27316640-Internal-Quality-Audit-for-ISO-9001-2008.ppt

7/25/2019 27316640-Internal-Quality-Audit-for-ISO-9001-2008.ppt

1/115

Internal Quality AuditInternal Quality Audit

FOR ISO 9001 : 2008FOR ISO 9001 : 2008

ISO 9001 : 2008ISO 9001 : 2008

No! 1"#1$! 2009No! 1"#1$! 2009

Prepared ByPrepared By::

Ashraf S. !ussef" Ph. #Ashraf S. !ussef" Ph. #..

QA $ Ind. %eth!ds %ana&erQA $ Ind. %eth!ds %ana&er

S.%. ASQ" '.A. BSI" %. ('I" %. (%SS.%. ASQ" '.A. BSI" %. ('I" %. (%S


2/115

%o&'() S*'&+*&')

Tutorial Sessions

Case Studies

Role Play

Games


3/115

,)-'./. O)+*/)(

To understand:Purpose, benefits and typical structure of aQuality Management System (QMS

Plan!"o!C#ec$ %ct (P"C% met#odology,and t#e process approac# to QualityManagement

T#e & principles of Quality Managementand #o' t#ey relate to t#e QMS and S)*++

Purpose, scope and uses of t#e S) *+++series standards

%uditing Process

Roles, responsibilities and competencere-uirements of auditors and lead auditors'it# reference to S) *+


4/115

.

13 4&'5o() -.6 (*'&+*&') o7o - S! 4%;o -.6 *


5/115

%o&'() -(()((@).*

Continual assessment/ou 'ill be informed of progress as 'e go

T#e e0am

10am Pass Criteria

2+3 pass mar$

)pen boo$

%s$ -uestions

t4s your tutors 5ob to ma$e problems go a'ay


6/115

S)((/o. 1

Purpose and structure of aQMS, P"C% and t#e &principles of -ualitymanagement


7/115

6#at is Quality7

Q is fitness for use8 Q is conformance to re-uirements8

Q is conformance to customer9user

re-uirements8

Meet9satisfy customer9user re-uirements,

needs, and e0pectations8

"egree to '#ic# a set of in#erent c#aracteristics fulfills re-uirements8

(S) *+++ : ++;


8/115


9/115


10/115


11/115


12/115


13/115


14/115


15/115


16/115


17/115


18/115


19/115

atc# ?, @ot ?, Code etc

Traceability:

Ability to trace the history, application or location ofthat which is under consideration

Status:

To identify t#e current status of product9 ra' material 'it# regardto inspection and test results8 Tag9 stic$er of A)@", R16)RB,

SCR%P dentified areas8


20/115

L?5)( o7 ;&6/*(

irst!party

Second!party

T#ird!party


21/115

L


22/115

Objectivity of Auditing

;DIL KININMS

;DIL%HILAHI; ;DILAIAN%A

;DIL %ON%,DSION

HA%OAN;LION

KOH ;DIL

%o.7o'@-.+) No.#%o.7o'@-.+)

-o' /.o'

I@5'o)@).*


23/115

;&6/* )*


24/115


25/115

ISO 9000:2008 K-@/=?

ISO 9000 ISO 9001

ISO 900"

ISOQIS 19011

O.=? ISO 9001 +-. ) &()6 7o'

+)'*/7/+-*/o. 5&'5o()(


26/115

L


27/115

%=-&()(QH)>&/')@).*(

Clause .8 Quality Management System

Clause ;8 Management Responsibility

Clause E8 Resource Management

Clause 28 Product Reali=ationClause &8 Measurement, %nalysis and

mpro


28/115

&-=/*? -.-)@).* 4'/.+/5=)(

Customer ocus

@eaders#ip

n


29/115

13 %&(*o@)' Ko+&(

)rgani=ations depend on t#eir customersF

t#erefore t#ey s#ould

Bno' t#eir current and future needs

Meet t#eir re-uirements

10ceed t#eir e0pectations

Get t#eir feedbac$

%DSLO

9AH

S;LISK

;%LION

%DSLO

9AH

S;LISK

;%LION

%DSLO

9AH

HA8DIH

A9ANLS

%DSLO

9AH

HA8DIH

A9ANLS


30/115

23 ,)-6)'(


31/115

E3 I.o=)@).* o7 4)o5=)

