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AS9100D:2016 REQUIREMENTS

Requirements AS9100D v 2016

You want to familiarize yourself with the structure of the standard, identify and understand the requirements of AS9100D v 2016, then it's up to you to play!

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The "AS9100D v 2016 Requirements" quiz will help you understand the main requirements of the standard.

The questions (requirements) included in this quiz are 113 of the 460 in the standard, but don't worry. These 113 requirements are among the most important, so do not hesitate to learn in a fun way!

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News about AS9100D version 2016 

Based on the ISO 9001: 2015 the 460 requirements (verb shall) of clauses 4 to 10 are as follows:

AS9100D: 2016 requirements 
No
Clause
PDCA cycle
Requirement No
Quantity
4
Context of the organization Plan 1 ÷ 30 30
5
Leadership PlanDoCheckAct
31 ÷ 60
30
6
Planning Plan
61 ÷ 87
27
7
Support Do
88 ÷ 140
53
8
Operation Do
141 ÷ 391
251
9
Performance evaluation Check
392 ÷ 438
47
10
Improvement Act
439 ÷ 460
22
Total
460

as9100d requirements

AS9100D 2016 requirements

 

pdca

The Deming PDCA cycle

Note 1. Any requirement normally begins with "The organization shall...". For simplicity's sake we present the requirements directly, starting with the verb.

Note 2. The ISO 9001 v 2015 requirements are on a light blue background.

Note 3. Specific AS9100D requirements are on beige background and in italics.

AS9100D - 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
Address also customer and applicable statutory and regulatory requirements
Cf. sub-clause 8.2.2
16
4.4.1 a
Determine process inputs and outputs Process sheet
17 4.4.1 b Determine the sequence and interaction of processes Flowchart
18 4.4.1 c Determine the criteria and methods to control processes Tools of the quality manager
19 4.4.1 d Determine and ensure the resources Needed to support processes. Cf. sub-clause 7.1
20 4.4.1 e Assign process responsibilities and authorities Job description of process owners
21 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
22 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
23 4.4.1 h Determine the improvement opportunities of processes and the QMS Cf. sub-clause 10.1
24
4.4.2 a
Maintain documented information on process operation Cf. sub-clause 7.5. The bare essential is sufficient. Use process map
25
4.4.2 b
Retain documented information on process operation Cf. sub-clause 7.5. The goal is to ensure that processes' results  are those planned 
26
4.4.2
Establish and maintain documented information that includes a general description of relevant interested parties
Cf. sub-clause 4.2. a
27
4.4.2
Establish and maintain documented information that includes the scope of the QMS Including boundaries and applicability, cf. sub-clause 4.3
28
4.4.2
Establish and maintain documented information that includes a description of the processes needed for the QMS And their application in the organization
29
4.4.2
Establish and maintain documented information that includes the sequence and interaction of these processes As sub-clause 4.4.1.b
30
4.4.2
Establish and maintain documented information that includes responsibilities and authorities for these processes As sub-clause 4.4.1.e
 
5
Leadership
Plan Do, CheckAct 
 
5.1 
Leadership and commitment
 
5.1.1 
General
31
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
32 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
33
5.1.1 c
Integrate QMS requirements in the internal process requirements  Cf. sub-clause 4.4 and sub-clause 7.1.4
34
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
35
5.1.1 e
Provide the necessary resources for the QMS Cf. sub-clause 7.1
36
5.1.1 f
Raise awareness on the importance of an effective and conforming QMS Third quality management principle (engagement of people)
37
5.1.1 g
Ensure the achievement of intended results of the QMS Essential commitment of top management
38
5.1.1 h
Support the staff contribution to the effectiveness of the QMS "Employees first, customers second". Vineet Nayar
39
5.1.1 i
Promote continual improvement Cf. sub-clause 10.3
40
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
41
5.1.2 a
Determine and meet customer, statutory and regulatory requirements Top management demonstrates leadership (assumes its responsibility and commitment) permanently
42
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
43
5.1.2 c
Maintain the objective of better satisfying the customer First quality management principle (customer focus)
44
5.1.2 d
Ensure product and service conformity and on-time delivery After measurement, appropriate action is taken if planned results are not, or will not be, achieved 
 
5.2
Policy
5.2.1
Establishing the quality policy
 
45
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
46 5.2.1 b Provide a framework to define and review the quality objectives Cf. sub-clause 6.2
47 5.2.1 c Include meeting the applicable requirements Cf. sub-clause 9.1.3
48 5.2.1 d Include a commitment to continuously improve the QMS Cf. sub-clause 10.3
 
5.2.2
Communicating the quality policy
49 5.2.2 a Maintain the quality policy as documented information And make it available inside the company. Cf. sub-clause 7.5
50 5.2.2 b Communicate the quality policy So it is understand and applied, cf. sub-clause 7.4
51 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
52
5.3
Define and communicate the responsibilities and authorities Top management assigns all relevant roles in the QMS
53
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
54
5.3 b
Define and communicate the responsibilities and authorities Top management assigns all relevant roles so that processes deliver expected results
55
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 
56
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)
57
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
58
5.3
Appoint a management representative
He is memeber of the organization's management
59
5.3
Have the responsibility and authority to establish and maintain the QMS
Cf. sub-clause 4.4.1
60
5.3
Have the organizational freedom and unrestricted access to top management
To resolve all problems related with quality management
 
