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When quality is paramount, everyone profits!

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T 35 - ISO 9001: 2008

internal audit

D 02 - Processes

T 16 - ISO/TS 16949:

2009 readiness

T 68 - OHSAS 18001

training package

The 524 requirements (shall in the text) of ISO/TS 16 949 clauses 4 to 8 (305 are ISO 9001 requirements) are

distributed as follows:

ISO/TS 16 949 : 2009 requirements

N Clause PDCA cycleRequirement

NQuantity

4 Quality management system Plan 1 56 56

5 Management responsibility Plan, Act 57 114 58

6 Resource management Plan 115 145 31

7 Product realization Do 146 398 253

8 Measurement, analysis and improvement Check, Act 399 516 118

Annex A Check 517 524 8

Total 524


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Requirements, clauses and sub-clauses of the technical specification ISO/TS 16 949


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PDCA wheel

ISO/TS 16 949 - Requirements and comments

NClause,

subclause

Requirement

(ISO 9001 requirements are on light

background colour, in italic and beige

background colour are ISO/TS 16 949

requirements)

PDCA, links, comments

4 Quality management system

4.1 General requirements

1 4.1 Establish the quality management system

(QMS)

Cf. sub-clauses 5.1and 5.6.1

2 4.1 Document the QMS Cf. sub-clause 4.2.3

3 4.1 Implement the QMS Cf. sub-clauses 5.1and 5.5.2

4 4.1 Update the QMS Cf. sub-clause 5.4.2

5 4.1 Improve the effectiveness of the QMS Cf. sub-clause 8.5

6 4.1 a Determine the necessary processes and their

application

See sub-clause 1.2 of ISO 9001; identify,

understand and evaluate all core activities

which form the overall look of the

organization


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7 4.1 b Determine the sequence and interaction of

processes

Although the process mapping is not

explicitly required in practice it is the best

response to this requirement

8 4.1 c Determine criteria and methods for

effectiveness of process operation and control

Establish the means to control processes

9 4.1 d Ensure the necessary resources for process

operation and monitoring

Cf. sub-clauses 6.1and 6.2

10 4.1 d Ensure the necessary information for process

operation and monitoring

Cf. sub-clause 8.2.3

11 4.1 e Monitor processes

12 4.1 e Measure processes When it makes sense; to achieve the

objectives of each process regularly monitor

the indicators

13 4.1 e Analyse processes

14 4.1 f Achieve planned results of processes

15 4.1 f Obtain continual improvement of processes Cf. sub-clause 8.5.1

16 4.1 Manage processes Cf. sub-clauses 7.2and 7.5

17 4.1 Ensure control of outsourced processes Control of an outsourced process includes

the establishment of specific provisions withthe subcontractor as contracts, procedures,

regulations for communication and an audit

agreement

18 4.1 Define type and extent of control of outsourced

processes

Quote or make a reference in the quality

manual of the implemented control means

for outsourced processes

19 4.1.1 Meet customer requirements by controlling the

outsourced processes

Cf. sub-clause 7.4.1.3; This also applies

to the sources approved by the customer

4.2 Documentation requirements

4.2.1 General Top of the page

20 4.2.1 a Document the quality policy The quality policy and the objectives areformalized in a relevant and simple

document

21 4.2.1 a Document the quality objectives

22 4.2.1 b Document the quality manual Cf. sub-clause 4.2.2

23 4.2.1 c Document the procedures 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


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8.5.2)

- preventive actions (cf. sub-clause 8.5.3)

24 4.2.1 c Determine the records related to procedures Cf. sub-clause 4.2.4

25 4.2.1 d Determine the documents ensuring the

planning, operation and control of processes

The bare minimum is often the best choice

4.2.2 Quality manual

26 4.2.2 Establish the quality manual In the quality manual clearly identify the

scope of application of the QMS (includekey products and customers). Do not forget

to indicate and justify the exclusion of

clause 7 - for example the design

27 4.2.2 Update the quality manual

28 4.2.2 a Determine the scope of the QMS and the

exclusions

See sub-clause 1.2 of ISO 9001

29 4.2.2 b Determine the documented procedures or a

refernece to them

Cf. sub-clause 4.2.1; if procedures are

not part of the quality manual then there is

a reference to them and the place where

you can find them is defined (this may be

the Intranet)

30 4.2.2 c Describe interactions between processes A process map meets this requirement. Youcan also use a table showing the

interactions between processes

4.2.3 Control of documents Top of the page

31 4.2.3 Control the documents Before starting to use a document, it is

approved (verified, validated) by a person

with defined responsibilities and authorities

32 4.2.3 Control the records Cf. sub-clause 4.2.4

33 4.2.3 a Document the procedure control of documents Cf. sub-clause 4.2.1; the mandatory

procedure for documents answers the

questions who, when, how, under what

conditions write, verify, validate, update,distribute and maintain documents

34 4.2.3 b Review, update and approve again documents The documents live with products and

processes

35 4.2.3 c Control changes Control of changes and versions of

documents is done by a person with

established responsibilities and authorities

36 4.2.3 c Control the relevant version

37 4.2.3 d Ensure the availability "The right document, at the right place at

the right moment" and with the right

version

38 4.2.3 e Ensure the legibility Chaque document est clair, simple comprendre, facile catgoriser


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39 4.2.3 e Identify documents Method for coding documents

40 4.2.3 f Control documents of external or igin External documents (standards,

specifications) are controlled (list, location,

version)

41 4.2.3 g Prevent use of obsolete documents Expired documents (obsolete) are

maintained, archived, destroyed or locked

up so that we can not use them normally

42 4.2.3 g Identify retained obsolete documents

4.2.3.1 Engineering specifications

43 4.2.3.1 Establish a process to control standards and

customer specifications

Meet tight deadlines

44 4.2.3.1 Control changes in agreement with the

customer

45 4.2.3.1 Keep a record of dates of implementation

of changes in production


46 4.2.3.1 Include changes of documents in records Cf. sub-clause 4.2.4; update production

part approval process (PPAP) , control plan

and FMEA

4.2.4 Control of records Top of the page

47 4.2.4 Control conformity records The records are filled daily (without delay).

Without them it's hard (or impossible) to

demonstrate compliance with the

requirements of the QMS

48 4.2.4 Control effectiveness records

49 4.2.4 Document the procedure control of records Cf. sub-clause 4.2.1; the mandatory

procedure for records answers the


conditions identify, use, store, distribute,

protect, maintain and dispose of records

50 4.2.4 Store records "Spoken words fly away, written ones stay.

