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OHSAS

18001:2007
Clause
4.1
Persyaratan
Umum

ISO
14001:2004
Clause

4.1 Persyarat
an Umum

Quality
managem
ent
system
4.1

4.2 Kebijakan 4.2 Kebijakan


K3
Lingkungan

4.3
4.3 Perencan
Perencanaan aan

4.1

4.1

4.1

4.1

4.1

4.3.1
Identifikasi
Bahaya,
4.3.1 Aspek
Penilaian
Lingkungan
Resiko, dan
Pengendalian
Resiko
4.3.2 Legal
dan
Persyaratan
Lain

4.3.2 Legal
dan
Persyaratan
Lain

4.3.3
4.3.3 Sasaran Sasaran,
dan Program Target, dan
Program

4.1 a

4.1 b

4.1 c

4.4
4.4 Implement
Implementasi
asi dan
dan
Operasional
Operasional

4.4.1
Sumberdaya,
Peran,
Tangung
Jawab, dan
Wewenan

4.4.1 Sumber
daya, Peran,
Tangung
Jawab, dan
Wewenan

4.4.2
4.4.2 Kompet
Kompetensi, ensi,
Pelatihan, dan Pelatihan, dan
Kesadaran
Kesadaran

4.4.3
Komunikasi,
Partisipasi,
dan
Konsultasi

4.4.3.1
Komunikasi

4.4.3.2
Partisipasi
dan
Konsultasi

Tidak Ada

4.1 d

10

4.1 d

11

4.1 e

12

4.1 e

13

4.1 e

4.4.3
Komunikasi

Tidak Ada

4.4.4
4.4.4
Dokumentasi Dokumentasi

4.4.5
4.4.5 Pengen
Pengendalian dalian
Dokumen
Dokumen

14
4.4.6
4.4.6 Pengen
Pengendalian dalian
Operasional Operasional

4.1 f

15

4.1 f

4.4.7
4.4.7 Persiapa
Persiapan dan
n dan Respon
Respon
Tanggap
Tanggap
Darurat
Darurat

