneral
as 6ell as in indi4id%al cases.
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: &*!&

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=$1" /!ALIT@ AN# TECHNICAL RECOR#S
0.1&.1 5he la3orator7 shall esta3lish and
im-lement -roced%res .or identi.ication;
collection; inde=in); access; stora)e;
maintenance and sa.e dis-osal o. >%alit7
and technical records.
0.1&.2 All records shall 3e le)i3le and stored s%ch
that the7 are readil7 retrie4a3le. /ecords
ma7 3e stored on an7 a--ro-riate medi%m
s%3<ect to national; re)ional; or local le)al
re>%irements. Facilities shall -ro4ide a
s%ita3le en4ironment to -re4ent dama)e;
deterioration; loss; or %na%thorised access.
0.1&.& 5he la3orator7 shall ha4e a -olic7 that
de.ines the len)th o. time 4ario%s records
-ertainin) to the >%alit7 mana)ement
s7stem and e=amination res%lts are to 3e
retained. /etention time shall 3e de.ined 37
the nat%re o. the e=amination or s-eci.icall7
.or each record.
National; re)ional and local re)%lations ma7
a--l7.
5hese records ma7 incl%de 3%t are not
limited to the .ollo6in):
a re>%est .orms (incl%din) the -atient
chart or medical record onl7 i. %sed as
the re>%est .orm$M
3 e=amination res%lts and re-ortsM
c instr%ment -rinto%tsM
d e=amination -roced%resM
e la3orator7 6ork83ooks or sheetsM
. accession recordsM
) cali3ration .%nctions and con4ersion
.actorsM
h >%alit7 control recordsM
i com-laints and action takenM
< records o. internal and e=ternal a%ditsM
k e=ternal >%alit7 assessment records*
interla3orator7 com-arisonsM
l >%alit7 im-ro4ement recordsM

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m instr%ment maintenance records;
incl%din) internal and e=ternal
cali3ration recordsM
n lot doc%mentation; certi.icates o.
s%--lies; -acka)e insertsM
o incident* accident records and action
takenM
- sta.. trainin) and com-etenc7 records.
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: *!&

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5$1 'ERSONNEL
.1.1 La3orator7 mana)ement shall ha4e an or)anisational
-lan; -ersonnel -olicies; and <o3 descri-tions that
de.ine >%ali.ications and d%ties .or all -ersonnel.
.1.2 5he la3orator7 mana)ement shall maintain records o.
the rele4ant ed%cational and -ro.essional
>%ali.ications; trainin) and e=-erience; and
com-etence o. all -ersonnel. 5his in.ormation shall
3e readil7 a4aila3le to rele4ant -ersonnel and ma7
incl%de:
a certi.ication or license; i. re>%ired;
3 re.erences .rom -re4io%s em-lo7ment;
c <o3 descri-tions;
d records o. contin%in) ed%cation and
achie4ements;
e com-etenc7 e4al%ations; and
. -ro4ision .or %nto6ard incident or accident
re-orts.
Other records a4aila3le to a%thorised -ersons relatin) to
-ersonnel health ma7 incl%de records o. e=-os%re to
occ%-ational haQards and records o. imm%nisation stat%s.
.1.& 5he la3orator7 shall 3e directed 37 a -erson or
-ersons ha4in) e=ec%ti4e res-onsi3ilit7 and the
com-etence to ass%me res-onsi3ilit7 .or the ser4ices
-ro4ided.
.1.0 5he res-onsi3ilities o. the la3orator7 director or
desi)nees shall incl%de -ro.essional; scienti.ic;
cons%ltati4e or ad4isor7 or)anisational; administrati4e
and ed%cational matters. 5hese shall 3e rele4ant to
the ser4ices o..ered 37 the la3orator7.
5he la3orator7 director or desi)nees .or each task
sho%ld ha4e the a--ro-riate trainin) and 3ack)ro%nd
to 3e a3le to dischar)e the .ollo6in) res-onsi3ilities:
a -ro4ide ad4ice to those re>%estin) in.ormation
a3o%t the choice o. tests; the %se o. the
la3orator7 ser4ice and the inter-retation o.
la3orator7 dataM
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: '*!&

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3 ser4e as an acti4e mem3er(s$ o. the medical sta..
.or those .acilities ser4ed; i. a--lica3le and
a--ro-riateM
c relate and .%nction e..ecti4el7(incl%din)
contract%al arran)ements; i. necessar7$; 6ith
1 a--lica3le accreditin) and re)%lator7
a)encies;
2 a--ro-riate administrati4e o..icials;
& the healthcare comm%nit7; and
0 the -atient -o-%lation ser4edM
d de.ine; im-lement; and monitor standards o.
-er.ormance and >%alit7 im-ro4ement o. the
medical la3orator7 ser4ice or ser4icesM
e im-lement the >%alit7 mana)ement s7stem (the
la3orator7 director and -ro.essional la3orator7
-ersonnel sho%ld -artici-ate as mem3ers o. the
4ario%s >%alit7 im-ro4ement committees o. the
instit%tion; i. a--lica3le$M
. monitor all 6ork -er.ormed in the la3orator7 to
determine that relia3le data are 3ein) )eneratedM
) ens%re that there are s%..icient >%ali.ied
-ersonnel 6ith ade>%ate doc%mented trainin)
and e=-erience to meet the needs o. the
la3orator7M
h -lan; set )oals; de4elo- and allocate reso%rces
a--ro-riate to the medical
en4ironmentM
i -ro4ide e..ecti4e and e..icient administration o.
the medical la3orator7 ser4ice; incl%din) 3%d)et
-lannin) and control 6ith res-onsi3le .inancial
mana)ement; in accordance 6ith instit%tional
assi)nment o. s%ch res-onsi3ilitiesM
< -ro4ide ed%cational -ro)rams .or the medical
and la3orator7 sta.. and -artici-ate in ed%cational
-ro)rams o. the instit%tionM
k -lan and direct research and de4elo-ment
a--ro-riate to the .acilit7M
l select and monitor all re.erral la3oratories .or
>%alit7 o. ser4iceM