Latin proverb"

51 4.2.4 Protect records

52 4.2.4 Ensure availability of records

53 4.2.4 Define retention time of records Number of years or life of the product plus

number of years

54 4.2.4 Define hte method of retrieval and disposition

of records

55 4.2.4 Ensure legibility of records

56 4.2.4.1 Meet regulatory and customer requirements of

record control

List of retention dates for all records

5 Management responsibility Plan, Act 5.1 Management commitment


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57 5.1 a Communicate the importance of meeting

customer requirements

"When you sweep the stairs, you start at

the bottom. Romanian proverb"

58 5.1 a Communicate the importance of meeting legal

requirements

59 5.1 b Establish the quality policy Define the quality policy is an unavoidable

commitment, direct and documented by top

management to implement and improve the

effectiveness of the QMS

60 5.1 c Establish the quality objectives Quantify quality objectives in eachdepartment consistent with the quality

policy and customer requirements

61 5.1 d Conduct management reviews Cf. sub-clause 5.6; keep records of

management reviews, which are evidence

that the QMS is relevant, effective and

continually improving

62 5.1 e Ensure availability of resources Cf. sub-clause 6.1; top management

provides the resources to achieve the

quality objectives

63 5.1.1 Review realization and support processes Cf. sub-clause 5.6

5.2 Customer focus Top of the page64 5.2 Determine customer requirements Cf. sub-clauses 7.2.1and 8.2.1

65 5.2 Meet customer requirements Cf. sub-clause 7.2

5.3 Quality policy

66 5.3 a Adapt the quality policy to the purpose of the

organization

The quality policy is consistent with

customer satisfaction and continual

improvement of the QMS

67 5.3 b Determine the commitment to comply with

requirements of the QMS

The quality policy is a direct and

documented commitment of top

management at its highest level

68 5.3 b Determine the commitment to continually

improve the effectiveness of the QMS

Cf. sub-clauses 5.1and 8.5.1

69 5.3 c Provide a framework for establishing the

quality objectives

Cf. sub-clause 5.6; the management

review is the best answer for this

requirement

70 5.3 d Communicate and explain the quality policy Cf. sub-clause 5.5.3

71 5.3 e Review the quality policy Cf. sub-clause 5.6; the quality policy is

constantly evolving. It is a goal of the

management review

5.4 Planning

5.4.1 Quality objectives

72 5.4.1 Establish the quality objectives Cf. sub-clause 7.1


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73 5.4.1 Determine quality objectives for product

requirements

Cf. sub-clause 7.2

74 5.4.1 Be able to measure the quality objectives Quality objectives are quantified, translated

(broken down) into indicators and

monitored regularly (dashboards). A

criterion of measurability can be "Yes / No"

75 5.4.1 Adapt the quality objectives with the quality

policy

76 5.4.1.1 Define quality objectives to include in the

business plan

The objectives are realistic, achievable,

ambitious and time-bound

5.4.2 Quality management system planning

77 5.4.2 a Follow the process approach when planning the

QMS

Cf. sub-clause 4.1

78 5.4.2 a Plan the QMS so as to meet quality objectives

79 5.4.2 b Keep the integrity of the QMS when changes

are implemented

Cf. sub-clause 7.3.7; play special

attention on control of changes and their

impact on the performance of the QMS

5.5Responsibility, authority and

communicationTop of the page

5.5.1 Responsibility and authority

80 5.5.1 Define responsibi lit ies and authorities "Responsibili ty can not be shared. Robert

Heilein"; clear and available internally job

descriptions (also organizational chart,

competency matrix)

81 5.5.1 Communicate responsibilities and authorities

82 5.5.1.1 Inform promptly managers of nonconformities

83 5.5.1.1 Stop production if quality problem

84 5.5.1.1 Provide all shifts with a person in charge of the

quality

5.5.2 Management representative85 5.5.2 Appoint a management representative He is a member of management and is not

necessarily from the quality department

86 5.5.2 a Establish the processes Cf. sub-clauses 7.2and 7.5

87 5.5.2 a Implement the processes Cf. sub-clause 4.1

88 5.2.2 a Update the processes

89 5.5.2 b Report to top management on the performance

of the QMS

Cf. sub-clause 5.6

90 5.5.2 b Report to top management on any need for

improvement

Cf. sub-clause 5.6

91 5.5.2 c Promote awareness of customer requirements

5.5.2.1 Customer representative


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92 5.5.2.1 Ensure that customer needs are taken into

account

Sspecial characteristics and product

activties

5.5.3 Internal communication

93 5.5.3 Establish communication processes Play special attent ion to feedback (surveys,

suggestion box)

94 5.5.3 Communicate on the effectiveness of the QMS

5.6 Management review

5.6.1 General95 5.6.1 Review the QMS by top management "No system is perfect", usually once or

twice a year, review the whole QMS to

monitor the achievement of quality

objectives

96 5.6.1 Evaluate the improvement opportunities Review the opportunities (cases, conditions,

options, circumstances) for continual

improvement of the QMS

97 5.6.1 Maintain the records from management

reviews


98 5.6.1.1 Include all requirements and performance

trends of the QMS

Cf. paragraphe 8.5

99 5.6.1.1 Cover the monitoring of quality objectives Cf. paragraphe 8.4

100 5.6.1.1 Evaluate the costs of (poor) quality Waste or in other words the cost of

obtaining qaulity (COQ)

101 5.6.1.1 Record the results of the achievement of the

quality objectives

Business plan

102 5.6.1.1 Record the level of customer satisfaction Cf. paragraphe 4.2.4

5.6.2 Review input Top of the page

103 5.6.2 a Include information audit results The internal audit reports and their

proposals are an important source of

information to improve the QMS

104 5.6.2 b Include information on customer feedback "Love your customers more than yourproducts", all data on customer satisfaction

and non satisfaction are an important

source of information to improve the QMS

105 5.6.2 c Include information on process performance Results of the achievement of quality

objectives and data analysis related to the

process malfunctions (nonconformities)

106 5.6.2 c Include information on product conformity Same for the products

107 5.6.2 d Include information on preventive and

corrective actions

Results of actions, their follow-up, the

obtained improvements

108 5.6.2 e Include information on follow-up actions Results of decisions made during the last

management review and their follow-up


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109 5.6.2 f Include information on changes 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)

110 5.6.2 g Include information on improvement

recommendations

Suggestions, opinions, proposals from all

staff and external intersted parties

5.6.2.1 Review input - Supplemental

111 5.6.2.1 Include an analysis of actual and potential

problems

Consider the impacts on quality, safety and

environment

5.6.3 Review output

112 5.6.3 a Decide actions related to improvement of the

effectiveness of the QMS and its processes

Decisions to improve the QMS, its

effectiveness and its processes are input

data of the continual improvement process

113 5.6.3 b Decide actions related to product improvement After analysis, the decisions of product

improvement, in line with customer

requirements, are formalized (performance

objectives)

114 5.6.3 c Decide actions related to resources needs After analyzing the decisions of ensuring

necessary human and material resourcesare formalized

6 Resource management Plan

6.1 Provision of resources Top of the page

115 6.1 a Determine and provide resources to implement

the QMS

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

116 6.1 a Determine and provide resources to update the

QMS

117 6.1 a Determine and provide resources to improve

continually the effectiveness of the QMS

118 6.1 b Determine and provide resources to enhance

customer satisfaction

Priority to the resources that are directly

related to customers and meeting their

requirements (commercial, reception, sales,

scheduling, design and development,

testing, inspection)

6.2 Human resources

6.2.1 General


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119 6.2.1 Ensure competence of staff Priority to identify and review (annual

performance) skills of persons with a direct

impact on quality

6.2.2 Competence, training and awareness

120 6.2.2 a Determine competence of personnel Identify requirements (job descriptions) in

competence of persons with a direct impact

on quality

121 6.2.2 b Provide training Identify and meet the needs of competence

improvement (training programme)

