100% found this document useful (3 votes)
868 views54 pages

ISO 9001 Audit & Gap Analysis Checklist

The document is an ISO 9001:2008 audit checklist that can be used for internal or external auditing purposes. It contains questions related to each clause of the ISO 9001:2008 standard to evaluate conformance. The checklist includes spaces for auditors to note findings, evidence, and opportunities for improvement for each question. It also allows for exclusions from the product realization process to be identified.

Uploaded by

tauqeer25
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
100% found this document useful (3 votes)
868 views54 pages

ISO 9001 Audit & Gap Analysis Checklist

The document is an ISO 9001:2008 audit checklist that can be used for internal or external auditing purposes. It contains questions related to each clause of the ISO 9001:2008 standard to evaluate conformance. The checklist includes spaces for auditors to note findings, evidence, and opportunities for improvement for each question. It also allows for exclusions from the product realization process to be identified.

Uploaded by

tauqeer25
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 54

ISO 9001:2008 Audit & Gap Analysis Checklist

(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 1 "! +,
Audit -ate:
Audit -esc#ipti"n:
.ead Audit"#:
Audit Team /eme#s:
ISO 9001:2008 Auditable Clauses
(Tick th"se t" e e0aluated du#in% this audit&
1ach audit"# sh"uld c"mplete the secti"n "! the checklist they ha0e een
assi%ned y the 2uality /ana%e# (Inte#nal audits& "# .ead Audit"# (e$te#nal
audits& 3delete as app#"p#iate4' The audit"# may p#"0ide additi"nal n"tes
and 5uesti"ns #e%a#din% the audit t#ail !"# each element in the lank space
"n the checklist'
The 2uality /ana%e# "# .ead Audit"# 3delete as app#"p#iate4 is #esp"nsile
!"# #e0ie6in% c"mpleted secti"ns "! the checklist and t" "#%ani(e all
indi0idual secti"ns int" "ne se5uential checklist at the c"nclusi"n "! the
audit'
,'1 ,'2'1 ,'2'2 ,'2'7 ,'2',
+'1 +'2 +'7 +','1 +','2
+'+'1 +'+'2 +'+'7 +'8'1 +'8'2
+'8'7 8'1 8'2'1 8'2'2 8'7
8', 9'1 9'2'1 9'2'2 9'2'7
9'7'1 9'7'2 9'7'7 9'7', 9'7'+
9'7'8 9'7'9 9','1 9','2 9','7
9'+'1 9'+'2 9'+'7 9'+', 9'+'+
9'8 8'1 8'2'1 8'2'2 8'2'7
8'2', 8'7 8', 8'+'1 8'+'2
8'+'7
PRODUCT REALIZATION PROCESS EXCLUSIONS
ISO 9001:2008 Pe!issible E"#lusi$%s
(Tick th"se applicale: i! any&
9'1 9'2'1 9'2'2 9'2'7 9'7'1
9'7'2 9'7'7 9'7', 9'7'+ 9'7'8
9'7'9 9','1 9','2 9','7 9'+'1
9'+'2 9'+'7 9'+', 9'+'+ 9'8
.e%end
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 2 "! +,
A
; Opp"#tunity !"#
Imp#"0ement
<
; /in"# ="n>
c"n!"#mance
C ; /a?"# ="n>c"n!"#mance S2 ; Supplementa#y 2uesti"n
C"n!"#mance: Adhe#ence 6ith the #e5ui#ements "! the standa#d' =" ma?"# "# min"# n"n>c"n!"#mances !"und
Opp"#tunity !"# Imp#"0ement
(O@I&:
A situati"n "# c"nditi"n "! a mana%ement system that may e 6eak: cume#s"me: #edundant: "0e#ly c"mple$: "# in
s"me "the# manne#: may: in the "pini"n "! the audit"#: "Ae# an "pp"#tunity !"# an "#%ani(ati"n t" imp#"0e its cu##ent
status'
O@Is d" n"t #e5ui#e any acti"n "n the pa#t "! the "#%ani(ati"nB h"6e0e#: the "#%ani(ati"n sh"uld %i0e them se#i"us
c"nside#ati"n in 0ie6 "! the audit"#Cs kn"6led%e and e$p"su#e t" simila# systems'
An O@I may e an imp#"0ement t" the mana%ement system "# c"uld p#e0ent !utu#e p#"lems'
/in"# ="n>c"n!"#mance: A n"n>c"n!"#mity that: ased "n the ?ud%ment and e$pe#ience "! the audit"#: is n"t likely t" #esult in the !ailu#e "! the
mana%ement system "# #educe its aility t" assu#e c"nt#"lled p#"cesses "# p#"ducts'
It may e eithe#:
A !ailu#e in s"me pa#t "! the supplie#Ds mana%ement system #elati0e t" a speciEed #e5ui#ement'
A sin%le "se#0ed lapse in !"ll"6in% "ne item "! a c"mpanyDs mana%ement system'
/a?"# ="n>c"n!"#mance: The asence ("missi"n: n"t add#essed& "# t"tal #eakd"6n (c"mmissi"n: !ailu#e: n"t implemented& "! a system t" meet a
speciEed #e5ui#ement'
A nume# "! min"# n"n>c"n!"#mities a%ainst "ne #e5ui#ement can #ep#esent a t"tal #eakd"6n "! the system and thus
e c"nside#ed a ma?"# n"n>c"n!"#mity'
Any n"n>c"mpliance that 6"uld #esult in the p#"ale shipment "! a n"n>c"n!"#min% p#"duct' C"nditi"ns that may #esult
in the !ailu#e "! "# mate#ially #educe the usaility "! the p#"ducts "# se#0ices !"# thei# intended pu#p"se'
A n"n>c"mpliance that: in the ?ud%ment and e$pe#ience "! the audit"#: is likely t" eithe# t" #esult in the !ailu#e "! the
mana%ement system "# t" mate#ially #educe its aility t" assu#e c"nt#"lled p#"cesses and p#"ducts'
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 7 "! +,
&'1 (e%eal Re)uie!e%ts
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A < C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 ,'1
Gas the "#%ani(ati"n estalished: d"cumented: implemented
and maintained a 2/S and c"ntinually imp#"0ed its
eAecti0enessH
2 ,'1a
Gas the "#%ani(ati"n identiEed the p#"cesses needed !"# the
2/S and thei# applicati"n th#"u%h"ut the "#%ani(ati"nH
7 ,'1
Gas the "#%ani(ati"n dete#mined the se5uence and inte#acti"n
"! 2/S p#"cessesH
, ,'1c
Ihat a#e the c#ite#ia and meth"ds the "#%ani(ati"n uses t"
ensu#e that the "pe#ati"n and c"nt#"l "! 2/S p#"cesses a#e
eAecti0eH
+ ,'1d
Gas the "#%ani(ati"n p#"0ided #es"u#ces and in!"#mati"n
needed t" supp"#t the "pe#ati"n and m"nit"#in% "! 2/S
p#"cessesH
8 ,'1e
-"es the "#%ani(ati"n m"nit"#: measu#e and analy(e 2/S
p#"cessesH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e , "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A < C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
9 ,'1!
