• E-learning courses E-Learning

    The benefits of e-learning?

    • cost reduction
    • greater flexibility
    • increased effectiveness
    • bigger individualization
  • games IZOGOOD GAMES

    The benefits of a game?

    • learn in a fun way
    • to be enriched by the skills of others
    • assimilate the content of clauses and sub-clauses
    • be better prepared for the certification
  • Documents for your management system Documents

    Documents for your management system?

    Are you looking to save time and cut costs?
    Why re-invent the wheel?

News

01 August 2018:

- Alignment of training prices

  Promotion of the week Promotion of the week

For week 46 the set of documents D 39v15 IMS QSE version 2015 internal audit is at 14 euros (instead of 28 euros) 

  Promotion of the month Promotion of the month

For November the course T 35v15 ISO 9001 version 2015 internal audit is with a 50% decrease (from 100 euros to 50 euros)

ISO 9001:2015 requirements

Requirements ISO 9001 v 2015

You want to familiarize yourself with the structure of the standard, identify and understand the requirements of ISO 9001 v 2015, then it's up to you to play!

Start

The "ISO 9001 v 2015 Requirements" quiz will help you understand the main requirements of the standard.

The questions (requirements) of this quiz are 60, don't worry. The requirements of the standard are 309 but these 60 requirements are among the most important, so do not hesitate to learn in a fun way!

Do not think you can finish this quiz in less than an hour, unless of course you are a little genius!

News about the ISO 9001 version 2015

The course T 15v15 ISO 9001 v 2015 readiness and its demo

The course T 35v15 ISO 9001 v 2015 internal audit and its demo

The package of courses T 65v15 training package ISO 9001 v 2015 readiness and internal audit

 

Based on the ISO 9001: 2015 the 309 requirements (verb shall) of clauses 4 to 10 are as follows:

ISO 9001 : 2015 requirements 
No
Clause
PDCA cycle
Requirement No
Quantity
4
Context of the organization Plan 1 ÷ 24 24
5
Leadership PlanDoCheckAct
25 ÷ 50
26
6
Planning Plan
51 ÷ 77
27
7
Support Do
78 ÷ 120
43
8
Operation Do
121 ÷ 248
128
9
Performance evaluation Check
249 ÷ 291
43
10
Improvement Act
291 ÷ 309
18
Total
309

iso 9001

ISO 9001 2015 requirements

pdca

The Deming PDCA cycle

Remark. Any requirement normally begins with "The organization shall...". For simplicity's sake we present the requirements directly, starting with the verb.

ISO 9001 - Requirements and comments
No
Clause, sub-clause
Requirement
Comment, link
  4
Context of the organization
 
4.1
The organization and its context
 
1
4.1
Determine external and internal issues Understand everything that can influence the purpose and strategic direction of the company (corporate culture, innovation, strategic direction, competition, market, compliance obligation)
2 4.1 Monitor and review information about issues Issue: what one can gain or lose during an activity (factors, conditions)
 
4.2
Needs and expectations of interested parties
3
4.2 a Identify the interested parties "There is only one valid definition of a business purpose: to create a customer. Peter Drucker". List of relevant interested parties
4
4.2 b
Clarify the requirements of interested parties Each need and expectation is unique. Aim for a partnership in the long term 
5
4.2
Monitor and review information about interested parties and their requirements Before accepting an order
 
4.3
Scope of the quality management system
6
4.3
Define the scope of the QMS Geographic and organizational scope available to interested parties
7
4.3 a
Take into account the external and internal issues Cf. sub-clause 4.1
8
4.3 b
Take into account the requirements of interested parties Cf. sub-clause 4.2
9
4.3 c
Take into account the products and services All products and services proposed by the company without exception
10
4.3
Apply any requirement of the ISO 9001 standard applicable within the scope of the QMS The requirements of the standard become internal requirements
11 4.3 Maintain the scope of the QMS as documented information Cf. sub-clause 7.5. Include all products and services
12
4.3
Include in the scope of the QMS justification for any requirements which cannot be met Every requirement of the ISO 9001 standard which cannot be applied in the company implies a justification
 
4.4
Quality management system and its processes
13
4.4.1
Establish, implement, maintain and improve a process-based QMS The company is free to decide how to apply the QMS without forgetting the issues (see sub-clause 4.1) and requirements (see sub-clause 4.2)
14 4.4.1 Determine the needed processes and their application "If you cannot describe what you are doing as a process, you do not know what you're doing. Edwards Deming". Process map
15
4.4.1 a
Determine process inputs and outputs Process sheet
16 4.4.1 b Determine the sequence and interaction of processes Flowchart
17 4.4.1 c Determine the criteria and methods to control processes Tools of the quality manager
18 4.4.1 d Determine and ensure the resources Needed to support processes. Cf. sub-clause 7.1
19 4.4.1 e Assign process responsibilities and authorities Job description of process owners
20 4.4.1 f Take into account the risks and opportunities for each process Plan and implement actions to address these risks, cf. sub-clause 6.1
21 4.4.1 g Evaluate processes and if necessary modify them Identify methods to monitor, measure, check and modify processes. Cf. sub-clause 9.1.1
22 4.4.1 h Determine the improvement opportunities of processes and the QMS Cf. sub-clause 10.1
23
4.4.2
Maintain documented information on process operation Cf. sub-clause 7.5. The bare essential is sufficient. Use process map
24
4.4.2
Retain documented information on process operation Cf. sub-clause 7.5. The goal is to ensure that processes' results  are those planned 
 
