Embed Size (px)
Citation preview
HOW TO CONDUCT AN ISO 9001:2015QUALITY MANAGEMENT SYSTEM INTERNAL AUDIT
[email protected] | www.riskza.com | 0861 RISK ZA | 28 Siphosethu Road, Mt. Edgecombe, KZN
© Risk ZA Corporate Sustainability (PTY) Ltd. Page 2
How to conduct an ISO 9001:2015 Quality Management System Internal Audit
The ISO 9001:2015 Quality Management System (QMS) is internationally recognised as the world’s leading quality management standard, and has been implemented by over a million organisations in more than 170 countries. ISO 9001:2015 implemented to its full potential becomes an invaluable asset to your organisation, and the standard can be used throughout an organisation to improve performance or within a
particular site, plant or department.
ISO 9001:2105 requires that internal audits be performed at planned intervals to establish whether the QMS conforms to the organisation’s own requirements for a Quality Management System, and the requirements of the ISO 9001:2015 standard; as well as to determine whether the QMS is effectively implemented and maintained. The following Guide To An Internal Audit Process, highlights some typical
areas an audit could address.
PLEASE NOTE:This Guide is not comprehensive and audit questions will vary and be
dependent on the audit scene.
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 3
CH
EC
KLI
STIS
O 9
00
1:20
15 Q
UA
LIT
Y M
AN
AG
EM
EN
T SY
STE
M A
UD
IT
Std
. R
ef.
Che
cklis
t Q
uest
ion
Sym
bo
lE
vid
ence
Ref
.
4C
ont
ext
of
the
org
aniz
atio
n
4.1
Und
erst
and
ing
the
org
aniz
atio
n an
d it
s co
ntex
t
Has
the
org
aniz
atio
n d
eter
min
ed in
tern
al is
sues
tha
t ar
e:
• R
elev
ant
to it
s p
urp
ose
?
• R
elev
ant
to it
s st
rate
gic
dir
ecti
on?
• R
elev
ant
to it
s ab
ility
to
ach
ieve
the
inte
nded
res
ults
of
its
QM
S?
Has
the
org
aniz
atio
n d
eter
min
ed e
xter
nal i
ssue
s th
at a
re:
• R
elev
ant
to it
s p
urp
ose
?
• R
elev
ant
to it
s st
rate
gic
dir
ecti
on?
• R
elev
ant
to it
s ab
ility
to
ach
ieve
the
inte
nded
res
ults
of
its
QM
S?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 4
4.2
Und
erst
and
ing
the
nee
ds
and
exp
ecta
tio
ns o
f in
tere
sted
par
ties
Has
the
org
aniz
atio
n d
eter
min
ed in
tere
sted
par
ties
rel
evan
t to
its
QM
S?
Has
the
org
aniz
atio
n d
eter
min
ed t
he r
equi
rem
ents
of
thes
e in
tere
sted
par
ties
tha
t ar
e re
leva
nt t
o t
he Q
MS
?
Has
the
org
aniz
atio
n m
oni
tore
d a
nd r
evie
wed
info
rmat
ion
abo
ut
thes
e in
tere
sted
par
ties
and
the
ir r
elev
ant
req
uire
men
ts?
4.3
Det
erm
inin
g t
he s
cop
e o
f th
e q
ualit
y m
anag
emen
t sy
stem
Has
the
org
aniz
atio
n d
eter
min
ed t
he b
oun
dar
ies
and
ap
plic
abili
ty
of
the
QM
S t
o e
stab
lish
its
sco
pe?
In d
eter
min
ing
the
sco
pe
of
the
QM
S h
as t
he o
rgan
izat
ion
cons
ider
ed:
• T
he in
tern
al a
nd e
xter
nal i
ssue
s id
enti
fied
ab
ove?
• T
he r
equi
rem
ents
of
rele
vant
inte
rest
ed p
arti
es?
• T
he p
rod
ucts
and
ser
vice
s o
f th
e o
rgan
izat
ion?
Has
the
org
aniz
atio
n d
ecid
ed t
o e
xclu
de
any
req
uire
men
ts o
f th
e IS
O 9
00
1 st
and
ard
fro
m t
he s
cop
e o
f it
s Q
MS
?
Is t
he s
cop
e d
ocu
men
ted
and
mai
ntai
ned
?
Do
es t
he d
ocu
men
ted
sco
pe
defi
ne p
rod
ucts
and
ser
vice
s co
vere
d
by
the
QM
S?
Do
es t
he d
ocu
men
ted
sco
pe
just
ify
any
excl
uded
cla
uses
fro
m IS
O
90
01?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 5
4.4
Qua
lity
man
agem
ent
syst
em a
nd it
s p
roce
sses
Has
the
org
aniz
atio
n es
tab
lishe
d a
QM
S?
Has
the
org
aniz
atio
n im
ple
men
ted
a Q
MS
?