Gas the "#%ani(ati"n implemented acti"ns necessa#y t" achie0e
planned #esults and c"ntinual imp#"0ement "! p#"cesses
needed !"# the 2/SH
8 ,'1
A#e p#"cesses needed !"# the 2/S mana%ed y the
"#%ani(ati"n in acc"#dance 6ith the #e5ui#ements "! ISO
9001:2008H
9 ,'1
G"6 d"es the "#%ani(ati"n maintain c"nt#"l "0e# "uts"u#ced
p#"cessesH
10 ,'1
A#e the necessa#y c"nt#"ls !"# "uts"u#ced p#"cesses that aAect
p#"duct c"n!"#mity 6ith #e5ui#ements identiEed 6ithin the
2/SH
11 ,'1
-"es "#%ani(ati"n ha0e ade5uate c"nt#"l "0e# "uts"u#ced
p#"cesses t" ensu#e c"n!"#mity t" all cust"me# #e5ui#ementsH
&'2'1 (e%eal
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e + "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 ,'2'1a -"es the "#%ani(ati"n ha0e a d"cumented 5uality p"licyH
2 ,'2'1a
-"es the "#%ani(ati"n ha0e a set "! d"cumented 5uality
"?ecti0esH
7 ,'2'1 -"es the "#%ani(ati"n ha0e a 5uality manualH
, ,'2'1c
-"es the "#%ani(ati"n "pe#ate a set "! d"cumented
p#"cedu#esH
+ ,'2'1d
A#e ade5uate d"cuments in place t" ensu#e the eAecti0e
plannin%: "pe#ati"n and c"nt#"l "! "#%ani(ati"nCs p#"cessesH
8 ,'2'1d
-"es d"cumentati"n include the #ec"#ds #e5ui#ed y ISO
9001:2008H
&'2'2 *ualit0 1a%ual
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 8 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 ,'2'2a
Ihe#e in the 5uality manual is the sc"pe "! the 2/S identiEed:
includin% details "! and ?ustiEcati"n !"# e$clusi"nsH
2 ,'2'2
Ihe#e d"es the 5uality manual c"ntain "# #e!e#ence the
d"cumented p#"cedu#es estalished !"# the 2/SH
7 ,'2'2c
Ihe#e d"es the 5uality manual include a desc#ipti"n "! the
inte#acti"n et6een the p#"cesses "! the 2/SH
&'2'2 C$%t$l $3 D$#u!e%ts
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 ,'2'7
-"es the "#%ani(ati"n "pe#ate an estalish d"cument c"nt#"l
p#"cedu#eH (I! yes: p#"ceed 6ith 5uesti"ns 22 t" 28&
2 ,'2'7a
-"es the d"cument c"nt#"l p#"cedu#e deEne the c"nt#"ls
needed t" app#"0e d"cuments !"# ade5uacy p#i"# t" issueH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 9 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
7 ,'2'7
-"es the d"cument c"nt#"l p#"cedu#e deEne the c"nt#"ls
needed t" #e0ie6 and update as necessa#y and #e>app#"0e
d"cumentsH
, ,'2'7c
-"es the d"cument c"nt#"l p#"cedu#e deEne the c"nt#"ls
needed t" ensu#e that chan%es and the cu##ent #e0isi"n status
"! d"cuments a#e identiEedH
+ ,'2'7d
-"es the d"cument c"nt#"l p#"cedu#e deEne the c"nt#"ls
needed t" ensu#e that #ele0ant 0e#si"ns "! applicale
d"cuments a#e a0ailale at p"ints "! useH
8 ,'2'7e
-"es the d"cument c"nt#"l p#"cedu#e deEne the c"nt#"ls
needed t" ensu#e that d"cuments #emain le%ile and #eadily
identiEaleH
9 ,'2'7!