5
Leadership
Plan Do, CheckAct 
 
5.1 
Leadership and commitment
 
5.1.1 
General
25
5.1.1 a
Assume responsibility for the effectiveness of the QMS "When you sweep the stairs, you start at the top. Romanian proverb". Top management demonstrates leadership (assumes its responsibility and commitment). Focus on quality and customers
26 5.1.1 b Establish a quality policy and quality objectives The policy and the objectives are compatible with strategic direction and context of the company
27
5.1.1 c
Integrate QMS requirements in the internal process requirements  Cf. sub-clause 4.4 and sub-clause 7.1.4
28
5.1.1 d
Raise awareness of the process approach and risk-based approach Cf. sub-clause 0.3 (introduction) and sub-clause 6.1
29
5.1.1 e
Provide the necessary resources for the QMS Cf. sub-clause 7.1
30
5.1.1 f
Raise awareness on the importance of an effective and conforming QMS Third quality management principle (engagement of people)
31
5.1.1 g
Ensure the achievement of intended results of the QMS Essential commitment of top management
32
5.1.1 h
Support the staff contribution to the effectiveness of the QMS "Employees first, customers second. Vineet Nayar"
33
5.1.1 i
Promote continual improvement Cf. sub-clause 10.3
34
5.1.1 j
Support the leadership of managers  Responsibility and authority of managers are backed at all times by top management
 
5.1.2
Customer focus
35
5.1.2 a
Determine and meet customer, statutory and regulatory requirements Top management demonstrates leadership (assumes its responsibility and commitment) permanently
36
5.1.2 b
Determine and address the potential risks and opportunities Any risk and opportunity that may influence the conformity of products and services and customer satisfaction. Preserving the goal to always provide compliant products and services
37
5.1.2 c
Maintain the objective of better satisfying the customer First quality management principle (customer focus)
 
5.2
Policy
5.2.1
Establishing the quality policy
 
38
5.2.1 a
Establish, implement and maintain a suitable quality policy Top management applies a policy adapted to the purpose, strategic direction, culture and business context
39 5.2.1 b Provide a framework to define and review the quality objectives Cf. sub-clause 6.2
40 5.2.1 c Include meeting the applicable requirements Cf. sub-clause 9.1.3
41 5.2.1 d Include a commitment to continuously improve the QMS Cf. sub-clause 10.3
 
5.2.2
Communicating the quality policy
42 5.2.2 a Maintain the quality policy as documented information And make it available inside the company. Cf. sub-clause 7.5
43 5.2.2 b Communicate the quality policy So it is understand and applied, cf. sub-clause 7.4
44 5.2.2 c Keep the quality policy available The quality policy cannot be a confidential document, it is available to relevant interested parties
 
5.3
Roles, responsibilities, authorities
45
5.3
Define and communicate the responsibilities and authorities Top management assigns all relevant roles in the QMS
46
5.3 a
Define and communicate the responsibilities and authorities Top management assigns all relevant roles according to the requirements of the ISO 9001 standard
47
5.3 b
Define and communicate the responsibilities and authorities Top management assigns all relevant roles so that processes deliver expected results
48
5.3 c
Define and communicate the responsibilities and authorities Top management assigns all relevant roles so that reporting on the performance of the QMS and improvement opportunities is done, cf. sub-clause 10.1 
49
5.3 d
Define and communicate the responsibilities and authorities Top management assigns all relevant roles so that customer focus is ensured (first quality management principle)
50
5.3 e
Define and communicate the responsibilities and authorities Top management assigns all relevant roles so that implemented changes to the QMS do not affect its integrity
 
6
Planning
 
6.1
Actions to address risks and opportunities
51
6.1.1 a
Take into account risks and opportunities In order to ensure that the QMS can achieve its expected results, cf. sub-clauses 4.1 (context) and 4.2 (interested parties). "Any decision involves a risk. Peter Barge"
52 6.1.1 b Take into account opportunities In order to increase the desirable effects (positive impact)
53
6.1.1 c
Take into account risks In order to reduce the undesirable effects (negative impacts)
54 6.1.1 d Take into account risks and opportunities In order to confirm the approach of continual improvement, cf. sub-clause 10.3
55 6.1.2 a Plan actions to address risks and opportunities Take into account risks in every process
56 6.1.2 b 1 Plan the way to implement actions Define how to integrate actions in the QMS processes, cf. sub-clause 4.4
57 6.1.2 b 2 Plan the way to evaluate actions Follow the results of each action
58 6.1.2  Adapt actions to risks and opportunities Compared to the potential impact on the conformity of products and services
 
