ISO 9001 2015 requirements, quality management systems

06/02/2025

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

The questions (requirements) included in this quiz are 60 of the 310 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 2015

The online training (course) T 15v15 ISO 9001 version 2015 readiness and its demo

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

The package of courses T 65v15 training package ISO 9001 version 2015 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 : 2015 requirements
No	Clause	PDCA cycle	Requirement No	Quantity
4	Context of the organization	Plan	1 ÷ 25	25
5	Leadership	Plan, Do, Check, Act	26 ÷ 51	26
6	Planning	Plan	52 ÷ 78	27
7	Support	Do	79 ÷ 121	43
8	Operation	Do	122 ÷ 249	128
9	Performance evaluation	Check	250 ÷ 292	43
10	Improvement	Act	293 ÷ 310	18
Total				310

requirements

ISO 9001 2015 requirements

pdca

The Deming PDCA cycle

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

ISO 9001 - Requirements and comments
No	Clause, sub-clause	Requirement	Comment, link
	4	Context of the organization	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)
3	4.1	Determine whether climate change is a relevant issue	Amendment 1 of ISO 9001: Climate action changes, 02/2024
	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
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	Monitor and review information about stakeholders and their requirements	Before accepting an order
	4.3	Scope of the quality management system
7	4.3	Define the scope of the QMS	Geographic and organizational scope available to stakeholders
8	4.3 a	Take into account the external and internal issues	Cf. sub-clause 4.1
9	4.3 b	Take into account the requirements of the stakeholders	Cf. sub-clause 4.2
10	4.3 c	Take into account the products and services	All products and services proposed by the company without exception
11	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
12	4.3	Maintain the scope of the QMS as a procedure	Cf. sub-clause 7.5. Include all products and services
13	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
14	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)
15	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
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	Maintain process operation as procedures	Cf. sub-clause 7.5. The bare essential is sufficient. Use process map
25	4.4.2	Retain records on process operation	Cf. sub-clause 7.5. The goal is to ensure that processes' results are those planned
	5	Leadership	Plan , Do, Check, Act
	5.1	Leadership and commitment
	5.1.1	General
26	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
27	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
28	5.1.1 c	Integrate QMS requirements in the internal process requirements	Cf. sub-clause 4.4 and sub-clause 7.1.4
29	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
30	5.1.1 e	Provide the necessary resources for the QMS	Cf. sub-clause 7.1
31	5.1.1 f	Raise awareness on the importance of an effective and conforming QMS	Third quality management principle (engagement of people)
32	5.1.1 g	Ensure the achievement of intended results of the QMS	Essential commitment of top management
33	5.1.1 h	Support the staff contribution to the effectiveness of the QMS	"Employees first, customers second". Vineet Nayar
34	5.1.1 i	Promote continual improvement	Cf. sub-clause 10.3
35	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
36	5.1.2 a	Determine and meet customer, statutory and regulatory requirements	Top management demonstrates leadership (assumes its responsibility and commitment) permanently
37	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
38	5.1.2 c	Maintain the objective of better satisfying the customer	First quality management principle (customer focus)
	5.2	Policy
	5.2.1	Establishing the quality policy
39	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
40	5.2.1 b	Provide a framework to define and review the quality objectives	Cf. sub-clause 6.2
41	5.2.1 c	Include meeting the applicable requirements	Cf. sub-clause 9.1.3
42	5.2.1 d	Include a commitment to continuously improve the QMS	Cf. sub-clause 10.3
	5.2.2	Communicating the quality policy
43	5.2.2 a	Maintain the quality policy as a procedure	And make it available inside the company. Cf. sub-clause 7.5
44	5.2.2 b	Communicate the quality policy	So it is understand and applied, cf. sub-clause 7.4
45	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
46	5.3	Define and communicate the responsibilities and authorities	Top management assigns all relevant roles in the QMS
47	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
48	5.3 b	Define and communicate the responsibilities and authorities	Top management assigns all relevant roles so that processes deliver expected results
49	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
50	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)
51	5.3 e	Define and communicate the responsibilities and authorities	Top management assigns all relevant roles so that implemented changes to the QMS do not affect its integrity
	6	Planning	Plan
	6.1	Actions to address risks and opportunities