-"es the d"cument c"nt#"l p#"cedu#e deEne the c"nt#"ls
needed t" ensu#e that d"cuments "! e$te#nal "#i%in a#e
identiEed and thei# dist#iuti"n c"nt#"lledH
8 ,'2'7%
-"es the d"cument c"nt#"l p#"cedu#e deEne the c"nt#"ls
needed t" p#e0ent the unintended use "! "s"lete d"cuments:
and t" apply suitale identiEcati"n t" them i! they a#e #etained
!"# any pu#p"seH
&'2'& C$%t$l $3 Re#$ds
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 8 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 ,'2',
-" #ec"#ds e$ist that p#"0ide e0idence "! c"n!"#mity t"
#e5ui#ements and "! the eAecti0e "pe#ati"n "! the 2/SH
(Sh"uld e #e0ie6ed th#"u%h"ut the audit&
2 ,'2',
-"es the "#%ani(ati"n ha0e a d"cumented p#"cedu#e deEnin%
the c"nt#"ls needed !"# the identiEcati"n: st"#a%e: p#"tecti"n:
#et#ie0al: #etenti"n time and disp"siti"n "! #ec"#dsH
7 ,'2',
A#e #ec"#ds le%ile: #eadily identiEale and #et#ie0aleH (Sh"uld
e #e0ie6ed th#"u%h"ut the audit&
, ,'2',
Ga0e the #ec"#d #e5ui#ements een #e0ie6ed t" ensu#e
c"n!"#mance 6ith c"nt#actual and cust"me# #e5ui#ementsH
4 1a%a,e!e%t Res5$%sibilit0
4'1 1a%a,e!e%t C$!!it!e%t
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 9 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +'1a
-"es the "#%ani(ati"n c"mmunicate the imp"#tance "! meetin%
cust"me#: statut"#y and #e%ulat"#y #e5ui#ementsH
2 +'1 -"es the "#%ani(ati"n ha0e an estalished 5uality p"licyH
7 +'1c A#e the 5uality "?ecti0es estalished y t"p mana%ementH
, +'1d -"es t"p mana%ement c"nduct mana%ement #e0ie6sH
+ +'1e
-"es t"p mana%ement ensu#e the a0ailaility "! #es"u#ces t"
supp"#t and c"ntinually imp#"0e the 2/SH
4'2 Cust$!e +$#us
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 10 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +'2
-"es t"p mana%ement ensu#e that cust"me# #e5ui#ements a#e
dete#mined and metH
4'2 *ualit0 P$li#0
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +'7a Is the 5uality p"licy app#"p#iate t" the "#%ani(ati"nH
2 +'7
-"es the 5uality p"licy include a c"mmitment t" c"ntinually
imp#"0e the eAecti0eness "! the 2/SH
7 +'7c
-"es the 5uality p"licy p#"0ide a !#ame6"#k t" estalish and
#e0ie6 5uality "?ecti0esH
, +'7d
Is the 5uality p"licy c"mmunicated eAecti0ely th#"u%h"ut the
"#%anisati"nH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 11 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
+ +'7e Is the 5uality p"licy #e0ie6ed t" c"nE#m suitailityH
4'& Pla%%i%,
4'&'1 *ualit0 Ob6e#ti-es
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +','1
Gas t"p mana%ement estalished 5uality "?ecti0es at #ele0ant
!uncti"ns and le0els 6ithin the "#%ani(ati"nH
2 +','1 A#e the 5uality "?ecti0es measu#aleH
7 +','1 A#e the 5uality "?ecti0es c"nsistent 6ith 5uality p"licyH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 12 "! +,
4'&'2 *ualit0 1a%a,e!e%t S0ste! Pla%%i%,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +','2a
Is the plannin% "! the 2/S c"nsistent 6ith the "#%anisati"nCs
5uality "?ecti0es and %ene#al #e5ui#ements "! ISO 9001:2008
(Clause ,'1&H
2 +','2
-"es the "#%ani(ati"n ensu#e that the inte%#ity "! the 2/S is
maintained 6hen chan%es t" the 2/S a#e planned and
implementedH
4'4 Res5$%sibilit07 Aut8$it0 a%d C$!!u%i#ati$%
4'4'1 Res5$%sibilit0 a%d Aut8$it0
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +'+'1
Gas the "#%ani(ati"n deEned and c"mmunicated #esp"nsiility
and auth"#ityH (e'%' "#%ani(ati"nal cha#t&
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 17 "! +,
4'4'2 1a%a,e!e%t Re5ese%tati-e
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +'+'2 -"es the "#%ani(ati"n ha0e a /ana%ement Fep#esentati0eH
2 +'+'2a
-"es the /ana%ement Fep#esentati0e ha0e #esp"nsiility and
auth"#ity t" ensu#e that p#"cesses needed !"# the 2/S a#e
estalished: implemented and maintainedH
7 +'+'2
-"es the /ana%ement Fep#esentati0e ha0e #esp"nsiility and
auth"#ity t" #ep"#t t" t"p mana%ement "n the pe#!"#mance "!
the 2/S and any need !"# imp#"0ementH
, +'+'2c
-"es the /ana%ement Fep#esentati0e ha0e #esp"nsiility and
auth"#ity t" ensu#e the p#"m"ti"n "! a6a#eness "! cust"me#
#e5ui#ements th#"u%h"ut the "#%ani(ati"nH
4'4'2 I%te%al C$!!u%i#ati$%
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 1, "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +'+'7
Is in!"#mati"n #e%a#din% the eAecti0eness "! the 2/S
c"mmunicated 6ithin the "#%ani(ati"nH
2 S2 I! yes: h"6 is the eAecti0eness "! the 2/S c"mmunicatedH
4'9 1a%a,e!e%t Re-ie:
4'9'1 (e%eal
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +'8'1 -"es t"p mana%ement unde#take mana%ement #e0ie6H
2 +'8'1
A#e the #ec"#ds "! mana%ement #e0ie6s maintained in
acc"#dance 6ith Clause ,'2',H
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 1+ "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
7 S2 Ihat is the !#e5uency "! mana%ement #e0ie6sH
, S2 Ihat s"#t "! in!"#mati"n is #e0ie6ed in mana%ement #e0ie6sH
+ S2
*lease sh"6 me 6hat #ec"#ds a#e a0ailale !#"m the m"st
#ecent mana%ement #e0ie6H
4'9'2 Re-ie: I%5ut
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +'8'2a -"es the #e0ie6 p#"cess c"nside# the #esults "! auditsH
2 +'8'2 -"es the #e0ie6 p#"cess c"nside# cust"me# !eedackH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 18 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
7 +'8'2c
-"es the #e0ie6 p#"cess c"nside# p#"cess pe#!"#mance and
p#"duct c"n!"#mityH
, +'8'2d
-"es the #e0ie6 p#"cess c"nside# the status "! the c"##ecti0e
and p#e0enti0e acti"nsH
+ +'8'2e
-"es the #e0ie6 p#"cess !"ll"6 up acti"ns !#"m p#e0i"us
mana%ement #e0ie6sH
8 +'8'2!
