ISO 9001 - Requirements and comments

Clause,
N Requirement
subclause

4 Quality management system

4.1 General requirements

1 4.1 Establish the quality management system (QMS)

2 4.1 Document the QMS

3 4.1 Implement the QMS
4 4.1 Update the QMS
5 4.1 Improve the effectiveness of the QMS

Determine the necessary processes and their

6 4.1 a
application

Determine the sequence and interaction of

7 4.1 b
processes

Determine criteria and methods for effectiveness of

8 4.1 c
process operation and control
Ensure the necessary resources for process
9 4.1 d
operation and monitoring
Ensure the necessary information for process
10 4.1 d
operation and monitoring
11 4.1 e Monitor processes

12 4.1 e Measure processes

13 4.1 e Analyse processes

14 4.1 f Achieve planned results of processes

15 4.1 f Obtain continual improvement of processes

16 4.1 Manage processes

17 4.1 Ensure control of outsourced processes

Define type and extent of control of outsourced

18 4.1
processes

4.2 Documentation requirements

4.2.1 General

19 4.2.1 a Document the quality policy

20 4.2.1 a Document the quality objectives

21 4.2.1 b Document the quality manual
22 4.2.1 c Document the procedures

23 4.2.1 c Determine the records related to procedures

Determine the documents ensuring the planning,

24 4.2.1 d
operation and control of processes

4.2.2 Quality manual

25 4.2.2 Establish the quality manual

26 4.2.2 Update the quality manual

27 4.2.2 a Determine the scope of the QMS and the exclusions

Determine the documented procedures or a

28 4.2.2 b
refernece to them

29 4.2.2 c Describe interactions between processes

4.2.3 Control of documents

30 4.2.3 Control the documents

31 4.2.3 Control the records

32 4.2.3 a Document the procedure control of documents

33 4.2.3 b Review, update and approve again documents

34 4.2.3 c Control changes

35 4.2.3 c Control the relevant version

36 4.2.3 d Ensure the availability

37 4.2.3 e Ensure the legibility

38 4.2.3 e Identify documents

39 4.2.3 f Control documents of external origin

40 4.2.3 g Prevent use of obsolete documents

41 4.2.3 g Identify retained obsolete documents

4.2.4 Control of records

42 4.2.4 Control conformity records

43 4.2.4 Control effectiveness records

44 4.2.4 Document the procedure control of records

45 4.2.4 Store records

46 4.2.4 Protect records

47 4.2.4 Ensure availability of records

48 4.2.4 Define retention time of records

Define hte method of retrieval and disposition of

49 4.2.4
records
50 4.2.4 Ensure legibility of records
5 Management responsibility

5.1 Management commitment

Communicate the importance of meeting customer

51 5.1 a
requirements
Communicate the importance of meeting legal
52 5.1 a
requirements

53 5.1 b Establish the quality policy

54 5.1 c Establish the quality objectives

55 5.1 d Conduct management reviews

56 5.1 e Ensure availability of resources

5.2 Customer focus

57 5.2 Determine customer requirements
58 5.2 Meet customer requirements

5.3 Quality policy

Adapt the quality policy to the purpose of the

59 5.3 a
organization

Determine the commitment to comply with

60 5.3 b
requirements of the QMS

Determine the commitment to continually improve

61 5.3 b
the effectiveness of the QMS

Provide a framework for establishing the quality

62 5.3 c
objectives

63 5.3 d Communicate and explain the quality policy

64 5.3 e Review the quality policy

5.4 Planning

5.4.1 Quality objectives

65 5.4.1 Establish the quality objectives

Determine quality objectives for product
66 5.4.1
requirements

67 5.4.1 Be able to measure the quality objectives

68 5.4.1 Adapt the quality objectives with the quality policy

5.4.2 Quality management system planning

69 5.4.2 a Follow the process approach when planning the QMS

70 5.4.2 a Plan the QMS so as to meet quality objectives

Keep the integrity of the QMS when changes are

71 5.4.2 b
implemented

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

72 5.5.1 Define responsibilities and authorities

73 5.5.1 Communicate responsibilities and authorities

5.5.2 Management representative

74 5.5.2 Appoint a management representative

75 5.5.2 a Establish the processes
76 5.5.2 a Implement the processes
77 5.2.2 a Update the processes
Report to top management on the performance of
78 5.5.2 b
the QMS
Report to top management on any need for
79 5.5.2 b
improvement
80 5.5.2 c Promote awareness of customer requirements