122 6.2.2 c Evaluate the effect iveness of training Review the improvement in competence

(evaluate trainings, measure their

effectiveness 3 to 6 months later)

123 6.2.2 d Ensure that personnel is aware of the way they

contribute to the achievement of the quality

objectives

"Quality is everybody's business"; staff

awareness of the link between training and

individual responsibility to achieve quality

objectives

124 6.2.2 e Maintain records of initial and professional

training, knwo-how and experience


6.2.2.1 Competence, training and awareness

125 6.2.2.1 Ensure competence of personnel in charge ofthe design

Control of tools and techniques

126 6.2.2.1 Identify tools and techniques Cf. sub-clause 4.2.4

6.2.2.2 Training

127 6.2.2.2 Document the procedure Training Cf. sub-clause 4.2.1; the compulsory

procedure for training answers the


conditions identify needs, achieve the skills,

motivate staff

128 6.2.2.2 Qualify persons performing specific tasks CAD (computer aided design) and other

6.2.2.3 Training on the job

129 6.2.2.3 Train personnel assigned to a new job Also after a change of set-up that can affect

the quality

130 6.2.2.3 Inform personnel about the consequences of

nonconformities

Applies to internal and external customer

6.2.2.4 Employee motivation and empowerment

131 6.2.2.4 Motivate employees The goal is to achieve the quality objectives

132 6.2.2.4 Raise awareness about quality And about innovation

133 6.2.2.4 Measure the level of awareness of personnel How every one contributes to continual

improvement

6.3 Infrastructure Top of the page


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134 6.3 Determine the infrastructure As appropriate identify buildings, facilities,

equipment (machines and documentations)

and support services that impact on

product conformity

135 6.3 Provide the infrastructure

136 6.3 Maintain the infrastructure Control the maintainance of the

infrastructure

6.3.1 Plant, facility and equipment p lanning

137 6.3.1 Plan the expansion or establishment of

factories, facilities or equipment

Cf. sub-clause 7.3.1.1

138 6.3.1 Optimize the transport, handling and floor

space use

139 6.3.1 Facilitate the flow of products

140 6.3.1 Evaluate the effectiveness of existing

operations

6.3.2 Contingency plans

141 6.3.1 Establish contigency plans Cf. sub-clause 4.2.4

6.4 Work environment

142 6.4 Determine the work environment Identify human and physical factors thataffect product conformity (motivation, work

organization, workstation ergonomics,

lighting, hygiene, temperature, security)

143 6.4 Control the work environment Control these factors

6.4.1 Personnel safety to achieve product quality

144 6.4.1 Address issues related to product safety

6.4.2 Cleanliness of premises

145 6.4.2 Maintain premises in a state of order Cleanliness about product and process

7 Product realization Do

7.1 Planning of product realization

146 7.1 Plan the processes for product realization 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

147 7.1 Develop the processes for product realization

148 7.1 Plan the product realization in conformity with

the requirements of the other processes

Cf. sub-clause 4.1; take into account

prevention wherever possible

149 7.1 a Determine the quality objectives Cf. sub-clause 5.4.1

150 7.1 a Determine the requirements for the product Cf. sub-clause 7.2

151 7.1 b Determine the processes specific to theproduct Establish and implement processes anddocumentation for each product


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152 7.1 b Establish the documents specific to the product

153 7.1 b Provide resources specific to the product

154 7.1 c Determine the activities specific to the product

such as verification, validation, monitoring,

measuring, inspection and test

Establish and implement monitoring and

measuring processes for each product

155 7.1 c Determine criteria for product acceptance

156 7.1 d Determine process specific records Cf. sub-clause 4.2.4

157 7.1 d Determine product specific records Cf. sub-clause 4.2.4158 7.1 Ensure that planning outputs are in a suitable

form

Usually it's the quality plan or any other

similar document

7.1.1 Planning of product realization - Supplemental

159 7.1.1 Include in the quality plan customer

requirements

References for technical specifications

7.1.2 Acceptance criteria

160 7.1.2 Define acceptance criteria In agreement with the customer

161 7.1.2 Apply zero defects Sampling for inspection by attributes

7.1.3 Confidentiality

162 7.1.3 Ensure the confidentiality List of confidentiality agreements for

products in production and development

7.1.4 Change control

163 7.1.4 Control product changes React in time; notify the customer;

customer approval

164 7.1.4 Evaluate the impact of changes Do not forget the changes made by the

supplier

165 7.1.4 Ensure product conformity after any change Testing the effects of changing

166 7.1.4 Validate the change Before implementation

167 7.1.4 Evaluate impact of propr ietary designs In agreement with the customer

168 7.1.4 Carry out additional verifications As for a new product when requested by

customer 7.2 Customer-related processes Top of the page

7.2.1Determination of requirements related to the

product

169 7.2.1 a Determine requirements specified by the

customer

"The only measure of quality is customer

satisfaction", identify and implement

customer needs and expectations

into internal product requirements

(production, delivery and after delivery)

170 7.2.1 b Determine requirements for intended use Identify and apply the implicit customer

needs and expectations (lifetime warranty,

exemplary reliability, easy maintenance)


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171 7.2.1 c Determine product statutory and regulatory

requirements

Identify all requirements applicable to the

product (including recycling and disposal)

and establish a regulatory watch

172 7.2.1 d Determine requirements considered necessary

by the organization

Identify internal requirements (constraints,

rules, confidentiality, health and safety,

hygiene)

7.2.1.1 Customer-designated special characteristics

173 7.2.1.1 Identify, document and control special

characteristics

Cf. sub-clause 4.2.4; Cf. annex A

7.2.2 Review of requirements related to the product

174 7.2.2 Review product requirements Review beforehand product requirements

(feasibility, profitability)

175 7.2.2 Conduct the review before committing to

supply a product to the customer

Beforehand means before any production

commitment

176 7.2.2 a Define product requirements Identify and approve all requirements

internally

177 7.2.2 b Resolve gaps between requirements Any change is taken into account

(approved) before completion of

production commitment

178 7.2.2 c Ensure that the organization has the ability to

meet the requirements

The requirements are defined and approved

179 7.2.2 Maintain the records of the results of the

review


180 7.2.2 Confirm not stated customer requirements In this case internal approval of

requirements before notifying the customer

181 7.2.2 Amend documents when product requirements

are changed

Each change of a product requirement

involves updating internal documents and

distribution of information to those

concerned

182 7.2.2 Inform the personnel about changed

requirements

7.2.2.1Review of requirements related to the product

- Supplemental

183 7.2.2.1 Obtain customer authorization when review is

impractical

Condition for waiving the requirements of

sub-clause 7.2.2

7.2.2.2 Organization manufacturing feasibi li ty

184 7.2.2.2 Analyse product feasibility, maintain records Cf. sub-clause 4.2.4; include risk

analysis

7.2.3 Customer communication Top of the page

185 7.2.3 a Determine arrangements for communicating

with customers on product information

"Good news walk, bad ones run. Swedish

proverb"


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186 7.2.3 a Implement arrangements for communicating

with customers on product information

Establish effective methods of

communication with the customer

187 7.2.3 b Determine arrangements for communicating

with customers on consulting, contracts, orders

and amendments

Job description of sales manager

188 7.2.3 b Implement arrangements for communicating

with customers on consulting, contracts, orders

and amendments

189 7.2.3 c Determine arrangements for communicatingwith customers on feedback

Identify methods of communication withthe customer on satisfaction and complaints

