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Internal Quality AuditInternal Quality Audit

FOR ISO 9001 : 2008FOR ISO 9001 : 2008

Prepared ByPrepared By::

Shamir PatniShamir Patni

ISO Management Sytem !"nultantISO Management Sytem !"nultant

ISO 9001 QMS #ead Audit"rISO 9001 QMS #ead Audit"r


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COURSE STRUCTURE

Tutorial Sessions

Case Studies

Role Play

Games


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LEARNING OBJECTIVES

To understand: Purose! "ene#its and tyi$al stru$ture o# a %uality

&ana'ement System (%&S)

Plan*+o*C,e$- A$t (P+CA) met,odolo'y! and t,e

ro$ess aroa$, to %uality &ana'ementT,e . rin$iles o# %uality &ana'ement and ,o/

t,ey relate to t,e %&S and ISO 0112

Purose! s$oe and uses o# t,e ISO 0111 seriesstandards

Auditin' Pro$ess Roles! resonsi"ilities and $ometen$e

re3uirements o# auditors and lead auditors /it,re#eren$e to ISO 20122


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4

1. Purpose and structure ofo a QMS, PDCAo and the 8 principles of quality manaement

!. "S#M $%%1 &'plored ( )nderstood!. "S#M $%%1 &'plored ( )nderstood*. "nternal Quality Audit Steps*. "nternal Quality Audit Steps

4. Auditor+s Sills ( -esponsiility4. Auditor+s Sills ( -esponsiility

AendaAenda


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COURSE ASSESS&ENT

Continual assessment4ou /ill "e in#ormed o# ro'ress as /e 'o

T,e e5am

E5am Pass Criteria 617 ass mar-

Oen "oo-

As- 3uestions It8s your tutors 9o" to ma-e ro"lems 'o a/ay


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SESSION 2

Purose and stru$ture o# a %&S!P+CA and t,e . rin$iles o# 3ualitymana'ement


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;AT IS %UALIT4userre3uirements=&eet>satis#y $ustomer>user re3uirements! needs!

and e5e$tations=

+e'ree to /,i$, a set o# in,erent

$,ara$teristi$s #ul#ills re3uirements= (ISO 0111 : ?11@)


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;AT IS AU+IT#? #9@&C/"3&S;M&AS)-&S?

#)/P)/S

"/> >#?Materials ;

&quipmentB

Support Processes,

Procedures ( MethodsB

Performance "ndicatorsB

Competence ; Sills ;

/raininB

EDA&PLE: &ANAGE&ENT


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EDA&PLE: &ANAGE&ENT!RESPONSIBILIT4

&ana'ement

resonsi"ility o"9e$tiesettin'

/it, /,at

&ana'ement Reie/#orumPreious year8s

results

inutsInternal audits

Customer satis#a$tiontrends

Pro$ess>Produ$tmeasures

aults>Comlaints data

measuresResults s lan

Customer sureys&ilestones

/it, /,o&ana'ement team%uality mana'erTeam leaders

oututsAnnual lan

Imroemento"9e$ties

,o/

Imlementation lanResour$e allo$ationRoles resonsi"ilities

Communi$ations

suortro$esses

IT systemsPur$,asin'

;R! Trainin'

S4STE& APPROAC; TO &ANAGE&ENT


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S4STE& APPROAC; TO &ANAGE&ENT

&ana'in' interrelated ro$esses as a system,els t,e or'aniation in a$,iein' itso"9e$ties in an e##e$tie and e##i$ientmanner

'' ! ti l I t!"ntinual Impr"(ement: P)!A ! lP)!A !y&le


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manaementmanaement

responsiilityresponsiility

manaementmanaement

responsiilityresponsiility

productproduct

reali=ationreali=ation

productproduct


resourceresource

manaementmanaement

resourceresource

manaementmanaementmeas., analysismeas., analysis

impro7ementimpro7ement

meas., analysismeas., analysis

impro7ementimpro7ement

PlanPlan

DoDo

ActAct

CheckCheck

'%'% !"ntinual Impr"(ement:!"ntinual Impr"(ement: P)!A !y&leP)!A !y&le

Continual "mpro7ement of the QMSContinual "mpro7ement of the QMSContinual "mpro7ement of the QMSContinual "mpro7ement of the QMS

ACTUAL APPROAC; TO +ECISION*


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ACTUAL APPROAC; TO +ECISION&AING

E##e$tie de$isions are "ased on t,e analysiso# data and in#ormation

info. flo


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.= &UTUALL4 BENEICIAL SUPPLIERRELATIONS;IP

Interrelated in*in

productproduct


productproduct

reali=ationreali=ationSupplierSupplier


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SESSION ?