5.5.3 Internal communication

81 5.5.3 Establish communication processes

82 5.5.3 Communicate on the effectiveness of the QMS

5.6 Management review

5.6.1 General

83 5.6.1 Review the QMS by top management

84 5.6.1 Evaluate the improvement opportunities

85 5.6.1 Maintain the records from management reviews

5.6.2 Review input

86 5.6.2 a Include information audit results

87 5.6.2 b Include information on customer feedback

88 5.6.2 c Include information on process performance

89 5.6.2 c Include information on product conformity

Include information on preventive and corrective
90 5.6.2 d
actions

91 5.6.2 e Include information on follow-up actions

92 5.6.2 f Include information on changes

Include information on improvement

93 5.6.2 g
recommendations

5.6.3 Review output

Decide actions related to improvement of the

94 5.6.3 a
effectiveness of the QMS and its processes

95 5.6.3 b Decide actions related to product improvement

96 5.6.3 c Decide actions related to resources needs

6 Resource management
6.1 Provision of resources

Determine and provide resources to implement the

97 6.1 a
QMS

98 6.1 a Determine and provide resources to update the QMS

Determine and provide resources to improve

99 6.1 a
continually the effectiveness of the QMS

Determine and provide resources to enhance

100 6.1 b
customer satisfaction

6.2 Human resources

6.2.1 General

101 6.2.1 Ensure competence of staff

6.2.2 Competence, training and awareness

102 6.2.2 a Determine competence of personnel

103 6.2.2 b Provide training

104 6.2.2 c Evaluate the effectiveness of training

Ensure that personnel is aware of the way they

105 6.2.2 d contribute to the achievement of the quality
objectives

Maintain records of initial and professional training,

106 6.2.2 e
knwo-how and experience

6.3 Infrastructure

107 6.3 Determine the infrastructure

108 6.3 Provide the infrastructure

109 6.3 Maintain the infrastructure

6.4 Work environment

110 6.4 Determine the work environment

111 6.4 Control the work environment

7 Product realization

7.1 Planning of product realization

112 7.1 Plan the processes for product realization

113 7.1 Develop the processes for product realization

Plan the product realization in conformity with the

114 7.1
requirements of the other processes

115 7.1 a Determine the quality objectives

116 7.1 a Determine the requirements for the product

117 7.1 b Determine the processes specific to the product

118 7.1 b Establish the documents specific to the product

119 7.1 b Provide resources specific to the product

Determine the activities specific to the product such

120 7.1 c as verification, validation, monitoring, measuring,
inspection and test

121 7.1 c Determine criteria for product acceptance

122 7.1 d Determine process specific records

123 7.1 d Determine product specific records

124 7.1 Ensure that planning outputs are in a suitable form

7.2 Customer-related processes

Determination of requirements related to the
7.2.1
product

125 7.2.1 a Determine requirements specified by the customer

126 7.2.1 b Determine requirements for intended use

Determine product statutory and regulatory

127 7.2.1 c
requirements

Determine requirements considered necessary by

128 7.2.1 d
the organization

7.2.2 Review of requirements related to the product

129 7.2.2 Review product requirements

Conduct the review before committing to supply a

130 7.2.2
product to the customer

131 7.2.2 a Define product requirements

132 7.2.2 b Resolve gaps between requirements

Ensure that the organization has the ability to meet

133 7.2.2 c
the requirements
134 7.2.2 Maintain the records of the results of the review

