ISO 19443 version 2018 requirements, nuclear safety management systems

23/05/2025

The "ISO 19443 version 2018 Requirements" quiz will help you understand the main requirements of the standard.

The questions (requirements) included in this quiz are 86 of the 444 in the standard, but don't worry. These 86 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 ISO 19443 version 2018

Based on the ISO 9001: 2015 the 444 requirements (verb shall) of clauses 4 to 10 are as follows:

ISO 19443: 2018 requirements
No	Clause	PDCA cycle	Requirement No	Quantity
4	Context of the organization	Plan	1 ÷ 27	27
5	Leadership	Plan, Do, Check, Act	28 ÷ 65	38
6	Planning	Plan	66 ÷ 102	37
7	Support	Do	103 ÷ 157	55
8	Operation	Do	158 ÷ 366	209
9	Performance evaluation	Check	367 ÷ 416	50
10	Improvement	Act	417 ÷ 444	28
Total				444

iso 19443 requirements

ISO 19443 requirements version 2018

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 version 2015 requirements are on a light blue background.

Note 3. Specific ISO 19443 requirements are on beige background and in italics.

ISO 19443 - 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	Cf. Amendment 1: Climate action changes
4	4.1	Include nuclear safety considerations	In external and internal issues
	4.2	Needs and expectations of stakeholders
5	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
6	4.2 b	Clarify the requirements of the stakeholders	Each need and expectation is unique. Aim for a partnership in the long term
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 account the external and internal issues	Cf. sub-clause 4.1
10	4.3 b	Take into account the requirements of the stakeholders	Cf. sub-clause 4.2
11	4.3 c	Take into account 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	Maintain the scope of the QMS as documented information	Cf. sub-clause 7.5. Include all products and services
14	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
15	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)
16	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
17	4.4.1 a	Determine process inputs and outputs	Process sheet
18	4.4.1 b	Determine the sequence and interaction of processes	Flowchart
19	4.4.1 c	Determine the criteria and methods to control processes	Tools of the quality manager
20	4.4.1 d	Determine and ensure the resources	Needed to support processes. Cf. sub-clause 7.1
21	4.4.1 e	Assign process responsibilities and authorities	Job description of process owners
22	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
23	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
24	4.4.1 h	Determine the improvement opportunities of processes and the QMS	Cf. sub-clause 10.1
25	4.4.2 a	Maintain documented information on process operation	Cf. sub-clause 7.5. The bare essential is sufficient. Use process map
26	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
27	4.4.3	Maintain documented information of how the requirements of the standard are met	For example a quality manual or quality plan
	5	Leadership	Plan , Do, Check, Act
	5.1	Leadership and commitment
	5.1.1	General
28	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
29	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
30	5.1.1 c	Integrate QMS requirements in the internal process requirements	Cf. sub-clause 4.4 and sub-clause 7.1.4
31	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
32	5.1.1 e	Provide the necessary resources for the QMS	Cf. sub-clause 7.1
33	5.1.1 f	Raise awareness on the importance of an effective and conforming QMS	Third quality management principle (engagement of people)
34	5.1.1 g	Ensure the achievement of intended results of the QMS	Essential commitment of top management
35	5.1.1 h	Support the staff contribution to the effectiveness of the QMS	"Employees first, customers second". Vineet Nayar
36	5.1.1 i	Promote continual improvement	Cf. sub-clause 10.3
37	5.1.1 j	Support the leadership of managers	Responsibility and authority of managers are backed at all times by top management
38	5.1.1	Ensure that nuclear safety is taken into account in decision making	And is not compromised by any decision taken
	5.1.2	Customer focus
39	5.1.2 a	Determine and meet customer, statutory and regulatory requirements	Top management demonstrates leadership (assumes its responsibility and commitment) permanently
40	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
41	5.1.2 c	Maintain the objective of better satisfying the customer	First quality management principle (customer focus)
	5.1.3	Nuclear safety culture
42	5.1.3 a	Ensure an appropriate nuclear safety culture by considaration of	Leadership and commitment, cf. sub-clauses 5.1 and 7.3
43	5.1.3 b	Ensure an appropriate nuclear safety culture by considaration of	A balanced, rigorous and prudent approach to decision making with respect to quality, cost and schedule, cf. sub-clause 5.1
44	5.1.3 c	Ensure an appropriate nuclear safety culture by considaration of	Transparency in communication, cf. sub-clause 7.4
45	5.1.3 d	Ensure an appropriate nuclear safety culture by considaration of	The use of suitable documentation, cf. sub-clause 7.5
46	5.1.3 e	Ensure an appropriate nuclear safety culture by considaration of	Reporting of human, technical and organizational issues, cf. sub-clauses 9.3 and 10.2
47	5.1.3 f	Ensure an appropriate nuclear safety culture by considaration of	Lessons learned, cf. sub-clause 10.1
48	5.1.3 g	Ensure an appropriate nuclear safety culture by considaration of	Challenging unsafe acts, behaviours and conditions, cf. sub-clauses 10.2 and 10.3
	5.2	Policy
	5.2.1	Establishing the quality policy
49	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
50	5.2.1 b	Provide a framework to define and review the quality objectives	Cf. sub-clause 6.2
51	5.2.1 c	Include meeting the applicable requirements	Cf. sub-clause 9.1.3
52	5.2.1 d	Include a commitment to continuously improve the QMS	Cf. sub-clause 10.3
53	5.2.1 e	Include appropiate considerations	Related to nuclear safety
54	5.2.1 f	Include a commitment to ensure that nuclear safety is not compromized	By other priorities
