1. ------IND- 2016 0294 CZ- EN- ------ 20160705 --- --- PROJET 
II. 
Draft  
 
DECREE  
of … 2016  
on management system requirements  
The State Office for Nuclear Safety stipulates , pursuant to §  236 of Act No .../... Coll., the 
Atomic Act , toward the implementatio n of § 24(7), § 29(7), and § 30(9): 
§ 1 
Subject matter  
This decree incorporates the relevant Euratom legislation1) and regulates  
a) requirements for the management system implementation , maintenance and 
improvement , 
b) the content of manageme nt system documentation and how it is kept , 
c) rules for conducting and managing of the processes and activities , including special 
processes , 
d) management system planning and the scope and method of its documentation , 
e) procedures for implementing changes to the  management system , 
f) rules for assessing the efficiency of the management system , including the processes and 
activities and changes thereto , 
g) non-conformity management procedures , 
h) how the appropriate qualifications of personnel conducting processes and acti vities are 
ensured , 
i) the scope of and method for ensuring permanent development and regular evaluation of 
the safety culture and  
j) content requirements for the management system programme . 
§ 2 
Definitions  
For the purposes of this implement ing decree , the following definitions apply : 
a) process guarantor - an employee who ensures the effective implementation and 
performance of a process and fulfilment of legislative requirements for this process , 
b) verification - a check that processes and activi ties and their inputs and outputs are 
conform with requirements concerning their properties stipulated in the management 
system documentation , 
                                                 
1)  Council Directive 2009/71 /Euratom of 25 June 2009  establishing a Community framework for the 
nuclear safety of nuclear installations . 
Council Directive 2011 /70/Euratom of 19 July 2011 establishing a Community framework for the respons ible 
and safe management of spent fuel and radioactive waste . 
Council Directive 2013 /59/Euratom of 5 December 2013 laying down basic safety standards for protection 
against the dangers arising from exposure to ionising radiation , and repealing Directives 89/618/Euratom , 
90/641/Euratom , 96/29/Euratom , 97/43/Euratom and 2003 /122/Euratom . 
Council Directive 2014 /87/Euratom of 8 July 2014 amending Directive 2009 /71/Euratom establishing a 
Community framework for the nuclear safety of nuclear installations . - 2 - 
c) process role - an employee 's expected behaviour and actions within the scope of a process 
that are intended to ac hieve reliable performance of assigned activities in accordance with 
the individual 's goals pursuant to § 29(1) of the Atomic Act (hereinafter the 'person 
implementing the management system '), 
d) review - an assessment of the suitability , adequacy and efficac y of processes and 
activities and their inputs and outputs from the perspective of nuclear safety , radiation 
protection , technical safety , radiation situation monitoring , handling radiological 
emergencies , and security , 
e) process efficacy indicator - data th at provides the process guarantor with information on 
the efficacy of a process and of the activities it comprises , from the perspective of 
ensuring and increasing nuclear safety , radiation protection , technical safety , radiation 
situation monitoring , hand ling radiological emergencies , and security , 
f) validation - a check whether processes and activities and their inputs and outputs are 
conform with their intended use stipulated in the management system documentation . 
§ 3 
Requirements for management system implementation , maintenance and improvement  
(1) The management system must be introduced , maintained , and improved so that  
a) the objective whose intent is to ensure and increase nuclear safety , radiation protection , 
technical safety , radiation situation monitoring , handling radiological emergencies , and 
security (hereinafter the 'management system objective ') is achieved in an effective 
manner and  
b) all the requirements that may serve to ensure and increase nuclear safety , radiation 
protection , technical safety , radiation situation monitoring , handling radiological 
emergencies , and security (hereinafter the 'integrated requirement ') are met . 
(2) During the decision -making process the person implementing the management system 
must primarily ensure that the management system objectives are achieved . 
(3) The management system processes and activities must be introduced so as to ensure 
the management system objectives are achieved and the integrated requirements are met . 
(4) The management system processes and acti vities must be performed in a planned and 
systematic manner . 