135 7.2.2 Confirm not stated customer requirements

Amend documents when product requirements are

136 7.2.2
changed
137 7.2.2 Inform the personnel about changed requirements

7.2.3 Customer communication

Determine arrangements for communicating with

138 7.2.3 a
customers on product information

Implement arrangements for communicating with

139 7.2.3 a
customers on product information

Determine arrangements for communicating with

140 7.2.3 b customers on consulting, contracts, orders and
amendments

Implement arrangements for communicating with

141 7.2.3 b customers on consulting, contracts, orders and
amendments

Determine arrangements for communicating with

142 7.2.3 c
customers on feedback

Implement arrangements for communicating with

143 7.2.3 c
customers on feedback

7.3 Design and development

7.3.1 Design and development planning

144 7.3.1 Plan the design and development of product

145 7.3.1 Control the design and development of product

146 7.3.1 a Determine the design and development stages

Determine review, verification and validation

147 7.3.1 b
activities at each stage

Determine the responsibilities and authorities for

148 7.3.1 c
design and development

149 7.3.1 Manage the interfaces between different groups

150 7.3.1 Update planning output

7.3.2 Design and development inputs

151 7.3.2 Determine inputs relating to product requirements

152 7.3.2 Maintain records

Determine functional and performances

153 7.3.2 a
requirements

154 7.3.2 b Determine statutory and regulatory requirements

Determine information derived from previous

155 7.3.2 c
designs

Determine other requirements essential for design

156 7.3.2 d
and development

157 7.3.2 Review inputs

Ensure that requirements are complete,

158 7.3.2
unambiguous and not in conflict with each other

7.3.3 Design and development outputs

159 7.3.3 Ensure that outputs are in a suitable form

160 7.3.3 Approve outputs

161 7.3.3 a Ensure that outputs meet input requirements

Ensure that outputs provide information for

162 7.3.3 b
purchasing, production and service provision

Ensure that outputs contain product acceptance

163 7.3.3 c
criteria or a reference to it

Ensure that outputs specify product characteristics

164 7.3.3 d
essential for its safe and proper use

7.3.4 Design and development review

165 7.3.4 a Evaluate the ability of results to meet requirements

166 7.3.4 b Identify problems

167 7.3.4 Determine participants in reviews

168 7.3.4 Maintain records of the results of the reviews

7.3.5 Design and development verification

169 7.3.5 Perform verification of the design and development

170 7.3.5 Maintain records of the results of verification

7.3.6 Design and development validation

171 7.3.6 Perform validation of design and development

Complete validation before the delivery or

172 7.3.6
implementation of the product

173 7.3.6 Maintain records of the results of the validation

7.3.7 Control of design and development changes

174 7.3.7 Identify design and development changes

175 7.3.7 Maintain records of changes

Review, verify and validate changes before

176 7.3.7
implementation

177 7.3.7 Approve changes before implementation

178 7.3.7 Evaluate the effect of changes

179 7.3.7 Maintain records of the results of change review

7.4 Purchasing

7.4.1 Purchasing process

Ensure that purchased product conforms to

180 7.4.1
requirements
181 7.4.1 Determine supplier control

182 7.4.1 Evaluate and select suppliers

Establish selection, evaluationand re-evaluation

183 7.4.1
criteria

184 7.4.1 Maintain records of results of evaluation

7.4.2 Purchasing information

185 7.4.2 Describe the product to be purchased

186 7.4.2 a Determine approval requirements

Determine requirements for qualification of

187 7.4.2 b
personnel

188 7.4.2 c Determine QMS requirements

189 7.4.2 Ensure adequacy of purchase requirements

7.4.3 Verification of purchased product

Ensure that purchased product meets purchase

190 7.4.3
requirements

Include in the purchasing information

191 7.4.3 arrangements of verification at supplier's
premises

7.5 Production and service provision

7.5.1 Control of production and service provision

192 7.5.1 Plan production and service provision activities

 Control the production and service provision
193 7.5.1
activities

Ensure the availability of information describing the

194 7.5.1 a
product

195 7.5.1 b Ensure the availability of work instructions

196 7.5.1 c Ensure the use of suitable equipment

Ensure the availability of monitoring and measuring

197 7.5.1 d
equipment

Ensure the use of monitoring and measuring

198 7.5.1 d
equipment

199 7.5.1 e Implement monitoring and measuring equipment

200 7.5.1 f Implement release activites

201 7.5.1 f Implement delivery activities

202 7.5.1 f Implement post-delivery activities
Validation of processes for production and service
7.5.2
provision

Validate special processes (where the output cannot

203 7.5.2
be verified)

Demonstrate the ability of these processes to

204 7.5.2
achieve planned results

205 7.5.2 a Define criteria for process review

206 7.5.2 a Define criteria for process approval

207 7.5.2 b Approve equipment

208 7.5.2 b Approve qualification of personnel

209 7.5.2 c Use specific methods and procedures
210 7.5.2 d Establish record requirements

211 7.5.2 e Establish provisions for revalidation

7.5.3 Identification and traceability

212 7.5.3 Identify the product

Identify product status throughout product

213 7.5.3
realization

214 7.5.3 Control the unique identification of the product

215 7.5.3 Maintain records

7.5.4 Customer property

216 7.5.4 Take care with customer property

217 7.5.4 Identify customer property

218 7.5.4 Verify customer property

219 7.5.4 Protect customer property

220 7.5.4 Safeguard customer property

When property is lost or damaged report it to the

221 7.5.4
customer

222 7.5.4 Maintain records of reports to the customer

7.5.5 Preservation of product

223 7.5.5 Preserve conformity of product to requirements

Provide product identification, handling, packaging,

224 7.5.5
storage and protection

225 7.5.5 Apply product preservation to components

Control of monitoring and measuring

7.6
equipment

Determine monitoring and measuring activities to be

226 7.6
undertaken

227 7.6 Determine monitoring and measuring equipment

228 7.6 Establish monitoring and measuring processes

229 7.6 a Calibrate and verify measuring equipment

230 7.6 a Record calibration and verification methods

231 7.6 b Agjust measuring equipment

232 7.6 c Identify calibration status

233 7.6 d Safeguard adjustments of measuring equipment

Safeguard measuring equipment from damage and

234 7.6 e
deterioration

235 7.6 Assess nonconforming equipment

236 7.6 Take appropriate actions on nonconforming product

Maintain records of the results of calibration and

237 7.6
verification
Confirm the ability of monitoring and
238 7.6 measuring software to satisfy intended
application
239 7.6 Undertake confirmation before initial use

