c Mr 01 02 Ims Check List

7/23/2019 c Mr 01 02 Ims Check List

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292315831.xls Revision: 02 18/05/2015

Quality Management System Internal Audit C

INTERNAL AUDITOR DEPARTMENT CONTACT INFORMATION / AUDITEE DE

Name:

Technical Expert / AUDITORSEmail:

FINDIN"S SUMMAR#

MA$OR A%!it S%mmar&:

Minor S&tem Stren'th:

Comment S&tem (ea)ne:

CLAUSE E*PECTATION DEFINED

Documented

Proven

Recorded

Generl !uestions durin" ll udit a

a

#.2.3 $ontrol of Documents a

A%!it Scope/Criteria:-area-. ein' a%!ite!0 applicale cla%e 1 rom ISO 23340 applicale A!minitrati5e Directi5e

re6%irement0 tate or 1e!eral re'%lation0 etc7.

%&P' ()'*P'$%+%,(-

Relationhip 8ithISO 2334:933

%is is t te stndrd is re!uestin" e document define rove nd/orrecord. + descrition of te tes of execttions son to te left4 is

emedded electronicll in te cell for ec execttion s comment. Italicstends to identif note or summr of t is ein" covered someere else.4

'vlac)font is comment/evidenti

Do ou no our ulit Polic ;t does it men;t re te or"nio do ou contriute to meetin" or"ni


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292315831.xls Revision: 02 18/05/2015

Documented

Proven

Recorded

'*P'$%+%,(-




'lac)font is comment/eviden

#.2.# $ontrol of Records a a

5.1 @n"ement $ommitment a

5.3 ulit Polic a

5.# Plnnin" a

a a

Does the organization have a documented !ecords control $rocedure thataddresses the ollo%ing?- identiication controls or records

- strorage re(uirements or records- $rotection re(uirements or records- retreival0access controls or records- retention $olicy or records- deine dis$osition o records ater their intended use

Are the records legible & identiiable?Do the records have $ro$er revision controls?Does the organization has a records control list? I so' does i t address all there(uired controls or records?

Does the organization have an established Quality Policy?Does the organization have a established Quality Objectives?1o% does the organization $rovide eective communication o customer'statutory & regulatory re(uirements?Does the management conduct Management revie% meetings?

Does the organization $rovide resources or eective o$eration o its$rocesses?

,s te documented !ulit olic rorite for te urose of teor"ni


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292315831.xls Revision: 02 18/05/2015

Documented

Proven

Recorded

'*P'$%+%,(-





5.6 @n"ement Revie a a

a

6.2 >umn Resources a a

a a

a a

+re @n"ement Revies conducted t lnned intervls to ensure tecontinued suitilit de!uec B effectiveness of its @?

+re records of @n"ement Revie minutes mintined

Does te @n"ement revies te into ccount of te folloin"A results of revious uditsA customer feedc/comlintsA rocess erformnce (=ectives4 B roduct conformit -$RCs4A sttus of corrective B reventive ctions $+/P+Cs4A folloAu ctions from revious mn"ement reviesA cn"es tt could ffect te @?A recommendtions/oortunities for imrovementDoes te result of @n"ement Revies rovide te folloin":A imrovement of te effectiveness of te @? B its rocessesA imrovement of roduct/service in reltion to its customersA ddress resource needs

;73 Reo%rce Mana'ement6.1 Provision of Resources

+re te resources needed to imlement mintin B continull imrove teeffectiveness of te @? B its rocesses determined B ein" rovided

+re resources needed to ennce customer stisfction determined B ein"rovided

,s te cometence of te ersonnel ffectin" !ulit of te roduct/servicedetermined in reltion to teir eduction trinin" sills nd exerience

+re te ersonnel ffectin" !ulit re ein" rovided it trinin",s te trinin" effective >o is it evlutedDoes stff understnd te imortnce of teir trinin" nd o teir ctivitiescontriute to te !ulit o=ectives of te or"ni


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292315831.xls Revision: 02 18/05/2015

Documented

Proven

Recorded

'*P'$%+%,(-




'lac)font is comment/evident

a a

a a

F.3.2 Desi"n B develoment inuts a a

a a

F.3.# Desi"n B develoment revie a a

a a

a a

5.2 $ustomer )ocusF.2 $ustomer Relted Processes

>o does te or"ni


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292315831.xls Revision: 02 18/05/2015

Documented

Proven

Recorded

'*P'$%+%,(-





a a

F.# Purcsin" a a

a

a a

F.5.3 ,dentifiction nd trceilit a a

F.5.# $ustomer roert a a

F.3.F Desi"n B develomentcn"es

+re desi"n cn"es revieed verified/vlidted nd roved eforeimlementtionDoes te revie of desi"n cn"es include its effect on constituent rts nd

roduct lred delivered+re te records of te results of desi"n cn"es nd n necessr ctionsroerl mintined

;t te nd extent of controls does te or"nio does te or"nio re records mintined in reltion to ndlin" of customer roert


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Documented

Proven

Recorded

'*P'$%+%,(-





F.5.5 Preservtion of roduct

a a

a

8.2.2 ,nternl udits a a

>o does te or"nio re tese clirted devices rotected f rom dm"e nd deteriortiondurin" ndlin" mintennce nd stor"e

+re te clirtion results verified B recorded +re te records roerlmintined

;en device is found to e outAof clirtion o does te or"ni


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292315831.xls Revision: 02 18/05/2015

Documented

Proven

Recorded

'*P'$%+%,(-





a

a a

a a

8.# +nlsis of Dt

a

8.5.2 $orrective ction a a

8.2.3 @onitorin" nd mesurementof rocesses

;t metods does te or"nio does te or"ni


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292315831.xls Revision: 02 18/05/2015

Documented

Proven

Recorded

'*P'$%+%,(-





8.5.3 Preventive ction a a Does te or"ni


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292315831.xls $(DA)R@A009 Revision: # 08/23/10

#nvir$nmental Management System Internal Audi

INTERNAL AUDITOR DEPARTMENT CONTACT INFORMATION / AUDITEE DETA

Name:


FINDIN"S SUMMAR# OF





Documented

Proven

Recorded


A%!it Scope/Criteria:-area-. ein' a%!ite!0 applicale cla%e 1rom ISO 4?334.

%&P' ()'*P'$%+%,(-

Relationhip 8ithISO 4?334:933?



'videlac)font is comment/evidentir

Do ou no our ulit Polic ;t does it men;t re te or"nio do ou contriute to meetin" or"ni


10/16


Documented

Proven

Recorded

'*P'$%+%,(-

Relationhip 8ithISO 4?334:933?



lac)font is comment/evide


11/16


%&SAS Internal Audit Checklist

INTERNAL AUDITOR DEPARTMENT CONTACT INFORMATION / AUDITEE DE

Name:


FINDIN"S SUMMAR# O





Documented

Proven

Recorded


A%!it Scope/Criteria:-area-. ein' a%!ite!0 applicale cla%e 1rom ISO 4334.

%&P' ()'*P'$%+%,(-