6
Planning
 
6.1
Actions to address risks and opportunities
61
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
62 6.1.1 b Take into account opportunities In order to increase the desirable effects (positive impact)
63
6.1.1 c
Take into account risks In order to reduce the undesirable effects (negative impacts)
64 6.1.1 d Take into account risks and opportunities In order to confirm the approach of continual improvement, cf. sub-clause 10.3
65 6.1.2 a Plan actions to address risks and opportunities Take into account risks in every process
66 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
67 6.1.2 b 2 Plan the way to evaluate actions Follow the results of each action
68 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
69
6.2.1
Establish quality objectives for processes  "He who has no goals will not achieve them". Sun Tzu
70 6.2.1 a Choose quality objectives Clarify criteria for setting objectives that are consistent with the quality policy
71
 6.2.1 b
Use measurable objectives And realistic
72
6.2.1 c
Consider applicable requirements Cf. sub-clause 4.2
73  6.2.1 d Adopt relevant objectives In order to ensure the conformity of products and services and improved customer satisfaction
74  6.2.1 e Monitor objectives Frequently
75
 6.2.1 f
Communicate on objectives At all levels
76  6.2.1 g Update objectives During management review, cf. sub-clause 9.3
77
6.2.1
Maintain documented information on the quality objectives Cf. sub-clause 7.5
78
6.2.2 a
Plan how to do In order to achieve quality objectives
79
6.2.2 b
Plan necessary resources  In order to achieve quality objectives
80
6.2.2 c
Plan responsibilities  In order to achieve quality objectives
81
6.2.2 d
Plan deadlines In order to achieve quality objectives
82
6.2.2 e
Plan the way to evaluate results In order to achieve quality objectives
 
 6.3
Planning of changes
83
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
84
6.3 a Plan the changes Taking into account the purpose of the change and the possible consequences
85
6.3 b Plan the changes Taking into account the maintenance of the integrity of the QMS
86
6.3 c Plan the changes Taking into account the available resources
87
6.3 d Plan the changes Taking into account the assigned responsibilities and authorities
 
 7
Support
 
 7.1
Resources
 
 
7.1.1 
General
88
 7.1.1 Provide the necessary resources In order to support the QMS
89
 7.1.1 a Take into account existing resources And their capabilities and constrains
90
 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
91
 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
92
 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
93
 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
 
94
7.1.5.1 Provide suitable monitoring and measuring resources In order to obtain expected inspection results
95
7.1.5.1 a
Provide adequate resources to the specific inspections To inspect is to monitor and measure. Cf. sub-clause 7.2
96 7.1.5.1 b Maintain resources In order to ensure fitness for their purpose
97 7.1.5.1 Retain documented information on the adequacy of inspection resources Cf. sub-clause 7.5
 
 7.1.5.2
Measurement traceability
98 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
99 7.1.5.2 b Identify the measuring equipment In order to monitor the validity of their calibration (or verification)
100 7.1.5.2 c Protect the measuring equipment Against activities that may invalidate the results of the measurement (settings or deterioration)
101 7.1.5.2 Conduct corrective action on previous measurement results When the verification or calibration of a measuring instrument is not in conformity
102
7.1.5.2
Establish, implement and maintain a process for the recall of monitoring and measuring equipment
When calibration or verification are required
103
7.1.5.2
Maintain a register of the monitoring and measuring equipment
List of equipment used including software, tester, personally owned and customer supplied equipment
104
7.1.5.2
Include in the register specific equipment data
Data such as type, unique identification, location, calibration or verification method, frequency and acceptance criteria
105
7.1.5.2
Ensure suitable environmental conditions for carrying out calibration or verification
Cf. sub-clause 7.1.4
 
 7.1.6
 Organizational knowledge  beginning
106  7.1.6 Determine the necessary knowledge In order to control the processes and the conformity of products and services
107  7.1.6 Acquire, maintain and make organizational knowledge available to the extend necessary In order to maintain the performance of the QMS
108  7.1.6 Take into account the need for additional knowledge When needs and trends have changed
   7.2
Competence
 beginning
109 7.2 a Determine the necessary competence Clarify quality competence requirements. Identify people who have an influence on the quality performance
110 7.2 b Ensure the competence Which are based on appropriate training or experience
111 7.2 c Undertake activities to acquire the necessary competence and evaluate the effectiveness of these activities Training, coaching, external providers
112 7.2 d Retain documented information on staff competence Cf. sub-clause 7.5
   7.3 Awareness
113 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
114 7.3 b Ensure the staff is aware of the quality objectives Cf. sub-clause 6.2
115 7.3 c Ensure the staff is aware of its contribution In order to improve the performance of the QMS
116 7.3 d Ensure the staff is aware of negative impacts If QMS requirements are not met
117
7.3 e
Make staff aware of QMS documented information
Including changes implemented, cf. sub-clause 7.5
118
7.3 f
Make staff aware of their contribution to product or service conformity
Cf. sub-clause 9.1.2
119
7.3 g
Make staff aware of their contribution to product safety Cf. sub-clause 8.1.3
120
7.3 h
Make staff aware of the importance of ethical behavior Corporate culture, happiness at work
   7.4
Communication 
 beginning
121 7.4 a Define the subjects on which to communicate Internally and externally. "Good news walks, bad news runs". Swedish proverb
122  7.4 b Define when to communicate Respond quickly to claims
123 7.4 c Define with whom to communicate Communication goes both ways
124
7.4 d 
Define how to communicate Orally, in writing; Internet, video
125
7.4 e 
Assign who will communicate The one who is closest to the subject
   7.5
Documented information
 
