ISO 9001 version 2026 requirements, quality management systems

1/10/2026

The "ISO 9001 version 2026 Requirements" quiz will help you understand the main requirements of the standard.

The questions (requirements) included in this quiz are 60 of the 332 in the standard, but don't worry. These 60 requirements are among the most important. So do not hesitate to learn in a fun way!

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

News about the ISO 9001 version 2026

The online training (course) T 15v26 ISO 9001 version 2026 readiness and its demo

The course T 35v26 ISO 9001 version 2026 internal audit and its demo

The package of courses T 75v26 training package ISO 9001 version 2026 readiness and internal audit

Based on the ISO 9001: 2015 the 310 requirements (verb shall) of clauses 4 to 10 are as follows:

ISO 9001 : 2026 requirements
No	Clause	PDCA cycle	Requirement No	Quantity
4	Context	Plan	1 to 27	27
5	Leadership	Plan, Do, Check, Act	28 to 59	32
6	Planning	Plan	60 to 95	36
7	Support	Do	96 to 139	44
8	Operation	Do	140 to 268	129
9	Performance	Check	269 to 314	46
10	Improvement	Act	315 to 332	18
Total				332

requirements

ISO 9001 version 2026 requirements

pdca

The Deming PDCA cycle

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

ISO 9001 - Requirements and comments
No	Clause, sub-clause	Requirement	Comment, link
	4	Context of the organization	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). Cf. sub-clause 6.1
2	4.1	Determine whether climate change is a relevant issue	Amendment 1 of ISO 9001 (february 2024) : changes concerning actions related to climate. It is a requirement!
3	4.1	Monitor and review information about issues	Issue: what one can gain or lose during an activity (factors, conditions). Some issues can change rapidly, so remain vigilant. Cf. sub-clause 9.3
	4.2	Needs and expectations of stakeholders
4	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, sub-clause. § 7.5
5	4.2 b	Clarify the requirements of the stakeholders	Each need and expectation is unique. Aim for a partnership in the long term
6	4.2 c	Determine which of these requirements will be addressed	Through the quality management system
7	4.2	Monitor and review information about stakeholders and their requirements	Before accepting an order
	4.3	Scope of the quality management system
8	4.3	Define the scope of the QMS	Geographic and organizational scope available to stakeholders
9	4.3 a	Take into consideration the external and internal issues	Cf. sub-clause 4.1
10	4.3 b	Take into consideration the requirements of the stakeholders	Cf. sub-clause 4.2
11	4.3 c	Take into consideration the products and services	All products and services proposed by the company without exception
12	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
13	4.3	Keep the scope of the QMS available as documented information	Cf. sub-clause 7.5
14	4.3	Include in the scope of the QMS justification for any requirements which cannot be met	Any requirement of the ISO 9001 standard that cannot be applied within the organization must be justified, as "requirements determined to be non-applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction."
15	4.3	Keep the scope available	As documented information, cf. sub-clause 7.5
	4.4	Quality management system and its processes
16	4.4.1	Establish, implement, maintain and improve a process-based QMS including process interactions	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). Process map
17	4.4.1 a	Determine the needed processes	And their application
18	4.4.1 b	Determine process inputs and outputs	Process sheet, process owner job description, cf. sub-clause 5.3
19	4.4.1 c	Determine the sequence and interaction of processes	Flowchart
20	4.4.1 d	Determine the criteria and methods to control processes	Tools of the quality manager, cf. sub-clause 9.1.1
21	4.4.1 e	Determine and ensure the resources	Needed to support processes. Cf. sub-clause 7.1. And ensure their availability
22	4.4.1 f	Assign process responsibilities and authorities	Job description of process owners, cf. sub-clause 5.3
23	4.4.1 g	Address the risks and opportunities for each process	In accordance with the requirements in sub-clause 6.1
24	4.4.1 h	Evaluate processes and if necessary implement any changes needed	In order to ensure that these processes achieve their intended results
25	4.4.1 i	Determine the improvement opportunities of processes and the QMS	Cf. sub-clause 10.1
26	4.4.2 a	Keep documented information available to the extent necessary (procedures)	In order to support the operation of the organization's processes. Cf. sub-clause 7.5
27	4.4.2 b	Keep documented information available to the extent necessary (records)	As evidence that the processes are being carried out as planned. Cf. sub-clause 7.5
	5	Leadership	Plan , Do, Check, Act
	5.1	Leadership and commitment
	5.1.1	General
28	5.1.1 a	Establish a quality policy and quality objectives, and demonstrate commitment to the QMS	The policy and objectives are consistent with the company’s strategic direction and context. "When you sweep the stairs, you start at the top". Romanian proverb. Focus on quality and customers
29	5.1.1 b	Integrate QMS requirements in the internal process requirements	Cf. sub-clause 4.4 and sub-clause 7.1.4
30	5.1.1 c	Provide the necessary resources for the QMS	And ensure their availability, cf. sub-clause 7.1