6.2
Quality objectives
59
6.2.1
Establish quality objectives for processes  "He who has no goals will not achieve them. Sun Tzu" 
60 6.2.1 a Choose quality objectives Clarify criteria for setting objectives that are consistent with the quality policy
61
 6.2.1 b
Use measurable objectives And realistic
62
6.2.1 c
Consider applicable requirements Cf. sub-clause 4.2
63  6.2.1 d Adopt relevant objectives In order to ensure the conformity of products and services and improved customer satisfaction
64  6.2.1 e Monitor objectives Frequently
65
 6.2.1 f
Communicate on objectives At all levels
66  6.2.1 g Update objectives During management review, cf. sub-clause 9.3
67
6.2.1
Maintain documented information on the quality objectives Cf. sub-clause 7.5
68
6.2.2 a
Plan how to do In order to achieve quality objectives
69
6.2.2 b
Plan necessary resources  In order to achieve quality objectives
70
6.2.2 c
Plan responsibilities  In order to achieve quality objectives
71
6.2.2 d
Plan deadlines In order to achieve quality objectives
72
6.2.2 e
Plan the way to evaluate results In order to achieve quality objectives
 
 6.3
Planning of changes
73
6.3 Plan the need for changes of the QMS "The only person who likes change is a wet baby". Cf. sub-clause 4.4
74
6.3 a Plan the changes Taking into account the purpose of the change and the possible consequences
75
6.3 b Plan the changes Taking into account the maintenance of the integrity of the QMS
76
6.3 c Plan the changes Taking into account the available resources
77
6.3 d Plan the changes Taking into account the assigned responsibilities and authorities
 
 7
Support
 
 7.1
Resources
 
 
7.1.1 
General
78
 7.1.1 Provide the necessary resources In order to support the QMS
79
 7.1.1 a Take into account existing resources And their capabilities and constrains
80
 7.1.1 b Take into account the need for the use of external providers In order to provide necessary services not available inside the company
 
 7.1.2
People
81
 7.1.2 Provide suitable people for the effective operation of the QMS and its processes "But in the long run - and I emphasize this - no matter how good or successful you are or how clever or crafty, your business and its future are in the hands of the people you hire. Akio Morita"
 
7.1.3 
 Infrastructure beginning
82
 7.1.3 Provide and maintain the infrastructure necessary to the functioning of processes In order to achieve conformity of products and services. Examples: buildings, equipment, transportation, hardware, software
 
7.1.4 
Process environment  beginning
83
 7.1.4 Provide and maintain the suitable environment necessary to the functioning of processes In order to achieve conformity of products and services. Examples: corporate culture, work atmosphere, temperature, ergonomics
 
 7.1.5
Monitoring and measuring resources
 7.1.5.1
General
 
84
7.1.5.1 Provide suitable monitoring and measuring resources In order to obtain expected inspection results
85
7.1.5.1 a
Provide adequate resources to the specific inspections To inspect is to monitor and measure. Cf. sub-clause 7.2
86 7.1.5.1 b Maintain resources In order to ensure fitness for their purpose
87 7.1.5.1 Retain documented information on the adequacy of inspection resources Cf. sub-clause 7.5
 
 7.1.5.2
Measurement traceability
88 7.1.5.2 a Verify or calibrate regularly the measuring equipment In order to have confidence in the measurement results. When no such standards exist retain documented information on the reference used, cf. sub-clause 7.5
89 7.1.5.2 b Identify the measuring equipment In order to monitor the validity of their calibration (or verification)
90 7.1.5.2 c Protect the measuring equipment Against activities that may invalidate the results of the measurement (settings or deterioration)
91 7.1.5.2 Conduct corrective action on previous measurement results When the verification or calibration of a measuring instrument is not in conformity
 
 7.1.6
 Organizational knowledge  beginning
92  7.1.6 Determine the necessary knowledge In order to control the processes and the conformity of products and services
93  7.1.6 Acquire, maintain and make organizational knowledge available to the extend necessary In order to maintain the performance of the QMS
94  7.1.6 Take into account the need for additional knowledge When needs and trends have changed
   7.2
Competence
 beginning
95 7.2 a Determine the necessary competence Clarify quality competence requirements. Identify people who have an influence on the quality performance
96 7.2 b Ensure the competence Which are based on appropriate training or experience
97 7.2 c Undertake activities to acquire the necessary competence and evaluate the effectiveness of these activities Training, coaching, external providers
98 7.2 d Retain documented information on staff competence Cf. sub-clause 7.5
   7.3 Awareness
99 7.3 a Ensure the staff is aware of the quality policy Including people who carry out work under the company's control. Cf. sub-clause 5.2
100 7.3 b Ensure the staff is aware of the quality objectives Cf. sub-clause 6.2
101 7.3 c Ensure the staff is aware of its contribution In order to improve the performance of the QMS
102 7.3 d Ensure the staff is aware of negative impacts If QMS requirements are not met
   7.4
Communication 
 beginning
103 7.4 a Define the subjects on which to communicate Internally and externally. "Good news walk, bad ones run. Swedish proverb"
104  7.4 b Define when to communicate Respond quickly to claims
105 7.4 c Define with whom to communicate Communication goes both ways
106
7.4 d 
Define how to communicate Orally, in writing; Internet, video
107
7.4 e 
Assign who will communicate The one who is closest to the subject
   7.5
Documented information
 