190 7.2.3 c Implement arrangements for communicating

with customers on feedback

7.2.3.1 Customer communication - Supplemental

191 7.2.3.1 Communicate in a customer-specified language

and format

CAD (computer aided design) and other

7.3 Design and development

7.3.1 Design and development planning

192 7.3.1 Plan the design and development of product Manage the design and product

development upstream by prevention

(FMEA, risk analysis)

193 7.3.1 Control the design and development of product "I have not failed. I just found 10,000 ways

that do not work. Thomas Edison"

194 7.3.1 a Determine the design and development stages Identify and formalize the key stages of

product design and development

195 7.3.1 b Determine review, verification and validation

activities at each stage

Identify and formalize the verification,

design validation and product development

steps. For each key step plan the action,

the manager, the expected result, the

criteria to be met, the materials required,

the time frame

196 7.3.1 c Determine the responsibilities and authoritiesfor design and development

Identify and formalize the persons withresponsibilities and authorities specified for

each key stage of product design and

development

197 7.3.1 Manage the interfaces between different

groups

Identify and formalize the relationships

between all actors in the product design

and development (meetings and reviews at

key stages)

198 7.3.1 Update planning output Planning is updated after each major

change of the product design and

development

7.3.1.1 Multidisciplinary approach


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199 7.3.1.1 Choose the multidisciplinary approach Product realization, monitoring special

characteristics, FMEA, control plans

7.3.2 Design and development inputs

200 7.3.2 Determine inputs relating to product

requirements

Identify, formalize and keep the information

needed to start the product design and

development

201 7.3.2 Maintain records Cf. sub-clause 4.2.4

202 7.3.2 a Determine functional and performances

requirements

The functional requirements found in the

specifications (dimensions, operating

conditions, tests)

203 7.3.2 b Determine statutory and regulatory

requirements

Requirements (qualifications or

recommendations) related to

transportation, packaging,

labels, instructions for use, expiry date,

traceability, components used

204 7.3.2 c Determine information derived from previous

designs

The results of design reviews of previous

similar products (tests, reliability,

feasibility) and feedback from users (sales,

recommendations, suggestions)

205 7.3.2 d Determine other requirements essential fordesign and development

Specific requirements of the product,components (selected suppliers, prohibited

materials), environmental aspects (disposal

of products)

206 7.3.2 Review inputs The project leader or another person verify

and validate the consistency of the input

207 7.3.2 Ensure that requirements are complete,

unambiguous and not in conflict with each

other

The project leader or another person verify

and validate for all input requirements the

lack of ambiguity and contradiction

7.3.2.1 Product design input

208 7.3.2.1 Control product requirements Cf. sub-clause 4.2.4; customer

requirements such as specialcharacteristics, traceability, packaging

209 7.3.2.1 Deploy information As experiences of previous projects,

competor analysis, feedback from suppliers

and internal and external customers

210 7.3.2.1 Control the objectives of product compliance Like product life, reliability, durability,

maintainability, cost, schedule

7.3.2.2 Manufacturing process design input

211 7.3.2.2 Control process requirements Cf. sub-clause 4.2.4; as product design

output data, process objectives, experience

from previous projects, error-proofing

equipment

7.3.2.3 Special characteristics


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212 7.3.2.3 Identify the special characteristics

213 7.3.2.3 Include the special characteristics in the

control plan

214 7.3.2.3 Use customer-specified symbols

215 7.3.2.3 Identify process contro l documents As control plans, FMEAs, work instructions

7.3.3 Design and development outputs Top of the page

216 7.3.3 Ensure that outputs are in a suitable form Identify measures that can determine

compliance between input and output217 7.3.3 Approve outputs Always confirm (approve) the outputs by

the project leader or another person prior

to use

218 7.3.3 a Ensure that outputs meet input requirements Conformity between outputs and input

requirements

219 7.3.3 b Ensure that outputs provide information for

purchasing, production and service provision

Full information from the BOM (component

specifications, raw materials, consumables)

220 7.3.3 c Ensure that outputs contain product

acceptance criteria or a reference to it

Identify the steps of monitoring

(inspections) and measurement (testing)

of production processes

221 7.3.3 d Ensure that outputs specify productcharacteristics essential for its safe and proper

use

Information about the intended andunintended use, security, maintenance

7.3.3.1 Product design outputs - Supplemental

222 7.3.3.1 Allow verification and validation

against product design input requirements


223 7.3.3.1 Include product design FMEA

224 7.3.3.1 Include product special characteristics

225 7.3.3.1 Include error-proofing equipment

226 7.3.3.1 Include product definition Last valid version

227 7.3.3.1 Include product design reviews results

228 7.3.3.1 Include product diagnostic

7.3.3.2 Manufacturing process design output

229 7.3.3.2 Allow verification and validation against

process design input requirements


230 7.3.3.2 Include specifications and drawings

231 7.3.3.2 Include process flow chart

232 7.3.3.2 Include process FMEAs

233 7.3.3.2 Include control plan Cf. sub-clause 7.5.1.1 ; Cf. annex A

234 7.3.3.2 Include work instructions

235 7.3.3.2 Include process approval acceptance criteria


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236 7.3.3.2 Include process perfo rmance data As data for quality, reliability,

maintainability, measurability

237 7.3.3.2 Include results of error-proofing acactivities

238 7.3.3.2 Include methods of nonconformities

7.3.4 Design and development review

239 7.3.4 a Evaluate the ability of results to meet

requirements


240 7.3.4 b Identify problems "A problem shared is a problem halved";the planned reviews can predict potential

problems and propose appropriate

preventive actions

241 7.3.4 Determine participants in reviews The reviews conducted by the project

leader or another person are

multidisciplinary with appropriate

participants for each step

242 7.3.4 Maintain records of the results of the reviews Cf. sub-clause 4.2.4

7.3.4.1 Monitoring

243 7.3.4.1 Define design and development measurements Carry out at key stages; take into account

quality risks, costs, lead-times

244 7.3.4.1 Analyse measurment results

245 7.3.4.1 Report results during management review Cf. sub-clause 5.6.2

7.3.5 Design and development verification

246 7.3.5 Perform verification of the design and

development

The reviews enable at key steps to verify

(trials, tests, measurements, calculations)

whether results are in line with objectives

247 7.3.5 Maintain records of the results of verification Cf. sub-clause 4.2.4

7.3.6 Design and development validation Top of the page

248 7.3.6 Perform validation of design and development After verification the design and

development are validated. This implies

that all customer requirements are met249 7.3.6 Complete validation before the delivery or

implementation of the product

In practice almost always the validation is

carried out upstream

250 7.3.6 Maintain records of the results of the validation Cf. sub-clause 4.2.4

7.3.6.1Design and development validation -

Supplemental

251 7.3.6.1 Validate design and development in accordance

with customer programme timing

7.3.6.2 Prototype programme

252 7.3.6.2 Define a prototype programme Cf. sub-clause 4.2.4

253 7.3.6.2 Define a control plan Cf. sub-clause 4.2.4


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254 7.3.6.2 Use the same suppliers, tooling and processes

as those for production

255 7.3.6.2 Monitor performance tests over time and

compliance with requirements

256 7.3.6.2 Take responsibility for outsourced services Technical leadership is part of it

7.3.6.3 Product approval process

257 7.3.6.3 Follow the procedure for product

approval process accepted by the customer


258 7.3.6.3 Follow the procedure for product

approval process to suppliers


7.3.7 Control of design and development changes

259 7.3.7 Identify design and development changes The changes are clearly identified

260 7.3.7 Maintain records of changes Cf. sub-clause 4.2.4

261 7.3.7 Review, verify and validate changes before

implementation

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

262 7.3.7 Approve changes before implementation

263 7.3.7 Evaluate the effect of changes Each change can affect the product (BOM,sales support). Assess risks and potential

impacts (simulation method)

264 7.3.7 Maintain records of the results of change

review


7.4 Purchasing

7.4.1 Purchasing process

265 7.4.1 Ensure that purchased product conforms to

requirements

"If you buy quality, you only cry once.