-"es the #e0ie6 p#"cess c"nside# chan%es that c"uld aAect the
2/SH
9 +'8'2%
-"es the #e0ie6 p#"cess make #ec"mmendati"ns !"#
imp#"0ementH
4'9'2 Re-ie: Out5ut
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 +'8'7a
-" the "utputs "! the #e0ie6 p#"cess include decisi"ns and
acti"ns c"nce#nin% the imp#"0ement "! the eAecti0eness "! the
2/S and its p#"cessesH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 19 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
2 +'8'7
-" the "utputs "! the #e0ie6 p#"cess include decisi"ns and
acti"ns c"nce#nin% the imp#"0ement "! p#"duct #elated
cust"me# #e5ui#ementsH
7 +'8'7c
-" the "utputs "! the #e0ie6 p#"cess include decisi"ns and
acti"ns c"nce#nin% the #es"u#ce #e5ui#ementsH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 18 "! +,
9 Res$u#e 1a%a,e!e%t
9'1 P$-isi$% $3 Res$u#es
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'1'1a
Gas the "#%ani(ati"n p#"0ided the necessa#y #es"u#ces t"
implement and maintain the 2/S and c"ntinually imp#"0e its
eAecti0enessH
2 8'1'1
Gas the "#%ani(ati"n p#"0ided the necessa#y #es"u#ces t"
ensu#e that cust"me# #e5ui#ements a#e metH
9'2 ;u!a% Res$u#es
9'2'1 (e%eal
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'2'1
-"es the "#%ani(ati"n ensu#e that pe#s"nnel ha0e the
necessa#y c"mpetence t" ensu#e p#"duct c"n!"#mityH
9'2'2 C$!5ete%#e7 Tai%i%, < A:ae%ess
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 19 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'2'2a
-"es the "#%ani(ati"n dete#mine the necessa#y educati"n:
t#ainin%: skills and e$pe#ience !"# pe"ple pe#!"#min% 6"#k
aAectin% p#"duct 5ualityH
2 8'2'2
-"es the "#%ani(ati"n initiate t#ainin% "# "the# acti"ns t"
achie0e the necessa#y le0el "! c"mpetenceH
7 8'2'2c
-"es the "#%ani(ati"n e0aluate the eAecti0eness "! t#ainin% "#
"the# acti"ns takenH
, 8'2'2d
-"es the "#%ani(ati"n ensu#e that pe#s"nnel a#e a6a#e "! the
#ele0ance and imp"#tance "! thei# acti0itiesH
+ 8'2'2d
-"es the "#%ani(ati"n ensu#e that pe#s"nnel a#e a6a#e "! h"6
they c"nt#iute t" the achie0ement "! the 5uality "?ecti0esH
9 8'2'2e
-"es the "#%ani(ati"n maintain t#ainin% #ec"#ds in acc"#dance
6ith Clause ,'2',H
9'2 I%3astu#tue
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 20 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'7
Gas the "#%ani(ati"n identiEed any sh"#tc"min%s in its
in!#ast#uctu#e and is it takin% app#"p#iate acti"nH
2 8'7a
A#e the uildin%s: 6"#kspace and utilities app#"p#iate !"# the
"#%ani(ati"n p#"duct "# se#0iceH
7 8'7
Is p#"cess e5uipment (includin% c"mpute# s"!t6a#e&
app#"p#iate !"# the "#%ani(ati"nCs p#"duct "# se#0iceH
, 8'7c
A#e supp"#t se#0ices (e'%' t#ansp"#t: c"mmunicati"ns: and
6aste disp"sal& app#"p#iate !"# the "#%ani(ati"nCs p#"duct "#
se#0iceH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 21 "! +,
9'& =$> E%-i$%!e%t
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8',
Is the 6"#k en0i#"nment app#"p#iate !"# achie0in% p#"duct "#
se#0ice #e5ui#ementsH
2 8', Is sa!ety and p#"tecti0e e5uipment p#"0ided 6he#e necessa#yH
7 8', A#e 6"#kstati"ns set "ut e#%"n"micallyH
, 8', A#e kitchen and t"ilet !acilities ade5uateH
+ 8', A#e heat: humidity: li%ht le0els and ai#J"6 c"nt#"llaleH
8 8',
A#e !act"#s aAectin% hy%iene: cleanliness: n"ise: 0i#ati"n and
p"lluti"n c"nt#"llaleH
9 8',
Gas the "#%ani(ati"n identiEed any sh"#tc"min%s and is it
takin% app#"p#iate acti"nH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 22 "! +,
? P$du#t Reali@ati$%
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#eAC$!!e%t
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9
Gas the "#%ani(ati"n e$cluded itsel! !#"m the #e5ui#ements "!
the *#"duct Feali(ati"n p#"cessH
2 9
Gas the "#%ani(ati"n ?ustiEed any pe#missile e$clusi"n in the
#ele0ant secti"n "! the 5uality manualH
?'1 Pla%%i%, < P$du#t Reali@ati$%
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#eAC$!!e%t
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'1 Ga0e the p#"cesses needed !"# p#"duct #eali(ati"n identiEedH
2 9'1
Is the plannin% "! p#"duct #eali(ati"n c"nsistent 6ith the
#e5ui#ements "! the "the# p#"cesses "! the 2/SH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 27 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#eAC$!!e%t
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
7 9'1a
Gas the "#%anisati"n dete#mined 5uality "?ecti0es !"# its
p#"ductsH
, 9'1
Gas the "#%anisati"n identiEed p#"cesses: d"cuments and
#es"u#ces #e5ui#ed y speciEc p#"ductsH
+ 9'1c
Gas the "#%anisati"n identiEed meth"ds !"# 0e#iEcati"n:
0alidati"n: m"nit"#in% and inspecti"n and test acti0ities t" meet
acceptance c#ite#iaH
8 9'1d
