F-3 Audit & Gap Analysis Checklist Edited

8/13/2019 F-3 Audit & Gap Analysis Checklist Edited

1/56

Company Name/Logo

ISO 9001:2008 Audit & Gap Analysis Ce!"list#$is !e!"list may %e used o' inte'nal o' e(te'nal auditing pu'poses)*

+,-

.e'sion 1

age 1 o

Audit ate:

Audit es!'iption:

Lead Audito':

Audit $eam 3em%e's:

ISO 9001:2008 Auditable Clauses

#$i!" tose to %e e4aluated du'ing tis audit)

5a! audito' sould !omplete te se!tion o te !e!"list tey a4e %een assigned%y te 6uality 3anage' #Inte'nal audits)o' Lead Audito' #e(te'nal audits)7delete asapp'op'iate*$e audito' may p'o4ide additional notes and uestions 'ega'ding teaudit t'ail o' ea! element in te %lan" spa!e on te !e!"list*

$e 6uality 3anage' o' Lead Audito' 7delete as app'op'iate is 'esponsi%le o''e4ieing !ompleted se!tions o te !e!"list and to o'gani;e all indi4idual se!tionsinto one seuential !e!"list at te !on!lusion o te audit*


2/56

Company Name/Logo


+,-

.e'sion 1

age 2 o

Legend

A ? Oppo'tunity o' Imp'o4ement @ ? 3ino' Non,!ono'man!e C ? 3ao' Non,!ono'man!e S6 ? Supplementa'y 6uestion

Cono'man!e: Ade'en!e it te 'eui'ements o te standa'd* No mao' o' mino' non,!ono'man!es ound

Oppo'tunity o' Imp'o4ement #O+I): A situation o' !ondition o a management system tat may %e ea"> !um%e'some> 'edundant> o4e'ly !omple(> o' in some ote' manne'>may> in te opinion o te audito'> oe' an oppo'tunity o' an o'gani;ation to imp'o4e its !u''ent status*

O+Is do not 'eui'e any a!tion on te pa't o te o'gani;ationB oe4e'> te o'gani;ation sould gi4e tem se'ious !onside'ation in 4ieo te audito's "noledge and e(posu'e to simila' systems*

An O+I may %e an imp'o4ement to te management system o' !ould p'e4ent utu'e p'o%lems*

3ino' Non,!ono'man!e: A non,!ono'mity tat> %ased on te udgment and e(pe'ien!e o te audito'> is not li"ely to 'esult in te ailu'e o te management systemo' 'edu!e its a%ility to assu'e !ont'olled p'o!esses o' p'odu!ts*

It may %e eite':

A ailu'e in some pa't o te supplie'Ds management system 'elati4e to a spe!iied 'eui'ement*

A single o%se'4ed lapse in olloing one item o a !ompanyDs management system*

Auditor Name (print): Initials: Date:


3/56

Company Name/Logo


+,-

.e'sion 1

age - o

3ao' Non,!ono'man!e: $e a%sen!e #omission> not add'essed) o' total %'ea"don #!ommission> ailu'e> not implemented) o a system to meet a spe!iied'eui'ement*

A num%e' o mino' non,!ono'mities against one 'eui'ement !an 'ep'esent a total %'ea"don o te system and tus %e !onside'ed a

mao' non,!ono'mity*

Any non,!omplian!e tat ould 'esult in te p'o%a%le sipment o a non,!ono'ming p'odu!t* Conditions tat may 'esult in te ailu'e o o'mate'ially 'edu!e te usa%ility o te p'odu!ts o' se'4i!es o' tei' intended pu'pose*

A non,!omplian!e tat> in te udgment and e(pe'ien!e o te audito'> is li"ely to eite' to 'esult in te ailu'e o te management systemo' to mate'ially 'edu!e its a%ility to assu'e !ont'olled p'o!esses and p'odu!ts*

