Decree No. 408 / 2016 Coll.
Regulation on requirements for the management system
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Effective from 01.01.2017
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408
DECLARATION
of 6 December 2016
on requirements for the management system
The State Authority on Nuclear Safety sets out, pursuant to § 236 of Act No. 263 / 2016 Coll., Atomic Act, for implementation of § 24 (7), § 29 (7) and § 30 (9):
Subject matter
This decree implements the relevant regulations of the Euraton1) and provides for:
(a) requirements for the establishment, maintenance and improvement of the management system;
(b) the content of the documentation of the management system and its management method;
(c) rules for the implementation and management of processes and activities;
(d) rules for the implementation and management of specific processes;
(e) the method of planning in the management system and the scope and manner of carrying out the documentation of such planning;
(f) the procedure for making changes to the management system;
(g) rules for assessing the effectiveness of the management system, including processes and activities and their changes;
(h) procedures for the management of non-conformity;
(i) the way in which staff performing processes and activities are qualified;
(j) the scope and manner of ensuring the continuous development and regular evaluation of the safety culture; and
(k) requirements for the content of the management system programme.
Terms
For the purposes of this decree:
(a) the guarantee of the process by a worker ensuring the establishment, monitoring and improvement of a process which affects nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security (hereinafter referred to as the "process") and compliance with the requirements laid down by law on this process;
(b) verification of compliance of processes and activities and their inputs and outputs with the requirements for their characteristics set out in the management system documentation;
(c) the procedural role of the expected behaviour and conduct of the process to be directed towards the reliable execution of the assigned activities in accordance with the objectives of the person under Paragraph 29 (1) of the Atomic Act (hereinafter referred to as the "person implementing the management system"),
(d) by examining the suitability, adequacy and effectiveness of processes and activities and their inputs and outputs in terms of nuclear safety, radiation protection, technical safety, monitoring of radiation situations, management of radiological emergencies and security;
(e) an indication of the process efficiency indicator providing the process guarantor with information on the process effectiveness and activities of which it is composed, in terms of securing and increasing the level of nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security;
(f) validation of the verification of compliance of processes and activities and their inputs and outputs with the requirements for their intended use set out in the management system documentation;
(g) senior management of a natural person who has the power to make decisions having a significant impact on the policy, resources and direction of the person implementing the management system.
Requirements for the establishment, maintenance and improvement of the management system
(1) The management system must be established, maintained and improved in such a way that:
(a) the safety objectives of the management system are effectively achieved in order to ensure and increase the level of nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security (hereinafter referred to as the "management system safety objective"); and
(b) all requirements which may serve to ensure and increase the level of nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security, hereinafter referred to as the integrated requirement, are met.
(2) The person implementing the management system shall ensure that the safety objective of the management system is achieved as a matter of priority in the decision-making process, so that there is no negative impact on the safety objective of the management system when achieving the other objectives of the management system and the process and activity requirements.
(3) Processes and activities in the management system must be implemented in such a way as to achieve the safety objectives of the management system and to meet the integrated requirements.
(4) Processes and activities in the management system must be carried out on a planned and systematic basis.
(5) The steering system must:
(a) the conditions for maintaining, improving and evaluating the management system, including its amendments;
(b) measures are in place to ensure and increase the level of nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security;
(c) in place measures to ensure compliance of activities carried out by a person implementing a management system with the requirements of legislation;
(d) integrated requirements to be met in such a way that nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security are permanently secured;
(e) measures are in place to prevent and prevent the use of fraudulent, falsified and suspected items;
(f) the method of management and the different levels of management,
(g) the ability of management to ensure and increase the level of nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security (hereinafter referred to as "management capacity") of the personnel responsible for management or with management capability (hereinafter referred to as "senior management") is developed and maintained;
(h) the ability of management to be developed and maintained at all levels of management so that it can be effectively applied in achieving the safety objective of the management system and developing and evaluating the safety culture;
(i) established risk management to achieve the safety objective of the management system; risk management must be in the context of the prevention of disagreement
1. a non-compliance which could arise ("potential non-compliance") and its possible causes have been sought,
2. Evaluation of the need for preventive action to prevent potential non-compliance,
3. preventive measures in place appropriate to the possible cause of potential disagreement; for the purpose of determining preventive measures, use shall be made of other persons' own operational experience and operational experience, where available; and
4. preventive measures are monitored and evaluated in the light of the state of its implementation and its effectiveness; and
(j) a uniform method of communication and the language which ensures it.
