ISO 9001 Checklist Audit Internal

Checklis Audit Internal
Bagian : Tanggal :
Auditor : Auditee :
No
Persyaratan
(Klasul
,
prosed
ur, IK,
dll)
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
1.
.
.
4.1 General
Requirements
Has the organization determined its processes to ensure its products
meet customer and applicable regulatory requirements including
outsourcing subcontract! o" any processes# processes include
management$ resources$ product realization$ measurement$ analysis
and impro%ement! &
'oes the organization manage measure$ monitor (here applicable$ )
analyze! its processes to ensure its products con"orm to customer
requirements#
'oes the organization implement actions necessary to achie%e planned
results and continual impro%ement o" their processes#
'oes the organization ensure the a%ailability o" resources and
in"ormation necessary to support the operation and monitoring o" their
processes#
Are the type and e*tent o" control to be applied to these outsourced
processes de"ined (ithin the quality management system#
+otes 1, 'ocumentation Re%ie( acti%ity: Requirements in Bold must be documented
-, The auditor shall ensure con"ormity (ith all requirements o" the standard (hether or not they are documented
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
+.T/: An 0outsourced process1 is a process that the organization needs "or its quality management system and (hich the organization chooses to ha%e
per"ormed by an e*ternal party.
+.T/: /nsuring control o%er outsourced processes does not absol%e the organization o" the responsibility o" con"ormity to all customer$ statutory and
regulatory requirements. The type and e*tent o" control to be applied to the outsourced process can be in"luenced by "actors such as: a! the potential
impact o" the outsourced process on the organization2s capability to pro%ide product that con"orms to requirements3 b! the degree to (hich the control
"or the process is shared3 c! the capability o" achie%ing the necessary control through the application o" clause 4.4.
-. 4.-.1.
General
'ocumenta
tion
Requirement
'oes the quality management system documentation include:
a! 'ocumented statements o" a quality policy and quality ob5ecti%es
b! A quality manual#
c! 'ocumented procedures and records required by this international
standard#
d! 'ocuments$ including records determined by the organization to be
necessary to ensure the e""ecti%e planning$ operation and control o"
its processes#
+.T/: A single document may address the requirements "or one or more procedures. A requirement "or a documented procedure may be co%ered by more
than one document.
+.T/: The decision to de%elop a procedure can di""er "rom one organization to another based on such "actors as size and type o" organization$ comple*ity and
interaction o" processes$ and competence o" personnel in%ol%ed in per"orming the (or6.
+.T/: The documentation can be in any "orm or type o" medium.
7. 4.-.-.
8uality
9anual
a! Has the organization established a (ritten quality manual that
includes the "ollo(ing:
b! The scope o" the quality management system$ including details o"
and 5usti"ication "or any e*clusions see 1.-!#
c! The documented procedures established "or the quality
management system$ or re"erence to them#
d! A description o" the interaction bet(een the processes o" the quality
management system#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
4 4.-.7.
:ontrol o"
'ocuments
;s a documented procedure to control documents including quality
records established and does the procedure include the "ollo(ing
controls:
a! to appro%e documents "or adequacy prior to use#
b! to re%ie( and update as necessary and re,appro%e documents#
c! to ensure that changes and the current re%ision status o" documents
are identi"ied#
d! to ensure that rele%ant %ersions o" applicable documents are
a%ailable at points o" use#
e! to ensure the documents remain legible and readily identi"iable#
"! to ensue that documents o" e*ternal origin determined by the
organization to be necessary "or the planning and operation o" the
quality management system are identi"ied and their distribution
controlled#
g! to pre%ent the unintended use o" obsolete documents and to apply
suitable identi"ication to them i" they are retained "or any purpose#
<. 4.-.4.
:ontrol o"
Records
;s there a documented procedure "or quality records co%ering:
a! ;denti"ication#
b! =torage#
c! >rotection#
d! Retrie%al#
e! Retention time#
"! 'isposition o" 8uality Assurance records#

Are records required by the quality management system established
and maintained to pro%ide e%idence o" con"ormity to requirements and
the e""ecti%e operation o" the 89= controlled#
Are records legible$ readily identi"iable and retrie%able#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
?. <.1.