16
4.5
Pengecekan

4.5
Pengecekan

4.5.1
Pengukuran
Performa dan
Monitoring

4.5.1
Monitoring
and
Pengukuran

4.1

17

4.1

4.5.2 Evaluasi 4.5.2 Evaluasi


Kesesuaian Kesesuaian

4.5.3
Investigasi
Kecelekaan,
Ketidaksesuai
Tidak Ada
an, Tindakan
Perbaikan
dan
Pencegahan

4.5.3.1
Investigasi
Kecelakaan

Tidak Ada

4.5.3.2 Ketida
ksesuaian,
Tindakan
Perbaikan
dan
Pencegahan

4.5.3 Ketidaks
esuaian,
Tindakan
Perbaikan
dan
Pencegahan

18

4.1

4.2

4.2.1

4.5.4
4.5.4
Pengendalian Pengendalian
Rekaman
Rekaman

19

4.2.1 a

20

4.2.1 a

21

4.2.1 b

4.5.5 Internal 4.5.5 Internal


Audit
Audit

4.6 Rapat
Tinjauan
Manajemen

4.6 Rapat
Tinjauan
Manajemen

22

4.2.1 c

4.2.1 c

23

4.2.1 c

24

4.2.1 d

4.2.2

25

4.2.2

26

4.2.2

27

4.2.2 a

28

4.2.2 b

29

4.2.2 c

4.2.3

30

4.2.3

31

4.2.3

32

4.2.3 a

33

4.2.3 b

34

4.2.3 c

35

4.2.3 c

36

4.2.3 d

37

4.2.3 e

38

4.2.3 e

39

4.2.3 f

40

4.2.3 g

41

4.2.3 g

4.2.4

42

4.2.4

43

4.2.4

44

4.2.4

45

4.2.4

46

4.2.4

47

4.2.4

48

4.2.4

49

4.2.4

50

4.2.4

5.1

51

5.1 a

52

5.1 a

53

5.1 b

54

5.1 c

55

5.1 d

56

5.1 e

5.2

57

5.2

58

5.2

5.3

59

5.3 a

60

5.3 b

61

5.3 b

62

5.3 c

63

5.3 d

64

5.3 e

5.4
5.4.1
65
5.4.1

66

5.4.1

67

5.4.1

68

5.4.1

5.4.2

69

5.4.2 a

70

5.4.2 a

71

5.4.2 b

5.5

5.5.1

72

5.5.1

73

5.5.1

5.5.2

74

5.5.2

75

5.5.2 a

76

5.5.2 a

77

5.2.2 a

78

5.5.2 b

79

5.5.2 b

80

5.5.2 c

5.5.3

81

5.5.3

82

5.5.3

5.6
5.6.1

5.6.1

83

5.6.1

84

5.6.1

85

5.6.1

5.6.2

86

5.6.2 a

87

5.6.2 b

88

5.6.2 c

89

5.6.2 c

90

5.6.2 d

91

5.6.2 e

92

5.6.2 f

93

5.6.2 g

5.6.3

94

5.6.3 a

95

5.6.3 b

96

5.6.3 c

6.1

97

6.1 a

97

6.1 a

98

6.1 a

99

6.1 a

100

6.1 b

6.2
6.2.1

101

6.2.1

6.2.2

102

6.2.2 a

103

6.2.2 b

104

6.2.2 c

105

6.2.2 d

106

6.2.2 e

6.3

107

6.3

108

6.3

109

6.3

6.4

110

6.4

111

6.4

7.1

112

7.1

113

7.1

114

7.1

115
7.1 a

116

7.1 a

117

7.1 b

118

7.1 b

119

7.1 b

120

7.1 c

121

7.1 c

122
7.1 d

123

7.1 d

124

7.1

7.2

7.2.1

125

7.2.1 a

126

7.2.1 b

127

7.2.1 c

128

7.2.1 d

7.2.2

129

7.2.2

130

7.2.2

131

7.2.2 a

132

7.2.2 b

133

7.2.2 c

134

7.2.2

135

7.2.2

136

7.2.2

137

7.2.2

7.2.3

138

7.2.3 a

139

7.2.3 a

140

7.2.3 b

141

7.2.3 b

142

7.2.3 c

143

7.2.3 c

7.3

7.3.1

144

7.3.1

145

7.3.1

146

7.3.1 a

147

7.3.1 b

148

7.3.1 c

149

7.3.1

150

7.3.1

7.3.2

151

7.3.2

152

7.3.2

153

7.3.2 a

154

7.3.2 b

155

7.3.2 c

156

7.3.2 d

157

7.3.2

158

7.3.2

7.3.3

159

7.3.3

160

7.3.3

161

7.3.3 a

162

7.3.3 b

163

7.3.3 c

164

7.3.3 d

7.3.4

7.3.4

165

7.3.4 a

166

7.3.4 b

167

7.3.4

168

7.3.4

7.3.5

169

7.3.5

170

7.3.5

7.3.6

171

7.3.6

172

7.3.6

173

7.3.6

7.3.7

174
7.3.7

175

7.3.7

176

7.3.7

177

7.3.7

178

7.3.7

179

7.3.7

7.4
7.4.1

180

7.4.1

181

7.4.1

182

7.4.1

183

7.4.1

184

7.4.1

7.4.2

185

7.4.2

186

7.4.2 a

187

7.4.2 b

188

7.4.2 c

189

7.4.2

7.4.3

190

7.4.3

191

7.4.3

7.5

7.5.1

192

7.5.1

193

7.5.1

194

7.5.1 a

195

7.5.1 b

196

7.5.1 c

197

7.5.1 d

198

7.5.1 d

199

7.5.1 e

200

7.5.1 f

201

7.5.1 f

202

7.5.1 f

7.5.2

203

7.5.2

204

7.5.2

205

7.5.2 a

206

7.5.2 a

207

7.5.2 b

208

7.5.2 b

209
7.5.2 c

210
7.5.2 d

211

7.5.2 e

7.5.3

212

7.5.3

213

7.5.3

214

7.5.3

215

7.5.3

7.5.4

216

7.5.4

217

7.5.4

218

7.5.4

219

7.5.4

220

7.5.4

221

7.5.4

222

7.5.4

7.5.5

223

7.5.5

224

7.5.5

225

7.5.5

7.6

226

7.6

227

7.6

228

7.6

229

7.6 a

230

7.6 a

231

7.6 b

232

7.6 c

233

7.6 d

234

7.6 e

235

7.6

236

7.6

237

7.6

238

7.6

239

7.6

8.1

240

8.1 a

241

8.1 a

242

8.1 b

243

8.1 b

244

8.1 c

245

8.1 c

246

8.1

8.2

8.2.1

247

8.2.1

248

8.2.1

8.2.2

249

8.2.2 a

250

8.2.2 a

251

8.2.2 a

252

8.2.2 b

253

8.2.2 b

254

8.2.2

255

8.2.2

256

8.2.2

257

8.2.2

258

8.2.2

259

8.2.2

260

8.2.2

261

8.2.2

262

8.2.2

8.2.3

263

8.2.3

264

8.2.3

265

8.2.3

8.2.4

266

8.2.4

267

8.2.4

268

8.2.4

269

8.2.4

270

8.2.4

8.3

271

8.3

272

8.3

273

8.3 a

274

8.3 b

275

8.3 c

276

8.3 d

277

8.3

278

8.3

8.4
279

8.4

280

8.4

281

8.4

282

8.4

283

8.4

284

8.4 a

285

8.4 b

286

8.4 c

287
8.4 d

8.5

8.5.1

288

8.5.1

8.5.2
289

8.5.2

290

8.5.2

291

8.5.2 a

292

8.5.2 b

293

8.5.2 c

294

8.5.2 d

295

8.5.2 d

296

8.5.2 e

297

8.5.2 f

8.5.3
298

8.5.3

299

8.5.3

300

8.5.3 a

301

8.5.3 b

302

8.5.3 c

303

8.5.3 c

304

8.5.3 d

305

8.5.3 e

General
requireme
nts
Establish
Cf. subthe quality clauses 5.1
manageme and 5.6.1
nt system
(QMS)

Document Cf. sub-clause 4.2.3


the QMS
Implement Cf. subthe QMS
clauses 5.1
and 5.5.2

Update the Cf. sub-clause 5.4.2


QMS
Improve
Cf. sub-clause 8.5
the
effectivene
ss of the
QMS

Determine
the
necessary
processes
and their
application

See subclause 1.2


of ISO
9001;
identify,
understand
and
evaluate all
core
activities
which form
the overall
look of the
organizatio
n

Determine
the
sequence
and
Although
interaction
the proce
of
ss mappin
processes

g is
notexplicit
ly
required, i
n practice
it
is the
best
response
to this
requireme
nt

Determine Establish
criteria and the means
methods
to control
for
processes
effectivene
ss of
process
operation
and control

Ensure the
necessary
resources
for process
operation
and
monitoring

Cf. subclauses
6.1 and 6.
2

Ensure the Cf. sub-clause 8.2.3


necessary
information
for process
operation
and
monitoring

Monitor
processes

Measure
processes

When it
makes
sense; to
achieve
the
objectives
of
each
process re
gularly
monitorth
e
indicators

Analyse
processes

Achieve
planned
results of
processes

Obtain
Cf. sub-clause 8.5.1
continual
improveme
nt of
processes

Manage
processes

Cf. subclauses
7.2 and 7.
5

Ensure
control of
outsourced
processes

Control of
an
outsource
d
process in
cludes the
establish
ment of
specific
provisions
with the
subcontra
ctor as co
ntracts,
procedure
s,regulati
ons
for comm
unication
and an au
ditagreem
ent

Define type
and extent
of control
of
Quote or
outsourced
make
processes

a referenc
e in
the
quality
manual of
the
implemen
ted
control m
eans foro
utsourced
processes

Document
ation
requireme
nts

General

Top of the page

Document
the quality
policy
The

quality
policy and
the
objectives
are
formalized
in
a
relevant
and
simple
document
Document
the quality
objectives

Document Cf. sub-clause 4.2.2


the quality
manual
Document The 6
the
mandatory
procedures procedures
are:

- control of documents (cf. sub-clause 4.2.3)

- control of records (cf. sub-clause 4.2.4)

- internal audit (cf. sub-clause 8.2.2)

- nonconforming product (cf. sub-clause 8.3)

- correctives actions (cf. sub-clause 8.5.2)

- preventive actions (cf. sub-clause 8.5.3)

Determine Cf. sub-clause 4.2.4


the records
related to
procedures

Determine
the
documents
ensuring
the
planning,
operation
and control
of
processes

Quality
manual

The bare
minimum i
s often the
best choice

Establish
the quality
manual

In
the
quality
manual cl
early
identify th
e scope of
applicatio
n
of the QM
S (include
key
products
and custo
mers). Do
not forget
to
indicate a
nd justify
the exclus
ion of
clause
7- for
example t
he design

Update the
quality
manual
Determine
the scope
of the QMS
and the
exclusions

See subclause 1.2


of ISO
9001

Determine
the
documente
d
procedures
or a
refernece
to them

Cf. sub-clause 4.2.1;if proceduresare not partof the quality manualthenthereis a referen

