ISO 9001 Audit & Gap Analysis Checklist

8/12/2019 ISO 9001 Audit & Gap Analysis Checklist

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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 !"# < ; /in"# ="n> C ; /a?"# ="n>c"n!"#mance S ; Supplementa#y uesti"n

C"n!"#mance: Adhe#ence 6i th the #e5ui#ements " ! the s tanda#d ' =" ma?"# "# min"# n"n>c"n!"#mances !"und

Opp"#tunity !"# Imp#" ement(O@I :

A situati"n "# c"nditi"n "! a mana%ement system that may e 6eak cum e#s"me #edundant " e#ly c"mple$ "# ins"me "the# manne# may in the "pini"n "! the audit"# " e# an "pp"#tunity !"# an "#%ani ati"n t" imp#" e its cu##entstatus'

O@Is d" n"t #e5ui#e any acti"n "n the pa#t "! the "#%ani ati"nB h"6e e# the "#%ani ati"n sh"uld %i e them se#i"usc"nside#ati"n in ie6 "! the audit"# s kn"6led%e and e$p"su#e t" simila# systems'

An O@I may e an imp#" ement t" the mana%ement system "# c"uld p#e ent !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 a ility 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 #elati e t" a speciEed #e5ui#ement'

A sin%le " se# ed lapse in !"ll"6in% "ne item "! a c"mpanyDs mana%ement system'

/a?"# ="n>c"n!"#mance: The a sence ("missi"n n"t add#essed "# t"tal #eakd"6n (c"mmissi"n !ailu#e n"t implemented "! a system t" meet aspeciEed #e5ui#ement'

A num e# "! min"# n"n>c"n!"#mities a%ainst "ne #e5ui#ement can #ep#esent a t"tal #eakd"6n "! the system and thuse c"nside#ed a ma?"# n"n>c"n!"#mity'

Any n"n>c"mpliance that 6"uld #esult in the p#" a le shipment "! a n"n>c"n!"#min% p#"duct' C"nditi"ns that may #esultin the !ailu#e "! "# mate#ially #educe the usa ility "! the p#"ducts "# se# ices !"# 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 "! themana%ement system "# t" mate#ially #educe its a ility t" assu#e c"nt#"lled p#"cesses and p#"ducts'

Auditor Name (print): Initials: Date:


3/54


T#an "ne

)e#si"n 1

*a%e 7 "! +,

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4/54


T#an "ne

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5/54


T#an "ne

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A / C ='


6/54


T#an "ne

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A / C ='


7/54


T#an "ne

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8/54


T#an "ne

)e#si"n 1

*a%e 8 "! +,

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A / C ='


9/54


T#an "ne

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A / C ='


10/54


T#an "ne

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*a%e 10 "! +,

2 u e s

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A / C ='


11/54


T#an "ne

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*a%e 11 "! +,

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A / C ='


12/54


T#an "ne

)e#si"n 1

*a%e 12 "! +,

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

2 u e s

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A / C ='


13/54


T#an "ne

)e#si"n 1

*a%e 17 "! +,

4'4'2 a%a,e!e%t Re5 ese%tati-e

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= " '

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A / C ='


14/54


T#an "ne

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*a%e 1, "! +,

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15/54


T#an "ne

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16/54


T#an "ne

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17/54


T#an "ne

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18/54


T#an "ne

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*a%e 18 "! +,

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A / C ='


19/54


T#an "ne

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*a%e 19 "! +,

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20/54


T#an "ne

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A / C='


21/54


T#an "ne

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*a%e 21 "! +,

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A / C ='


22/54

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23/54


T#an "ne

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*a%e 27 "! +,

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24/54


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25/54


T#an ne

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26/54


T#an ne

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27/54


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28/54


T#an ne

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*a%e 28 "! +,

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29/54


)e#si"n 1

*a%e 29 "! +,

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30/54


)e#si"n 1

*a%e 70 "! +,

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31/54


)e#si"n 1

*a%e 71 "! +,

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32/54

SO 9001 2008 A di & G A l i Ch kli T#an "ne


33/54


)e#si"n 1

*a%e 77 "! +,

2 u e s

t i " n

= " '