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m im-lement a sa.e la3orator7 en4ironment in
com-liance 6ith )ood -ractice and a--lica3le
re)%lationsM
n address an7 com-laint; re>%est; or s%))estion
.rom %sers o. la3orator7 ser4icesM
o ens%re )ood sta.. morale.
5he la3orator7 director need not -er.orm all
res-onsi3ilities -ersonall7. ?o6e4er; it is the
la3orator7 director 6ho remains res-onsi3le .or the
o4erall o-eration and administration o. the la3orator7;
to ens%re that >%alit7 ser4ices are -ro4ided .or
-atients.
.1. 5here shall 3e sta.. reso%rces ade>%ate to the
%ndertakin) o. the 6ork re>%ired and the carr7in) o%t
o. other .%nctions o. the >%alit7 mana)ement s7stem.
.1.' (ersonnel shall ha4e trainin) s-eci.ic to >%alit7
ass%rance and >%alit7 mana)ement .or ser4ices
o..ered.
.1.7 La3orator7 mana)ement shall a%thorise -ersonnel to
-er.orm -artic%lar tasks s%ch as sam-lin);
e=amination and o-eration o. -artic%lar t7-es o.
e>%i-ment; incl%din) %se o. com-%ters in the
la3orator7 in.ormation s7stem.
.1.! (olicies shall 3e esta3lished 6hich de.ine 6ho ma7
%se the com-%ter s7stem; 6ho ma7 access -atient
data and 6ho is a%thorised to enter and chan)e
-atient res%lts; correct 3illin) or modi.7 com-%ter
-ro)rams.
.1." 5here shall 3e a contin%in) ed%cation -ro)ram
a4aila3le to sta.. at all le4els.
.1.1# @m-lo7ees shall 3e trained to -re4ent or contain the
e..ects o. ad4erse incidents.
.1.11 5he com-etenc7 o. each -erson to -er.orm assi)ned
tasks shall 3e assessed .ollo6in) trainin) and
-eriodicall7 therea.ter. /etrainin) and reassessment
shall occ%r 6hen necessar7.
.1.12 5he -ersonnel makin) -ro.essional <%d)ements 6ith
re.erence to e=aminations shall ha4e the a--lica3le
theoretical and -ractical 3ack)ro%nd as 6ell as recent
e=-erience. (ro.essional <%d)ements can 3e
e=-ressed as o-inions; inter-retations; -redictions;
sim%lations and models and 4al%es and sho%ld 3e in
accordance 6ith national; re)ional; and local
re)%lations.
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(ersonnel shall take -art in re)%lar -ro.essional
de4elo-ment or other -ro.essional liaison.
.1.1& Con.identialit7 o. in.ormation re)ardin) -atients shall
3e maintained 37 all -ersonnel.
5$2 ACCOMMO#ATION AN# EN;IRONMENTAL CON#ITIONS
.2.1 5he la3orator7 shall ha4e s-ace allocated so that its
6orkload can 3e -er.ormed 6itho%t com-romisin)
the >%alit7 o. 6ork; >%alit7 control -roced%res; sa.et7
o. -ersonnel or -atient care ser4ices. 5he la3orator7
director shall determine the ade>%ac7 o. this s-ace.
5he reso%rces shall 3e o. a de)ree necessar7 to
s%--ort the acti4ities o. the la3orator7. La3orator7
reso%rces shall 3e maintained in a .%nctional and
relia3le condition. Similar -ro4isions sho%ld 3e made
.or -rimar7 sam-le collection and e=aminations at
sites other than the -ermanent la3orator7 .acilit7.
.2.2 5he la3orator7 shall 3e desi)ned .or the e..icienc7 o.
its o-eration; to o-timise the com.ort o. its occ%-ants
and to minimise the risk o. in<%r7 and occ%-ational
illness. (atients; em-lo7ees and 4isitors shall 3e
-rotected .rom reco)nised haQards.
.2.& 9hen -rimar7 sam-le collection .acilities are
-ro4ided; consideration shall 3e )i4en to the
accommodation o. -atient disa3ilities; com.ort and
-ri4ac7; in addition to the o-timisation o. collection
conditions.
.2.0 5he la3orator7 desi)n and en4ironment shall 3e
s%ita3le .or the tasks carried o%t therein. 5he
en4ironment in 6hich the -rimar7 sam-le collection
or e=aminations or 3oth are %ndertaken shall not
in4alidate the res%lts; or ad4ersel7 a..ect the re>%ired
>%alit7 o. an7 meas%rement.
La3orator7 .acilities .or e=amination sho%ld -ermit
correct -er.ormance o. e=aminations. 5hese incl%de;
3%t are not limited to; ener)7 so%rces; li)htin);
4entilation; 6ater; 6aste and re.%se dis-osal; and
en4ironmental conditions. 5he la3orator7 sho%ld
ha4e -roced%res .or checkin) that the en4ironment
does not ad4ersel7 a..ect the -er.ormance o.
s-ecimen collection and e>%i-ment.
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.2. 5he la3orator7 shall monitor; control and record
en4ironmental conditions; as re>%ired 37 rele4ant
s-eci.ications or 6here the7 ma7 in.l%ence the >%alit7
o. the res%lts. Attention sho%ld 3e -aid to sterilit7;
d%st; electroma)netic inter.erence; radiation;
h%midit7; electrical s%--l7; tem-erat%re and so%nd
and 4i3ration le4els; as a--ro-riate to the technical
acti4ities concerned.
.2.' 5here shall 3e e..ecti4e se-aration 3et6een ad<acent
la3orator7 sections in 6hich there are incom-ati3le
acti4ities. :eas%res shall 3e taken to -re4ent cross8
contamination.
.2.7 Access to; and %se o.; areas a..ectin) the >%alit7 o.
the e=aminations shall 3e controlled. A--ro-riate
meas%res shall 3e taken to sa.e)%ard sam-les and
reso%rces .rom %na%thorised access.
.2.! Comm%nication s7stems 6ithin the la3orator7 shall 3e
those a--ro-riate to the siQe and com-le=it7 o. the
.acilit7 and the e..icient trans.er o. messa)es.
.2." /ele4ant stora)e s-ace and conditions shall 3e
-ro4ided to ens%re the contin%in) inte)rit7 o.
sam-les; slides; histolo)7 3locks; retained micro8
or)anisms; doc%ments; .iles; man%als; e>%i-ment;
rea)ents; la3orator7 s%--lies; records and res%lts.
.2.1# 9ork areas shall 3e clean and 6ell maintained.
Stora)e and dis-osal o. dan)ero%s materials shall 3e
those s-eci.ied 37 rele4ant re)%lations.
:eas%res shall 3e taken to ens%re )ood
ho%sekee-in) in the la3orator7. S-ecial -roced%res
and trainin) .or -ersonnel ma7 3e necessar7 to that
end.
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5$" LABORATOR@ E/!I'MENT
.&.1 5he la3orator7 shall 3e .%rnished 6ith all items o.
e>%i-ment re>%ired .or the -ro4ision o. ser4ices
(incl%din) -rimar7 sam-le collection; and sam-le
-re-aration and -rocessin); e=amination and
stora)e$. In those cases 6here the la3orator7 needs
to %se e>%i-ment o%tside its -ermanent control; the
la3orator7 mana)ement shall ens%re that the
re>%irements o. this International Standard are met.
9hen selectin) e>%i-ment; acco%nt sho%ld 3e taken
o. the %se o. ener)7 and .%t%re dis-osal (care o. the
en4ironment$.
.&.2 @>%i-ment shall 3e sho6n (%-on installation and in
ro%tine %se$ to 3e ca-a3le o. achie4in) the
-er.ormance re>%ired and shall com-l7 6ith
s-eci.ications rele4ant to the e=aminations
concerned.
La3orator7 mana)ement shall esta3lish a -ro)ramme
that re)%larl7 monitors and demonstrates -ro-er
cali3ration and .%nction o. instr%ments; rea)ents; and
anal7tical s7stems. It shall also ha4e a doc%mented
and recorded -ro)ramme o. -re4enti4e maintenance
(c.. 0.2.$; 6hich; at a minim%m; .ollo6s the
man%.act%rer2s recommendations.
9hen man%.act%rer2s instr%ctions; o-erator2s
man%als; or other doc%mentation are a4aila3le; the7
ma7 3e %sed to esta3lish re>%irements; .or
com-liance 6ith rele4ant standards or to s-eci.7
re>%irements .or -eriodic cali3ration; as a--ro-riate;
to .%l.il -art or all o. this re>%irement.
.&.& @ach item o. e>%i-ment shall 3e %ni>%el7 la3elled;
marked; or other6ise identi.ied.
.&.0 /ecords shall 3e maintained .or each item o.
e>%i-ment contri3%tin) to the -er.ormance o.
e=aminations. 5hese records shall incl%de at least
the .ollo6in):
a identit7 o. the e>%i-mentM
3 man%.act%rer2s name; t7-e identi.ication and
serial n%m3er or other %ni>%e identi.icationM
c man%.act%rer2s contact -erson and tele-hone
n%m3er; as a--ro-riateM
d date o. recei4in) and date o. -%ttin) into ser4iceM
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e c%rrent location; 6here a--ro-riateM
. condition 6hen recei4ed (e.).; ne6; %sed or
reconditioned$M
) man%.act%rerPs instr%ctions; i. a4aila3le; or
re.erence to their retentionM
h e>%i-ment -er.ormance records that con.irm
e>%i-ment2s s%ita3ilit7 .or %seM
i maintenance carried o%t and that -lanned .or the
.%t%reM
< dama)e to; or mal.%nction; modi.ication or re-air
o. the e>%i-mentM
k -redicted re-lacement date; i. -ossi3le.
5he -er.ormance records re.erred to in h$ sho%ld
incl%de co-ies o. re-orts* certi.icates o. all
cali3rations and*or 4eri.ications incl%din) dates; time
and res%lts; ad<%stments; the acce-tance criteria and
d%e date o. the ne=t cali3ration and* or 4eri.ication;
to)ether 6ith the .re>%enc7 o. checks carried o%t
3et6een maintenance* cali3ration; as a--ro-riate; to
.%l.il -art or all o. this re>%irement. :an%.act%rer2s
instr%ctions ma7 3e %sed to esta3lish acce-tance
criteria; -roced%res and .re>%enc7 o. 4eri.ication .or
maintenance or cali3ration or 3oth; as a--ro-riate; to
.%l.il -art or all o. this re>%irement.
5hese records shall 3e maintained and shall 3e
readil7 a4aila3le .or the li.e s-an o. the e>%i-ment or
.or an7 time -eriod re>%ired 37 national; re)ional and
local re)%lations.
.&. @>%i-ment shall 3e o-erated 37 a%thorised -ersonnel
onl7. F-8to8date instr%ctions on the %se and
maintenance o. e>%i-ment (incl%din) an7 rele4ant
man%als and directions .or %se -ro4ided 37 the
man%.act%rer o. the e>%i-ment$ shall 3e readil7
a4aila3le to la3orator7 -ersonnel.
.&.' @>%i-ment shall 3e maintained in a sa.e 6orkin)
condition. 5his shall incl%de e=amination o. electrical
sa.et7; emer)enc7 sto- de4ices and the sa.e handlin)
and dis-osal o. chemical; radioacti4e and 3iolo)ical
materials 37 a%thorised -ersons. :an%.act%rer2s
s-eci.ications or instr%ctions or 3oth shall 3e %sed; as
a--ro-riate.

