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8/20/2019 ASQ Meeting Slides Whittington
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 1
Requirements and Guidance
for
Internal AuditsLearning from
Industry Sources
Whittington & Associates, LLC636 Gun! "oad, #a$ietta, GA 3006%
'WhittingtonAssociates'co(
)00*+0+*%5)5 o$ %%0*55*%5)5
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 2
Audit References
REQUIREMENTS(No additional audit requirements in TL 9000:2001 or ISO 13485:2003)
-S. 001/2000 Qualit! #anage(ent S!ste(s Q#S * "eui$e(ents
AS100/200+ Qualit! S!ste(s * Ae$os4ace * "eui$e(ents
-S.S 16+/ 2002 Q#S * Auto(oti7e Su44lie$s * "eui$e(ents 8o$ the A44lication o8 -S. 001/2000
-S. 1+001/ 200+ 9n7i$on(ental #anage(ent S!ste(s 9#S * "eui$e(ents ith Guidance 8o$ :se
GUIDANCE (No additional audit uidan!e in "S910#:2003)
-S. 00+/2000 Qualit! #anage(ent S!ste(s * Guidelines 8o$ ;e$8o$(ance -(4$o7e(ent
-S.S 16+/2002 -(4le(entation Guide
-S. 1+00+/ 200+ 9#S * Gene$al Guidelines on ;$inci4les, S!ste(s, and Su44o$ting echniues
-S. 0003/200+ Guidelines 8o$ the A44lication o8 -S. 001/2000 to Co(4ute$ So8ta$e
-S. 1011/ 2002 Guidelines 8o$ Qualit! ando$ 9n7i$on(ental #anage(ent S!ste(s Auditing
Q91011S/ 200+ Guidelines 8o$ Q#S ando$ 9#S Auditing/ :S e$ ?andout Audit Wo$>sheet u$tle Diag$a( 8$o( Whittington & Associates
S4ea>e$ ?andout Audit Quic> "e8e$ence 8$o( Whittington & Associates, LLC
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 3
Audit Definition
S$stemati!% inde&endent% and do!umented &ro!ess 'or otainin audit eiden!e and
ealuatin it o*e!tiel$ to determine t+e
e,tent to -+i!+ areed !riteria are 'ul'illed.
-S. 000/2000 * Clause 3''1
@unda(entals and
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QAD 2006 © 2005 Whittington & Associates, LLC Slide +
Requirements - ISO !!"#$!!!
Clause )'2'2 Docu(ented 4$ocedu$e 8o$ inte$nal audits
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 5
Audit Guidance - ISO !!%#$!!!
Clause )'2'1'3/9stalish e88ecti7e and e88icient inte$nal audits
Assess st$engths and ea>nesses o8 the Q#S
:se as (anage(ent tool 8o$ inde4endent 7ie.tain oBecti7e e7idence that $eui$e(ents (et
udge e88ecti7eness and e88icienc! o8
o$ganiation
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 6
Audit Guidance - ISO !!%#$!!!
Clause )'2'1'3/9nsu$e i(4$o7e(ent actions a$e ta>en on $esults
9stalish 8leEile audit 4lans 8o$ inte$nal audits
;e$(it changes in e(4hasis ased on e7idenceDe7elo4 4lans ith in4ut 8$o( a$eas to e audited
Conside$ 4lanning in4ut 8$o( inte$ested 4a$ties
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QAD 2006 © 2005 Whittington & Associates, LLC Slide %
Audit Su&'ects - ISO !!%#$!!!
Clause )'2'1'3/988ecti7e and e88icient 4$ocess i(4le(entation.44o$tunities 8o$ continual i(4$o7e(ent
Ca4ailit! o8 4$ocesses988ecti7e and e88icient use o8 statistical techniues:se o8 in8o$(ation technolog!
Anal!sis o8 ualit! cost data988ecti7e and e88icient use o8 $esou$ces;$ocess and 4$oduct 4e$8o$(ance $esults
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QAD 2006 © 2005 Whittington & Associates, LLC Slide )
Audit Su&'ects - ISO !!%#$!!!
Clause )'2'1'3/;e$8o$(ance (easu$e(ents/
F Adeuac! F Accu$ac!