Has
the
org
aniz
atio
n m
aint
aine
d t
he Q
MS
?
Has
the
org
aniz
atio
n co
ntin
ually
imp
rove
d it
s Q
MS
?
Do
the
se a
rran
gem
ents
incl
ude
pro
cess
es n
eed
ed a
nd t
heir
in
tera
ctio
n?
Are
the
se a
rran
gem
ents
in a
cco
rdan
ce w
ith
the
req
uire
men
ts o
f IS
O 9
00
1?
Has
the
org
aniz
atio
n d
eter
min
ed t
he p
roce
sses
nee
ded
fo
r th
e Q
MS
?
Has
the
org
aniz
atio
n d
eter
min
ed h
ow
the
se p
roce
sses
ap
ply
th
roug
hout
the
org
aniz
atio
n?
Are
the
inp
uts
and
out
put
s o
f th
e p
roce
sses
det
erm
ined
?
Is t
he s
eque
nce
and
inte
ract
ion
of
thes
e p
roce
sses
det
erm
ined
?
Are
the
cri
teri
a, m
etho
ds,
mea
sure
men
ts a
nd r
elat
ed p
erfo
rman
ce
ind
icat
ors
nee
ded
to
ens
ure
effec
tive
op
erat
ion
of
thes
e p
roce
sses
d
eter
min
ed?
Are
the
cri
teri
a, m
etho
ds,
mea
sure
men
ts a
nd r
elat
ed p
erfo
rman
ce
ind
icat
ors
nee
ded
to
co
ntro
l the
se p
roce
sses
det
erm
ined
?
Are
the
res
our
ces
need
ed t
o e
nsur
e th
e av
aila
bili
ty o
f th
ese
pro
cess
es d
eter
min
ed?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 6
Are
res
po
nsib
iliti
es a
nd a
utho
riti
es a
ssig
ned
fo
r th
ese
pro
cess
es?
Are
ris
ks a
nd o
pp
ort
unit
ies
of
thes
e p
roce
sses
det
erm
ined
?
Are
ap
pro
pri
ate
acti
ons
to
ad
dre
ss r
isks
and
op
po
rtun
itie
s re
late
d
to t
hese
pro
cess
es d
eter
min
ed?
Are
met
hod
s fo
r m
oni
tori
ng t
hese
pro
cess
es d
eter
min
ed?
Whe
re n
eed
ed, a
re c
hang
es t
o p
roce
sses
mad
e to
ens
ure
they
ac
hiev
e in
tend
ed r
esul
ts?
Are
op
po
rtun
itie
s to
imp
rove
pro
cess
es d
eter
min
ed?
Are
op
po
rtun
itie
s to
imp
rove
the
QM
S d
eter
min
ed?
Do
es t
he o
rgan
izat
ion
mai
ntai
n d
ocu
men
tati
on
as n
eed
ed t
o
sup
po
rt p
roce
ss o
per
atio
n?
Are
rec
ord
s to
pro
vid
e co
nfid
ence
tha
t th
e p
roce
sses
mee
t p
lann
ed a
rran
gem
ents
ava
ilab
le?
5Le
ader
ship
5.1
Lead
ersh
ip a
nd c
om
mit
men
t
5.1.1
Lead
ersh
ip a
nd c
om
mit
men
t fo
r th
e q
ualit
y m
anag
emen
t sy
stem
Do
es T
op
man
agem
ent
dem
ons
trat
e co
mm
itm
ent
wit
h re
spec
t to
th
e Q
MS
by:
• Ta
king
acc
oun
tab
ility
of
the
effec
tive
ness
of
the
QM
S?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 7
• E
nsur
ing
the
qua
lity
po
licy
and
qua
lity
ob
ject
ives
?
• E
nsur
ing
the
se a
re c
om
pat
ible
wit
h th
e st
rate
gic
dir
ecti
on
and
co
ntex
t o
f th
e o
rgan
izat
ion?
• E
nsur
ing
the
qua
lity
po
licy
is c
om
mun
icat
ed?
• E
nsur
ing
the
qua
lity
po
licy
is u
nder
sto
od
?
• E
nsur
ing
the
qua
lity
po
licy
is a
pp
lied
wit
hin
the
org
aniz
atio
n?
• E
nsur
ing
th
e in
teg
rati
on
of
the
QM
S
req
uire
men
ts
into
th
e o
rgan
isat
ion’
s b
usin
ess
pro
cess
es?
• P
rom
oti
ng a
war
enes
s o
f th
e p
roce
ss a
pp
roac
h?
• E
nsur
ing
the
ava
ilab
ility
of
reso
urce
s ne
eded
fo
r th
e Q
MS
?
• C
om
mun
icat
ing
the
imp
ort
ance
of e
ffec
tive
qua
lity
man
agem
ent?