&'1 (e%eal Re)uie!e%ts

6uestionNo*

ClauseEe&*

Audit *uesti$%

+i%di%,

Audit E-ide%#e

.ES NO N*@* 'o4ide 'ee'en!es to do!umentation e'ene!essa'y

1


4/56

Company Name/Logo


+,-

.e'sion 1

age < o

6uestionNo*

C

lauseEe&*

Audit *uesti$%

+i%di%,Audit E-ide%#e


< 6FS5 5(e! Eoles and Eesponsi%ilities

measu'e and analy;e 63S p'o!esses

=


5/56

Company Name/Logo


+,-

.e'sion 1

age o

6uestionNo*

C

lauseEe&*

Audit *uesti$%



11


6/56

Company Name/Logo


+,-

.e'sion 1

age o

6uestionNo*

C

lauseEe&*

Audit *uesti$%



<


7/56

Company Name/Logo


+,-

.e'sion 1

age = o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%



- p'o!eed it uestions 22 to 28)

2


8/56

Company Name/Logo


+,-

.e'sion 1

age 8 o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%


.ESNO

N*@* 'o4ide 'ee'en!es to do!umentation e'ene!essa'y


9/56

Company Name/Logo


+,-

.e'sion 1

age 9 o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%


.ESNO

A 3 CN*@* 'o4ide 'ee'en!es to do!umentation e'e

ne!essa'y

2 p'ote!tion> 'et'ie4al>'etention time and disposition o 'e!o'ds

-


10/56

Company Name/Logo


+,-

.e'sion 1

age 10 o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 *1aoes te o'gani;ation !ommuni!ate te impo'tan!e o meeting!ustome'> statuto'y and 'egulato'y 'eui'ements

2 *1% oes te o'gani;ation a4e an esta%lised uali ty pol i!y

- *1! A'e te uali ty o%e!ti4es esta%lised %y top management

< *1d oes top management !ondu!t management 'e4ies

*1eoes top management ensu'e te a4aila%ility o 'esou'!es to suppo'tand !ontinually imp'o4e te 63S

4'2 Cust$!e +$#us



11/56

Company Name/Logo


+,-

.e'sion 1

age 11 o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 *2oes top management ensu'e tat !ustome' 'eui'ements a'edete'mined and met

4' *ualit/ P$li#/

6ue

stionNo*

Cla

useEe&*

Audit *uesti$%


.ES

NO

A 3 C N*@* 'o4ide 'ee'en!es to do!umentation e'ene!essa'y

1 *-a Is te uality pol i!y app'op'iate to te o'gani;ation

2 *-%oes te uality poli!y in!lude a !ommitment to !ontinually imp'o4e teee!ti4eness o te 63S

- *-!oes te uality poli!y p'o4ide a 'ameo'" to esta%lis and 'e4ieuality o%e!ti4es

< *-dIs te uality poli!y !ommuni!ated ee!ti4ely t'ougout teo'ganisation



12/56

Company Name/Logo


+,-

.e'sion 1

age 12 o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

*-e Is te uality pol i!y 'e4ieed to !oni'm suita%i li ty

4'& Pla%%i%,

4'&'1 *ualit/ Ob6e#ti-es

6uestion

No*

ClauseE

e&*

Audit *uesti$%

+i%di%,

Audit E-ide%#e

.ESNO


ne!essa'y

1 *


13/56

Company Name/Logo


+,-

.e'sion 1

age 1- o

4'&'2 *ualit/ a%a,e!e%t S/ste! Pla%%i%,

6uestionNo*

Clause

Ee&*

Audit *uesti$%


.ESNO


ne!essa'y

1 *


14/56

Company Name/Logo


+,-

.e'sion 1

age 1< o

4'4'2 a%a,e!e%t Re5ese%tati-e

6uestionNo*

Clause

Ee&*

Audit *uesti$%


.ESNO


ne!essa'y

1 **2 oes te o'gani;ation a4e a 3anagement Eep'esentati4e

2 **2aoes te 3anagement Eep'esentati4e a4e 'esponsi%ility and auto'ityto ensu'e tat p'o!esses needed o' te 63S a'e esta%lised>implemented and maintained

- **2%oes te 3anagement Eep'esentati4e a4e 'esponsi%ility and auto'ityto 'epo't to top management on te pe'o'man!e o te 63S and anyneed o' imp'o4ement