(5) Within a management system  
a) conditions must be created for the maintenance , improvement , and evaluation of the 
management system , including changes thereto , 
b) measures must be introduced to ensure a nd increase nuclear safety , radiation protection , 
technical safety , radiation situation monitoring , handling radiological emergencies , and 
security , 
c) measures must be implemented to ensure that the activities performed by the person 
implementing the managem ent system comply with legislative requirements , 
d) the integrated requirements must be met in mutual accordance to permanently ensure 
nuclear safety , radiation protection , technical safety , radiation situation monitoring , 
handling radiological emergencies , and security , 
e) the integrated requirements must be linked to permanently ensure nuclear safety , 
radiation protection , technical safety , radiation situation monitoring , handling 
radiological emergencies , and security , - 3 - 
f) the management method and the individual management levels must be stipulated within 
the scope of the organizational structure , 
g) the ability to manage employees to ensure and increase nuclear safety , radiation 
protection , technical safety , radiation situation monitoring , handling radiological 
emer gencies , and security (hereinafter 'management ability ') of an employee delegated to 
manage or with managerial abilities (hereinafter a 'manager ') must be developed and 
maintained and  
h) management ability must be developed and maintained at all levels of man agement so 
that it can be effectively applied in achieving the objectives of the management system 
and developing and evaluating safety culture . 
CELEX : 32009 L0071  
CELEX : 32011 L0070  
CELEX : 32013 L0059  
CELEX : 32014 L0087  
Process and activity scope , performance , and management  
§ 4 
(1) A process guarantor must be designated for each process . The process roles must be 
stipulated for each process . 
(2) Processes and activities must  
a) be performed and managed in accordance with  
1. the intended use of their out puts, 
2. the requirements stipulated in the management system documentation , including the 
requirements for the scope of quality assurance of their outputs and acceptability 
criteria for these outputs , 
b) have related processes and activities stipulated as well as a mutual interface with related 
processes and activities to permanently ensure nuclear safety , radiation protection , 
technical safety , radiation situation monitoring , handling radiological emergencies , and 
security ; the interface between processes and a ctivities must include  
1. material or non -material processes and activity inputs and outputs , 
2. the information that is shared during the performance of related processes and 
activities and  
3. mutual relationships between the persons performing and managing relate d processes 
and activities , 
c) be systematically monitored to verify their ability to achieve the stipulated objective of 
the management system , 
d) be documented pursuant to § 14(b) points 4 and 5 and § 14(c); 
e) be performed under the following conditions : 
1. the doc umentation applicable to processes and activities must be available to every 
person participating in the processes and activities for their entire duration , 
2. the processes and activities must be subjected to ongoing checks to verify their 
correct performanc e and the quality of their outputs at a given moment , 
3. suitable equipment must be used and appropriate work conditions and environment 
must be ensured , 
4. the relationships between the persons performing and managing processes and the 
activities must be config ured to achieve the objectives of the management system 
and to meet the integrated requirements , - 4 - 
5. an employee must be qualified to perform his or her process role and must know the 
requirements for the processes and activities to which the process role pert ains and  
6. the equipment used for processes and activities must be kept in a condition that 
ensures permanent conformance of process and activity outputs with the 
requirements placed on them . 
(3) If a checkpoint is stipulated in the process and activity document ation , the processes 
and activities cannot continue without the approval of a specified employee . The approval for 
continued performance of processes and activities may be granted only if the results pass the 
check performed within the scope of the checkpo int. The approval of continued performance 
of processes and activities must be recorded . 
CELEX : 32009 L0071  
CELEX : 32014 L0087  
§ 5 
(1) Processes and activities and their inputs and outputs must be reviewed , verified , and 
validated prior to th eir first use . 
(2) Acceptability criteria must be stipulated for review , verification , and validation of 
processes and activities . 
(3) Process review , verification , and validation must be performed by the process 
guarantor or a delegated employee with the same qua lifications as the guarantor . 
(4) For a special process , requirements must be stipulated that correspond to the nature of 
the special process , for 
a) the qualifications of employees that manage , perform , and evaluate it , 
b) the procedure used to perform the process and 
c) the equipment and a suitable work environment and the conditions for its performance . 
