ISO 9001 Audit & Gap Analysis Checklist

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$%s
(Tick th"se applicale: i! any&
9'1 9'2'1 9'2'2 9'2'7 9'7'1
9'7'2 9'7'7 9'7', 9'7'+ 9'7'8
9'7'9 9','1 9','2 9','7 9'+'1
9'+'2 9'+'7 9'+', 9'+'+ 9'8
.e%end
Auditor Name (print): Initials: Date:
T#an("ne
)e#si"n 1
*a%e 2 "! +,
A
; Opp"#tunity !"#
Imp#"0ement
<
; /in"# ="n>
c"n!"#mance
C ; /a?"# ="n>c"n!"#mance S2 ; Supplementa#y 2uesti"n
C"n!"#mance: Adhe#ence 6ith the #e5ui#ements "! the standa#d' =" ma?"# "# min"# n"n>c"n!"#mances !"und
Opp"#tunity !"# Imp#"0ement
(O@I&:
A situati"n "# c"nditi"n "! a mana%ement system that may e 6eak: cume#s"me: #edundant: "0e#ly c"mple$: "# 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$pe#ience "! the audit"#: is likely t" eithe# t" #esult in the !ailu#e "! the
mana%ement system "# t" mate#ially #educe its aility t" assu#e c"nt#"lled p#"cesses and p#"ducts'
T#an("ne
)e#si"n 1
*a%e 7 "! +,
&'1 (e%eal Re)uie!e%ts
2
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Audit *uesti$%
+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
T#an("ne
)e#si"n 1
*a%e , "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A < C
6he#e necessa#y
9 ,'1!
Gas the "#%ani(ati"n implemented acti"ns necessa#y t" achie0e
planned #esults and c"ntinual imp#"0ement "! p#"cesses
needed !"# the 2/SH
8 ,'1
A#e p#"cesses needed !"# the 2/S mana%ed y the
"#%ani(ati"n in acc"#dance 6ith the #e5ui#ements "! ISO
9001:2008H
9 ,'1
G"6 d"es the "#%ani(ati"n maintain c"nt#"l "0e# "uts"u#ced
p#"cessesH
10 ,'1
A#e the necessa#y c"nt#"ls !"# "uts"u#ced p#"cesses that aAect
p#"duct c"n!"#mity 6ith #e5ui#ements identiEed 6ithin the
2/SH
11 ,'1
-"es "#%ani(ati"n ha0e ade5uate c"nt#"l "0e# "uts"u#ced
p#"cesses t" ensu#e c"n!"#mity t" all cust"me# #e5ui#ementsH
&'2'1 (e%eal
T#an("ne
)e#si"n 1
*a%e + "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
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
T#an("ne
)e#si"n 1
*a%e 8 "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 ,'2'2a
Ihe#e in the 5uality manual is the sc"pe "! the 2/S identiEed:
includin% details "! and ?ustiEcati"n !"# e$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
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 ,'2'7
-"es the "#%ani(ati"n "pe#ate an estalish d"cument c"nt#"l
p#"cedu#eH (I! yes: p#"ceed 6ith 5uesti"ns 22 t" 28&
2 ,'2'7a
-"es the d"cument c"nt#"l p#"cedu#e deEne the c"nt#"ls
needed t" app#"0e d"cuments !"# ade5uacy p#i"# t" issueH
T#an("ne
)e#si"n 1
*a%e 9 "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
7 ,'2'7
needed t" #e0ie6 and update as necessa#y and #e>app#"0e
d"cumentsH
, ,'2'7c
needed t" ensu#e that chan%es and the cu##ent #e0isi"n status
"! d"cuments a#e identiEedH
+ ,'2'7d
needed t" ensu#e that #ele0ant 0e#si"ns "! applicale
d"cuments a#e a0ailale at p"ints "! useH
8 ,'2'7e
needed t" ensu#e that d"cuments #emain le%ile and #eadily
identiEaleH
9 ,'2'7!
