ISO QMS Presentation

8/9/2019 ISO QMS Presentation

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ISO 9001 : 2008

QUALITY MANAGEMENT SYSTEM

24 November 2009


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EXTERNAL AUDIT PROGRAMME

TIME ATI!ITY TO "E ASSESSED AUDITOR#TEAMMEM"ER

IN!OL!ED

9.00am-9.15am Opening Audit Team

9.15am-12.30pm

Site tour – Check on client! location and !ite !peci"iccondition!

#A#

$ocument #e%ie&- Ade'uac( on le%el 1)*anual+ and ,e%el 2)rocedure+

Check on ualit( olic()5.3+/ Oecti%e! )5..1 4.1+

nternal Audit )6.2.2+ and *anagement #e%ie& )5.7+

12.30pm-1.30pm 8orking ,unch

1.30pm-5.00pm

Check on Client! under!tanding &ith re!pect to identi"icationo" ke( per"ormance a!pect!)4.1+ and proce!!).1+

#A#Check on !cope o" management !(!tem ).2.+ and related!tatutor( and regulator()4.2.1+

Check on Client! *S and !ite operation! remote !iteoperation! and po!!ile !igni"icant a!pect! to e con!idered

1.30pm-5.00pm $i!cu!!ion &ith *# and preparation "or Clo!ing *eeting


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WHAT IS ISO ?

: ISO $% I&'er&('$o&() Or*(&$+('$o& ,or S'(&-(r-$+('$o&. (/or)-/$-e ,e-er('$o& o, &('$o&() %'(&-(r-% bo-$e% %$&e194

: "(%e- $& Ge&ev(. S/$'+er)(&-

: ISO e%'(b)$%3e% (&- romo'e% '3e 5%e o, $&'er&('$o&()%'(&-(r-% '3ro5*3 $'% v(r$o5% Te3&$() omm$''ee%o&%$%'$&* o, /e))67&o/& eer'% $& v(r$o5% ,$e)-%

: T3e ISO 9000 %'(&-(r-% /ere e%'(b)$%3e- b ISO Te3&$()omm$''ee 1


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DEFINITION OF ISO 9000

1; ISO 9000 $% ( %er$e% o, Q5()$' M(&(*eme&' S%'em

%'(&-(r-%<

2; ISO 9000 $% &o' ( ro-5' %'(&-(r-<

=; ISO 9000 $% &o' (& ()'er&('$ve 'o ro-5' >'e3&$();

re?5$reme&'%<

4; ISO 9001 o&'($&% '3e Q5()$' M(&(*eme&' S%'emre?5$reme&'%


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WHAT IS QUALITY MANAGEMENT SYSTEM ?

Q5()$' M(&(*eme&' S%'em >QMS; $% ( m(&(*eme&' %%'em'o -$re' (&- o&'ro) (& or*(&$+('$o& /$'3 re*(r- 'o ?5()$'

*S

ualit( lanning

ualit( A!!urance

ualit( Control

ualit( mpro%ement


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EVOLUTION OF QMS STANDARDS

"S @@0 : 199

ISO 9000 : 198 ISO 9000 : 1994

ISO 9000 : 2000

ISO 9001 : 2008


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SIENTIGE QUALITY MANAGEMENT SYSTEM

: S$e&'$*e 3(% e%'(b)$%3e- '3e Q5()$' M(&(*eme&' S%'em >QMS;,or o&'$&5() $mroveme&' $& (or-(&e /$'3 I&'er&('$o&() S'(&-(r-

: S$e&'$*e QMS $% %'r5'5re- (&- (-('e- 'o '3e om(&% &('5re o,b5%$&e%% (&- '(7e% $&'o (o5&' '3e ,o))o/$&*%:

(; Proe%% ,or '3e QMS (&- '3e$r ()$('$o&<b; Se?5e&e (&- $&'er('$o& o, '3e%e roe%%e%<

; De'erm$&e r$'er$( (&- me'3o-% 'o e&%5re e,,e'$ve oer('$o& (&- o&'ro)o, '3e%e roe%%e%<