< **2!oes te 3anagement Eep'esentati4e a4e 'esponsi%ility and auto'ityto ensu'e te p'omotion o aa'eness o !ustome' 'eui'ementst'ougout te o'gani;ation

4'4' I%te%al C$!!u%i#ati$%



15/56

Company Name/Logo


+,-

.e'sion 1

age 1 o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%


.ESNO

A 3 C

N*@* 'o4ide 'ee'en!es to do!umentation e'e

ne!essa'y

1 **-Is ino'mation 'ega'ding te ee!ti4eness o te 63S !ommuni!ateditin te o'gani;ation

2 S6 I yes> o is te ee!ti4eness o te 63S !ommuni!ated

4' a%a,e!e%t Re-ie

4''1 (e%eal

6uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 **1 oes top management unde'ta"e management 'e4ie

2 **1A'e te 'e!o'ds o management 'e4ies maintained in a!!o'dan!e itClause


16/56

Company Name/Logo


+,-

.e'sion 1

age 1 o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%


.ESNO

A 3 C


ne!essa'y

- S6 Hat is te 'euen!y o management 'e4ies

< S6 Hat so't o ino'mation is 'e4ieed in management 'e4ies

S6lease so me at 'e!o'ds a'e a4aila%le 'om te most 'e!entmanagement 'e4ie

4''2 Re-ie I%5ut

6uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 **2a oes te 'e4ie p'o!ess !onside' te 'esults o audits

2 **2% oes te 'e4ie p'o!ess !onside' !ustome' eed%a!"



17/56

Company Name/Logo


+,-

.e'sion 1

age 1= o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%


.ESNO

A 3 C


ne!essa'y

- **2!oes te 'e4ie p'o!ess !onside' p'o!ess pe'o'man!e and p'odu!t!ono'mity

< **2does te 'e4ie p'o!ess !onside' te status o te !o''e!ti4e andp'e4enti4e a!tions

**2eoes te 'e4ie p'o!ess ollo up a!tions 'om p'e4ious management'e4ies

**2 oes te 'e4ie p'o!ess !onside' !anges tat !ould ae!t te 63S

= **2g oes te 'e4ie p'o!ess ma"e 'e!ommendations o' imp'o4ement

4'' Re-ie Out5ut



18/56

Company Name/Logo


+,-

.e'sion 1

age 18 o

6

uestionNo*

C

lauseEe&*

Audit *uesti$%


.ESNO

A 3 C


ne!essa'y

1 **-ao te outputs o te 'e4ie p'o!ess in!lude de!isions and a!tions!on!e'ning te imp'o4ement o te ee!ti4eness o te 63S and itsp'o!esses

2 **-%o te outputs o te 'e4ie p'o!ess in!lude de!isions and a!tions!on!e'ning te imp'o4ement o p'odu!t 'elated !ustome' 'eui'ements

- **-!o te outputs o te 'e4ie p'o!ess in!lude de!isions and a!tions!on!e'ning te 'esou'!e 'eui'ements



19/56

Company Name/Logo


+,-

.e'sion 1

age 19 o

Res$u#e a%a,e!e%t

'1 P$-isi$% $ Res$u#es

6uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 *1*1aFas te o'gani;ation p'o4ided te ne!essa'y 'esou'!es to implementand maintain te 63S and !ontinually imp'o4e its ee!ti4eness

2 *1*1%Fas te o'gani;ation p'o4ided te ne!essa'y 'esou'!es to ensu'e tat

!ustome' 'eui'ements a'e met

'2 ;u!a% Res$u#es

'2'1 (e%eal

6uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 *2*1oes te o'gani;ation ensu'e tat pe'sonnel a4e te ne!essa'y!ompeten!e to ensu'e p'odu!t !ono'mity



20/56

Company Name/Logo


+,-

.e'sion 1

age 20 o

'2'2 C$!5ete%#e7 Tai%i%, < Aae%ess

6uestionNo*

Clause

Ee&*

Audit *uesti$%


.ESNO


ne!essa'y

1 *2*2aoes te o'gani;ation dete'mine te ne!essa'y edu!ation> t'aining> s"illsand e(pe'ien!e o' people pe'o'ming o'" ae!t ing p'odu!t uality