   7.5.1
General
 beginning
126  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)
127  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
128 7.5.2 a Create, identify and describe the documented information Codification, title, author, subject, product
129 7.5.2 b Choose the format and the media of the documented information Language, graphics; paper, electronic
130 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
131 7.5.3.1 a  Control the availability of the documented information Where and when required in a form that is suitable for use
132 7.5.3.1 b Control the protection of the documented information Loss of confidentiality, loss of integrity, misuse
133 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
134 7.5.3.2 b Control the storage of the documented information Including preservation, protection and readability
135 7.5.3.2 c Control the changes of the documented information Use of updated versions, restricted access to obsolete versions
136 7.5.3.2 d Control the retention time and the removal of the documented information Retention period, disposal method
137
7.5.3.2 e
Prevent unintended use of obsolete documented information
By removal, by placing them out of reach or by applying an appropriate identification
138 7.5.3.2 Control the documented information of external origin Unique codification, access, protection
139 7.5.3.2 Protect the documented information Who has the right to read, who has the right to change
140
7.5.3.2
Define a process for the protection of documented information in electronic form
Automatic backup (every night), change rigths established and respected
   8
Operation
Do
   8.1
Operational planning and control
 beginning
141  8.1 a Plan and determine the requirements for the products and services By controlling processes. Cf. sub-clauses 4.4 et 6.1 
142  8.1 b 1 Establish the criteria For processes
143  8.1 b 2 Establish the criteria For the acceptance of conforming products and services
144  8.1 c Determine necessary resources Needed to achieve conformity of products and services
145  8.1 d Control the processes In accordance with the criteria of sub-clauses 8.1 b 1 and 8.1 b 2
146  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
147  8.1 e 2 Determine, maintain and retain the documented information on product and service conformity Meet applicable requirements. Cf. sub-clause 7.5
148
8.1 f
Determine the processes and controls needed to manage critical items
Including production process inspections when key characteristics are modified
149
8.1 g
Engage representatives of affected functions
In order to ensure operational planning and control
150
8.1 h
Determine the processes and resources
In order to support the use and maintenance of the products and services
151
8.1 i
Determine the products and services to be obtained from external providers
Cf. sub-clause 8.4
152
8.1 j
Establish the controls needed
To prevent the delivery of nonconforming products and services
153
8.1
Plan and manage product and service provision in a structured and controlled manner
Including scheduled events with an acceptable risk within resource and schedule constraints. In other words, project planning and management or programme management
154 8.1 Adapt planning outputs to internal operating modes Cf. sub-clauses 4.4 and 6.1

155

8.1 Control planned and unplanned changes Analyse the consequences of unplanned changes, actions to limit the effects

156

8.1 Control the outsourced processes Cf. sub-clause 8.4 
157
8.1
Establish, implement and maintain a process to transfer of work
In order to ensure continuing conformity of the work to requirements
158
8.1
Manage work transfer impacts and risks
Cf. sub-clause 8.1.1

 
 8.1.1
Operational risk management
 
159
8.1.1 a
Plan, implement and control a process for managing operational risks by assignment of responsibilities
As appropriate to the company and the products and services. The risk being considered as the probability of occurrence and the severity of the consequences
160
8.1.1 b
Plan, implement and control a process for managing operational risks by definition of risk assessment criteria Such as likelihood, consequences, risk acceptance
161
8.1.1 c
Plan, implement and control a process for managing operational risks by identification, assessment and communication of risks Throughout product realization
162
8.1.1 d
Plan, implement and control a process for managing operational risks by identification, implementation and management of actions In order to mitigate risks that exceed acceptance criteria
163
8.1.1 e
Plan, implement and control a process for managing operational risks by acceptance of resdual risks After implementation of mitigating actions

 
 8.1.2
Configuration management
 
164
8.1.2
Plan, implement and control a process for configuration management
As appropriate to the company and its products and services in order to ensure the identification and control of physical and functional attributes throughout the product lifecycle
165
8.1.2 a
Control product identity and traceability
Including the implementation of identified changes
166
8.1.2 b
Ensure that the documented information is consistent with the actual attributes of the products and services
Documented information on requirements, design, verification, validation and acceptance

 
 8.1.3
Product safety
 
167
8.1.3
Plan, implement and control the processes to ensure product safety during the product life cycle as appropriate to the company and the product Such as hazard identification, management of associated risks, management of safety critical items, analysis and reporting of occurred safety-related events, safety training of staff

 
 8.1.4
Prevention of counterfeit parts
 
168
8.1.4
Plan, implement and control processes for the prevention of counterfeit parts
Including suspicion of use or their inclusion in product delivered to the customer. Consider staff training and awareness, application of a parts obsolescence monitoring programme, controls for acquiring externally provided product from original or authorized manufacturers and distributors, traceability requirements for parts and components, verification and tests to detect counterfeit parts, monitoring of reports from external sources, quarantine of suspected or detected parts
   8.2
Requirements for products and services
 