Describe
interaction
s between
processes

A process
map meet
s
this
requireme
nt. You
can
also
use a
table
showing
the intera
ctions
between
processes

Control of
Top of the page
documents
Control the
documents

Before
starting
to use
a
document
, it is
approved
(verified,
validated)
by
a
personwit
h defined
responsibi
lities
and autho
rities

Control the Cf. sub-clause 4.2.4


records

Document
the
procedure
control of
documents

Cf. sub-clause 4.2.1;the mandatory procedurefor documentsanswers the questions who,w

Review,
update and
approve
again
documents

The
documents
live with
products
and
processes

Control
changes

Control of
changes a
nd version
s ofdocum
ents
is
done by a
person wit
hestablish
ed respon
sibilities
and autho
rities

Control the
relevant
version
Ensure the "The right
availability document,
at the right
place at
the right
moment"
and with
the right
version

Ensure the Chaque


legibility
document
est clair,
simple
comprendr
e, facile
catgoriser

Identify
Method for
documents coding doc
uments

Control
documents
of external
origin
External

document
s (standar
ds,
specificati
ons) are
controlled
(list, loca
tion,
version)

Prevent
use of
obsolete
documents Expired

document
s (obsolet
e) are
maintaine
d, archive
d, destroy
ed or lock
ed
upso that
we can
not use
them nor
mally

Identify
retained
obsolete
documents
Control of
Top of the page
records

Control
conformity
records

The
records ar
e
filled daily
(without
delay).Wit
hout
them it's
hard (or
impossibl
e)
todemons
trate
complianc
e
with
therequire
ments of
the QMS

Control
effectivene
ss records

Document
the
procedure
control of
records

Cf. sub-clause 4.2.1;the mandatory procedurefor recordsanswers the questions who,whe

Store
records

Protect
records
Ensure
availability
of records

"Spoken
words fly
away,
written
ones stay.
Latin
proverb"

Define
retention
time of
records

Number
of
years
or life of
the produ
ct plus
number of
years

Define hte
method of
retrieval
and
disposition
of records

Ensure
legibility of
records
Managem
Planifier (
ent
Plan), Agir
responsib
(Act)
ility
Managem
ent
commitm
ent
Communic "When you
ate the
sweep the
importance stairs, you
of meeting start at the
customer bottom.
requiremen Romanian
ts
proverb"

Communic
ate the
importance
of meeting
legal
requiremen
ts

Establish
the quality
policy

Define the
quality
policy is a
n unavoid
ablecomm
itment, di
rect and d
ocumente
d by top
managem
ent
to implem
ent
and impro
ve the
effectiven
ess
of
the QMS

Establish
the quality
objectives

Quantify
quality
objectives
in each
departme
nt consist
ent with t
he quality
policy
and custo
mer
requireme
nts

Conduct
manageme
nt reviews

Cf. sub-clause 5.6;keeprecords ofmanagement reviews,which areevidence that theQMS

Ensure
availability
of
resources Cf.

subclause
6.1;
top mana
gement
provides t
he
resources
to achieve
the
quality ob
jectives

Customer
Top of the page
focus
Determine Cf. subcustomer clauses
requiremen 7.2.1 and
ts
8.2.1

Meet
Cf. sub-clause 7.2
customer
requiremen
ts
Quality
policy
Adapt the
quality
policy to
the
purpose of
the
organizatio
n

The quality
policy
is consiste
nt with cus
tomer
satisfaction
and
continual
improveme
nt of
the QMS

Determine
the
commitme The
nt to
quality
comply
policy
with
is a direct
requiremen
and
ts of the
document
QMS

edcommit
ment of
top
managem
ent
at
itshighest
level

Determine Cf. subthe


clauses 5.1
commitme and 8.5.1
nt to
continually
improve
the
effectivene
ss of the
QMS
Provide a Cf. sub-clause 5.6; the management review is the best answer for this requirement
framework
for
establishin
g the
quality
objectives

Communic Cf. sub-clause 5.5.3


ate and
explain the
quality
policy

Review the Cf. sub-clause 5.6; the quality policyis constantly evolving. It is a goal of the management
quality
policy

Planning
Quality
objectives
Establish
Cf. sub-clause 7.1
the quality
objectives

Determine Cf. sub-clause 7.2


quality
objectives
for product
requiremen
ts

Be able to
measure
the quality
objectives

Quality
objectives
are quantifi
ed, translat
ed(broken
down) into
indicators
and
monitoredr
egularly (d
ashboards)
.A
criterion
ofmeasura
bility can
be
"Yes / No"

Adapt the
quality
objectives
with the
quality
policy

Quality
manageme
nt system
planning
Follow the Cf. sub-clause 4.1
process
approach
when
planning
the QMS
Plan the
QMS so as
to meet
quality
objectives

Keep the
integrity of
the QMS
when
changes
are
implement
ed

Cf. sub-clause 7.3.7;play special attentionon control ofchangesand their impact onthe pe

Responsib
ility,
authority
Top of the page
and
communic
ation
Responsibil
ity and
authority

Define
responsibili
ties and
authorities

"Responsi
bility can
not
be shared
. RobertH
eilein"; cl
ear
and
available
internally
job
descriptio
ns (also o
rganizatio
nal
chart,com
petency
matrix)

Communic
ate
responsibili
ties and
authorities

Manageme
nt
representa
tive
Appoint a
manageme
nt
representa
tive

Establish
the
processes

He is a
member of
manageme
nt and is
notnecessa
rily from
the quality
departmen
t

Cf. subclauses
7.2 and 7.
5

Implement Cf. sub-clause 4.1


the
processes
Update the
processes

Report to Cf. sub-clause 5.6


top
manageme
nt on the
performanc
e of the
QMS
Report to Cf. sub-clause 5.6
top
manageme
nt on any
need for
improveme
nt
Promote
awareness
of
customer
requiremen
ts
Internal
communica
tion
Establish
Play special
communica attention t
tion
o
processes feedback (
surveys,su
ggestion
box)

Communic
ate on the
effectivene
ss of the
QMS
Managem
ent
review
General

General
Review the
QMS by
top
manageme "No
system
nt

is perfect"
, usually o
nce
or
twicea
year,
review th
e
whole QM
S to monit
or
the
achievem
ent of
quality
objectives

Evaluate
the
improveme
Review
nt
opportuniti the opport
unities (ca
es

ses, condi
tions,opti
ons, circu
mstances)
for contin
ual
improvem
ent of the
QMS