	5.2.2	Communicating the quality policy
55	5.2.2 a	Maintain the quality policy as documented information	And make it available inside the company. Cf. sub-clause 7.5
56	5.2.2 b	Communicate the quality policy	So it is understand and applied, cf. sub-clause 7.4
57	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
58	5.3	Define and communicate the responsibilities and authorities	Top management assigns all relevant roles in the QMS
59	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
60	5.3 b	Define and communicate the responsibilities and authorities	Top management assigns all relevant roles so that processes deliver expected results
61	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
62	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)
63	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
64	5.3 a	Appoint a member of the organization's management	Who has the organizational independence and authority to manage nuclear safety and quality issues
65	5.3 b	Appoint a member of the organization's management	Who has unrestricted access to top management
	6	Planning	Plan
	6.1	Actions to address risks and opportunities
66	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
67	6.1.1 b	Take into account opportunities	In order to increase the desirable effects (positive impact)
68	6.1.1 c	Take into account risks	In order to reduce the undesirable effects (negative impacts)
69	6.1.1 d	Take into account risks and opportunities	In order to confirm the approach of continual improvement, cf. sub-clause 10.3
70	6.1.2 a	Plan actions to address risks and opportunities	Take into account risks in every process
71	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
72	6.1.2 b 2	Plan the way to evaluate actions	Follow the results of each action
73	6.1.2	Adapt actions to risks and opportunities	Compared to the potential impact on the conformity of products and services
74	6.1.2	Maintain and retain documentation	On actions to address risks and opportunities, cf. sub-clause 7.5
	6.1.3	*Determination of ITNS items and activities*
75	6.1.3 a	Break down ITNS products and services	Into items and activities
76	6.1.3 b	Determine the items and activities that may jeopardize the products or services safety functions specified by the customer	In line with Licensee's safety classification of Systems, Structures and Components
77	6.1.3	Maintain and retain documentation	Cf. sub-clause 7.5
	6.1.4	*Graded approach to the applicatioin of quality requirements*	Plan
78	6.1.4 a	Grade the application of quality requirements	Taking account of the requirements for ITNS products or services
79	6.1.4 b	Grade the application of quality requirements	Taking account of the complexity of each item or activity
80	6.1.4 c	Grade the application of quality requirements	Taking account of the organizational aspects
81	6.1.4	Maintain and retain documentation	Cf. sub-clause 7.5
	6.2	Quality objectives
82	6.2.1	Establish quality objectives for processes	"He who has no goals will not achieve them". Sun Tzu
83	6.2.1 a	Choose quality objectives	Clarify criteria for setting objectives that are consistent with the quality policy. They should address nuclear safety
84	6.2.1 b	Use measurable objectives	And realistic
85	6.2.1 c	Consider applicable requirements	Cf. sub-clause 4.2
86	6.2.1 d	Adopt relevant objectives	In order to ensure the conformity of products and services and improved customer satisfaction
87	6.2.1 e	Monitor objectives	Frequently. They should address nuclear safety
88	6.2.1 f	Communicate on objectives	At all levels
89	6.2.1 g	Update objectives	During management review, cf. sub-clause 9.3
90	6.2.1	Maintain documented information on the quality objectives	Cf. sub-clause 7.5
91	6.2.2 a	Plan how to do	In order to achieve quality objectives
92	6.2.2 b	Plan necessary resources	In order to achieve quality objectives
93	6.2.2 c	Plan responsibilities	In order to achieve quality objectives
94	6.2.2 d	Plan deadlines	In order to achieve quality objectives
95	6.2.2 e	Plan the way to evaluate results	In order to achieve quality objectives
	6.3	Planning of changes
96	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
97	6.3 a	Plan the changes	Taking into account the purpose of the change and the possible consequences
98	6.3 b	Plan the changes	Taking into account the maintenance of the integrity of the QMS
99	6.3 c	Plan the changes	Taking into account the available resources
100	6.3 d	Plan the changes	Taking into account the assigned responsibilities and authorities
*101*	6.3 e	Plan the changes	Taking into account the communication of changes
*102*	6.3	Manage the changes to the quality management system	In order to ensure nuclear safety is not compromized
	7	Support	Do
	7.1	Resources
	7.1.1	General
103	7.1.1	Provide the necessary resources	In order to support the QMS
104	7.1.1 a	Take into account existing resources	And their capabilities and constrains
105	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
*106*	7.1.1	Ensure that nuclear safety is not compromized	By determination and provisions of resources
	7.1.2	People
107	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
108	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
109	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, non-blaming as psychological factor, , cleanliness as physical factor
	7.1.5	Monitoring and measuring resources
	7.1.5.1	General
110	7.1.5.1	Provide suitable monitoring and measuring resources	In order to obtain expected inspection results
111	7.1.5.1 a	Provide adequate resources to the specific inspections	To inspect is to monitor and measure. Cf. sub-clause 7.2
112	7.1.5.1 b	Maintain resources	In order to ensure fitness for their purpose
113	7.1.5.1	Retain documented information on the adequacy of inspection resources	Cf. sub-clause 7.5
*114*	7.1.5.1	Take into account the measuring range and measurement accuracy	When considering the specified tolerances for the products and services, the suitability of the monitoring and measuring resources
	7.1.5.2	Measurement traceability
115	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