(5) The meeting of requirements pursuant to (4)(a) and (b) must be validated prior to the 
performance of a special process . 
(6) Only the equipment whose condition and suitabi lity for the performance of the special 
process has been checked may be used to perform it . 
CELEX : 32009 L0071  
CELEX : 32014 L0087  
§ 6 
Management system planning and the scope and method of its documentation  
(1) During the planning process in the management system  
a) a plan to achieve the objectives of the management system and to implement the safety 
policy pursuant to § 14(a) (hereinafter the 'management system plan ') must be created and 
followed , 
b) the management system plan must be known to ever y worker performing activities to 
ensure nuclear safety , radiation protection , technical safety , radiation situation 
monitoring , handling radiological emergencies , and security , 
c) the quality of the management system plan must be continuously improved to pre vent a 
decline in nuclear safety , radiation protection , technical safety , radiation situation 
monitoring , handling radiological emergencies , and security , - 5 - 
d) the implementation of the management system plan and the efficacy of its continuous 
quality improveme nt must be evaluated from the perspective of its compliance with the 
planned results and  
e) effective measures must be implemented to eliminate non -conformance in the 
management system plan . 
(2) The management system plan must comply with safety policy pursuant t o § 14(a). 
CELEX : 32009 L0071  
CELEX : 32014 L0087  
§ 7 
Procedures for implementing changes to the management system  
(1) Changes to the management system must be planned . The management system plan 
must be performed to prevent a decline in nucle ar safety , radiation protection , technical 
safety , radiation situation monitoring , handling radiological emergencies , and security . 
(2) A proposed change to the management system must be justified and must be 
evaluated from the perspective of the purpose of th e change to the management system and its 
future influence on nuclear safety , radiation protection , technical safety , radiation situation 
monitoring , handling radiological emergencies , and security . 
(3) The efficacy of a change to the management system must be  continuously monitored 
and then subjected to independent evaluation pursuant to § 10(1). 
(4) When making changes to the management system , the following must be 
documented : 
a) the proposed change to the management system , 
b) the decision on the change to the manage ment system , 
c) the manner in which the change to the management system will be prepared , 
d) the implementation of the change to the management system , 
e) the manner in which the change to the management system will be evaluated , and the 
evaluation , 
f) the schedule fo r implementing the change to the management system . 
(5) Once the change to the management system has been made , its true effect on nuclear 
safety , radiation protection , technical safety , radiation situation monitoring , handling 
radiological emergencies , and se curity must be evaluated . 
(6) A change to the system is also defined as a change to individual processes and 
activities in the management system . 
CELEX : 32009 L0071  
CELEX : 32014 L0087  
Rules for assessing the efficiency of the management system , including process es and 
activities and changes thereto  
§ 8 
(1) Through the assessment of the management system , individual processes and 
activities and changes thereto , it must be determined whether these are  
a) suitable and adequate to achieve the objectives of the management system ; and 
b) capable of achieving the planned result . - 6 - 
(2) The efficacy of the management system and of individual processes , activities , and 
changes thereto must be assessed to continuously search for ways to improve the management 
system , including processes and activities and changes thereto . 
(3) A process efficacy indicator must be specified and used to assess the process efficacy . 
(4) The process efficacy indicator must be regularly evaluated by the process guarantor 
from the perspective of its abi lity to detect process efficacy . 
(5) The management system efficacy assessment must take place internally and via an 
independent evaluation . 
CELEX : 32009 L0071  
CELEX : 32014 L0087  
§ 9 
(1) The evaluation itself must be performed regularly for each process by the process 
guarantor by comparing the process outputs with the requirements placed on the process by 
the management system documentation for  
a) the verification of process suitability , adequacy , and efficacy , 
b) the identification or prevention of no n-conformity that prevents the achievement of the 
objectives of the management system ; and 
c) finding and adopting a measure to eliminate the non -conformity pursuant to (b), a 
corrective measure leading to the prevention of repeated occurrence of non -conformi ty, 
or a preventive measure to prevent it . 