2 *2*2%oes te o'gani;ation initiate t'aining o' ote' a!tions to a!ie4e tene!essa'y le4el o !ompeten!e

- *2*2! oes te o'gani;ation e4aluate te ee!ti4eness o t'aining o' ote'a!tions ta"en

< *2*2does te o'gani;ation ensu'e tat pe'sonnel a'e aa'e o te 'ele4an!eand impo'tan!e o tei' a!ti4ities

*2*2does te o'gani;ation ensu'e tat pe'sonnel a'e aa'e o o tey!ont'i%ute to te a!ie4ement o te uality o%e!ti4es

= *2*2e oes te o'gani;ation maintain t'aining 'e!o'ds in a!!o'dan!e itClause


21/56

Company Name/Logo


+,-

.e'sion 1

age 21 o

' I%astu#tue

6uestio

nNo*

Clause

Ee&*

Audit *uesti$%


.ESNO


ne!essa'y

1 *-Fas te o'gani;ation identiied any so't!omings in its in'ast'u!tu'e andis it ta"ing app'op'iate a!tion

2 *-aA'e te %uildings> o'"spa!e and utilities app'op'iate o' teo'gani;ation p'odu!t o' se'4i!e

- *-% Is p'o!ess euipment #in!luding !ompute' sota'e) app'op'iate o' teo'gani;ations p'odu!t o' se'4i!e

< *-!A'e suppo't se'4i!es #e*g* t'anspo't> !ommuni!ations> and astedisposal) app'op'iate o' te o'gani;ations p'odu!t o' se'4i!e



22/56

Company Name/Logo


+,-

.e'sion 1

age 22 o

'& =$> E%-i$%!e%t

6uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 * do!uments and 'esou'!es'eui'ed %y spe!ii! p'odu!ts

=*1!Fas te o'ganisation identiied metods o' 4e'i i!ation> 4alidation>monito'ing and inspe!tion and test a!ti4ities to meet a!!eptan!e !'ite'ia

=*1dFas te o'ganisation dete'mined at 'e!o'ds a'e needed to p'o4idee4iden!e tat 'eui'ements o' spe!ii! p'odu!ts a4e %een met

= =*1eIs te'e an identiia%le output 'om te planning p'o!ess> in anapp'op'iate o'mat in a!!o'dan!e it


26/56

Company Name/Logo


+,-

.e'sion 1

age 2 o

6

uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO

A 3 C


ne!essa'y

1 =**2Fas te o'ganisation dete'mined p'odu!t 'eui'ements p'io' to!ommitment to supply

2 =*2*1a Custome's spe!iied 'eui'ements> deli4e'y> a''anty and se'4i!e

- =*2*1% Eeui'ements ne!essa'y o' te p'odu!ts intended use

< =*2*1! Statuto'y and 'egulato'y 'eui'ements

=*2*1d Any additional 'eui'ements dete'mined %y te o'ganisation

?'2'2 Re-ie $ Re)uie!e%ts Related t$ te P$du#t



27/56

Company Name/Logo


+,-

.e'sion 1

age 2= o

6

uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO

A 3 C


ne!essa'y

1 =*2*2oes te o'gani;ation unde'ta"e a 'e4ie to ensu'e tat teo'gani;ation as te a%ility to meet 'eui'ements %eo'e !ommitting tosupply p'odu!t

2 =*2*2aoes te o'gani;ation ensu'e tat p'odu!t 'eui'ements a'e deined and'e4ieed %eo'e !ommitting to supply p'odu!t

- =*2*2%oes te o'gani;ation ensu'e tat !ont'a!t o' o'de' 'eui'ementsdie'ing 'om tose p'e4iously e(p'essed a'e 'esol4ed %eo'e!ommitting to supply p'odu!t

< =*2*2! oes te o'gani;ation ensu'e tat it as te a%ility to meet te deined'eui'ements

S6Can you so me 'e!o'ds o te p'odu!t 'eui'ement 'e4ie 'esults anda!tions 'esulting 'om tem