116	7.1.5.2 b	Identify the measuring equipment	In order to monitor the validity of their calibration (or verification)
117	7.1.5.2 c	Protect the measuring equipment	Against activities that may invalidate the results of the measurement (settings or deterioration)
118	7.1.5.2	Conduct corrective action on previous measurement results	When the verification or calibration of a measuring instrument is not in conformity
*119*	7.1.5.2	Retain the outputs of the above determination and actions taken	Cf. sub-clause 7.5.3
	7.1.6	Organizational knowledge
120	7.1.6	Determine the necessary knowledge	In order to control the processes and the conformity of products and services
121	7.1.6	Acquire, maintain and make organizational knowledge available to the extend necessary	In order to maintain the performance of the QMS
122	7.1.6	Take into account the need for additional knowledge	When needs and trends have changed
	7.2	Competence
123	7.2 a	Determine the necessary competence	Clarify quality competence requirements. Identify people who have an influence on the quality performance
124	7.2 b	Ensure the competence	Which are based on appropriate training or experience
125	7.2 c	Undertake activities to acquire the necessary competence and evaluate the effectiveness of these activities	Training, coaching, external providers
126	7.2 d	Retain documented information on staff competence	Cf. sub-clause 7.5
*127*	7.2	Address qualification of persons when necessary	When determining competence
*128*	7.2	Maintain competence and qualification	IBased on appropriate training and experience
	7.3	Awareness
129	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
130	7.3 b	Ensure the staff is aware of the quality objectives	Cf. sub-clause 6.2
131	7.3 c	Ensure the staff is aware of its contribution	In order to improve the performance of the QMS
132	7.3 d	Ensure the staff is aware of negative impacts	If QMS requirements are not met
*133*	7.3	Train the persons involved in the realization of ITNSproducts and services	On the importance of their tasks, such as potential nuclear safety consequences of errors in their activities
	7.4	Communication
134	7.4 a	Define the subjects on which to communicate	Internally and externally. "Good news walks, bad news runs". Swedish proverb
135	7.4 b	Define when to communicate	Respond quickly to claims
136	7.4 c	Define with whom to communicate	Communication goes both ways
137	7.4 d	Define how to communicate	Orally, in writing; Internet, video
138	7.4 e	Assign who will communicate	The one who is closest to the subject
	7.5	Documented information
	7.5.1	General
139	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 manual (sub-clause 5.2) quality policy (sub-clause 5.2.2 a) risk management (sub-clause 6.1) ITNS items and activities (sub-clause 6.1.3) graded approach (sub-clause 6.1.4) quality objectives (sub-clause 6.2.1) operational control (sub-clause 8.1) processes control (sub-clause 8.1) design and development controls (§ 8.3.4) external providers (§ 8.4.1) nonconforming outputs (§ 8.7) Documented information to retain (records): issues (§ 4.1) stakeholders (§ 4.2) process performance (sub-clause 4.4.2 b) job descriptions (§ 5.3) risks (§ 6.1) ITNS items and activities (§ 6.1.3) graded approach (§ 6.1.4) fitness for purpose of inspection resources (sub-clause 7.1.5.1) action plans (§ 7.1.5.2) staff competence (sub-clause 7.2) communication (§ 7.4) effectiveness of the QMS (sub-clause 7.5.1) list of documents (§ 7.5.1) calibration (sub-clause 7.1.5.2) documents of external origin (§ 7.5.3.2) protection (§ 7.5.3.2) 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 activities (§ 8.3.1) design and development requirements (§ 8.3.2) 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 testing (§ 8.3.4.1) 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) monitoring and measuring activities (§ 8.5.1.2) identification and 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 outputs (sub-clause 9.3.3) nonconformities, actions and results (sub-clause 10.2.2) Policy: quality policy (sub-clause 5.2)
140	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
141	7.5.2 a	Create, identify and describe the documented information	Codification, title, author, subject, product
142	7.5.2 b	Choose the format and the media of the documented information	Language, graphics; paper, electronic
143	7.5.2 c	Review and approve the adequacy of the documented information	Who writes, codifies, who approves
*144*	7.5.2	Ensure the completeness and accuracy of the translation	Where translation is required
*145*	7.5.2	Perform review and approval	By competent and authorized individuals
*146*	7.5.2	Determine when the review shall be performed	By individuals different from the authors
	7.5.3	Control of documented information
147	7.5.3.1 a	Control the availability of the documented information	Where and when required in a form that is suitable for use
148	7.5.3.1 b	Control the protection of the documented information	Loss of confidentiality, loss of integrity, misuse
*149*	7.5.3.1	Control that documentation is adequately traceable	And authenticated
150	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
151	7.5.3.2 b	Control the storage of the documented information	Including preservation, protection and readability
152	7.5.3.2 c	Control the changes of the documented information	Use of updated versions, restricted access to obsolete versions
153	7.5.3.2 d	Control the retention time and the removal of the documented information	Retention period, disposal method
154	7.5.3.2	Control the documented information of external origin	Unique codification, access, protection
155	7.5.3.2	Protect the documented information	Who has the right to read, who has the right to change
*156*	7.5.3.2	Made personnel aware of changes	To documentation
*157*	7.5.3.2	Prevent the unintended use	Of obsolete documents
	8	Operation	Do
	8.1	Operational planning and control
158	8.1 a	Plan and determine the requirements for the products and services	By controlling processes. Cf. sub-clauses 4.4 et 6.1
159	8.1 b 1	Establish the criteria	For processes