People are t#e essence of an

organi=ationF t#erefore

T#ey s#ould be fully in


32/115

).). Pr!*ess Appr!a*hPr!*ess Appr!a*h

-.-) -+*//*/)( -.6 ')=-*)6-.-) -+*//*/)( -.6 ')=-*)6

')(o&'+)( -( - 4HO%ASS')(o&'+)( -( - 4HO%ASS

OrderOrder ProductProduct

H)/)RH)/)R4&'+


33/115

TL&'*=)U ;55'o-+&)(* ;&6/* 4'o'-@ -.-)'

23 I6).*/7? ,)-6 ;&6/*o' 4'o'-@ -.-)'

E3 )7/.) ;&6/* S+o5) 4'o'-@ -.-)'

C ,)-6 ;&6/*o'

? 5

I@5o'*-.+) o7 4')5-'-*/o.


49/115

5 5

AB)'+/():I./*/-*/o.


50/115

6#o is responsible for sc#eduling t#eaudits7

6#en are internal audits sc#eduled7

Ao' often are audits performed7

6#o is responsible for selecting t#eauditors7

6#at criteria are important for selecting

auditors7

;..&-= ;&6/* 4=-.


51/115

Considerations

%ppro


52/115

6#y is t#e audit performed7

6#at is being audited7

6#ic# re-uirements7

SO,DLION:


53/115

Purpose:

To


54/115

SLA4S HAS4ONSII,IL\

"3 S)=)+* ;&6/* L)-@ ,)-6 ;&6/*o'

Z3 D.6)'(*-.6 O'3 ;&6/* L)-@

$3 H)/)R o+&@).*-*/o. ;&6/* L)-@

[3 4=-. *


55/115

Consider team member -ualifications Consider acti


56/115

/./*/-*/o. ')/)R6o+&@).*(

5=-.

-&6/*

)*

-55'o-=(

AB)'+/(): H)/)R o+&@).*-*/o.


57/115

or t#e Training acti


58/115

Quality manual

Procedures orms

)rgani=ation c#art

acility floor plan

Past audit performance

Customer feedbac$ Humber of employees

6or$ing #ours

4=-. ;&6/*


59/115

Confer 'it# audit team members

"on4t forget t#e appro


60/115

;&6/* 4=-.: )+)@)' 22#2E! 2001

4&'5o(): Lo )'/7? +o@5=/-.+) R/*< &-=/*? -.&-= -.6 ISO 9001:2000

;&6/* S+o5): L'-/./.

H)>&/')@).*(: ;( (5)+/7/)6 /.

# ISO 9001:2008

# &-=/*? -.&-=!

# VH 4'o+)6&')

O)'-== S+


61/115

SLA4S HAS4ONSII,IL\93 %o.6&+* O5)./. ))*/. ,)-6 ;&6/*o'

103 ))* R/*< -.-)@).* ;&6/* L)-@

113 I.*)'/)R C O()') ;&6/* L)-@

123 ;(()(( A/6).+) ;&6/* L)-@

I./*/-*/o.

4')5-'-*/o.

A-=&-*/o.


62/115

;. -&6/*o'F( @)@o'? /(

-( (


63/115

To collect ob5ecti


64/115

documented

based on inter


65/115

%


66/115

%


67/115

%


68/115

%


69/115

%


70/115

>e based on information ae modified '#en necessary

%llo' follo'!up

>e balanced to coe created by indi


71/115

Restrict auditor4s in-uiry

>e completely generic >e yes9no lists

Lo %')-*) - %


72/115


73/115


74/115

RECORDS ARE THE MOSTRELIABLE SOURCE OF

INFORMATION


75/115

Sample s#ould be representati


76/115

Tal$ to t#e rig#t people

T#ose responsible for t#e acti


77/115

nformal briefings

)pportunity to s#areinformation

"iscuss necessary

ad5ustments to plan "e


78/115

Conduct before start of field acti


79/115

Sign!in s#eet

"istribute detailed audit sc#edule

%ddress any auditee sc#eduling

concerns

Re


80/115

Re


81/115

%s$ing -uestions

)bser


82/115

%o.7/'@ *


83/115

,ooG 7o'&.6o+&@).*)6

-+*//*/)(

R


84/115

%o.7/'@ -.(R)'(

R


85/115

%uditee Reactions

Ta$e o


86/115

I.*)'/)R/.

ntroduce yourself


87/115

oduce you se

10plain '#y you are t#ere n


88/115

nter


89/115

T'o eyes

T'o ears

)ne mout#

Ratio of use:

O.) o7 (5)-G/.