S6Hen !ustome's dont a4e do!umented 'eui'ements> o do you!oni'm tei' 'eui'ements %eo'e a!!epting o'de's

= S6Hen p'odu!t 'eui'ements a'e !anged> o do you ensu'e tat'ele4ant do!uments a'e !anged and tat 'ele4ant pe'sonnel a'e made

aa'e o te !anges

?'2' Cust$!e Satisa#ti$%



28/56

Company Name/Logo


+,-

.e'sion 1

age 28 o

6

uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO

A 3 C


ne!essa'y

1 =*2*-aFas te o'gani;ation implemented ee!ti4e a''angements o'!ommuni!ating p'odu!t ino'mation

2 =*2*-%Fas te o'gani;ation implemented ee!ti4e a''angements o'!ommuni!ating enui'ies

- =*2*-%Fas te o'gani;ation implemented ee!ti4e a''angements o'!ommuni!ating !ont'a!ts o' o'de' andling in!luding amendments

< =*2*-!Fas te o'gani;ation implemented ee!ti4e a''angements o'!ommuni!ating !ustome' eed%a!"

=*2*-!Fas te o'gani;ation implemented ee!ti4e a''angements o'!ommuni!ating !ustome' !omplaints



29/56

Company Name/Logo


+,-

.e'sion 1

age 29 o

?' Desi,% < De-el$5!e%t

?''1 Desi,% < De-el$5!e%t Pla%%i%,

6uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 =*-*1aFa4e stages o design and de4elopment %een dete'mined o' tep'odu!t

2 =*-*1%A'e 'eui'ements o' 'e4ie> 4e'ii!ation and 4alidation deined o' ea!stage

- =*-*1% Is 4alidation !ompleted p'io' to deli4e'y o' use> e'e p'a!ti!al

< =*-*1! A'e 'esponsi%ilities o' design and de4elopment deined

=*-*1Is te'e ee!ti4e !ommuni!ation %eteen die'ent mem%e's o' g'oupsin te design team

=*-*1Is planning output updated as app'op'iate as te design andde4elopment p'og'esses



30/56

Company Name/Logo


+,-

.e'sion 1

age -0 o

?''2 Desi,% < De-el$5!e%t I%5uts

6uestio

nNo*

Clause

Ee&*

Audit *uesti$%


.ESNO


ne!essa'y

1 =*-*2A'e 'e!o'ds o design inputs maintained in a!!o'dan!e it Clause


31/56

Company Name/Logo


+,-

.e'sion 1

age -1 o

?'' Desi,% < De-el$5!e%t Out5uts

6uestio

nNo*

Clause

Ee&*

Audit *uesti$%


.ESNO


ne!essa'y

1 =*-*-a o te outputs meet input 'eui'ements o' design and de4elopment

2 =*-*-%o te outputs p'o4ide ino'mation 'eui'ed o' pu'!asing> p'odu!tionand se'4i!e p'o4ision

- =*-*-! o te outputs !ontain o' 'ee'en!e p'odu!t a!!eptan!e !'ite'ia

< =*-*-d o outputs spe!iy !a'a!te'isti!s o' te p'odu!ts sae and p'ope' use

?''& Desi,% < De-el$5!e%t Re-ie



32/56

Company Name/Logo


+,-

.e'sion 1

age -2 o

6

uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 =*-* deli4e'y and post deli4e'y a!ti4itiesimplemented

?'4'2 alidati$% P$#esses $ P$du#ti$% < Se-i#e P$-isi$%



39/56

Company Name/Logo


+,-

.e'sion 1

age -9 o

6uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 =**2aIs p'odu!tion o' p'o4ision o se'4i!e i! !annot %e 4e'iied %ysu%seuent monito'ing o' measu'ing adeuately 4alidated todemonst'ate tat planned 'esults a'e %eing a!ie4ed