160	8.1 b 2	Establish the criteria	For the acceptance of conforming products and services
161	8.1 c	Determine necessary resources	Needed to achieve conformity of products and services
162	8.1 d	Control the processes	In accordance with the criteria of sub-clauses 8.1 b 1 and 8.1 b 2
163	8.1 e 1	Determine, maintain and Retain documented information on process control	To have confidence that the process results are as expected. Cf. sub-clause 7.5
164	8.1 e 2	Determine, maintain and Retain documented information on product and service conformity	Meet applicable requirements. Cf. sub-clause 7.5
165	8.1	Adapt planning outputs to internal operating modes	Cf. sub-clauses 4.4 and 6.1
166	8.1	Control planned and unplanned changes	Analyse the consequences of unplanned changes, actions to limit the effects
167	8.1	Control the outsourced processes	Cf. sub-clause 8.4
*168*	8.1	Consider project and configuration management aspects	In operational planning and control
*169*	8.1	Take into account schedule and interface management	When considering the above requirements
	8.1.1	Provisions for counterfeit, fraudulent or suspect (CFS) items
*170*	8.1.1 a	Prevent CFS items at all levels of operation	Including selection of external providers, cf. sub-clause 8.4.1
*171*	8.1.1 b	Prevent CFS items at all levels of operation	Including specific information to external providers, cf. sub-clause 8.4.3 and requirements for control of their sub tier providers
*172*	8.1.1 c	Prevent CFS items at all levels of operation	Including control of externally provided processes, products and services, cf. sub-clause 8.4.2
*173*	8.1.1 d	Prevent CFS items at all levels of operation	Including monitoring and measurement activities, cf. sub-clause 8.5.1.2
*174*	8.1.1	Manage CFS items, when detected, as nonconformities	And inform relevant parties, including the customer without delay, cf. sub-clause 10.2
	8.2	Requirements for products and services
	8.2.1	Customer communication
175	8.2.1 a	Provide information to customers	Related to products and services
176	8.2.1 b	Control communication with customers	Related to contracts, orders, changes and consultations
177	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
178	8.2.1 d	Control communication with customers	Regarding their property. Cf. sub-clause 8.5.3
179	8.2.1 e	Control communication with customers	Regarding specific requirements for contingency actions
*180*	8.2.1 f	Control communication with customers	Including managing the interfaces with external parties
	8.2.2	Determining the requirements related to products and services
181	8.2.2 a 1	Develop specific activities for products and services	In order to clarify statutory and regulatory requirements
182	8.2.2 a 2	Define internal requirements	Related to processes, products and services. And check that the requirements can be met
183	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
184	8.2.3.1	Be able to respond to customers	Regarding requirements of proposed products and services
185	8.2.3.1 a	Review explicit customer requirements	Before order acceptance. Including delivery and post-delivery activities requirements
186	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
187	8.2.3.1 c	Review internal requirements	Between requirements of an order and those previously expressed
188	8.2.3.1 d	Review statutory and regulatory requirements	Applicable to the products and services
189	8.2.3.1 e	Review gaps	Between requirements of an order (or contract) and those previously expressed
190	8.2.3.1	Resolve gaps	Before order acceptance and commitment to provide products and services
*191*	8.2.3.1	Involve in the review all rlevant functional groups associated with the supply of the products or services	Such as design, procurement, manufacture, quality, inspection and test
192	8.2.3.1	Confirm requirements before accepting an order	When requirements are not documented
193	8.2.3.2 a	Retain documented information on the results of the reviews of requirements	Cf. sub-clause 7.5
194	8.2.3.2 b	Retain documented information on any new or changed requirement for the products and services	Cf. sub-clause 7.5
*195*	8.2.3.2 c	Retain documentation on the actions taken	As the results of the review, cf. sub-clause 8.2.3.2 a
	8.2.4	Changes to requirements for products and services
196	8.2.4	Communicate changes to relevant persons	After changing requirements in the documented information
*197*	8.2.4	Manage properly changes to requirements	For products and services, cf. sub-clauses 8.2.2 and 8.2.3
	8.3	Design and development of products and services
	8.3.1	General
198	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
*199*	8.3.1	Identify the internal and external design interfaces and associated controls	For the design and development process
*200*	8.3.1	Document and detail enough the design and development activities to demonstrate that the products or services meet the requirements for their specific intended use or application	To avoid ambiguity or misunderstanding
*201*	8.3.1	Demonstrate that design tools are fit for purpose	Such as computation codes or computerized models
	8.3.2	Design and development planning
202	8.3.2 a	Plan the design and development stages	Taking into account the specificity of design and development activities
203	8.3.2 b	Plan the design and development stages	Taking into account the process requirements and applicable reviews
204	8.3.2 c	Plan the design and development stages	Taking into account the verification and validation activities
205	8.3.2 d	Plan the design and development stages	Taking into account the necessary responsibilities and authorities
206	8.3.2 e	Plan the design and development stages	Taking into account the needs of internal and external resources
207	8.3.2 f	Plan the design and development stages	Taking into account the relations between persons participating in the design and development
208	8.3.2 g	Plan the design and development stages	Taking into account the need for involvement of customers and users
209	8.3.2 h	Plan the design and development stages	Taking into account the requirements for subsequent products and services