(2) The internal evaluation must be planned . The internal evaluation plan must stipulate  
a) the manner in which the internal evaluation shall be implemented , 
b) the frequency of internal evaluation ; and 
c) the focus of the int ernal evaluation in the planned period . 
(3) The process guarantor performing the internal evaluation must  
a) set the objective and scope of the internal evaluation , 
b) set the process efficacy indicator according to which the efficacy of the process or 
activity is t o be assessed , 
c) draw up an internal evaluation performance programme , 
d) compare the process under evaluation and its activities with the set objective and the 
process efficacy indicator ; and 
e) based on the results of the internal evaluation , propose  
1. a measure t o eliminate the non -conformity , if identified , 
2. a corrective measure leading to the prevention of repeated occurrence of non -
conformity ; and 
3. a preventive measure to prevent non -conformity , including a proposal to improve 
process efficacy . 
§ 10 
(1) The independent evaluation must evaluate a change in the management system and in 
the processes and activities , and must be performed  
a) using a suitable method for evaluating the ability of the management system to achieve 
its objectives , 
b) at regular i ntervals and  - 7 - 
c) by a qualified employee who does not participate in the planning , management , and the 
performance of the processes and activities that are under evaluation . 
(2) The result of the independent evaluation must  
a) be formulated in a clear manner and in a ccordance with its intended use for management 
system improvement , 
b) contain information facilitating a review , 
c) make it possible to implement  
1. measures to eliminate non -conformity , if identified ; and 
2. a preventive measure to prevent non -conformity . 
§ 11 
Non-conformity management procedures  
(1) Within the scope of non -conformity management , during non -conformity detection  
a) the employee charged with ensuring non -conformity correction must immediately be 
informed that one has occurred , 
b) the symptoms of non -conformity must be identified immediately after it has been found , 
c) non-conformity must be documented as soon as it has been found , 
d) a procedure must be implemented to handle the processes and activities and their inputs 
and outputs and sources that t he non -conformity concerns , including a plan to eliminate 
non-conformity , 
e) requirements must be stipulated to prevent unsuitable handling of processes and activities 
and their inputs , outputs , or sources that the non -conformity concerns and  
f) the resulting an d possible impact on nuclear safety , radiation protection , technical safety , 
radiation situation monitoring , handling radiological emergencies , and security must be 
evaluated . 
(2) Within the scope of non -conformity management , during non -conformity correction  
a) the seriousness of non -conformity must be evaluated , 
b) a root cause analysis of non -conformity must be performed , 
c) a measure to eliminate non -conformity must be specified and implemented , 
d) the measure implemented to eliminate non -conformity must be monitored a nd assessed 
from the perspective of its performance status and its efficacy , 
e) the need for a corrective measure that would prevent the repeated occurrence of non -
conformity must be evaluated , 
f) a corrective measure that would prevent the repeated occurrence o f non -conformity that 
is commensurate to its consequences must be specified and implemented and  
g) the corrective measure implemented to eliminate non -conformity must be monitored and 
assessed from the perspective of its performance status and its efficacy . 
(3) Within the scope of non -conformity management , in the interest of preventing non -
conformity and its repeated occurrence  
a) a non -conformity that could occur (hereinafter a 'potential non -conformity ') and its 
possible causes must be searched for , 
b) the need for a  preventive measure to prevent the occurrence of a potential non -conformity 
must be evaluated , 
c) a preventive measure commensurate to the possible cause of a potential non -conformity 
must be implemented ; internal operating experience and the operating experi ence of 
another person , if available , must be used to stipulate the preventive measure and  - 8 - 
d) the preventive measure must be monitored and evaluated from the perspective of its 
implementation status and its efficacy . 
§ 12 
How appropriate q ualifications of personnel conducting processes and activities are 
ensured  
(1) In order to ensure an employee performing processes and activities in a management 
system it is necessary that  
a) the qualification requirements are stipulated , including years of prof essional experience 
corresponding to the type and significance of the process and activity the employee 
performs , 
b) a system for theoretical preparation of personnel conducting processes and activities must 
be used , 
c) a system for practical training of personn el conducting processes and activities must be 
used and  
d) the efficacy of the system for theoretical preparation and practical training of personnel 
conducting processes and activities must be evaluated . 