8 Measurement, analysis and improvement

8.1 General

Plan the processes necessary to demonstrate

240 8.1 a
conformity to product requirements

Implement the processes necessary to demonstrate

241 8.1 a
conformity to product requirements

Plan the processes necessary to ensure conformity

242 8.1 b
of the QMS

Implement the processes necessary to ensure

243 8.1 b
conformity of the QMS

Plan the processes necessary to continually

244 8.1 c
improve the effectiveness of the QMS

Implement the processes necessary to

245 8.1 c continually improve the effectiveness of the
QMS

Determine monitoring, measurement, analysis and

246 8.1
improvement methods

8.2 Monitoring and measurement

8.2.1 Customer satisfaction
247 8.2.1 Monitor customer perception

Determine monitoring of customer satisfaction

248 8.2.1
methods

8.2.2 Internal audit

Conduct internal audits to determine whether the

249 8.2.2 a
QMS conforms to the planned arrangements

Conduct internal audits to determine whether the

250 8.2.2 a QMS conforms to the requirements of the ISO 9001
standard

Conduct internal audits to determine whether

251 8.2.2 a the QMS conforms to the requirements of the
organization

Conduct internal audits to determine whether

252 8.2.2 b
the QMS is effectively implemented

Conduct internal audits to determine whether

253 8.2.2 b
the QMS is effectively maintained

254 8.2.2 Plan the audit programme

Define the audit criteria, scope, frequency and

255 8.2.2
methods
256 8.2.2 Ensure objectivity and impartiality of internal audits

257 8.2.2 Ensure that auditors don't audit their own work

258 8.2.2 Establish a documented procedure for internal audits

259 8.2.2 Maintain records of the audit results

Ensure that the corrections and correctives actions

260 8.2.2
are taken without undue delay

261 8.2.2 Verify the taken actions

262 8.2.2 Record the report of the results of the verification

 8.2.3 Monitoring and measurement of processes

263 8.2.3 Monitor and measure QMS processes

Demonstrate the ability of the processes to achieve

264 8.2.3
planned results

Undertake corrections and corrective actions

265 8.2.3 when planned results of processes are not
achieved

8.2.4 Monitoring and measuremnt of product

266 8.2.4 Monitor and measure product characteristics

Monitor and measure the product at appropriate

267 8.2.4
stages
Maintain evidence of conformity with the acceptance
268 8.2.4
criteria
Record the person having authorised the
269 8.2.4
product release

Release of product only after planned

270 8.2.4
arrangements have been satisfied

8.3 Control of nonconforming product

Ensure that nonconforming product is identified

271 8.3
and controlled to prevent its unintended use

Establish the documented procedure control of

272 8.3
nonconforming product

Undertake actions to eliminate the detected

273 8.3 a
nonconformity
Authorize its use, release or acceptance under
274 8.3 b
concession

275 8.3 c Undertake actions not allowing intended use

Undertake actions when a nonconforming

276 8.3 d
product is detected after delivery

Maintain records of the nature of nonconformities

277 8.3
and actions taken
278 8.3 Verify again the corrected nonconforming product

8.4 Analysis of data

Determine data to demonstarte the suitability and

279 8.4
effectiveness of the QMS

Collect data to demonstarte the suitability and

280 8.4
effectiveness of the QMS

Analyse data to demonstarte the suitability and

281 8.4
effectiveness of the QMS

Evaluate the opportunities to improve the

282 8.4
effectiveness of the QMS

Include data from monitoring and measuring

283 8.4
activities

284 8.4 a Provide information on customer satisfaction

285 8.4 b Provide information on conformity to product requirements

Provide information on trends of processes and

286 8.4 c
products
287 8.4 d Provide information on on suppliers

8.5 Improvement

8.5.1 Continual improvement

288 8.5.1 Continually improve the effectiveness of the QMS

8.5.2 Corrective action

Undertake action to eliminate the causes of

289 8.5.2
nonconformities

Adapt corrective actions to the effects of

290 8.5.2
nonconformities
 Establish the documented procedure for corrective
291 8.5.2 a
action and review nonconformities