   8.2.1
Customer communication
 beginning
169  8.2.1 a Provide information to customers Related to products and services
170  8.2.1 b Control communication with customers Related to contracts, orders, changes and consultations
171  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
172  8.2.1 d Control communication with customers Regarding their property. Cf. sub-clause 8.5.3
173  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
174 8.2.2 a 1 Develop specific activities for products and services In order to clarify statutory and regulatory requirements
175 8.2.2 a 2 Define internal requirements Related to processes, products and services. And check that the requirements can be met
176 8.2.2 b Be able to respond to claims In a relevant way (with facts)
177
8.2.2 c
Determine special requirements for products and services
High level risks. Take into account the complexity of the product and the process, the performance requirements at the limit of technical possibilities
178
8.2.2 d
Identify operational risks
Cf. sub-clause 8.1.1. Such as new technology, short delivery time frame, ability and capacity to provide
   8.2.3 Review of requirements related to products and services
179  8.2.3.1 Be able to respond to customers Regarding requirements of proposed products and services
180  8.2.3.1 a Review explicit customer requirements Before order acceptance. Including delivery and post-delivery activities requirements
181  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
182
 8.2.3.1 c
Review internal requirements Between requirements of an order and those previously expressed
183
 8.2.3.1 d
Review statutory and regulatory requirements Applicable to the products and services
184  8.2.3.1 e Review gaps Between requirements of an order (or contract) and those previously expressed
185  8.2.3.1 Resolve gaps Before order acceptance and commitment to provide products and services
186
8.2.3.1
Coordinate the review With functions concerned
187
8.2.3.1
Negotiate a mutually acceptable requirement with the customer
When the review shows that some customer requirements cannot be met or can only partially be met
188 8.2.3.1 Confirm requirements before accepting an order When requirements are not documented
189 8.2.3.2 a Retain the documented information on the results of the reviews of requirements Cf. sub-clause 7.5
190 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
191  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
192  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
193 8.3.2 a Plan the design and development stages Taking into account the specificity of design and development activities
194 8.3.2 b Plan the design and development stages Taking into account the process requirements and applicable reviews
195 8.3.2 c Plan the design and development stages Taking into account the verification and validation activities
196 8.3.2 d Plan the design and development stages Taking into account the necessary responsibilities and authorities
197 8.3.2 e Plan the design and development stages Taking into account the needs of internal and external resources
198 8.3.2 f Plan the design and development stages Taking into account the relations between persons participating in the design and development
199 8.3.2 g Plan the design and development stages Taking into account the need for involvement of customers and users
200 8.3.2 h Plan the design and development stages Taking into account the requirements for subsequent products and services
201 8.3.2 i Plan the design and development stages Taking into account the level of control expected by interested parties
202 8.3.2 j Plan the design and development stages Taking into account the documented information meeting design and development requirements. Cf. sub-clauses 8.3.38.3.5 and 8.3.6
203
8.3.2
Divide, when appropriate, the design and development effort into distinct activities
For each activity define the tasks, necessary resources, responsibilities , inputs and outputs
204
8.3.2
Consider the ability to provide, verify, test and maintain products and services
Cf. sub-clause 8.1. a
   8.3.3
Design and development inputs
 beginning
205  8.3.3 Determine essential requirements On specific types of products and services from design and development
206  8.3.3 a Determine functional requirements Taking into account also the performance requirements
207  8.3.3 b Clarify inputs Taking into account the information from similar activities
208  8.3.3 c Clarify inputs Taking into account the statutory and regulatory requirements
209  8.3.3 d Clarify inputs Taking into account the corporate culture, internal rules of art
210  8.3.3 e Clarify inputs Taking into account the potential consequences of product and service failure
211
8.3.3 f
Take into account the potential consequences of obsolescence
Such as consequences related to materials, processes, components, equipment, products
212  8.3.3 Check that the input items are complete and unambiguous In order to realize suitable design and development process
213 8.3.3 Resolve potential conflicts between inputs In order to obtain complete and unambiguous inputs
214 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
215 8.3.4 a Define clearly the expected results Regarding processes, products and services
216 8.3.4 b Conduct reviews as planned Regarding processes, products and services
217  8.3.4 c Check that outputs meet input requirements Cf. sub-clause 8.3.5
218 8.3.4 d Validate products and services To ensure that the specified application requirements or those for the intended use are satisfied
219 8.3.4 e Take actions in response to identified problems During reviews, verifications and validations
220 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
221
8.3.4 g
Authorize progression to the next stage
Before beginning next stage
222
8.3.4 h
Include representatives of functions concerned
For the review of design and development stages
223
8.3.4.1 a
Plan, control, review and document tests necessary for verification and validation
In order to ensure and prove that the tests or specifications identify the product to be tested and the resources to be used, define test objectives and conditions, parameters to be recorded and relevant acceptance criteria
224
8.3.4.1 b
Ensure and prove that test procedures describe the test methods to be used
And also how to perform the test and how to record the results
225
8.3.4.1 c
Ensure and prove that the configuration of the test item is correct Cf. sub-clause 8.1.2
226
8.3.4.1 d
Ensure and prove that the requirements of the test plan are observed And also test procedures
227
8.3.4.1 e
Ensure and prove that the acceptance criteria are met Also for the tests necessary for verification and validation
228
8.3.4.1 
Control monitoring and measuring devices used for testing
Cf. sub-clause 7.1.5
229
8.3.4.1 
Ensure that reports, calculations, test results, and others are able to demonstrate that the design for the product or service meets the specification requirements for all identified operational conditions At the completion of design and development
   8.3.5 Design and development outputs
230 8.3.5 a Ensure that outputs meet input requirements Cf. sub-clause 8.3.3
231 8.3.5 b Ensure that outputs are in line with the subsequent processes Regarding the products and services
232 8.3.5 c Ensure that outputs include monitoring and measuring requirements Including acceptance criteria
233 8.3.5 d Ensure that outputs are suitable for their intended use Proper use or planned by the customer in complete safety
234
8.3.5 e
Specify, as applicable, any critical items and concerned actions to be taken
Including key characteristics
235
8.3.5 f
Ensure that outputs are approved by authorized person
Prior to release
236
8.3.5
Define the data required to allow the product to be identified, manufactured, verified, used and maintained
Such as drawings, part lists needed to define the configuration and the design characteristics, materials, processes, manufacturing and assembly data, handling, packaging and preservation to ensure conforming product or service, technical data for repair and maintenance
237 8.3.5 Retain the documented information on outputs Cf. sub-clause 7.5 
 
 8.3.6
Design and development changes
 beginning
238 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
239
8.3.6
Implement a process with criteria for notifying its customer about changes that affect customer requirements
Prior to implementation
240 8.3.6 a Retain the documented information on changes Cf. sub-clause 7.5 
241 8.3.6 b Retain the documented information on results of reviews Cf. sub-clause 7.5 
242 8.3.6 c Retain the  documented information on who authorized the changes Cf. sub-clause 7.5 
243 8.3.6 d Retain the documented information on actions In order to prevent negative impacts. Cf. sub-clause 7.5 
244
8.3.6
Control design and development changes in accordance with the configuration management process
Cf. sub-clause 8.1.2
   8.4
External providers
 beginning
   8.4.1
General
 