31	5.1.1 d	Raise awareness on the importance of an effective and conforming QMS	Essential management commitment to a customer focus, cf. sub-clause 5.1.2
32	5.1.1 e	Ensure the achievement of intended results of the QMS	Third quality management principle (engagement of people)
33	5.1.1 f	Support the staff contribution to the effectiveness of the QMS	"Employees first, customers second". Vineet Nayar
34	5.1.1 g	Promote continual improvement	Cf. sub-clause 10.1
35	5.1.1 h	Support the leadership of managers	Responsibility and authority of managers are backed at all times by top management
36	5.1.1 i	Promote quality culture	And ethical behavior (shared values, attitudes and practices), cf. ISO 10010
37	5.1.1 j	Promote the process approach	Cf. sub-clause 0.3 of the Introduction
38	5.1.1 k	Promote the risk approach	Cf. sub-clause 6.1
39	5.1.1 l	Take accountability for the effectiveness of the QMS	Top management demonstrates leadership (assumes its responsibility and commitment)
	5.1.2	Customer focus
40	5.1.2 a	Determine and meet customer, statutory and regulatory requirements	Top management demonstrates leadership (assumes its responsibility and commitment) permanently, cf. sub-clause 8.2
41	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
42	5.1.2 c	Maintain the objective of better satisfying the customer	First quality management principle (customer focus), cf. sub-clause 9.1.2
	5.2	Policy
43	5.2.1	Establish a quality policy	Taking into account the company’s purpose (its raison d’être, strategic direction, culture, and business context)
44	5.2.1 a	Ensure that the quality policy is appropriate	To the purpose of the organization
45	5.2.1 b	Provide a framework to define and review the quality objectives	Cf. sub-clause 6.2
46	5.2.1 c	Include meeting the applicable requirements	Cf. sub-clause 9.1.3
47	5.2.1 d	Include a commitment to continually improve the QMS	Cf. sub-clause 10.1
48	5.2.1 e	Take into account the context of the organization	And support its strategic direction
49	5.2.2 a	Keep the quality policy available 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
52	5.2.2 d	Implement and make the quality policy understood	And applied within the organization
	5.3	Roles, responsibilities, authorities
53	5.3	Assign and communicate the responsibilities and authorities	Top management ensures that all relevant roles in the QMS are assigned
54	5.3 a	Assign and communicate the responsibilities and authorities	In order to ensure that the QMS conforms to the requirements of the ISO 9001 standard
55	5.3 b	Assign and communicate the responsibilities and authorities	In order to report on the performance of the QMS to top management
56	5.3 c	Assign and communicate the responsibilities and authorities	In order to ensure that the processes are delivering their intended results, cf. sub-clause 8.5.1
57	5.3 d	Assign and communicate the responsibilities and authorities	In order to ensure that customer focus is ensured (first quality management principle), cf. sub-clauses 5.1 and 7.3
58	5.3 e	Assign and communicate the responsibilities and authorities	In order to report on opportunities for improvement to top management, sub-clause 10.1
59	5.3 f	Assign and communicate the responsibilities and authorities	In order to ensure that the integrity of the QMS is maintained, including when changes are planned and implemented
	6	Planning	Plan
	6.1	Actions to address risks and opportunities
	6.1.1	Determining risks and opportunities
60	6.1.1 a	Consider the external and internal issues and determine the 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
61	6.1.1 b	Consider the external and internal issues and determine the risks and opportunities	In order to prevent, or reduce, undesired effects
62	6.1.1 c	Consider the external and internal issues and determine the risks and opportunities	In order to achieve continual improvement, cf. sub-clause 10.1
63	6.1.1 d	Consider the external and internal issues and determine the risks and opportunities	In order to enhance desired effects
	6.1.2	Actions to address risks
64	6.1.2	Determine, analyze and evaluate risks	That can have an undesired effect on products and services and customer satisfaction. Possible actions: avoid the risk, take a risk in order to seize an opportunity, eliminate the source of the risk, share the risk
65	6.1.2 a	Plan actions	In order to address these risks
66	6.1.2 b 1	Plan how to integrate	And implement the actions into its QMS processes
67	6.1.2 b 2	Plan how to evaluate	The effectiveness of these actions
68	6.1.2	Adapt actions to risks	Compared to the potential impact of the risks on the intended results of the QMS
	6.1.3	Actions to address opportunities
69	6.1.3	Determine, analyze and evaluate opportunities	Capable of having a desired impact on products, services, and customer satisfaction. Possible actions include new practices, new products, new partnerships, new technologies, and initiatives designed to address the evolving needs and expectations of customers
70	6.1.3 a	Plan the actions	In order to address these opportunities
71	6.1.3 b	Plan how to integrate	And implement the actions into its QMS processes
72	6.1.3 c	Plan how to evaluate	The effectiveness of these actions
73	6.1.3	Adapt actions to opportunities	Compared to the organization's context and support the achievement of desired results