• C
om
mun
icat
ing
th
e im
po
rtan
ce
of
conf
orm
ing
to
Q
MS
re
qui
rem
ents
?
• E
nsur
ing
the
QM
S a
chie
ves
its
inte
nded
res
ults
?
• E
ngag
ing
, dir
ecti
ng a
nd s
upp
ort
ing
per
sons
to
co
ntri
but
e to
the
eff
ecti
vene
ss o
f th
e Q
MS
?
• P
rom
oti
ng c
ont
inua
l im
pro
vem
ent?
• S
upp
ort
ing
oth
er r
elev
ant
man
agem
ent
role
s to
dem
ons
trat
e le
ader
ship
as
app
licab
le t
o t
heir
are
as o
f re
spo
nsib
ility
?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 8
5.1.
2C
usto
mer
fo
cus
Do
es T
op
man
agem
ent
dem
ons
trat
e le
ader
ship
and
co
mm
itm
ent
wit
h re
spec
t to
cus
tom
er f
ocu
s b
y en
suri
ng t
hat:
• C
usto
mer
req
uire
men
ts a
re d
eter
min
ed a
nd m
et?
• A
pp
licab
le le
gal
req
uire
men
ts a
re d
eter
min
ed a
nd m
et?
• T
he r
isks
and
op
po
rtun
itie
s th
at a
ffec
t p
rod
uct
conf
orm
ity
are
det
erm
ined
and
ad
dre
ssed
• T
he r
isks
and
op
po
rtun
itie
s th
at a
ffec
t th
e ab
ility
to
enh
ance
cu
sto
mer
sat
isfa
ctio
n ar
e d
eter
min
ed a
nd a
dd
ress
ed?
• T
he f
ocu
s o
n co
nsis
tent
ly p
rovi
din
g p
rod
ucts
and
ser
vice
tha
t m
eet
cust
om
er r
equi
rem
ents
is m
aint
aine
d?
• T
he f
ocu
s o
n co
nsis
tent
ly p
rovi
din
g p
rod
ucts
and
ser
vice
tha
t m
eet
leg
al r
equi
rem
ents
is m
aint
aine
d?
• T
he f
ocu
s o
n en
hanc
ing
cus
tom
er s
atis
fact
ion
is m
aint
aine
d?
5.2
Qua
lity
po
licy
Has
the
org
aniz
atio
n es
tab
lishe
d, r
evie
wed
and
mai
ntai
ned
a
qua
lity
po
licy?
5.2.
1D
oes
the
qua
lity
po
licy:
• D
emo
nstr
ate
that
it
is
ap
pro
pri
ate
to
the
pur
po
se
of
the
org
aniz
atio
n?
• D
emo
nstr
ate
that
it
is
ap
pro
pri
ate
to
the
cont
ext
of
the
org
aniz
atio
n?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 9
• P
rovi
de
a fr
amew
ork
for
sett
ing
and
revi
ewin
g q
ualit
y o
bje
ctiv
es?
• In
clud
e a
com
mit
men
t to
sat
isfy
ap
plic
able
req
uire
men
ts?
• In
clud
e a
com
mit
men
t to
co
ntin
ual i
mp
rove
men
t o
f th
e Q
MS
?
5.2.
2Is
the
qua
lity
po
licy:
Do
cum
ente
d?
Co
mm
unic
ated
, und
erst
oo
d a
nd a
pp
lied
?
Ava
ilab
le t
o r
elev
ant
inte
rest
ed p
arti
es?
5.3
Org
anis
atio
nal r
ole
s, r
esp
ons
ibili
ties
and
aut
hori
ties
Has
To
p m
anag
emen
t en
sure
d t
hat
resp
ons
ibili
ty a
nd a
utho
rity
fo
r re
leva
nt r
ole
s is
:
• A
ssig
ned
wit
hin
the
org
aniz
atio
n?
• C
om
mun
icat
ed w
ithi
n th
e o
rgan
izat
ion?
• U
nder
sto
od
wit
hin
the
org
aniz
atio
n?
Has
To
p m
anag
emen
t as
sig
ned
res
po
nsib
ility
and
aut
hori
ty f
or:
• E
nsur
ing
the
QM
S c
onf
orm
s to
ISO
90
01?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
0
• E
nsur
ing
the
pro
cess
es d
eliv
er in
tend
ed o
utp
uts?
• R
epo
rtin
g o
n th
e p
erfo
rman
ce o
f th
e Q
MS
?
• R
epo
rtin
g o
n o
pp
ort
unit
ies
for
imp
rove
men
t?
• R
epo
rtin
g o
n th
e ne
ed f
or
chan
ge?
• R
epo
rtin
g o
n th
e ne
ed f
or
inno
vati
on?
• R
epo
rtin
g t
o t
op
man
agem
ent?