9anagement
:ommitment
Has top management pro%ided e%idence o" its commitment to the
de%elopment and implementation o" the organization2s 89=#
Has top management communicated the importance o" meeting
customer as (ell as statutory and regulatory requirements#
Has top management established its quality policy#
Has top management established its quality ob5ecti%es#
'oes top management per"orm management re%ie( o" the 89=#
'oes top management pro%ide and ma6e a%ailable required resources#
4. <.-.
:ustomer
@ocus
Has top management ensured customers2 requirements ha%e been
determined and are "ul"illed (ith the aim o" enhancing customer
satis"action#
A. <.7.
8uality >olicy
'oes top management ensure the policy is appropriate to the purpose
o" the organization# &
;s there a speci"ic commitment in the quality policy to comply (ith
requirements and continually impro%e the e""ecti%eness o" the 89=# &
'oes the quality policy pro%ide the "rame(or6 "or establishing and
re%ie(ing quality ob5ecti%es# &
;s the policy communicated$ understood and implemented (ithin the
organization#
;s the quality policy re%ie(ed "or continuing suitability#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
B. <.4.1.
8uality
.b5ecti%es
Has the top management established quality ob5ecti%es including those
needed to meet requirements "or product at each rele%ant! "unction
and le%el# &
Are quality ob5ecti%es measurable#
Are quality ob5ecti%es consistent (ith the quality policy# &
'o ob5ecti%es support the organization2s quality policy commitment to
continual impro%ement#
'o ob5ecti%es include those requirements needed "or products#
1C. <.4.-.
89=
>lanning
Has top management ensured that:
a! the planning o" the 89= is per"ormed to meet the quality ob5ecti%es
and requirements#
b! the integrity o" the 89= is maintained during changes initiated in
processes and acti%ities#
11. <.<.1
Responsibility
) Authority
Has top management ensured that the responsibilities and authorities
ha%e been de"ined and communicated to rele%ant le%els in the
organization# e.g. 5ob "unctions$ interrelations! &
1-. <.<.-.
9anagement
Representati%
e
Has top management appointed a 9anagement Representati%es!
9R!# &
'oes the 9R ensure a 89= is established$ implemented$ and
maintained#
'oes the 9R pro%ide input to organization top management on the
per"ormance o" the 89= and needs "or impro%ement#
'oes the 9R promote a(areness o" customer requirements throughout
the organization#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
;s the 9anagement Representati%e a member o" the organization2s
management#
+.T/: The responsibility o" a management representati%e can include liaison (ith e*ternal parties on matters relating to the quality management system.
17 <.<.7.
;nternal
communicatio
n
Has the organization established processes to ensure %arious le%els
and "unctions (ithin the organization communicate about the
e""ecti%eness o" the quality management system#
14 <.?.1.
9anagement
Re%ie(
General
Are management re%ie(s conducted at planned inter%als# &
'oes management re%ie( include an e%aluation o" the 89= to ensure
its continuing suitability$ adequacy and e""ecti%eness#
'oes the re%ie( e%aluate the need "or changes to the organization2s
89=#
Are the 89= quality policy and ob5ecti%es part o" management re%ie(#
Are records "rom management re%ie(s maintained see 4.-.4!#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
1< <.?.-.
Re%ie( ;nput
'o management re%ie(s include in"ormation inputs to the "ollo(ing
areas:
a! results o" audits e.g. internal and 7
rd
party!
b! customer "eedbac6
c! process per"ormance and product con"ormity
d! status o" pre%enti%e and correcti%e actions
e! "ollo(,up actions "rom pre%ious management re%ie(s
"! planned changes that could a""ect the quality management system
g! recommendations "or impro%ement A.<.1!
1? <.?.7.
Re%ie(
.utput
'o outputs "rom management re%ie( include actions related to:
a! impro%ement o" the e""ecti%eness o" the quality management
system and its processes
b! impro%ement o" product related to customer requirements
c! resource needs
14 ?.1.
>ro%ision o"
Resources
'oes management determine and pro%ide resources needed:
a! to implement$ and maintain the quality management system and
continually impro%e its e""ecti%eness#
b! to enhance customer satis"action by meeting customer
requirements#
1A ?.-.1
HR,Genreal
'oes the organization assign personnel per"orming (or6 a""ecting
con"ormity to product requirements (ho are competent based upon
applicable education$ training$ s6ills and e*perience#
+.T/: :on"ormity to product requirements can be a""ected directly or indirectly by personnel per"orming any tas6 (ithin the quality management system.