245 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
246
8.4.1
Be responsible for the conformity of all externally provided processes, products and services
Including from sources defined by the customer
247
8.4.1
Ensure, when required, that customer-designated or approved external providers are used
Including process sources e.g. special processes
248
8.4.1

Identify and manage the risks associated with the external provision of processes, products and services

Including the selection and use of external providers
249
8.4.1
Require that external providers apply appropriate controls to their direct and sub-tier external providers
To ensure that requirements are met
250 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
251 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
252 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
253 8.4.1 Establish and implement evaluation and selection criteria of external providers and monitor their performance Including regular re-evaluation
254 8.4.1 Retain the documented information on the results of the evaluation and monitoring Cf. sub-clause 7.5
255
8.4.1.1 a
Define the process, responsibilities and authority for the approval status decision, changes of the approval status
In order to use external providers depending on their approval status
256
8.4.1.1 b
Maintain a register of its external providers that includes approval status (approved, conditional, disapproved)
Including the scope of the approval such as product type, process family
257
8.4.1.1 c
Periodically review external provider performance
Such as process, product and service conformity, on-time delivery performance
258
8.4.1.1 d
Define the necessary actions to take when dealing with external providers that do not meet requirements
Cf. sub-clauses 8.7 and 10.2
259
8.4.1.1 e
Define the requirements for controlling documented information created or retained by external providers
Cf. sub-clause 7.5
   8.4.2
Type and extent of control
 beginning
260 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
261 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
262 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!
263 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
264 8.4.2 c 2 Take into account the control of the external provider And effectiveness of this control
265
8.4.2 c 3
Take into account the results of the periodic review of external provider performance
Cf. sub-clause 8.4.1.1 c
266 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
267
8.4.2
Perform verification activities of externally provided processes, products and services according to the risks identified
Cf. sub-clause 8.1.1. Audit at the external provider's premises, review of required documentation, review of production part approval process, product inspection and service verification upon receipt
268
8.4.2
Include inspection or periodic testing, as applicable, when there is high risk of nonconformities
Including counterfeit parts
269
8.4.2
Identify and record in order to allow recall and replacement if later it is found that the product does not meet requirements
When externally provided product is released for production use, pending completion of all required verification activities
270
8.4.2
Define the scope and requirements for delegation for verification activities to the external provider
Cf. sub-clause 7.5. Maintain a register of delegations
271
8.4.2
Periodically monitor the external provider's delegated verification activities
And record the results
272
8.4.2
Implement a process to evaluate the data in the test reports to confirm that the product meets requirements
When test reports are utilized to verify externally provided products
273
8.4.2
Implement a process to validate the accuracy of test reports
When a customer (or organization) has identified raw material as significant operational risk (critical items)
   8.4.3
Information for external providers
 beginning
274 8.4.3  Check the adequacy of the requirements And only after communicate them to the external provider
275 8.4.3 a Communicate to external providers the requirements  Regarding the processes, products and services to provide
276 8.4.3 b 1 Communicate to external providers the requirements  Regarding the approval of products and services
277 8.4.3 b 2 Communicate to external providers the requirements  Regarding the approval of methods, processes and equipment
278 8.4.3 b 3 Communicate to external providers the requirements  Regarding the approval of the release of products and services
279 8.4.3 c Communicate to external providers the requirements  Regarding the competence (including required qualifications)
280 8.4.3 d Communicate to external providers the requirements  Regarding the relations between the external provider and the company
281 8.4.3 e Communicate to external providers the requirements  Regarding the control and monitoring of the external provider's performance
282 8.4.3 f Communicate to external providers the requirements  Regarding the verification or validation activities that the company or its customer intends to realize at the external provider's premises
283
8.4.3 g
Communicate to external providers the requirements
Regarding design and development control
284
8.4.3 h
Communicate to external providers the requirements Regarding special requirements, critical items or key characteristics
285
8.4.3 i
Communicate to external providers the requirements Regarding test, inspection, and verification, including production process verification
286
8.4.3 j
Communicate to external providers the requirements Regarding the use of statistical techniques for product acceptance and related instructions for acceptance by the organization
287
8.4.3 k
Communicate to external providers the requirements Regarding the need to implement a QMS
288
8.4.3 k
Communicate to external providers the requirements Regarding the need to use customer-designated or approved external providers, including process sources
289
8.4.3 k
Communicate to external providers the requirements Regarding the need to notify the organization of nonconforming processes, products or services and obtain approval for their disposition
290
8.4.3 k
Communicate to external providers the requirements Regarding the need to prevent the use of counterfiet parts, cf. sub-clause 8.1.4
291
8.4.3 k
Communicate to external providers the requirements Regarding the need to notify the organization of changes to processes, products or services, including changes of their external providers or location of manufacture and obtain the organization's approval
292
8.4.3 k
Communicate to external providers the requirements Regarding the need to flow down to external providers applicable requirements including customer requirements
293
8.4.3 k
Communicate to external providers the requirements Regarding the need to provide test specimens for design approval, inspection/verification, investigation or auditing
294
8.4.3 k
Communicate to external providers the requirements Regarding the need to retain documented information, including retention periods and disposition requirements
295
8.4.3 l
Communicate to external providers the requirements Regarding the right of access by the company, their customer and regulatory authorities to the applicable areas of facilities and to applicable documented information at any level of the supply chain
296
8.4.3 m
Communicate to external providers the requirements Regarding the assurance that persons are made aware of their contribution to product or service conformity
297
8.4.3 m
Communicate to external providers the requirements Regarding the assurance that persons are made aware of their contribution to product safety
298
8.4.3 m
Communicate to external providers the requirements Regarding the assurance that persons are made aware of the importance of ethical behavior
   8.5
Production and service provision
 