	6.2	Quality objectives
74	6.2.1	Establish quality objectives for processes	"He who has no goals will not achieve them". Sun Tzu"
75	6.2.1 a	Choose quality objectives	Clarify criteria for setting objectives that are consistent with the quality policy
76	6.2.1 b	Use measurable objectives	And realistic
77	6.2.1 c	Consider applicable requirements	Cf. sub-clause 4.2
78	6.2.1 d	Monitor objectives	Frequently
79	6.2.1 e	Communicate on objectives	At all levels
80	6.2.1 f	Update objectives	During management review, cf. sub-clause 9.3
81	6.2.1 g	Keep available as documented information the quality objectives	Cf. sub-clause 7.5
82	6.2.1 h	Keep the quality objectives relevant	To the conformity of products and services and the ability to enhance customer satisfaction
83	6.2.2 a	Determine how to do	In order to achieve its quality objectives
84	6.2.2 b	Determine what resources will be required	In order to achieve its quality objectives
85	6.2.2 c	Determine who will be responsible	In order to achieve its quality objectives
86	6.2.2 d	Determine deadlines	In order to achieve its quality objectives
87	6.2.2 e	Determine how the results will be evaluated	In order to achieve its quality objectives
	6.3	Planning of changes
88	6.3	Plan the need for changes to the QMS in a planned manner	"The only person who likes change is a wet baby". Cf. sub-clause 4.4
89	6.3 a	Plan the changes	Taking into account the purpose of the change and the possible consequences
90	6.3 b	Plan the changes	Taking into account the maintenance of the integrity of the QMS
91	6.3 c	Plan the changes	Taking into account the available resources and information
92	6.3 d	Plan the changes	Taking into account the allocation and reallocation of responsibilities and authorities
93	6.3 e	Plan the changes	Taking into account the communication of the changes
94	6.3 f	Plan the changes	Taking into account how the effectiveness of the changes will be monitored and evaluated
95	6.3 g	Plan the changes	Taking into account how the results of the changes will be reviewed
	7	Support	Do
	7.1	Resources
	7.1.1	General
96	7.1.1	Provide the necessary resources	In order to support the QMS, cf. sub-clause 9.3
97	7.1.1 a	Take into account existing resources	And their capabilities and constrains, cf. sub-clause 7.1.2
98	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
99	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." Cf. ISO 30201
	7.1.3	Infrastructure
100	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, cf. ISO 30201
	7.1.4	Process environment
101	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
102	7.1.5.1	Provide suitable monitoring and measuring resources	In order to obtain expected inspection results, cf. ISO 10012 and ISO 10009
103	7.1.5.1 a	Provide adequate resources to the specific inspections	To inspect is to monitor and measure. Cf. sub-clause 7.2
104	7.1.5.1 b	Maintain resources	In order to ensure fitness for their purpose
105	7.1.5.1	Keep documented information available as evidence on the adequacy of inspection resources	Cf. sub-clause 7.5
	7.1.5.2	Measurement traceability
106	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 keep documented information available as evidence on the reference used, cf. sub-clause 7.5
107	7.1.5.2 b	Identify the measuring equipment	In order to monitor the validity of their calibration (or verification)
108	7.1.5.2 c	Protect the measuring equipment	Against activities that may invalidate the results of the measurement (settings or deterioration)
109	7.1.5.2	Conduct corrective action on previous measurement results	When the verification or calibration of a measuring instrument is not in conformity
	7.1.6	Organizational knowledge
110	7.1.6	Determine the necessary knowledge	In order to control the processes and the conformity of products and services, cf. ISO 30401
111	7.1.6	Acquire, maintain and make organizational knowledge available to the extent necessary	In order to maintain the performance of the QMS, cf. sub-clause 7.2
112	7.1.6	Take into account the need for additional knowledge	When needs and trends have changed
	7.2	Competence
113	7.2 a	Determine the necessary competence	Clarify quality competence requirements. Identify people who have an influence on the quality performance, cf. ISO 10015
114	7.2 b	Ensure that these persons are competent	Which are based on appropriate education, training or experience
115	7.2 c	Undertake actions to acquire the necessary competence and evaluate the effectiveness of these actions	Training, coaching, external providers
116	7.2	Keep appropriate documented information available on staff competence	Cf. sub-clause 7.5
	7.3	Awareness
117	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 and ISO 10018
118	7.3 b	Ensure the staff is aware of their contribution to the effectiveness of the QMS	Including the benefits of improved performance
119	7.3 c	Ensure the staff is aware of the implications	Of not conforming to the QMS requirements, cf. sub-clause 8.7
120	7.3 d	Ensure the staff is aware of relevant quality objectives	If QMS requirements are not met. Cf. sub-clause 6.2
121	7.3 d	Ensure the staff is aware of the organizational quality culture	And ethical behavior
	7.4	Communication
122	7.4 a	Define the subjects on which to communicate	Internally and externally. "Good news walks, bad news runs". Swedish proverb