1B ?.-.-.
:ompetence
A(areness$
and training
'oes the organization identi"y ho( they determine and pro%ide
competent personnel to per"orm (or6 a""ecting con"ormity o" product # &
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
'oes the organization pro%ide training or ta6e other actions to achie%e
the necessary competence#
'oes the organization e%aluate the e""ecti%eness o" actions ta6en#
'oes the organization ensure personnel are in"ormed about the
rele%ance and importance o" their acti%ities and ho( they contribute to
the achie%ement o" the quality ob5ecti%es#
'oes the organization maintain records o" education$ training$ s6ills and
e*perience#
-C. ?.7.
;n"rastructure
Has the organization identi"ied its in"rastructure "acility! needs to
achie%e con"ormity o" product#determined$ pro%ide and
maintain!
/*amples:
a! buildings$ (or6space and associated utilities
b! process equipment$ both hard(are and so"t(are
c! supporting ser%ices such as transport or communication or
in"ormation systems.
-1. ?.4.
Dor6 /n%iront
ment
Has the organization identi"ied and does it manage the "actors needed
human and physical! to support the (or6 en%ironment needed to
achie%e con"orming product#
+.T/: The term 0(or6 en%ironment1 relates to those conditions under (hich (or6 is per"ormed including physical$ en%ironmental and other "actors such as
noise$ temperature$ humidity$ lighting or (eather!.
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
--. 4.1.
>lanning o"
>roduct
Realization
Has the organization planned de"ined the sequence! the processes and
sub,processes it needs "or product realization to ha%e in place to
produce its product or pro%ide its ser%ices!# &
The output o" this planning shall be in a "orm suitable "or the
organization2s method o" operations. The organization shall
determine the "ollo(ing$ as appropriate:
a! quality ob5ecti%es and requirements "or products
b! the need to establish processes$ documents$ and pro%ide resources
speci"ic to the product
c! required %eri"ication$ %alidation$ monitoring$ measurement$
inspection and test acti%ities speci"ic to the product and the criteria
"or product acceptance
d! records needed to pro%ide e%idence that the realization processes
and resulting product "ul"ill requirements
-7. 4.-.1.
'etermination
."
requirement
Related to the
product
Has the organization determined customer requirements relating to the
product that include:
a! requirements speci"ied by the customer$ including the requirements
"or deli%ery and post,deli%ery acti%ities
b! requirements not stated by the customer but necessary "or speci"ied
use or 6no(n and intended use
c! statutory and regulatory requirements applicable to the product$
d! any additional requirements considered necessary by the
organization
+.T/: >ost,deli%ery acti%ities include$ "or e*ample$ actions under (arranty pro%isions$ contractual obligations such as maintenance ser%ices$ and
supplementary ser%ices such as recycling or "inal disposal.
-4 4.-.-.
Re%ie( o"
Requirements
Related to the
'oes the organization re%ie( the requirements related to the product
internal ) e*ternal! be"ore committing to supply the product#
e.g. submission o" tenders$ acceptance o" contracts or orders$
acceptance o" changes to contracts or orders!
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
product 'oes the organization ensure product requirements are clearly de"ined#
'oes the organization resol%e any di""erences bet(een the contract or
order accepted and the customer requirements#
'oes the organization assess its ability to meet de"ined requirements#
'oes the organization maintain records o" re%ie(s requirements! and
subsequent "ollo(,up actions#
Dhen the organization accepts a %erbal order E or (here no
documentation is pro%ided , are customer requirements
con"irmed be"ore they are accepted#
'oes the organization ha%e a process in place to amend rele%ant
documents (hen product requirements are changed#
'oes the organization ha%e a process in place to noti"y rele%ant
personnel (hen requirements are changed#
-<. 4.-.7.