(6) The members of senior management must ensure that:
(a) a security policy has been established and its safety objective of the management system has been met;
(b) the objectives of the management system aimed at meeting the safety objective of the management system, the management plans and the tasks of the person implementing the management system are consistent with the safety policy and their impact on nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiation emergencies and security are taken into account and managed in such a way that nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiation incidents and security are not jeopardised by other priorities;
(c) the suitability and effectiveness of the management system have been monitored and evaluated; and
(d) self-evaluation and independent evaluation of:
1. the pursuit of the activities of the CS in relation to the safety objective of the management system carried out by the senior management member;
2. leadership capabilities in the field of nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security, including culture of safety and fundamental attitudes and behaviour.
(7) The management system must be established and documented before the start of the nuclear-related activity since processes and activities may affect the future achievement of the safety objective of the management system. The management system documentation shall include a management system programme in this case.
Scope and manner of implementation and management of processes and activities
(1) For each process, the guarantor of the process must be designated. The procedural roles must be defined within each process.
(2) Processes and activities must:
(a) be implemented and managed in accordance with:
1. the intended purpose of using their outputs; and
2. the requirements set out in the documentation of the management system which complies with Section 15 (1), including requirements for the scope of quality assurance of their outputs and the criteria for the acceptability of such outputs;
(b) have associated processes and activities and interfaces with related processes and activities so that nuclear safety, radiation protection, technical safety, radiation monitoring, radiation emergency management and security are permanently secured; Part of the interface between processes and activities must be
1. physical or intangible inputs and outputs of processes and activities;
2. information shared in the implementation of related processes and activities; and
3. the relationship between persons carrying out and managing related processes and activities,
(c) be regularly monitored to verify their ability to achieve the stated safety objective of the management system;
(d) be documented in accordance with Sections 14 (b) (4) and (5) and 14 (c); and
(e) be carried out under the following conditions:
1. documentation relating to processes and activities shall be made available to each person involved in the implementation of processes and activities throughout the process and activity,
2. a continuous check must be carried out on the processes and activities to verify the correctness of their implementation and the quality of their outputs at a certain time;
3. appropriate technical equipment must be used and appropriate working conditions and environment ensured;
4. the interaction between persons implementing and managing processes and activities must be set in such a way as to achieve the safety objective of the management system and to meet integrated requirements;
5. the worker must be qualified to fulfil the procedural role and to carry out the assigned activity and to know the requirements for the processes and activities to which the procedural roles belong;
6. technical equipment for carrying out processes and activities shall be maintained in a state ensuring that the outputs from processes and activities are consistently aligned with the requirements laid down therein; and
7. For the management and evaluation of the processes and activities carried out by the supplier, the corresponding number of own personnel of the person implementing the management system shall be ensured.
(3) Where a control point is provided for in the documentation of processes and activities, their implementation may not be continued without the consent of the designated worker. The authorisation to continue the implementation of processes and activities shall be documented by recording.
(1) The processes and activities and their inputs and outputs must be reviewed and verified before their first use.
(2) Eligibility criteria shall be established for the examination and verification of processes and activities.
(3) The review and verification of the process shall be carried out by a process guarantor or by a staff member who is as competent as the process guarantor.
(4) Requirements corresponding to the nature of the specific process shall be laid down for the specific process:
(a) the ability of the staff managing it to carry out and evaluate it;
(b) the process implementation process; and
(c) technical equipment and an appropriate working environment and the conditions for its implementation.
(5) Compliance with the requirements of paragraph 4 (a) and (b) must be verified by validation before carrying out the specific process.
(6) Only technical equipment for which the condition and eligibility for such implementation have been checked before its application may be used for the implementation of a specific process.