292 8.5.2 b Determine the causes of nonconformities

293 8.5.2 c Evaluate the need to undertake corrective action

294 8.5.2 d Determine the necessary action

295 8.5.2 d Implement the necessary action

296 8.5.2 e Record the results of the corrective action

Review the effectiveness of the corrective action

297 8.5.2 f
undertaken

8.5.3 Preventive action

Determine the action allowing the elimination of the

298 8.5.3
causes of potential nonconformities

Adapt preventive actions to the effects of the

299 8.5.3
potential problems

Establish the documented procedure preventive

300 8.5.3 a action and determine potential nonconformities and
their causes

301 8.5.3 b Evaluate the need to undertake preventive action

302 8.5.3 c Determine the necessary action

303 8.5.3 c Implement the necessary action

304 8.5.3 d Record the results of the preventive action

 Review the effectiveness of the preventive action
305 8.5.3 e
undertaken
ements and comments

PDCA, links, comments

Cf. sub-clauses 5.1 and 5.6.1

Cf. sub-clause 4.2.3

Cf. sub-clauses 5.1 and 5.5.2
Cf. sub-clause 5.4.2
Cf. sub-clause 8.5
See sub-clause 1.2 of ISO 9001; identify, understand
and evaluate all core activities which form the overall
look of the organization

Although the process mapping is not explicitly

required, in practice it is the best response to this
requirement

Establish the means to control processes

Cf. sub-clauses 6.1 and 6.2

Cf. sub-clause 8.2.3

When it makes sense; to achieve the objectives of

each process regularly monitor the indicators

Cf. sub-clause 8.5.1

Cf. sub-clauses 7.2 and 7.5

Control of an outsourced process includes the

establishment of specific provisions with the
subcontractor as contracts, procedures, regulations
forcommunication and an audit agreement

Quote or make a reference in the quality manual of

the implemented control means for outsourced
processes

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The quality policy and the objectives are formalized

in a relevant and simple document

Cf. sub-clause 4.2.2

The 6 mandatory 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)
Cf. sub-clause 4.2.4

The bare minimum is often the best choice

In the quality manual clearly identify the scope of

application of the QMS (include key products
andcustomers). Do not forget to indicate and justify
theexclusion of clause 7 - for example the design

See sub-clause 1.2 of ISO 9001

Cf. sub-clause 4.2.1;if proceduresare not partof the quality manualthenthereis a reference tothem an

A process map meets this requirement. You can also

use a table showing the interactions between
processes

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Before starting to use a document, it is

approved(verified, validated) by a
person with defined responsibilities and authorities

Cf. sub-clause 4.2.4

Cf. sub-clause 4.2.1;the mandatory procedurefor documentsanswers the questions who,when, how,un

The documents live with products and processes

Control of changes and versions of documents is

done by a person with established responsibilities
andauthorities

"The right document, at the right place at the right

moment" and with the right version
Chaque document est clair, simple comprendre, facile
catgoriser
Method for coding documents
External documents (standards, specifications) are
controlled (list, location, version)

Expired documents (obsolete) are

maintained,archived, destroyed or locked up so that
we can notuse them normally

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The records are filled daily (without delay). Without

them it's hard (or impossible) to demonstrate
compliance with the requirements of the QMS

Cf. sub-clause 4.2.1;the mandatory procedurefor recordsanswers the questions who,when, how,under

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

Number of years or life of the product plus number

of years

Planifier (Plan), Agir (Act)

"When you sweep the stairs, you start at the bottom.

Romanian proverb"

Define the quality

policy is an unavoidable commitment, direct and do
cumented by top management to implement
and improve the effectiveness of the QMS

Quantify quality objectives in each

departmentconsistent with the quality policy
and customer requirements

Cf. sub-clause 5.6;keeprecords ofmanagement reviews,which areevidence that theQMSis relevant, e

Cf. sub-clause 6.1; top management provides the

resources to achieve the quality objectives

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Cf. sub-clauses 7.2.1 and 8.2.1
Cf. sub-clause 7.2

The quality policy is consistent with customer

satisfaction and continual improvement of the QMS

The quality policy is a direct and

documentedcommitment of top management at
its highest level

Cf. sub-clauses 5.1 and 8.5.1

Cf. sub-clause 5.6; the management review is the best answer for this requirement

Cf. sub-clause 5.5.3

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

Cf. sub-clause 7.1

Cf. sub-clause 7.2

Quality objectives are quantified, translated (broken

down) into indicators and
monitored regularly(dashboards). A criterion
of measurability can be "Yes/ No"

Cf. sub-clause 4.1

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

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"Responsibility can not

be shared. Robert Heilein"; clear and available
internally job descriptions (alsoorganizational
chart, competency matrix)

He is a member of management and is

not necessarilyfrom the quality department
Cf. sub-clauses 7.2 and 7.5
Cf. sub-clause 4.1