   8.5.1
Control of production and service provision
 beginning
299 8.5.1 Apply controlled conditions of production and service provision Including delivery and post-delivery activities
300 8.5.1 a 1 Save documented information of specifications of products and services and the expected activities Cf. sub-clause 7.5
301 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
302 8.5.1 b Include in the controlled conditions the inspection resources Cf. sub-clause 7.1.5
303 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
304
8.5.1 c 1
Ensure that documented information for monitoring and measurement activity includes criteria for acceptance or rejection
Cf. sub-clause 7.5
305
8.5.1 c 1
Ensure that documented information for monitoring and measurement activity includes stages where the verification operations are to be performed Cf. sub-clause 7.5
306
8.5.1 c 1
Ensure that documented information for monitoring and measurement activity includes measurement results to be obtained At a minimum an indication of acceptance or rejection
307
8.5.1 c 1
Ensure that documented information for monitoring and measurement activity includes any specific monitoring and measurement equipment required And instruction associated with their use
308
8.5.1 c 2
Ensure that when sampling is used as a means of product acceptance, the sampling plan is justified on the basis of recognized statistical principles and appropriate for use Match the sampling plan to the criticality of the product and the process capability
309 8.5.1 d Include in the controlled conditions adequate infrastructure and environment Cf. sub-clauses 7.1.3 et 7.1.4
310 8.5.1 e Include in the controlled conditions the staff competence Including the necessary qualification, cf. sub-clause 7.2
311 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
312 8.5.1 g Include in the controlled conditions the actions to prevent human error Use tools such as Poka-Yoke

313

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
314
8.5.1 i
Include in the controlled conditions the establishment of criteria for workmanship Such as written standards, representative samples, illustrations
315
8.5.1 j
Include in the controlled conditions the accountability for all products during production Such as parts quantity, split orders, nonconforming product
316
8.5.1 k
Include in the controlled conditions the control and monitoring of identified critical items in accordance with established processes Including key characteristics
317
8.5.1 l
Include in the controlled conditions the determination of methods to measure variable data Such as tooling, on-machine probing, inspection equipment
318
8.5.1 m
Include in the controlled conditions the identification of in-process inspection/verification points When adequate verification of conformity cannot be performed at later stages
319
8.5.1 n
Include in the controlled conditions the availability of evidence that all production and inspection/verification operations have beeen complited as planned Or as otherwise documented and authorized
320
8.5.1 o
Include in the controlled conditions the provision for the prevention, detection and removal of foreign objects Cf. sub-clause 8.1.3
321
8.5.1 p
Include in the controlled conditions the control and monitoring of utilities and supplies to the extent they affect conformity of product requirements Such as water, compressed air, electricity, chemical products
322
8.5.1 q
Include in the controlled conditions the identification and recording of products released for subsequent production use to allow recall and replacement if it is later found that the product does not meet requirements Pending completition of all required measuring and monitoring activities
   8.5.1.1
Control of equipment, tools and software programs
 beginning
323
8.5.1.1
Validate and maintain equipment, tools and software programs used to automate, control, monitor or measure production processes
Prior to release for production
324
8.5.1.1
Define storage requirements for production equipment and tooling in storage
Including any necessary periodic preservation or condition checks
   8.5.1.2
Validation and conrol of special processes
 
325

8.5.1.2 a

 
Establish, as applicable, arrangements for definition of criteria for the review and approval of the processes
For processes where the resulting output cannot be verified by subsequent monitoring or measurement
326
8.5.1.2 b
Establish, as applicable, arrangements for determination of conditions to maintain the approval For processes where the resulting output cannot be verified by subsequent monitoring or measurement
327
8.5.1.2 c
Establish, as applicable, arrangements for approval of facilities and equipment For processes where the resulting output cannot be verified by subsequent monitoring or measurement
328
8.5.1.2 d
Establish, as applicable, arrangements for qualification of persons For processes where the resulting output cannot be verified by subsequent monitoring or measurement
329
8.5.1.2 e
Establish, as applicable, arrangements for use of specific methods and procedures for implementation and monitoring the processes For processes where the resulting output cannot be verified by subsequent monitoring or measurement
330
8.5.1.2 f
Establish, as applicable, arrangements for requirements for documented information to be retained For processes where the resulting output cannot be verified by subsequent monitoring or measurement. Cf. sub-clause 7.5
  8.5.1.3
Production process verification
 
