ISO9000_G1

Page 1

ISO 9000 ISO 9000 498 34270 26 $ % ก'( ) 498 34292 26 * ( + 498 34372 26 , + 498 34670 26 - + ก + 498 34773 26 1


Agenda

What is The Model ? Model Concept Model Approach Briefly Explanation About Model's Requirement Model's Approach for QA Benefits of The Model What is Next ? 2


What is Model ? 3


ISO O)P ภ? ISO QRS -OT) U V W)

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( The International Organization for Standardization )

ภX) U RY . . 1947 U ) 'X TภQ+ R Q Q[) \( ] ISO ^%XP-X _ X) { acronym } !"#$ %ภ'$ ( $ -- IOS [International Organization for Standardization]- ภ-- OIN [Organisation Internationale de Normalisation] - 4


ISO O)P ก ? ISO

ก ก isos ก ก d Q X Q %ก e (equal) % h R Q OT) d . % . /012 0 20034 52 %6 78 '97: 0 ; $ 52 %6 78 (7'<%= / '>?@4A . 5ก 0 ก/ ก 07"B ก"B#2 $3B4%) C5D0"12 0 6E$ 4ก e !" #ก กก 130 $ % ก & ' ( $) " '# #ก '# $& ) 5


) X i( W) ) ภISO

% j %^ \ W) kl( % (ISO film speed code) W ] 'm ) Q Q ) [ Q-X W ] 20 ft. ; W ] 40 ft. ] % j Q ] \( ATM % j W ]ภ] q A4 (ISO 216 [rT % + ภDIN 7 W) Q ) % ) % j t( ภq P T -mP m Ru % h ภ(\ -OT)R Q X Q \( q % j X)Q-X m, kg, k, mol, W) X SI UNIT 6


%QRS % W) % j ISO 9000 y T rT (First Edition) ))ภP-mP RY . . 1987 R ภ) ]m % j ( ภ5 - ] y T ) (Second Edition) ))ภP-mP RY . . 1994 R ภ) ]m % j ( ภ5 - ] y T % (Third Edition) ))ภP-mP RY . . 2000 [ issued : 15 Dec. 2000 ] O) y ME - Millenium Edition R ภ) ]m % j ( ภ3 - ]

7


Model Concept 8


ISO 9000:1994 ( 2)

ISO 8402

ก ก ! "#$ %&

ISO 9000

ก ( & )) *+,

ISO 9004

! ))) - *+, ISO 9001 ISO 9002 ISO 9003 9


, m ) ก %% j ISO 9000 y RY . . 2000 R ก P-mQ%OT) 15

. . 2000 % % j Q 3 y O) [1] ISO 9000:2000 :- _ \( ( กก T] [2] ISO 9001:2000 :- Wm)ก_ ]P

[3] ISO 9004:2000 :- \ ก R R i(ก ]_ Q W) ) ก

10


, m W) ) ก %% j ISO 9000:2000

ISO 9004:2000

ISO 9001:2000 ISO 9000-1994

ISO 8402:1994

ISO 9000:2000

11


Model Approach 12


Wm)ก_ ]W) % j ISO 9000 1. 2. 3. 4. 5. 6. 7.

% i ]-) ]m ก

ก Wm) ก( ก %ก ))ก\ ก %Q)ก \( Wm)%'( ก + ][OU) ก %i( | T X %) ,] ('ก m 13


Wm)ก_ ]W) % j ISO 9000 8. 9. 10. 11. 12. 13. 14.

ก - U X \( ) ก( ^]mW) i( | ก %ก ก ก +\( ก ] ) ก %Q OT) + Q OT) ] \( Q OT) ] ) h ก + \( ก ] ) ก %i( | ^ T %XQRS ^R %Wm)ก_ ] ก R} ก \กm^W \( ก R~) ก 14


Wm)ก_ ]W) % j ISO 9000 15. 16. 17. 18. 19. 20.

