QUALITY SYSTEM PROCEDURE

FOR
CONTROL OF DOCUMENTS
(QSP-01)
Copy No:
Copy Holder:
Issue No. : 01 Revision No. : --
Issue Date: 01.02.2012 Revision Date: --
Issued By: Approved By:
(Manae!ent Representative" (C#airperson"
EACH ONE TEACH ONE CHARITABLE FOUNDATION
$%%. &.' .Road($pp. )under &o*er( Hir+i Bau(
)e*ri (,"( Mu!-ai -.0001/
&el: 022-2.102//02.01./10
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Revision
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TABLE OF CONTENTS
&I&67 2A87
C$97R 2A87 1
&AB67 $: C$N&7N&) 2
AM7NDM7N& )H77& ;
1.0 2<R2$)7.............................................................................................................
2.0 )C$27.................................................................................................................
..0 R7:7R7NC7..........................................................................................................
/.0 D7:INI&I$N) 0 ACR$N=M)....................................................................................
>.0 :<NC&I$NA6 CHAR&..............................................................................................
?.0 R7)2$N)IBI6I&= AND A<&H$RI&=..........................................................................
3.0 2R$C7D<R7 :$R C$N&R$6 $: D$C<M7N&)............................................................/
1.0 R7C$RD)..........................................................................................................?
EACH ONE TEACH ONE CHARITABLE
FOUNDATION
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Do4 No. 5)2-01
AMENDMENT SHEET
:or!
:0MR00/
Rev 00
)r.
No
7%%e4tive
Date
2ae
No.
Ne* Revision
no.
A!end!ent Details MR
Approval
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Issue No. 0Date 01 0 01.02.2012
Revision
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QUALITY SYSTEM PROCEDURE FOR
CONTROL OF DOCUMENTS
2ae No 0. o% 03
Do4 No. 5)2-01
1.0 PURPOSE
1.1 &o ensure proper 4ontrol o% do4u!ents at 7ACH $N7 &7ACH $N7 CHARI&AB67
:$<NDA&I$N
2.0 SCOPE
2.1 &#e pro4edure 4overs all t#e @uality !anae!ent syste! do4u!ents at 7ACH $N7 &7ACH
$N7 CHARI&AB67 :$<NDA&I$N.
2.2 3.0 PROCESS OBJECTIVES
)r. No.
$B'7C&I97) 5<AN&I:I7D 2ARAM7&7R)
01 Revie* o% ade@ua4y o% 5M) Do4u!entation In ea4# MRM
4.0 REFERENCE
ISO 001!200"
CLAUSE
NUMBERS
CLAUSE TITTLE
..2 Do4u!entation Re@uire!ents
..2.2 5uality Manual
..2.; Control o% Do4u!ents
#.0 DEFINITIONS $ ACRONYMS
/.1 MR : Manae!ent Representative
/.2 5M) : 5uality Manae!ent )yste!
/.; 5uality Manae!ent )yste! do4u!ents: 4o!prises o% @uality poli4y( @uality o-+e4tives(
@uality !anual( @uality syste! pro4edures and %or!ats.
/.. MRM : Manae!ent Revie* Meetin
%.0 FUNCTIONAL CHART
&.0 RESPONSIBILITY AND AUTHORITY
&.1 C'()*+,*-./
?.1.1 )#all revie* and approve all @uality !anae!ent syste!s do4u!ents.
&.2 M(/(0,1,/2 R,+*,-,/2(2)3, (MR)
?.2.1 )#all -e overall responsi-le %or !aintainin t#e pro4edure o% 4ontrol o% do4u!ents.
?.2.2 )#all issue all t#e @uality !anae!ent syste! do4u!ents to t#e 4opy#olders.
?.2.; )#all prepare and !aintain Master list o% do4u!ents( !aster list o% eAternal oriin
do4u!ents.
?.2.. )#all looB a%ter any %uture 4#anes in t#e do4u!ented pro4edure( !aBe a!end!ents( and
C#airperson
MR
in4orporate in t#e do4u!ented pro4edure and issuin to t#e 4on4erned 4opy#olders.