Maintain the
Cf.records
sub-clause
from4.2.4
management reviews

Review
input

Top of the page

Include
information
audit
results

The intern
al
audit
reports an
d
their
proposals
are an
important
source
of informa
tion
to
improve
the QMS

Include
information
on
customer
feedback

"Love
your custo
mers mor
e
than your
products",
all
data
on custom
er satisfac
tion
and
non satisf
action
are an
important
source
of informa
tion
to
improve
the QMS

Include
information
on process
performanc
Results of
e

the achiev
ement of
qualityobj
ectives an
d data
analysis r
elated to
theproces
s malfunct
ions (nonc
onformitie
s)

Include
Same for
information the
on product products
conformity

Include
Results of
information actions,
on
their
preventive follow-up,
and
the
corrective obtained
actions
improveme
nts
Include
information
on follow- Results
up actions of decisio

ns made
during
the lastm
anagemen
t
review an
d
their
follow-up

Include
information
on changes

Consider,
evaluate
and
analyze a
ny
changesth
at
may
impact on
the QMS (
new prod
ucts
/processe
s, new
customers
, new
features a
nd / or re
sponsibilit
ies, legal
and
regulatory
changes)

Include
information
on
Suggestio
improveme ns,
nt
opinions,
recommen proposals
dations

from all
staff and
external i
ntersted
parties

Review
output

Decide
actions
related to
improveme
nt of the
effectivene
ss of the
QMS and
its
processes

Decisions
to
improve
the QMS, i
ts
effectiven
ess and
its
processes
are input
data of th
e
continual
improvem
ent
process

Decide
actions
related to
After anal
product
improveme ysis, the
nt
decisions

of product
improvem
ent, in
line
with custo
mer
requireme
nts, are
formalized
(perform
ance
objectives
)

Decide
actions
related to
resources
needs

After
analyzing
the
decisions
of
ensuringn
ecessary
human
and
material
resources
are
formalized

Resource
managem Planifier(Plan)
ent
Provision
Top of the page
of
resources
Determine
and
provide
resources
To Improv
to
implement e the
the QMS
effectiven

ess of
theQMS id
entify and
ensure
the needs
of present
and future
resources
:

- human (
quantity
and
quality - s
kills)

- infrastru
cture (buil
dings,
equipmen
t)

- work
environm
ent (ergo
nomics, h
ygiene,he
alth
and
safety)

- financial
resources
Determine
and
provide
resources
to update
the QMS
Determine
and
provide
resources
to improve
continually
the
effectivene
ss of the
QMS

Determine
and
provide
resources
to enhance
customer Priority to
satisfaction the

resources
that
are directl
y related
to custom
ers and m
eeting
theirrequi
rements (
commerci
al, recepti
on, sales,
schedulin
g, design
and
developm
ent, testin
g,inspecti
on)

Human
resources
General

Ensure
competenc
e of staff

Priority to
identify a
nd
review (a
nnual
performan
ce) skills
of persons
with a
direct
impact
on quality

Competenc
e, training
and
awareness
Determine
competenc
e of
personnel Identify re

quirement
s (job
descriptio
ns) in
competen
ce of
persons
with a
direct
impact
on quality

Provide
training

Evaluate
the
effectivene
ss of
training

Identify
and meet
the needs
of compe
tence
improvem
ent (traini
ng
programm
e)
Review the
improveme
nt in
competenc
e (evaluate
trainings,
measure
their
effectivene
ss 3 to 6
months
later)

Ensure that
personnel
is aware of
the way
they
"Quality
contribute is everybo
to the
dy's
achieveme business";
nt of the
staff
quality
awarenes
objectives

s of the
link betwe
en
training a
nd
individual
responsibi
lity to achi
eve qualit
yobjective
s

Maintain
Cf. sub-clause 4.2.4
records of
initial and
professiona
l training,
knwo-how
and
experience

Infrastruc
Top of the page
ture

Determine
the
infrastructu
re

As
appropriat
e identify
buildings,
facilities,
equipmen
t (machin
es and do
cumentati
ons)and s
upport
services t
hat
impact on
product
conformit
y

Provide the
infrastructu
re
Maintain
Control the
the
maintainan
infrastructu ce of the
re
infrastructu
re

Work
environm
ent

Determine
the work
environme
nt

Identify h
uman and
physical
factors th
at
affect pro
duct
conformit
y (motivat
ion, work
organizati
on, works
tation erg
onomics,li
ghting, hy
giene, te
mperature
, security)

Control the Control


work
these
environme factors
nt
Product
realizatio Drouler(Do)
n
Planning
of product
realizatio
n

Plan the
processes
for product
realization

These
are all
processes
that
meet the
needsand
expectatio
ns
of
customers
(fromquo
tation to
after sales
service).
Process
mapping c
an lighten
the overal
l image of
product
realization

Develop
the
processes
for product
realization

Plan the
Cf. sub-clause 4.1;take intoaccountpreventionwherever possible
product
realization
in
conformity
with the
requiremen
ts of the
other
processes

Determine Cf. sub-clause 5.4.1


the quality
objectives

Determine Cf. sub-clause 7.2


the
requiremen
ts for the
product
Determine
the
processes Establish
specific to and
the product implemen

t processe
s and
document
ation for
each
product
Establish
the
documents
specific to
the product

Provide
resources
specific to
the product

Determine Establish a
the
nd
activities
implement
specific to monitoring
the product and
such as
measuring
verification processes f
,
or each
validation, product
monitoring,
measuring,
inspection
and test

Determine
criteria for
product
acceptance

Determine Cf. sub-clause 4.2.4


process
specific
records
Determine Cf. sub-clause 4.2.4
product
specific
records
Ensure that Usually
planning
it's the
outputs are quality
in a
plan or any
suitable
other
form
similar doc
ument

Customer
-related Top of the page
processes

Determinat
ion of
requiremen
ts related
to the
product
Determine
requiremen
ts specified
by the
customer

"The only
measure
of quality
is custom
er
satisfactio
n", identif
y
and imple
ment
customer
needs
and expec
tationsint
o internal
product re
quirement
s(producti
on, delive
ry and
after deliv
ery)

Determine
requiremen
ts for
Identify
intended
and apply
use

the implici
t custome
rneeds
and
expectatio
ns (lifetim
e
warranty,
exemplary
reliability,
easy
maintena
nce)

Determine
product
statutory Identify
and
all
regulatory
requireme
requiremen
nts applic
ts

able
to
the
product (i
ncluding r
ecycling
and
disposal)a
nd
establish
a regulato
ry watch

Determine
requiremen
ts
considered Identify in
necessary ternal
by the
requireme
organizatio
nts (const
n

raints,rule
s, confide
ntiality, he
alth and
safety,hyg
iene)

