AS9100D 2016 requirements, aerospace quality management systems

21/08/2017

The "AS9100D version 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!

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

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	Plan, Do, Check, Act	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	Plan
	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 stakeholders
3	4.2 a	Identify stakeholders	"There is only one valid definition of a business purpose: to create a customer". Peter Drucker. List of relevant stakeholders
4	4.2 b	Clarify the requirements of the stakeholders	Each need and expectation is unique. Aim for a partnership in the long term
5	4.2	Monitor and review information about stakeholders 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 stakeholders
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 the stakeholders	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 stakeholders	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, Check, Act
	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 stakeholders
	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	Plan
	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 (stakeholders). "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	Do
	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
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
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
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
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
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
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
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
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
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
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
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
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
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 stakeholders
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 8.3.3, 8.3.5 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
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
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 8.3.3, 8.3.5 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
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
	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
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
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
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
*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
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
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
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
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 the stakeholders	And customers especially
356	8.5.5 e	Take into account customer feedback	From stakeholders, 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
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
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
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*	8.7.1	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*	8.7.1	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*	8.7.1	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 stakeholders such as external providers, distributors and regulatory authorities
*378*	8.7.1	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
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
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
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
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
	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
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
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
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
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