Method of planning in the management system and scope and method of carrying out documentation of such planning
(1) When planning in a management system,
(a) a plan to achieve the security objective of the management system and the implementation of the security policy referred to in Article 14 (a) (hereinafter referred to as the management system plan);
(b) the management system plan is known to the leader;
(c) the management plan shall be kept under constant review from the point of view of accuracy and up-to-date and maintained in such a way as to avoid a reduction in the level of nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security;
(d) the implementation of the management system plan and its effectiveness are regularly assessed in terms of their compliance with the planned outcome; and
(e) effective measures are taken to achieve the results of the management system plan referred to in point (d).
(2) The management system plan must comply with the safety policy referred to in Article 14 (a).
Method of making changes to the management system
(1) A change to the management system must be planned. The change plan for the management system shall be implemented in such a way as to avoid reducing the level of nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security.
(2) The proposal for a change to the management system shall be justified and evaluated in the light of the purpose of the change to the management system and its future impact on nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security.
(3) The implementation of the change to the management system shall be monitored on an ongoing basis in terms of its effectiveness and subsequently independently evaluated in accordance with Section 10 (1).
(4) When changing the management system, the record shall be documented:
(a) a proposal to amend the management system;
(b) the decision to amend the management system;
(c) the arrangements for preparing the change to the management system;
(d) making changes to the management system;
(e) the method and conduct of evaluating the change in the management system; and
(f) the timetable for the implementation of the change to the management system.
(5) Following the change in the management system, its actual impact on nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security must be evaluated.
(6) A change in the management system shall also mean a change in the processes and activities of the management system.
(7) Where a change in the management system does not affect nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of a radiological emergency or security, the requirements of paragraphs 2 to 5 shall not apply.
Rules for assessing the effectiveness of the management system, including processes and activities and their changes
(1) The assessment of the effectiveness of the management system, processes and activities and their changes must determine whether they are:
(a) appropriate and proportionate to achieve the safety objective of the management system; and
(b) capable of achieving the intended result.
(2) The assessment of the effectiveness of the management system, processes and activities and their changes shall continuously seek opportunities to improve the management system, including processes and activities and their changes.
(3) In assessing the efficiency of the management system, the process efficiency indicator shall be identified and used.
(4) The process efficiency indicator shall be regularly evaluated by the process guarantor in terms of its ability to provide information on process effectiveness.
(5) Assessment of the effectiveness of the management system shall be carried out by self-evaluation and independent evaluation.
(1) The actual evaluation shall be carried out regularly for each process by the process guarantor by comparing the process output with the requirements laid down for the process documentation of the management system to:
(a) examination of the suitability, adequacy and effectiveness of the process;
(b) identify or prevent non-compliance which prevents the achievement of the safety objective of the management system; and
(c) finding and taking measures to eliminate non-conformity as referred to in (b), corrective action to prevent the recurrence of non-conformity or preventive action to prevent it.
(2) Self-evaluation must be planned. The own evaluation plan shall provide for:
(a) the way in which self-evaluation is introduced;
(b) the frequency of its own evaluation; and
(c) the focus of the own evaluation during the planned period.
(3) The guarantor of the self-evaluation process must:
(a) establish the objective and scope of self-evaluation;
(b) determine the process efficiency indicator by which the process or activity efficiency is to be assessed;
(c) develop a programme for carrying out its own evaluation;
(d) carry out a comparison of the evaluation process and its activities with the objective and indicator of process effectiveness; and
(e) on the basis of the results of its own evaluation, propose:
1. measures to eliminate non-conformity, if identified;
2. corrective action to prevent recurrence of non-conformity; and
3. preventive measures to prevent disagreement, including a proposal to improve the effectiveness of the process.
(1) The independent evaluation must assess the management system, including processes and activities, and must be carried out
(a) a method suitable for assessing the ability of the management system to achieve the safety objective of the management system;
(b) at regular intervals; and
(c) by a qualified worker with adequate powers to implement it, who is not involved in the planning, management and implementation of the processes and activities under evaluation.
(2) The independent evaluation output must:
(a) be formulated clearly and in accordance with its intended use for improving the management system;
(b) contain information enabling its review; and
(c) allow admission
1. measures to eliminate non-conformity, if identified; and
2. preventive measures to prevent disagreement.