needed t" ensu#e that d"cuments "! e$te#nal "#i%in a#e
identiEed and thei# dist#iuti"n c"nt#"lledH
8 ,'2'7%
needed t" p#e0ent the unintended use "! "s"lete d"cuments:
and t" apply suitale identiEcati"n t" them i! they a#e #etained
!"# any pu#p"seH
&'2'& C$%t$l $3 Re#$ds
T#an("ne
)e#si"n 1
*a%e 8 "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 ,'2',
-" #ec"#ds e$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
T#an("ne
)e#si"n 1
*a%e 9 "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 +'1a
-"es the "#%ani(ati"n c"mmunicate the imp"#tance "! meetin%
cust"me#: statut"#y and #e%ulat"#y #e5ui#ementsH
2 +'1 -"es the "#%ani(ati"n ha0e an estalished 5uality p"licyH
7 +'1c A#e the 5uality "?ecti0es estalished y t"p mana%ementH
, +'1d -"es t"p mana%ement c"nduct mana%ement #e0ie6sH
+ +'1e
-"es t"p mana%ement ensu#e the a0ailaility "! #es"u#ces t"
supp"#t and c"ntinually imp#"0e the 2/SH
4'2 Cust$!e +$#us
T#an("ne
)e#si"n 1
*a%e 10 "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
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$li#0
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
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
T#an("ne
)e#si"n 1
*a%e 11 "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
+ +'7e Is the 5uality p"licy #e0ie6ed t" c"nE#m suitailityH
4'& Pla%%i%,
4'&'1 *ualit0 Ob6e#ti-es
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
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
T#an("ne
)e#si"n 1
*a%e 12 "! +,
4'&'2 *ualit0 1a%a,e!e%t S0ste! Pla%%i%,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 +','2a
Is the plannin% "! the 2/S c"nsistent 6ith the "#%anisati"nCs
5uality "?ecti0es and %ene#al #e5ui#ements "! ISO 9001:2008
(Clause ,'1&H
2 +','2
-"es the "#%ani(ati"n ensu#e that the inte%#ity "! the 2/S is
maintained 6hen chan%es t" the 2/S a#e planned and
implementedH
4'4 Res5$%sibilit07 Aut8$it0 a%d C$!!u%i#ati$%
4'4'1 Res5$%sibilit0 a%d Aut8$it0
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
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&
T#an("ne
)e#si"n 1
*a%e 17 "! +,
4'4'2 1a%a,e!e%t Re5ese%tati-e
2
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F
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!
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 +'+'2 -"es the "#%ani(ati"n ha0e a /ana%ement Fep#esentati0eH
2 +'+'2a
-"es the /ana%ement Fep#esentati0e ha0e #esp"nsiility and
auth"#ity t" ensu#e that p#"cesses needed !"# the 2/S a#e
estalished: implemented and maintainedH
7 +'+'2
auth"#ity t" #ep"#t t" t"p mana%ement "n the pe#!"#mance "!
the 2/S and any need !"# imp#"0ementH
, +'+'2c
auth"#ity t" ensu#e the p#"m"ti"n "! a6a#eness "! cust"me#
#e5ui#ements th#"u%h"ut the "#%ani(ati"nH
4'4'2 I%te%al C$!!u%i#ati$%
T#an("ne
)e#si"n 1
*a%e 1, "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
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
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F
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 +'8'1 -"es t"p mana%ement unde#take mana%ement #e0ie6H
2 +'8'1
A#e the #ec"#ds "! mana%ement #e0ie6s maintained in
acc"#dance 6ith Clause ,'2',H
T#an("ne
)e#si"n 1
*a%e 1+ "! +,
2
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
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
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F
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 +'8'2a -"es the #e0ie6 p#"cess c"nside# the #esults "! auditsH
2 +'8'2 -"es the #e0ie6 p#"cess c"nside# cust"me# !eedackH
T#an("ne
)e#si"n 1
*a%e 18 "! +,
2
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F