123	7.4 b	Define when to communicate	Respond quickly to claims
124	7.4 c	Define with whom to communicate	Communication goes both ways
125	7.4 d	Define how to communicate	Orally, in writing; Internet, video
126	7.4 e	Assign who will communicate	The one who is closest to the subject
	7.5	Documentation
	7.5.1	General
127	7.5.1 a	Include the documentation required by the ISO 9001 standard	Documented procedures (documented information to keep available): scope of the QMS (sub-clause 4.3) process control (sub-clause 4.4.2) quality policy (sub-clause 5.2.2 a) quality objectives (sub-clause 6.2.1) Records (documented information to keep available as evidence): 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) operational control, 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 program and audit results (sub-clause 9.2.2) management review results (sub-clause 9.3.3) nonconformities, actions and results (sub-clause 10.2.2)
128	7.5.1 b	Select the documentation deemed necessary to the effectiveness of the QMS	"Spoken words fly away, written one stay". Latin proverb
	7.5.2	Creating and updating
129	7.5.2 a	Create, identify and describe the documentation	Codification, title, author, subject, product, cf. ISO 10013
130	7.5.2 b	Choose the format and the media of the documentation	Language, graphics; paper, electronic
131	7.5.2 c	Review and approve the adequacy of the documentation	Who writes, codifies, who approves
	7.5.3	Control of documentation
132	7.5.3.1 a	Control the availability of the documentation	Where and when required in a form that is suitable for use
133	7.5.3.1 b	Control the protection of the documentation	Loss of confidentiality, loss of integrity, misuse
134	7.5.3.2 a	Control the distribution, access and use of the documentation	Who is in charge, method to use, rule to follow
135	7.5.3.2 b	Control the storage of the documentation	Including preservation, protection and readability
136	7.5.3.2 c	Control the changes of the documentation	Use of updated versions, restricted access to obsolete versions
137	7.5.3.2 d	Control the retention time and the removal of the documentation	Retention period, disposal method
138	7.5.3.2	Control the documents of external origin	Unique codification, access, protection
139	7.5.3.2	Protect the documentation	Who has the right to read, who has the right to change
	8	Operation	Do
	8.1	Operational planning and control
140	8.1 a	Plan and determine the requirements for the products and services	By controlling processes. Cf. sub-clauses 4.4 et 6.1
141	8.1 b	Establish the criteria	For processes
142	8.1 c	Establish the criteria	For the acceptance of conforming products and services
143	8.1 d	Control the processes	In accordance with the criteria of sub-clauses 8.1 b and c
144	8.1 e	Determine the resources needed to achieve conformity	To the product and service requirements
145	8.1	Keep documented information available to the extent necessary	In order to have confidence that the processes have been carried out as planned. Cf. sub-clause 7.5
146	8.1	Control planned and unplanned changes	Analyze the consequences of unplanned changes, actions to limit the effects
147	8.1	Control the outsourced processes	Cf. sub-clauses 8.4 and 7.5
148	8.1	Keep documented information available	As evidence of the conformity of products and services. Cf. sub-clause 7.5
	8.2	Requirements for products and services
	8.2.1	Customer communication
149	8.2.1 a	Provide information to customers	Related to products and services, cf. sub-clause 7.4
150	8.2.1 b	Control communication with customers	Related to contracts, orders, changes and consultations
151	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
152	8.2.1 d	Control communication with customers	Regarding their property. Cf. sub-clause 8.5.3
153	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
154	8.2.2 a 1	Develop specific activities for products and services	In order to clarify statutory and regulatory requirements
155	8.2.2 a 2	Define internal requirements	Related to processes, products and services. And check that the requirements can be met
156	8.2.2 b	Be able to respond to claims	In a relevant way (with facts)
	8.2.3	Review of requirements related to products and services
157	8.2.3.1	Be able to respond to customers	Regarding requirements of proposed products and services
158	8.2.3.1 a	Review explicit customer requirements	Before order acceptance. Including delivery and post-delivery activities requirements
159	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
160	8.2.3.1 c	Review internal requirements	Between requirements of an order and those previously expressed
161	8.2.3.1 d	Review statutory and regulatory requirements	Applicable to the products and services
162	8.2.3.1 e	Review gaps	Between requirements of an order (or contract) and those previously expressed
163	8.2.3.1	Resolve gaps	Before order acceptance and commitment to provide products and services
164	8.2.3.1	Confirm requirements before accepting an order	When requirements are not documented
165	8.2.3.2 a	Keep documented information available on on the results of the reviews of requirements	As evidence. Cf. sub-clause 7.5
166	8.2.3.2 b	Keep documented information available on any new or changed requirement for the products and services	As evidence. Cf. sub-clause 7.5