EACH ONE TEACH ONE CHARITABLE
FOUNDATION
Issue No. 0Date 01 0 01.02.2012
Revision
No0Date
--
QUALITY SYSTEM PROCEDURE FOR
CONTROL OF DOCUMENTS
2ae No 0/ o% 03
Do4 No. 5)2-01
".0 PROCEDURE FOR CONTROL OF DOCUMENTS
".1 D.451,/2- /516,*)/0 -7-2,1 - I8,/2)9)4(2)./
A" Q5(:)27 M(/5(: s#all -e identi%ied as QM.
B" QSP-;; *#ere QSP stands %or Q5(:)27 S7-2,1 P*.4,85*,
;; indi4ates t#e 5uality )yste! 2ro4edure nu!-er.
C" F$;; .* ;;;$YY C ,#ere <F= stands %or F.*1$F.*1(2( ;;$;;; C )tands %or 2ro4ess
A4rony! and YY stands %or uni@ue S,*)(: N..
".2 P*,+(*(2)./> (++*.3(: (/8 )--5(/4,
3.2.1 &#e preparin( approvin and issuin aut#orities %or t#e 5M) do4u!ents are as %ollo*s:
L,3,: D.451,/2 I--5,8 B7 A++*.3,8 B7
I 5uality Manual MR C#airperson
II 5uality )yste! 2ro4edures MR C#airperson
III :or!ats MR C#airperson
3.2.2 &#e C#airperson s#all approve t#e 5M) do4u!ents %or ade@ua4y prior to issue.
3.2.; MR s#all prepare and issue t#e approved do4u!ents to t#e respe4tive 4opy#olders( as per
t#e M(-2,* L)-2 .9 D.451,/2- (:0MR001".
".3 C./2*.:
3.;.1 &#e oriinal o% every 5M) do4u!ent s#all -e sta!ped ?MASTER COPY? on t#e -otto!
%ront side o% every pae.
3.;.2 &#e aut#oriDed 4opy #olders as de4ided -y !anae!ent are 4ontrolled 4opy #olders. )u4#
4ontrolled 4opy #olders list is de%ined in Master 6ist o% Do4u!ents. &#e 4opies o% 5M)
do4u!ents s#all -e !ade as per Master 6ist o% Do4u!ents and issued to t#e 4ontrolled
4opy #olders a%ter sta!pin as C$N&R$667D C$2= on t#e top %ront side o% ea4# pae.
3.;.; &#ose *#o are not aut#oriDed to #old t#e 4opies are issued as <UNCONTROLLED COPY=
as and *#en re@uired. In t#is 4ase( su4# do4u!ent is identi%ied as <UNCONTROLLED
COPY= on t#e top %ront side o% every pae.
N.2,: T', )8,/2)9)4(2)./ .9 QMS 8.451,/2- @)2' 4.:.5* -2(1+ )- 8./, (- 9.::.@-!
MASTER COPY A BLUE COLOUR
CONTROLELD COPY $ UNCONTROLLED A RED COLOUR
OBSOELTE COPY A BREEN COLOUR
3.;.. &#e !aster %or!ats o% t#e 5M) are identi%ied as spe4i!en %or!ats and Bept in a separate
%ile. &#e list o% all su4# 5M) %or!ats is !aintained as per 5)2-02 in Master 6ist o% Re4ords
(:0MR002". MR ensures t#at only 4ontrolled %or!ats are issued to t#e 4on4erned
depart!ent
3.;./ All 4ontrolled do4u!ents s#all not -e p#oto4opied *it#out t#e approval o% C#airperson.
3.;.> MR s#all ensure availa-ility o% 4urrent revisions o% appli4a-le do4u!ents at points o% use.
EACH ONE TEACH ONE CHARITABLE
FOUNDATION
Issue No. 0Date 01 0 01.02.2012
Revision
No0Date
--
QUALITY SYSTEM PROCEDURE FOR
CONTROL OF DOCUMENTS
2ae No 0> o% 03
Do4 No. 5)2-01
3.;.? &#e MR s#all not provide any @uality !anae!ent syste! do4u!ent0 data0re4ord et4.( to
any eAternal person( *it#out approval %ro! C#airperson. Custo!er re@uired re4ords as per
t#e 4ontra4ts s#ould -e !ade availa-le to t#e 4usto!er.