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Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
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
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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
2 +'8'7
acti"ns c"nce#nin% the imp#"0ement "! p#"duct #elated
cust"me# #e5ui#ementsH
7 +'8'7c
acti"ns c"nce#nin% the #es"u#ce #e5ui#ementsH
T#an("ne
)e#si"n 1
*a%e 18 "! +,
9 Res$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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 8'1'1a
Gas the "#%ani(ati"n p#"0ided the necessa#y #es"u#ces t"
implement and maintain the 2/S and c"ntinually imp#"0e its
eAecti0enessH
2 8'1'1
Gas the "#%ani(ati"n p#"0ided the necessa#y #es"u#ces t"
ensu#e that cust"me# #e5ui#ements a#e metH
9'2 ;u!a% Res$u#es
9'2'1 (e%eal
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 8'2'1
-"es the "#%ani(ati"n ensu#e that pe#s"nnel ha0e the
necessa#y c"mpetence t" ensu#e p#"duct c"n!"#mityH
9'2'2 C$!5ete%#e7 Tai%i%, < A:ae%ess
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 8'2'2a
-"es the "#%ani(ati"n dete#mine the necessa#y educati"n:
t#ainin%: skills and e$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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 8'7
Gas the "#%ani(ati"n identiEed any sh"#tc"min%s in its
in!#ast#uctu#e and is it takin% app#"p#iate acti"nH
2 8'7a
A#e the uildin%s: 6"#kspace and utilities app#"p#iate !"# the
"#%ani(ati"n p#"duct "# se#0iceH
7 8'7
Is p#"cess e5uipment (includin% c"mpute# s"!t6a#e&
app#"p#iate !"# the "#%ani(ati"nCs p#"duct "# se#0iceH
, 8'7c
A#e supp"#t se#0ices (e'%' t#ansp"#t: c"mmunicati"ns: and
6aste disp"sal& app#"p#iate !"# the "#%ani(ati"nCs p#"duct "#
se#0iceH
T#an("ne
)e#si"n 1
*a%e 21 "! +,
9'& =$> E%-i$%!e%t
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 8',
Is the 6"#k en0i#"nment app#"p#iate !"# achie0in% p#"duct "#
se#0ice #e5ui#ementsH
2 8', Is sa!ety and p#"tecti0e e5uipment p#"0ided 6he#e necessa#yH
7 8', A#e 6"#kstati"ns set "ut e#%"n"micallyH
, 8', A#e kitchen and t"ilet !acilities ade5uateH
+ 8', A#e heat: humidity: li%ht le0els and ai#J"6 c"nt#"llaleH
8 8',
A#e !act"#s aAectin% hy%iene: cleanliness: n"ise: 0i#ati"n and
p"lluti"n c"nt#"llaleH
9 8',
Gas the "#%ani(ati"n identiEed any sh"#tc"min%s and is it
takin% app#"p#iate acti"nH
T#an("ne
)e#si"n 1
*a%e 22 "! +,
? P$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
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%,
.ES
NO
A / C
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
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$%
+i%di%,
.ES
NO
A / C
6he#e necessa#y
7 9'1a
Gas the "#%anisati"n dete#mined 5uality "?ecti0es !"# its
p#"ductsH
, 9'1
Gas the "#%anisati"n identiEed p#"cesses: d"cuments and
#es"u#ces #e5ui#ed y speciEc p#"ductsH
+ 9'1c
Gas the "#%anisati"n identiEed meth"ds !"# 0e#iEcati"n:
0alidati"n: m"nit"#in% and inspecti"n and test acti0ities t" meet
acceptance c#ite#iaH
8 9'1d
Gas the "#%anisati"n dete#mined 6hat #ec"#ds a#e needed t"
p#"0ide e0idence that #e5ui#ements !"# speciEc p#"ducts ha0e
een metH
9 9'1e
Is the#e an identiEale "utput !#"m the plannin% p#"cess: in an
app#"p#iate !"#mat in acc"#dance 6ith ,'2',H
?'2 Cust$!eBelated P$#esses
?'2'1 Dete!i%ati$% $3 Re)uie!e%ts Related t$ t8e P$du#t
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
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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9'2'2
-"es the "#%ani(ati"n unde#take a #e0ie6 t" ensu#e that the
"#%ani(ati"n has the aility t" meet #e5ui#ements e!"#e
c"mmittin% t" supply p#"ductH
2 9'2'2a
-"es the "#%ani(ati"n ensu#e that p#"duct #e5ui#ements a#e