:ustomer
:ommunicatio
n
Has the organization identi"ied and implemented e""ecti%e
arrangements "or communication (ith its customers in relation to:
a! product in"ormation#
b! enquiries$ contracts or order handling$ including amendments#
c! customer "eedbac6$ including customer complaints#
-?. 4.7.1
'esign andFor
'e%elopment
planning
'oes the organization plan and control its product design and
de%elopment acti%ities#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
'oes the organization prepare design plans (hich include:
a! the design and de%elopment stages#
b! the re%ie($ %eri"ication and %alidation that are appropriate to each
design and de%elopment stage#
c! the responsibilities and authorities "or design and de%elopment#
Are inter"aces established to support e""ecti%e communication and to
clari"y responsibility#
Are planning outputs updated as the design process progresses#
-4
.
4.7.-
'esign and
'e%elopment
;nput
Are product "unctional requirements de"ined and recorded#
Are product per"ormance requirements part o" the design inputs#
Are applicable regulatory and legal requirements part o" the design
inputs#
Are requirements "rom pre%ious or similar designs included in the
design inputs#
Are any other requirements essential "or design and de%elopment
included in the design inputs#
'oes the organization re%ie( design inputs "or adequacy#
'oes the organization resol%e incomplete$ ambiguous or con"licting
requirements#

No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
-A. 4.7.7
'esign and
'e%elopment
.utputs
Are outputs documented in a (ay that promotes %eri"ication against
input requirements and are outputs appro%ed prior to release#
'o design outputs meet design input requirements#
'o design outputs pro%ide in"ormation "or purchasing$ production$ and
ser%ice pro%ision#
'o design outputs contain or re"erence product acceptance criteria#
'o design outputs speci"y list! characteristics "or the product that are
essential "or its sa"e and proper use#
+.T/: ;n"ormation "or production and ser%ice pro%ision can include details "or the preser%ation o" product.
-B. 4.7.4
'esign and
'e%elopment
Re%ie(
At suitable points in the design andFor de%elopment process$ does the
organization conduct systematic re%ie(s o" the design andFor
de%elopment#
'o design re%ie(s include an e%aluation o" the organization2s ability to
"ul"ill requirements#
'o design re%ie(s include problem identi"ication and propose "ollo(,up
actions#
'oes the organization include representati%es o" "unctions concerned in
the design re%ie( andFor de%elopment stages being re%ie(ed#
General!
'oes the organization maintain records o" design re%ie( results and
actions#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
7C 4.7.<.
'esign and
'e%elopment
%eri"ication
'oes the organization plan "or and per"orm %eri"ication acti%ities#
'oes the organization ensure output meets design and de%elopment
input requirements#
Are %eri"ication re%ie(s and any required actions recorded#
71 4.7.?.
'esign and
'e%elopment
Galidation
'oes the organization per"orm design and de%elopment %alidation in
accordance (ith planned arrangements see 4.1.7!#
'o %alidation acti%ities con"irm the product is able to meet the speci"ied
or intended 6no(n use$ or application requirements#
Dhen possible$ does the organization do a complete %alidation be"ore
product deli%ery or implementation#
Dhen complete %alidation is not possible$ does the organization
per"orm to the ma*imum e*tent practical E a partial %alidation#
'oes the organization maintain records o" %alidation acti%ities and
necessary actions#
7- 4.7.4
:ontrol o"
'esign and
'e%elopment
:hanges
'oes the organization identi"y$ document and control design and
de%elopment changes#
Are changes re%ie(ed$ %eri"ied$ and %alidated$ as appropriate$ and
appro%ed be"ore implementation#
'oes the change process include an e%aluation o" the e""ects o"
changes on constituent parts#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
'oes the change process include e%aluation o" deli%ered products#
'oes the organization maintain records o" the re%ie( and necessary
actions#
77. 4.4.1.
>urchasing
>rocess
'oes the organization ensure that purchased product con"orms to
speci"ied purchase requirements#
;s the e*tent o" control o%er suppliers dependent on the impact o"
purchased product on subsequent product realization or the "inal
product#
'oes the organization e%aluate and select suppliers sub contractors or
%endors! based on the supplier2s ability to satis"y the organizations
requirements#
Has the organization established criteria "or selection$ e%aluation$ and
ree%aluation o" its suppliers#
'oes the organization maintain records o" e%aluation and subsequent
actions#
74 4.4.-
>urchasing
;n"ormation
'oes purchasing in"ormation describe requirements "or the product and
ser%ice! to be purchased including (hen appropriate:
a! requirement "or appro%al o" product$ procedures$ processes and
equipment#
b! Requirements "or quali"ication o" personnel#
c! 8uality management system requirements#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
'oes the organization ensure purchasing in"ormation is adequate
be"ore release to the supplier#
7<. 4.4.7.