ISO 0111 series e5lored andunderstood

STRUCTURE O ISO 0112:?11.


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STRUCTURE O ISO 0112:?11.

1=2 General 1=? Pro$ess Aroa$, 1= Relations,i /it, ISO 011 1= Comati"ility /it, ot,er standards 2 S$oe ?Normatie Re#eren$es Terms +e#initions = %uality &ana'ement system @= &ana'ement Resonsi"ility

= Resour$e &ana'ement 6= Produ$t Realiation .= &easurement! Analysis Imroement

: %UALIT4 &ANAGE&ENT S4STE&


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: %UALIT4 &ANAGE&ENT S4STE&

General re3uirements (=2)General re3uirements #or aroa$, $ontent o#

t,e %&S (e='= #or t,e adotion o# t,e ro$essaroa$,)

Outsour$in' +o$umentation re3uirements (=?)&andatory ro$edures

&anual! Poli$y O"9e$ties

General su##i$ien$y o# do$umentation and re$ords System #or +o$ument Control

System #or Control o# Re$ords

@: &ANAGE&ENT RESPONSIBILIT4


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@ G S O S

T,e areas /,ere dire$t To &ana'ementinolement is mandatory+emonstratin' $ommitment

+emonstratin' $ustomer #o$us

Inut into oli$y deeloment reie/ Identi#i$ation o# o"9e$ties and inut into t,e

lannin' ro$ess

+e#inin' resonsi"ilities! roidin' resour$es

Ensurin' internal $ommuni$ations are e##e$tie Inolement in mana'ement reie/

: RESOURCES


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;uman Resour$es Ensurin' ade3ua$y arti$ularly in rese$t o#

trainin'

In#rastru$ture

Buildin's! /or- sa$e! e3uiment! e,i$les!in#ormation systems et$

Enironmental $ontrols (Ali'ned /it,ISO2111)

;eat! li',t! ,umidity! temerature! $lean rooms In #a$t any $ontrols t,at are ali$a"le

6: PRO+UCT REALISATION


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T,in- o# t,is as Produ$tionM or Seri$e+elieryM Control o# t,e $ore day to day oerations

Oerational lannin' (6=2)

;andlin' $ontra$ts! en3uiries $ustomer$ommuni$ation systems (6=?)

+esi'n (6=)

&ana'ement o# sulies and suliers (6=)

Oerational $ontrols (6=@)

Cali"ration (6=)

E5$lusions may aly

.: &EASURE&ENT! ANAL4SIS


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I&PROVE&ENT

T,e $olle$tion and $onstru$tie use o# data&easurin' rodu$t ($on#ormity $,e$-s and inse$tion)

&easurin' ro$ess (e##i$ien$y measures)

Customer satis#a$tion (Surey! eed"a$-! Comlaint)

Internal audit

Control o# 3uarantine>isolation a$tiities Analysis o# data (you must do somet,in' /it, data)

Continual imroement (t,e standard en$oura'es t,eali$ation o# t,e ro$ess aroa$, to imroement)

Corre$tie a$tion (Corre$tion Corre$tie A$tion)

Preentie a$tion


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SESSION

Internal %uality Audit Stes

INTERNAL %UALIT4 AU+IT STEPS


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"nitiation

Preparation

&7aluation

-eportin

0i'in

INTERNAL %UALIT4 AU+IT STEPS


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"nitiation S/&PS -&SP#S"9""/1. -equest Audit Proram Manaer

!. "dentify ead Auditor Proram Manaer

*. Define Audit Scope Proram Manaer

( ead Auditor

S/&PS -&SP#S"9""/

1. -equest Audit Proram Manaer

!. "dentify ead Auditor Proram Manaer

*. Define Audit Scope Proram Manaer

( ead Auditor

I&PORTANCE O PREPARATION


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EDERCISE: INITIATION


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,o is resonsi"le #or s$,edulin' t,e audits< ,en are internal audits s$,eduled

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