deEned and #e0ie6ed e!"#e c"mmittin% t" supply p#"ductH
7 9'2'2
-"es the "#%ani(ati"n ensu#e that c"nt#act "# "#de#
#e5ui#ements diAe#in% !#"m th"se p#e0i"usly e$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$!e Satis3a#ti$%
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
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
c"mmunicatin% en5ui#iesH
7 9'2'7
c"mmunicatin% c"nt#acts "# "#de# handlin% includin%
amendmentsH
, 9'2'7c
c"mmunicatin% cust"me# !eedackH
+ 9'2'7c
c"mmunicatin% cust"me# c"mplaintsH
?'2 Desi,% < De-el$5!e%t
?'2'1 Desi,% < De-el$5!e%t Pla%%i%,
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
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
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
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
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
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:
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
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$5!e%t CeiD#ati$%
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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9'7'8
Gas 0alidati"n een c"mpleted in acc"#dance 6ith the desi%n
and de0el"pment plan t" c"nE#m that the p#"duct is suitale
!"# its speciEed applicati"n "# intended useH
2 9'7'8
A#e #ec"#ds maintained "! the #esults "! 0alidati"n and any
necessa#y acti"ns in acc"#dance 6ith Clause ,'2',H
?'2'? C$%t$l $3 Desi,% < De-el$5!e%t C8a%,es
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9'7'9
Ga0e chan%es een #e0ie6ed t" e0aluate thei# eAect "n
c"nstituent pa#ts and "n p#"duct al#eady deli0e#edH
2 9'7'9 Ga0e chan%es een app#"0ed p#i"# t" implementati"nH
7 9'7'9 Ga0e chan%es een app#"p#iately 0e#iEed and 0alidatedH
, 9'7'9
A#e #ec"#ds maintained "! the #esults "! chan%e #e0ie6s and
any necessa#y acti"ns in acc"#dance 6ith Clause ,'2',H
?'& Pu#8asi%,
?'&'1 Pu#8asi%, P$#ess
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9','1
A#e 0e#iEcati"n #e5ui#ements app#"p#iate !"# the p#"ductCs
applicati"nH
2 9','1
A#e supplie#s e0aluated and selected (in acc"#dance 6ith
estalished c#ite#ia& "n the asis "! thei# aility t" meet
speciEed #e5ui#ementsH
7 9','1
A#e supplie#s pe#i"dically #e>e0aluated in acc"#dance 6ith
estalished c#ite#iaH
, 9','1
A#e #ec"#ds maintained "! the #esults "! supplie# e0aluati"ns in
acc"#dance 6ith Clause ,'2',H
?'&'2 Pu#8asi%, I%3$!ati$%
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9','2
-"es pu#chasin% in!"#mati"n ade5uately desc#ie the p#"duct
t" e pu#chasedH
2 9','2a
-"es pu#chasin% in!"#mati"n ade5uately desc#ie the
#e5ui#ements !"# app#"0al "! p#"duct: p#"cedu#es and
e5uipmentH
7 9','2
-"es pu#chasin% in!"#mati"n ade5uately desc#ie the
#e5ui#ements !"# 5ualiEcati"n "! pe#s"nnelH
, 9','2c
-"es pu#chasin% in!"#mati"n ade5uately desc#ie 5uality
mana%ement system #e5ui#ementsH
+ 9','2
-"es the "#%anisati"n ensu#e that pu#chasin% in!"#mati"n is
ade5uate p#i"# t" issue t" the supplie#H
?'&'2 CeiD#ati$% $3 Pu#8ased P$du#t
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9','7
Is pu#chased p#"duct 0e#iEed in acc"#dance 6ith speciEed
#e5ui#ementsH
2 9','7
-"es pu#chasin% in!"#mati"n c"ntain details "! any 0e#iEcati"n
t" e pe#!"#med at the supplie#Cs p#emisesH
?'4 P$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
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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
7 9'+'1c Is suitale e5uipment a0ailaleH
, 9'+'1d A#e #e5ui#ed m"nit"#in% and measu#in% de0ices a0ailaleH
+ 9'+'1e
A#e #e5ui#ed m"nit"#in% and measu#in% de0ices used in
acc"#dance 6ith 6"#k inst#ucti"ns andK"# the 5uality planH
8 9'+'1!