Gas the "#%anisati"n dete#mined 6hat #ec"#ds a#e needed t"
p#"0ide e0idence that #e5ui#ements !"# speciEc p#"ducts ha0e
een metH
9 9'1e
Is the#e an identiEale "utput !#"m the plannin% p#"cess: in an
app#"p#iate !"#mat in acc"#dance 6ith ,'2',H
?'2 Cust$!eBelated P$#esses
?'2'1 Dete!i%ati$% $3 Re)uie!e%ts Related t$ t8e P$du#t
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 2, "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9''2
Gas the "#%anisati"n dete#mined p#"duct #e5ui#ements p#i"# t"
c"mmitment t" supplyH
2 9'2'1a
Cust"me#Cs speciEed #e5ui#ements: deli0e#y: 6a##anty and
se#0iceH
7 9'2'1 Fe5ui#ements necessa#y !"# the p#"ductCs intended useH
, 9'2'1c Statut"#y and #e%ulat"#y #e5ui#ementsH
+ 9'2'1d Any additi"nal #e5ui#ements dete#mined y the "#%anisati"nH
?'2'2 Re-ie: $3 Re)uie!e%ts Related t$ t8e P$du#t
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 2+ "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'2'2
-"es the "#%ani(ati"n unde#take a #e0ie6 t" ensu#e that the
"#%ani(ati"n has the aility t" meet #e5ui#ements e!"#e
c"mmittin% t" supply p#"ductH
2 9'2'2a
-"es the "#%ani(ati"n ensu#e that p#"duct #e5ui#ements a#e
deEned and #e0ie6ed e!"#e c"mmittin% t" supply p#"ductH
7 9'2'2
-"es the "#%ani(ati"n ensu#e that c"nt#act "# "#de#
#e5ui#ements diAe#in% !#"m th"se p#e0i"usly e$p#essed a#e
#es"l0ed e!"#e c"mmittin% t" supply p#"ductH
, 9'2'2c
-"es the "#%ani(ati"n ensu#e that it has the aility t" meet the
deEned #e5ui#ementsH
+ S2
Can y"u sh"6 me #ec"#ds "! the p#"duct #e5ui#ement #e0ie6
#esults and acti"ns #esultin% !#"m themH
8 S2
Ihen cust"me#s d"nCt ha0e d"cumented #e5ui#ements: h"6 d"
y"u c"nE#m thei# #e5ui#ements e!"#e acceptin% "#de#sH
9 S2
Ihen p#"duct #e5ui#ements a#e chan%ed: h"6 d" y"u ensu#e
that #ele0ant d"cuments a#e chan%ed and that #ele0ant
pe#s"nnel a#e made a6a#e "! the chan%esH
?'2'2 Cust$!e Satis3a#ti$%
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 28 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'2'7a
Gas the "#%ani(ati"n implemented eAecti0e a##an%ements !"#
c"mmunicatin% p#"duct in!"#mati"nH
2 9'2'7
Gas the "#%ani(ati"n implemented eAecti0e a##an%ements !"#
c"mmunicatin% en5ui#iesH
7 9'2'7
Gas the "#%ani(ati"n implemented eAecti0e a##an%ements !"#
c"mmunicatin% c"nt#acts "# "#de# handlin% includin%
amendmentsH
, 9'2'7c
Gas the "#%ani(ati"n implemented eAecti0e a##an%ements !"#
c"mmunicatin% cust"me# !eedackH
+ 9'2'7c
Gas the "#%ani(ati"n implemented eAecti0e a##an%ements !"#
c"mmunicatin% cust"me# c"mplaintsH
?'2 Desi,% < De-el$5!e%t
?'2'1 Desi,% < De-el$5!e%t Pla%%i%,
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 29 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'7'1a
Ga0e sta%es "! desi%n and de0el"pment een dete#mined !"#
the p#"ductH
2 9'7'1
A#e #e5ui#ements !"# #e0ie6: 0e#iEcati"n and 0alidati"n deEned
!"# each sta%eH
7 9'7'1
Is 0alidati"n c"mpleted p#i"# t" deli0e#y "# use: 6he#e
p#acticalH
, 9'7'1c A#e #esp"nsiilities !"# desi%n and de0el"pment deEnedH
+ 9'7'1
Is the#e eAecti0e c"mmunicati"n et6een diAe#ent meme#s "#
%#"ups in the desi%n teamH
8 9'7'1
Is plannin% "utput updated as app#"p#iate as the desi%n and
de0el"pment p#"%#essesH
?'2'2 Desi,% < De-el$5!e%t I%5uts
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 28 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'7'2
A#e #ec"#ds "! desi%n inputs maintained in acc"#dance 6ith
Clause ,'2',H
2 9'7'2a A#e #e5ui#ements deEned !"# !uncti"n and pe#!"#manceH
7 9'7'2 A#e applicale statut"#y and #e%ulat"#y #e5ui#ements deEnedH
, 9'7'2c Is in!"#mati"n t" e used !#"m p#e0i"us desi%ns deEnedH
+ 9'7'2d
A#e "the# #e5ui#ements essential !"# desi%n and de0el"pment
ade5uately deEnedH
8 9'7'2
A#e desi%n inputs #e0ie6ed !"# ade5uacy t" c"nE#m that they
a#e c"mplete: unami%u"us and n"t in c"nJictH
?'2'2 Desi,% < De-el$5!e%t Out5uts
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 29 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'7'7a
-" the "utputs meet input #e5ui#ements !"# desi%n and
de0el"pmentH
2 9'7'7
-" the "utputs p#"0ide in!"#mati"n #e5ui#ed !"# pu#chasin%:
p#"ducti"n and se#0ice p#"0isi"nH
7 9'7'7c
-" the "utputs c"ntain "# #e!e#ence p#"duct acceptance
c#ite#iaH
, 9'7'7d
-" "utputs speci!y cha#acte#istics !"# the p#"ductCs sa!e and
p#"pe# useH
?'2'& Desi,% < De-el$5!e%t Re-ie:
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 70 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'7',
Ga0e desi%n and de0el"pment #e0ie6s taken place (in0"l0in%
#ep#esentati0es "! all #ele0ant !uncti"ns& in acc"#dance 6ith the
desi%n and de0el"pment planH
2 9'7',
-" pa#ticipants in desi%n #e0ie6s include #ep#esentati0es "!