English proverb"; the purchase process

includes activities to ensure compliance of

components, materials and supplies

purchased

266 7.4.1 Determine supplier control Compared to the impact on the production

and the final product

267 7.4.1 Evaluate and select suppliers 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)

268 7.4.1 Establish selection, evaluationand

re-evaluation criteria

The purchasing process includes the

continual evaluation criteria (monthly or

quarterly) of suppliers (% of nonconforming

purchased products detected at


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reception inspection, production and after

sales service)

269 7.4.1 Maintain records of results of evaluation Cf. sub-clause 4.2.4

7.4.1.1 Regulatory conformity

270 7.4.1.1 Meet applicable regulatory requirements For purchased products, components and

materials

7.4.1.2Supplier quality management system

development

271 7.4.1.2 Encourage suppliers to develop their QMS Start with compliance and registration to

ISO 9001 and then to ISO/TS 16 949

272 7.4.1.2 Request supplier to be registered by an

accredited certification body


7.4.1.3 Customer-approved sources

273 7.4.1.3 Buy the products, components and raw

materials from approved sources

274 7.4.1.3 Take responsibility for the suppliers designated

by the customer

7.4.2 Purchasing information Top of the page

275 7.4.2 Descr ibe the product to be purchased Are taken into account all data on thepurchased product (specifications, transport

conditions, packing, receiving, testing,

storage and other)

276 7.4.2 a Determine approval requirements

277 7.4.2 b Determine requirements for qualification of

personnel

For specific cases staff receive appropriate

training (new type product, machine or

equipment not previously used)

278 7.4.2 c Determine QMS requirements Everything concerning the control of

nonconformities related to purchased

product and actions, person in charge and

time frame to implement

279 7.4.2 Ensure adequacy of purchase requirements Communicate requirements to the supplier

wich are realistic and appropriate with the

QMS

7.4.3 Verification of purchased product

280 7.4.3 Ensure that purchased product meets purchase

requirements

The purchasing process includes the

identification and implementation of

inspections at receiving and during

production

281 7.4.3 Include in the purchasing information

arrangements of verification at supplier's

premises

In the particular case of inspection and

release at supplier premises all these

activities are formalized (contract,

specifications with acceptance criteria)


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7.4.3.1 Incoming product quality

282 7.4.3.1 Evaluate statistical data Cf. sub-clause 4.2.4

283 7.4.3.1 Carry out receiving inspection Cf. annex A

284 7.4.3.1 Assess suppliers on site

285 7.4.3.1 Give evaluation away to a laboratory

286 7.4.3.1 Use another method authorized by the

customer

7.4.3.2 Supplier monitoring 287 7.4.3.2 Monitor supplier with the indicator delivered

product conformity


288 7.4.3.2 Monitor supplier with the indicator customer

disruptions

289 7.4.3.2 Monitor supplier with the indicator delivery

schedule performance

290 7.4.3.2 Monitor supplier with the indicator problem

quantity

291 7.4.3.2 Encourage the supplier to monitor himself the

performance of its processes

7.5 Production and service provision

7.5.1 Control of production and service provision

292 7.5.1 Plan production and service provision activities Identify, develop and plan all stages of

product realization process

293 7.5.1 Control the production and service provision

activities

294 7.5.1 a Ensure the availability of information

describing the product

The product specification information is

freely available to staff

295 7.5.1 b Ensure the availability of work instructions Work instructions, record sheets and others

are where needed

296 7.5.1 c Ensure the use of suitable equipment Equipment maintenance is regularly carried

out

297 7.5.1 d Ensure the availability of monitoring and

measuring equipment

Monitoring and measurement equipment

are maintained in good condition and the

staff are trained in their use

298 7.5.1 d Ensure the use of monitoring and measuring

equipment

299 7.5.1 e Implement monitoring and measuring

equipment

Monitoring and measurement equipment

are used regularly

300 7.5.1 f Implement release activites The release, transport and after sale service

are formalized and managed

301 7.5.1 f Implement delivery activities

302 7.5.1 f Implement post-delivery activities


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7.5.1.1 Control plan

303 7.5.1.1 Establish control plans Cf. annex A

304 7.5.1.1 MImplement control plans

305 7.5.1.1 Take into account results of design and process

FMEAs

306 7.5.1.1 List inspection types

307 7.5.1.1 Specify the monitoring of special

characteristics

Cf. sub-clause 7.3.2.3

308 7.5.1.1 Include the customer-required information

309 7.5.1.1 Initiate the reaction plan Cf. sub-clause 8.2.3.1; fight against

unstable processes

310 7.5.1.1 Perform an update after any changes Cf. sub-clause 7.1.4

7.5.1.2 Work instructions

311 7.5.1.2 Establish work instructions Cf. sub-clause 4.2.4

312 7.5.1.2 Facilitate the availability of instructions at the

work station

313 7.5.1.2 Establish the instructions from the quality plan,

the control plan and the realization process

Cf. annex A

7.5.1.3 Verification of job set-ups

314 7.5.1.3 Verify the job set-ups at every initial run New material or job change

315 7.5.1.3 Put work instructions available to the staff

316 7.5.1.3 Use statistical methods of verification

7.5.1.4 Preventive and predictive maintenance

317 7.5.1.4 Identify key process equipment Cf. sub-clause 4.2.4

318 7.5.1.4 Provide maintenance means

319 7.5.1.4 Develop a preventive maintenance system

320 7.5.1.4 Include planned maintenance activities

321 7.5.1.4 Include packaging and preservation Equipement, tooling, measuring means

322 7.5.1.4 Provide replacement parts for key equipment

323 7.5.1.4 Document, evaluate and improve maintenance

objectives


324 7.5.1.4 Use predictive maintenance methods

7.5.1.5 Management o f production tooling

325 7.5.1.5 Provide resources for design, manufacturing

and verification of tools

326 7.5.1.5 Determine personnel and facilities Cf. sub-clause 4.2.4

327 7.5.1.5 Determine the storage and recovery system

328 7.5.1.5 Determine set-up

329 7.5.1.5 Determine the renewal tool system


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330 7.5.1.5 Document tool changes Cf. sub-clause 4.2.4