-(4$o7e(ent acti7ities"elationshi4s ith inte$ested 4a$ties
-nte$nal Audit "e4o$ting/Sha$e e7idence o8 eEcellent 4e$8o$(ance;$o7ide o44o$tunities 8o$ $ecognition#oti7ate 4eo4le
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QAD 2006 © 2005 Whittington & Associates, LLC Slide
Requirements - AS"!!(#$!!%
De7elo4 detailed audit tools and techniues, e'g',Chec>sheets, ;$ocess 8locha$ts, o$
Si(ila$ (ethodsto su44o$t audits o8 the Q#S $eui$e(ents'
#easu$e acce4tailit! o8 audit tools against/
988ecti7eness o8 inte$nal audit 4$ocess ;e$8o$(ance o8 o7e$all o$ganiation
Assess cont$act ando$ $egulato$! $eui$e(ents'
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 10
Requirements - ISO)TS "*%
+,$,$," Qualit Mana.ement Sstem Audit Audit the Q#S to 7e$i8! co(4liance ith -S.S 16+ and
an! additional ualit! (anage(ent s!ste( $eui$e(ents'
+,$,$,$ Manufacturin. /rocess Audit Audit the e88ecti7eness o8 each (anu8actu$ing 4$ocess'
+,$,$,0 /roduct Audit Audit 4$oducts at a44$o4$iate stages o8 4$oduction and
deli7e$! to 7e$i8! con8o$(ance to all s4eci8ied $eui$e(ents,
such as 4$oduct dimensions, 'un!tionalit$ , &a!/ain , and
laelin at a de8ined 8$euenc!'
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 11
Requirements - ISO)TS "*%
+,$,$,% Internal Audit /lans Co7e$ all ualit! (anage(ent $elated 4$ocesses,
acti7ities, and shi8ts Schedule acco$ding to an annual 4lan' -nc$ease audit 8$euenc! hen inte$nal o$ eEte$nal
noncon8o$(ities o$ custo(e$ co(4laints occu$
ote/ S4eci8ic chec>lists should e used 8o$ each audit
+,$,$,1 Internal Auditor Qualification :se inte$nal audito$s ho a$e uali8ied to audit the
$eui$e(ents o8 -S.S 16+
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 12
Guidance - ISO)TS "*%#$!!$
-S.S 16+ -(4le(entation Guide
Qualit! #anage(ent S$stem AuditH :se the 4$ocess a44$oach to (onito$ natu$al o$> 8lo
#anu8actu$ing ro!ess AuditH @ocus on a 4$ocess ithin ualit! (anage(ent s!ste(
rodu!t AuditH @ocus on the 4$oduct cha$acte$istics
H
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 13
Turtle Dia.ram - ISO)TS "*%
/ROCESS
"
9
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-
"
9
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9
S
"
9
Q
:
-
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9
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ResourcesWhoK
ResourcesWhatK
Met2ods?o DoneK
MeasuresWhat "esultsK
OUT/UTDeli7e$
hatK
IN/UT"ecei7e
WhatK
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 1+
Requirements - ISO "%!!"#$!!%
Clause +'5'5 is si(ila$ to -S. 001/2000, eEce4t/
ISO !!"#$!!!.$ganiation (ust conduct inte$nal audits'
ISO "%!!"#$!!%.$ganiation (ust ensu$e the! a$e conducted'
ISO !!"#$!!!Dete$(ine i8 S has een e88ecti7el! i(4le(ented'
ISO "%!!"#$!!%Dete$(ine i8 S has een 4$o4e$l! i(4le(ented'
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 15
Requirements - ISO "%!!"#$!!%
#issing di$ect co7e$age o8 these -S. 001/2000 $eui$e(ents/
ISO !!"#$!!! * #anage(ent $es4onsile 8o$ a$ea eing
audited (ust ensure a!tions are ta/en ithout undue dela!
to eli(inate detected noncon8o$(ities and thei$ causes'
ISO "%!!"#$!!% * ot included'
ISO !!"#$!!! * @ollo*u4 acti7ities (ust include eri'i!ation
o' a!tions ta/en and the re&ortin o' eri'i!ation results'
ISO "%!!"#$!!% * ot included'
Add$essed indi$ectl! ! -S. 1+001/200+, clause +'5'3, on
oncon8o$(it!, Co$$ecti7e Action, and ;$e7enti7e Action'
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 16
Audit Guidance - ISO "%!!"#$!!%
Guidance on :se 8$o( AnneE A'5'5 ;e$8o$( inte$nal audits ! 4e$sonnel 8$o( ithin
the o$ganiation o$ ! eEte$nal 4e$sons selected
! the o$ganiation, o$>ing on its ehal8 9nsu$e 4e$sons conducting audit a$e co(4etent
and in 4osition to do so i(4a$tiall! and oBecti7el!