• E
nsur
ing
th
e p
rom
oti
on
of
cust
om
er
focu
s th
roug
hout
th
e o
rgan
izat
ion?
• E
nsur
ing
the
inte
gri
ty o
f th
e Q
MS
is m
aint
aine
d w
hen
chan
ges
to
th
e Q
MS
are
pla
nned
and
imp
lem
ente
d?
6P
lann
ing
fo
r th
e q
ualit
y m
anag
emen
t sy
stem
6.1
Act
ions
to
ad
dre
ss r
isks
and
op
po
rtun
itie
s
6.1.
1H
as t
he o
rgan
izat
ion
cons
ider
ed:
• T
he c
ont
ext
of
the
org
aniz
atio
n w
hen
pla
nnin
g t
he Q
MS
?
• T
he r
equi
rem
ents
of
inte
rest
ed p
arti
es w
hen
pla
nnin
g t
he Q
MS
?
In c
ons
ider
ing
the
ab
ove,
has
the
org
aniz
atio
n d
eter
min
ed t
he r
isk
and
op
po
rtun
itie
s th
at n
eed
to
be
add
ress
ed t
o:
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
1
• G
ive
assu
ranc
e th
at t
he Q
MS
can
ach
ieve
its
inte
nded
res
ults
?
• P
reve
nt o
r re
duc
e un
des
ired
eff
ects
?
• A
chie
ve c
ont
inua
l im
pro
vem
ent?
6.1.
2H
as t
he o
rgan
izat
ion
pla
nned
:
• A
ctio
ns t
o a
dd
ress
the
se r
isks
and
op
po
rtun
itie
s?
• H
ow
to
in
teg
rate
an
d
imp
lem
ent
the
acti
ons
in
to
its
QM
S
pro
cess
es?
• H
ow
to
eva
luat
e th
e eff
ecti
vene
ss o
f th
ese
acti
ons
?
Are
act
ions
to
ad
dre
ss r
isks
and
op
po
rtun
itie
s p
rop
ort
iona
te t
o
the
po
tent
ial i
mp
act
on
pro
duc
t o
r se
rvic
e co
nfo
rmit
y?
6.2
Qua
lity
ob
ject
ives
and
pla
nnin
g t
o a
chie
ve t
hem
Has
the
org
aniz
atio
n es
tab
lishe
d q
ualit
y o
bje
ctiv
es a
t:
• R
elev
ant
func
tio
ns?
• R
elev
ant
leve
ls?
• R
elev
ant
pro
cess
es?
Are
the
qua
lity
ob
ject
ives
:
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
2
• C
ons
iste
nt w
ith
the
qua
lity
po
licy?
• M
easu
reab
le?
• Ta
king
ap
plic
able
req
uire
men
ts in
to a
cco
unt?
• R
elev
ant
to c
onf
orm
ity
of
pro
duc
ts a
nd s
ervi
ces?
• R
elev
ant
to e
nhan
cem
ent
of
cust
om
er s
atis
fact
ion?
• M
oni
tore
d?
• C
om
mun
icat
ed?
• U
p-t
o-d
ate
Is d
ocu
men
ted
info
rmat
ion,
rel
ativ
e to
qua
lity
ob
ject
ives
ret
aine
d?
6.2
.2D
oes
the
org
aniz
atio
n, w
hen
pla
nnin
g t
o a
chie
ve q
ualit
y o
bje
ctiv
es, d
eter
min
e:
• W
hat
will
be
do
ne?
• W
hat
reso
urce
s w
ill b
e re
qui
red
?
• W
ill w
ill b
e re
spo
nsib
le?
• W
hen
it w
ill b
e co
mp
lete
d?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
3
Ho
w t
he r
esul
ts w
ill b
e ev
alua
ted
?
6.3
Pla
nnin
g o
f ch
ang
es
Are
cha
nges
to
the
QM
S p
lann
ed a
nd c
arri
ed o
ut in
a p
lann
ed a
nd
syst
emat
ic m
anne
r?
Do
pla
nned
cha
nges
co
nsid
er:
• T
he p
urp
ose
and
po
tent
ial c
ons
eque
nces
of
the
chan
ge?
• T
he in
teg
rity
of
the
QM
S?
• T
he a
vaila
bili
ty o
f re
sour
ces?
• T
he a
lloca
tio
n/ r
eallo
cati
on
of
resp
ons
ibili
ties
and
aut
hori
ties
?
7Su
pp
ort
7.1
Res
our
ces
7.1.1
Gen
eral
Are
res
our
ces
pro
vid
ed f
or
the
esta
blis
hmen
t, im
ple
men
tati
on,
m
aint
enan
ce a
nd c
ont
inua
l im
pro
vem
ent
of
the
QM
S?