	8.2.4	Changes to requirements for products and services
167	8.2.4	Communicate changes to relevant persons	After changing requirements in the documentation, cf. sub-clauses 7.4 and 7.5
	8.3	Design and development of products and services
	8.3.1	General
168	8.3.1	Establish, implement and maintain a process of design and development	Cf. ISO 10007. "I have not failed. I just found 10,000 ways that will not work". Thomas Edison
	8.3.2	Design and development planning
169	8.3.2 a	Plan the design and development stages	Taking into account the specificity of design and development activities
170	8.3.2 b	Plan the design and development stages	Taking into account the process requirements and applicable reviews
171	8.3.2 c	Plan the design and development stages	Taking into account the verification and validation activities
172	8.3.2 d	Plan the design and development stages	Taking into account the necessary responsibilities and authorities
173	8.3.2 e	Plan the design and development stages	Taking into account the needs of internal and external resources
174	8.3.2 f	Plan the design and development stages	Taking into account the relations between persons participating in the design and development
175	8.3.2 g	Plan the design and development stages	Taking into account the need for involvement of customers and users
176	8.3.2 h	Plan the design and development stages	Taking into account the requirements for subsequent products and services
177	8.3.2 i	Plan the design and development stages	Taking into account the level of control expected by stakeholders
178	8.3.2 j	Plan the design and development stages	Taking into account the documentation needed to demonstrate design and development requirements. Cf. sub-clauses 8.3.3, 8.3.5 and 8.3.6
	8.3.3	Design and development inputs
179	8.3.3	Determine essential requirements	On specific types of products and services from design and development
180	8.3.3 a	Determine functional requirements	Taking into account also the performance requirements
181	8.3.3 b	Clarify inputs	Taking into account the information from similar activities
182	8.3.3 c	Clarify inputs	Taking into account the statutory and regulatory requirements
183	8.3.3 d	Clarify inputs	Taking into account the corporate culture, internal rules of art
184	8.3.3 e	Clarify inputs	Taking into account the potential consequences of product and service failure
185	8.3.3	Check that the input items are complete and unambiguous	In order to realize suitable design and development process
186	8.3.3	Resolve potential conflicts between inputs	In order to obtain complete and unambiguous inputs
187	8.3.3	Keep available documented information on design and development inputs	As evidence. Cf. sub-clause 7.5
	8.3.4	Design and development controls
188	8.3.4 a	Define clearly the expected results	Regarding processes, products and services
189	8.3.4 b	Conduct reviews as planned	Regarding processes, products and services
190	8.3.4 c	Check that outputs meet input requirements	Cf. sub-clause 8.3.5
191	8.3.4 d	Validate products and services	To ensure that the specified application requirements or those for the intended use are satisfied
192	8.3.4 e	Take actions in response to identified problems	During reviews, verifications and validations
193	8.3.4 f	Ensure that the documented information is available	As evidence of theses activities. Cf. sub-clause 7.5. Cf. sub-clauses 8.3.3, 8.3.5 and 8.3.6
	8.3.5	Design and development outputs
194	8.3.5 a	Ensure that outputs meet input requirements	Cf. sub-clause 8.3.3
195	8.3.5 b	Ensure that outputs are in line with the subsequent processes	Regarding the products and services
196	8.3.5 c	Ensure that outputs include monitoring and measuring requirements	Including acceptance criteria
197	8.3.5 d	Ensure that outputs are suitable for their intended use	Proper use or planned by the customer in complete safety
198	8.3.5	Ensure that the documented information is available on outputs	As evidence. Cf. sub-clause 7.5
	8.3.6	Design and development changes
199	8.3.6	Determine, review and control changes made during the design and development of products and services	In order to ensure that there is no adverse impact on conformity to requirements
200	8.3.6 a	Keep documented information available on changes	As evidence. Cf. sub-clause 7.5
201	8.3.6 b	Keep documented information available on results of reviews	As evidence. Cf. sub-clause 7.5
202	8.3.6 c	Keep documented information available on who authorized the changes	As evidence. Cf. sub-clause 7.5
203	8.3.6 d	Keep documented information available on actions taken to prevent adverse impacts	As evidence. Cf. sub-clause 7.5
	8.4	External providers
	8.4.1	General
204	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
205	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
206	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
207	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
208	8.4.1	Establish and implement evaluation and selection criteria of external providers and monitor their performance	Including regular re-evaluation
209	8.4.1	Keep documented information available on the results of the evaluation and monitoring	As evidence. Cf. sub-clause 7.5
	8.4.2	Type and extent of control
210	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
211	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
