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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 cycle
Requirement
N
Quantity
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
Requirements, clauses and sub-clauses of the technical specification ISO/TS 16 949

PDCA wheel
ISO/TS 16 949 - Requirements and comments
N
Clause,
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 5.1 and 5.6.1
2 4.1 Document the QMS Cf. sub-clause 4.2.3
3 4.1 Implement the QMS Cf. sub-clauses 5.1 and 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
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 6.1 and 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 7.2 and 7.5
17 4.1 Ensure control of outsourced processes Control of an outsourced process includes
the establishment of specific provisions with
the 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 are
formalized 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
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 (include
key 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. You
can 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
39 4.2.3 e Identify documents Method for coding documents
40 4.2.3 f Control documents of external origin 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
Cf. sub-clause 4.2.4
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
questions who, when, how, under what
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
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 each
department 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 page
64 5.2 Determine customer requirements Cf. sub-clauses 7.2.1 and 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 5.1 and 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
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
5.5
Responsibility, authority and
communication
Top of the page
5.5.1 Responsibility and authority
80 5.5.1 Define responsibilities and authorities "Responsibility 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 representative
85 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 7.2 and 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
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 attention to feedback (surveys,
suggestion box)
94 5.5.3 Communicate on the effectiveness of the QMS
5.6 Management review
5.6.1 General
95 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
Cf. sub-clause 4.2.4
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 your
products", 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
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 resources
are 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
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 effectiveness 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
Cf. sub-clause 4.2.4
6.2.2.1 Competence, training and awareness
125 6.2.2.1 Ensure competence of personnel in charge of
the 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
questions who, when, how, under what
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
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 planning
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 that
affect 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 the
product
Establish and implement processes and
documentation for each product
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 4.2.4
158 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 proprietary 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
7.2.1
Determination 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)
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
Cf. sub-clause 4.2.4
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

7.2.2.1
Review 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 feasibility
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"
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 communicating
with customers on feedback
Identify methods of communication with
the 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 authorities
for design and development
Identify and formalize the persons with
responsibilities 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
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 for
design 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 special
characteristics, 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
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 control 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 output
217 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 product
characteristics essential for its safe and proper
use
Information about the intended and
unintended 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
Cf. sub-clause 4.2.4
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
Cf. sub-clause 4.2.4
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
236 7.3.3.2 Include process performance 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
Cf. sub-clause 7.3.1
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 met
249 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
7.3.6.1
Design 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
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
Cf. sub-clause 4.2.4
258 7.3.6.3 Follow the procedure for product
approval process to suppliers
Cf. sub-clause 4.2.4
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
Cf. sub-clause 4.2.4
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
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
7.4.1.2
Supplier 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
Cf. sub-clause 4.2.4
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 Describe the product to be purchased Are taken into account all data on the
purchased 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)
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
Cf. sub-clause 4.2.4
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
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
Cf. sub-clause 4.2.4
324 7.5.1.4 Use predictive maintenance methods
7.5.1.5 Management of 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
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 after
delivery
Cf. sub-clause 4.2.4
7.5.1.8 Service agreement with customer
336 7.5.1.8 Verify the effectiveness of service centres after
delivery
Cf. sub-clause 4.2.4
337 7.5.1.8 Verify the effectiveness of tools and measuring
devices
Cf. sub-clause 4.2.4
338 7.5.1.8 Verify the effectiveness of staff training Cf. sub-clause 4.2.4
7.5.2
Validation of processes for production and
service provision
Top 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 Establish provisions for revalidation Every change require a new validation of
the process
7.5.2.1
Validation 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)
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 in
reception (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
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
7.6
Control 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
Cf. sub-clause 4.2.4
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

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
Cf. sub-clause 4.2.4
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
Cf. sub-clause 4.2.4
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
Cf. sub-clause 4.2.4
392 7.6.3.1 Apply the technical requirements for the
adequacy 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

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, data
analysis, 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 statistical 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
Cf. sub-clause 4.2.4
412 8.2.1.1 Base the performance indicators on
information from the quality of products
delivered

413 8.2.1.1 Base the performance indicators on
information from customer disruptions

414 8.2.1.1 Base the performance indicators on
information from delivery schedule

415 8.2.1.1 Base the performance indicators on
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 planned
arrangements
Cf. sub-clause 7.1
418 8.2.2 a Conduct internal audits to determine whether
the QMS conforms to the requirements of the
ISO 9001 standard
Annual programme of internal audits
419 8.2.2 a Conduct internal audits to determine whether
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 questions
who, 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 the
verification
Cf. sub-clause 8.5.2
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
Cf. sub-clause 6.2.2
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 method
438 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
Cf. sub-clause 8.5.2
8.2.3.1
Monitoring 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
specifications
442 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 production a 100 %
inspection is undertaken
448 8.2.3.1 Complete a corrective action 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
Cf. sub-clause 4.2.4
8.2.4 Monitoring 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
Cf. sub-clause 4.2.4
454 8.2.4 Record the person having authorised the
product release
Cf. sub-clause 4.2.4
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;
Cf. sub-clause 4.2.4
457 8.2.4.1 Perform functional testing on products According to the control plan; Cf. annex A;
Cf. sub-clause 4.2.4
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
questions who, when, how, under what
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
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 of
nonconformities and actions taken
Cf. sub-clause 4.2.4
467 8.3 Verify again the corrected nonconforming
product
Any corrected nonconforming product is
always verified before being returned with
other products
8.3.1
Control 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
Cf. sub-clause 4.2.3
8.3.3 Customer information
470 8.3.3 Promptly notify the
customer when nonconforming product has
been shipped
Cf. sub-clause 4.2.4
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
Cf. sub-clause 4.2.4
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
Cf. sub-clause 4.2.4
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
the management review about continual
improvement
478 8.4 Collect data to demonstarte the suitability and
effectiveness of the QMS

479 8.4 Analyse data to demonstarte the suitability and
effectiveness of the QMS

480 8.4 Evaluate the opportunities to improve the
effectiveness of the QMS
Any opportunity for improvement is
evaluated before its implementation
481 8.4 Include data from monitoring and measuring
activities
Analysis of indicators related among other
things 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
Cf. sub-clause 8.2.4
484 8.4 c Provide information on trends of processes and
products
Cf. sub-clauses 8.2.3 and 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
Cf. sub-clause 4.2.4
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 of
nonconformities, 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
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
Cf. sub-clause 4.2.1; the mandatory
procedure for corrective action answers the
questions who, when, how, under what
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 implement
499 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 solving process Identify root causes and eliminate them;
Cf. sub-clause 4.2.4
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
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 potential
nonconformities and their causes
Cf. sub-clause 4.2.1; the mandatory
procedure for preventive actions answers
the 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 for
each 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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