210	8.3.2 i	Plan the design and development stages	Taking into account the level of control expected by stakeholders
211	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
*212*	8.3.2	Identify those stages requiring authorization before progressing to the next stage	For the required process stages, including applicable design and development reviews
	8.3.3	Design and development inputs
213	8.3.3	Determine essential requirements	On specific types of products and services from design and development
214	8.3.3 a	Determine functional requirements	Taking into account also the performance requirements
215	8.3.3 b	Clarify inputs	Taking into account the information from similar activities
216	8.3.3 c	Clarify inputs	Taking into account the statutory and regulatory requirements
217	8.3.3 d	Clarify inputs	Taking into account the corporate culture, internal rules of art
218	8.3.3 e	Clarify inputs	Taking into account the potential consequences of product and service failure
219	8.3.3	Check that the input items are complete and unambiguous	In order to realize suitable design and development process
220	8.3.3	Resolve potential conflicts between inputs	In order to obtain complete and unambiguous inputs
221	8.3.3	Retain documented information on design and development inputs	Cf. sub-clause 7.5
	8.3.4	Design and development controls
222	8.3.4 a	Define clearly the expected results	Regarding processes, products and services
223	8.3.4 b	Conduct reviews as planned	Regarding processes, products and services
224	8.3.4 c	Check that outputs meet input requirements	Cf. sub-clause 8.3.5
225	8.3.4 d	Validate products and services	To ensure that the specified application requirements or those for the intended use are satisfied
226	8.3.4 e	Take actions in response to identified problems	During reviews, verifications and validations
227	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
*228*	8.3.4	Include authorization to progress to the next stage	In the reviews, cf. sub-clause 8.3.2 b
*229*	8.3.4	Perform verification and validation of design and development	By competent persons different from those having performed the design
*230*	8.3.4	Maintain documentation for design and development controls	Cf. sub-clause 7.5
	8.3.4.1	Design and development verification and validation testing
*231*	8.3.4.1 a	Plan, perform, control, review and document tests to ensure	Test plans and specifications identify the products or services being tested and resources being used
*232*	8.3.4.1 b	Plan, perform, control, review and document tests to ensure	Test plans and specifications define test objectives and conditions, parameters to be recorded and relevant acceptance criteria
*233*	8.3.4.1 c	Plan, perform, control, review and document tests to ensure	Test procedures describe the method of operation, the performance and the results
*234*	8.3.4.1 d	Plan, perform, control, review and document tests to ensure	Correct configuration of the products or services tested
*235*	8.3.4.1 e	Plan, perform, control, review and document tests to ensure	Requirements of the test plan and procedures are met
*236*	8.3.4.1 f	Plan, perform, control, review and document tests to ensure	Acceptance criteria are met
	8.3.5	Design and development outputs
235	8.3.5 a	Ensure that outputs meet input requirements	Cf. sub-clause 8.3.3
236	8.3.5 b	Ensure that outputs are in line with the subsequent processes	Regarding the products and services
237	8.3.5 c	Ensure that outputs include monitoring and measuring requirements	Including acceptance criteria
238	8.3.5 d	Ensure that outputs are suitable for their intended use	Proper use or planned by the customer in complete safety
239	8.3.5	Retain documented information on outputs	Cf. sub-clause 7.5
*240*	8.3.5 e	Ensure that design and development outputs specify the conditions under which commercial grade items or activities can be used	As ITNS items or activities
	8.3.6	Design and development changes
241	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
242	8.3.6 a	Retain documented information on changes	Cf. sub-clause 7.5
243	8.3.6 b	Retain documented information on results of reviews	Cf. sub-clause 7.5
244	8.3.6 c	Retain documented information on who authorized the changes	Cf. sub-clause 7.5
245	8.3.6 d	Retain documented information on actions	In order to prevent negative impacts. Cf. sub-clause 7.5
*246*	8.3.6	Include substantiation of design and development	In the documentation, cf. sub-clause 7.5
*247*	8.3.6	Designate the personnel involved in the design and development changes competent in the specific design area	And have knowledge of the requirements and the intent of the original design
	8.4	External providers
	8.4.1	General
248	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
249	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
250	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
251	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
252	8.4.1	Establish and implement evaluation and selection criteria of external providers and monitor their performance	Including regular re-evaluation
253	8.4.1	Retain documented information on the results of the evaluation and monitoring	Cf. sub-clause 7.5
*254*	8.4.1	Consider any level of the supply chain for controls to be applied to externally provided processes	And take into account the graded approach outputs, cf. sub-clause 6.1.4
*255*	8.4.1	Be responsible for demonstrating equivalence of provisions taken when an external provider, responsible for an ITNS items or activities	Cannot demonstrate its quality management system meets the requirements of ISO 19443
*256*	8.4.1	Ensure that the result of evaluation of external providers is valid	For a limited period of time and a stated scope
*257*	8.4.1	Maintain and retain documentation	Related to control of external providers, cf. sub-clause 7.5
	8.4.2	Type and extent of control
258	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
259	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
260	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!