212	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!
213	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
214	8.4.2 c 2	Take into account the control of the external provider	And effectiveness of this control
215	8.4.2 d	Define how to control the outputs of externally provided processes	Verification and other activities necessary to ensure that the provision of external providers does not affect the conformity of products and services delivered to the customer
	8.4.3	Information for external providers
216	8.4.3	Check the adequacy of the requirements	And only after communicate them to the external provider
217	8.4.3 a	Communicate the requirements to the external provider	Regarding the processes, products and services to provide
218	8.4.3 b 1	Communicate the requirements to the external provider	Regarding the approval of products and services
219	8.4.3 b 2	Communicate the requirements to the external provider	Regarding the approval of methods, processes and equipment
220	8.4.3 b 3	Communicate the requirements to the external provider	Regarding the approval of the release of products and services
221	8.4.3 c	Communicate the requirements to the external provider	Regarding the competence (including required qualifications)
222	8.4.3 d	Communicate the requirements to the external provider	Regarding the relations between the external provider and the company
223	8.4.3 e	Communicate the requirements to the external provider	Regarding the control and monitoring of the external provider's performance
224	8.4.3 f	Communicate the requirements to the external provider	Regarding the verification or validation activities that the company or its customer intends to realize at the external provider's premises
	8.5	Production and service provision
	8.5.1	Control of production and service provision
225	8.5.1	Apply controlled conditions of production and service provision	Including delivery and post-delivery activities
226	8.5.1 a 1	Keep available documented information that defines the characteristics of the products and services	Cf. sub-clause 7.5
227	8.5.1 a 2	Keep available documented information that defines the activities to be performed	Cf. sub-clause 7.5. "A quality control that does not show results is no control". Kaoru Ishikawa
228	8.5.1 a 3	Keep available documented information that defines the results to be achieved	Cf. sub-clause 7.5
229	8.5.1 b	Include in the controlled conditions the availability and use of suitable monitoring and measuring resources	Cf. sub-clause 7.1.5
230	8.5.1 c	Include in the controlled conditions the implementation of monitoring and measurement activities	In order to verify that the appropriate stages of the processes' outputs meet the criteria
231	8.5.1 d	Include in the controlled conditions the use of suitable infrastructure and environment	For the operation of processes. Cf. sub-clauses 7.1.3 et 7.1.4
232	8.5.1 e	Include in the controlled conditions the appointment of competent persons	Including the necessary qualification, cf. sub-clause 7.2
233	8.5.1 f	Include in the controlled conditions the validation (and revalidation) of the ability of a process to achieve the planned results	When the resulting output cannot be verified by subsequent inspection
234	8.5.1 g	Include in the controlled conditions the actions to prevent human error	Use tools such as Poka-Yoke
235	8.5.1 h	Include in the controlled conditions the activities of release, delivery and post-delivery	Cf. sub-clause 8.6 and sub-clause 8.5.5
	8.5.2	Identification and traceability
236	8.5.2 a	Use appropriate means to control the unique identification of process outputs	In order to ensure the conformity of products and services when needed, cf. sub-clause 8.5.1
237	8.5.2 b	Inspect processes throughout the production and service provision	In order to identify the status of process outputs, cf. sub-clause 8.2.2
238	8.5.2 c	Control the traceability of process outputs	When traceability is a requirement, the unique identification is used
239	8.5.2 d	Ensure that documented information necessary to enable traceability	Is available as evidence. Cf. sub-clause 7.5.
	8.5.3	Property belonging to customers or external providers
240	8.5.3	Exercise care with property owned by customer or external provider	During its use or protection
241	8.5.3	Identify, check, protect, monitor and safeguard customer or external provider property	When used or incorporated with updated labels
242	8.5.3	Notify the customer or external provider when his property has been damaged or lost and keep documented information available	As evidence of what has occurred. Following incorrect or improper use. Cf. sub-clause 7.5.
	8.5.4	Preservation
243	8.5.4	Preserve the process outputs throughout production and service provision activities	Some examples of preservation methods: identification, packaging, handling, storage, transport, protection
	8.5.5	Post-delivery activities
244	8.5.5	Meet the requirements for post-delivery activities	Examples of post-delivery activities: exchange new product, maintenance, recycling, final disposal
245	8.5.5 a	Take into account statutory and regulatory requirements	Cf. sub-clause 4.2
246	8.5.5 b	Take into account negative impacts related to products and services	These are consequences of potential risks, cf. sub-clause 8.7
247	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