De(onst$ate audito$ inde4endence in s(alle$o$ganiations ! the audito$ eing 8$ee 8$o(
$es4onsiilit! 8o$ the acti7it! eing audited
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 1%
Audit Guidance - ISO "%!!%#$!!%
;e$8o$( inte$nal audits to identi8! o44o$tunities 8o$i(4$o7e(ent in en7i$on(ental s!ste(
9stalish an audit 4$og$a( to di$ect the 4lanning
and conduct o8 audits and identi8! the auditsneeded to (eet the 4$og$a(s oBecti7es
ase 4$og$a( on the natu$e o8 o4e$ations, in te$(s
o8 its en7i$on(ental as4ects and 4otential i(4acts,
the $esults o8 4ast audits, and othe$ $ele7ant 8acto$s
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 1)
Audit Guidance - ISO "%!!%#$!!%
9ach inte$nal audit need not co7e$ enti$e s!ste(,so long as audit 4$og$a( ensu$es all o$ganiational
units and 8unctions, s!ste( ele(ents, and 8ull
sco4e o8 the 9#S a$e audited 4e$iodicall!
;lan and conduct audits ! oBecti7e and i(4a$tial
audito$s, aided ! technical eE4e$ts, as
a44$o4$iate, selected 8$o( ithin o$ganiation o$
8$o( eEte$nal sou$ces
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 1
Audit Guidance - ISO "%!!%#$!!%
Collecti7e co(4etence o8 audito$s should esu88icient to (eet oBecti7es and sco4e o8 the
4a$ticula$ audit and 4$o7ide con8idence as to the
deg$ee o8 $eliailit! that can e 4laced on $esults
"esults o8 an inte$nal 9#S audit can e 4$o7ided
in the 8o$( o8 a $e4o$t and used to/
F Co$$ect o$ 4$e7ent s4eci8ic noncon8o$(ities
F @ul8ill one o$ (o$e oBecti7es o8 the audit 4$og$a(
F ;$o7ide in4ut to the (anage(ent $e7ie
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 20
Audit Guidance - ISO !!!0#$!!%
When so8ta$e o$ganiations se4a$ate thei$ o$>into 4$oBects, inte$nal audit 4lanning should/
De8ine a selection o8 4$oBects
Co7e$ all stages and all 4$ocesses Assess co(4liance o8 4$oBect ualit! 4lan to
Q#S
Assess 4$oBect co(4liance to 4$oBect ualit! 4lan
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 21
Audit Guidance - ISO !!!0#$!!%
Audit 7a$ious 4$oBects at di88e$ent stages o84$oduct de7elo4(ent li8e c!cle, o$
Audit a single 4$oBect as it 4$og$esses
th$ough 7a$ious stages'
-8 intended 4$oBect changes its ti(escale,
$e7ie inte$nal audit schedule to/
1' Change ti(ing o8 the audit, o$
2' Conside$ a di88e$ent 4$oBect'
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 22
Audit Guidance - ISO "!""#$!!$
Guidelines 8o$ S and S AuditingH :nde$standing 4$inci4les o8 auditing
H -denti8!ing needed audito$ co(4etence
H Selecting audit tea(s
H Conducting inte$nal and eEte$nal audits
H#anaging audit 4$og$a(s
H 97aluating audito$ 4e$8o$(ance
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 23
Audit Acti3ities - ISO "!""#$!!$
1' Initiation De8ine audit oBecti7es'2' Re3ie4 9Ea(ine the docu(ents'
3' /re5aration;lan 8o$ onsite acti7ities'
+' E6ecution Audit the ualit! s!ste('
5' Re5ortin. "e4o$t the audit $esults'
6' Com5letion Co(4lete the audit 4lan'
. Follow-Up ondu!t 'ollo-6u& audit.