3.;.3 MR s#all !aintain a !aster list o% t#e @uality !anae!ent syste! do4u!ents 4ontainin
t#eir 4urrent revision nu!-er.
3.;.1 7very pae o% a @uality !anae!ent syste! do4u!ent s#all 4ontain details o% pae
nu!-er( do4u!ent identi%i4ation E revision nu!-er and date o% revision.
3.;.10 7very pae o% every do4u!ent s#all 4ontain sinatures o% t#e persons *#o #as approved
and issued it. &#e 4over pae s#all -ear t#e Copy No.( issue no. and t#e date o% issue(
do4u!ent identi%i4ation E revision nu!-er and date o% revision.
3.;.11 All do4u!ents s#all 4ontain an A!end!ent )#eet and s#all -e appropriately -ound to
prevent loss o% paes and or da!ae to t#e!.
3.;.12 All paes o% t#eF MASTER COPY? o% do4u!ents s#all -e sta!ped as <MASTER COPY?( all
paes o% t#e ?CONTROLLED COPYF s#all -e sta!ped as ?CONTROLLED COPY? and all
paes o% <UNCONTROLLED COPY= s#all -e sta!ped as UNCONTROLLED COPY and -e
lei-le.
3.;.1; &#e 4opy#olders o% 5uality !anae!ent syste! Do4u!ents s#all -e responsi-le %or ut!ost
4are( sa%e storae and easy retrieval. It is ensured -y 4opy #olders t#at *#en ever su4#
5M) do4u!ents are taBen out %or readin( it !ust -e Bept -a4B in t#e 4up-oard
i!!ediately. In 4ase o% any da!ae to t#e do4u!ent *#i4# !i#t o44ur due to any reason
liBe %allin o% *ater( inB et4. ,#ere it leads to -eyond reada-le( in su4# it !ust -e reported
to MR i!!ediately. MR ensures i!!ediate issue o% t#at 4ontrolled do4u!ent %or!ally and
taBes -a4B t#e da!aed do4u!ent and destroys -y tearin it o%% properly.
".4 C'(/0,- - A88)2)./> D,:,2)./ (/8 S56-2)252)./
3...1 &#e 4on4erned 4ontrolled 4opy#olders o% t#e do4u!ent s#all raise a re@uest %or 4#ane in
t#e 4on4erned do4u!ent( t#rou# t#e C'(/0, R,C5,-2 F.*1 G:0MR00.H to t#e MR. &#e
MR s#all revie* t#e re@uested 4#ane in 4onsultation *it# C#airperson -e%ore
i!ple!entation.
".4.2 A%ter t#e 4#ane is approved -y C#airperson( MR s#all !aBe 4#anes in t#e 4on4erned
do4u!ent and -rin out a revised 4opy o% t#e pae0do4u!ent and distri-ute t#e sa!e as
per t#e M(-2,* L)-2 .9 D.451,/2 G:0MR001H. &#e 4opy#older a4Bno*ledes t#e re4eipt o%
a!ended 4opy on t#e Master 6ist o% Do4u!ents. &#e 4#anes are re%le4ted in t#e
A1,/81,/2 S',,2 G:0MR00/H also. ,#enever any 4#ane is !ade in any pae o% 5uality
Manual or 5uality )yste! 2ro4edure( t#e 4over pae o% t#is do4u!ent is also revised ea4#
ti!e.
".4.3 MR s#all -rin out a ne* issue o% a do4u!ent( a%ter 10 4#anes in any pae o% t#e
parti4ular do4u!ent. &#ese 4#anes s#all -e identi%ied in t#e A1,/81,/2 S',,2
G:0MR00/H.