!uncti"ns c"nce#ned 6ith the desi%n de0el"pment sta%e ein%
#e0ie6edH
7 9'7',
A#e #ec"#ds "! #e0ie6s a0ailale in acc"#dance 6ith Clause
,'2',H
, 9'7',a
Can the "#%ani(ati"n c"nE#m that the #esults "! desi%n and
de0el"pment ha0e een e0aluatedH
+ 9'7', Ie#e p#"lems identiEed and 6e#e acti"ns taken !"# #es"luti"nH
?'2'4 Desi,% < De-el$5!e%t CeiD#ati$%
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 71 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'7'+
Gas 0e#iEcati"n een c"mpleted in acc"#dance 6ith the desi%n
and de0el"pment plan t" c"nE#m that desi%n and de0el"pment
"utputs meet #e5ui#ements "! inputsH
2 9'7'+
A#e #ec"#ds maintained "! the #esults "! 0e#iEcati"n and any
necessa#y acti"ns in acc"#dance 6ith Clause ,'2',H
?'2'9 Desi,% < De-el$5!e%t Calidati$%
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'7'8
Gas 0alidati"n een c"mpleted in acc"#dance 6ith the desi%n
and de0el"pment plan t" c"nE#m that the p#"duct is suitale
!"# its speciEed applicati"n "# intended useH
2 9'7'8
A#e #ec"#ds maintained "! the #esults "! 0alidati"n and any
necessa#y acti"ns in acc"#dance 6ith Clause ,'2',H
?'2'? C$%t$l $3 Desi,% < De-el$5!e%t C8a%,es
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 72 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'7'9
Ga0e chan%es een #e0ie6ed t" e0aluate thei# eAect "n
c"nstituent pa#ts and "n p#"duct al#eady deli0e#edH
2 9'7'9 Ga0e chan%es een app#"0ed p#i"# t" implementati"nH
7 9'7'9 Ga0e chan%es een app#"p#iately 0e#iEed and 0alidatedH
, 9'7'9
A#e #ec"#ds maintained "! the #esults "! chan%e #e0ie6s and
any necessa#y acti"ns in acc"#dance 6ith Clause ,'2',H
?'& Pu#8asi%,
?'&'1 Pu#8asi%, P$#ess
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 77 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9','1
A#e 0e#iEcati"n #e5ui#ements app#"p#iate !"# the p#"ductCs
applicati"nH
2 9','1
A#e supplie#s e0aluated and selected (in acc"#dance 6ith
estalished c#ite#ia& "n the asis "! thei# aility t" meet
speciEed #e5ui#ementsH
7 9','1
A#e supplie#s pe#i"dically #e>e0aluated in acc"#dance 6ith
estalished c#ite#iaH
, 9','1
A#e #ec"#ds maintained "! the #esults "! supplie# e0aluati"ns in
acc"#dance 6ith Clause ,'2',H
?'&'2 Pu#8asi%, I%3$!ati$%
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 7, "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9','2
-"es pu#chasin% in!"#mati"n ade5uately desc#ie the p#"duct
t" e pu#chasedH
2 9','2a
-"es pu#chasin% in!"#mati"n ade5uately desc#ie the
#e5ui#ements !"# app#"0al "! p#"duct: p#"cedu#es and
e5uipmentH
7 9','2
-"es pu#chasin% in!"#mati"n ade5uately desc#ie the
#e5ui#ements !"# 5ualiEcati"n "! pe#s"nnelH
, 9','2c
-"es pu#chasin% in!"#mati"n ade5uately desc#ie 5uality
mana%ement system #e5ui#ementsH
+ 9','2
-"es the "#%anisati"n ensu#e that pu#chasin% in!"#mati"n is
ade5uate p#i"# t" issue t" the supplie#H
?'&'2 CeiD#ati$% $3 Pu#8ased P$du#t
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 7+ "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9','7
Is pu#chased p#"duct 0e#iEed in acc"#dance 6ith speciEed
#e5ui#ementsH
2 9','7
-"es pu#chasin% in!"#mati"n c"ntain details "! any 0e#iEcati"n
t" e pe#!"#med at the supplie#Cs p#emisesH
?'4 P$du#t < Se-i#e P$-isi$%
?'4'1 C$%t$l $3 P$du#ti$% < Se-i#e P$-isi$%
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'+'1a
Is #e5ui#ed in!"#mati"n a0ailale t" desc#ie p#"duct
cha#acte#isticsH
2 9'+'1 A#e necessa#y 6"#k inst#ucti"ns a0ailaleH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 78 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
7 9'+'1c Is suitale e5uipment a0ailaleH
, 9'+'1d A#e #e5ui#ed m"nit"#in% and measu#in% de0ices a0ailaleH
+ 9'+'1e
A#e #e5ui#ed m"nit"#in% and measu#in% de0ices used in
acc"#dance 6ith 6"#k inst#ucti"ns andK"# the 5uality planH
8 9'+'1!
A#e #e5ui#ements !"# #elease: deli0e#y and p"st deli0e#y
acti0ities implementedH
?'4'2 Calidati$% P$#esses 3$ P$du#ti$% < Se-i#e P$-isi$%
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 79 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'+'2a
Is p#"ducti"n "# p#"0isi"n "! se#0ice 6hich cann"t e 0e#iEed y
suse5uent m"nit"#in% "# measu#in% ade5uately 0alidated t"
dem"nst#ate that planned #esults a#e ein% achie0edH
2 9'+'2 A#e c#ite#ia deEned !"# #e0ie6 and app#"0al "! the p#"cessesH
7 9'+'2c A#e pe#s"nnel 5ualiEed and is e5uipment app#"0edH
, 9'+'2d
A#e #e5ui#ed #ec"#ds maintained in acc"#dance 6ith Clause
,'2',H
+ 9'+'2e Is the time inte#0al !"# p#"cess #e>0alidati"n deEnedH
8 9'+'2!
-"es 0alidati"n dem"nst#ate the aility "! the p#"cess t"
achie0e planned #esultsH
?'4'2 Ide%tiD#ati$% < Ta#eabilit0
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 78 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'+'7
Is p#"duct identiEcati"n and t#aceaility #e5ui#ed t" e
maintained th#"u%h"ut p#"ducti"n (!"# any p#"ducts&H
2 9'+'7
Is inspecti"n and test status ade5uately deEned maintained
th#"u%h"ut p#"ducti"nH
7 9'+'7
I! t#aceaility is a #e5ui#ement a#e #ec"#ds "! uni5ue
identiEcati"n "! the p#"duct a0ailale in acc"#dance 6ith
Clause ,'2',H
?'4'& Cust$!e P$5et0
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'+',
-"es the "#%anisati"n ade5uately identi!y: 0e#i!y: p#"tect and
sa!e%ua#d cust"me# p#"pe#tyH
2 9'+', Is the cust"me#Cs intellectual p#"pe#ty c"nt#"lledH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e 79 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
7 9'+',
A#e #ec"#ds maintained "! any l"ss "# dama%e t" cust"me#
p#"pe#ty in acc"#dance 6ith Clause ,'2',H
?'4'4 Pese-ati$% $3 P$du#t
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'+'+
A#e c"mp"nents ade5uately identiEed: handled: packa%ed:
st"#ed and p#"tected p#i"# t" useH
2 9'+'+
A#e Enished p#"ducts ade5uately identiEed: handled: packa%ed:
st"#ed and p#"tected p#i"# t" deli0e#yH