Whe
n p
rovi
din
g r
eso
urce
s d
oes
the
org
aniz
atio
n co
nsid
er:
• C
apab
iliti
es o
f re
sour
ces?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
4
• C
ons
trai
nts
on
reso
urce
s?
• W
hat
need
s to
be
ob
tain
ed f
rom
ext
erna
l pro
vid
ers?
7.1.
2P
eop
le
Do
es t
he o
rgan
izat
ion
pro
vid
e p
erso
ns f
or
the
effec
tive
op
erat
ion
of
the
QM
S?
Do
es t
he o
rgan
izat
ion
pro
vid
e p
erso
ns f
or
the
effec
tive
op
erat
ion
of
the
pro
cess
es n
eed
ed?
Whe
n p
rovi
din
g t
he p
eop
le n
eed
ed, d
oes
it e
nsur
e it
can
co
nsis
tent
ly m
eet
cust
om
er r
equi
rem
ents
?
Whe
n p
rovi
din
g t
he p
eop
le n
eed
ed, d
oes
it e
nsur
e it
can
co
nsis
tent
ly m
eet
leg
al r
equi
rem
ents
?
7.1.
3In
fras
truc
ture
Has
the
org
aniz
atio
n d
eter
min
ed in
fras
truc
ture
fo
r th
e o
per
atio
n o
f it
s p
roce
sses
to
ach
ieve
co
nfo
rmit
y o
f p
rod
ucts
and
ser
vice
s?
Has
the
org
aniz
atio
n p
rovi
ded
infr
astr
uctu
re f
or
the
op
erat
ion
of
its
pro
cess
es t
o a
chie
ve c
onf
orm
ity
of
pro
duc
ts a
nd s
ervi
ces?
Has
the
org
aniz
atio
n m
aint
aine
d in
fras
truc
ture
fo
r th
e o
per
atio
n o
f it
s p
roce
sses
to
ach
ieve
co
nfo
rmit
y o
f p
rod
ucts
and
ser
vice
s?
7.1.
4E
nvir
onm
ent
for
the
op
erat
ion
of
pro
cess
es
Has
the
org
aniz
atio
n d
eter
min
ed t
he e
nvir
onm
ent
nece
ssar
y fo
r th
e o
per
atio
n o
f it
s p
roce
sses
to
ach
ieve
co
nfo
rmit
y o
f p
rod
ucts
an
d s
ervi
ces?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
5
Has
the
org
aniz
atio
n p
rovi
ded
the
env
iro
nmen
t ne
cess
ary
for
the
op
erat
ion
of
its
pro
cess
es t
o a
chie
ve c
onf
orm
ity
of
pro
duc
ts a
nd
serv
ices
?
Has
the
org
aniz
atio
n m
aint
aine
d t
he e
nvir
onm
ent
nece
ssar
y fo
r th
e o
per
atio
n o
f it
s p
roce
sses
to
ach
ieve
co
nfo
rmit
y o
f p
rod
ucts
an
d s
ervi
ces?
7.1.
5M
oni
tori
ng a
nd m
easu
ring
res
our
ces
Are
the
re r
eso
urce
s ne
eded
to
mo
nito
r an
d m
easu
re p
rod
uct
and
se
rvic
e co
nfo
rmit
y?
Do
the
se r
eso
urce
s p
rovi
de
for
valid
and
rel
iab
le m
oni
tori
ng a
nd
mea
suri
ng r
esul
ts?
Has
the
org
aniz
atio
n en
sure
d t
hat
reso
urce
s p
rovi
ded
?
• A
re s
uita
ble
fo
r th
e ty
pe
of
mo
nito
ring
and
mea
sure
men
t b
eing
un
der
take
n?
• A
re m
aint
aine
d t
o e
nsur
e co
ntin
ued
fitn
ess
for
pur
po
se?
Has
the
org
aniz
atio
n m
aint
aine
d d
ocu
men
tati
on
as e
vid
ence
of
fitn
ess
for
the
pur
po
se o
f th
ese
reso
urce
s?
Has
the
org
aniz
atio
n d
eter
min
ed:
• T
he le
gal
req
uire
men
ts f
or
mea
sure
men
t?
• C
usto
mer
or
inte
rest
ed p
arty
req
uire
men
ts f
or
mea
sure
men
t?
• It
s o
wn
req
uire
men
ts f
or
mea
sure
men
t to
pro
vid
e co
nfid
ence
of
mea
sure
men
t re
sult
s?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
6
Whe
re t
hese
hav
e b
een
det
erm
ined
are
mea
suri
ng in
stru
men
ts:
• V
erifi
ed o
r ca
libra
ted
pri
or
to u
se?
• C
alib
rate
d a
gai
nst
mea
sure
men
t st
and
ard
s th
at a
re t
race
able
to
in
tern
atio
nal o
f na
tio
nal m
easu
rem
ent
stan
dar
ds?