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A / C='


34/54


)e#si"n 1

*a%e 7, "! +,

2 u e s

t i " n

= " '

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A / C='


35/54


)e#si"n 1

*a%e 7+ "! +,

2 u e s

t i " n

= " '

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A / C='


36/54


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*a%e 7 "! +,

2 u e s

t i " n

= " '

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A / C='


37/54


)e#si"n 1

*a%e 7 "! +,

2 u e s

t i " n

= " '

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38/54


)e#si"n 1

*a%e 78 "! +,

2 u e s

t i " n

= " '

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A / C='


39/54


)e#si"n 1

*a%e 79 "! +,

2 u e s

t i " n

= " '

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Audit *uesti$%


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A / C='


40/54


)e#si"n 1

*a%e ,0 "! +,

2 u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C='ad?usted as necessa#y (inacc"#dance 6ith manu!actu#e# s inst#ucti"ns H

+ ' c Is each de ice identiEed t" ena le cali #ati"n status t" edete#minedH

' d Is each de ice sa!e%ua#ded !#"m ad?ustment 6hich 6"uldin alidate the measu#ement #esultH

' e Is each de ice p#"tected !#"m dama%e "# dete#i"#ati"n du#in%handlin% maintenance "# st"#a%eH


ISO 9001:2008 Audit & Gap Analysis Checklist T#an "ne


41/54


)e#si"n 1

*a%e ,1 "! +,

2 u e s

t i " n

= " '

C l a u s e

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! '

Audit *uesti$%


.ESNO

A / C='


42/54


)e#si"n 1

*a%e ,2 "! +,

2 u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='


43/54


)e#si"n 1

*a%e ,7 "! +,

2 u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='


44/54


)e#si"n 1

*a%e ,, "! +,

2 u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='


45/54

SO 900 : 008 ud t & Gap a ys s C ec st (This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses '

)e#si"n 1

*a%e ,+ "! +,

2 u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='


46/54

p y (This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses '

)e#si"n 1

*a%e , "! +,

2

u e s

t i " n

= " '

C l a u s e

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! '

Audit *uesti$%


.ESNO

A / C ='


47/54


)e#si n 1

*a%e , "! +,

2

u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='


48/54


)e#si n 1

*a%e ,8 "! +,

2

u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='c"n!"#mity maintained in acc"#dance 6ith Clause ,'2',H

8'7 -" the #ec"#ds detail any #e>6"#k unde#taken t" eliminate thedetected n"n>c"n!"#mityH

8 8'7 -" the #ec"#ds detail meth"ds and c#ite#ia !"# #e> e#iEcati"n t"dem"nst#ate c"n!"#mityH


ISO 9001:2008 Audit & Gap Analysis Checklist T#an "ne

)e#si"n 1


49/54

(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses ')e#si n 1

*a%e ,9 "! +,

2

u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='c"n!"#min% p#"ducts 6e#e6ithd#a6n !#"m intended useH

8'& A%al sis $3 Data

2 u e s

t i " n

= " '

C l a u s e

F e

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Audit *uesti$%


.ESNO

A / C ='


50/54

(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses ')e#si n 1

*a%e +0 "! +,

2

u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='


51/54

(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses ')

*a%e +1 "! +,

2

u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='


52/54


*a%e +2 "! +,

2

u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='


53/54


*a%e +7 "! +,

2

u e s

t i " n

= " '

C l a u s e

F e

! '

Audit *uesti$%


.ESNO

A / C ='


54/54

(This checklist may e used !"# inte#nal "# e$te#nal auditin% pu#p"ses '*a%e +, "! +,

2

u e s

t i " n

= " '

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Audit *uesti$%


.ESNO

A < C ='

Documents

ISO 9001 Audit & Gap Analysis Checklist