Cf. sub-clause 5.6

Cf. sub-clause 5.6

Play special attention to feedback (surveys,suggestion

box)

"No system is perfect", usually once or twice a year,

review the whole QMS to monitor the
achievement of quality objectives

Review
the opportunities (cases, conditions, options,circum
stances) for continual improvement of the QMS

Cf. sub-clause 4.2.4

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The internal audit reports and their proposals are an

important source of information to improve the QMS

"Love your customers more than your products", all

data on customer satisfaction and non satisfaction
are an important source of information to improve
theQMS

Results of the achievement of

quality objectives anddata analysis related to
the process malfunctions(nonconformities)

Same for the products

Results of actions, their follow-up, the obtained
improvements

Results of decisions made during

the last management review and their follow-up
Consider, evaluate and analyze any changes that
may impact on
the QMS (new products / processes, new
customers, new
features and / or responsibilities, legal and
regulatory changes)

Suggestions, opinions, proposals from all

staff andexternal intersted parties

Decisions to improve the QMS, its effectiveness and

its processes are input data of the continual
improvement process

After analysis, the decisions of product

improvement,in line with customer
requirements, are formalized(performance
objectives)
After analyzing the decisions of
ensuring necessaryhuman and material
resources are formalized
Planifier(Plan)
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To Improve the effectiveness of

the QMS identify and ensure the needs of present
and future resources:

- human (quantity and quality - skills)

- infrastructure (buildings, equipment)

- work environment (ergonomics, hygiene, health

and safety)

- financial resources

Priority to the resources that are directly related

tocustomers and meeting
their requirements(commercial, reception, sales, sc
heduling, design and
development, testing, inspection)

Priority to identify and review (annual

performance)skills of persons with a direct impact
on quality
Identify requirements (job descriptions) in
competence of persons with a direct impact
on quality

Identify and meet the needs of competence

improvement (training programme)
Review the improvement in competence (evaluate
trainings, measure their effectiveness 3 to 6 months
later)

"Quality is everybody's business"; staff

awareness ofthe link between training and
individual responsibilityto achieve quality objectives

Cf. sub-clause 4.2.4

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As appropriate identify buildings, facilities,

equipment(machines and documentations) and sup
port servicesthat impact on product conformity

Control the maintainance of the infrastructure

Identify human and physical factors that

affect product conformity (motivation, work
organization, workstation ergonomics, lighting, hygi
ene, temperature, security)

Control these factors

Drouler(Do)

These are all processes that meet the needs and

expectations of customers (from quotation to after
sales service). Process mapping can lighten
the overall image of product realization

Cf. sub-clause 4.1;take intoaccountpreventionwherever possible

Cf. sub-clause 5.4.1

Cf. sub-clause 7.2

Establish and implement processes and

documentationfor each product
Establish and implement monitoring and
measuring processes for each product

Cf. sub-clause 4.2.4

Cf. sub-clause 4.2.4
Usually it's the quality plan or any other similar document

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"The only measure of quality is customer

satisfaction",identify and implement customer needs
andexpectations into internal product requirements(
production, delivery and after delivery)

Identify and apply the implicit customer needs and

expectations (lifetime warranty, exemplary
reliability,easy maintenance)

Identify all requirements applicable to the

product(including recycling and disposal) and
establish aregulatory watch

Identify internal
requirements (constraints, rules,confidentiality, heal
th and safety, hygiene)

Review beforehand product

requirements (feasibility,profitability)
Beforehand means before
any production commitment
Identify and approve all requirements internally

Any change is taken into

account (approved) beforecompletion of production
commitment
The requirements are defined and approved

Cf. sub-clause 4.2.4

In this
case internal approval of requirements before
notifying the customer

Each change of
a product requirement involvesupdating internal
documents and distribution of information to those
concerned
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"Good news walk, bad ones run. Swedish proverb"

Establish effective methods of communication with the

customer

Job description of sales manager

Identify methods of communication with the

customer on satisfaction and complaints

Manage the design and product

development upstream by prevention (FMEA, risk
analysis)
"I have not failed. I just found 10,000 ways that do not
work. Thomas Edison"

Identify and formalize the key stages of product design

and development

Identify and formalize the verification, design

validation and product development steps. For
eachkey step plan the action, the manager, the
expected result, the criteria to be met, the
materials required, the time frame

Identify and formalize the persons with

responsibilities and authorities specified for each
key stage of product design and development

Identify and formalize the relationships between all

actors in the product design
and development(meetings and reviews at key
stages)

Planning is updated after each major

change of the product design and development
Identify, formalize and keep the information
needed to start the product design
and development
Cf. sub-clause 4.2.4

