-
8/17/2019 iso 9001 trg 15_12_15
1/19
ISO 9001: 2008
QUALITY MANAGEMENT
SYSTEM
Presentation
byiren!ra Sa"!e#
-
8/17/2019 iso 9001 trg 15_12_15
2/19
A$OUT ISO 9001
It’s a Quality Management System Standard
Initially published in 1987
First revision in 1994, Seond revision in !"""
IS# 9""1$!""8 is the latest version released in 14%ov !""8
Strong emphasis on %&sto'er Satis(a)tion and%ontin&a*
I'+ro#e'ent
-
8/17/2019 iso 9001 trg 15_12_15
3/19
INT,O-U%TION
Quality Fitness &or purpose '(ellene
Meeting )ustomer '(petations not *ust needs
Management +lanning, #rganiing, -ireting, )ontrolling,
Struturing
System .or/ ulture
Frame0or/
+oliies proedures
-
8/17/2019 iso 9001 trg 15_12_15
4/19
GENE,I% STAN-A,-
IS# 9""1 $!""8 is a .eneri) standard2
Generi) means that the same standards
an be applied$ to any or.ani/ation, large or small,
0hatever
its produt or servie, in any se)tor o& ativity,
and 0hether it is a business enterprise, a publi
administration, or a government department
-
8/17/2019 iso 9001 trg 15_12_15
5/19
P,O%ESS APP,OA%
3nderstanding and meeting reuirements 5he need to onsider
proesses in terms o& added value
#btaining results o& proess per&ormane
ande6etiveness
)ontinual improvement o& proesses based on
ob*etivemeasurement
+%
)5 -#
)'):
-
8/17/2019 iso 9001 trg 15_12_15
6/19
AT IS A P,O%ESS
Seuene o& interdependent andlin/ed +
-
8/17/2019 iso 9001 trg 15_12_15
7/19A !""! Syste( Servies 7
P,O%ESS APP,OA%MO-EL
)#%5I%3 IM+
-
8/17/2019 iso 9001 trg 15_12_15
8/19
%ontin&o&s #s %ontin&a* I'+ro#e'ent
omparision
)ontinuous Improvement
Initial evel o& +er&ormane
+oint o& Failure
)ontinual Improvement
+oint o& Failure
ast Improved evel
Improvement+hase
)onsolidation +hase
Initial evel o& +er&ormane
-
8/17/2019 iso 9001 trg 15_12_15
9/19
ISO 9001:2008 MAIN
%LAUSES
42 Quality Management System
C2 Management
-
8/17/2019 iso 9001 trg 15_12_15
10/19
3 QUALITY
MANAGEMENT SYSTEM341 Genera* ,e5&ire'ents
342 -o)&'entation re5&ire'ents34241 Genera*
,e5&ire'ents
34242 Q&a*ity Man&a*
34246 %ontro* o( -o)&'ents
34243 %ontro* o( ,e)or!s
vs
-
8/17/2019 iso 9001 trg 15_12_15
11/19
,ESPONSI$ILITY
741 Mana.e'ent %o''it'ent 'stablish poliy and ob*etives
>SM
-
8/17/2019 iso 9001 trg 15_12_15
12/19
,ESPONSI$ILITY
74< Mana.e'ent ,e#ie=74
-
8/17/2019 iso 9001 trg 15_12_15
13/19
< ,ESOU,%E MANAGEMENT
-
8/17/2019 iso 9001 trg 15_12_15
14/19
? P,O-U%T ,EALI@ATION
?41 P*annin. o( Pro!&)t ,ea*i/ation
?42 %&sto'er ,e*ate! +ro)esses?4241 -eter'ination o(
re5&ire'ents re*ate! to t"e
+ro!&)t
?4242 ,e#ie= o( re5&ire'ents re*ate! to t"e +ro!&)t
?4246 %&sto'er %o''&ni)ation
E)ontdE
-
8/17/2019 iso 9001 trg 15_12_15
15/19
? P,O-U%T ,EALI@ATION
?46 -esi.n ; -e#e*o+'ent?4641 -esi.n ; -e#e*o+'ent P*annin.
?4642 -esi.n ; -e#e*o+'ent In+&ts
?4646 -esi.n ; -e#e*o+'ent O&t+&ts
?4643 -esi.n ; -e#e*o+'ent ,e#ie=?4647 -esi.n ; -e#e*o+'ent
eri)ation
?464< -esi.n ; -e#e*o+'ent a*i!ation
?464? %ontro* o( -esi.n ; !e#e*o+'ent %"an.es
?43 P&r)"asin.?4341 P&r)"asin. +ro)ess @endor Seletion
evaluation
?4342 P&r)"asin. In(or'ation
?4346 eri)ation o( P&r)"ase! +ro!&)t
E)ontdE
-
8/17/2019 iso 9001 trg 15_12_15
16/19
? P,O-U%T ,EALI@ATION
?47 Pro!&)tion ; Ser#i)e Pro#ision?4741 %ontro* o(
Pro!&)tion ; Ser#i)e Pro#ision
?4742 a*i!ation o( Pro!&)tion ; Ser#i)e Pro#ision
?4746 I!enti)ation ; Tra)eabi*ity
?4743 %&sto'er Pro+erty
?4747 Preser#ation o( Pro!&)t
?4< %ontro* o( Monitorin. ;
Meas&rin. E5&i+'ent %a*ibration
E)ontd
8 MEASU,EMENT ANALYSIS
-
8/17/2019 iso 9001 trg 15_12_15
17/19
8 MEASU,EMENT ANALYSIS; IMP,OEMENT
841 Genera*842 Monitorin. ; Meas&re'ent84241 %&sto'er
Satis(a)tion
84242 Interna* A&!it
84246 Monitorin. ; Meas&re'ent o( Pro)esses
84243 Monitorin. ; Meas&re'ent o( Pro!&)t846 %ontro* o(
NonB)on(or'in. Pro!&)t
843 Ana*ysis o( -ata)ustomer Satis&ation
)on&ormity to produt reuirements
847 I'+ro#e'ent84741 %ontin&a* I'+ro#e'ent through poliy,
ob*etives,
audit results, analysis84742 %orre)ti#e A)tion
84746 Pre#enti#e A)tion
E
-
8/17/2019 iso 9001 trg 15_12_15
18/19
$ENEITS O ISO 9001:2008
)larity in denition o& authorities and
responsibilities'nhaned orporate image and mar/et positioningGetter
reords and doumentation in ase o& litigation3se o& reognied
mar/ >o& erti&ying ageny? on
stationary and advertisement
-
8/17/2019 iso 9001 trg 15_12_15
19/19
5%: B#3