Review of
requiremen
ts related
to the
product
Review
product
requiremen
Review be
ts

forehand
product
requireme
nts(feasibi
lity, profit
ability)

Conduct
the review
before
committing
to supply a
product to
the
customer

Beforehan
d means
before
any produ
ctioncom
mitment

Define
Identify
product
and
requiremen approve all
ts
requiremen
ts
internally

Resolve
gaps
between
requiremen Any
ts
change is

taken into
account (
approved)
before co
mpletion
of produc
tion com
mitment

Ensure that The


the
requiremen
organizatio ts are
n has the defined
ability to
and
meet the approved
requiremen
ts

Maintain
Cf. sub-clause 4.2.4
the records
of the
results of
the review

Confirm
not stated
customer In
this
requiremen case inter
ts
nal appro

val of req
uirements
before
notifying t
he
customer
Amend
documents
when
product
requiremen
Each chan
ts are
ge
of
changed

a product
requireme
ntinvolves
updating
internal
document
s and
distributio
n of
informatio
n to those
concerned

Inform the
personnel
about
changed
requiremen
ts
Customer
communica Top of the page
tion

Determine "Good
arrangeme news walk,
nts for
bad ones
communica run.
ting with
Swedish
customers proverb"
on product
information

Implement Establish ef
arrangeme fective
nts for
methods of
communica communica
ting with
tion with
customers the
on product customer
information

Determine Job
arrangeme description
nts for
of sales
communica manager
ting with
customers
on
consulting,
contracts,
orders and
amendmen
ts

Implement
arrangeme
nts for
communica
ting with
customers
on
consulting,
contracts,
orders and
amendmen
ts

Determine Identify
arrangeme methods of
nts for
communica
communica tion with
ting with
the
customers customer o
on
n satisfacti
feedback
on and co
mplaints

Implement
arrangeme
nts for
communica
ting with
customers
on
feedback

Design
and
developm
ent
Design and
developme
nt planning

Plan the
design and
developme
nt of
Manage
product
the

design an
d product
developm
entupstre
am by pre
vention (F
MEA, risk
analysis)

Control the
design and
developme
nt of
product

"I have
not failed.
I just
found 10,0
00 waystha
t do not
work. Tho
mas Edison
"

Determine
the design
and
developme
nt stages

Identify
and
formalize
the key
stages ofpr
oduct desig
n
and develo
pment

Determine
review,
Identify
verification and
and
formalize
validation
activities at the verific
each stage ation,desi

gn
validation
and produ
ct
developm
entsteps.
For
each key
step plan
the
action,
the
manager,
the
expected
result, the
criteria to
be
met,
the
materials
required,
the time
frame

Determine
the
responsibili
ties and
authorities
for design
and
developme
nt

Manage
the
interfaces
between
different
groups

Identify
and
formalize
the perso
ns with
responsibi
lities
and autho
rities spec
ified
foreach
key
stage of p
roduct de
sign
anddevelo
pment

Identify
and
formalize
the relatio
nshipsbet
ween all
actors in
the produ
ct design
anddevelo
pment (m
eetings an
d
reviews at
key
stages)

Update
planning
output

Planning
is updated
after
each
major
change of
the produ
ct design
anddevelo
pment

Design and
developme
nt inputs
Determine
inputs
relating to
Identify, f
product
requiremen ormalize
and keep
ts

the
informatio
n
needed to
start
the produ
ct design
anddevelo
pment

Maintain
records

Cf. sub-clause 4.2.4

Determine
functional
and
performanc The
functional
es
requiremen requireme
ts
nts found

in the
specificati
ons
(dimensio
ns, operat
ing
conditions
, tests)

Determine
statutory
and
regulatory
requiremen Requirem
ts
ents (qual

ifications
or
recomme
ndations)
related to
transporta
tion,
packaging
,
labels, ins
tructions
for
use, expir
y
date,
traceabilit
y,
componen
tsused

Determine
information
derived
from
previous
designs
The

results of
design
reviews of
previous
similar
products (
tests, reli
ability, fea
sibility)an
d feedbac
k
from user
s (sales,re
commend
ations, su
ggestions)

Determine
other
requiremen
ts essential
Specific
for design
requireme
and
of
developme nts
the
produ
nt

ct,
componen
ts (selecte
d
suppliers,
prohibited
materials)
,
environm
ental
aspects (d
isposal of
products)

Review
inputs

The
project
leader or
another
person ve
rify
and
validate
the consis
tency
of
the input

Ensure that
requiremen
ts are
complete,
unambiguo The
us and not project
in conflict leader or
with each another
other
person ve

rify
and
validate
for all inp
ut require
ments the
lack of
ambiguity
and
contradicti
on

Design and
developme Top of the page
nt outputs

Ensure that
outputs are
in a
Identify
suitable
measures
form
that

can deter
minecomp
liance bet
ween inpu
t
and
output
Approve
outputs

Always co
nfirm
(approve)
the outpu
ts by the
project
leader or
another
person pri
or to use

Ensure that
outputs
Conformit
meet input
y
requiremen
between o
ts

utputs an
d inputreq
uirements

Ensure that
outputs
provide
information Full
informatio
for
from
purchasing n
,
the BOM (
production componen
and service t
provision specificati

ons, raw
materials,
consuma
bles)

Ensure that
outputs
contain
product
Identify
acceptance the
criteria or
steps of
a reference
monitorin
to it

g (inspecti
ons)and
measure
ment (tes
ting) of pr
oduction
processes

Ensure that
outputs
specify
Informati
product
on
characteris about the
tics
intended
essential
and
for its safe
and proper unintende
d
use,
use

security,
maintena
nce

Design and
developme
nt review

Design and
developme
nt review
Evaluate
Cf. sub-clause 7.3.1
the ability
of results
to meet
requiremen
ts
Identify
problems

"A proble
m
shared is
a problem
halved"; t
heplanned
reviews c
an
predict po
tential
problems
and
propose a
ppropriate
preventiv
e actions

Determine
participant
s in
reviews

The
reviews c
onducted
by the
project
leaderor
another
person ar
e
multidisci
plinary wit
happropri
ate
participan
ts for
each step

Maintain
Cf. sub-clause 4.2.4
records of
the results
of the
reviews

Design and
developme
nt
verification

Perform
verification
of the
design and
developme
The
nt

reviews e
nable at k
ey
steps to
verify(trial
s, tests,
measure
ments, cal
culations)
whether
results ar
e in
line
with
objectives