The functional requirements found in the

specifications (dimensions, operating
conditions, tests)

Requirements (qualifications or
recommendations)related to transportation,
packaging, labels, instructions for use, expiry date,
traceability, components used

The results of design reviews of previous similar

products (tests, reliability, feasibility) and feedback
from users (sales, recommendations, suggestions)

Specific requirements of the product,

components(selected suppliers, prohibited
materials), environmental aspects (disposal of
products)

The project leader or another person verify and

validate the consistency of the input

The project leader or another person verify and

validate for all input requirements the lack of
ambiguity and contradiction
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Identify measures that

can determine compliancebetween input and output

Always confirm (approve) the outputs by the project

leader or another person prior to use

Conformity between outputs and input requirements

Full information from the BOM (component

specifications, raw materials, consumables)

Identify the steps of monitoring (inspections) and

measurement (testing) of production processes

Information about the intended and unintended

use, security, maintenance

Cf. sub-clause 7.3.1

"A problem shared is a problem
halved"; the planned reviews can predict potential
problems and proposeappropriate preventive
actions

The reviews conducted by the project leader or

another person are
multidisciplinary with appropriate participants for
each step
Cf. sub-clause 4.2.4

The reviews enable at key steps to

verify (trials, tests,measurements, calculations) whe
ther results are in line with objectives

Cf. sub-clause 4.2.4

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After verification the design and development

arevalidated. This implies that all customer
requirementsare met

In practice almost always the validation is carried out

upstream

Cf. sub-clause 4.2.4

The changes are clearly identified

Cf. sub-clause 4.2.4

Each change is reviewed, verified and

validated by the project leader or another
person. The same person or another person in
charge gives final approval

Each change can affect the product (BOM, sales

support). Assess risks and potential impacts
(simulation method)

Cf. sub-clause 4.2.4

"If you buy quality, you only cry once. English

proverb"; the purchase process includes activities
to ensure compliance
of components, materials andsupplies purchased
Compared to the impact on the production and the
final product

The purchasing process includes the evaluation and

selection of suppliers (incoming inspection, audit at
supplier premises, product
purchased with supplier quality assurance = product
inspection is made at supplier premises)

The purchasing process includes the continual

evaluation criteria (monthly or quarterly) of
suppliers(% of nonconforming purchased products d
etected at
reception inspection, production and after sales
service)

Cf. sub-clause 4.2.4

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Are taken into account all data on the purchased

product (specifications, transport
conditions, packing,
receiving, testing, storage and other)

For specific cases staff receive appropriate

training(new type product, machine or equipment
notpreviously used)

Everything concerning the control

of nonconformitiesrelated
to purchased product and actions, person in charge
and time frame to implement

Communicate requirements to the supplier wich

arerealistic and appropriate with the QMS

The purchasing process includes the identification

andimplementation of inspections at receiving and
during production

In the particular case of inspection and release at

supplier premises all these activities are
formalized(contract, specifications with acceptance
criteria)

Identify, develop and plan all stages of product

realization process
The product specification information is freely
available to staff

Work instructions, record sheets and others

are where needed
Equipment maintenance is regularly carried out

Monitoring and
measurement equipment aremaintained in good
condition and the staff are trained in their use

Monitoring and measurement equipment are

usedregularly

The release, transport and after sale service are

formalized and managed

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When the product cannot be measured (price too

high,can be done only after use) the process is
checked and validated

The validation of the process ensures compliant

products

The criteria for process monitoring and

measuring are strengthened

Checking equipment and staff training are

reinforced

Cf. sub-clause 4.2.4

Every change require a new validation of the process

When appropriate identification of the product and

components shows its status relative to the
production stages (bar code, card, label)

The identification of the product also shows its

status (results) relative to monitoring and
measuring stages

Product traceability (who, when, with which

batch)shows the history of production stages

Cf. sub-clause 4.2.4

Customer property includes:
- raw materials
- components
- packaging materials
- equipment
- testers and software (intellectual property)

Inspection of customer property in reception (where

appropriate), specific storage and protection when
requested by customer

Any concern with customer

property is controlled as anonconformity (identificati
on, analysis, decision,recording) and more than
that required communication with the customer

Cf. sub-clause 4.2.4

The product is protected internally and up to

deliveryto the customer (packaging, storage
conditions)

Preservation of the product includes all stages

ofproduct life cycle (receiving, production, handling,
storage, delivery)

Components, raw
materials and semi finished productsare part of the
product

The process of monitoring and measurement are in

place to collect evidence of product compliance

Equipment list with serial numbers

Monitoring and
measuringdevices meet internal, customer and
regulatory requirements