331
8.5.1.3
Implement production process verification activities to ensure the production process is able to produce products that meet requirements
Such as risk assessment, capacity studies, capability studies, control plans. These activities are "First article inspection", cf. AS 9102
332
8.5.1.3
Use a representative item from the first production run of a new part or assembly
In order to verify that the production processes, production documentation and tooling are able to produce parts and assemblies that meet requirements
333
8.5.1.3
Repeat this activity when changes occur that invalidate the original results
Such as engineering, production process and tooling changes
334
8.5.1.3
Retain documented information on the results of production process verification
Cf. sub-clause 7.5
   8.5.2
Identification and traceability
 beginning
335 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
336
8.5.2
Maintain the identification of the configuration of the products and services
In order to identify any differences between the actual and the required configuration
337 8.5.2 Inspect processes throughout the production and service provision In order to identify the status of process outputs
338
8.5.2
Establish controls for the media when acceptance authority media is used
Such as stamps, electronic signatures, passwords
339 8.5.2 Control the traceability of process outputs When traceability is a requirement, the unique identification is used
340 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
341 8.5.3 Exercise care with property owned by customer or external provider During its use or protection
342 8.5.3 Identify, check, protect, monitor and safeguard customer or external provider property When used or incorporated with updated labels
343 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
344 8.5.4 Preserve the process outputs throughout production and service provision activities Some examples of preservation methods: identification, packaging, handling, storage, transport, protection
345
8.5.4 a
Include in preservation of outputs provisions for cleaning
When applicable in accordance with specifications and applicable statutory and regulatory requirements
346
8.5.4 b
Include in preservation of outputs provisions for prevention, detection and removal of foreign objects When applicable in accordance with specifications and applicable statutory and regulatory requirements
347
8.5.4 c 
Include in preservation of outputs provisions for special handling and storage for sensitive products When applicable in accordance with specifications and applicable statutory and regulatory requirements
348
8.5.4 d
Include in preservation of outputs provisions for marking and labelling, including safety warnings and cautions When applicable in accordance with specifications and applicable statutory and regulatory requirements
349
8.5.4 e
Include in preservation of outputs provisions for shelf life control and stock rotation When applicable in accordance with specifications and applicable statutory and regulatory requirements
350
8.5.4 f
Include in preservation of outputs provisions for special handling and storage for hazardous materials When applicable in accordance with specifications and applicable statutory and regulatory requirements
   8.5.5
 Post-delivery activities
 beginning
351 8.5.5 Meet the requirements for post-delivery activities Examples of post-delivery activities: exchange new product, maintenance, recycling, final disposal
352 8.5.5 a Take into account statutory and regulatory requirements Cf. sub-clause 4.2
353 8.5.5 b Take into account negative impacts related to products and services These are consequences of potential risks
354 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
355 8.5.5 d Take into account the requirements of interested parties And customers especially
356 8.5.5 e Take into account customer feedback Of interested parties, when the extent of post-delivery activities has been clarified
357
8.5.5 f
Take into account collection and analysis of in-service data
Such as performance, reliability, lessons learned
358
8.5.5 g
Take into account control, updating and provision of technical documentation Such as product use, maintenance, repair and overhaul
359
8.5.5 h
Take into account controls required for work undertaken external to the organization Such as off-site work
360
8.5.5 i
Take into account product/customer support Such as queries, training, warranties, maintenance, replacement parts, resources, obsolescence
361
8.5.5
Take appropriate action when problems are detected after delivery
Including investigation and reporting
   8.5.6
Control of changes
 beginning
362 8.5.6 Review and control unplanned changes Cf. sub-clause 6.3 (planned changes)
363
8.5.6
Identify persons authorized to approve production and service provision changes
Such as changes affecting processes, production equipment, tools or software programs
364 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
365 8.6 Check products and services with activities at appropriate stages "Inspection does not improve quality, nor guarantee quality". Edwards Deming
366 8.6 Release products and services after verification of conformity Unless written approval (concession) by a competent authority or client
367 8.6 Retain the documented information on the release of products and services Cf. sub-clause 7.5
368 8.6 a Include in the documented information evidence of conformity These are the results of inspections compared to the acceptance criteria
369 8.6 b Include in the documented information the traceability of products and services Including the person having authorized the release
370
8.6
Ensure that retained documented information provides evidence that the products and services meet the defined requirements
When required to demonstrate product qualification
371
8.6
Ensure that all documented information required to accompany the products and services are present at delivery
Cf. sub-clause 7.5
   8.7
Control of nonconforming outputs
 beginning
372 8.7.1 Identify and treat nonconforming process, products and services outputs Marking and isolation to prevent unintended use or mixing with conforming outputs
373 8.7.1 Carry out corrective actions commensurate to impacts Including after delivery. Cf. sub-clause 10.2
374 8.7.1 Carry out corrective actions on post-delivery activities Cf. sub-clause 8.5.5
375
10.3
Maintain documented information on the nonconformity control process including the provisions for defining the responsibility and authority for the review and disposition of nonconforming outputs
Including the process for approving persons making these decisions
376
10.3
Maintain documented information on the nonconformity control process including the provisions for taking necessary actions In order to limit the effect of nonconformity on other processes, products or services
377
10.3
Maintain documented information on the nonconformity control process including the provisions for timely reporting of nonconformities affecting delivered products and services To the customer and to relevant interested parties such as external providers, distributors and regulatory authorities
378
10.3
Maintain documented information on the nonconformity control process including the provisions for defining corrective actions for nonconforming products and services detected after delivery Corrective actions as appropriate to their impacts. Cf. sub-clause 10.2
379 8.7.1 a Handle nonconforming outputs with corrections Repeat work, retouching, repair, recycling
380 8.7.1 b Handle nonconforming outputs by segregation Including customer returns or products and services not released
381 8.7.1 c Inform the customer Cf. sub-clause 7.4
382 8.7.1 d Handle nonconforming outputs by asking authorization To use-as-is (acceptance under concession), by a relevant authority, and when applicable, by the customer
383
8.7.1
Implement dispositions of use-as-is or repair for the acceptance of nonconforming products only after approval by an authorized representative
The representative is authorized by the organization responsible for design or by persons having delegated authority
384
8.7.1
Implement dispositions of use-as-is or repair for the acceptance of nonconforming products only after authorization by the customer If the nonconformity results in a departure from the contract requirements
385
8.7.1
Conspicuously and permanently mark product dispositioned for scrap until physically rendered unusable
Or isolate it in a safe place
386
8.7.1
Inspect counterfeit, or suspected counterfeit parts
In order to prevent reentry into the supply chain
387 8.7.1 Check conformity after any correction After any correction go through the normal flow
388 8.7.2 a Retain the documented information on the description of nonconformities Cf. sub-clause 7.5.
389 8.7.2 b Retain the documented information on implemented actions Cf. sub-clause 7.5.
390 8.7.2 c Retain the documented information on approved concessions Cf. sub-clause 7.5.
391 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
392 9.1.1 a Determine what is necessary to inspect "If you can’t measure it, you can’t manage it". Peter Drucker
393 9.1.1 b Determine the methods for inspection, analysis and evaluation In order to ensure valid results
394 9.1.1 c Determine when to inspect At key stages (essential) or upon the customer's request
395 9.1.1 d Determine when to analyse and evaluate inspection results When that brings added value
396 9.1.1 Evaluate the performance and effectiveness of the QMS In order to ensure that specified requirements are met
397 9.1.1 Retain the documented information on the inspection results Cf. sub-clause 7.5
   9.1.2
Customer satisfaction
 beginning
398 9.1.2 Regularly monitor customer perception about their level of satisfaction "The only measure of quality is customer satisfaction"
399 9.1.2 Determine methods for obtaining and using customer information Satisfaction surveys, claims, customer returns, recommendations
400
9.1.2
Include in the information to be monitored and used for the evaluation of customer satisfaction product and service conformity, on-time delivery performance and customer complaints
And corrective action request
401
9.1.2
Develop and implement plans that address deficiencies identified and assess the effectiveness of the results
In order to improve customer satisfaction
   9.1.3
Analysis and evaluation 
 beginning
402 9.1.3 Analyse and evaluate inspection data "Get the facts, analyze them and then do what seems right". Robert Waterman
403 9.1.3 a Use analysis results In order to evaluate how requirements are met. Cf. sub-clause 4.2
404 9.1.3 b Use analysis results In order to evaluate the level of customer satisfaction. Cf. sub-clause 9.1.2
405 9.1.3 c Use analysis results In order to evaluate the performance and effectiveness of the QMS
406 9.1.3 d Use analysis results In order to evaluate the effectiveness of planning. Cf. sub-clause 8.1
407 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
408 9.1.3 f Use analysis results In order to evaluate the performance of external providers. Cf. sub-clause 8.4
409 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
410 9.2.1 a 1 Conduct regularly planned internal audits In order to determine whether the QMS meets internal company requirements. Cf. ISO 19011
411 9.2.1 a 2 Conduct regularly planned internal audits In order to determine whether the QMS meets requirements of the ISO 9001 standard
412 9.2.1 b Conduct regularly planned internal audits In order to determine whether the QMS is effectively implemented and maintained
413 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)
414 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
415 9.2.2 b Define the scope and audit criteria Limit the area to be audited; use specific and known by the auditee criteria
416 9.2.2 c Select auditors Do not audit your department. "No one is judge in his own case". Latin proverb
417 9.2.2 d Communicate audit results to management concerned Cf. sub-clause 7.4 
418 9.2.2 e Undertake a correction quickly and corrective actions if necessary Cf. sub-clause 10.2
419 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
 