248	8.5.5 d	Take into account the requirements of the stakeholders	And customers especially, cf. sub-clause 8.2.2
249	8.5.5 e	Take into account customer feedback	From stakeholders, when the extent of post-delivery activities has been clarified, cf. sub-clause 8.2.1
	8.5.6	Control of changes
250	8.5.6	Review and control unplanned changes	Cf. sub-clause 6.3 (planned changes)
251	8.5.6	Keep documented information available on unplanned changes as evidence	Cf. sub-clause 7.5. Include the results of reviews, the authorization of changes and actions implemented
	8.6	Release of products and services
252	8.6	Check products and services with activities at appropriate stages	"Inspection does not improve quality, nor guarantee quality". Edwards Deming
253	8.6	Release products and services after verification of conformity	Unless written approval (concession) by a competent authority or client
254	8.6	Keep documented information available as evidence on the release of products and services	As evidence. Cf. sub-clause 7.5.
255	8.6 a	Include in the documented information evidence of conformity	These are the results of inspections compared to the acceptance criteria
256	8.6 b	Include in the documented information traceability of products and services	Including the person having authorized the release
	8.7	Control of nonconforming outputs
257	8.7.1	Identify and treat nonconforming process, products and services outputs	Marking and isolation to prevent unintended use or mixing with conforming outputs. Cf. ISO 10002
258	8.7.1	Carry out corrective actions commensurate to impacts	Including after delivery. Cf. sub-clause 10.2
259	8.7.1	Carry out corrective actions on post-delivery activities	Cf. sub-clause 8.5.5
260	8.7.1 a	Handle nonconforming outputs with corrections	Repeat work, retouching, repair, recycling
261	8.7.1 b	Handle nonconforming outputs by segregation	Including customer returns or products and services not released
262	8.7.1 c	Inform the customer	Cf. sub-clause 7.4
263	8.7.1 d	Handle nonconforming outputs by asking authorization	To use in is (acceptance under concession)
264	8.7.1	Check conformity after any correction	After any correction go through the normal flow
265	8.7.2 a	Keep documented information available on the description of nonconformities	As evidence. Cf. sub-clause 7.5.
266	8.7.2 b	Keep documented information available on implemented actions	As evidence. Cf. sub-clause 7.5.
267	8.7.2 c	Keep documented information available on approved concessions	As evidence. Cf. sub-clause 7.5.
268	8.7.2 d	Keep documented information available on the person having decided the handling of the nonconformities	As evidence. Cf. sub-clause 7.5
	9	Performance evaluation	Check
	9.1	Monitoring, measurement, analysis and evaluation
	9.1.1	General
269	9.1.1 a	Determine what is necessary to inspect	"If you can’t measure it, you can’t manage it". Peter Drucker
270	9.1.1 b	Determine the methods for inspection, analysis and evaluation	In order to ensure valid results
271	9.1.1 c	Determine when to inspect	At key stages (essential) or upon the customer's request
272	9.1.1 d	Determine when to analyze and evaluate inspection results	When that brings added value
273	9.1.1	Evaluate the performance and effectiveness of the QMS	In order to ensure that specified requirements are met
274	9.1.1	Keep documented information available on the inspection results	As evidence. Cf. sub-clause 7.5
	9.1.2	Customer satisfaction
275	9.1.2	Regularly monitor customer perception about their level of satisfaction	"The only measure of quality is customer satisfaction"
276	9.1.2	Determine methods for obtaining and using customer information	Satisfaction surveys, claims, customer returns, recommendations
	9.1.3	Analysis and evaluation
277	9.1.3	Analyze and evaluate inspection data	"Get the facts, analyze them and then do what seems right". Robert Waterman
278	9.1.3 a	Use analysis results	In order to evaluate how requirements are met. Cf. sub-clause 4.2
279	9.1.3 b	Use analysis results	In order to evaluate the level of customer satisfaction. Cf. sub-clause 9.1.2
280	9.1.3 c	Use analysis results	In order to evaluate the performance and effectiveness of the QMS
281	9.1.3 d	Use analysis results	In order to evaluate the effectiveness of planning. Cf. sub-clause 8.1
282	9.1.3 e	Use analysis results	In order to evaluate the effectiveness of actions implemented to address risks. Cf. sub-clause 6.1
283	9.1.3 f	Use analysis results	In order to evaluate the effectiveness of actions taken to address opportunities. Cf. sub-clause 6.1
284	9.1.3 g	Use analysis results	In order to evaluate the performance of external providers. Cf. sub-clause 8.4
285	9.1.3 h	Use analysis results	In order to evaluate the need for improvements to the QMS. Cf. sub-clause 10.1
	9.2	Internal audit
	9.2.1	General
286	9.2.1 a 1	Conduct regularly planned internal audits	In order to determine whether the QMS meets internal company requirements. Cf. ISO 19011
287	9.2.1 a 2	Conduct regularly planned internal audits	In order to determine whether the QMS meets requirements of the ISO 9001 standard
288	9.2.1 b	Conduct regularly planned internal audits	In order to determine whether the QMS is effectively implemented and maintained
	9.2.2	Programme d'audit interne