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.&.7 9hene4er e>%i-ment is .o%nd to 3e de.ecti4e; it shall
3e taken o%t o. ser4ice; clearl7 la3elled and
a--ro-riatel7 stored %ntil it has 3een re-aired and
sho6n 37 cali3ration; 4eri.ication or testin) to meet
s-eci.ied acce-tance criteria. 5he la3orator7 shall
e=amine the e..ect o. this de.ect on -re4io%s
e=aminations and instit%te the -roced%re )i4en in 0.".
5he la3orator7 shall take reasona3le meas%res to
decontaminate e>%i-ment -rior to ser4ice; re-air or
decommissionin).
.&.! A list o. the meas%res taken to red%ce contamination
shall 3e -ro4ided to the -erson 6orkin) on the
e>%i-ment. 5he la3orator7 shall -ro4ide s%ita3le
s-ace .or re-airs and a--ro-riate -ersonal -rotecti4e
e>%i-ment.
.&." 9hene4er -ractica3le; e>%i-ment %nder the control o.
the la3orator7 6hich re>%ires cali3ration or
4eri.ication shall 3e la3elled or other6ise coded to
indicate the stat%s o. cali3ration or 4eri.ication and the
date 6hen recali3ration or re4eri.ication is d%e.
.&.1# 9hen e>%i-ment is remo4ed .rom the direct control o.
the la3orator7 or is re-aired or ser4iced; the
la3orator7 shall ens%re that it is checked and sho6n
to 3e .%nctionin) satis.actoril7 3e.ore 3ein) ret%rned
to la3orator7 %se.
.&.11 9hen com-%ters or a%tomated e=amination
e>%i-ment are %sed .or the collection; -rocessin);
recordin); re-ortin); stora)e or retrie4al o.
e=amination data; the la3orator7 shall ens%re that
a com-%ter so.t6are; incl%din) that 3%ilt into
e>%i-ment; is doc%mented and s%ita3l7 4alidated
as ade>%ate .or %se in the .acilit7;
3 -roced%res are esta3lished and im-lemented .or
-rotectin) the inte)rit7 o. data at all times;
c com-%ters and a%tomated e>%i-ment are
maintained to ens%re -ro-er .%nctionin) and
-ro4ided 6ith en4ironmental and o-eratin)
conditions necessar7 .or maintainin) the inte)rit7
o. data; and
d com-%ter -ro)rammes and ro%tines are
ade>%atel7 -rotected to -re4ent access;
alteration; or destr%ction 37 cas%al or
%na%thorised -ersons.
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.&.12 5he la3orator7 shall ha4e -roced%res .or sa.e
handlin); trans-ort; stora)e and %se o. e>%i-ment to
-re4ent its contamination or deterioration.
.&.1& 9here cali3rations )i4e rise to a set o. correction
.actors; the la3orator7 shall ha4e -roced%res .or
ens%rin) that co-ies o. -rior correction .actors are
correctl7 %-dated.
.&.10 @>%i-ment; incl%din) hard6are; so.t6are; re.erence
materials; cons%ma3les; rea)ents; and anal7tical
s7stems shall 3e sa.e)%arded .rom ad<%stments or
tam-erin) that mi)ht in4alidate e=amination res%lts.
5$= 'REBEFAMINATION 'ROCE#!RES
.0.1 5he re>%est .orm shall contain in.ormation s%..icient
to identi.7the -atient and the a%thorised re>%ester; as
6ell as -ro4idin) -ertinent clinical data. National;
re)ional or local re>%irements shall a--l7.
5he re>%est .orm or an electronic e>%i4alent sho%ld
allo6 s-ace .or the incl%sion o.; 3%t not 3e limited to;
the .ollo6in):
a %ni>%e identi.ication o. the -atientM
3 name or other %ni>%e identi.ier o. -h7sician or
other -erson le)all7 a%thorised to re>%est
e=aminations or %se medical in.ormation
to)ether 6ith the destination .or the re-ort. 5he
re>%estin) clinician2s address sho%ld 3e -ro4ided
as -art o. the re>%est .orm in.ormation 6hen it is
di..erent .rom that o. the recei4in) la3orator7.
c t7-e o. -rimar7 sam-le and the anatomic site o.
ori)in; 6here a--ro-riateM
d e=aminations re>%estedM
e clinical in.ormation rele4ant to the -atient; 6hich
sho%ld incl%de )ender and date o. 3irth; as a
minim%m; .or inter-retation -%r-osesM
. date and time o. -rimar7 sam-le collectionM
) date and time o. recei-t o. sam-les 37 the
la3orator7.
5he .ormat o. the re>%est .orm (e.).; electronic or
-a-er$ and the manner in 6hich re>%ests are to 3e
comm%nicated to the la3orator7 sho%ld 3e
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.0.2 S-eci.ic instr%ctions .or the -ro-er collection and
handlin) o. -rimar7 sam-les shall 3e doc%mented
and im-lemented 37 la3orator7 mana)ement (see
0.2.0$ and made a4aila3le to those res-onsi3le .or
-rimar7 sam-le collection. 5hese instr%ctions shall 3e
contained in a -rimar7 sam-le collection man%al.
.0.& 5he -rimar7 sam-le collection man%al shall incl%de
the .ollo6in):
a co-ies o. or re.erences to
1 lists o. a4aila3le la3orator7 e=aminations
o..ered;
2 consent .orms; 6hen a--lica3le;
& in.ormation and instr%ctions -ro4ided to
-atients in relation to their o6n -re-aration
3e.ore -rimar7 sam-le collection;
0 in.ormation .or %sers o. la3orator7 ser4ices
on medical indications and a--ro-riate
selection o. a4aila3le -roced%resM
3 -roced%res .or:
1 -re-aration o. the -atient (e.).; instr%ctions
to care)i4ers and -hle3otomists$;
2 identi.ication o. -rimar7 sam-le;
& -rimar7 sam-le collection (e.).; -hle3otom7;
skin -%nct%re; 3lood; %rine and other 3od7
.l%ids$; 6ith descri-tions o. the -rimar7
sam-le containers and an7 necessar7
additi4esM
c instr%ctions .or
1 com-letion o. re>%est .orm or electronic
re>%est;
2 t7-e and amo%nt o. the -rimar7 sam-le to
3e collected;
& s-ecial timin) o. collection; i. re>%ired;
0 an7 s-ecial handlin) needs 3et6een time o.
collection and time recei4ed 37 the
la3orator7 (trans-ort re>%irements;
re.ri)eration; 6armin); immediate deli4er7;
etc.$;
la3ellin) o. -rimar7 sam-les;
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' clinical in.ormation (e.).; histor7 o.
administration o. dr%)s$;
7 -ositi4e identi.ication; in detail; o. the -atient
.rom 6hom a -rimar7 sam-le is collected;
! recordin) the identit7 o. the -erson collectin)
the -rimar7 sam-le;
" sa.e dis-osal o. materials %sed in the
collectionM
d instr%ctions .or
1 stora)e o. e=amined sam-les;
2 time limits .or re>%estin) additional
e=aminations;
& additional e=aminations;
0 re-eat e=amination d%e to anal7tical .ail%re
or .%rther e=aminations o. same -rimar7
sam-leM
.0.0 5he -rimar7 sam-le collection man%al shall 3e -art o.
the doc%ment control s7stem (see 0.&.1$.
.0. (rimar7 sam-les shall 3e tracea3le; normall7 37 a
re>%est .orm; to an identi.ied indi4id%al. (rimar7
sam-les lackin) -ro-er identi.ication shall not 3e
acce-ted or -rocessed 37 the la3orator7.
9here there is %ncertaint7 in the identi.ication o. the
-rimar7 sam-le or insta3ilit7 o. the anal7tes in the
-rimar7 sam-le (cere3ros-inal .l%id; 3io-s7; etc.$; and
the -rimar7 sam-le is irre-lacea3le or critical; the
la3orator7 ma7 choose initiall7 to -rocess the sam-le
3%t not release the res%lts %ntil the re>%estin)
-h7sician or -erson res-onsi3le .or the -rimar7
sam-le collection takes res-onsi3ilit7 .or identi.7in)
and acce-tin) the sam-le; or .or -ro4idin) -ro-er
in.ormation; or all these. In s%ch an instance; the
si)nat%re o. that -erson takin) res-onsi3ilit7 .or the
-rimar7 sam-le identi.ication sho%ld 3e recorded on;
or tracea3le to; the re>%est .orm. I. this re>%irement is
not met .or an7 reason; the -erson res-onsi3le
sho%ld 3e identi.ied in the re-ort i. the e=amination is
carried o%t. Sam-les to 3e set aside .or .%t%re
e=amination (e.).; 4iral anti3odies; meta3olites
rele4ant to the clinical s7ndrome$ sho%ld also 3e
identi.ia3le.
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.0.' 5he la3orator7 shall monitor the trans-ortation o.
sam-les to the la3orator7 s%ch that the7 are
trans-orted
a 6ithin a time .rame a--ro-riate to the nat%re o.
the re>%ested e=aminations and the la3orator7
disci-line concerned;
3 6ithin a tem-erat%re inter4al s-eci.ied in the
-rimar7 sam-le collection man%al and 6ith the
desi)nated -reser4ati4es to ens%re the inte)rit7
o. sam-les; and
c in a manner that ens%res sa.et7 .or the carrier;
the )eneral -%3lic and the recei4in) la3orator7; in
com-liance 6ith national; re)ional; or local
re)%lator7 re>%irements.
.0.7 All -rimar7 sam-les recei4ed shall 3e recorded in an
accession 3ook; 6orksheet; com-%ter or other
com-ara3le s7stem. 5he date and time o. recei-t o.
sam-les; as 6ell as the identit7 o. the recei4in)
o..icer; shall 3e recorded.
.0.! Criteria shall 3e de4elo-ed and doc%mented .or
acce-tance or re<ection o. -rimar7 sam-les. I.
com-romised -rimar7 sam-les are acce-ted; the .inal
re-ort shall indicate the nat%re o. the -ro3lem and; i.
a--lica3le; that ca%tion is re>%ired 6hen inter-retin)
the res%lt.
.0." 5he la3orator7 shall -eriodicall7 re4ie6 its sam-le
4ol%me re>%irements .or -hle3otom7 (and other
sam-les s%ch as cere3ros-inal .l%id$ to ens%re that
neither ins%..icient nor e=cessi4e amo%nts o. sam-le
are collected.
.0.1# A%thoriQed -ersonnel shall s7stematicall7 re4ie6
re>%ests and sam-les and decide 6hich
e=aminations are to 3e -er.ormed and the methods to
3e %sed in -er.ormin) them.
.0.11 5he la3orator7 shall; i. rele4ant; ha4e a doc%mented
-roced%re .or the recei-t; la3ellin); -rocessin) and
re-ortin) o. those -rimar7 sam-les recei4ed 37 the
la3orator7 and s-eci.icall7 marked as %r)ent. 5he
-roced%re shall incl%de details o. an7 s-ecial la3ellin)
o. the re>%est .orm and -rimar7 sam-le; the
mechanism o. trans.er o. the -rimar7 sam-le to the
e=amination area o. the la3orator7; an7 ra-id
-rocessin) mode to 3e %sed and
an7 s-ecial re-ortin) criteria to 3e .ollo6ed.