   7.5.1
General
 beginning
108  7.5.1 a Include the documented information required by the ISO 9001 standard Documented information to maintain (documented procedures) :
  • scope of the QMS (sub-clause 4.3)
  • process control (sub-clause 4.4.2 a)
  • quality policy (sub-clause 5.2.2 a)
  • quality objectives (sub-clause 6.2.1)
  • operational control (sub-clause 8.1)
Documented information to retain (records) :
  • process performance (sub-clause 4.4.2 b)
  • fitness for purpose of inspection resources (sub-clause 7.1.5.1)
  • calibration (sub-clause 7.1.5.2)
  • staff competence (sub-clause 7.2)
  • necessary for the effectiveness of the QMS (sub-clause 7.5.1)
  • achieving processes as planned, conformity of products and services (sub-clause 8.1)
  • results of the review of products and services' old and new requirements (sub-clause 8.2.3.2)
  • design and development inputs (sub-clause 8.3.3)
  • design and development expected results, reviews, verifications and validations (sub-clause 8.3.4)
  • design and development outputs (sub-clause 8.3.5)
  • design and development changes (sub-clause 8.3.6)
  • evaluation activities and actions of external providers (sub-clause 8.4.1)
  • product and service characteristics or activities to be performed, results to be achieved (sub-clause 8.5.1)
  • traceability of products and services (sub-clause 8.5.2)
  • situation of the property of a customer (sub-clause 8.5.3)
  • results of the review of changes (sub-clause 8.5.6)
  • release of products and services (sub-clause 8.6)
  • treatment of nonconforming products and services (sub-clause 8.7.2)
  • inspection results (sub-clause 9.1.1)
  • audit programme and audit results (sub-clause 9.2.2)
  • management review outputs (sub-clause 9.3.3)
  • nonconformities, actions and results (sub-clause 10.2.2)
109  7.5.1 b Select the documented information deemed necessary to the effectiveness of the QMS "Spoken words fly away, written one stay. Latin proverb"
   7.5.2
Creating and updating
 beginning
110 7.5.2 a Create, identify and describe the documented information Codification, title, author, subject, product
111 7.5.2 b Choose the format and the media of the documented information Language, graphics; paper, electronic
112 7.5.2 c Review and approve the adequacy of the documented information Who writes, codifies, who approves
   7.5.3
Control of documented information 
 beginning
113 7.5.3.1 a  Control the availability of the documented information Where and when required in a form that is suitable for use
114 7.5.3.1 b Control the protection of the documented information Loss of confidentiality, loss of integrity, misuse
115 7.5.3.2 a Control the distribution, access and use of the documented information  Who is in charge, method to use, rule to follow
116 7.5.3.2 b Control the storage of the documented information Including preservation, protection and readability
117 7.5.3.2 c Control the changes of the documented information Use of updated versions, restricted access to obsolete versions
118 7.5.3.2 d Control the retention time and the removal of the documented information Retention period, disposal method
119 7.5.3.2 Control the documented information of external origin Unique codification, access, protection
120 17.5.3.2 Protect the documented information Who has the right to read, who has the right to change
   8
Operation
Do
   8.1
Operational planning and control
 beginning
121  8.1 a Plan and determine the requirements for the products and services By controlling processes. Cf. sub-clauses 4.4 et 6.1 
122  8.1 b 1 Establish the criteria For processes
123  8.1 b 2 Establish the criteria For the acceptance of conforming products and services
124  8.1 c Determine necessary resources Needed to achieve conformity of products and services
125  8.1 d Control the processes In accordance with the criteria of sub-clauses 8.1 b 1 and 8.1 b 2
126  8.1 e 1 Determine, maintain and retain the documented information on process control To have confidence that the process results are as expected. Cf. sub-clause 7.5
127  8.1 e 2 Determine, maintain and retain the documented information on product and service conformity Meet applicable requirements. Cf. sub-clause 7.5
128 8.1 Control planned and unplanned changes Analyse the consequences of unplanned changes, actions to limit the effects
129 8.1 Control the outsourced processes Cf. sub-clause 8.4 
   8.2
Requirements for products and services
 