Do
suc
h st
and
ard
s ex
ist,
if n
or:
• Is
the
bas
is o
f ca
libra
tio
n o
r ve
rifi
cati
on
reta
ined
as
reco
rds?
• A
re t
hey
iden
tifi
ed in
ord
er t
o d
eter
min
e th
eir
calib
rati
on
stat
us?
• A
re
they
p
rote
cted
ag
ains
t ad
just
men
ts,
dam
age
and
d
eter
iora
tio
n?
• D
oes
thi
s p
rote
ctio
n p
reve
nt in
valid
atio
n o
f th
e ca
libra
tio
n st
atus
an
d s
ubse
que
nt m
easu
rem
ent
resu
lts?
Do
es t
he o
rgan
izat
ion
det
erm
ine
if t
he v
alid
ity
of
pre
vio
us r
esul
ts
have
bee
n aff
ecte
d d
urin
g u
se o
f th
e eq
uip
men
t?
Whe
n an
inst
rum
ent
is f
oun
d d
efec
tive
do
es t
he o
rgan
izat
ion
take
co
rrec
tive
act
ion
7.1.
6O
rgan
isat
iona
l kno
wle
dg
e
Do
es t
he o
rgan
izat
ion
det
erm
ine
the
kno
wle
dg
e ne
cess
ary
for
op
erat
ion
of
its
pro
cess
es?
Do
es t
he o
rgan
izat
ion
det
erm
ine
the
kno
wle
dg
e ne
cess
ary
for
achi
evem
ent
of
pro
duc
t o
r se
rvic
e co
nfo
rmit
y?
Is t
his
kno
wle
dg
e m
aint
aine
d a
nd m
ade
avai
lab
le?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
7
Do
es t
he o
rgan
izat
ion
cons
ider
cur
rent
kno
wle
dg
e w
hen
add
ress
ed c
hang
ing
nee
ds
and
tre
nds?
Do
es t
he o
rgan
izat
ion
det
erm
ine
how
to
acq
uire
or
acce
ss
add
itio
nal k
now
led
ge
und
er s
uch
circ
umst
ance
s?
7.2
Co
mp
eten
ce
Do
es t
he o
rgan
izat
ion
det
erm
ine
the
com
pet
ence
of
tho
se u
nder
it
s co
ntro
l tha
t aff
ect
qua
lity
per
form
ance
?
Do
es t
he o
rgan
izat
ion
ensu
re t
hat
thes
e p
eop
le a
re c
om
pet
ent?
Do
es t
he o
rgan
izat
ion
take
act
ion
to a
cqui
re c
om
pet
ence
whe
re
app
licab
le?
Do
es t
he o
rgan
izat
ion
eval
uate
the
act
ions
tak
en t
o a
cqui
re
com
pet
ence
?
Do
es t
he o
rgan
izat
ion
keep
rec
ord
s o
f co
mp
eten
ce?
7.3
Aw
aren
ess
Are
the
peo
ple
wo
rkin
g u
nder
the
org
anis
atio
n’s
cont
rol a
war
e o
f:
• T
he q
ualit
y p
olic
y?
• R
elev
ant
qua
lity
ob
ject
ives
?
• T
heir
co
ntri
but
ion
to t
he e
ffec
tive
ness
of
the
QM
S?
• T
he b
enefi
ts o
f im
pro
ved
per
form
ance
?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
8
• T
he im
plic
atio
ns o
f no
t co
nfo
rmin
g t
o t
he Q
MS
req
uire
men
ts?
7.4
Co
mm
unic
atio
n
Has
the
org
aniz
atio
n d
eter
min
ed t
he in
tern
al c
om
mun
icat
ions
re
leva
nt t
o t
he Q
MS
?
Has
the
org
aniz
atio
n d
eter
min
ed t
he e
xter
nal c
om
mun
icat
ions
re
leva
nt t
o t
he Q
MS
?
Do
the
se c
om
mun
icat
ions
incl
ude:
• W
hat
will
be
com
mun
icat
ed?
• W
hen
to c
om
mun
icat
e?
• H
ow
to
co
mm
unic
ate?
7.5
Do
cum
ente
d in
form
atio
n
7.5.
1G
ener
al
Do
es t
he Q
MS
incl
ude
all d
ocu
men
tati
on
req
uire
d b
y IS
O 9
00
1?
Do
es t
he Q
MS
incl
ude
do
cum
ente
d in
form
atio
n d
eter
min
ed b
y th
e o
rgan
izat
ion
as n
eed
ed f
or
effec
tive
ness
of
the
QM
S?
7.5.
2C
reat
ing
and
up
dat
ing
Whe
n cr
eati
ng &
up
dat
ing
do
cum
ente
d in
form
atio
n, d
oes
the
o
rgan
izat
ion
ensu
re:
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 1
9
• Id
enti
fica
tio
n an
d d
escr
ipti
on
(tit
le, d
ate,
aut
hor,
ref.
no.)