See ?andout/ IAudit Quic> "e8e$enceJ
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 2+
Audit Guidance - QE"!""S#$!!%
-S. 1011 4$o7ides guidance and eEa(4les:S decided additional guidance as needed
;ulished AS--S.ASQ Q91011S/200+
Q91011S includes -S. 1011 guidance
Q91011S adds guidance and eEa(4les 8o$/
F @i$st*4a$t! inte$nal audits F Second*4a$t! eEte$nal audits F S(all o$ganiations
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 25
Audit Guidance - QE"!""S#$!!%
*,1,7 Conductin. a Closin. Meetin.
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 26
ISO !!"#$!!! Inter5retations
Go to/ htt4/'tc1%6'o$ginte$4$e'as4Request# "@-*036 8o$ Clause )'2'2
Clause )'2'2/ IAn audit 4$og$a( shall e 4lanned, ta>ing into conside$ation the
status and i(4o$tance o8 the 4$ocesses and a$eas to e audited, '''J'
-s it a $eui$e(ent o8 this clause that the c$ite$ia to dete$(ine the status and thei(4o$tance o8 the 4$ocesses and a$eas to e audited ha7e to e docu(entedK
(ac:.round#he$e is di7e$gence ith the audito$ $ega$ding a $eui$e(ent 8o$ docu(entation
o8 Istatus and i(4o$tance c$ite$iaJ des4ite the 8act that e7idence as 4$o7idedthat the 4lanning o8 the audit 4$og$a( has ta>en the status and i(4o$tance o8
the 4$ocesses and a$eas to e audited into conside$ation'
Inter5retation# o'
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 2%
ISO !!"#$!!! Auditin. ;it
http://www.iso.org/tc17/IS!"##1$uditing%ractices&roup he need 8o$ a 2*stage a44$oach to auditing
#easu$ing Q#S e88ecti7eness and i(4$o7e(ents
-denti8ication o8 4$ocesses
:nde$standing the 4$ocess a44$oach Dete$(ination o8 the Ihe$e a44$o4$iateJ 4$ocesses
Auditing the Ihe$e a44$o4$iateJ $eui$e(ents
De(onst$ating con8o$(it! to the standa$d
Lin>ing audit o8 a tas>, acti7it! o$ 4$ocess to o7e$all s!ste(
Auditing continual i(4$o7e(ent
Auditing a Q#S hich has (ini(u( docu(entation
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 2)
ISO !!"#$!!! Auditin. ;it
?o to audit to4 (anage(ent 4$ocesses he $ole and 7alue o8 the audit chec>list
Sco4e o8 -S. 001, Q#S, and ce$ti8ication
?o to add 7alue du$ing the audit 4$ocess
Auditing co(4etence and e88ecti7eness o8 actions ta>en
Auditing statuto$! and $egulato$! $eui$e(ents
Auditing the ualit! 4olic! and ualit! oBecti7es
Auditing %'6 ontrol o' monitorin and measurin dei!es #a>ing e88ecti7e use o8 -S. 1011
Auditing custo(e$ 8eedac> 4$ocesses
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 2
ISO !!"#$!!! Auditin. ;it
Docu(enting a noncon8o$(it! Guidance 8o$ $e7ieing and closing noncon8o$(ities
Auditing inte$nal co((unications
Auditing 4$e7enti7e action
Auditing se$7ice o$ganiations
hi$d 4a$t! audito$ i(4a$tialit! and con8lict o8 inte$est
Auditing the e88ecti7eness o8 the inte$nal audit
Auditing elect$onic*ased (anage(ent s!ste(s Auditing the (anage(ent o8 $esou$ces
Auditing custo(e$ co((unications
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QAD 2006 © 2005 Whittington & Associates, LLC Slide 30
Remainin. Questions<
Audit Requirements< Audit Guidance<-S. 001/2000 -S. 00+/2000
AS100/200+ -S.S 16+ Guide
-S.S 16+/2002 -S. 1+00+/200+-S. 1+001/200+ -S. 0003/200+
=andouts< -S. 1011/2002
Audit Wo$>sheet Q91011S/200+
Audit Quic> "e8e$ence 'iso'o$g