?'9 C$%t$l $3 1$%it$i%, < 1easui%, E)ui5!e%t
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,0 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 9'8
A#e m"nit"#in% and measu#in% de0ices #e5ui#ed y the 2/S
c"nt#"lledH
2 9'8a
Is each de0ice cali#ated "# 0e#iEed at speciEed inte#0als ("#
p#i"# t" use& a%ainst measu#ement standa#ds t#aceale t"
nati"nal "# inte#nati"nal standa#dsH
7 9'8a
Ihe#e n" such standa#ds e$ist is the asis "! cali#ati"n "#
0e#iEcati"n deEnedH
, 9'8
Is each de0ice ad?usted "# #e>ad?usted as necessa#y (in
acc"#dance 6ith manu!actu#e#Cs inst#ucti"ns&H
+ 9'8c
Is each de0ice identiEed t" enale cali#ati"n status t" e
dete#minedH
8 9'8d
Is each de0ice sa!e%ua#ded !#"m ad?ustment: 6hich 6"uld
in0alidate the measu#ement #esultH
9 9'8e
Is each de0ice p#"tected !#"m dama%e "# dete#i"#ati"n du#in%
handlin%: maintenance "# st"#a%eH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,1 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
8 9'8
Is the 0alidity "! p#e0i"us #esults assessed and app#"p#iate
acti"n taken: 6hen a de0ice is !"und n"t t" c"n!"#m t"
#e5ui#ementsH
9 9'8
A#e #ec"#ds "! the #esults "! cali#ati"n and 0e#iEcati"n
maintained in acc"#dance 6ith Clause ,'2',H
10 9'8
Ihen c"mpute# s"!t6a#e is used in the m"nit"#in% and
measu#in% e5uipment is it 0alidated p#i"# t" initial useH
11 9'8
Ihen c"mpute# s"!t6a#e is used in the m"nit"#in% and
measu#in% e5uipment is it #e>c"nE#med as necessa#yH
8'0 1easue!e%t7 A%al0sis < I!5$-e!e%t
8'1 (e%eal
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,2 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'1a
Gas the "#%ani(ati"n implemented app#"p#iate measu#ement:
analysis and imp#"0ement p#"cesses needed t" dem"nst#ate
p#"duct c"n!"#mityH
2 8'1
Gas the "#%ani(ati"n implemented app#"p#iate measu#ement:
analysis and imp#"0ement p#"cesses needed t" ensu#e
c"n!"#mity "! the 2/S
7 8'1c
Gas the "#%ani(ati"n implemented app#"p#iate measu#ement:
analysis and imp#"0ement p#"cesses needed t" c"ntinually
imp#"0e the eAecti0eness "! the 2/SH
, 8'1
-"es the "#%ani(ati"n apply statistical techni5ues and
dete#mine the e$tent "! thei# useH
8'2 1$%it$i%, < 1easue!e%t
8'2'1 Cust$!e Satis3a#ti$%
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,7 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'2'1 -"es the "#%ani(ati"n m"nit"# cust"me# satis!acti"nH
2 8'2'1
-"es the "#%ani(ati"n use this in!"#mati"n in acc"#dance 6ith
deEned meth"dsH
8'2'2 Audit
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'2'2
Is the#e a d"cumented p#"cedu#e 6hich deEnes #esp"nsiility
and #e5ui#ements !"# plannin% and c"nductin% auditsH
2 8'2'2
Is the#e a d"cumented p#"cedu#e 6hich deEnes #esp"nsiility
and #e5ui#ements !"# #ep"#tin% audit #esultsH
7 8'2'2
Is the#e an audit p#"%#amme in place deEnin% audit c#ite#ia:
sc"pe: !#e5uency and meth"dsH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,, "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
, 8'2'2 A#e #ec"#ds "! audits maintainedH
+ 8'2'2 -" audit #ec"#ds c"nE#m that audits 6e#e c"nductedH
8 8'2'2
-" audit #ec"#ds c"nE#m that audits 6e#e c"nducted in
acc"#dance 6ith the audit scheduleH
9 8'2'2
Ie#e app#"p#iate !"ll"6 up acti"ns taken t" eliminate n"n>
c"n!"#mances and thei# #""t causeH
8 8'2'2 Ie#e the #esults "! any !"ll"6 up acti"ns 0e#iEedH
9 8'2'2
A#e eAecti0e meth"ds used t" m"nit"# (and measu#e i!
applicale& the p#"cesses "! the 2/S and the "#%anisati"nH
10 8'2'2
-" the #esults c"nE#m that they a#e capale "! achie0in%
planned #esultsH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,+ "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
11 8'2'2
I! planned #esults a#e n"t achie0ed has app#"p#iate acti"n een
takenH
8'2'2 1$%it$i%, < 1easue!e%t $3 P$#esses
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'2'7
A#e eAecti0e meth"ds used t" m"nit"# and measu#e the
p#"cesses "! the 2/S and the "#%anisati"nH
2 8'2'7
-" the #esults c"nE#m that the p#"cesses a#e capale "!
achie0in% planned #esultsH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,8 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
7 8'2'7
I! planned #esults a#e n"t achie0ed has app#"p#iate acti"n een
takenH
8'2'& 1$%it$i%, < 1easue!e%t $3 P$du#t
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'2',
A#e p#"duct cha#acte#istics measu#ed t" c"nE#m that p#"duct
#e5ui#ements a#e metH
2 8'2',
-" m"nit"#in% and measu#in% acti0ities take place at
p#edete#mined sta%es du#in% the p#"duct #eali(ati"n p#"cessH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,9 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
7 8'2',
A#e #ec"#ds "! e0idence "! c"n!"#mity 6ith acceptance c#ite#ia
maintained in acc"#dance 6ith Clause ,'2',H
, 8'2',
A#e #ec"#ds that indicate auth"#i(ed #elease "! a p#"duct t" the
ne$t sta%e a0ailaleH
+ 8'2',
-" a##an%ements e$ist t" ensu#e that a p#"duct is n"t #eleased
until the all #e5ui#ements ha0e een met
8 8'2',
-" a##an%ements e$ist t" ensu#e that i! a p#"duct must e
#eleased p#i"# satis!yin% the #e5ui#ements: is it app#"0edH
8'2 C$%t$l $% N$%B#$%3$!i%, P$du#t
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#eAC$!!e%t
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'7
Is the#e a d"cumented p#"cedu#e 6hich desc#ies h"6 n"n>
c"n!"#min% p#"duct is dealt 6ithH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,8 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#eAC$!!e%t
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
2 8'7
Is the#e a d"cumented p#"cedu#e 6hich desc#ies the
identiEcati"n "! n"n>c"n!"#mities and acti"ns t" p#e0ent
unintended use "# deli0e#yH
7 8'7
Is the#e a d"cumented p#"cedu#e 6hich desc#ies the
necessa#y #esp"nsiility and auth"#ity !"# dealin% 6ith n"n>
c"n!"#min% p#"ductH
, 8'7
Is the#e a d"cumented p#"cedu#e 6hich desc#ies meth"ds "!