331 7.5.1.5 Control tool modifications

332 7.5.1.5 Identify status of tool usage Production, repair or disposal

333 7.5.1.5 Monitor outsourced activities

7.5.1.6 Production scheduling

334 7.5.1.6 Schedule production Cf. sub-clause 4.2.4

7.5.1.7 Feedback of information from service

335 7.5.1.7 Communicate feedback from service afterdelivery


7.5.1.8 Service agreement with customer

336 7.5.1.8 Verify the effectiveness of service centres after

delivery


337 7.5.1.8 Verify the effectiveness of tools and measuring

devices


338 7.5.1.8 Verify the effectiveness of staff training Cf. sub-clause 4.2.4

7.5.2Validation of processes for production and

service provisionTop of the page

339 7.5.2 Validate special processes (where the output

cannot be verified)

When the product cannot be measured

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

340 7.5.2 Demonstrate the ability of these processes to

achieve planned results

The validation of the process ensures

compliant products

341 7.5.2 a Define criteria for process review The criteria for process monitoring and

measuring are strengthened

342 7.5.2 a Define criteria for process approval

343 7.5.2 b Approve equipment Checking equipment and staff training are

reinforced

344 7.5.2 b Approve qualification of personnel

345 7.5.2 c Use specific methods and procedures

346 7.5.2 d Establish record requirements Cf. sub-clause 4.2.4

347 7.5.2 e Establ ish provisions for reval idation Every change require a new val idation of

the process

7.5.2.1Validation of processes for production and

service provision- Supplemental

348 7.5.2.1 Validate all production and service provision

processes

Apply requirements of sub-clause 7.5.2

7.5.3 Identification and traceability

349 7.5.3 Identify the product When appropriate identification of the

product and components shows its status

relative to the production stages (bar code,card, label)


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350 7.5.3 Identify product status throughout product

realization

The identification of the product also shows

its status (results) relative to monitoring

and measuring stages

351 7.5.3 Control the unique identification of the product Product traceability (who, when, with which

batch) shows the history of

production stages

352 7.5.3 Maintain records Cf. sub-clause 4.2.4

7.5.3.1 Identification et traceability - Supplemental

353 7.5.3.1 Always apply unique product identification Cf. sub-clause 7.5.3

7.5.4 Customer property

354 7.5.4 Take care with customer property Customer property includes:

- raw materials

- components

- packaging materials

- equipment

- testers and software (intellectual

property)

355 7.5.4 Identify customer property

356 7.5.4 Verify customer property

357 7.5.4 Protect customer property Inspection of customer property inreception (where appropriate), specific

storage and protection when requested by

customer

358 7.5.4 Safeguard customer property

359 7.5.4 When property is lost or damaged report it to

the customer

Any concern with customer property is

controlled as a

nonconformity (identification, analysis,

decision, recording) and more than that

required communication with the customer

360 7.5.4 Maintain records of reports to the customer Cf. sub-clause 4.2.4

7.5.4.1 Customer-owned production tooling 361 7.5.4.1 Mark permently and visibly customer-owned

tooling

Including all customer-owned tools and

equipment used in production

7.5.5 Preservation of product

362 7.5.5 Preserve conformity of product to requirements The product is protected internally and up

to delivery to the customer (packaging,

storage conditions)

363 7.5.5 Provide product identification, handling,

packaging, storage and protection

Preservation of the product includes all

stages of product life cycle (receiving,

production, handling, storage, delivery)

364 7.5.5 Apply product preservation to components Components, raw materials and semi

finished products are part of the product


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7.5.5.1 Storage and inventory

365 7.5.5.1 Regularly inspect storage conditions Cf. annex A

366 7.5.5.1 Optimally manage the stocks over time For example the FIFO (first in, first out)

system

367 7.5.5.1 Treat as obsolete nonconforming components

7.6Control of monitoring and measuring

equipment

368 7.6 Determine monitoring and measuring activities

to be undertaken

The process of monitoring and

measurement are in place to collect

evidence of product compliance

369 7.6 Determine monitoring and measuring

equipment

Equipment list with serial numbers

370 7.6 Establish monitoring and measuring processes Monitoring and measuring

devices meet internal, customer and

regulatory requirements

371 7.6 a Calibrate and verify measuring equipment Measuring equipment (hardware and

software) are calibrated or verified regularly

372 7.6 a Record calibration and verification methods Cf. sub-clause 4.2.4

373 7.6 b Agjust measuring equipment Measuring equipment are adjusted regularly

374 7.6 c Identify calibration status The validity date is available on the

equipment

375 7.6 d Safeguard adjustments of measuring

equipment

Protection against actions of intended or

unintended misadjustment

376 7.6 e Safeguard measuring equipment from damage

and deterioration

Effective protection not only during their

use (travel, maintenance, storage)

377 7.6 Assess nonconforming equipment This concerns the potentially

nonconforming products

378 7.6 Take appropriate actions on nonconforming

product

Equipment is verified and calibrated.

Products are inspected, validated (with or

without concession) or identified as

nonconforming

379 7.6 Maintain records of the results of calibration

and verification


380 7.6 Confirm the ability of monitoring and

measuring software to satisfy intended

application

Monitoring and measurement software is

validated before use

381 7.6 Undertake confirmation before initial use Make a second validation if the first one is

not satisfactory

7.6.1 Measurement system analysis

382 7.6.1 Conduct statistical studies of measuring and

test systems


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383 7.6.1 Apply to measurement systems referenced in

the control plan

384 7.6.1 Use analytical methods and acceptance criteria

specified by the customer

Or approved by the customer

7.6.2 Calibration/verification records

385 7.6.2 Identify the equipment Cf. sub-clause 4.2.4;and measurement

standard

386 7.6.2 Include any out-of-specification readings Cf. sub-clause 4.2.4

387 7.6.2 Assess the impact of out-of-specification

condition


388 7.6.2 Include status of conformity to specifications Cf. sub-clause 4.2.4

389 7.6.2 Notify to the customer if any doubt of

nonconforming product shipped


7.6.3 Laboratory requirements

7.6.3.1 Internal laboratory

390 7.6.3.1 Own a description of activities Cf. sub-clause 4.2.4

391 7.6.3.1 Include the description of activities in the QMS

documentation


392 7.6.3.1 Apply the technical requirements for theadequacy of procedures

393 7.6.3.1 Apply the technical requirements for the

competence of staff

394 7.6.3.1 Apply the technical requirements for testing

395 7.6.3.1 Apply the technical requirements for the

realization of services

396 7.6.3.1 Apply the technical requirements for the review

of records

7.6.3.2 External laboratory

397 7.6.3.2 Own a description of activities Cf. sub-clause 4.2.4

398 7.6.3.2 Be acceptable to the customer or accredited to

ISO 17 025 or equivalent

8 Measurement, analysis and improvement Check, Act

8.1 General Top of the page

399 8.1 a Plan the processes necessary to demonstrate

conformity to product requirements

"If you can't measure it, you can't manage

it. Peter Drucker"; control of product

compliance is demonstrated by inspection

processes throughout the production stages

400 8.1 a Implement the processes necessary to

demonstrate conformity to product

requirements


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401 8.1 b Plan the processes necessary to ensure

conformity of the QMS

Control of the conformity of the QMS is

ensured among other things on

management processes (strategy, auditing,

continual improvement, self assessment)