52	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
53	6.1.1 b	Take into account opportunities	In order to increase the desirable effects (positive impact)
54	6.1.1 c	Take into account risks	In order to reduce the undesirable effects (negative impacts)
55	6.1.1 d	Take into account risks and opportunities	In order to confirm the approach of continual improvement, cf. sub-clause 10.3
56	6.1.2 a	Plan actions to address risks and opportunities	Take into account risks in every process
57	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
58	6.1.2 b 2	Plan the way to evaluate actions	Follow the results of each action
59	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
60	6.2.1	Establish quality objectives for processes	"He who has no goals will not achieve them". Sun Tzu"
61	6.2.1 a	Choose quality objectives	Clarify criteria for setting objectives that are consistent with the quality policy
62	6.2.1 b	Use measurable objectives	And realistic
63	6.2.1 c	Consider applicable requirements	Cf. sub-clause 4.2
64	6.2.1 d	Adopt relevant objectives	In order to ensure the conformity of products and services and improved customer satisfaction
65	6.2.1 e	Monitor objectives	Frequently
66	6.2.1 f	Communicate on objectives	At all levels
67	6.2.1 g	Update objectives	During management review, cf. sub-clause 9.3
68	6.2.1	Maintain the quality objectives as a procedure	Cf. sub-clause 7.5
69	6.2.2 a	Plan how to do	In order to achieve quality objectives
70	6.2.2 b	Plan necessary resources	In order to achieve quality objectives
71	6.2.2 c	Plan responsibilities	In order to achieve quality objectives
72	6.2.2 d	Plan deadlines	In order to achieve quality objectives
73	6.2.2 e	Plan the way to evaluate results	In order to achieve quality objectives
	6.3	Planning of changes
74	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
75	6.3 a	Plan the changes	Taking into account the purpose of the change and the possible consequences
76	6.3 b	Plan the changes	Taking into account the maintenance of the integrity of the QMS
77	6.3 c	Plan the changes	Taking into account the available resources
78	6.3 d	Plan the changes	Taking into account the assigned responsibilities and authorities
	7	Support	Do
	7.1	Resources
	7.1.1	General
79	7.1.1	Provide the necessary resources	In order to support the QMS
80	7.1.1 a	Take into account existing resources	And their capabilities and constrains
81	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
82	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
83	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
84	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
85	7.1.5.1	Provide suitable monitoring and measuring resources	In order to obtain expected inspection results
86	7.1.5.1 a	Provide adequate resources to the specific inspections	To inspect is to monitor and measure. Cf. sub-clause 7.2
87	7.1.5.1 b	Maintain resources	In order to ensure fitness for their purpose
88	7.1.5.1	Retain records on the adequacy of inspection resources	Cf. sub-clause 7.5
	7.1.5.2	Measurement traceability
89	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 the records on the reference used, cf. sub-clause 7.5
90	7.1.5.2 b	Identify the measuring equipment	In order to monitor the validity of their calibration (or verification)
91	7.1.5.2 c	Protect the measuring equipment	Against activities that may invalidate the results of the measurement (settings or deterioration)
92	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
93	7.1.6	Determine the necessary knowledge	In order to control the processes and the conformity of products and services
94	7.1.6	Acquire, maintain and make organizational knowledge available to the extend necessary	In order to maintain the performance of the QMS
95	7.1.6	Take into account the need for additional knowledge	When needs and trends have changed
	7.2	Competence
96	7.2 a	Determine the necessary competence	Clarify quality competence requirements. Identify people who have an influence on the quality performance
97	7.2 b	Ensure the competence	Which are based on appropriate training or experience
98	7.2 c	Undertake activities to acquire the necessary competence and evaluate the effectiveness of these activities	Training, coaching, external providers
99	7.2 d	Retain records on staff competence	Cf. sub-clause 7.5
	7.3	Awareness
100	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
101	7.3 b	Ensure the staff is aware of the quality objectives	Cf. sub-clause 6.2
102	7.3 c	Ensure the staff is aware of its contribution	In order to improve the performance of the QMS
103	7.3 d	Ensure the staff is aware of negative impacts	If QMS requirements are not met
	7.4	Communication
104	7.4 a	Define the subjects on which to communicate	Internally and externally. "Good news walks, bad news runs". Swedish proverb
105	7.4 b	Define when to communicate	Respond quickly to claims
106	7.4 c	Define with whom to communicate	Communication goes both ways
107	7.4 d	Define how to communicate	Orally, in writing; Internet, video
108	7.4 e	Assign who will communicate	The one who is closest to the subject
	7.5	Documentation
	7.5.1	General