ก Q (OT) m ก Qก ก + ก กq \( ก X %) ก % rก

ก + ] % P ก ก) % ก ก ก( $ h

15


Wm)ก_ ] ISO 9001:2000 16


CD 4

CD 5 + ", " ก

CD 6 ก

ก ! ก

CD 8

ก " ก # $ ก

Input CD 7

ก ก +

QMS $ ก ก

+ 0# / ก

Output

17


2 A 1 7 7

8 ก " ก # $ ก 7 ก ก + / ก ก

ISO 9001:2000

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3 9 : !#$ 9

4 5 + ", 7 => 18


( ภภ8 R ภThe Quality Management Principles (8 QMPƒs) 1 2 3 4 5 6 7 8

Hภ! D IภD JID ภC K ภภภ$" ŕ¸

ภ" #& $"" ภ" ! ' ภ' ) # " K L ( CD M # K NHภ"JIDC K $% H ภ19


( ภภT : 1 ) ภT% X Q m ('ภm (Customer-Focus Organization) ( ภภ: Organizations depend on their customer and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. \ R} QWm P+ % m) ภW) ('ภm U QR~ % W) ) ภภ% m) ภW) ('ภm OT) % m) ภW) ('ภm ^RP m T U ) ภR Q% i( _ Q +W) + ภภm % r )P+P m('ภm 20


( ภภT : 2 %QRS i'm _ (Leadership) ( ภภ: Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizationƒs objectives. \ R} ภ_ ] TQ m ('ภm U QR~ % T m \( i( ภ] ภm P m ภ% X X % m X % \( QRS m \ + $ % T] Q % m X W) ]m , ภ€ ภ) % \( ภP m,)ภT m % % h 21


( ภภT : 3 ภ% X X %W) ภ(Involvement of People) ( ภภ: People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization benefit. \ R} W+ ] T TRl]ภU % % hW) ภ))ภ^R+ ภP m ภ% X X %P ภ\ภm^WRut %) % ,] _ r hr ภ^]mP-m % % h ' ]W) ( % ภ\(ภQR( T % 'm\( R ภ) X ) R Q% i( Q ภQR~ % X (]m 22


( ภภT : 4 ภ%) \ ภภ(Process Approach) ( ภภ: A desired result is achieved more efficiently when activities and related resources are managed as a process. \ R} ภ_ ]ภ+ภ% T+_ QRS X)ภ( QR~ % ) ภภ_ ]i'm T i ]-) \( + ]R X V P ) ภ,] Q m ภT+_ QRS X) % _ Q +W) \ X( ภภ,] %) QRS ภภT )]R ภ) X QRS 23


( ภภT : 5 ภ) X QRS (System Approach to Management) ( ภภ: Identifying, understanding and managing interrelated processes as a system contributes to the organizationƒs effectiveness and efficiency in achieving its objectives. \ R} QWm P+P % % $ X ภภX V P ) ภR Q% i(ภ]_ Q ภW) ภภ\ QRS ภ\ภm^WRut P m%) P ] ภภX) \( %) P ] ) ภ,] P m%) U ภ]_ Q 24


( ภภT : 6 ภR R ) X X)Q OT) (Continual Improvement) ( ภภ: Continual improvement of the organizationƒs overall performance should be a permanent objective of the organization. \ R} i'm m) \ ] %QRS i'm _ P ]m ภm % ภX)ภR R ) X X)Q OT) ) % $ ภ\( Q OT) %O) _ P-mP ภR R ) X X)Q OT) R R ) X X)Q OT) U ) ภm P m ภR R QRS QR~ % W) ภP ) ภP m X \( ภ)% X)ภR R ) X X)Q OT) 25