402 8.1 b Implement the processes necessary to ensure

conformity of the QMS

403 8.1 c Plan the processes necessary to continually

improve the effectiveness of the QMS

The overall improvement in the

effectiveness of the QMS is the result of all

improvement activities (audits, dataanalysis, new objectives, corrective and

preventive actions)

404 8.1 c Implement the processes necessary to

continually improve the effectiveness of the

QMS

405 8.1 Determine monitoring, measurement, analysis

and improvement methods

Data analysis, statistical techniques (SPC,

statistical process control), Kaizen,

Ishikawa diagram (5 M)

8.1.1 Identification of statistical tools

406 8.1.1 Identify statistical tools for each process Cf. sub-clause 4.2.4

407 8.1.1 Include statistical tools in the control plan Cf. annex A 8.1.2 Knowledge of basic stat istical concepts

408 8.1.2 Understand and use basic statistical concepts Such as process variation, stability,

over-adjustment

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

409 8.2.1 Monitor customer perception Measure the level of satisfaction of

customer needs and expectations

(congratulations, returns, complaints,

recommendations). The customer may be

the direct customer (distributor) or the end

customer (consumer)410 8.2.1 Determine monitoring of customer satisfaction

methods

Examples: surveys, feedback, open doors,

tracking returns and customer complaints,

benchmarking

8.2.1.1 Customer satisfaction - Supplemental

411 8.2.1.1 Evaluate continually the performance of

realization processes


412 8.2.1.1 Base the performance indicators on

information from the quality of products

delivered


information from customer disruptions


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information from delivery schedule


information from customer notifications

416 8.2.1.1 Monitor performance of manufacturing

processes

8.2.2 Internal audit

417 8.2.2 a Conduct internal audits to determine whether

the QMS conforms to the plannedarrangements

Cf. sub-clause 7.1


the QMS conforms to the requirements of the

ISO 9001 standard

Annual programme of internal audits


the QMS conforms to the requirements of the

organization

Audits specific to the organization

420 8.2.2 b Conduct internal audits to determine whether

the QMS is effectively implemented

Internal audits allow measuring the

performance of the QMS

421 8.2.2 b Conduct internal audits to determine whether

the QMS is effectively maintained

The frequency of audits is appropriate

422 8.2.2 Plan the audit programme The audit programme focuses on sensitive

processes and areas without forgetting the

results of previous audits

423 8.2.2 Define the audit criteria, scope, frequency and

methods

Mandatory information included in the

procedure "Internal Audit"

424 8.2.2 Ensure objectivity and impartiality of internal

audits

Training and selection of auditors

425 8.2.2 Ensure that auditors don't audit their own work "No one is a judge in his own case. Latin

proverb"

426 8.2.2 Establish a documented procedure for internal

audits

Cf. sub-clause 4.2.1; the mandatory

procedure for audits answers the questionswho, when, how, under what conditions

plan (audit programme), define the criteria,

scope, frequency and methods of audits

427 8.2.2 Maintain records of the audit results Cf. sub-clause 4.2.4; audit report

428 8.2.2 Ensure that the corrections and correctives

actions are taken without undue delay

The person in charge of the actions is on

schedule to identify and eliminate the

causes of nonconformities

429 8.2.2 Verify the taken actions The results of the follow-up of

the corrective actions are verified and

recorded

430 8.2.2 Record the report of the results of theverification Cf. sub-clause 8.5.2


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8.2.2.1 Quality management system audit

431 8.2.2.1 Conduct QMS audits Verify compliance with ISO/TS 16 949

requirements

8.2.2.2 Manufactoring process audit

432 8.2.2.2 Audit each process Determine the effectiveness of each process

8.2.2.3 Product audit

433 8.2.2.3 Audit products Verify compliance with all specified product

requirements

8.2.2.4 Internal audit plans

434 8.2.2.4 Cover every year all QMS processes Do not forget the night shift

435 8.2.2.4 Increase audit frequency If occurrence of unexpected

nonconformities

8.2.2.5 Internal auditor qualification

436 8.2.2.5 Train internal auditors with the ISO/TS 16 949

requirements


8.2.3 Monitoring and measurement of processes Top of the page

437 8.2.3 Monitor and measure QMS processes Monitor and measure the process

objectives and indicators using an

established method438 8.2.3 Demonstrate the ability of the processes to

achieve planned results

When objectives and indicators are

achieved the process is effective

(inspections at key stages)

439 8.2.3 Undertake corrections and corrective actions

when planned results of processes are not

achieved


8.2.3.1Monitoring and measurement of manufactoring

processes

440 8.2.3.1 Study the new manufacturing processes Check their capability to meet requirements

441 8.2.3.1 Record the results of studies Cf. sub-clause 4.2.4; production

specifications442 8.2.3.1 Include the objectives of the processes Capability, reliability, acceptance criteria

443 8.2.3.1 Improve process performance

444 8.2.3.1 Implement the cotrol plan and process flow

diagram

Follow the measurement techniques,

sampling plans for inspection, acceptance

criteria, reaction plans

445 8.2.3.1 Maintain records of changes and repairs Cf. sub-clause 4.2.4; for tools and

machinery

446 8.2.3.1 Initiate the reaction plan If the process is unstable or statistically

not capable

447 8.2.3.1 Isolate nonconforming products If products are back in product ion a 100 %

inspection is undertaken


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448 8.2.3.1 Complete a correct ive act ion plan The goal is to restore stability and process

capability; fix the responsibility for each

action and specific timing

449 8.2.3.1 Review plans with the customer If requested obtain customer approval

450 8.2.3.1 Maintain records of implementation dates of

process changes


8.2.4 Monitor ing and measuremnt of product

451 8.2.4 Monitor and measure product characteristics Monitoring of product characteristics verify

satisfaction to product requirements(inspections at key stages)

452 8.2.4 Monitor and measure the product at

appropriate stages

Cf. sub-clause 7.1

453 8.2.4 Maintain evidence of conformity with the

acceptance criteria


454 8.2.4 Record the person having authorised the

product release


455 8.2.4 Release of product only after planned

arrangements have been satisfied

Cf. sub-clause 7.1

8.2.4.1 Layout inspection and functional testing

456 8.2.4.1 Inspect the layout of each product reference According to the control plan; Cf. annex A;


457 8.2.4.1 Perform functional testing on products According to the control plan; Cf. annex A;


458 8.2.4.1 Keep available to the customer the results of

inspections

8.2.4.2 Appearance items

459 8.2.4.1 Provide appropiate resources for appearance

items

Lighting, appearance masters, maintenance

standards, competence and qualification of

personnel

8.3 Control of nonconforming product

460 8.3 Ensure that nonconforming product is identified

and controlled to prevent its unintended use

"Any problem hides an opportunity for

improvement "; identification and isolation

of nonconforming product for treatment

461 8.3 Establish the documented procedure control of

nonconforming product

"Quality shine from afar, defects from up

close. Victor Hugo", cf. sub-clause 4.2.1,

the mandatory procedure for

nonconforming product answers the


conditions eliminate nonconformities, root

causes, prevent the use

462 8.3 a Undertake actions to eliminate the detected

nonconformity

Identify nonconformities and treat them like

scrap


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463 8.3 b Authorize its use, release or acceptance under

concession

464 8.3 c Undertake actions not allowing intended use Correction, repair, rehabilitation or scrap