Maintain
Cf. sub-clause 4.2.4
records of
the results
of
verification

Design and
developme
Top of the page
nt
validation

Perform
validation
of design After
and
verificatio
developme
n the
nt

design an
d
developm
ent
are valida
ted. This
implies
that
all custom
er
requireme
nts are
met

Complete In
validation practice al
before the most
delivery or always the
implement validation i
ation of the s carried
product
out
upstream

Maintain
Cf. sub-clause 4.2.4
records of
the results
of the
validation

Control of
design and
developme
nt changes
Identify
design and
developme
nt changes

The
changes
are clearly
identified

Maintain
Cf. sub-clause 4.2.4
records of
changes
Review,
verify and
validate
changes
before
implement
ation

Approve
changes
before
implement
ation

Each
change is
reviewed,
verified
and
validated
by the
project
leader or
another
person. T
he same
person or
another
personin
charge giv
es
final
approval

Evaluate
the effect
of changes

Each chan
ge
can
affect the
product (
BOM,sales
support).
Assess
risks and
potential
impacts
(simulatio
n
method)

Maintain
Cf. sub-clause 4.2.4
records of
the results
of change
review

Purchasin
g
Purchasing
process

Ensure that
purchased
product
conforms
to
requiremen "If
you
ts
buy qualit

y, you
only
cry
once.Engli
sh
proverb";
the
purchase
processinc
ludes
activities
to ensure
complianc
e
ofcompon
ents, mat
erials and
suppliesp
urchased

Determine
supplier
control
Compared

to the
impact on
the
productio
n and the
final
product

Evaluate
and select
The
suppliers

purchasin
g
process in
cludes the
evaluation
and
selection
of supplie
rs(incomi
ng
inspection
, audit at
supplier
premises,
product
purchased
with supp
lierquality
assurance
= produc
t
inspection
is
made at s
upplier
premises)

Establish
selection,
evaluationa The
nd repurchasin
evaluation
g
criteria

process in
cludes
thecontin
ual
evaluation
criteria (
monthly o
r
quarterly)
of
suppliers
(% of non
conformin
gpurchase
d product
s detected
at
reception
inspection
, producti
on and aft
er
sales
service)

Maintain
Cf. sub-clause 4.2.4
records of
results of
evaluation

Purchasing
Top of the page
information

Describe
the product
to be
purchased

Are taken
into
account al
l data on
thepurcha
sed
product (s
pecificatio
ns,
transport
conditions
, packing,
receiving,
testing,st
orage and
other)

Determine
approval
requiremen
ts
Determine
requiremen
ts for
qualificatio For
specific
n of
personnel cases staf

f receive
appropriat
e
training (
new type
product,
machine
orequipm
ent
not previo
usly used)

Determine
QMS
requiremen
ts

Everythin
g
concernin
g the
control
ofnonconf
ormities r
elated
to purcha
sedproduc
t and
actions, p
erson
in
charge
andtime
frame to
implemen
t

Ensure
adequacy
of
purchase Communi
requiremen cate requi
ts

rements t
o
the
supplierwi
ch
are realist
ic and
appropriat
e with
theQMS

Verification
of
purchased
product

Ensure that
purchased
product
The
meets
purchasin
purchase
g
requiremen
process in
ts

cludes the
identificati
on
and imple
mentation
ofinspecti
ons at
receiving
and
during
productio
n

In
the
particular
case of
Include in inspection
the
andreleas
purchasin e at
g
supplier p
informatio remises al
n
l
these
arrangem activities
ents
of are
verificatio formalized
n
at (contract,
supplier's specificati
premises ons
with acce
ptance
criteria)

Productio
n and
service
provision

Control of
production
and service
provision
Plan
production
and service Identify, d
provision evelop an
activities
d plan all

stages ofp
roduct
realization
process
Control the
production
and service
provision
activities

Ensure the
availability The produ
of
ct
information
describing specificati
the product on inform

ation isfre
ely
available
to staff

Ensure the
availability
Work
of work
instruction instructio
s
ns, record

sheets an
d others
are where
needed

Ensure the
use of
Equipmen
suitable
t
equipment

maintena
nce is
regularly
carried
out

Ensure the
availability
of
monitoring Monitorin
and
g and
measuring
measure
equipment

ment equi
pment are
maintaine
d in good
condition
and
the
staff
are traine
d in their
use

Ensure the
use of
monitoring
and
measuring
equipment

Implement
monitoring
Monitorin
and
measuring g and
equipment measure

ment equi
pment are
used regu
larly

Implement
release
activites

The releas
e,
transport
and after
sale
serviceare
formalized
and
managed

Implement
delivery
activities

Implement
postdelivery
activities

Validation
of
processes
Top of the page
for
production
and service
provision

Validate
special
processes
(where the
When the
output
cannot be product c
verified)
annot be

measured
(price too
high, can
be
done only
after use)
the
process is
checked
and
validated

Demonstr
The valida
ate
the
tion of
ability of
the proce
these
ss
processes
ensuresco
to achieve
mpliant
planned
products
results

Define
criteria for
The
process
criteria
review

for proces
s monitori
ng
and
measurin
g are
strengthe
ned

Define
criteria for
process
approval
Approve
equipment

Checking
equipmen
t and staff
training ar
e
reinforced

Approve
qualificatio
n of
personnel
Use
specific
methods
and
procedures
Establish
Cf. sub-clause 4.2.4
record
requiremen
ts
Establish
Every
provisions change
for
require a
revalidatio new
n
validation
of the
process
Identificati
on and
traceability

Identify
the product

When
appropriat
e identific
ation
of
the
product a
nd
componen
ts shows i
ts
statusrela
tive to the
productio
n stages
(bar
code,card,
label)

Identify
product
status
throughout The
product
identificati
realization

on of the
product al
so
showsits
status
(results)
relative
to monitor
ing
and
measurin
g stages

Control the
unique
identificatio
n of the
Product
product
traceabilit

y (who,
when, wit
h which
batch) sh
ows the hi
story
of
productio
n stages

Maintain records
Cf. sub-clause 4.2.4

Customer
property
Take care
with
customer
property

Customer
property i
ncludes:
- raw
materials
- compon
ents
packaging
materials
- equipme
nt

- testers a
nd softwa
re (intelle
ctual
property)

Identify
customer
property
Verify
customer
property
Protect
customer
property

Inspection
of custo
mer
property i
n
reception
(where
appropriat
e), specifi
c
storage a
ndprotecti
on when
requested
by
customer

Safeguard
customer
property

When
property is
lost or
damaged
report it to
the
Any
customer concern w

ith custo
mer
property i
scontrolle
d as a no
nconformi
ty (identifi
cation,ana
lysis, deci
sion, reco
rding) and
more tha
n
that requi
red comm
unication
with
the
customer