( ภภT : 7 ภ] P+ OU j Wm)Q ++ (Factual Approach to Decision Making) ( ภภ: Effective decisions are based on the analysis of data and information. \ R} i'm TP-mWm)%'( m) QWm hr Wm)%'(^]m % T m) ภm) Q Wm)%'(Q OT)P m^]m Q Th'ภm) \( Q-OT)hO)^]m ภภ] P+ m) ภ_ P ] ( T% ] % 'm \( )_ + ] P+Q ) P-m U Wm)Q ++ R ภ\( t- t P ภ] P+ \( ]_ Q ภQ OT)i(ภ]_ Q T] 26


( ภภT : 8 % % $ ภi'mW Q OT)R , - X %ภ(Mutually Beneficial Supplier Relationships) ( ภภ: An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create values. \ R} ภ_ ]\( ]Q(O)ภi'mW / 'X m T _ tV ^%X% ภm % % $ ,] + hr R , - U \( \ X Ru /\(ภQR( T %-_ t\( ภX %ภm Q O)WX % X %%O)ภ) X QRS 'R$ % ภm X Q % P mQ hr X W) ภR i( _ Q + X %ภ27


ก ] % _ Q +W) INPUT

PROCESS

OUTPUT

OUTCOME 0& 12 3 4?

Target ก ก ก ก 28


QR~ % W) P ISO 9000 $ # N# K {Efficiency}

$ # N#J {Effectiveness}

ภ" OUTPUT INPUT -- ' L ) \C $"" $ภ!] K (QA)

ภ" OUTCOME TARGET - ' L ) \C $"" " #& !] KC Hภ(QMS)

29


W U ) ภ+ ] _ ISO 9001:2000 PLAN PLAN DO DO

J )D J )D ! !]] K K )) ŕ¸

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$"" !]] K K $ภD ŕ¸

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Technical Technicalcheck check

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CHECK CHECK

Managerial Managerialcheck check

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ภ' $ # ภ' $ # ! !]] K K

ACT ACT

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( TQภT Wm) P , ภ#$ % ภ& ภ#' ภISO 9000 ภ# 1. i'm ] ' ( Top Management ) O) Q+m W) ภ+ภ2. \ €Š (QMR) 3. ภTR rภq , ภ( Consultant ) 4. _ + ] _ Q)ภ( Working Party ) 5. i'm +R Q% P (IQA) 6. i'm +R Q% )ภ+ ภX ) ( Certification Body : CB ) 7. ภภP ) ภT) 'XP ISO 9000 31


W) i'm ] ' ( Top Management )

_ %Wm) 5 \( + ] Wm) 6 (P ISO 9001:2000) ] % + (monitor) % O m , ภ\( \ภm^WRut R - % $ P m P ) ภ\( Qภ] % ภ_ 3S - School (P m % 'm) ; Standard (+ ] _ % j ) ; \( Sample ( _ QRS ) X T] )

32


W) \ €Š ( QMR ) Prepare Implement Promote

]_ Q ภP m% ภ+ ] _ QMS TQ % %ภ) ภ\( _ ^RR} i(ภR ภP-m QMS X) i'm ] ' \( Q )\ %+_ QRS T m) % ภR R X Q %P m ภV U ) ภ% % ภX) ภ_ P m ( hr % m) ภW) ('ภm

33


W) _ + ] _ Q)ภ( Working Party )

rภq Wm)ภ_ ] ISO 9001 rภq ภT+ _ Q)ภภX Q)ภ\( Q P mi'mQภT Wm) \ภm^W _ Q)ภ^RP-m ] %ภP-mQ OT)R R

34


W) i'm +R Q% P ( IQA)

ภ€ ภ) %\( ) P miX \ X W) WX i ]-) + ] _ ภ_ ]ภ+ + ] _ Audit Checklists ]_ Q ภ+R Q% ))ภP CAR ( Corrective Action Request ) \( Audit Report +R Q% [U_ Q OT)Rl]P CAR

35


ภP ) ภT% ISO 9000

'm\( ( , ) rภq \( QWm P+ (Q)ภP ) R} % Q)ภ\( ( h R ]m

Q )\ Rut \( Wm) ภX) Q OT)ภR R QRS i'm ภ+R Q% (Auditee) T] % + _ rภX) \( % _ t T) ภm) ) ) X) % m) ภW) ('ภm P m^]m