(2) Requirements pursuant to (1) must be met in a manner t hat ensures the employee 
performing processes and activities is capable of performing the process or activity and is 
informed of the influence the process or activity has on ensuring and increasing nuclear 
safety , radiation protection , technical safety , radiation situation monitoring , handling 
radiological emergencies , and security . 
(3) The qualifications of an employee performing processes and activities must be 
independently verified prior to the first commencement of the process or activity , and 
subsequently  on a regular basis . 
(4) The qualifications of an employee performing processes and activities must be 
continuously maintained in order to ensure the requirements for processes and activities are 
met and that they are effective . 
CELEX : 32009 L0071  
CELEX : 32014 L0087  
§ 13 
The scope of and method for ensuring permanent development and regular evaluation 
of the safety culture  
(1) In order to continuously develop a safety culture in the management system of the 
subject implementing the management syst em: 
a) it is necessary to ensure that the main principles of a safety culture for managers and for 
employees performing processes and activities are understandable and that they are well 
acquainted with them , 
b) the subject implementing the management system mus t ensure that a manager shall 
search for information regarding the achievement of the management system objectives 
and share it with other employees of the subject implementing the management system , 
c) the subject implementing the management system must crea te conditions for informing 
the manager on how to achieve the objectives of the management system through the 
employees of this subject , - 9 - 
d) it is necessary to ensure that an employee of the subject implementing the management 
system is prepared to perform the  activity necessary to achieve the objectives of the 
management system , 
e) the employee of the subject implementing the management system must be guided by the 
manager to search for opportunities for improving the management system and processes 
and activitie s, and conditions for this search must be created and  
f) the adequacy , suitability , and efficacy of sources must be assessed in a commensurate 
manner pursuant to § 8 to 10. 
(2) The subject implementing the management system must ensure that the manager 
contribute s to constant improvement and development of the safety culture and performs his 
or her own regular evaluation of the safety culture according to the process role he or she has . 
(3) Regular evaluations of the safety culture must take place at least once a year  and the 
result of the safety culture evaluation and measures adopted must be documented . 
(4) Every employee of the subject implementing the management system and its 
suppliers of products or services must be informed of the result of the safety culture 
evalua tion. 
CELEX : 32009 L0071  
CELEX : 32014 L0087  
Management system documentation  
§ 14 
The management system documentation must include : 
a) a safety policy containing a description of  
1. the objective of the management system , 
2. the objective leading t o ensuring and improving the quality of management of 
processes and activities and their results , 
3. the measures to meet the objective pursuant to points 1 and 2 and its monitoring , 
b) a description of the management system containing a description of  
1. the organ isational structure of the subject implementing the management system , 
2. the rights and responsibilities of personnel who plan , manage , perform , and evaluate 
processes and activities and their mutual relationships , communication methods , and 
decision -making methods at every level of management , 
3. the method of communication between the subject implementing the management 
system and a product or service supplier , another subject that participates in ensuring 
nuclear safety , radiation protection , technical safety , radiation situation monitoring , 
handling radiological emergencies , and security , and with the State Office for 
Nuclear Safety (hereinafter the 'Office '); 
4. processes and activities , their results and their mutual effects , based on the safety 
policy pursuan t to a ) and containing information on their preparation , review , 
verification and validation , performance , evaluation , and improvement , and 
recording of data applicable to processes and activities and their results ; and 
5. managing records pursuant to (c), 
c) records  
1. of the manner in which a process or activity is performed , 
2. of the achieved results upon fulfilment of requirements for the management system 
and results of processes and activities and  
3. fulfilment of the requirements for other management system docume ntation ; - 10 - 
d) requirements for the processes and activities performed by a product or service supplier 
and 
e) other documentation of the subject implementing a management system that is used to 
manage processes and activities , especially contracts , programmes , lists of selected 
equipment , limits and conditions , safety reports , and internal regulations . 