465 8.3 d Undertake actions when a nonconforming

product is detected after delivery

Recall (prevent use after delivery),

withdrawal (prevent the distribution),

communication, batch identification,

isolation, root cause analysis, corrective

and preventive actions

466 8.3 Maintain records of the nature ofnonconformities and actions taken


467 8.3 Verify again the corrected nonconforming

product

Any corrected nonconforming product is

always verified before being returned with

other products

8.3.1Control of nonconforming product -

Supplemental

468 8.3.1 Consider any unidentified or suspect

product as nonconforming

8.3.2 Control of reworked product

469 8.3.2 Give free access to instructions for rework to

personnel


8.3.3 Customer information

470 8.3.3 Promptly notify the

customer when nonconforming product has

been shipped


8.3.4 Customer waiver

471 8.3.4 Obtain a customer concession each time a

nonconformity appears

So not to stop production

472 8.3.4 Maintain a record of the amount authorized to

waive


473 8.3.4 Ensure compliance of new product after the

end of the waiver

474 8.3.4 Identify the product delivered under waiver Each package is marked as containing

products under waiver

475 8.3.4 Apply the identification of the product delivered

under concession from a supplier

476 8.3.4 Approve a request from a supplier and then

submit it to the customer


8.4 Analysis of data Top of the page

477 8.4 Determine data to demonstarte the suitability

and effectiveness of the QMS

The preparation of the management review

includes the collection and analysis of data

(indicators, audit results, level of customer

satisfaction). After synthesis decisions of


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the management review about continual

improvement

478 8.4 Collect data to demonstarte the suitability and


479 8.4 Analyse data to demonstarte the suitability and


480 8.4 Evaluate the opportunities to improve the


Any opportunity for improvement is

evaluated before its implementation

481 8.4 Include data from monitoring and measuringactivities

Analysis of indicators related among otherthings to monitoring and measurement

482 8.4 a Provide information on customer satisfaction Cf. sub-clause 8.2.1

483 8.4 b Provide information on conformity to product

requirements


484 8.4 c Provide information on trends of processes and

products

Cf. sub-clauses 8.2.3and 8.2.4

485 8.4 d Provide information on on suppliers Cf. sub-clause 7.4

8.4.1 Analysis and use of data

486 8.4.1 Compare trends and performance against

objectives

487 8.4.1 Find solutions to customer problems

488 8.4.1 Determine trends in the indicators related to

customer requirements


489 8.4.1 Collect usage information of the product Cf. sub-clause 4.2.4

8.5 Improvement

8.5.1 Continual improvement

490 8.5.1 Continually improve the effectiveness of the

QMS

"Quality is a journey not a destination";

apply the process continual improvement of

the QMS (turn the Deming wheel). Identify

opportunities for improvement, find and

eradicate the root causes ofnonconformities, promote preventive

actions

8.5.1.1 Continual improvement of the organization

491 8.5.1.1 Define the continual improvement process Cf. sub-clause 4.2.4

8.5.1.2 Manufacturing process improvement

492 8.5.1.2 Control the variation in product characteristics

and manufacturing processes parameters

Improvement is possible only when

processes are stable and capable

8.5.2 Corrective action

493 8.5.2 Undertake action to eliminate the causes of

nonconformities

Analysis and eradication of the causes of

nonconformities in the process, product or

QMS


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494 8.5.2 Adapt corrective actions to the effects of

nonconformities

Make arrangements with respect to real

effects (watch out for excessive zeal)

495 8.5.2 a Establish the documented procedure for

corrective action and review nonconformities


procedure for corrective action answers the


conditions identify and

treat nonconformities. Determine and

eliminate causes, assess the need for

corrective actions, implement corrective

actions and review actions

496 8.5.2 b Determine the causes of nonconformities Include in the procedure methods to find

the causes of nonconformities (Ishikawa

diagram, MSP)

497 8.5.2 c Evaluate the need to undertake corrective

action

What could be achieved if an action is

applied? The resources needed are they

available? (Some nonconformities do not

require corrective actions)

498 8.5.2 d Determine the necessary action Include the procedure the method for

determining responsibilities, authorities,

time frames, resources and monitoring of

actions to implement499 8.5.2 d Implement the necessary action

500 8.5.2 e Record the results of the corrective action Cf. sub-clause 4.2.4

501 8.5.2 f Review the effectiveness of the corrective

action undertaken

Analyse the monitoring of actions

(possibility of a new audit), improve

documentation

8.5.2.1 Problem solving

502 8.5.2.1 Define the problem solv ing process Identify root causes and eliminate them;


503 8.5.2.1 Use the customer-prescribed problem-solving

format

When it is requested by customer

8.5.2.2 Error-proofing

504 8.5.2.2 Apply error-proofing methods in corrective

actions

8.5.2.3 Corrective action impact

505 8.5.2.3 Apply implemented correctives actions to

similar processes and products

8.5.2.4 Rejected product test/analysis

506 8.5.2.4 Analyse rejected parts promptly

507 8.5.2.4 Maitain records of performed analyses Cf. sub-clause 4.2.4

508 8.5.2.4 Prevent any recurrence of the problem Effectiveness of the analysis and corrective

actions


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8.5.3 Preventive action Top of the page

509 8.5.3 Determine the action allowing the elimination

of the causes of potential nonconformities

Analysis and elimination of potential causes

of nonconformities of processes or of the

QMS

510 8.5.3 Adapt preventive actions to the effects of the

potential problems

Make arrangements with respect to

potential effects (stay within available

resources)

511 8.5.3 a Establish the documented procedure

preventive action and determine potentialnonconformities and their causes


procedure for preventive actions answersthe questions, who, when, how, under what

conditions identify potential

nonconformities, determine their causes,

evaluate the need for preventive actions,

implement preventive actions and monitor

actions

512 8.5.3 b Evaluate the need to undertake preventive

action

Will the occurence avoided? The resources

needed are they available?

513 8.5.3 c Determine the necessary action Include in the procedure the method for

determining responsibilities, authorities,

time frames, resources and monitoring of

actions to implement

514 8.5.3 c Implement the necessary action Find the causes

515 8.5.3 d Record the results of the preventive action Cf. sub-clause 4.2.4

516 8.5.3 e Review the effectiveness of the preventive

action undertaken

Analyse the monitoring of actions

(possibility of a new audit), improve

documentation

Annexe A Control plan Check

517 A.1 Cover, as appropriate, the three phases -

prototypes, pre-launch and production

518 A.1 Implement the prototype control plan If required by the customer

519 A.1 Establish a control plan for each part Cf. sub-clause 4.2.4; a control plan foreach product family is often sufficient

520 A.2 Include the general data In the header of the control plan

521 A.2 Include product control Special characteristics, specifications,

tolerance

522 A.2 Include process control Parameters, special characteristics,

machines, tools, jigs, tooling

523 A.2 Include methods Measurement techniques, error-proofing

equipment, sampling, control methods

524 A.2 Include reaction plan and corrective actions Corrective action and reaction plans

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