Geri"ication o"
>urchased
>roduct
Has the organization determined and implemented necessary
inspection or other acti%ities to ensure purchased product meets
speci"ied purchase requirements#
Are %eri"ication requirements and methods o" release speci"ied in the
purchasing documents (hen the organization or its customer intends to
per"orm %eri"ication at the %endors location#
7? 4.<.1.
:ontrol o"
>roduction
and =er%ice
>ro%ision
'oes the organization conduct production andFor pro%ision under
planned and controlled conditions#
'o the organization2s controlled conditions include as applicable:
a! a%ailability o" in"ormation that describes the characteristics o" the
product#
b! the a%ailability o" (or6 instructions#
c! the use o" suitable equipment#
d! the a%ailability and use o" monitoring and measuring equipment #
e! the implementation o" monitoring and measurement#
"! the implementation o" product release$ deli%ery and post,deli%ery
acti%ities#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
74 4.<.-
Galidation o"
>rocess and
=er%ice
pro%ision
'oes the organization %alidate any processes "or production and
ser%ice pro%ision (here the resulting output cannot be %eri"ied by
subsequent monitoring or measurement# and as a consequence$
de"iciencies become apparent only a"ter the product is in use or the
ser%ice has been deli%ered!
'oes the method o" %alidation demonstrate the ability o" the processes
to achie%e planned results#
'o %alidation processes include the "ollo(ing$ as applicable#
a! 'e"ined criteria "or re%ie( and appro%al o" the process#
b! Appro%al o" equipment and quali"ication o" personnel#
c! Hse o" speci"ied methods and procedures#
d! Requirements "or quality records see 4.-.4!#
e! Re,%alidation#
7A 4.<.7
;denti"ication
and
traceability
Has the organization identi"ied product by suitable means throughout
production or ser%ice! realization operations!#
'oes the organization identi"y the status o" the product (ith respect to
monitoring and measurement requirements#
'oes the organization control and record unique identi"ication o"
products (here traceability is a requirement see 4.-.4!#
'oes the organization identi"y the product status (ith respect to
monitoring and measurement requirements throughout product
realization#
+ote: ;n some industry sectors$ con"iguration management is a means by (hich identi"ication and traceability are maintained.
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
7B 4.<.4
:ustomer
property
'oes the organization care "or and protect customers2 property under
their control or being used by them#
'oes the organization identi"y$ %eri"y$ store and maintain customer
property "or use or incorporation into the product#
'oes the organization record and report any lost$ damaged or
unsuitable property to the customer#
+.T/: :ustomer property can include intellectual property and personal data.
4C 4.<.<
>reser%ation
o" product
'oes the organization preser%e the con"ormity o" product including the
constituent parts o" a product! during internal processing identi"ication$
pac6aging$ storage$ preser%ation and handling! and deli%ery to intended
designation#
41 4.?
:ontrol o"
monitoring
and
measuring
de%ices
'oes the organization identi"y monitoring and measuring acti%ities to be
underta6en and the monitoring and measuring de%ices needed to
pro%ide e%idence o" con"ormity o" product to determined requirements
guide re"erence 4.-.1!#
;s a process established to ensure that monitoring and measurement
de%ices are used in a manner that is consistent (ith the monitoring and
measurement requirements#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
Dhere necessary to ensure %alid results$ is measuring equipment:
a! calibrated or %eri"ied$ or both$ at speci"ied inter%als$ or prior to use$
against measurement standards traceable to international or
national measurement standards3 (here no such standards e*ist$ is
the basis "or calibration or %eri"ication recorded# guide re"erence
4.-.4!
b! ad5usted or re,ad5usted as necessary#
c! ha%e identi"ication in order to determine its calibration status#
d! sa"eguarded "rom ad5ustments that (ould in%alidate the
measurement result#
e! protected "rom damage and deterioration during handling$
maintenance and storage#
'oes the organization assess the %alidity o" pre%ious inspections and
tests (hen a de%ice is "ound out o" calibration# That is$ does the
organization ta6e appropriate action (hen product has been released
using "aulty calibration de%ices#
'oes the organization maintain records o" the results o" calibration and
%eri"ication#
;s so"t(are used "or %eri"ication %alidated to determine the ability to
satis"y the intended application prior to initial use and recon"irmed as
necessary#
+.T/: :on"irmation o" the ability o" computer so"t(are to satis"y the intended application (ould typically include its %eri"ication and con"iguration management
to maintain its suitability "or use.