109	7.5.1 a	Include the documentation required by the ISO 9001 standard	Documented procedures (documented information to maintain): 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 retain): 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 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)
110	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
111	7.5.2 a	Create, identify and describe the documentation	Codification, title, author, subject, product
112	7.5.2 b	Choose the format and the media of the documentation	Language, graphics; paper, electronic
113	7.5.2 c	Review and approve the adequacy of the documentation	Who writes, codifies, who approves
	7.5.3	Control of documentation
114	7.5.3.1 a	Control the availability of the documentation	Where and when required in a form that is suitable for use
115	7.5.3.1 b	Control the protection of the documentation	Loss of confidentiality, loss of integrity, misuse
116	7.5.3.2 a	Control the distribution, access and use of the documentation	Who is in charge, method to use, rule to follow
117	7.5.3.2 b	Control the storage of the documentation	Including preservation, protection and readability
118	7.5.3.2 c	Control the changes of the documentation	Use of updated versions, restricted access to obsolete versions
119	7.5.3.2 d	Control the retention time and the removal of the documentation	Retention period, disposal method
120	7.5.3.2	Control the documents of external origin	Unique codification, access, protection
121	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
122	8.1 a	Plan and determine the requirements for the products and services	By controlling processes. Cf. sub-clauses 4.4 et 6.1
123	8.1 b 1	Establish the criteria	For processes
124	8.1 b 2	Establish the criteria	For the acceptance of conforming products and services
125	8.1 c	Determine necessary resources	Needed to achieve conformity of products and services
126	8.1 d	Control the processes	In accordance with the criteria of sub-clauses 8.1 b 1 and 8.1 b 2
127	8.1 e 1	Determine, maintain and retain the documentation on process control	To have confidence that the process results are as expected. Cf. sub-clause 7.5
128	8.1 e 2	Determine, maintain and retain the documentation on product and service conformity	Meet applicable requirements. Cf. sub-clause 7.5
129	8.1	Control planned and unplanned changes	Analyse the consequences of unplanned changes, actions to limit the effects
130	8.1	Control the outsourced processes	Cf. sub-clause 8.4
	8.2	Requirements for products and services
	8.2.1	Customer communication
131	8.2.1 a	Provide information to customers	Related to products and services
132	8.2.1 b	Control communication with customers	Related to contracts, orders, changes and consultations
133	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
134	8.2.1 d	Control communication with customers	Regarding their property. Cf. sub-clause 8.5.3
135	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
136	8.2.2 a 1	Develop specific activities for products and services	In order to clarify statutory and regulatory requirements
137	8.2.2 a 2	Define internal requirements	Related to processes, products and services. And check that the requirements can be met
138	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
139	8.2.3.1	Be able to respond to customers	Regarding requirements of proposed products and services
140	8.2.3.1 a	Review explicit customer requirements	Before order acceptance. Including delivery and post-delivery activities requirements
141	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
142	8.2.3.1 c	Review internal requirements	Between requirements of an order and those previously expressed
143	8.2.3.1 d	Review statutory and regulatory requirements	Applicable to the products and services
144	8.2.3.1 e	Review gaps	Between requirements of an order (or contract) and those previously expressed
145	8.2.3.1	Resolve gaps	Before order acceptance and commitment to provide products and services
146	8.2.3.1	Confirm requirements before accepting an order	When requirements are not documented
147	8.2.3.2 a	Retain the recordson on the results of the reviews of requirements	Cf. sub-clause 7.5
148	8.2.3.2 b	Retain the records 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
149	8.2.4	Communicate changes to relevant persons	After changing requirements in the documentation
	8.3	Design and development of products and services
	8.3.1	General
150	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
151	8.3.2 a	Plan the design and development stages	Taking into account the specificity of design and development activities
152	8.3.2 b	Plan the design and development stages	Taking into account the process requirements and applicable reviews
153	8.3.2 c	Plan the design and development stages	Taking into account the verification and validation activities
154	8.3.2 d	Plan the design and development stages	Taking into account the necessary responsibilities and authorities
155	8.3.2 e	Plan the design and development stages	Taking into account the needs of internal and external resources
156	8.3.2 f	Plan the design and development stages	Taking into account the relations between persons participating in the design and development