CELEX : 32009 L0071  
CELEX : 32014 L0087  
§ 15 
(1) The management system documentation must be  
a) drawn up so that the procedure it describes  
1. facilitates the achievement of the management system objective , 
2. leads to the fulfilment of integrated requirements , 
b) reviewed pursuant to § 5 prior to its implementation , 
c) approved by a designated employee ; a change to management system documentation 
must be approved by the  employee who approved the management system 
documentation , and if this is not possible , it must be approved by an employee with the 
same process role , 
d) comprehensible , legible , complete , clearly and easily identifiable and traceable , 
e) securely stored and ar chived for the period stipulated by the Act on Archives and Records 
Management , or if the archival period is not stipulated in this manner , for the period 
stipulated in the management system documentation , 
f) regularly assessed to its entire extent during thr ee consecutive years from the perspective 
of 
1. fulfilment of requirements for the processes and activities it describes and  
2. the efficacy of processes and activities , 
g) maintained in accordance with the assessment results pursuant to (f). 
(2) The safety policy purs uant to § 14(a) must be  
a) notified to all employees at all management levels and to the product or service suppliers 
so that the requirements it contains are always met to the extent corresponding to the 
activity being performed , 
b) monitored continuously from the perspective of fulfilment of the objective of system 
management and  
c) assessed annually by the subject implementing the management system from the 
perspective of the adequacy and efficacy of its implementation . 
(3) The safety policy pursuant to § 14(a) must stipulate a requirement for the systematic 
improvement of nuclear safety , radiation protection , technical safety , radiation situation 
monitoring , handling radiological emergencies , and security through  
1. identification and assessment of new information appli cable to nuclear safety , 
2. safety assessments and  
3. timely implementation of measures to increase nuclear safety . 
§ 16 
The management system programme must contain  
a) the subject , place of performance , and scope of the activity being authorise d, - 11 - 
b) except for a Category III workplace , the identification information of the direct supplier 
of a product or service being utilised by the subject implementing the management 
system to a similar extent as information pursuant to (a), 
c) a list of processes a nd activities to which the management system programme applies , 
with respect to the type of activity being authorised and identifying the process that shall 
be outsourced , 
d) the identification of the employee who must ensure the coordination and maintenance of 
the management system and compliance of the management system with the 
requirements of this decree and a description of the rights and responsibilities of this 
employee , 
e) a description of the management system including a description of  
1. the rights , respo nsibilities , and mutual relationships of employees who plan , manage , 
verify , and assess processes and activities , 
2. mutual relationships and organisation of departments participating in planning , 
management , performance , review , verification , and validation of processes and 
activities , 
3. the communication method for internal communication and communication with a 
product or service supplier and with the Office , 
4. how the management system requirements in this decree applicable to the activity 
being authorised are  fulfilled , including clear identification of documentation 
pursuant to which these requirements are fulfilled , 
5. how the efficacy of the management system and of processes and activities is 
assessed , including a description of the principles by which the in dependence of 
management system assessment , internal assessment , and recording of assessment 
results is ensured , 
6. how the ability of a product or service supplier to deliver the required product or 
service is verified , including how the product or service q uality is ensured , and to 
fulfil requirements applicable to ensuring nuclear safety , radiation protection , 
technical safety , radiation situation monitoring , handling radiological emergencies , 
and security , 
7. except for a Category III workplace , the scope and  manner in which the requirements 
of this decree shall be applied to the management system of a product or service 
supplier , including how the efficacy of the management system is assessed and how 
outsourced processes and activities are assessed and  
8. how an d how often the management system programme is updated . 
CELEX : 32013 L0059  
§ 17 
The management system while performing or arranging activities within the scope of 
exposure situations  
While performing or arranging activities within the sc ope of exposure situations in 
Category III workplaces , the management system must meet the requirements of § 3 to 5, § 7 
to 12, § 14(b) to (e), § 15(1), and § 16. 
CELEX : 32013 L0059  - 12 - 
§ 18 
Notification  
This Decree has been notified in acco rdance with Directive (EU) No 2015 /1535 of the 
European Parliament and of the Council of 9 September 2015 laying down a procedure for the 
provision of information in the field of technical regulations and of rules on Information 
Society services , as amende d. 
The President :