4- A.1 General 'oes the organization plan$ and implement a process to measure$
monitor and impro%e processes needed:
a! to demonstrate con"ormity o" the product# &
b! to ensure con"ormity o" the quality management system# &
c! to continually impro%e the e""ecti%eness o" the quality management
system# &
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
'oes the organization determine the applicable methods$ including
statistical techniques$ and the e*tent o" their use as part o" its
measurement program#
4- A.-.1
:ustomer
satis"action
'oes the organization monitor in"ormation relating to customer
perception as to (hether the organization has "ul"illed customer
requirements#
Has the organization determined the methods to obtain and use this
in"ormation#
+.T/: 9onitoring customer perception can include obtaining input "rom sources such as customer satis"action sur%eys$ customer data on deli%ered product
quality$ user opinion sur%eys$ lost business analysis$ compliments$ (arranty claims and dealer reports.
47 A.-.-
;nternal audit
Has the organization documented a procedure that de"ines the
responsibilities and requirements "or planning and conducting audits$
establishing records and "or reporting results and maintaining records#
see 4.-.4! &
'oes the organization conduct internal audits at planned inter%als to
determine (hether the quality management system con"orms to:
a! planned arrangements see 4.1! &
b! the requirements o" the ;=. BCC1:-CCC &
c! the organizations quality management system &
'oes the internal audit program assess ho( (ell e""ecti%eness! the
organization2s 89= is implemented and maintained#
Are areas processes! selected to be audited based on their status and
importance#
'oes the organization consider the results o" pre%ious audits (hen
determining (hich areas to audit# General!
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
'o the internal audit documents de"ine:
a! audit scope area or acti%ity to be audited!
b! "requency ho( o"ten this area is audited!
c! methodologies re%ie( o" records$ procedures$ operations$ and
inter%ie(s o" personnel are typical methodologies used to conduct
audits!
d! responsibilities including auditors$ team leaders$ auditees$ and
senior management!
e! recording and reporting results see 4.-.4! as part o" the
management re%ie($ to the audited organization$ and to the
management representati%e andFor quality manager!
'oes selection o" auditors and the conduct o" audits ensure ob5ecti%ity
and impartiality o" the audit process# Auditors shall not audit their o(n
(or6#
'o "ollo(,up acti%ities include the %eri"ication o" the actions ta6en and
the reporting o" %eri"ication results# guide re"erence A.<.-!
'oes the organization2s process$ as documented in its procedure$
requires management responsible "or the area being audited to ensure
that any necessary corrections and correcti%e actions are ta6en (ithout
undue delay to eliminate detected noncon"ormities and their causes#
+.T/: =ee ;=. 1BC11$ "or guidance
44 A.-.7
9easurement
and
monitoring o"
processes
'oes the organization apply suitable methods to monitor and$ (here
applicable$ measure the quality management2s system processes# &
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
'oes the organization measure and monitor processes to demonstrate
the processes ability to achie%e planned results#
Dhen planned results are not achie%ed$ is correcti%e action ta6en$ as
required$ to ensure con"ormity o" the product#
+.T/: Dhen determining suitable methods$ it is ad%isable that the organization consider the type and e*tent o" monitoring or measurement appropriate to each
o" its processes in relation to their impact on the con"ormity to product requirements and on the e""ecti%eness o" the quality management system.