• F
orm
at (
lang
uag
e, s
oft
war
e ve
rsio
n, g
rap
hics
)
• M
edia
(p
aper
, ele
ctro
nic)
• R
evie
w a
nd a
pp
rova
l fo
r su
itab
ility
and
ad
equa
cy?
7.5.
3C
ont
rol o
f d
ocu
men
ted
info
rmat
ion
Is d
ocu
men
ted
info
rmat
ion
need
ed f
or
the
QM
S:
• A
vaila
ble
whe
re a
nd w
hen
need
ed?
• S
uita
ble
whe
re a
nd w
hen
need
ed?
• A
deq
uate
ly p
rote
cted
(lo
ss, c
onfi
den
tial
ity,
imp
rop
er u
se, l
oss
of
inte
gri
ty)?
Are
the
fo
llow
ing
act
ivit
ies
add
ress
es f
or
do
cum
ent
cont
rol:
• D
istr
ibut
ion?
• A
cces
s?
• R
etri
eval
?
• U
se?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 2
0
• S
tora
ge?
• P
rese
rvat
ion?
• P
rese
rvat
ion
of
leg
ibili
ty?
• C
ont
rol o
f ch
ang
es (
vers
ion
cont
rol)
• R
etai
ned
?
• D
isp
osi
tio
n?
Are
do
cum
ents
of
exte
rnal
ori
gin
det
erm
ined
as
need
ed b
y th
e o
rgan
isat
ion?
Are
the
se d
ocu
men
ts id
enti
fied
?
Are
the
se d
ocu
men
ts c
ont
rolle
d?
8O
per
atio
n
8.1
Op
erat
iona
l pla
nnin
g a
nd c
ont
rol
Do
es t
he o
rgan
izat
ion
pla
n, im
ple
men
t an
d c
ont
rol i
ts b
usin
ess
and
qua
lity
man
agem
ent
pro
cess
es?
Do
the
se p
lans
and
co
ntro
ls p
rovi
de
for
sati
sfac
tio
n o
f re
qui
rem
ents
fo
r p
rod
ucts
and
ser
vice
s?
Do
the
se p
lans
and
co
ntro
ls p
rovi
de
for
acti
ons
to
ad
dre
ss r
isks
an
d o
pp
ort
unit
ies?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 2
1
Do
the
se p
lans
and
co
ntro
ls in
clud
e:
• D
eter
min
ing
req
uire
men
ts f
or
pro
duc
ts a
nd s
ervi
ces?
• E
stab
lishi
ng c
rite
ria
for
the
pro
cess
es?
• E
stab
lishi
ng c
rite
ria
for
the
acce
pta
nce
of p
rod
ucts
and
ser
vice
s?
• D
eter
min
ing
the
res
our
ces
need
ed f
or
conf
orm
ity?
• Im
ple
men
ting
co
ntro
l o
f th
e p
roce
sses
in
ac
cord
ance
w
ith
crit
eria
?
• R
eten
tio
n o
f re
cord
s to
dem
ons
trat
e th
at p
roce
sses
hav
e b
een
carr
ied
out
as
pla
nned
?
• R
eten
tio
n o
f re
cord
s to
dem
ons
trat
e co
nfo
rmit
y o
f p
rod
ucts
and
se
rvic
es?
Are
pla
nnin
g o
utp
uts
suit
able
fo
r th
e o
rgan
isat
ion’
s o
per
atio
ns?
Do
es t
he o
rgan
izat
ion
cont
rol p
lann
ed c
hang
es?
Do
es t
he o
rgan
izat
ion
revi
ew t
he c
ons
eque
nces
of
unin
tend
ed
chan
ges
?
Do
es t
he o
rgan
izat
ion
take
mit
igat
ing
act
ion
for
the
adve
rse
effec
ts o
f ch
ang
es?
Are
out
sour
ced
pro
cess
es c
ont
rolle
d in
acc
ord
ance
wit
h th
e re
qui
rem
ents
fo
r co
ntro
l of
exte
rnal
ly p
rovi
ded
pro
duc
ts a
nd
serv
ices
?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 2
2
8.2
Det
erm
inat
ion
of
req
uire
men
ts f
or
pro
duc
ts a
nd s
ervi
ces
8.2.
1C
usto
mer
co
mm
unic
atio
n
Has
the
org
aniz
atio
n es
tab
lishe
d p
roce
sses
fo
r co
mm
unic
atin
g
wit
h th
e cu
sto
mer
in r
egar
d t
o:
• In
form
atio
n re
lati
ng t
o p
rod
ucts
and
ser
vice
s?
• E
nqui
ries
, co
ntra
cts
and
ord
er h
and
ling
, inc
lud
ing
cha
nges
?
