Overview of Iso 9001 2008

7/23/2019 Overview of Iso 9001 2008

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OVERVIEW OF ISO9001:2008

7/23/2019 Overview of Iso 9001 2008


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What is ISO?

International Organization forStandardization

ISO -Greek word i!o!" #ean! e$%al"

Worldwide federation of national!tandard! &odie!

'ore t(an 1)0 *o%ntrie! re+re!ented ,on-goern#ental organization

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W(. ISO 9000/

'S %alit. 'anage#ent S.ate#3

'et(od of working t(at (el+! %! to a*(iee

o%r o&4e*tie! in an en4o.a&le5 e6*ient 7

ee*tie #anner at *on!i!tentl. and relia&l.

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ISO 9001

Initial objectives of ISO 9001:2008:

to improve the eistin! stan"ar"#

to provi"e !reater clarit$ an" ease of%se&

to improve compatibilit$ 'ith ISO

14001:2004

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ISO 9001 Scope

(his international stan"ar" speci)es re*%irementsfor a +%alit$ ,ana!ement S$stem 'here anOr!ani-ation

.a/ ee"s to "emonstrate its abilit$ to cosistentl$

provi"e pro"%ct that meets c%stomer an" applicablestat%tar$ an" re!%lator$ re*%irements& an"

.b/ ims to enhance c%stomer satisfaction thro%!h theeective application of the s$stem&incl%"in!

processes for contin%al improvement of the s$steman" the ass%rance of conformit$ to c%stomer an"applicable stat%tor$ an" re!%lator$ re*%irements

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ISO 9001 Sections

1 SO56

2 O7,(I6 766766

3 (67,S 6I(IOS 4 +;<I(= ,>6,6( S=S(6,

,>6,6( 76S5OSI@I<I(=

A 76SO;76 ,>6,6(

B 57O;( 76<IC(IO

8 ,6S;76,6( & <=SIS I,57O6,6(

A

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ISO 9001

40 +;<I(= ,>6,6( S=S(6, DD Section

41 >667< 76+;I76,6(S DD la%se 42 O;,6((IO 76+;I76,6(S DD la%se

421 >667< DD S%bDla%se

421 .a/ DD lphabetical Sro

B

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6cl%sion

Where an$ re*%irement.s/ of stan"ar"cannot be applie" "%e to the nat%re ofan or!ani-ation an" its pro"%cts & thiscan be consi"er" for ecl%sion

In o%r or!ani-ation

E B3 esi!n an" evelopment E

Is ecl%"e"

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oc%mente" 5roce"%re

1 423 ontrol of oc%ments

2 424 ontrol of 7ecor"s

3 822 Internal %"it4 83 ontrol of pro"%ct

82 orrective ction

A 83 5reventive ction

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7ecor"s

1 A ,ana!ement 7evie'

2 A22 ompetence&(rainin! F 'areness

3 B1 5lannin! for 5ro"%ct 7eali-ation

4 B22 7evie' of re*%irements relate" to the pro"%ct

B32 esi!n F evelopment inp%tsA B34 esi!n F evelopment revie'

B B3 esi!n F evelopment veri)cation

8 B3A esi!n F evelopment vali"ation

9 B3B ontrol of esi!n F evelopment chan!es

10 B41 5%rchasin! process

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7ecor"s

1 B2 ali"ation of process for pro"%ction F serviceprovision

2 B3 I"enti)cation F (racebilit$

3 B4 %stomer 5roper$4 BA ontrol of ,onitorin! F ,eas%rin! 6*%ipments

822 Internal %"it

A 824 ,onitorin! F ,eas%rin! of 5ro"%ct

B 83 ontrol of pro"%ct

8 82 orrective ction

9 83 5reventive ction

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+%alit$ ,ana!ement5rinciples

%stomer foc%s

<ea"ership

Involvement of people 5rocess approach

S$stem approach to mana!ement

ontin%al improvement

act%al approach to "ecision maGin!