4< A.-.4
9onitoring
and
measurement
o" product
'oes the organization monitor and measure its product characteristics
to %eri"y product requirements ha%e been met# &
'o monitoring and measuring acti%ities o" product characteristics
demonstrate requirements are "ul"illed#
Are monitoring and measuring acti%ities carried out at appropriate
stages o" the product realization process and in accordance (ith the
planned arrangements see 4.1!#
'o records include e%idence o" con"ormity to the acceptance criteria#
'o records clearly indicate the persons! authorizing release o" the
product "or deli%ery to the customer#
'oes the organization ma6e sure all monitoring and measuring
acti%ities ha%e been satis"actorily completed be"ore product release and
ser%ice deli%ery$ unless other(ise appro%ed by the rele%ant authority$
and (here applicable by the customer#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
4? A.7 :ontrol o"
noncon"ormin
g product
'oes the organization ha%e a documented procedure that de"ines the
methods used to control noncon"orming products including the
responsibility and authority "or re%ie( and disposition o" noncon"orming
products#
'oes the organization ensure that noncon"orming product is identi"ied
and controlled to pre%ent unintended use or deli%ery#
'oes the organization deal (ith noncon"orming product by one or more
o" the "ollo(ing (ays#
a! Ta6ing action to eliminate the detected noncon"ormity
b! Authorizing its use$ release or acceptance under concession by a
rele%ant authority$ and (here applicable$ the customer
c! Ta6ing action to preclude its original intended use or application
d! By ta6ing action appropriate to the e""ects$ or potential e""ects$ o"
the noncon"ormity (hen noncon"orming product is detected a"ter
deli%ery or use has started
;s the nature o" the noncon"ormity and any subsequent actions ta6en
including concessions obtained and recorded# =ee 4.-.4
'oes the documented procedure contain a requirement$ and does the
organization meet the requirement$ to re,%eri"y noncon"orming product
a"ter it is corrected#
44 A.4 Analysis
o" data
'oes the organization determine$ collect and analyze data to assess the
suitability and e""ecti%eness o" the 89=# Are monitoring and
measurement acti%ities included as (ell as other sources "or points o"
data collection "or purpose o" analysis#
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
'oes the organization use data to e%aluate identi"y! (here continual
impro%ement o" the quality management system can be made#
'oes the analysis o" data pro%ide in"ormation relating to:
a! customer satis"action dissatis"action! guide re"erence A.-.1
b! con"ormance to customer requirements# =ee A.-.4
c! characteristics and trends o" processes and products including
opportunities "or pre%enti%e action. =ee A.-.7 and A.-.4
d! suppliers =ee 4.4
4A A.<.1
:ontinual
impro%ement
'oes the organization continually impro%e the e""ecti%eness o" the
quality management system through the use o":
a! quality policy
b! quality ob5ecti%es
c! audit results
d! analysis o" data
e! correcti%e and pre%enti%e action
"! management re%ie(
4B A.<.-
:orrecti%e
action
'oes the organization ha%e a documented procedure established to
de"ine requirements "or:
a! re%ie(ing noncon"ormities including customer complaints!
b! determining causes o" noncon"ormities
c! e%aluating the need "or actions to ensure noncon"ormities do no
recur
d! determining and implementing actions needed
e! recording the results o" actions ta6en guide re"erence 4.-.4!
"! re%ie(ing correcti%e action ta6en
No
Persyaratan
(Klasul
,
prosed
Kriteria Audit
Status
Auditor Comment
OK
Tidak
OK
Are correcti%e actions appropriate to the e""ects o" the problem
encountered#
'oes the organization ta6e correcti%e action to eliminate the causes o"
problems and to pre%ent their recurrence#
'oes the organization2s process$ as documented in its procedure$ de"ine
requirements "or re%ie(ing the e""ecti%eness o" the correcti%e action
ta6en#
<C A.<.7
>re%enti%e
action
'oes the organization ha%e a documented procedure established to
de"ine requirements "or:
a! determining potential noncon"ormities and their causes#
b! e%aluating the need "or action to pre%ent occurrence o"
noncon"ormities#
c! determining and implementing action needed#
d! recording results o" actions ta6en#
e! re%ie(ing pre%enti%e actions ta6en#
'oes the organization determine and eliminate causes o" potential
noncon"ormities in order to pre%ent their occurrence#
Are pre%enti%e actions appropriate to the problem#
'oes the organization2s process$ as documented in its procedure$ de"ine
requirements re%ie(ing the e""ecti%eness o" the pre%enti%e action
ta6en#
Auditor +ame :
=ignature :

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