   8.2.1
Customer communication
 beginning
130  8.2.1 a Provide information to customers Related to products and services
131  8.2.1 b Control communication with customers Related to contracts, orders, changes and consultations
132  8.2.1 c Control communication with customers Regarding the perception, opinions, complaints and recommendations. "The most important thing in communication is hearing what is not said. Peter Drucker"
133  8.2.1 d Control communication with customers Regarding their property. Cf. sub-clause 8.5.3
134  8.2.1 e Control communication with customers Regarding specific requirements for contingency actions
   8.2.2
Determining the requirements related to products and services
 beginning
135 8.2.2 a 1 Develop specific activities for products and services In order to clarify statutory and regulatory requirements
136 8.2.2 a 2 Define internal requirements Related to processes, products and services. And check that the requirements can be met
137 8.2.2 b Be able to respond to claims In a relevant way (with facts)
   8.2.3 Review of requirements related to products and services
138  8.2.3.1 Be able to respond to customers Regarding requirements of proposed products and services
139  8.2.3.1 a Review explicit customer requirements Before order acceptance. Including delivery and post-delivery activities requirements
140  8.2.3.1 b Review implicit customer requirements Before order acceptance. Unformulated requirements but necessary for specified use or use intended by the customer
141
 8.2.3.1 c
Review internal requirements Between requirements of an order and those previously expressed
142
 8.2.3.1 d
Review statutory and regulatory requirements Applicable to the products and services
143  8.2.3.1 e Review gaps Between requirements of an order (or contract) and those previously expressed
144  8.2.3.1 Resolve gaps Before order acceptance and commitment to provide products and services
145 8.2.3.1 Confirm requirements before accepting an order When requirements are not documented
146 8.2.3.2 a Retain the documented information on the results of the reviews of requirements Cf. sub-clause 7.5
147 8.2.3.2 b Retain the documented information on any new or changed requirement for the products and services Cf. sub-clause 7.5
   8.2.4 Changes to requirements for products and services
148  8.2.4 Communicate changes to relevant persons After changing requirements in the documented information
   8.3
Design and development of products and services
 
   8.3.1
General
 beginning
149  8.3.1 Establish, implement and maintain a process of design and development When the product or service requirements are not yet defined. "I have not failed. I just found 10,000 ways that will not work. Thomas Edison"
   8.3.2 Design and development planning  beginning
150 8.3.2 a Plan the design and development stages Taking into account the specificity of design and development activities
151 8.3.2 b Plan the design and development stages Taking into account the process requirements and applicable reviews
152 8.3.2 c Plan the design and development stages Taking into account the verification and validation activities
153 8.3.2 d Plan the design and development stages Taking into account the necessary responsibilities and authorities
154 8.3.2 e Plan the design and development stages Taking into account the needs of internal and external resources
155 8.3.2 f Plan the design and development stages Taking into account the relations between persons participating in the design and development
156 8.3.2 g Plan the design and development stages Taking into account the need for involvement of customers and users
157 8.3.2 h Plan the design and development stages Taking into account the requirements for subsequent products and services
158 8.3.2 i Plan the design and development stages Taking into account the level of control expected by interested parties
159 8.3.2 j Plan the design and development stages Taking into account the documented information meeting design and development requirements. Cf. sub-clauses 8.3.3, 8.3.5 and 8.3.6
   8.3.3
Design and development inputs
 beginning
160  8.3.3 Determine essential requirements On specific types of products and services from design and development
161  8.3.3 a Determine functional requirements Taking into account also the performance requirements
162  8.3.3 b Clarify inputs Taking into account the information from similar activities
163  8.3.3 c Clarify inputs Taking into account the statutory and regulatory requirements
164  8.3.3 d Clarify inputs Taking into account the corporate culture, internal rules of art
165  8.3.3 e Clarify inputs Taking into account the potential consequences of product and service failure
166  8.3.3 Check that the input items are complete and unambiguous In order to realize suitable design and development process
167 8.3.3 Resolve potential conflicts between inputs In order to obtain complete and unambiguous inputs
168 8.3.3 Retain the documented information on design and development inputs Cf. sub-clause 7.5
   8.3.4
Design and development controls
 beginning
169 8.3.4 a Define clearly the expected results Regarding processes, products and services
170 8.3.4 b Conduct reviews as planned Regarding processes, products and services
171  8.3.4 c Check that outputs meet input requirements Cf. sub-clause 8.3.5
172 8.3.4 d Validate products and services To ensure that the specified application requirements or those for the intended use are satisfied
173 8.3.4 e Take actions in response to identified problems During reviews, verifications and validations
174 8.3.4 f Ensure that the documented information is retained Cf. sub-clause 7.5. Cf. sub-clauses 8.3.38.3.5 and 8.3.6
   8.3.5 Design and development outputs
175 8.3.5 a Ensure that outputs meet input requirements Cf. sub-clause 8.3.3
176 8.3.5 b Ensure that outputs are in line with the subsequent processes Regarding the products and services
177 8.3.5 c Ensure that outputs include monitoring and measuring requirements Including acceptance criteria
178 8.3.5 d Ensure that outputs are suitable for their intended use Proper use or planned by the customer in complete safety
179 8.3.5 Retain the documented information on outputs Cf. sub-clause 7.5 
 
 8.3.6
Design and development changes
 beginning
180 8.3.6 Identify, review and control the changes made to inputs and outputs To ensure that the changes have no impact on meeting the requirements
181 8.3.6 a Retain the documented information on changes Cf. sub-clause 7.5 
182 8.3.6 b Retain the documented information on results of reviews Cf. sub-clause 7.5 
183 8.3.6 c Retain the  documented information on who authorized the changes Cf. sub-clause 7.5 
184 8.3.6 d Retain the documented information on actions In order to prevent negative impacts. Cf. sub-clause 7.5 
   8.4
External providers
 beginning
   8.4.1
General
 