Procedures for managing non-conformity
(1) In the context of the management of non-conformity, when detecting non-conformity,
(a) information on the occurrence of non-conformity notified to the worker who is intended to ensure the correction of non-conformity immediately after its detection;
(b) signs of non-conformity identified immediately after its detection;
(c) non-conformity documented immediately after its detection;
(d) a procedure for the management of processes and activities, their inputs and outputs and the resources involved in the non-compliance, including a non-compliance plan;
(e) requirements are laid down to avoid inappropriate treatment of processes and activities and their inputs, outputs or sources of non-compliance;
(f) assessed the resulting and possible impact of non-compliance on nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security; and
(g) in the event of the detection of a fraudulent, falsified or suspected item, the Office shall be informed without delay.
(2) In the context of the management of non-conformity, when correcting non-conformity,
(a) the seriousness of the disagreement has been assessed;
(b) analysis of the causes of non-conformity,
(c) measures are identified and implemented to eliminate non-conformity;
(d) the measures taken to eliminate non-conformity are monitored and evaluated in the light of the state of its implementation and its effectiveness;
(e) the need for corrective action to prevent recurrence of non-conformity has been evaluated;
(f) a corrective action is identified and implemented to prevent a repeated occurrence of non-conformity which is proportionate to the consequences of non-conformity; and
(g) corrective action taken to prevent the recurrence of non-conformity shall be monitored and evaluated in the light of the state of its implementation and its effectiveness.
Method of ensuring the qualification of process and activity personnel
(1) In order to ensure the qualification of a worker carrying out processes and activities in the management system,
(a) the qualification requirements, including the length of professional experience, and the requirements for language and communication skills corresponding to the type and importance of the process and activity carried out by the worker;
(b) a system of theoretical preparation of process and activity personnel used;
(c) a system of practical training for process and activity personnel; and
(d) the effectiveness of the system of theoretical preparation and practical training of personnel performing processes and activities is evaluated.
(2) The requirements referred to in paragraph 1 must be fulfilled in such a way that a worker performing processes and activities is able to carry out a process and activity and is aware of the impact of the process and activity on the level of nuclear safety, radiation protection, technical safety, monitoring of the radiation situation, management of radiological emergencies and security.
(3) The qualification of a process and activity worker must be verified on a regular basis before the first start of the process and activity.
(4) The qualification of a process and activity worker must be maintained permanently in order to ensure compliance with the process and activity requirements and their effectiveness.
Development and evaluation of a safety culture
(1) The continuous development of a safety culture in the management system of the person implementing the management system must be:
(a) effectively ensure the clarity and awareness of the key principles of the safety culture for leaders and practitioners,
(b) effectively ensure the search for information on the achievement of the management system safety objective by the lead worker and their sharing with other personnel of the person implementing the management system;
(c) effectively create the conditions for informing the lead worker of the way in which the management system's security objective is achieved by the person implementing the management system of the personnel of that person;
(d) effectively ensure that the activities of senior staff will lead to the development of a safety culture in its entirety appropriate to the focus of the person implementing the management system, including for workers, leaders and organisations, in particular:
1. supporting the reporting of nuclear safety, radiation protection, technical security, monitoring of the radiation situation and management of radiological emergencies;
2. developing a query approach; and
3. rectification of actions or conditions which may have an adverse effect on nuclear safety, radiation protection, technical safety, monitoring of the radiation situation and management of the radiological emergency;
(e) effectively ensure the preparedness of the worker of the person implementing the management system to act to achieve the safety objective of the management system, using his / her competence to be maintained by the person implementing the management system from his / her internal resources, including:
1. competence to lead to nuclear safety, radiation protection, technical safety, monitoring of the radiation situation and management of radiological emergencies at all levels of management,
2. competence to promote and maintain a strong safety culture; and
3. expertise in understanding technical, human and organisational aspects or activities to ensure nuclear safety, radiation protection, technical safety, monitoring of the radiation situation and management of radiological emergencies,
(f) the worker of the person implementing the management system led by the lead worker to seek opportunities to improve the management system and processes and activities and to create conditions for such search;
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Regulation Information
| Citation | Decree No. 408 / 2016 Coll., on Management System Requirements |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 14.12.2016 |
|---|---|
| Effective from | 01.01.2017 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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