A#e #e5ui#ements !"# #elease: deli0e#y and p"st deli0e#y
acti0ities implementedH
?'4'2 Calidati$% P$#esses 3$ P$du#ti$% < Se-i#e P$-isi$%
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9'+'2a
Is p#"ducti"n "# p#"0isi"n "! se#0ice 6hich cann"t e 0e#iEed y
suse5uent m"nit"#in% "# measu#in% ade5uately 0alidated t"
dem"nst#ate that planned #esults a#e ein% achie0edH
2 9'+'2 A#e c#ite#ia deEned !"# #e0ie6 and app#"0al "! the p#"cessesH
7 9'+'2c A#e pe#s"nnel 5ualiEed and is e5uipment app#"0edH
, 9'+'2d
A#e #e5ui#ed #ec"#ds maintained in acc"#dance 6ith Clause
,'2',H
+ 9'+'2e Is the time inte#0al !"# p#"cess #e>0alidati"n deEnedH
8 9'+'2!
-"es 0alidati"n dem"nst#ate the aility "! the p#"cess t"
achie0e planned #esultsH
?'4'2 Ide%tiD#ati$% < Ta#eabilit0
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9'+'7
Is p#"duct identiEcati"n and t#aceaility #e5ui#ed t" e
maintained th#"u%h"ut p#"ducti"n (!"# any p#"ducts&H
2 9'+'7
Is inspecti"n and test status ade5uately deEned maintained
th#"u%h"ut p#"ducti"nH
7 9'+'7
I! t#aceaility is a #e5ui#ement a#e #ec"#ds "! uni5ue
identiEcati"n "! the p#"duct a0ailale in acc"#dance 6ith
Clause ,'2',H
?'4'& Cust$!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
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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
7 9'+',
A#e #ec"#ds maintained "! any l"ss "# dama%e t" cust"me#
p#"pe#ty in acc"#dance 6ith Clause ,'2',H
?'4'4 Pese-ati$% $3 P$du#t
2
u
e
s
t
i
"
n

=
"
'
C
l
a
u
s
e

F
e
!
'
Audit *uesti$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9'+'+
A#e c"mp"nents ade5uately identiEed: handled: packa%ed:
st"#ed and p#"tected p#i"# t" useH
2 9'+'+
A#e Enished p#"ducts ade5uately identiEed: handled: packa%ed:
st"#ed and p#"tected p#i"# t" deli0e#yH
?'9 C$%t$l $3 1$%it$i%, < 1easui%, E)ui5!e%t
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 9'8
A#e m"nit"#in% and measu#in% de0ices #e5ui#ed y the 2/S
c"nt#"lledH
2 9'8a
Is each de0ice cali#ated "# 0e#iEed at speciEed inte#0als ("#
p#i"# t" use& a%ainst measu#ement standa#ds t#aceale t"
nati"nal "# inte#nati"nal standa#dsH
7 9'8a
Ihe#e n" such standa#ds e$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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
8 9'8
Is the 0alidity "! p#e0i"us #esults assessed and app#"p#iate
acti"n taken: 6hen a de0ice is !"und n"t t" c"n!"#m t"
#e5ui#ementsH
9 9'8
A#e #ec"#ds "! the #esults "! cali#ati"n and 0e#iEcati"n
maintained in acc"#dance 6ith Clause ,'2',H
10 9'8
Ihen c"mpute# s"!t6a#e is used in the m"nit"#in% and
measu#in% e5uipment is it 0alidated p#i"# t" initial useH
11 9'8
Ihen c"mpute# s"!t6a#e is used in the m"nit"#in% and
measu#in% e5uipment is it #e>c"nE#med as necessa#yH
8'0 1easue!e%t7 A%al0sis < I!5$-e!e%t
8'1 (e%eal
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 8'1a
Gas the "#%ani(ati"n implemented app#"p#iate measu#ement:
analysis and imp#"0ement p#"cesses needed t" dem"nst#ate
p#"duct c"n!"#mityH
2 8'1
analysis and imp#"0ement p#"cesses needed t" ensu#e
c"n!"#mity "! the 2/S
7 8'1c
analysis and imp#"0ement p#"cesses needed t" c"ntinually
imp#"0e the eAecti0eness "! the 2/SH
, 8'1
-"es the "#%ani(ati"n apply statistical techni5ues and
dete#mine the e$tent "! thei# useH
8'2 1$%it$i%, < 1easue!e%t
8'2'1 Cust$!e Satis3a#ti$%
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
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
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
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