261	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
262	8.4.2 c 2	Take into account the control of the external provider	And effectiveness of this control
263	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
*264*	8.4.2	Define and implement the responsibilities and authorities	For control of externally provided processes, products or services
*265*	8.4.2	Include appropriate control of the supply chain	Related to controls applied by external provider, cf. sub-clause 8.4.2 c 2
*266*	8.4.2	Consider the critical characteristics of commercial grade items or activities	Related to the verification, cf. sub-clause 8.4.2 d
*267*	8.4.2	Be responsible for the conformity of all externally provided processes	And products and sevices
	8.4.3	Information for external providers
268	8.4.3	Check the adequacy of the requirements	And only after communicate them to the external provider
269	8.4.3 a	Communicate to external providers the requirements	Regarding the processes, products and services to provide
270	8.4.3 b 1	Communicate to external providers the requirements	Regarding the approval of products and services
271	8.4.3 b 2	Communicate to external providers the requirements	Regarding the approval of methods, processes and equipment
272	8.4.3 b 3	Communicate to external providers the requirements	Regarding the approval of the release of products and services
273	8.4.3 c	Communicate to external providers the requirements	Regarding the competence (including required qualifications)
274	8.4.3 d	Communicate to external providers the requirements	Regarding the relations between the external provider and the company
275	8.4.3 e	Communicate to external providers the requirements	Regarding the control and monitoring of the external provider's performance
276	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
*277*	8.4.3 a 1	Include also	Associated QMS requirements
*278*	8.4.3 a 2	Include also	Technical specifications, such as instructions and acceptance criteria
*279*	8.4.3 a 3	Include also	List of applicable documentation such as drawings, codes, standards, regulations (with reference, revision, status)
*280*	8.4.3 a 4	Include also	Identification of the documentation that the external provider must submit
*281*	8.4.3 a 5	Include also	Identification of spare parts and how to order these parts
*282*	8.4.3 b 1	Include also	The requirements for approval of products and services and their documentation
*283*	8.4.3 d 1	Include also the need for the external provider to	Notify the organization of nonconforming products and services including ITNS items
*284*	8.4.3 d 2	Include also the need for the external provider to	Obtain the organization's approval for nonconforming products and services disposition
*285*	8.4.3 d 3	Include also the need for the external provider to	Notify the organization of changes in products and services, of sub external providers, of manufacturing facility location and, where required, to obtain the organization's approval
*286*	8.4.3 d 4	Include also the need for the external provider to	Provide access to the organization, its customers, third party organizations, regulatory bodies, relevant areas of all facilities, at any level of the supply chain and to all relevant information
*287*	8.4.3	Communicate to external providers its requirements	For passing down relevant requirements to all levels of its supply chain
*288*	8.4.3	Review its requirements for adequacy prior to communication to external provider	Ensuring cascadingof relevant customer requirements
*289*	8.4.3	Submit procurement changes affecting the requirements	To the same process and control as used in production of the original requirements
*290*	8.4.3	Retain relevant documentation	Cf. sub-clause 7.5
	8.5	Production and service provision
	8.5.1	Control of production and service provision
291	8.5.1	Apply controlled conditions of production and service provision	Including delivery and post-delivery activities
292	8.5.1 a 1	Save documented information of specifications of products and services and the expected activities	Cf. sub-clause 7.5
293	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
294	8.5.1 b	Include in the controlled conditions the inspection resources	Cf. sub-clause 7.1.5
295	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
296	8.5.1 d	Include in the controlled conditions adequate infrastructure and environment	Cf. sub-clauses 7.1.3 et 7.1.4
297	8.5.1 e	Include in the controlled conditions the staff competence	Including the necessary qualification, cf. sub-clause 7.2
298	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
299	8.5.1 g	Include in the controlled conditions the actions to prevent human error	Use tools such as Poka-Yoke
300	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
*301*	8.5.1 i	Include in the controlled conditions customer and applicable statutory and regulatory requirements	Related to monitoring and measurement activities, cf. sub-clause 8.5.1.2
*302*	8.5.1 j	Include in the controlled conditions evidence that all production and monitoring and measurement activities have been completed as planned	Or otherwise are authorized and documented, cf. sub-clause 8.1 e
*303*	8.5.1 k	Include in the controlled conditions top management involvement to ensure that product conformity and on-time delivery performance are measured	And that appropriate action is taken if planned results are not achieved, while, at the same time, ensuring that nuclear safety is not compromized
*304*	8.5.1	Take into account the graded approach outputs	Related to controlled conditions, cf. sub-clause 6.1.4
	8.5.1.1	Control of product equipment
*305*	8.5.1.1	Validate and maintain computer controlled aided production equipment	Prior to release for production
*306*	8.5.1.1	Define storage requirements for production equipment or tooling in storage	Including periodic preservation/condition monitoring
	8.5.1.2	Monitoring and measurement activities
*307*	8.5.1.2	Take into account the gaded approach outputs	Related to provisions and methods used for monitoring and measurement activities
*308*	8.5.1.2	Perform ITNS items and activities, monitoring and measurement intended for product acceptance	By competent persons different from those who performed the work
*309*	8.5.1.2 a	Retain documentation and identify, as a minimum	Item inspected
*310*	8.5.1.2 b	Retain documentation and identify, as a minimum	Monitoring or measurement performed
*311*	8.5.1.2 c	Retain documentation and identify, as a minimum	Date of performance
*312*	8.5.1.2 d	Retain documentation and identify, as a minimum	Identification of personnel who performed
*313*	8.5.1.2 e	Retain documentation and identify, as a minimum	Reference of the documentation used
*314*	8.5.1.2 f	Retain documentation and identify, as a minimum	Acceptance criteria
*315*	8.5.1.2 g	Retain documentation and identify, as a minimum	Acceptability
*316*	8.5.1.2 h	Retain documentation and identify, as a minimum	Follow-up actions, including results on actions taken in connection with nonconformities
	8.5.2	Identification and traceability
317	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
318	8.5.2	Inspect processes throughout the production and service provision	In order to identify the status of process outputs
319	8.5.2	Control the traceability of process outputs	When traceability is a requirement, the unique identification is used
320	8.5.2	Retain documented information on traceability	Cf. sub-clause 7.5. When traceability is a requirement, the unique identification of outputs is used
*321*	8.5.2	Ensure that when identification marks and labels are used	They do not prejudice product conformity
*322*	8.5.2	Establish appropriate controls for the media when used for identification of persons	Including clear identification of the user by means of stamps or electronic signatures
	8.5.3	Property belonging to customers or external providers
323	8.5.3	Exercise care with property owned by customer or external provider	During its use or protection
324	8.5.3	Identify, check, protect, monitor and safeguard customer or external provider property	When used or incorporated with updated labels
325	8.5.3	Notify the customer or external provider when his property has been damaged or lost and retain the documented information on the situation	Following incorrect or improper use. Cf. sub-clause 7.5.