*o 7o&' ')+)//.

I.*)'/)R/.


90/115

R


91/115


92/115

s it really'rong7

"oes #e $no' it is 'rong7 6#at is #is e0planation7

s it an isolated e


93/115

y

failure to meet a specifiedre-uirement:

Quality Manual Policies

Procedures

S) *++:+++ re-8

Go


94/115

90%or more o processes can !e

"mpro#ed

!y mod"y"n$ or$an"at"onal systems

&a mana$ement respons"!"l"ty'rather

than attempt"n$ to mod"y an

"nd"#"dual employee(s perormance)

3 A6R-'6( )@/.

Ho problems


95/115

Ho problems

don4t panic

Mo


96/115

%uditing role play

I.*)'.-= &-=/*? ;&6/* S*)5(


97/115

SLA4S HAS4ONSII,IL\

1E3 '/*) No.+o.7o'@/*/)( ;&6/* L)-@

1"3 %o.6&+* %=o(/. ))*/. ;&6/* L)-@1Z3 '/*) - S&@@-'? H)5o'* ,)-6 ;&6/*o'

I./*/-*/o.

4')5-'-*/o.

A-=&-*/o.

H)5o'*/.

o I


98/115

/1S

if you #a


99/115

Ma5or

System element is missing

System element is not implemented

System element is not effecti


100/115

No.+o.7o'@/*? S*-*)@).*

State t#e e


101/115

State t#e e


102/115

p g g

Correct )b5ecti


103/115

X ?Y

.o.+o.7o'@/*? o. *


104/115

Report t#e results to management %gree on follo'!up

1ntertain -uestions

;).6- o7 %=o(/. ))*/.

8 ntroduction I purpose of meeting

T#an$s for cooperation


105/115

8 T#an$s for cooperation

8 "istribute list of attendees

.8 Re


106/115

Sent promptly to Aeads of audited area

;&6/* H)5o'* %o.*).*

%udited area

@ead %uditor and members

%udit date

%udit scope

%udit criteria (list of $ey documents

Summary of findings

Good practices

Total number of nonconformities

"escriptions and discussion of nonconformities

Conclusion

I./*/-*/o.

I.*)'.-= &-=/*? ;&6/* S*)5(


107/115

SLA4S HAS4ONSII,IL\

1$3 L-G) %o'')+*/) ;+*/o.( ;&6/*))

1[3 )'/7? %o'')+*/) ;+*/o.( ;&6/* L)-@

4')5-'-*/o.

A-=&-*/o.

H)5o'*/.

K/B/.

Ko==oR#D5 K=oR+


108/115

;'))J;'))J

OP

.o* OP

N%! /((&) N%HN%! /((&) N%H 7o' %;! (/. /*7o' %;! (/. /*

4'o5o() %;

5=-.

4'o5o() %;

5=-.

I@5=)@).*

%;

I@5=)@).*

%;

)'/7? %;

C

%=o() N%H

)'/7? %;

C

%=o() N%H


109/115

S)((/o. "

%uditor4s S$ills I Responsibilities

;&6/*o'F( H)(5o.(//=/*/)(

Communicating


110/115

Planning and e0ecuting "ocumenting

Reporting

Oerifying Safeguarding

Cooperating

;&6/*o'F( &-=/7/+-*/o.(

1ducation


111/115

Training 10perience

Personal %ttributes

Management S$ills

;&6/*o' SG/==(

Communication s$ills


112/115

nterpersonal s$ills

%nalytic s$ills

;&6/*o' A*


113/115

business connections, interests, oraffiliations t#at mig#t influence my

5udgment or impair t#e e-uitable

c#aracter of my ser


114/115

%cts as a consultant


115/115

;

Date post:	28-Feb-2018
Category:	Documents
Upload:	jeff-ong-soon-huat
View:	213 times
Download:	0 times

27316640-Internal-Quality-Audit-for-ISO-9001-2008.ppt

Documents