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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
11 8'2'2
I! planned #esults a#e n"t achie0ed has app#"p#iate acti"n een
takenH
8'2'2 1$%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
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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
7 8'2'7
I! planned #esults a#e n"t achie0ed has app#"p#iate acti"n een
takenH
8'2'& 1$%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
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
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
7 8'2',
A#e #ec"#ds "! e0idence "! c"n!"#mity 6ith acceptance c#ite#ia
maintained in acc"#dance 6ith Clause ,'2',H
, 8'2',
A#e #ec"#ds that indicate auth"#i(ed #elease "! a p#"duct t" the
ne$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%,
.ES
NO
A / C
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
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%,
.ES
NO
A / C
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
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%,
.ES
NO
A / C
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%,
.ES
NO
A / C
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
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$%
+i%di%,
.ES
NO
A / C
6he#e necessa#y
2 8',
-"es the analysis "! data include in!"#mati"n #elatin% t"
cust"me# satis!acti"nH
7 8',
-"es the analysis "! data include in!"#mati"n #elatin% t" the
c"n!"#mity t" p#"duct #e5ui#ementsH
, 8',
cha#acte#istics and t#ends "! p#"cesses and p#"ductsH
+ 8',
imp#"0ement "pp"#tunities and p#e0enti0e acti"nH
8 8',
supplie#sH
8'4 I!5$-e!e%t
8'4'1 C$%ti%ual I!5$-e!e%t
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
1 8'+'1
-"es the "#%anisati"n c"ntinually imp#"0e the eAecti0eness "!
the 2/S th#"u%h use "! the 5uality p"licyH
2 8'+'1
the 2/S th#"u%h use "! 5uality "?ecti0esH
7 8'+'1
the 2/S th#"u%h use "! audit #esultsH
, 8'+'1
the 2/S th#"u%h use "! data analysisH
+ 8'+'1
the 2/S th#"u%h use "! c"##ecti0e and p#e0enti0e acti"nH
8 8'+'1
the 2/S th#"u%h use "! mana%ement #e0ie6sH
8'4'2 C$e#ti-e A#ti$%
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
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
!"# the #e0ie6 "! dete#minin% the causes "! n"n>c"n!"#mitiesH
8 8'+'2c
!"# e0aluatin% the need !"# acti"n t" ensu#e that n"n>
c"n!"#mities d" n"t #ecu#H
9 8'+'2d
!"# dete#minin% and implementin% acti"n neededH
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$%
+i%di%,
Audit E-ide%#e
.ES
NO
A / C
6he#e necessa#y
8 8'+'2e
!"# the #ec"#ds "! the #esults "! acti"n takenH
9 8'+'2!
!"# #e0ie6in% the eAecti0eness "! c"##ecti0e acti"ns takenH
10 8'+'2
Ga0e c"##ecti0e acti"ns een implemented in acc"#dance 6ith
the d"cumented p#"cedu#eH
8'4'2 Pe-e%ti-e A#ti$%
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
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
!"# e0aluatin% 6hethe# acti"n needs t" e taken t" p#e0ent
"ccu##enceH
7 8'+'7c
!"# dete#minin% 6hat acti"n is #e5ui#ed and ensu#in% that it is
implementedH
, 8'+'7d
!"# maintainin% #ec"#ds (in acc"#dance 6ith Clause ,'2',& "! the
#esults "! acti"n takenH
+ 8'+'7e
!"# #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

ISO 9001 Audit & Gap Analysis Checklist

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ISO 9001:2008 Audit & Gap Analysis Checklist

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ISO 9001 Audit & Gap Analysis Checklist

ISO 9001 Audit & Gap Analysis Checklist