	8.5.4	Preservation
326	8.5.4	Preserve the process outputs throughout production and service provision activities	Some examples of preservation methods: identification, packaging, handling, storage, transport, protection
*327*	8.5.4 a	Consider for the preservation of ITNS products deterioration which may compromize their intended use	Access limitation to avoid undue intervation
*328*	8.5.4 b	Consider for the preservation of ITNS products deterioration which may compromize their intended use	Cleaning
*329*	8.5.4 c	Consider for the preservation of ITNS products deterioration which may compromize their intended use	Prevention, detection and removal of foreign objects
*330*	8.5.4 d	Consider for the preservation of ITNS products deterioration which may compromize their intended use	Special handling for sensitive products or hazardous materials
*331*	8.5.4 e	Consider for the preservation of ITNS products deterioration which may compromize their intended use	Identification and labeling, including safety warnings
	8.5.5	Post-delivery activities
332	8.5.5	Meet the requirements for post-delivery activities	Examples of post-delivery activities: exchange new product, maintenance, recycling, final disposal
333	8.5.5 a	Take into account statutory and regulatory requirements	Cf. sub-clause 4.2
334	8.5.5 b	Take into account negative impacts related to products and services	These are consequences of potential risks
335	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
336	8.5.5 d	Take into account the requirements of the stakeholders	And customers especially
337	8.5.5 e	Take into account customer feedback	From stakeholders, when the extent of post-delivery activities has been clarified
*338*	8.5.5 f	Take actions when problems are detected after deliver	Including investigation and reporting
	8.5.6	Control of changes
339	8.5.6	Review and control unplanned changes	Cf. sub-clause 6.3 (planned changes)
340	8.5.6	Retain 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
341	8.6	Check products and services with activities at appropriate stages	"Inspection does not improve quality, nor guarantee quality". Edwards Deming
342	8.6	Release products and services after verification of conformity	Unless written approval (concession) by a competent authority or client
343	8.6	Retain documented information on the release of products and services	Cf. sub-clause 7.5.
344	8.6 a	Include in the documented information evidence of conformity	These are the results of inspections compared to the acceptance criteria
345	8.6 b	Include in the documented information the traceability of products and services	Including the person having authorized the release
*346*	8.6 c	Include in the documentation statement of conformity	Cf. sub-clause 7.5
*347*	8.6	Ensure that all required documentation to accompany the products and services	Is present at delivery. Cf. sub-clause 7.5
	8.7	Control of nonconforming outputs
348	8.7.1	Identify and treat nonconforming process, products and services outputs	Marking and isolation to prevent unintended use or mixing with conforming outputs
349	8.7.1	Carry out corrective actions commensurate to impacts	Including after delivery. Cf. sub-clause 10.2
350	8.7.1	Carry out corrective actions on post-delivery activities	Cf. sub-clause 8.5.5
351	8.7.1 a	Handle nonconforming outputs with corrections	Repeat work, retouching, repair, recycling
352	8.7.1 b	Handle nonconforming outputs by segregation	Including customer returns or products and services not released
353	8.7.1 c	Inform the customer	Cf. sub-clause 7.4
354	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
355	8.7.1	Verify conformity to the requirements	When nonconforming outputs are corrected
*356*	8.7.1 e	Take actions necessary to contain the effect of the nonconformity	On other processes or products
*357*	8.7.1 f	Handle nonconforming outputs	When no other solution, scrap them
*358*	8.7.1 c	Include those nonconformities	To be reported to the customer
*359*	8.7.1 d	Request customer approval	For a "use-as-is" or repair justification
*360*	8.7.1	Handle nonconforming outputs for ITNS items and activities	By taking into account sub-clauses 8.7 b, c and e
*361*	8.7.1	Maintain documentation for the control of nonconforming outputs	Cf. sub-clause 7.5
362	8.7.2 a	Retain documented information on the description of nonconformities	Cf. sub-clause 7.5
363	8.7.2 b	Retain documented information on implemented actions	Cf. sub-clause 7.5
364	8.7.2 c	Retain documented information on approved concessions	Cf. sub-clause 7.5
365	8.7.2 d	Retain documented information on the person having decided the handling of the nonconformities	Cf. sub-clause 7.5
*366*	8.7.2	Include justifications	For sub-clauses 8.7.2 b and c
	9	Performance evaluation	Check
	9.1	Monitoring, measurement, analysis and evaluation
	9.1.1	General
367	9.1.1 a	Determine what is necessary to inspect	"If you can’t measure it, you can’t manage it". Peter Drucker
368	9.1.1 b	Determine the methods for inspection, analysis and evaluation	In order to ensure valid results
369	9.1.1 c	Determine when to inspect	At key stages (essential) or upon the customer's request
370	9.1.1 d	Determine when to analyse and evaluate inspection results	When that brings added value
371	9.1.1	Evaluate the performance and effectiveness of the QMS	In order to ensure that specified requirements are met
372	9.1.1	Retain documented information on the inspection results	Cf. sub-clause 7.5
*373*	9.1.1	Consider demonstration of conformity to products and services requirements	And the ability of the processes to achieve planned results
	9.1.2	Customer satisfaction
374	9.1.2	Regularly monitor customer perception about their level of satisfaction	"The only measure of quality is customer satisfaction"
375	9.1.2	Determine methods for obtaining and using customer information	Satisfaction surveys, claims, customer returns, recommendations
	9.1.3	Analysis and evaluation
376	9.1.3	Analyse and evaluate inspection data	"Get the facts, analyze them and then do what seems right". Robert Waterman
377	9.1.3 a	Use analysis results	In order to evaluate how requirements are met. Cf. sub-clause 4.2
378	9.1.3 b	Use analysis results	In order to evaluate the level of customer satisfaction. Cf. sub-clause 9.1.2