157	8.3.2 g	Plan the design and development stages	Taking into account the need for involvement of customers and users
158	8.3.2 h	Plan the design and development stages	Taking into account the requirements for subsequent products and services
159	8.3.2 i	Plan the design and development stages	Taking into account the level of control expected by stakeholders
160	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
161	8.3.3	Determine essential requirements	On specific types of products and services from design and development
162	8.3.3 a	Determine functional requirements	Taking into account also the performance requirements
163	8.3.3 b	Clarify inputs	Taking into account the information from similar activities
164	8.3.3 c	Clarify inputs	Taking into account the statutory and regulatory requirements
165	8.3.3 d	Clarify inputs	Taking into account the corporate culture, internal rules of art
166	8.3.3 e	Clarify inputs	Taking into account the potential consequences of product and service failure
167	8.3.3	Check that the input items are complete and unambiguous	In order to realize suitable design and development process
168	8.3.3	Resolve potential conflicts between inputs	In order to obtain complete and unambiguous inputs
169	8.3.3	Retain the records on design and development inputs	Cf. sub-clause 7.5
	8.3.4	Design and development controls
170	8.3.4 a	Define clearly the expected results	Regarding processes, products and services
171	8.3.4 b	Conduct reviews as planned	Regarding processes, products and services
172	8.3.4 c	Check that outputs meet input requirements	Cf. sub-clause 8.3.5
173	8.3.4 d	Validate products and services	To ensure that the specified application requirements or those for the intended use are satisfied
174	8.3.4 e	Take actions in response to identified problems	During reviews, verifications and validations
175	8.3.4 f	Ensure that the records are retained	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
176	8.3.5 a	Ensure that outputs meet input requirements	Cf. sub-clause 8.3.3
177	8.3.5 b	Ensure that outputs are in line with the subsequent processes	Regarding the products and services
178	8.3.5 c	Ensure that outputs include monitoring and measuring requirements	Including acceptance criteria
179	8.3.5 d	Ensure that outputs are suitable for their intended use	Proper use or planned by the customer in complete safety
180	8.3.5	Retain the records on outputs	Cf. sub-clause 7.5
	8.3.6	Design and development changes
181	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
182	8.3.6 a	Retain the records on changes	Cf. sub-clause 7.5
183	8.3.6 b	Retain the records on results of reviews	Cf. sub-clause 7.5
184	8.3.6 c	Retain the records on who authorized the changes	Cf. sub-clause 7.5
185	8.3.6 d	Retain the records on actions	In order to prevent negative impacts. Cf. sub-clause 7.5
	8.4	External providers
	8.4.1	General
186	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
187	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
188	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
189	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
190	8.4.1	Establish and implement evaluation and selection criteria of external providers and monitor their performance	Including regular re-evaluation
191	8.4.1	Retain the records on the results of the evaluation and monitoring	Cf. sub-clause 7.5
	8.4.2	Type and extent of control
192	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
193	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
194	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!
195	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
196	8.4.2 c 2	Take into account the control of the external provider	And effectiveness of this control
197	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
198	8.4.3	Check the adequacy of the requirements	And only after communicate them to the external provider
199	8.4.3 a	Communicate the requirements to the external provider	Regarding the processes, products and services to provide
200	8.4.3 b 1	Communicate the requirements to the external provider	Regarding the approval of products and services
201	8.4.3 b 2	Communicate the requirements to the external provider	Regarding the approval of methods, processes and equipment
202	8.4.3 b 3	Communicate the requirements to the external provider	Regarding the approval of the release of products and services
203	8.4.3 c	Communicate the requirements to the external provider	Regarding the competence (including required qualifications)
204	8.4.3 d	Communicate the requirements to the external provider	Regarding the relations between the external provider and the company
205	8.4.3 e	Communicate the requirements to the external provider	Regarding the control and monitoring of the external provider's performance
206	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
207	8.5.1	Apply controlled conditions of production and service provision	Including delivery and post-delivery activities
208	8.5.1 a 1	Save the records of specifications of products and services and the expected activities	Cf. sub-clause 7.5