36


( ก P ISO 9000 TOP MGT

SUPPORT

OPERATION 37


Wm) QภT ภภ, ภISO 9000 (&

4

FIXITY

Procedures

Policy

MN&) ) - & ( & O* , "P &3O&

38


Q \ X %(m%Q ( P ก _ , ก ( V ) ก + ] _ ISO 9000 \(m ]ก( Q X .. 1 i'm ] ' ) 'XQ O)Rut U R 2 i'm ] ก( X X _ m % X Qก T ก 3 _ QW Q)ก ^%XQ % % 4 ก %ก ^%X^]m _ m T T\ m+ 5 i'm)OT QW Q)ก P m,] TQ+m W) ก ก ^%X 'm]m 4FGกH'%1'HC5D D4%7: 0 กIก # 6E$6JK5 C5K

39


Q \ X %(m%Q ( P ก _ , ก 6 i'm% m T + Q)ก ^%X + O)^%X )%( % 7 i'mR} ^%X )% _ % TQW P Q)ก 8 ^%X% ก +R Q% P 9 % ก +R Q% P \(m ^%Xก(m Rl] CAR 10 Q%OT)Qก ] %W ]\ m ก ^%X% P % Q T\ m+ \ XP-m $ T P m-() , ก ^RกX) (,] ^%X% ก_ ])

40


Briefly Explanation about Model's Requirement 41


ISO 9000 ก ก( X%QR~ %

ก i(

Wm) 1 - 8

Wm) 1 6, 8 42


ISO 9000 ก ก P-m

HOSPITALITY SERVICES COMMUNICATIONS HEALTH SERVICES MAINTENANCE TRADING PROFESSIONALS ADMINISTRATION SCIENTIFIC

43


Model's Approach for QA 44


ภ$ภ!] K (Quality Assurance) X rT W) ภT% X Q m P ]m ภ_ P mQภ] %% T P+ X Wm)ภ_ ]]m ^]m ภ) ) (part of quality management focused on providing confidence that quality requirements will be fulfilled) ภR ภO ) R} ภU %] T \i ) X QRS \(m _ % R ภP-mP Q) P m) ภQ-OT)% T X i( | O) ภQRS ^R %Wm) ภ( ]m T ^ m 45


ISO 9000:2000 tt X Quality Assurance: Part of quality management, focused on providing confidence that quality requirement will be fulfilled

46


Benefits of the Model 47


Hก

1. 2. 3. 4. 5.

Hก ก " #& ก &D" #ก $"" $ $ # N#J Hก $""ก " ! ก $CD I ) Hก $""ก " ! " mก !] K ) Hก ก " ! $K n $""ก &D ก#) $ # N#J # CmL Hก j)D "ก " $""ก j)D ' ( $) " % ก ( ก ) 48


6. 7.

"! ก ก g#" ' # $"" $ C " C' ) # CmL

\m ก K n ก / $ก $ ก $& )'D ! ก &D" #ก C Hก

49


)OT V

Iก D $JID D JID p#"' #

D C $JID ! JID )& $&! D

50


What is Next? 51


ISO 9001:200x NEW Version ( X ภ_ ( ] %ภQR( T \R( W) ISO9000 [rT Ru++ O)Q ) - T RY 2000 X + R ภP-mQ ) - T P %XQ%OT)^ ,] % Tภ_ ] O)R % ภV 5 RY m) % ภ\( R R P %X i ]-) ,] ภ%ภISO/TC 176 \( % \i P ) \ ภX + % ISO9000 Q ) - T P %XP ^ % T 3 W) RY 2007 ,] % ภ) W) ภR R O) m) P-m ( ภภ% i(ภm) V (Low impact) \( % R , - % ภ(High benefit)

52


Thank You 53


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