289	9.2.2	Plan, establish, implement and update an audit program	Include the frequency, methods, responsibilities, planning requirements (audit program) and reporting requirements (audit report)
290	9.2.2	Take into account in the audit program 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
291	9.2.2 a	Define the scope and audit criteria	Limit the area to be audited; use specific and known by the auditee criteria
292	9.2.2 b	Select auditors	Do not audit your department. "No one is judge in his own case". Latin proverb
293	9.2.2 c	Communicate audit results to management concerned	Cf. sub-clause 7.4
294	9.2.2 d	Undertake a correction quickly and corrective actions if necessary	Cf. sub-clause 10.2
295	9.2.2	Keep documented information available on the audit program and the audit reports	As evidence. Cf. sub-clause 7.5
	9.3	Management review
	9.3.1	General
296	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
297	9.3.2 a	Plan and carry out the management review	Regarding the status of actions of the previous review
298	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
299	9.3.2 c	Carry out the management review taking into account the changes in needs and expectations of stakeholders	That are relevant to the QMS
300	9.3.2 d 1	Take into account the information on the performance of the QMS and trends	Concerning nonconformities and correctives actions, cf. sub-clause 10.2
301	9.3.2 d 2	Take into account the information on the performance of the QMS and trends	Concerning inspection results. Cf. sub-clause 9.1 Process performance and conformity of outputs. Cf. sub-clause 9.1
302	9.3.2 d 3	Take into account the information on the performance of the QMS and trends	Concerning audit results. Cf. sub-clause 9.2
303	9.3.2 d 4	Take into account the information on the performance of the QMS and trends	Concerning customer satisfaction and feedback from relevant stakeholders
304	9.3.2 d 5	Take into account the information on the performance of the QMS and trends	Concerning the extent to which quality objectives have been met, cf. sub-clause 6.2
305	9.3.2 d 6	Take into account the information on the performance of the QMS and trends	Concerning process performance and conformity of products and services
306	9.3.2 d 7	Take into account the information on the performance of the QMS and trends	Performance of external providers. Cf. sub-clause 8.4
307	9.3.2 e	Take into account the improvement opportunities	Implemented to address opportunities. Cf. sub-clause 6.1
308	9.3.2 f	Take into account the adequacy of resources	And availability of resources. Cf. sub-clause 7.1
309	9.3.2 g	Take into account the effectiveness of actions taken to address risks	Cf. sub-clause 6.1.2
310	9.3.2 h	Take into account the effectiveness of actions taken to address opportunities improvement opportunities	Cf. sub-clause 6.1.3
	9.3.3	Management review results
311	9.3.3	Include decisions regarding opportunities for continual improvement in the management review results	Cf. sub-clause 10.1
312	9.3.3	Include decisions regarding eventual changes to the QMS	Cf. sub-clause 6.3
313	9.3.3	Include decisions regarding new resource needs	Cf. sub-clause 7.1
314	9.3.3	Keep documented information available as evidence of the results of management reviews	Cf. sub-clause 7.5
	10	Improvement	Act
	10.1	Continual improvement
315	10.1	Improve continually the suitability, adequacy and effectiveness of the QMS	In order to enhance customer satisfaction
316	10.1	Consider the results of inspection, analysis, and evaluation of data and information, as well as the results of the management review	In order to determine opportunities
317	10.1	Address these opportunities	As part of continual improvement
318	10.1 a	Include in actions taken	Improving processes, products and services
319	10.1 b	Include in actions taken	Addressing future needs and expectations
320	10.1 c	Include in actions taken	Correcting, preventing or reducing undesired effects. "Where there is a problem, there is potential for improvement". Masaaki Imai
	10.2	Nonconformity and corrective action
321	10.2.1 a 1	React to the nonconformity by taking action to control and correct it	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
322	10.2.1 a 2	React to the nonconformity by dealing with the consequences	Think risk approach
323	10.2.1 b 1	Evaluate the need for action in order to eliminate the cause of the nonconformity by	Reviewing it
324	10.2.1 b 2	Evaluate the need for action in order to eliminate the cause of the nonconformity by	Determining the causes of the nonconformity
325	10.2.1 b 3	Evaluate the need for action in order to eliminate the cause of the nonconformity by	Determining if similar nonconformity exist
326	10.2.1 c	Implement the necessary corrective actions	In order to treat the nonconformity
327	10.2.1 d	Review the effectiveness of any implemented corrective action	In order to check whether the action is finalized
328	10.2.1 e	Update risks and opportunities	Determined during planning, if necessary
329	10.2.1 f	Make changes to the QMS	If necessary
330	10.2.1	Respond proportionally to the effects of the nonconformities	Do not make too much quality
332	10.2.2 a	Keep documented information available as evidence of the nature of the nonconformities	And any actions taken. Cf. sub-clause 7.5
332	10.2.2 a	Keep documented information available as evidence of the results of any corrective action	Cf. sub-clause 7.5