2 =**2% A'e !'ite'ia deined o' 'e4ie and app'o4al o te p'o!esses

- =**2! A'e pe'sonnel ualiied and is euipment app'o4ed

< =**2d A'e 'eui'ed 'e!o'ds maintained in a!!o'dan!e it Clause


40/56


41/56

Company Name/Logo


+,-

.e'sion 1

age


42/56

Company Name/Logo


+,-

.e'sion 1

age i! ould in4alidate temeasu'ement 'esult

= =*eIs ea! de4i!e p'ote!ted 'om damage o' dete'io'ation du'ing andling>maintenan!e o' sto'age



43/56

Company Name/Logo


+,-

.e'sion 1

age


44/56

Company Name/Logo


+,-

.e'sion 1

age analysisand imp'o4ement p'o!esses needed to ensu'e !ono'mity o te 63S

- 8*1!

Fas te o'gani;ation implemented app'op'iate measu'ement> analysis

and imp'o4ement p'o!esses needed to !ontinually imp'o4e teee!ti4eness o te 63S

< 8*1oes te o'gani;ation apply statisti!al te!niues and dete'mine tee(tent o tei' use

8'2 $%it$i%, < easue!e%t

8'2'1 Cust$!e Satisa#ti$%



45/56

Company Name/Logo


+,-

.e'sion 1

age


46/56

Company Name/Logo


+,-

.e'sion 1

age s!ope>'euen!y and metods

< 8*2*2 A'e 'e!o'ds o audi ts maintained

8*2*2 o audit 'e!o'ds !oni'm tat audits e'e !ondu!ted

8*2*2o audit 'e!o'ds !oni'm tat audits e'e !ondu!ted in a!!o'dan!e itte audit s!edule

= 8*2*2He'e app'op'iate ollo up a!tions ta"en to eliminate non,!ono'man!esand tei' 'oot !ause

8 8*2*2 He'e te 'esults o any ollo up a!tions 4e'iied

9 8*2*2A'e ee!ti4e metods used to monito' #and measu'e i appli!a%le) tep'o!esses o te 63S and te o'ganisation



47/56

Company Name/Logo


+,-

.e'sion 1

age


48/56

Company Name/Logo


+,-

.e'sion 1

age


49/56

Company Name/Logo


+,-

.e'sion 1

age is it app'o4ed

8' C$%t$l $% N$%B#$%$!i%, P$du#t



50/56

Company Name/Logo


+,-

.e'sion 1

age 0 o

6uestionNo*

ClauseEe&*

Audit *uesti$%

+i%di%,Audit E-ide%#eC$!!e%t

.ESNO


ne!essa'y

1 8*-Is te'e a do!umented p'o!edu'e i! des!'i%es o non,!ono'mingp'odu!t is dealt it

2 8*-Is te'e a do!umented p'o!edu'e i! des!'i%es te identii!ation onon,!ono'mities and a!tions to p'e4ent unintended use o' deli4e'y

- 8*-Is te'e a do!umented p'o!edu'e i! des!'i%es te ne!essa'y'esponsi%ility and auto'ity o' dealing it non,!ono'ming p'odu!t

< 8*-Is te'e a do!umented p'o!edu'e i! des!'i%es metods o dealingit non,!ono'ming p'odu!t

8*-Is te'e a do!umented p'o!edu'e i! des!'i%es te a!tion to %e ta"eni non,!ono'mity is dete!ted ate' deli4e'y

8*-A'e te'e 'e!o'ds o a!tion ta"en olloing identii!ation o a non,!ono'mity maintained in a!!o'dan!e it Clause


51/56

Company Name/Logo


+,-

.e'sion 1

age 1 o

6uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

8 8*-o te 'e!o'ds detail metods and !'ite'ia o' 'e,4e'ii!ation todemonst'ate !ono'mity

9 8*-o te 'e!o'ds detail a!!eptan!es unde' !on!ession %y a 'ele4antauto'ity

10 8*-o te 'e!o'ds detail i non,!ono'ming p'odu!ts e'e itd'an 'omintended use

8'& A%al/sis $ Data



52/56

Company Name/Logo


+,-

.e'sion 1

age 2 o

6uestionNo*

ClauseEe&*

Audit *uesti$%


.ESNO


ne!essa'y

1 8*

Documents

F-3 Audit & Gap Analysis Checklist Edited