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.0.12 Sam-le -ortions shall also 3e tracea3le to the ori)inal
-rimar7 sam-le.
.0.1& 5he la3orator7 shall ha4e a 6ritten -olic7 concernin)
4er3al re>%ests .or sam-le e=aminations
.0.10 Sam-les shall 3e stored .or a s-eci.ied time; %nder
conditions that ens%rin) sta3ilit7 o. sam-le -ro-erties;
to ena3le re-etition o. the e=amination a.ter re-ortin)
o. the res%lt or .or additional e=aminations.
5$5 EFAMINATION 'ROCE#!RES
..1 5he la3orator7 shall %se e=amination -roced%res;
incl%din) those .or selectin)* takin) sam-le -ortions;
6hich meet the needs o. the %sers o. la3orator7
ser4ices and are a--ro-riate .or the e=aminations.
(re.erred -roced%res are those that ha4e 3een
-%3lished in esta3lished*a%thoritati4e te=t3ooks; -eer8
re4ie6ed te=ts or <o%rnals; or in international; national
or re)ional )%idelines. I. in8ho%se -roced%res are
%sed; the7 shall 3e a--ro-riatel7 4alidated .or their
intended %se and .%ll7 doc%mented.
..2 5he la3orator7 shall %se onl7 4alidated -roced%res .or
con.irmin) that the e=amination -roced%res are
s%ita3le .or the intended %se. 5he 4alidations shall 3e
as e=tensi4e as are necessar7 to meet the needs in
the )i4en a--lication or .ield o. a--lication. 5he
la3orator7 shall record the res%lts o3tained and the
-roced%re %sed .or the 4alidation.
5he methods and -roced%res selected .or %se shall
3e e4al%ated and .o%nd to )i4e satis.actor7 res%lts
3e.ore 3ein) %sed .or medical e=aminations. A re4ie6
o. -roced%res 37 the la3orator7 director or desi)nated
-erson shall 3e %ndertaken initiall7 and at de.ined
inter4als. S%ch a re4ie6 is normall7 carried o%t
ann%all7. 5hese re4ie6s shall 3e doc%mented.
..& All -roced%res shall 3e doc%mented and 3e a4aila3le
at the 6orkstation .or rele4ant sta... Doc%mented
-roced%res and necessar7 instr%ctions shall 3e
a4aila3le in a lan)%a)e commonl7 %nderstood 37 the
sta.. in the la3orator7.
Card .iles or similar s7stems that s%mmarise ke7
in.ormation are acce-ta3le .or %se as a >%ick
re.erence at the 6ork3ench; -ro4ided that a com-lete
man%al is a4aila3le .or re.erence. 5he card .ile or
similar s7stems shall corres-ond to the com-lete
man%al. An7 s%ch a3rid)ed -roced%res shall 3e -art
o. the doc%ment control s7stem
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: '!*!&