185 8.4.1 Ensure that the outputs of external providers meet specified requirements "You can outsource the activity, but you cannot outsource risk. Michael Gallagher"
186 8.4.1 a Apply the requirements for the control of products and services provided by external providers When the products and services are integrated internally
187 8.4.1 b Apply the requirements for the control of products and services When the products and services are provided directly to customers by external providers on behalf of the company
188 8.4.1 c Apply the requirements for the control of process done by external providers When a decision has been made to outsource the process
189 8.4.1 Establish and implement evaluation and selection criteria of external providers and monitor their performance Including regular re-evaluation
190 8.4.1 Retain the documented information on the results of the evaluation and monitoring Cf. sub-clause 7.5
   8.4.2
Type and extent of control
 beginning
191 8.4.2 Ensure the level of control of external providers on meeting the requirements In order that the provision of external providers do not affect the conformity of products and services delivered to the customer
192 8.4.2 a Ensure that the processes of external providers are controlled In conformity with the external service provider QMS. Any outsourced process is included in the scope of the QMS
193 8.4.2 b Define how to control the external provider and its process outputs The level of control (or influence) of an external service provider is sometimes a very sensitive area. Stay alert and caring!
194 8.4.2 c 1 Take into account the potential impact of the outputs of the external provider On meeting the requirements of products and services delivered to the customer and on statutory and regulatory requirements
195 8.4.2 c 2 Take into account the control of the external provider And effectiveness of this control
196 8.4.2 d Define how to control the outputs of externally provided processes Verification and other activities necessary to ensure that the provision of external providers does not affect the conformity of products and services delivered to the customer
   8.4.3
Information for external providers
 beginning
197 8.4.3  Check the adequacy of the requirements And only after communicate them to the external provider
198 8.4.3 a Communicate the requirements to the external provider Regarding the processes, products and services to provide
199 8.4.3 b 1 Communicate the requirements to the external provider Regarding the approval of products and services
200 8.4.3 b 2 Communicate the requirements to the external provider Regarding the approval of methods, processes and equipment
201 8.4.3 b 3 Communicate the requirements to the external provider Regarding the approval of the release of products and services
202 8.4.3 c Communicate the requirements to the external provider Regarding the competence (including required qualifications)
203 8.4.3 d Communicate the requirements to the external provider Regarding the relations between the external provider and the company
204 8.4.3 e Communicate the requirements to the external provider Regarding the control and monitoring of the external provider's performance
205 8.4.3 f Communicate the requirements to the external provider Regarding the verification or validation activities that the company or its customer intends to realize at the external provider's premises
   8.5
Production and service provision
 