-; E&%5re (v($)(b$)$' o, re%o5re% (&- $&,orm('$o& 'o %5or' oer('$o& (&-mo&$'or$&* o, '3e%e roe%%e%<

e; Mo&$'or. me(%5re. (&- (&()+e '3e%e roe%%e%< (&-,; Im)eme&' ('$o&% 'o (3$eve )(&&e- re%5)'% (&- o&'$&5() $mroveme&'


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QMS DOUMENTATION

: T3e QMS -o5me&'('$o& $&)5-e% '3e ,o))o/$&*%:

(; Q5()$' M(&5()<

b; Bob De%r$'$o&%#Se$,$('$o&%<

; Q5()$' Proe-5re%<

-; Corm%<

e; E'er&() Do5me&'%<,; or7 I&%'r5'$o&%< (&-

*; Do5me&'% (&- reor-% &ee-e- 'o e&%5re '3e e,,e'$ve )(&&$&*.oer('$o& (&- o&'ro) o, '3e om(&% roe%%e%

: T3e re)('e- -o5me&' ,or ?5()$' roe-5re o, -o5me&'('$o& $%

SI6QA6P001 : QUALITY PROEDURE

>Do5me&'('$o& Re?5$reme&'%;


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QUALITY MANUAL F QUALITY PROEDURES

: T3e Q5()$' M(&5() o&'($&% '3e ,o))o/$&* -o5me&'e-%'('eme&'%:

$ !$%$o& F M$%%$o&<

$$ Q5()$' Po)$ *5$-e om(& -$re'$o&<

$$$ Q5()$' ObHe'$ve% om(&% Q5()$' PI<

$v Q5()$' Proe-5re% roe%%e%< (&-

v Q5()$' Reor-%

: Q5()$' Proe-5re% %'$5)('e 3o/ '3$&*% %3o5)- be -o&e $&%e?5e&e o, %'e% 'o ee5'e /3(' 3(ve bee& re%r$be- $&'3e Po)$


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SIENTIGE !ISION

: To be '3e Core,ro&' o, Se$()$+e- E&*$&eer$&* (&-N$3e Te3&o)o* So)5'$o& P(r'&er

SIENTIGE MISSION

: Prov$-$&* $&'e*r('e- m5)'$6-$%$)$&e %e$()$+e-e&*$&eer$&* %o)5'$o& *)ob())


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SIENTIGE QUALITY POLIY

: E&%5r$&* '3e 'e3&o)o* rov$-e- (re '3e N$3e Te3&o)o*(&- '3e rov$%$o& $% (' '3e r$*3' )(e (&- '$me

: A)) om(& rere%e&'('$ve (re ro,e%%$o&()% $& '3e$r ,$e)- (&-re%e&'(b)e 'o '3e )$e&'%#5%'omer

: M($&'($&$&* ee))e&' omm5&$('$o&% /$'3 )$e&'% (&-r$&$()% (' ()) '$me

: M($&'($&$&* '3e ?5()$' o, %erv$e% rov$-e- $& (& $&%'())('$o&or o&%5)'(&


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SIENTIGE QUALITY O"BETI!ES

: To (3$eve ( 5%'omer %('$%,('$o& )eve) o, @J<

:To e&%5re '3(' ()) em)oee% (re *$ve& ( roer'r($&$&* $& '3e$r ,$e)- (' )e(%' @ 3o5r% ( e(r ,or e(3em)oee<

: To e&%5re '3(' )e%% '3(& @ om)($&'% ,rom e(3)$e&'%#r$&$() er e(r< (&-

: To e&%5re %('$%,('or er,orm(&e ,rom %5)$er(&- %5bo&'r('or 'o ( )eve) o, @J


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ONTROL OC DOUMENTS AND REORDS

: A)) -o5me&'% re?5$re- b '3e QMS (re o&'ro))e-

: Reor-% rov$-$&* ev$-e&e o, o&,orm$' 'o re?5$reme&'%(&- ,or e,,e'$ve oer('$o& o, '3e QMS (re ()%o o&'ro))e-