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5he -roced%re shall 3e 3ased in 6hole or in -art on
the instr%ctions .or %se (e.). -acka)e insert$ 6ritten
37 the man%.act%rer; -ro4ided that the7 are in
accordance 6ith ..1 and ..2 and that the7
descri3e the -roced%re as it is -er.ormed in the
la3orator7 and are 6ritten in a lan)%a)e commonl7
%nderstood 37 the sta.. o. the la3orator7. An7
de4iation shall 3e re4ie6ed and doc%mented.
Additional in.ormation that co%ld 3e re>%ired
to -er.orm the e=amination shall also 3e doc%mented.
@ach ne6 4ersion o. e=amination kits 6ith ma<or
chan)es in rea)ents or -roced%re shall 3e checked
.or -er.ormance and s%ita3ilit7 .or intended %se. An7
-roced%ral chan)es shall 3e dated and a%thorised as
.or other -roced%res.
In addition to doc%ment control identi.iers;
doc%mentation sho%ld incl%de; 6hen a--lica3le; the
.ollo6in):
a -%r-ose o. the e=aminationM
3 -rinci-le o. the -roced%re %sed .or e=aminationsM
c -er.ormance s-eci.ications (e.). linearit7;
-recision; acc%rac7 e=-ressed as %ncertaint7 o.
meas%rement; detection limit; meas%rin) inter4al;
tr%eness o. meas%rement; sensiti4it7 and
s-eci.icit7$M
d -rimar7 sam-le s7stem (e.). -lasma; ser%m;
%rine$M
e t7-e o. container and additi4eM
. re>%ired e>%i-ment and rea)entsM
) cali3ration -roced%res (metrolo)ical tracea3ilit7$M
h -roced%ral ste-sM
i >%alit7 control -roced%resM
< inter.erences (e.). li-emia; hemol7sis;
3ilir%3inemia$ and cross reactionsM
k -rinci-le o. -roced%re .or calc%latin) res%lts;
incl%din) meas%rement %ncertaint7M
l 3iolo)ical re.erence inter4alsM
m re-orta3le inter4al o. -atient e=amination res%ltsM
n alert* critical 4al%es; 6here a--ro-riateM
Iss%e No: #& Iss%e Date:27.#'.2#12 Amend No: ## Amend Date: 88 (a)e No: '"*!&

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o la3orator7 inter-retationM
- sa.et7 -reca%tionsM
> -otential so%rces o. 4aria3ilit7.
@lectronic man%als are acce-ta3le -ro4ided that the
a3o4e8s-eci.ied in.ormation is incl%ded. 5he same
re>%irements .or doc%ment control sho%ld also a--l7
to electronic man%als.
5he la3orator7 director shall 3e res-onsi3le .or
ens%rin) that the contents o. e=amination -roced%res
are com-lete; c%rrent; and has 3een thoro%)hl7
re4ie6ed.
..0 (er.ormance s-eci.ications .or each -roced%re %sed
in an e=amination shall relate to the intended %se o.
that -roced%re.
.. Biolo)ical re.erence inter4als shall 3e -eriodicall7
re4ie6ed. I. the la3orator7 has reason to 3elie4e that
a -artic%lar inter4al is no lon)er a--ro-riate .or the
re.erence -o-%lation; then an in4esti)ation shall 3e
%ndertaken; .ollo6ed; i. necessar7; 37 correcti4e
action. A re4ie6 o. 3iolo)ical re.erence inter4als shall
also take -lace 6hen the la3orator7 chan)es an
e=amination -roced%re or -re8e=amination -roced%re;
i. a--ro-riate.
..' F-on re>%est; the la3orator7 shall make its list o.
c%rrent e=amination -roced%res; incl%din) -rimar7
sam-le re>%irements and rele4ant -er.ormance
s-eci.ications and re>%irements; a4aila3le to %sers o.
la3orator7 ser4ices
..7 I. the la3orator7 intends to chan)e an e=amination
-roced%re s%ch that res%lts or their inter-retations
co%ld 3e si)ni.icantl7 di..erent; the im-lications shall
3e e=-lained to %sers o. the la3orator7 ser4ices in
6ritin) -rior to the introd%ction o. the chan)e.
5$% ASS!RIN2 /!ALIT@ OF EFAMINATION 'ROCE#!RES
.'.1 5he la3orator7 shall desi)n internal >%alit7 control
s7stems that 4eri.7 the attainment o. the intended
>%alit7 o. res%lts. It is im-ortant that the control
s7stem -ro4ide sta.. mem3ers 6ith clear and easil7
%nderstood in.ormation on 6hich to 3ase technical
and medical decisions. S-ecial attention sho%ld 3e
-aid to the elimination o. mistakes in the -rocess o.
handlin) sam-les; re>%ests; e=aminations; re-orts;
etc.

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.'.2 5he la3orator7 shall determine the %ncertaint7 o.
res%lts; 6here rele4ant and -ossi3le. Fncertaint7
com-onents 6hich are o. im-ortance shall 3e taken
into acco%nt. So%rces that contri3%te to %ncertaint7
ma7 incl%de sam-lin); sam-le -re-aration; sam-le
-ortion selection; cali3rators; re.erence materials;
in-%t >%antities; e>%i-ment %sed; en4ironmental
conditions; condition o. the sam-le; and chan)es o.
o-erator.
.'.& A -ro)ramme .or cali3ration o. meas%rin) s7stems
and 4eri.ication o. tr%eness shall 3e desi)ned and
-er.ormed so as to ens%re that res%lts are tracea3le
to SI %nits or 37 re.erence to a nat%ral constant or
other stated re.erence. 9here none o. these are
-ossi3le or rele4ant; other means .or -ro4idin)
con.idence in the res%lts shall 3e a--lied incl%din)
3%t not limited to the .ollo6in):
a -artici-ation in a s%ita3le -ro)ramme o.
Interla3orator7 com-arisonsM
3 %se o. s%ita3le re.erence materials; certi.ied to
indicate the characterisation o. the materialM
c e=amination or cali3ration 37 another -roced%reM
d ratio or reci-rocit78t7-e meas%rementsM
e m%t%al consent standards or methods 6hich are
clearl7 esta3lished; s-eci.ied; characterised and
m%t%all7 a)reed %-on 37 all -arties concernedM
. doc%mentation o. statements re)ardin) rea)ents;
-roced%res or the e=amination s7stem 6hen
tracea3ilit7 is -ro4ided 37 the s%--lier or
man%.act%rer.
.'.0 5he la3orator7 shall -artici-ate in interla3orator7
com-arisons s%ch as those or)anised 37 e=ternal
>%alit7 assessment schemes. La3orator7
mana)ement shall monitor the res%lts o. e=ternal
>%alit7 assessment and -artici-ate in the
im-lementation o. correcti4e actions 6hen control
criteria are not .%l.illed. Interla3orator7 com-arison
-ro)rams shall 3e in s%3stantial a)reement 6ith ISO*
I@C +%ide 0&81.
@=ternal >%alit7 assessment -ro)rammes sho%ld; as
.ar as -ossi3le; -ro4ide clinicall7 rele4ant challen)es
that mimic -atient sam-les and ha4e the e..ect o.
checkin) the entire e=amination -rocess; incl%din)
-re8 and -ost8e=amination -roced%res.