209	8.5.1 a 2	Save the records of results to be achieved	Cf. sub-clause 7.5. "A quality control that does not show results is no control". Kaoru Ishikawa
210	8.5.1 b	Include in the controlled conditions the inspection resources	Cf. sub-clause 7.1.5
211	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
212	8.5.1 d	Include in the controlled conditions adequate infrastructure and environment	Cf. sub-clauses 7.1.3 et 7.1.4
213	8.5.1 e	Include in the controlled conditions the staff competence	Including the necessary qualification, cf. sub-clause 7.2
214	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
215	8.5.1 g	Include in the controlled conditions the actions to prevent human error	Use tools such as Poka-Yoke
216	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
217	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
218	8.5.2	Inspect processes throughout the production and service provision	In order to identify the status of process outputs
219	8.5.2	Control the traceability of process outputs	When traceability is a requirement, the unique identification is used
220	8.5.2	Retain the records 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
221	8.5.3	Exercise care with property owned by customer or external provider	During its use or protection
222	8.5.3	Identify, check, protect, monitor and safeguard customer or external provider property	When used or incorporated with updated labels
223	8.5.3	Notify the customer or external provider when his property has been damaged or lost and maintain the records on the situation	Following incorrect or improper use. Cf. sub-clause 7.5.
	8.5.4	Preservation
224	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
225	8.5.5	Meet the requirements for post-delivery activities	Examples of post-delivery activities: exchange new product, maintenance, recycling, final disposal
226	8.5.5 a	Take into account statutory and regulatory requirements	Cf. sub-clause 4.2
227	8.5.5 b	Take into account negative impacts related to products and services	These are consequences of potential risks
228	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
229	8.5.5 d	Take into account the requirements of the stakeholders	And customers especially
230	8.5.5 e	Take into account customer feedback	From stakeholders, when the extent of post-delivery activities has been clarified
	8.5.6	Control of changes
231	8.5.6	Review and control unplanned changes	Cf. sub-clause 6.3 (planned changes)
232	8.5.6	Retain the records 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
233	8.6	Check products and services with activities at appropiate stages	"Inspection does not improve quality, nor guarantee quality". Edwards Deming
234	8.6	Release products and services after verification of conformity	Unless written approval (concession) by a competent authority or client
235	8.6	Retain the records on the release of products and services	Cf. sub-clause 7.5.
236	8.6 a	Include in the records evidence of conformity	These are the results of inspections compared to the acceptance criteria
237	8.6 b	Include in the records the traceability of products and services	Including the person having authorized the release
	8.7	Control of nonconforming outputs
238	8.7.1	Identify and treat nonconforming process, products and services outputs	Marking and isolation to prevent unintended use or mixing with conforming outputs
239	8.7.1	Carry out corrective actions commensurate to impacts	Including after delivery. Cf. sub-clause 10.2
240	8.7.1	Carry out corrective actions on post-delivery activities	Cf. sub-clause 8.5.5
241	8.7.1 a	Handle nonconforming outputs with corrections	Repeat work, retouching, repair, recycling
242	8.7.1 b	Handle nonconforming outputs by segregation	Including customer returns or products and services not released
243	8.7.1 c	Inform the customer	Cf. sub-clause 7.4
244	8.7.1 d	Handle nonconforming outputs by asking authorization	To use in is (acceptance under concession)
245	8.7.1	Check conformity after any correction	After any correction go through the normal flow
246	8.7.2 a	Retain the records on the description of nonconformities	Cf. sub-clause 7.5.
247	8.7.2 b	Retain the records on implemented actions	Cf. sub-clause 7.5.
248	8.7.2 c	Retain the records on approved concessions	Cf. sub-clause 7.5.
249	8.7.2 d	Retain the records 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
250	9.1.1 a	Determine what is necessary to inspect	"If you can’t measure it, you can’t manage it". Peter Drucker
251	9.1.1 b	Determine the methods for inspection, analysis and evaluation	In order to ensure valid results
252	9.1.1 c	Determine when to inspect	At key stages (essential) or upon the customer's request
253	9.1.1 d	Determine when to analyse and evaluate inspection results	When that brings added value
254	9.1.1	Evaluate the performance and effectiveness of the QMS	In order to ensure that specified requirements are met
255	9.1.1	Retain the records on the inspection results	Cf. sub-clause 7.5
	9.1.2	Customer satisfaction
256	9.1.2	Regularly monitor customer perception about their level of satisfaction	"The only measure of quality is customer satisfaction"