379	9.1.3 c	Use analysis results	In order to evaluate the performance and effectiveness of the QMS
380	9.1.3 d	Use analysis results	In order to evaluate the effectiveness of planning. Cf. sub-clause 8.1
381	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
382	9.1.3 f	Use analysis results	In order to evaluate the performance of external providers. Cf. sub-clause 8.4
383	9.1.3 g	Use analysis results	In order to evaluate the improvement opportunities of the QMS. Cf. sub-clause 10.3
*384*	9.1.1	Use analysis results	In order to apply nuclear safety culture aspects
	9.2	Internal audit
385	9.2.1 a 1	Conduct regularly planned internal audits	In order to determine whether the QMS meets internal company requirements. Cf. ISO 19011
386	9.2.1 a 2	Conduct regularly planned internal audits	In order to determine whether the QMS meets requirements of the ISO 9001 standard
387	9.2.1 b	Conduct regularly planned internal audits	In order to determine whether the QMS is effectively implemented and maintained
*388*	9.2.1 3	Conduct regularly planned internal audits	Also apply customer requirements
389	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)
390	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
391	9.2.2 b	Define the scope and audit criteria	Limit the area to be audited; use specific and known by the auditee criteria
392	9.2.2 c	Select auditors	Do not audit your department. "No one is judge in his own case". Latin proverb
393	9.2.2 d	Communicate audit results to management concerned	Cf. sub-clause 7.4
394	9.2.2 e	Undertake a correction quickly and corrective actions if necessary	Cf. sub-clause 10.2
395	9.2.2 f	Retain documented information on the audit programme and the audit reports	Cf. sub-clause 7.5
*396*	9.2.2	Qualify auditors	Train auditors, cf. sub-clause 7.2
*397*	9.2.2	Do not allow auditors to audit that they have undertaken	Do not audit your department. "No one is judge in his own case". Latin proverb
	9.3	Management review
	9.3.1	General
398	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"
*399*	9.3.1	Ensure nuclear safety receives the attention	Warranted by its significance
	9.3.2	Management review inputs
400	9.3.2 a	Plan and carry out the management review	Regarding the status of actions of the previous review
401	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
402	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
403	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
404	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
405	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
406	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
407	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
408	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
409	9.3.2 d	Take into account resources	Availability of resources. Cf. sub-clause 7.1
410	9.3.2 e	Take into account the effectiveness of actions	Implemented to address risks and opportunities. Cf. sub-clause 6.1
411	9.3.2 f	Take into account improvement opportunities	Continual improvement. Cf. sub-clause 10.3
*412*	9.3.2	Include lessons learned from nuclear experience	Related to opportunities, cf. sub-clause 9.3.2 f
	9.3.3	Management review outputs
413	9.3.3 a	Include decisions regarding opportunities for continual improvement in the outputs of the management review	Cf. sub-clause 10.3
414	9.3.3 b	Include decisions regarding eventual changes to the QMS in the outputs of the management review	Cf. sub-clause 6.3
415	9.3.3 c	Include decisions regarding new resource needs in the outputs of the management review	Cf. sub-clause 7.1
416	9.3.3	Retain documented information on outputs of the review of management	Cf. sub-clause 7.5
	10	Improvement	Act
	10.1	General
417	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
418	10.1 a	Improve products and services	Support innovation. In order to better meet current requirements and anticipate future requirements
419	10.1 b	Reduce negative impacts	Implementing corrective actions and global prevention (efficient QMS)
420	10.1 c	Improve the results of the QMS	To achieve the objectives of the QMS regarding performance
*421*	10.1 d	Include lessons learned	From experience
*422*	10.1 e	Include risk mitigation	Cf. sub-clause 6.1
*423*	10.1 f	Apply also technical advances	And research and development
*424*	10.1 g	Apply methods	For identifying good practices
*425*	10.1	Provide adequate resources	For improvement plans
*426*	10.1	Share with customers and dissiminate to supply chain organizations relevant learning	From experience
	10.2	Nonconformity and corrective action
427	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
428	10.2.1 a 2	Take into account consequences	Think risk-based approach
429	10.2.1 b 1	Examine the nonconformity	And if necessary decide to carry out a corrective action
430	10.2.1 b 2	Investigate root causes	So that the nonconformity does not happen again
431	10.2.1 b 3	Search for similar nonconformities	In order to apply the same recipe (why reinvent the wheel?)
432	10.2.1 c	Implement the necessary corrective actions	In order to treat the nonconformity
433	10.2.1 d	Review the effectiveness of any implemented corrective action	In order to check whether the action is finalized
434	10.2.1 e	Update risks and opportunities	If necessary
435	10.2.1 f	Make changes to the QMS	If necessary
436	10.2.1	Respond proportionally to nonconformities consequences	Do not make too much quality
*437*	10.2.1	Ensure that nonconformities and corrective actions are managed and reported without undue delay to the relevant level of management	And, as appropriate, to the customer
*438*	10.2.1	Include in the analysis the impact assessment of the nonconformity	Related to sub-clause 10.2.1 b 1
*439*	10.2.1	Undertake root cause analysis, as applicable	Related to sub-clause 10.2.1 b 2
440	10.2.2 a	Retain documented information on the nature of nonconformities	Cf. sub-clause 7.5
441	10.2.2 b	Retain documented information on results of implemented actions	Cf. sub-clause 7.5
	10.3	Continual improvement
442	10.3	Improve continually the performance of the QMS	In order to find improvement opportunities
443	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
*444*	10.3	Encompass nuclear safety culture	Related to continual improvement