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.'. 9hene4er a .ormal interla3orator7 com-arison
-ro)ramme is not a4aila3le; the la3orator7 shall
de4elo- a mechanism .or determinin) the
acce-ta3ilit7 o. -roced%res not other6ise e4al%ated.
9hene4er -ossi3le; this mechanism shall %tilise
e=ternall7 deri4ed challen)e materials s%ch as
e=chan)e o. sam-les 6ith other la3oratories.
La3orator7 mana)ement shall monitor the res%lts o.
this mechanism o. inter la3orator7 com-arison and
-artici-ate in the im-lementation and recordin) o.
correcti4e actions.
.'.' For those e=aminations -er.ormed %sin) di..erent
-roced%res or e>%i-ment or at di..erent sites; or all
these; there shall 3e a de.ined mechanism .or
4eri.7in) the com-ara3ilit7 o. res%lts thro%)ho%t the
clinicall7 a--ro-riate inter4als. S%ch 4eri.ication shall
3e -er.ormed at de.ined -eriods o. time a--ro-riate
to the characteristics o. the -roced%re or instr%ment.
.'.7 5he la3orator7 shall doc%ment; record and; as
a--ro-riate; e=-editio%sl7 act %-on res%lts .rom these
com-arisons. (ro3lems or de.iciencies identi.ied shall
3e acted %-on and records o. actions retained.
5$7 'OSTBEFAMINATION 'ROCE#!RES
.7.1 A%thorised -ersonnel shall s7stematicall7 re4ie6 the
res%lts o. e=aminations; e4al%ate them in con.ormit7
6ith the clinical in.ormation a4aila3le re)ardin) the
-atient and a%thorise the release o. the res%lts.
.7.2 Stora)e o. the -rimar7 sam-le and other la3orator7
sam-les shall 3e in accordance 6ith a--ro4ed -olic7.
.7.& Sa.e dis-osal o. sam-les no lon)er re>%ired .or
e=amination shall 3e carried o%t in accordance 6ith
local re)%lations or recommendations .or 6aste
mana)ement.
5$8 RE'ORTIN2 OF RES!LTS
.!.1 La3orator7 mana)ement shall 3e res-onsi3le .or
.ormattin) re-orts. 5he .ormat o. the re-ort .orm (i.e.
electronic or -a-er$ and the manner in 6hich it is to
3e comm%nicated .rom the la3orator7 sho%ld 3e
ser4ices.
.!.2 La3orator7 mana)ement shares res-onsi3ilit7 6ith
the re>%ester .or ens%rin) that re-orts are recei4ed
37 the a--ro-riate indi4id%als 6ithin an a)reed8%-on
time inter4al.

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.!.& /es%lts shall 3e le)i3le; 6itho%t mistakes in
transcri-tion and re-orted to -ersons a%thorised to
recei4e and %se medical in.ormation. 5he re-ort shall
also incl%de; 3%t not 3e limited to; the .ollo6in):
a Clear; %nam3i)%o%s identi.ication o. the
e=amination incl%din); 6here a--ro-riate; the
meas%rement -roced%reM
3 the identi.ication o. the la3orator7 that iss%ed the
re-ortM
c %ni>%e identi.ication and location o. the -atient;
6here -ossi3le; and destination o. the re-ortM
d name or other %ni>%e identi.ier o. the re>%ester
and the re>%ester2s addressM
e date and time o. -rimar7 sam-le collection; 6hen
a4aila3le and rele4ant to -atient care; and time o.
recei-t 37 the la3orator7M
. date and time o. release o. re-ort; 6hich; i. not
on the re-ort; shall 3e readil7 accessi3le 6hen
neededM
) so%rce and s7stem (or -rimar7 sam-le t7-e$M
h res%lts o. the e=amination re-orted in SI %nits or
%nits tracea3le to SI %nits (see ISO +%ide &1$;
6here a--lica3leM
i 3iolo)ical re.erence inter4als; 6here a--lica3leM
< inter-retation o. res%lts; 6here a--ro-riateM
k other comments (e.).; >%alit7 or ade>%ac7 o.
-rimar7 sam-le 6hich ma7 ha4e com-romised
the res%lt; res%lts*inter-retations .rom re.erral
la3oratories; %se o. de4elo-mental -roced%re$M
the re-ort sho%ld identi.7 e=aminations
%ndertaken as -art o. a de4elo-ment -ro)ramme
and .or 6hich no s-eci.ic claims on meas%rement
-er.ormance are made; and; 6here a--lica3le;
in.ormation on detection limit and %ncertaint7 o.
meas%rement sho%ld 3e -ro4ided %-on re>%est.
l identi.ication o. the -erson a%thorisin) the
release o. the re-ortM
m i. rele4ant; ori)inal and corrected res%ltsM
n si)nat%re or a%thorisation o. the -erson checkin)
or releasin) the re-ort; 6here -ossi3le.

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.!.0 As a--ro-riate; the descri-tion o. e=aminations
-er.ormed and their res%lts sho%ld .ollo6 the
4oca3%lar7 and s7nta= recommended 37 one or more
o. the .ollo6in) or)anisations:
8 International Co%ncil .or StandardiQation in
?aematolo)7 (ICS?$M
8 International Societ7 o. ?aematolo)7 (IS?$M
8 International Federation o. Clinical Chemistr7
and La3orator7 :edicine (IFCC$M
8 International Fnion o. (%re and A--lied
Chemistr7 (IF(AC$M
8 International Societ7 o. 5hrom3osis and
?aemostasis (IS5?$M
8 @%ro-ean Committee .or Standardisation (C@N$M
As a--ro-riate; the descri-tion and res%lts sho%ld
.ollo6 the nomenclat%re recommended 37 one or
more o. the .ollo6in) or)anisations:
8 International Fnion o. Biochemistr7 and
:olec%lar Biolo)7 (IFB:B$M
8 International Fnion o. :icro3iolo)ical Societies
(IF:S$M
8 International Fnion o. Imm%nolo)ical Societies
(IFIS$M
8 SNO:@D International (Colle)e o. American
(atholo)ists$M
8 9orld ?ealth Or)aniQation (9?O$.
.!. 5he re-ort shall indicate i. the >%alit7 o. the -rimar7
sam-le recei4ed 6as %ns%ita3le .or e=amination or
co%ld ha4e com-romised the res%lt.
.!.' Co-ies or .iles o. re-orted res%lts shall 3e retained 37
the la3orator7 s%ch that -rom-t retrie4al o. the
in.ormation is -ossi3le. 5he len)th o. time that
re-orted data are retained ma7 4ar7M ho6e4er; the
re-orted res%lts shall 3e retrie4a3le .or as lon) as
medicall7 rele4ant or as re>%ired 37 national;
re)ional; or local re>%irements.