420  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
 
421 9.3.2 a Plan and carry out the management review  Regarding the status of actions of the previous review
422 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
423 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
424 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 
425 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
426 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
427 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
428 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
429 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
430
9.3.2.c 8
Take into account the information on the performance of the QMS and trends
EOn-time delivery performance. Cf. sub-clause 8.1
431 9.3.2 d Take into account resources Availability of resources. Cf. sub-clause 7.1
432 9.3.2 e Take into account the effectiveness of actions Implemented to address risks and opportunities. Cf. sub-clause 6.1
433 9.3.2 f Take into account improvement opportunities Continual improvement. Cf. sub-clause 10.3
   9.3.3
Management review outputs
 beginning
434 9.3.3 a Include decisions regarding opportunities for continual improvement in the outputs of the management review Cf. sub-clause 10.3
435 9.3.3 b Include decisions regarding eventual changes to the QMS in the outputs of the management review Cf. sub-clause 6.3
436 9.3.3 c Include decisions regarding new resource needs in the outputs of the management review Cf. sub-clause 7.1
437
9.3.3 d
Include decisions regarding risks identified in the outputs of the management review
Cf. sub-clause 8.1.1
438 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
439 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
440 10.1 a Improve products and services Support innovation. In order to better meet current requirements and anticipate future requirements
441 10.1 b Reduce negative impacts Implementing corrective actions and global prevention (efficient QMS)
442 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
443 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
444 10.2.1 a 2 Take into account consequences Think risk-based approach
445 10.2.1 b 1 Examine the nonconformity And if necessary decide to carry out a corrective action
446 10.2.1 b 2 Investigate root causes So that the nonconformity does not happen again
447 10.2.1 b 3 Search for similar nonconformities In order to apply the same recipe (why reinvent the wheel?)
448 10.2.1 c Implement the necessary corrective actions In order to treat the nonconformity
449 10.2.1 d Review the effectiveness of any implemented corrective action In order to check whether the action is finalized
450 10.2.1 e Update risks and opportunities If necessary
451 10.2.1 f Make changes to the QMS If necessary
452
10.2.1 g
Flow down corrective action requirements to an external provider
When it is determined that the external provider is responsible for the nonconformity
453
10.2.1 h
Take specific actions when timely corrective actions are not achieved
And actions were not effective
454 10.2.1  Respond proportionally to nonconformities consequences Do not make too much quality
455
10.2.1
Maintain documented information that defines the nonconformity and corrective action processes
Cf. sub-clause 7.5
456 10.2.2 a Retain documented information on the nature of nonconformities Cf. sub-clause 7.5
457 10.2.2 a Retain documented information on results of implemented actions Cf. sub-clause 7.5
   10.3
Continual improvement
 beginning
458  10.3 Improve continually the performance of the QMS In order to find improvement opportunities
459  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
460
10.3
Monitor the implementation of improvement activities
And evaluate the effectiveness of the results