• O
bta
inin
g c
usto
mer
vie
ws
and
per
cep
tio
ns, i
nclu
din
g c
om
pla
ints
?
• T
he h
and
ling
or
trea
tmen
t o
f cu
sto
mer
pro
per
ty?
• S
pec
ial r
equi
rem
ents
fo
r co
ntin
gen
cy a
ctio
ns?
8.2.
2D
eter
min
atio
n o
f re
qui
rem
ents
rel
ated
to
pro
duc
ts a
nd s
ervi
ces
Has
the
org
aniz
atio
n es
tab
lishe
d, i
mp
lem
ente
d a
nd m
aint
aine
d a
p
roce
ss t
o d
eter
min
e p
rod
uct
and
ser
vice
req
uire
men
ts?
Has
the
org
aniz
atio
n en
sure
d t
hat:
• P
rod
uct
and
ser
vice
req
uire
men
ts a
re d
efine
d?
• Le
gal
req
uire
men
ts h
ave
bee
n d
efine
d?
• It
has
the
ab
ility
to
mee
t th
e d
efine
d r
equi
rem
ents
?
Ho
w t
o c
ond
uct
an IS
O 9
00
1:20
15 Q
ualit
y M
anag
emen
t S
yste
m In
tern
al A
udit
© R
isk
ZA
Co
rpo
rate
Su
stai
nab
ilit
y (P
TY
) Ltd
.
Pag
e 2
3
• It
has
the
ab
ility
to
sub
stan
tiat
e th
e cl
aim
s?
8.2.
3R
evie
w o
f re
qui
rem
ents
rel
ated
to
pro
duc
ts a
nd s
ervi
ces
Has
the
org
aniz
atio
n re
view
ed:
• R
equi
rem
ents
sp
ecifi
ed b
y th
e cu
sto
mer
• D
oes
thi
s re
view
inc
lud
e re
qui
rem
ents
fo
r d
eliv
ery
and
po
st-
del
iver
y ac
tivi
ties
?
• R
equi
rem
ents
no
t st
ated
by
the
cust
om
er b
ut n
eces
sary
fo
r in
tend
ed u
sed
?
• A
dd
itio
nal
app
licab
le l
egal
req
uire
men
ts t
hat
are
app
licab
le t
o
the
pro
duc
t o
r se
rvic
e?
• C
ont
ract
or
ord
er r
equi
rem
ents
diff
erin
g f
rom
tho
se p
revi
ous
ly
exp
ress
ed?
Are
rev
iew
s co
nduc
ted
pri
or
to c
om
mit
men
t to
sup
ply
pro
duc
ts o
r se
rvic
e?
Do
the
rev
iew
s en
sure
req
uire
men
ts d
iffer
ing
fro
m t
hose
p
revi
ous
ly d
efine
d a
re r
eso
lved
?
In t
he a
bse
nce
of
do
cum
ente
d c
usto
mer
sta
tem
ents
of
thei
r re
qui
rem
ents
, do
es t
he o
rgan
izat
ion
confi
rm t
hese
bef
ore
ac
cep
tanc
e?
Do
es t
he o
rgan
izat
ion
reta
in r
eco
rds
of
the
resu
lts
of
the
revi
ew?
Do
the
se r
eco
rds
incl
ude
new
or
chan
ged
req
uire
men
ts?
Do
es t
he o
rgan
izat
ion
amen
d d
ocu
men
ted
info
rmat
ion
and
no
tify
re
leva
nt p
erso
nnel
in t
he e
vent
of
chan
gin
g r
equi
rem
ents
?
How to conduct an ISO 9001:2015 Quality Management System Internal Audit
© Risk ZA Corporate Sustainability (PTY) Ltd. Page 24
HOW CAN RISK ZA ASSIST?The performance of an organisation is affected by both its internal processes and those of its supply chain. To support the successful achievement of its objectives, as well as continual improvement, an organisation must be capable of identifying non-conformances as well as other areas of concern. This function must include the organisation’s own system, and its components, as well as those of its suppliers. Although experience is absolutely essential for auditors to discharge their duties effectively and consistently, formal training is recognised as being a strong developer of the competence of employees.
To assist our clients and their success, Risk ZA runs a variety of ISO 9001:2015 courses. Our 2-day Internal and Supplier Quality Management Systems Auditor training is based on ISO 9001:2015 and ISO 19011:2018 and provides knowledge of the techniques and methodologies required to conduct internal and suppler QMS. Although theoretical competence is a major focal point, this course pays significant attention to practical application and includes case studies, exercises, a written examination and continuous assessment.
We also offer extensive consulting against the ISO 9001:2015 standard, which includes pre-certification audits and guiding you towards successfully implementing and maintaining a QMS.
Contact us to discuss how you and your organisation are able to move forward with the ISO 9001:2015 Quality Management standard.
+27 (0) 31 569 5900 or [email protected]