   8.5.1
Control of production and service provision
 beginning
206 8.5.1 Apply controlled conditions of production and service provision Including delivery and post-delivery activities
207 8.5.1 a 1 Save documented information of specifications of products and services and the expected activities Cf. sub-clause 7.5
208 8.5.1 a 2 Save the documented information of results to be achieved Cf. sub-clause 7.5"A quality control that does not show results is no control. Kaoru Ishikawa"
209 8.5.1 b Include in the controlled conditions the inspection resources Cf. sub-clause 7.1.5
210 8.5.1 c Include in the controlled conditions the inspection activities To verify that the appropriate stages of the processes' outputs meet the criteria
211 8.5.1 d Include in the controlled conditions adequate infrastructure and environment Cf. sub-clauses 7.1.3 et 7.1.4
212 8.5.1 e Include in the controlled conditions the staff competence Including the necessary qualification, cf. sub-clause 7.2
213 8.5.1 f Include in the controlled conditions the validation of the ability of a process to achieve the expected results Only in the case when the outputs cannot be checked a posteriori
214 8.5.1 g Include in the controlled conditions the actions to prevent human error Use tools such as Poka-Yoke
215 8.5.1 h Include in the controlled conditions the activities of release, delivery and post-delivery Cf. sub-clause 8.6 and sub-clause 8.5.5
   8.5.2
Identification and traceability
 beginning
216 8.5.2 Use appropriate means to control the unique identification of process outputs In order to ensure the conformity of products and services when needed
217 8.5.2 Inspect processes throughout the production and service provision In order to identify the status of process outputs
218 8.5.2 Control the traceability of process outputs When traceability is a requirement, the unique identification is used
219 8.5.2 Retain the documented information on traceability Cf. sub-clause 7.5. When traceability is a requirement, the unique identification of outputs is used
   8.5.3
Property belonging to customers or external providers
 beginning
220 8.5.3 Exercise care with property owned by customer or external provider During its use or protection
221 8.5.3 Identify, check, protect, monitor and safeguard customer or external provider property When used or incorporated with updated labels
222 8.5.3 Notify the customer or external provider when his property has been damaged or lost and maintain the documented information on the situation Following incorrect or improper use. Cf. sub-clause 7.5.
   8.5.4
Preservation 
 beginning
223 8.5.4 Preserve the process outputs throughout production and service provision activities Some examples of preservation methods: identification, packaging, handling, storage, transport, protection
   8.5.5
 Post-delivery activities
 beginning
224 8.5.5 Meet the requirements for post-delivery activities Examples of post-delivery activities: exchange new product, maintenance, recycling, final disposal
225 8.5.5 a Take into account statutory and regulatory requirements Cf. sub-clause 4.2
226 8.5.5 b Take into account negative impacts related to products and services These are consequences of potential risks
227 8.5.5 c Take into account the nature, the intended use and lifetime of products and services When the extent of post-delivery activities has been clarified
228 8.5.5 d Take into account the requirements of interested parties And customers especially
229 8.5.5 e Take into account customer feedback Of interested parties, when the extent of post-delivery activities has been clarified
   8.5.6
Control of changes
 beginning
230 8.5.6 Review and control unplanned changes Cf. sub-clause 6.3 (planned changes)
231 8.5.6 Retain the documented information on unplanned changes Cf. sub-clause 7.5. Include the results of reviews, the authorization of changes and actions implemented
   8.6
Release of products and services
 beginning
232 8.6 Check products and services with activities at appropiate stages "Inspection does not improve quality, nor guarantee quality. Edwards Deming"
233 8.6 Release products and services after verification of conformity Unless written approval (concession) by a competent authority or client
234 8.6 Retain the documented information on the release of products and services Cf. sub-clause 7.5
235 8.6 a Include in the documented information evidence of conformity These are the results of inspections compared to the acceptance criteria
236 8.6 b Include in the documented information the traceability of products and services Including the person having authorized the release
   8.7
Control of nonconforming outputs
 beginning
237 8.7.1 Identify and treat nonconforming process, products and services outputs Marking and isolation to prevent unintended use or mixing with conforming outputs
238 8.7.1 Carry out corrective actions commensurate to impacts Including after delivery. Cf. sub-clause 10.2
239 8.7.1 Carry out corrective actions on post-delivery activities Cf. sub-clause 8.5.5
240 8.7.1 a Handle nonconforming outputs with corrections Repeat work, retouching, repair, recycling
241 8.7.1 b Handle nonconforming outputs by segregation Including customer returns or products and services not released
242 8.7.1 c Inform the customer Cf. sub-clause 7.4
243 8.7.1 d Handle nonconforming outputs by asking authorization To use in is (acceptance under concession)
244 8.7.1 Check conformity after any correction After any correction go through the normal flow
245 8.7.2 a Retain the documented information on the description of nonconformities Cf. sub-clause 7.5.
246 8.7.2 b Retain the documented information on implemented actions Cf. sub-clause 7.5.
247 8.7.2 c Retain the documented information on approved concessions Cf. sub-clause 7.5.
248 8.7.2 d  Retain the documented information on the person having decided the handling of the nonconformities Cf. sub-clause 7.5
   9
Performance evaluation
Check
   9.1
Monitoring, measurement, analysis and evaluation

   9.1.1
General
 beginning
249 9.1.1 a Determine what is necessary to inspect "If you can’t measure it, you can’t manage it. Peter Drucker"
250 9.1.1 b Determine the methods for inspection, analysis and evaluation In order to ensure valid results
251 9.1.1 c Determine when to inspect At key stages (essential) or upon the customer's request
252 9.1.1 d Determine when to analyse and evaluate inspection results When that brings added value
253 9.1.1 Evaluate the performance and effectiveness of the QMS In order to ensure that specified requirements are met
254 9.1.1 Retain the documented information on the inspection results Cf. sub-clause 7.5
   9.1.2
Customer satisfaction
 beginning
255 9.1.2 Regularly monitor customer perception about their level of satisfaction "The only measure of quality is customer satisfaction"
256 9.1.2 Determine methods for obtaining and using customer information Satisfaction surveys, claims, customer returns, recommendations
   9.1.3
Analysis and evaluation 
 beginning
257 9.1.3 Analyse and evaluate inspection data "Get the facts, analyze them and then do what seems right. Robert Waterman"
258 9.1.3 a Use analysis results In order to evaluate how requirements are met. Cf. sub-clause 4.2
259 9.1.3 b Use analysis results In order to evaluate the level of customer satisfaction. Cf. sub-clause 9.1.2
260 9.1.3 c Use analysis results In order to evaluate the performance and effectiveness of the QMS
261 9.1.3 d Use analysis results In order to evaluate the effectiveness of planning. Cf. sub-clause 8.1
262 9.1.3 e Use analysis results In order to evaluate the effectiveness of actions implemented to address risks and opportunities. Cf. sub-clause 6.1
263 9.1.3 f Use analysis results In order to evaluate the performance of external providers. Cf. sub-clause 8.4
264 9.1.3 g Use analysis results In order to evaluate the improvement opportunities of the QMS. Cf. sub-clause 10.3
   9.2
Internal audit
 beginning
265 9.2.1 a 1 Conduct regularly planned internal audits In order to determine whether the QMS meets internal company requirements. Cf. ISO 19011
266 9.2.1 a 2 Conduct regularly planned internal audits In order to determine whether the QMS meets requirements of the ISO 9001 standard
267 9.2.1 b Conduct regularly planned internal audits In order to determine whether the QMS is effectively implemented and maintained
268 9.2.2 a Plan, establish, implement and update an audit programme Include the frequency, methods, responsibilities, planning requirements (audit programme) and reporting requirements (audit report)
269 9.2.2 a Take into account in the audit programme essential points Essentials points :
  • process importance
  • changes having an impact on the company
  • results of previous audits
"The quality control should verify the process, not the product. Edwards Deming"
270 9.2.2 b Define the scope and audit criteria Limit the area to be audited; use specific and known by the auditee criteria
271 9.2.2 c Select auditors Do not audit your department. "No one is judge in his own case. Latin proverb"
272 9.2.2 d Communicate audit results to management concerned Cf. sub-clause 7.4 
273 9.2.2 e Undertake a correction quickly and corrective actions if necessary Cf. sub-clause 10.2
274 9.2.2 f Retain the documented information on the audit programme and the audit reports Cf. sub-clause 7.5 
   9.3
Management review
beginning
   9.3.1
General
 