Maintain
Cf. sub-clause 4.2.4
records of
reports to
the
customer

Preservatio
n of
product

Preserve
conformity
of product
to
requiremen The produ
ct
is
ts

protected
internally
and up to
delivery t
o
the
customer
(packagin
g, storage
conditions
)

Provide
product
identificatio
n,
handling,
Preservati
packaging,
on of the
storage
product
and
protection includes a

ll stages
of product
life cycle (
receiving,
productio
n, handlin
g,
storage,
delivery)

Apply
product
preservatio
Compone
n to
raw
component nts,
materials
s

and semi
finishedpr
oducts ar
e part of
the
product

Control of
monitorin
g and
measurin
g
equipmen
t
Determine
monitoring
and
measuring The proce
activities to ss of moni
be
toring and
undertaken

measure
mentare
in
place
to collect
evidence
of product
complianc
e

Determine
monitoring Equipmen
and
t
measuring
equipment list with s

erial
numbers

Establish
monitoring
and
measuring Monitorin
processes g and

measurin
gdevices
meet inter
nal, custo
mer and
regulatory
requirem
ents

Calibrate
and verify
measuring Measuring
equipment equipmen

t (hardwa
re
and
software)
are
calibrated
or
verified re
gularly
Record
Cf. sub-clause 4.2.4
calibration
and
verification
methods
Agjust
measuring Measuring
equipment

equipmen
t are
adjusted r
egularly

Identify
The validity
calibration date is
status
available o
n the
equipment

Safeguard
adjustment
Protection
s of
measuring against ac
equipment tions of

intended
or
unintende
d misadju
stment
Safeguard
measuring
equipment Effective
from
protection
damage
not
and
only durin
deterioratio
g their
n

use(travel
,
maintena
nce,
storage)

Assess
nonconfor
This
ming
equipment concerns t

he potenti
ally nonco
nforming
products

Take
appropriate
actions on
nonconfor Equipmen
ming
t
product

is verified
and
calibrated
.Products
are
inspected,
validated
(with
or
without co
ncession)
or identifi
ed
as
nonconfor
ming

Maintain
Cf. sub-clause 4.2.4
records of
the results
of
calibration
and
verification

Confirm
the ability
of
Monitorin
monitorin g and
g
and measure
measurin ment soft
g
ware
software isvalidate
to satisfy d before
intended use
applicatio
n

Undertake
a
confirmatio Make
second va
n before
initial use lidation if

the
first one i
s
not
satisfactor
y
Measurem
ent,
Constater
analysis
(Check), A
and
gir (Act)
improvem
ent
General Top of the page
Plan the
processes
necessary
to
demonstrat "If
you
e
can't mea
conformity sure
to product
it, you
requiremen
can't man
ts

age it.Pet
er Drucke
r"; control
of product
complian
ce
is demons
trated
by inspect
ion
processes
throughou
t
the produ
ction
stages

Implement
the
processes
necessary
to
demonstrat
e
conformity
to product
requiremen
ts

Plan the
processes
necessary
to ensure
conformity Control
of the QMS of the

conformit
y of
the
QMS is
ensured a
mong
other
things
on manag
ement
processes
(strategy,
auditing,
continual
improvem
ent, self
assessme
nt)

Implement
the
processes
necessary
to ensure
conformity
of the QMS

The overal
l
improvem
ent in the
effectiven
ess
of
Plan
the
the QMS i
processes
s
the
necessary
result of
to
all improv
continuall
ement
y improve
activities (
the
audits, da
effectiven
ta
ess of the
analysis,
QMS
new
objectives
, correctiv
e
and
preventiv
e actions)

Implemen
t
the
processes
necessary
to
continuall
y improve
the
effectiven
ess of the
QMS

Determine
monitoring,
measurem
ent,
Data
analysis
analysis, s
and
tatistical
improveme
nt methods technique

s (SPC,sta
tistical
process
control),
Kaizen, Is
hikawa
diagram (
5 M)

Monitorin
g and
measure
ment
Customer
satisfaction

Monitor
customer
perception Measure

the level
of satisfac
tion
of custom
erneeds
and expe
ctations (c
ongratulat
ions,retur
ns, compl
aints, rec
ommenda
tions). Th
e
customer
may
be the
direct
customer(
distributor
) or the
end
customer
(consume
r)

Examples:
surveys,
feedback,
Determine
open
monitorin
doors,trac
g
of
king retur
customer
ns
satisfactio
and custo
n
mer
methods
complaint
s,benchm
arking

Internal
audit

Conduct
Cf. sub-clause 7.1
internal
audits to
determine
whether
the QMS
conforms
to the
planned
arrangeme
nts

Conduct
internal
audits to
determine
whether
the QMS
conforms Annual
programm
to the
requiremen e of
internal
ts of the
ISO 9001 audits
standard

Conduct
internal
audits to
determine
whether Audits spe
the QMS cific to the
conforms organizati
to
the on
requireme
nts of the
organizati
on

Conduct
internal
Internal
audits to audits allo
determine w
whether measurin
the QMS g the
is
performan
effectively ce
of
implemen the QMS
ted

Conduct
internal
audits to
The
determine
frequency
whether
of
the QMS
audits is a
is
ppropriate
effectively
maintaine
d

Plan the
audit
programm
e

The audit
programm
e focuses
on sensiti
veprocess
es
and areas
without
forgetting
theresult
s
of
previous
audits

Mandator
Define the
y
audit
informatio
criteria,
n included
scope,
in the
frequency
procedure
and
"Internal
methods
Audit"
Ensure
objectivity
and
impartiality
of internal
audits

Training
and select
ion
of
auditors

Ensure that
auditors
don't audit "No one is
their own a judge in
work
his
own

case. Lati
n
proverb"

Establish a
documente
d
procedure
for internal
audits

Cf. sub-clause 4.2.1;the mandatory procedureforauditsanswers the questionswho, when,

Maintain
Cf. sub-clause 4.2.4;audit report
records of
the audit
results

Ensure that
the
corrections The perso
and
n
in
correctives charge of
actions are
the
taken
actions is
without
on
undue
schedule t
delay

o identify
and
eliminate
the
causesof
nonconfor
mities

Verify the
taken
actions

The
results of
the
follow-up
of
the correc
tive
actions ar
e verified
and recor
ded

Record the Cf. sub-clause 8.5.2


report of
the results
of the
verification

Monitoring
and
measurem Top of the page
ent of
processes

Monitor
and
measure
QMS
processes

Monitor
and
measure t
he proces
sobjective
s and indi
cators usi
ng an
establishe
d method