Measuring equipment (hardware and software) are

calibrated or verified regularly

Cf. sub-clause 4.2.4

Measuring equipment are adjusted regularly

The validity date is available on the equipment

Protection against actions of intended or
unintendedmisadjustment

Effective protection not only during their

use (travel, maintenance, storage)

This concerns the potentially nonconforming

products

Equipment is verified and calibrated. Products are

inspected, validated (with or
without concession) oridentified as nonconforming

Cf. sub-clause 4.2.4

Monitoring and measurement software

is validatedbefore use

Make a second validation if the first one is not

satisfactory
Constater (Check), Agir (Act)

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"If you can't measure it, you

can't manage it. PeterDrucker"; control
of product compliance isdemonstrated by inspection
processes throughout theproduction stages

Control of the conformity of the QMS is

ensured among other things on management
processes (strategy,auditing, continual
improvement, self assessment)

The overall improvement in the effectiveness of

theQMS is the result of all improvement
activities (audits,data analysis, new
objectives, corrective and preventive actions)

Data analysis, statistical techniques (SPC, statistical

process control), Kaizen, Ishikawa diagram (5 M)
Measure the level of satisfaction of customer needs
and expectations (congratulations, returns,complai
nts, recommendations). The customer may bethe
direct customer (distributor) or the end customer
(consumer)

Examples: surveys, feedback, open

doors, trackingreturns and customer
complaints, benchmarking

Cf. sub-clause 7.1

Annual programme of internal audits

Audits specific to the organization

Internal audits allow measuring the performance of

theQMS

The frequency of audits is appropriate

The audit
programme focuses on sensitive processes
and areas without forgetting the results of previous
audits

Mandatory information included in the

procedure"Internal Audit"
Training and selection of auditors

"No one is a judge in his own case. Latin proverb"

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

Cf. sub-clause 4.2.4;audit report

The person in charge of the actions is on

schedule to identify and eliminate the causes of
nonconformities

The results of the follow-up of the corrective

actionsare verified and recorded

Cf. sub-clause 8.5.2

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Monitor and
measure the process objectives andindicators using
an established method

When objectives and indicators are achieved

the process is effective (inspections at key stages)

Cf. sub-clause 8.5.2

Monitoring of product
characteristics verify satisfactionto product
requirements (inspections at key stages)

Cf. sub-clause 7.1

Cf. sub-clause 4.2.4

Cf. sub-clause 4.2.4

Cf. sub-clause 7.1

"Any problem hides an opportunity for

improvement ";identification and isolation of
nonconforming productfor treatment

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

Identify nonconformities and treat them like scrap

Correction, repair, rehabilitation or scrap

Recall (prevent
use after delivery), withdrawal(prevent the
distribution), communication, batch identification, is
olation, root cause analysis, corrective and
preventive actions

Cf. sub-clause 4.2.4

Any corrected nonconforming product is always
verified before being returned with other products
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The preparation of the management review includes

the collection and analysis of data (indicators, audit
results, level of customer satisfaction). After
synthesisdecisions of the management review about
continual improvement

Any opportunity for improvement is evaluated

beforeits implementation

Analysis of indicators related among other things to

monitoring and measurement

Cf. sub-clause 8.2.1

Cf. sub-clause 8.2.4

Cf. sub-clauses 8.2.3 and 8.2.4

Cf. sub-clause 7.4

"Quality is a journey not a destination"; apply

theprocess continual improvement of
the QMS (turn the Deming wheel). Identify
opportunities forimprovement, find and eradicate
the root causes of
nonconformities, promote preventive actions

Analysis and eradication of the causes of

nonconformities in the process, product or QMS

Make arrangements with respect to real

effects (watch out for excessive zeal)
Cf. sub-clause 4.2.1;the mandatory procedureforcorrective actionanswers the questionswho, when,how

Include in the procedure methods to find the

causes of nonconformities (Ishikawa diagram, MSP)

What could be achieved if an action is applied? The

resources needed are they available? (Some
nonconformities do not require corrective actions)

Include the procedure the method for determining

responsibilities, authorities, time
frames, resourcesand monitoring of actions to
implement

Cf. sub-clause 4.2.4

Analyse the monitoring of actions (possibility of a

newaudit), improve documentation
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Analysis and elimination of potential causes of

nonconformities of processes or of the QMS

Make arrangements with respect to potential

effects(stay within available resources)

Cf. sub-clause 4.2.1;the mandatory procedureforpreventive actionsanswers the questions,who, when,

Will the occurence avoided? The resources

needed are they available?

Include in the procedure the method for

determining responsibilities, authorities, time
frames, resourcesand monitoring of actions to
implement

Find the causes

Cf. sub-clause 4.2.4

Analyse the monitoring of actions (possibility of a
newaudit), improve documentation

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