: A -o5me&'e- roe-5re %3o5)- be e%'(b)$%3e- 'o -e,$&e'3e o&'ro)% &ee-e- ,or $-e&'$,$('$o&. %'or(*e. ro'e'$o&.

re'r$ev() (&- -$%o%$'$o& o, reor-%

: Reor-% %3o5)- rem($& )e*$b)e. re(-$) $-e&'$,$(b)e (&-re'r$ev(b)e


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QUALITY PROEDURES

: Q5()$' Proe-5re% %'$5)('e 3o/ '3$&*% %3o5)- be

-o&e $& %e?5e&e o, %'e% 'o ee5'e /3(' 3(vebee& re%r$be- $& '3e Po)$


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QUALITY PROEDURES

1; SI6QA6P001:

Do5me&'('$o& Re?5$reme&'%

2; SI6QA6P002:

I&'er&() A5-$'

=; SI6QA6P00=:

Mo&$'or$&* F Me(%5reme&' o, ProHe'#Pro-5'

F No&6o&,orm$' o&'ro)

4; SI6QA6P004:

o&'$&5() Imroveme&'

Microsoft Word

Document

Microsoft Word

Document

Microsoft Word

Document

Microsoft Word

Document


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QUALITY PROEDURES >o&';

@; SI6R6P001:

Em)oer Tr($&$&* F Deve)ome&'

; SI6IT6P001:

I&,orm('$o&. omm5&$('$o& F Te3&o)o*

Proe%%

; SI6CN6P001:

P5r3(%$&*

8; SI6ADM6P001:

(&-)$&* F M($&'e&(&e o, om(& !e3$)e

Microsoft Word

Document

Microsoft Word

Document

Microsoft Word

Document

Microsoft Word

Document


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QUALITY PROEDURES >o&';

9; SI6M"D6P001:

Proe%% F Te&-er$&* Eer$%e

10; SI6PO6P001:ProHe' Ee5'$o& P)(&

11; SI6PO6P002:

ProHe' m(&(*eme&'

Microsoft Word

Document

Microsoft Word

Document

Microsoft Word

Document


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ONTINUAL IMPRO!EMENT

: S$e&'$*e /or7% 'o/(r-% o&'$&5() $mroveme&'

o, ?5()$' m(&(*eme&' %%'em '3ro5*3 '3e 5%e o,'3e ?5()$' o)$. ?5()$' obHe'$ve%. (5-$' re%5)'%.(&()%$% o, -('(. orre'$ve (&- reve&'$ve ('$o&%(&- m(&(*eme&'


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DOUMENT MASTER LIST

: T3e Do5me&' M(%'er L$%' o&'($&% '3e ,o))o/$&*S$e&'$*e Q5()$' M(&(*eme&' S%'em -o5me&'%:

>$; Q5()$' M(&5()<

>$$; Q5()$' Proe-5re%<>$$$; Bob De%r$'$o&%#Se$,$('$o&%<

>$v; Corm%< (&-

>v; or7$&* I&%'r5'$o&%

: T3e Do5me&' M(%'er L$%' $% (% (''(3e- be)o/:

Microsoft Word

Document


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MANAGEMENT OMMITMENT

S$e&'$*e M(&(*eme&' $% omm$''e- 'o -eve)o. $m)eme&' (&-m($&'($& '3e QMS. (&- 'o o&'$&5()) $mrove $'% e,,e'$ve&e%%

'3ro5*3 '3e ,o))o/$&*%:

: E%'(b)$%3$&* '3e ?5()$' o)$ (&- ?5()$' obHe'$ve%

: E&%5r$&* '3e $mor'(&e o, mee'$&* 5%'omer (% /e)) (% %'('5'or (&-re*5)('or re?5$reme&'% (re omm5&$('e- '3ro5*3o5' '3eor*(&$+('$o&