Demonstra
te the
ability of
the
When
processes objectives
to achieve
and indic
planned
ators are
results

achieved
the proce
ss is
effective (
inspection
s at
key
stages)

Cf. sub-clause 8.5.2

Undertake
correction
s
and
corrective
actions
when
planned
results of
processes
are
not
achieved

Monitoring
and
measurem
nt of
product
Monitor
and
measure
product
Monitorin
characteris
g of
tics

product
characteri
stics verif
ysatisfacti
on to
product
requireme
nts(inspec
tions at
key
stages)

Monitor
Cf. sub-clause 7.1
and
measure
the product
at
appropriate
stages

Maintain
Cf. sub-clause 4.2.4
evidence of
conformity
with the
acceptance
criteria

Record
the
person
having
authorise
d
the
product
release

Cf. sub-clause 4.2.4

Cf. sub-clause 7.1


Release of
product
only after
planned
arrangem
ents have
been
satisfied

Control of
nonconfor
ming
product

"Any
problem h
Ensure
ides an
that
opportunit
nonconfor
y
for
ming
improvem
product is
ent "; ide
identified
ntification
and
and isolati
controlled
on of
to prevent
nonconfor
its
ming
unintende
product fo
d use
r treatme
nt

Establish
the
documente
d
procedure
control of
nonconfor
ming
product

"Quality shine from afar, defects from up close.VictorHugo",cf. sub-clause 4.2.1,themand

Undertake
Identify n
actions to
onconfor
eliminate
mities and
the
treat
detected
them
nonconfor
likescrap
mity
Authorize
its use,
release or
acceptance
under
concession

Undertake
actions
Correction
not
, repair, re
allowing habilitatio
intended n or scrap
use

Recall (pr
event
use after
delivery),
withdrawa
Undertake l (prevent
actions
the
when
a distributio
nonconfor n),commu
ming
nication,
product is batch iden
detected tification,i
after
solation, r
delivery oot cause
analysis, c
orrective
and
preventiv
e actions

Maintain
Cf. sub-clause 4.2.4
records of
the nature
of
nonconfor
mities and
actions
taken

Verify
again the
corrected
nonconfor Any corre
ming
cted nonc
product

onforming
product is
always
verified b
efore
being retu
rned with
other pro
ducts

Analysis
Top of the page
of data
Determine
The
data to
demonstart preparatio
n of the
e the
suitability managem
and
ent
effectivene reviewincl
ss of the
udes the
QMS

collection
and
analysis
of data(in
dicators,
audit
results, le
vel
of custom
er
satisfactio
n). After
synthesis
decisions
of the
managem
ent
review ab
out
continual
improvem
ent

Collect
data to
demonstart
e the
suitability
and
effectivene
ss of the
QMS
Analyse
data to
demonstart
e the
suitability
and
effectivene
ss of the
QMS
Evaluate
the
opportuniti
es to
improve
the
effectivene
ss of the
QMS

Include
data from
monitoring
and
measuring
activities

Any oppor
tunity for
improvem
ent is
evaluated
before its
implemen
tation

Analysis o
f indicator
s
related a
mong
other
things to
monitorin
g and
measure
ment

Provide information
Cf. sub-clause
on customer
8.2.1 satisfaction

Cf. sub-clause 8.2.4

Provide information on conformity to product requirements

Provide
informatio
n
on
trends of
processes
and
products

Cf. subclauses
8.2.3 and
8.2.4

Provide
Cf. sub-clause 7.4
information
on on
suppliers
Improve
ment
Continual
improveme
nt

Continually
improve
the
effectivene
ss of the
QMS

"Quality
is a journ
ey
not
a destinati
on";apply
the proce
ss
continual
improvem
ent of
the QMS (
turn the
Deming
wheel). Id
entify
opportunit
ies
for improv
ement, fin
d
anderadic
ate
the
root
causes of
nonconfor
mities,pro
mote prev
entive
actions

Corrective
action
Undertake
action to
eliminate
the causes Analysis a
of
nd eradica
nonconfor
tion of the
mities

causes of
nonconfor
mities in
the
process, p
roduct
orQMS

Adapt
corrective
actions to
the effects
of
nonconfor
mities

Make
arrangem
ents with
respect
to real
effects (w
atch
out
for excess
ive zeal)

Establish
the
documente
d
procedure
for
corrective
action and
review
nonconfor
mities

Cf. sub-clause 4.2.1;the mandatory procedureforcorrective actionanswers the questions

Determine
the causes
of
nonconfor Include in
mities
the

procedure
methods
to find the
causes of
nonconfor
mities (Is
hikawa
diagram,
MSP)

Evaluate
the need to
undertake
corrective
action

What
could be
achieved i
f an actio
n
is
applied? T
he
resources
needed ar
e
theyavaila
ble? (Som
e
nonconfor
mities do
not
require co
rrective
actions)

Determine
the
necessary Include th
action

e
procedure
the
method fo
r
determini
ng
responsibi
lities, aut
horities, ti
me
frames, re
sources a
nd
monitorin
g
of
actionsto
implemen
t

Implement
the
necessary
action
Record the Cf. sub-clause 4.2.4
results of
the
corrective
action

Review the
effectivene
ss of the
corrective Analyse
action
the monit
undertaken

oring
of
actions
(possibilit
y
of
a
new audit
), improve
document
ation

Preventive
Top of the page
action
Determine
the action
allowing
the
elimination
of the
causes of
potential
nonconfor
mities

Adapt
preventive
actions to
the effects
of the
potential
problems

Analysis
and elimin
ation of p
otential
causesof
nonconfor
mities of
processes
or of the
QMS

Make
arrangem
ents with
respect
to potenti
al
effects (st
ay
within ava
ilable
resources
)

Establish
the
documente
d
procedure
preventive
action and
determine
potential
nonconfor
mities and
their
causes

Cf. sub-clause 4.2.1;the mandatory procedureforpreventive actionsanswers the question

Evaluate
the need to
undertake Will
the
preventive occurence
action
avoided?

The
resources
needed ar
e
they avail
able?

Determine
the
necessary Include in
action

the
procedure
the
method fo
r
determini
ng
responsibi
lities, aut
horities, ti
me
frames, re
sources a
nd
monitorin
g
of
actionsto
implemen
t

Implement Find the


the
causes
necessary
action
Record the Cf. sub-clause 4.2.4
results of
the
preventive
action

Review the
effectivene
ss of the
preventive
action
undertaken

Analyse
the monito
ring of
actions
(possibility
of a
new audit),
improve
documenta
tion