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.!.7 5he la3orator7 shall ha4e -roced%res .or immediate
noti.ication o. a -h7sician (or other clinical -ersonnel
res-onsi3le .or -atient care$ 6hen e=amination
res%lts .or critical -ro-erties .all 6ithin esta3lished
RalertR or RcriticalR inter4als. 5his incl%des res%lts
recei4ed on sam-les sent to re.erral la3oratories .or
e=amination.
.!.! In order that local clinical needs can 3e ser4ed; the
la3orator7 shall determine the critical -ro-erties and
their Ralert* criticalR inter4als; in a)reement 6ith the
clinicians %sin) the la3orator7. 5his a--lies to all
e=aminations; incl%din) nominal and ordinal
-ro-erties.
.!." For res%lts transmitted as an interim re-ort; the .inal
re-ort shall al6a7s 3e .or6arded to the re>%ester.
.!.1# /ecords o. actions taken in res-onse to res%lts in the
critical inter4als shall 3e maintained. 5hese shall
incl%de date; time; res-onsi3le la3orator7 sta..
mem3er; -erson noti.ied; and e=amination res%lts.
An7 di..ic%lt7 enco%ntered in meetin) this re>%irement
shall 3e recorded and re4ie6ed d%rin) a%dits.
.!.11 La3orator7 mana)ement; in cons%ltation 6ith the
re>%esters; shall esta3lish t%rnaro%nd times .or each
o. its e=aminations. A t%rnaro%nd time shall re.lect the
clinical needs.
5here shall 3e a -olic7 .or noti.7in) the re>%ester
6hen an e=amination is dela7ed. 5%rnaro%nd times
as 6ell as an7 .eed3ack .rom clinicians in relation to it
shall 3e monitored; recorded; and re4ie6ed 37
la3orator7 mana)ement. 9here necessar7; correcti4e
action shall 3e taken to address an7 -ro3lems so
identi.ied.
5his does not mean that the clinical -ersonnel are to
3e noti.ied o. all dela7s in e=amination; 3%t onl7 in
those sit%ations 6here the dela7 co%ld com-romise
-atient care. 5his -roced%re sho%ld 3e de4elo-ed in
colla3oration 3et6een clinical and la3orator7
-ersonnel.
.!.12 9hen e=amination res%lts .rom a re.erral la3orator7
need to 3e transcri3ed 37 the re.errin) la3orator7;
-roced%res .or 4eri.7in) the correctness o. all
transcri-tions shall 3e in -lace.
.!.1& 5he la3orator7 shall ha4e clearl7 doc%mented
-roced%res .or the release o. e=amination res%lts;
incl%din) details o. 6ho ma7 release res%lts and to
6hom. 5he -roced%res shall also incl%de )%idelines
.or the release o. res%lts directl7 to -atients.

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.!.10 5he la3orator7 shall esta3lish -olicies and -ractices
.or ens%rin) that res%lts distri3%ted 37 tele-hone or
other electronic means reach onl7 a%thorised
recei4ers. /es%lts -ro4ided 4er3all7 shall 3e .ollo6ed
37 a -ro-erl7 recorded re-ort.
.!.1 5he la3orator7 shall ha4e 6ritten -olicies and
-roced%res re)ardin) the alteration o. re-orts.
9hen altered; the record m%st sho6 the time; date;
and name o. the -erson res-onsi3le .or the chan)e.
Ori)inal entries shall remain le)i3le 6hen alterations
are made.
Ori)inal electronic records shall 3e retained and
alterations added to the record thro%)h a--ro-riate
editin) -roced%res so that re-orts clearl7 indicate the
alteration.
.!.1' /es%lts that ha4e 3een a4aila3le .or clinical decision8
makin) and re4ised shall 3e retained in s%3se>%ent
c%m%lati4e re-orts and 3e clearl7 identi.ied as ha4in)
3een re4ised. I. the re-ortin) s7stem cannot ca-t%re
amendments; chan)es or alterations; an a%dit lo)
shall 3e %sed.

ASSESSMENT RE'ORT
'a(e o+

CHECKLIST ": FOR ME#ICAL LABORATOR@ COLLECTION CENTRES
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5he .ollo6in) -a)es -resent a checklist .or a%ditin) the collection centres; 6hich .orms the additional
re>%irements .or accreditation o. :edical la3oratories o-eratin) collection centres. 5he )%idelines .or
o-eratin) collection centre o. the :edical la3oratories are doc%mented in NABL 112.
5he Assessor 6ill ascertain the a4aila3ilit7 o. the -rimar7 sam-le collection man%al at the collection
centre and 4eri.7 com-liance 6ith the re>%irements as sti-%lated in this checklist. 5he Assessor m%st
4eri.7 that the doc%mented s7stem is indeed im-lemented and assess the collection centres
com-etence to -er.orm s-eci.ic tasks related to tests in the sco-e o. accreditation o. the main
la3orator7. 5he Assessor m%st com-lete this checklist; -%t initials on each -a)e.
5he assessor 6ill also ascertain at the main la3orator7 that the Internal A%dit o. the collection centre
has 3een carried o%t 37 the main la3orator7 and co4ered in the mana)ement re4ie6.
All non con.ormities m%st 3e identi.ied and re-orted se-aratel7 on each sheet in NAF80. D%rin) the
assessment o. a collection centre; i. there are ma<or non8con.ormities or a total s7stem .ail%re; the
assessor shall 3rin) o%t this as a -art in the assessment s%mmar7 NAF '.
Se-arate checklist & sho%ld 3e .illed .or each collection centre and s%3mitted as a -art o. the
assessment re-ort. 9hen the collection centres are 3ein) a%dited se-aratel7 at a di..erent time than
the assessment o. the main la3orator7; the assessment re-ort .orms NAF 1 to ' (6hiche4er
a--lica3le$ are re>%ired to 3e .illed alon) 6ith the checklist &.
.
LABO/A5O/C ASS@SS@D* CI5C
LOCA5ION OF COLL@C5ION C@N5/@
ASS@SS:@N5 DA5@(S$ OF C@N5/@
ASS@SSO/2S NA:@
SI+NA5F/@
Iss%e No: #2 Iss%e Date:#1.#2.2##! Amend No: # Amend Date: #1.#".2##! (a)e No: 77*!&

ASSESSMENT RE'ORT
'a(e o+

Checklist &
CHECKLIST FOR ME#ICAL LABORATOR@ COLLECTION CENTRES
Co&&e0*-on Cen*.e: GGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGG
GGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGG
'.e,-ses
/emarks
1. 57-e o. the Collection Centre O6ned *
:ana)ed *
Franchise
2. SiQe o. -remises GGGG S>. Feet
&. Collection Centre is o-erational .rom
(date$
0. Does it meet the re>%irement o. the
6orkload
Ces * No
. /ece-tion and 6aitin) area se-arate .rom
collection area
Ces * No
'. ?and 6ashin) .acilities Ces * No
7. Clean toilet .acilit7 Ces * No
!. (ro4ision o. -ri4ac7 d%rin) collections Ces * No
". ?o%rs o. o-eration ha4e 3een dis-la7ed Ces * No
A00o,,oda*-on and En9-.on,en*a& Cond-*-ons
1. Is it ade>%atel7 lit and clean Ces * No
2. Is the h%midit7 and tem-erat%re s%ita3le Ces * No
&. Are cleanin) -olicies a4aila3le Ces * No
0. Is it ade>%atel7 4entilated and -re4ented
.rom d%st
Ces * No
. Does it ha4e ade>%ate s-ace , se-aration
to a4oid cross contamination
Ces * No
'. Is the ho%se kee-in) ade>%ate Ces * No
ED)-7,en*
1. /e.ri)erator Ces * No
2. Centri.%)e; i. needed Ces * No
&. (ro-er stora)e o. s%--lies Ces * No
0. S%ita3le chair and* or co%ch .or collection
o. 3lood; etc.
Ces * No
. Basic .irst8aid materials Ces * No
'. 5ele-hone Ces * No
7. AC .or controllin) tem-erat%re; i. needed Ces * No
!. (o6er 3ack%- .or e>%i-ments Ces * No
Iss%e No: #2 Iss%e Date:#1.#2.2##! Amend No: # Amend Date: #1.#".2##! (a)e No: 7!*!&

ASSESSMENT RE'ORT
'a(e o+

Ma*e.-a&s
1. :aterial re>%ired .or s-ecimen collection
e). e4ac%ated 3lood collection t%3es;
s7rin)es; t%3es; s6a3s etc.
Ces * No
2. No e=-ired material in the -remises Ces * No
S*a++-n(
1. Sta.. mem3ers GGGG nos.
2. Is it a--ro-riate to the 6orkloadS Ces * No
&. Initial trainin) records Ces * No
0. On)oin) trainin) records Ces * No
. Does the sta.. -ossess kno6led)e o. .irst8
aid meas%res to deal 6ith sit%ations the7
are likel7 to enco%nter in the co%rse o.
s-ecimen collectionS
Ces * No
'. A--ro-riate identi.ication to 3e 6orn 37
the sta..
Ces * No
#o0),en*a*-on
1. List o. ser4ices -ro4ided Ces * No
2. List o. ser4ices e=cl%ded Ces * No
&. Sam-le collection man%al a4aila3le Ces * No
0 /ecords o. Internal a%dit
(a4aila3le at la3orator7$
Ces * No