: o&-5'$&* M(&(*eme&' Rev$e/% Mee'$&*% 28#10#09

: E&%5r$&* '3e (v($)(b$)$' o, re%o5re%

: Tr($&$&* 'o e&%5re '3e ?5()$' o, /or7 (rr$e- o5' b em)oee%o&'r$b5'e% 'o/(r-% '3e Q5()$' Po)$ (&- Q5()$' ObHe'$ve%


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ISO MANAGEMENT REPRESENTATI!E

AND OORDINATOR

: T3e Q5()$' M(&(*eme&' Rere%e&'('$ve >QMR; 3(% '3e (5'3or$'(&- re%o&%$b$)$' 'o e&%5re '3e QMS $% e,,e'$ve) (&- e,,$$e&')$m)eme&'e- (&- m($&'($&e- o&'$&5o5%)

: T3e QMR% (5'3or$' (&- re%o&%$b$)$' $&)5-e '3e ,o))o/$&*%:

(; Reor' o& '3e er,orm(&e (&- (& &ee- ,or $mroveme&' o, '3e

?5()$' m(&(*eme&' %%'em 'o '3e M(&(*eme&'<

b; E&%5r$&* '3e romo'$o& o, (/(re&e%% o, 5%'omer re?5$reme&'%'3ro5*3o5' '3e om(&< (&-

; L$($%e /$'3 e'er&() bo-$e% o& m(''er% re)('$&* 'o '3e ISO 9001?5()$' m(&(*eme&' %%'em

: T3e ISO oor-$&('or >M% A,,($+( Y('$;. ('$&* (% '3e Do5me&'%o&'ro))er. (%%$%'% $& '3e re(r('$o& (&- ,$&()$+$&* '3e ISO QMS-o5me&'%


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AUDITS

: I&'er&() (5-$'%

29 F =0 Se' 2009

: E'er&() (5-$'%

Do5me&'% rev$e/ -o&e. S'(*e 1 E(r) November 2009. S'(*e 2 E&- o, November 2009


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INTERNAL AUDIT

: I&'er&() (5-$'% /$)) be o&-5'e- (' )(&&e- $&'erv()% 'o -e'erm$&e/3e'3er '3e QMS o&,orm% 'o '3e )(&&e- (rr(&*eme&'%. (&- $%e,,e'$ve) $m)eme&'e- (&- m($&'($&e-

: T3e $&'er&() (5-$'% (re (rr$e- o5' b 'r($&e- $&'er&() (5-$'or%

: Se)e'$o& o, $&'er&() (5-$'or% (&- o&-5' o, $&'er&() (5-$'%%3o5)- e&%5re obHe'$v$' (&- $m(r'$()$' o, (5-$' roe%%

: I&'er&() (5-$'or% %3o5)- &o' (5-$' '3e$r o/& /or7

: A)) &o&6om)$(&e% (re reor'e- (&- ('$o&% ,or re'$,$('$o& (rereomme&-e-

: A'$o&% ,or re'$,$('$o& (re '(7e& /$'3$& %e$,$ '$me er$o- 'o

e)$m$&('e '3e -e'e'e- &o&o&,orm$'$e% (&- '3e$r (5%e% 'o e&%5ree,,e'$ve $m)eme&'('$o& o, '3e QMS

: Reor-% o, (5-$'% (re -o5me&'e-. m($&'($&e- (&- -$%'r$b5'e- 'oe(-% o, De(r'me&'%


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IMPLEMENTATION PLAN


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ROLE OC SIENTIGE OCCIERS

: E&%5re '3(' '3e S$e&'$*e QMS (&- ()) '3e Q5()$' Proe-5re%-eve)oe- (&- -o5me&'e- (re %'r$') (&- e,,e'$ve)$m)eme&'e- $& '3e roe%% o, -e)$ver$&* o5r /or7 (&- ro-5'%

: T(7e &ee%%(r ('$o&% 'o (3$eve '3e )(&&e- re%5)'% (&-o&'$&5() $mroveme&' o, /or7 roe%%e%

: ee ()) reor-% (&- roo,% '3(' '3e Q5()$' Proe-5re% (re be$&*,o))o/e-


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TAN YOU

Documents

ISO QMS Presentation