275  9.3.1  Proceed at least once a year to review the QMS In order to confirm that it is still relevant, appropriate and effective. "No system is perfect"
   9.3.2
Management review inputs
 
276 9.3.2 a Plan and carry out the management review  Regarding the status of actions of the previous review
277 9.3.2 b Carry out the management review taking into account the changes of external and internal issues for the QMS Including strategic direction
278 9.3.2 c 1 Take into account the information on the performance of the QMS and trends Customer satisfaction, feedback. Cf. sub-clauses 8.7 et 10.2
279 9.3.2 c 2 Take into account the information on the performance of the QMS and trends The achievement of quality objectives, cf. sub-clause 6.2 
280 9.3.2 c 3 Take into account the information on the performance of the QMS and trends Process performance and conformity of outputs. Cf. sub-clause 9.1
281 9.3.2 c 4 Take into account the information on the performance of the QMS and trends Nonconformities and corrective actions. Cf. sub-clause 10.2
282 9.3.2 c 5 Take into account the information on the performance of the QMS and trends Inspection results. Cf. sub-clause 9.1
283 9.3.2 c 6 Take into account the information on the performance of the QMS and trends Audit results. Cf. sub-clause 9.2
284 9.3.2 c 7 Take into account the information on the performance of the QMS and trends Performance of external providers. Cf. sub-clause 8.4
285 9.3.2 d Take into account resources Availability of resources. Cf. sub-clause 7.1
286 9.3.2 e Take into account the effectiveness of actions Implemented to address risks and opportunities. Cf. sub-clause 6.1
287 9.3.2 f Take into account improvement opportunities Continual improvement. Cf. sub-clause 10.3
   9.3.3
Management review outputs
 beginning
288 9.3.3 a Include decisions regarding opportunities for continual improvement in the outputs of the management review Cf. sub-clause 10.3
289 9.3.3 b Include decisions regarding eventual changes to the QMS in the outputs of the management review Cf. sub-clause 6.3
290 9.3.3 c Include decisions regarding new resource needs in the outputs of the management review Cf. sub-clause 7.1
291 9.3.3 Retain the documented information on outputs of the review of management Cf. sub-clause 7.5
   10
Improvement
Act
   10.1
General
beginning
292 10.1 Find improvement opportunities and implement necessary actions In order to enhance customer satisfaction. "Where there is a problem, there is potential for improvement. Masaaki Imai"
293 10.1 a Improve products and services Support innovation. In order to better meet current requirements and anticipate future requirements
294 10.1 b Reduce negative impacts Implementing corrective actions and global prevention (efficient QMS)
295 10.1 c Improve the results of the QMS To achieve the objectives of the QMS regarding performance
   10.2
Nonconformity and corrective action
 beginning
296 10.2.1 a 1 React to the nonconformity In order to reduce costs. Including all claims by processing, controlling, correcting. "One of the best ways to measure quality is to calculate the price of nonconformities. Philip Crosby"
297 10.2.1 a 2 Take into account consequences Think risk-based approach
298 10.2.1 b 1 Examine the nonconformity And if necessary decide to carry out a corrective action
299 10.2.1 b 2 Investigate root causes So that the nonconformity does not happen again
300 10.2.1 b 3 Search for similar nonconformities In order to apply the same recipe (why reinvent the wheel?)
301 10.2.1 c Implement the necessary corrective actions In order to treat the nonconformity
302 10.2.1 d Review the effectiveness of any implemented corrective action In order to check whether the action is finalized
303 10.2.1 e Update risks and opportunities If necessary
304 10.2.1 f Make changes to the QMS If necessary
305 10.2.1  Respond proportionally to nonconformities consequences Do not make too much quality
306 10.2.2 a Retain documented information on the nature of nonconformities Cf. sub-clause 7.5
307 10.2.2 a Retain documented information on results of implemented actions Cf. sub-clause 7.5
   10.3
Continual improvement
 beginning
308  10.3 Improve continually the performance of the QMS In order to find improvement opportunities
309  10.3 Take into account the outputs of the analysis, evaluation and management review Cf. sub-clause 9.1.3 and sub-clause 9.3