,%t%all$ bene)cial s%pplier relationships

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Sr,o

arti*%lar! la%!e Referen*e

1 %stomer oc%s 11.b/& 1.a/& 2& 3& 41&2.c/& A1.b/& B21& 821

2 <ea"ership 0& A22."/& 3."/& 41& 2.c/&3

3 Involvement of 5eople A22."/& A4

4 5rocess pproach 41.a/& 421."/& 2.a/& B1& 823

S$stems pproach in,ana!ement

422. c/& 42& 3& A1& A1.a/&B1

A ontin%al Improvement 11.b/& 41& 1& 3& 41& A1&A2& A3.a/& A1.a/& 81. c/&

822& 8

B act%al pproach toecision ,aGin!

41.e/& 41& 82& 84

8 ,%t%all$ @ene)cialS% lier 7elationshi

41& B1& B21& B23& B4

%alit. 'anage#entrin*i+le!

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@asic process approach

MANAGEMENT

ACTIVITIES

RESO;RES

I,;<I,;< O;<;<O;<;< %!to#er%!to#er%!to#er%!to#er

5rocess is "e)ne" as an activit$ or !ro%p of activities&that taGes an inp%t& a""s val%e to it& an" provi"e an

o%tp%t to an internal or eternal c%stomer 5rocesses%se an or!ani-ationHs reso%rces to provi"e "e)nitiveres%lts

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5rocess ,o"el .ISO 9001:2008/

Customer

Measurement

Analysis and

Improvement

(8)

Resource

Management

( 6)

Requirements Input Output

Continual Improvement of the Quality Management System

Product

Realization (7)

Product

Customer

Satisfaction

Management

Responsibility

( 5 )

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1A

Deming’s wheel

(P.D.C.A.)

Deming’s wheel

(P.D.C.A.)

ISO9000

PLAN

4!"

DO

#

ACT

$.4$.!

C%EC&$.'$.$.

Continuous

Improvement

Continuous improvement ?

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1B

ro*e!! a++roa*( =ontin%al i#+roe#ent! of ro*e!!

PDCA C*+leP,-+esses in e,ms

O/ Ae V1l2e

DO ( # )

C-nin21l im3,-emens

-/ P,-+esses 51se -n

-56e+ie me1s2,emens

ACTION ( $.4$.! )

Me1s2,e ,es2ls -/ 3,-+essPe,/-,m1n+e 1n e//e+ieness

7 O56e+ie Me1s2,emens

C%EC& ( $.'$.$. )

8ne,s1nings

meeing ,e:2i,emens

PLAN ( 4!" )

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6.1 Provision of

resources

6.2 Human

resources

6.3 Infrastructures

Work

environment

" ;es-2,+e

M1n1gemen

4.1 General

requirements

4.2 Documentation

Requirements

7.1 Plannin

7.2 !ustomer

relate"#rocesses

7.3 Desin $

"evelo#ment

7.4 Purc%asin

Pro"uction $

service #rovision

&.1 'anaement

!ommitment

&.2 !ustomer focus

&.3 (ualit) #olic)

&.4 Plannin

&.& Res. *aut%orit) $

communication

&.6 'anaement

Revie+s

! M1n1gemen

;es3-nsi5ili*

$ Me1s2,emen

An1l*sis im3,-emen

S.!te# Re$%ire#ent! > Str%*t%re oft(e Standard

4 <21li*

M1n1gemenS*sem

# P,-2+

;e1li=1i-n

,.1 General

,.2 'onitorin $measurement

,.3 !ontrol of -!P

,.4 nal)sis of "ata

,.& Im#rovements

#." C-n,-l

-/ M-ni-,ing

Me1s2,ing E:2i3.

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Inherent @ene)ts of ISO 9000 It a""s to $o%r marGet !oo"'ill an" enhance acceptabilit$

of $o%r pro"%ctservices cts as a silent marGetin! tool to an %nGno'n c%stomer ,aGes the 'orGin! transparent 'hich lea"s to reco!ni-in!

opport%nit$ for improvement an" th%s to hi!herpro)tabilit$

ontin%o%s improvement in terms of pro"%ct*%alit$services& competitive e"!e an" timel$ "eliveriesstren!thens $o%r c%stomer base

lear "e)nition of 'orG enhances eJcienc$& sense ofachievement lea"in! to pleas%re amon! emplo$ees& 'hich

is a vital motivation factor for mana!in! b%sinesseectivel$

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Overview of Iso 9001 2008

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