Hea&*3 and Sa+e*:
1. Collection sta.. to o3ser4e %ni4ersal
-reca%tions (to 6ear )lo4es; la3 coat ,
-rotecti4e mask$
Ces * No
2. Daccinated a)ainst ?e-atitis B Ces * No
&. Daccinated a)ainst other -re4enti4e
disease
Ces * No
Sa+e*: and ?as*e #-s7osa&
1. A--ro4ed rece-tacles .or shar-s and .or
contaminated 6aste a4aila3le
Ces * No
2. 5rans-ort and dis-osal o. 6aste is in
accordance 6ith a--lica3le re)%lator7
re>%irements
Ces * No
Iss%e No: #2 Iss%e Date:#1.#2.2##! Amend No: # Amend Date: #1.#".2##! (a)e No: 7"*!&

ASSESSMENT RE'ORT
'a(e o+

T.ans7o.* o+ 'a*3o&o(: S7e0-,ens
1. Does the collection centre .ollo6 national*
international re)%lations .or the trans-ort
o. in.ectio%s and other dia)nostic
s-ecimens 37 air and 37 s%r.ace so that in
the e4ent o. an accident occ%rrin); co%rier
sta.. and the )eneral -%3lic ma7 not 3e
e=-osed to 3lood and 3od7 .l%ids
Ces * No
2. ?as the s-ecimen collection sta..
-artici-ated in trainin) in s-ecimen
collection; trans-ort; handlin) o.
emer)encies etcS
Ces * No
&. ?as the a3o4e sta.. -artici-ated in
retrainin) %ndertaken at not )reater than
t6o 7ear inter4alS
Ces * No
0. Is the -arcel o. in.ectio%s s%3stances
attached 6ith a -lastic en4elo-e
containin) doc%ment 1 TB-oB3aHa.do)s
d-a(nos*-0 s7e0-,ens2S
Ces * No
'a05-n(
1. Is the -rimar7 container containin)
s-ecimen leak -roo. t%3e or 4ialS
Ces * No
2. Does the secondar7 container -ossess
s%..icient a3sor3ent material to a3sor3 the
contents i. the -rimar7 container leaksS
Ces * No
&. Are 3oth the a3o4e containers -ro-erl7
la3elledS
Ces * No
0. Is the secondar7 container -acked into
a--ro-riate o%ter -ackin) and la3elled
a--ro-riatel7S
Ces * No
. Is coolin) a)ent incl%ded in the o%ter
-acka)e i. cold chain is to 3e maintainedS
Ces * No
'. Is the o%ter -acka)e la3elled; addressed
and ta-ed sec%rel7
Ces * No
7. Are the -a- smears mailed in ri)id slide
mailers to -re4ent 3reaka)e o. the slideS
Ces * No
Co,7&a-n*s < Feed1a05
1. Does the collection centre has -ro4ision
.or recei4in) o. com-laints * .eed3ack
Ces * No
2 Are the com-laints * .eed3ack re4ie6ed
and resol4ed 37 the la3orator7
Ces * No
Iss%e No: #2 Iss%e Date:#1.#2.2##! Amend No: # Amend Date: #1.#".2##! (a)e No: !#*!&

FORM 71
RECOMMEN#E# A!THORISE# SI2NATORIES
Field : Disci-line (s$:
5he .ollo6in) -ersons ha4e 3een recommended as A%thorised Si)natories .or a%thenticit7 and iss%e o. 5est
/e-orts:
S& La1o.a*o.:<
#e7a.*,en*<
Se0*-on
I Na,e 6
#es-(na*-on o+
S-(na*o.:
/)a&-+-0a*-on
A-*3
S7e0-a&-Ha*-on
E87e.-en0e -n
:ea.s +o.
A)*3o.-Hed a.ea
Re&e9an*
T.a-n-n(
A)*3o.-Hed
+o. A3-03
s7e0-+-0 a.ea
S7e0-,en
S-(na*).e
B An7 chan)es in the A%thorised Si)natories shall 3e in.ormed 37 the la3orator7 to NABL 6ithin 1 da7s
Si)nat%re; Name ,
Desi)nation o. ?ead o.
La3orator7
Si)nat%re , Name o. Assessor(s$ Si)nat%re , Name o. Lead
Assessor
Iss%e No: #& Iss%e Date:88888 Amend No: ## Amend Date: 88 (a)e No: !1*!&

FORM 72
RECOMMEN#E# SCO'E OF ACCRE#ITATION
Field : Disci-line(s$:
S& '.od)0*(s <
Ma*e.-a& o+
*es*
S7e0-+-0 *es*s
7e.+o.,ed
I Tes* Me*3od L-,-*s o+ o7e.a*-on<
Ran(e o+ *es*-n(<
L-,-* o+ de*e0*-on
JC; < M!II
( )
B 9hen re.errin) to -%3lications like NCCLS; I(; B(; FS(; AS5:; AOAC etc. kindl7 mention the cla%se * cha-ter * -a)e
n%m3er; as a--ro-riate.
BB 5he la3oratories are enco%ra)ed to -ro4ide estimates o. :eas%rement o. Fncertaint7 (:F$.
Si)nat%re , Name o. La3
/e-resentati4e
Si)nat%re , Name o. Assessor(s$ Si)nat%re , Name o.
Lead Assessor
Iss%e No: #& Iss%e Date:88888 Amend No: ## Amend Date: 88 (a)e No: !2*!&

FORM 7=
#ECLARATION OF IM'ARTIALIT@ 6 CONFI#ENTIALIT@
(to 3e .illed in 37 each Assessor and enclosed 6ith the Assessment re-ort$
Na,e Assesso. I# :
(5o 3e .illed in 37 NABL
Sect.$
#es-(na*-on
O.(an-sa*-on
Add.ess
Ca7a0-*: Lead Assessor / Tec1nical Assessor / Tec1nical 62pert / $bserver
La1o.a*o.: Assessed
#a*e o+ 9-s-*(s
T:7e o+ 9-s-* Assessment / 1
st
I GGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGG; 3e.e1: de0&a.e *3a*
i. I ha4e not o..ered an7 cons%ltanc7; )%idance; s%-er4ision or other ser4ices to the
la3orator7; in an7 6a7.
ii. I am * am notB an e=8em-lo7ee o. the la3orator7 and am* am notB related to an7 -erson
o. the mana)ement o. the la3orator7.
iii. I )ot an o--ort%nit7 to )o thro%)h 4ario%s doc%ments like A%alit7 :an%al; (roced%ral
:an%als; 9ork instr%ctions; Internal re-orts etc. o. the a3o4e la3orator7 and other
related in.ormation that mi)ht ha4e 3een )i4en 37 NABL. I %ndertake to maintain strict
con.identialit7 o. the in.ormation ac>%ired in co%rse o. dischar)e o. m7 res-onsi3ilit7 and
shall not disclose to an7 -erson other than that re>%ired 37 NABL.
B strike o%t 6hich is not a--lica3le
Date:
(lace : Si)nat%re
Iss%e No: #& Iss%e Date:88888 Amend No: ## Amend Date: 88 (a)e No: !&*!&

&
rd
Floor; NISCAI/
10; Satsan) Dihar :ar)
Ne6 :ehra%li /oad
Ne6 Delhi 1 11# #'7
5el.: U "1811 0'0"""""
Fa=: U "1811 2'2"71'
9e3site: AAA$na1&B-nd-a$o.(

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