257	9.1.2	Determine methods for obtaining and using customer information	Satisfaction surveys, claims, customer returns, recommendations
	9.1.3	Analysis and evaluation
258	9.1.3	Analyse and evaluate inspection data	"Get the facts, analyze them and then do what seems right". Robert Waterman
259	9.1.3 a	Use analysis results	In order to evaluate how requirements are met. Cf. sub-clause 4.2
260	9.1.3 b	Use analysis results	In order to evaluate the level of customer satisfaction. Cf. sub-clause 9.1.2
261	9.1.3 c	Use analysis results	In order to evaluate the performance and effectiveness of the QMS
262	9.1.3 d	Use analysis results	In order to evaluate the effectiveness of planning. Cf. sub-clause 8.1
263	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
264	9.1.3 f	Use analysis results	In order to evaluate the performance of external providers. Cf. sub-clause 8.4
265	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
266	9.2.1 a 1	Conduct regularly planned internal audits	In order to determine whether the QMS meets internal company requirements. Cf. ISO 19011
267	9.2.1 a 2	Conduct regularly planned internal audits	In order to determine whether the QMS meets requirements of the ISO 9001 standard
268	9.2.1 b	Conduct regularly planned internal audits	In order to determine whether the QMS is effectively implemented and maintained
269	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)
270	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
271	9.2.2 b	Define the scope and audit criteria	Limit the area to be audited; use specific and known by the auditee criteria
272	9.2.2 c	Select auditors	Do not audit your department. "No one is judge in his own case". Latin proverb
273	9.2.2 d	Communicate audit results to management concerned	Cf. sub-clause 7.4
274	9.2.2 e	Undertake a correction quickly and corrective actions if necessary	Cf. sub-clause 10.2
275	9.2.2 f	Retain the records on the audit programme and the audit reports	Cf. sub-clause 7.5
	9.3	Management review
	9.3.1	General
276	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
277	9.3.2 a	Plan and carry out the management review	Regarding the status of actions of the previous review
278	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
279	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
280	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
281	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
282	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
283	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
284	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
285	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
286	9.3.2 d	Take into account resources	Availability of resources. Cf. sub-clause 7.1
287	9.3.2 e	Take into account the effectiveness of actions	Implemented to address risks and opportunities. Cf. sub-clause 6.1
288	9.3.2 f	Take into account improvement opportunities	Continual improvement. Cf. sub-clause 10.3
	9.3.3	Management review outputs
289	9.3.3 a	Include decisions regarding opportunities for continual improvement in the outputs of the management review	Cf. sub-clause 10.3
290	9.3.3 b	Include decisions regarding eventual changes to the QMS in the outputs of the management review	Cf. sub-clause 6.3
291	9.3.3 c	Include decisions regarding new resource needs in the outputs of the management review	Cf. sub-clause 7.1
292	9.3.3	Retain the records on outputs of the review of management	Cf. sub-clause 7.5
	10	Improvement	Act
	10.1	General
293	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
294	10.1 a	Improve products and services	Support innovation. In order to better meet current requirements and anticipate future requirements
295	10.1 b	Reduce negative impacts	Implementing corrective actions and global prevention (efficient QMS)
296	10.1 c	Improve the results of the QMS	To achieve the objectives of the QMS regarding performance
	10.2	Nonconformity and corrective action
297	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
298	10.2.1 a 2	Take into account consequences	Think risk-based approach
299	10.2.1 b 1	Examine the nonconformity	And if necessary decide to carry out a corrective action
300	10.2.1 b 2	Investigate root causes	So that the nonconformity does not happen again
301	10.2.1 b 3	Search for similar nonconformities	In order to apply the same recipe (why reinvent the wheel?)
302	10.2.1 c	Implement the necessary corrective actions	In order to treat the nonconformity
303	10.2.1 d	Review the effectiveness of any implemented corrective action	In order to check whether the action is finalized
304	10.2.1 e	Update risks and opportunities	If necessary
305	10.2.1 f	Make changes to the QMS	If necessary
306	10.2.1	Respond proportionally to nonconformities consequences	Do not make too much quality
307	10.2.2 a	Retain records on the nature of nonconformities	Cf. sub-clause 7.5
308	10.2.2 a	Retain records on results of implemented actions	Cf. sub-clause 7.5
	10.3	Continual improvement
309	10.3	Improve continually the performance of the QMS	In order to find improvement opportunities
310	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