dealin% 6ith n"n>c"n!"#min% p#"ductH
+ 8'7
Is the#e a d"cumented p#"cedu#e 6hich desc#ies the acti"n t"
e taken i! n"n>c"n!"#mity is detected a!te# deli0e#yH
8 8'7
A#e the#e #ec"#ds "! acti"n taken !"ll"6in% identiEcati"n "! a
n"n>c"n!"#mity maintained in acc"#dance 6ith Clause ,'2',H
9 8'7
-" the #ec"#ds detail any #e>6"#k unde#taken t" eliminate the
detected n"n>c"n!"#mityH
8 8'7
-" the #ec"#ds detail meth"ds and c#ite#ia !"# #e>0e#iEcati"n t"
dem"nst#ate c"n!"#mityH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e ,9 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#eAC$!!e%t
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
9 8'7
-" the #ec"#ds detail acceptances unde# c"ncessi"n y a
#ele0ant auth"#ityH
10 8'7
-" the #ec"#ds detail i! n"n>c"n!"#min% p#"ducts 6e#e
6ithd#a6n !#"m intended useH
8'& A%al0sis $3 Data
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#eAC$!!e%t
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8',
A#e data c"llected and analy(ed t" dem"nst#ate the suitaility
and eAecti0eness "! the 2/S and t" e0aluate 6he#e c"ntinual
imp#"0ement "! its eAecti0eness can e madeH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e +0 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#eAC$!!e%t
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
2 8',
-"es the analysis "! data include in!"#mati"n #elatin% t"
cust"me# satis!acti"nH
7 8',
-"es the analysis "! data include in!"#mati"n #elatin% t" the
c"n!"#mity t" p#"duct #e5ui#ementsH
, 8',
-"es the analysis "! data include in!"#mati"n #elatin% t"
cha#acte#istics and t#ends "! p#"cesses and p#"ductsH
+ 8',
-"es the analysis "! data include in!"#mati"n #elatin% t"
imp#"0ement "pp"#tunities and p#e0enti0e acti"nH
8 8',
-"es the analysis "! data include in!"#mati"n #elatin% t"
supplie#sH
8'4 I!5$-e!e%t
8'4'1 C$%ti%ual I!5$-e!e%t
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e +1 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'+'1
-"es the "#%anisati"n c"ntinually imp#"0e the eAecti0eness "!
the 2/S th#"u%h use "! the 5uality p"licyH
2 8'+'1
-"es the "#%anisati"n c"ntinually imp#"0e the eAecti0eness "!
the 2/S th#"u%h use "! 5uality "?ecti0esH
7 8'+'1
-"es the "#%anisati"n c"ntinually imp#"0e the eAecti0eness "!
the 2/S th#"u%h use "! audit #esultsH
, 8'+'1
-"es the "#%anisati"n c"ntinually imp#"0e the eAecti0eness "!
the 2/S th#"u%h use "! data analysisH
+ 8'+'1
-"es the "#%anisati"n c"ntinually imp#"0e the eAecti0eness "!
the 2/S th#"u%h use "! c"##ecti0e and p#e0enti0e acti"nH
8 8'+'1
-"es the "#%anisati"n c"ntinually imp#"0e the eAecti0eness "!
the 2/S th#"u%h use "! mana%ement #e0ie6sH
8'4'2 C$e#ti-e A#ti$%
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e +2 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'+'2
Is the#e a d"cumented p#"cedu#e 6hich desc#ies h"6
c"##ecti0e acti"n is unde#takenH
2 8'+'2
-" c"##ecti0e acti"ns #ec"#ds identi!y and add#ess #""t
cause(s&H
7 8'+'2 A#e acti"ns taken app#"p#iate t" the se0e#ity "! the p#"lemH
, 8'+'2a
-"es the c"##ecti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# the #e0ie6 "! n"n>c"n!"#mities (includin% cust"me#
c"mplaints&H
+ 8'+'2d
-"es the c"##ecti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# the #e0ie6 "! dete#minin% the causes "! n"n>c"n!"#mitiesH
8 8'+'2c
-"es the c"##ecti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# e0aluatin% the need !"# acti"n t" ensu#e that n"n>
c"n!"#mities d" n"t #ecu#H
9 8'+'2d
-"es the c"##ecti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# dete#minin% and implementin% acti"n neededH
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e +7 "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
8 8'+'2e
-"es the c"##ecti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# the #ec"#ds "! the #esults "! acti"n takenH
9 8'+'2!
-"es the c"##ecti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# #e0ie6in% the eAecti0eness "! c"##ecti0e acti"ns takenH
10 8'+'2
Ga0e c"##ecti0e acti"ns een implemented in acc"#dance 6ith
the d"cumented p#"cedu#eH
8'4'2 Pe-e%ti-e A#ti$%
Auditor Name (print): Initials: Date:
ISO 9001:2008 Audit & Gap Analysis Checklist
(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses&'
T#an("ne
)e#si"n 1
*a%e +, "! +,
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A < C
='<' *#"0ide #e!e#ences t" d"cumentati"n
6he#e necessa#y
1 8'+'7a
-"es the p#e0enti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# dete#minin% causes "! p"tential n"n>c"n!"#mitiesH
2 8'+'7
-"es the p#e0enti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# e0aluatin% 6hethe# acti"n needs t" e taken t" p#e0ent
"ccu##enceH
7 8'+'7c
-"es the p#e0enti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# dete#minin% 6hat acti"n is #e5ui#ed and ensu#in% that it is
implementedH
, 8'+'7d
-"es the p#e0enti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# maintainin% #ec"#ds (in acc"#dance 6ith Clause ,'2',& "! the
#esults "! acti"n takenH
+ 8'+'7e
-"es the p#e0enti0e acti"n p#"cedu#e deEne the #e5ui#ements
!"# #e0ie6in% p#e0enti0e acti"n takenH
8 8'+'7
Gas p#e0enti0e acti"n een implemented in acc"#dance 6ith
the d"cumented p#"cedu#eH
Auditor Name (print): Initials: Date:

You might also like