EACH ONE TEACH ONE CHARITABLE
FOUNDATION
Issue No. 0Date 01 0 01.02.2012
Revision
No0Date
--
QUALITY SYSTEM PROCEDURE FOR
CONTROL OF DOCUMENTS
2ae No 0? o% 03
Do4 No. 5)2-01
".4.4 MR s#all !aintain all o-solete do4u!ents0paes (./:7 .9 M(-2,* C.+7)( *#i4# are
retained %or Bno*lede0statutory purposes( a%ter suita-ly identi%yin t#e! as ?OBSOLETE
".4.# COPY? in reen 4olour on %ront side and storin t#e! separately in $-solete 4opy %ile to
prevent %ro! unintended use.
".4.% <OBSOLETE= Master Copies s#all -e stored until t#e se4ond neAt issue is -rou#t out. $n4e
se4ond issue o% 5M) do4u!ent is -rou#t out( t#e previous issue o% !aster 4opy s#all -e
destroyed -y MR t#rou# )#redder.
".4.& MR s#all -e responsi-le %or proper repla4e!ent o% all do4u!ents0paes( *#i4# are 4#aned(
*it# t#e ne* Revisions at all t#e 4orrespondin lo4ations.
Note 2: -&#e entire do4u!ent !i#t -e 4#aned *it#out oin t#rou# t#e a-ove pro4edure i%
t#ere is a !a+or 4#ane in t#e syste!s as de4ided -y t#e C#airperson. Ho*ever o-solete
do4u!ents s#all -e !aintained and t#e %res# pro4edures s#all -e a!ended -y
in4re!entin t#e issue no. -y 01.
3...? No unaut#oriDed !arBins s#all -e !ade on t#e ?CONTROLLED? do4u!ents.
3...3 Do4u!ent Holders is responsi-le %or proper usae and !aintenan4e o% t#e do4u!ents.
".# C./2*.: .9 ED2,*/(: O*)0)/ D.451,/2-
3./.1 Do4u!ents o% eAternal oriin as deter!ined -y 7ACH $N7 &7ACH $N7 CHARI&AB67
:$<NDA&I$N *#i4# are ne4essary %or plannin and operation o% t#e @uality !anae!ent
syste! are identi%ied and t#eir distri-ution is 4ontrolled.
3./.2 MR s#all also arrane to update %ro! Bno*n sour4es( return -a4B a%ter use and0or dispose
o% t#ese do4u!ents dependin on t#e re@uire!ent. 7Aternal oriin do4u!ents in4lude
1. )tatutory0Reulatory Do4u!ents
2. Manual 0 BooBs related to !edi4ine
;. National 0 International )tandard
3./.; MR s#all prepare a L)-2 .9 ED2,*/(: O*)0)/ D.451,/2- G:0MR00;H 4ontainin all t#e
appli4a-le do4u!ents as !entioned in pararap# 3./.2.
3./.. &#e MR s#all Beep t#e tra4B o% any revision in su4# -ooBs0do4u!ents0standards t#rou#
4on4erned aut#ority( asso4iation( 4usto!er eit#er t#rou# telep#one( e!ail or personal
visits at reular internals.
3././ ,#enever su4# revision taBes pla4e t#e( revised eAternal oriin do4u!ent s#all -e pro4ured
i!!ediately and !ade availa-le to t#e 4on4erned lo4ation -y distri-utin t#e!. &#e
distri-ution 4ontrol s#all -e done -y MR and a44ordinly L)-2 .9 ED2,*/(: O*)0)/
D.451,/2- G:0MR00;H s#all -e updated. &#e old su4# do4u!ent s#all -e *it#dra*n
i!!ediately -y MR %ro! point o% use( !arBed $B)$67&7 or disposed o%% (i% re@uired" and
!aintained properly.
EACH ONE TEACH ONE CHARITABLE
FOUNDATION
Issue No. 0Date 01 0 01.02.2012
Revision
No0Date
--
QUALITY SYSTEM PROCEDURE FOR
CONTROL OF DOCUMENTS
2ae No 03 o% 03
Do4 No. 5)2-01
.0 RECORDS F.*1 N..
1.1 Master 6ist o% Do4u!ents G:0MR001H
1.2 6ist o% 7Aternal $riin Do4u!ents G:0MR00;H
1.; C#ane Re@uest :or! G:0MR00.H
1.. A!end!ent )#eet G:0MR00/H