Decree No. 132 / 2008 Coll.
Decree on the quality system for the implementation and provision of activities related to the use of nuclear energy and radiation activities and on the quality assurance of selected equipment with regard to their classification in safety classes
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Effective from 01.05.2008
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01.05.2008
21.04.2008
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132
DECLARATION
of 4 April 2008
on the quality system for the implementation and provision of activities related to the use of nuclear energy and radiation activities and the quality assurance of selected equipment with regard to their classification in safety classes
According to § 47 (7) for the implementation of § 2 (i), § 4 (8) and § 13 (3) (d) and § 5 of Act No. 18 / 1997 Coll., on the Peaceful Use of Nuclear Energy and Ionising Radiation (Atomic Act) and on the amendment and addition of certain laws, as amended by Act No. 13 / 2002 Coll. and Act No. 253 / 2005 Coll.:
Subject matter and scope of the adjustment
This decree regulates
(a) requirements for a quality system in the conduct or provision of activities related to the use of nuclear energy or radiation activities;
(b) requirements for the fulfilment of the quality assurance programme;
(c) criteria for the classification and distribution of selected equipment into security classes;
(d) the essential requirements for ensuring the quality of the selected equipment with regard to their classification in the safety classes; and
(e) the scope and manner of implementation of the list of selected devices.
Scale approach
Anyone implementing a quality system shall apply a graduated approach. The graduated approach shall take into account:
(a) the complexity of the process, activity, their inputs and outputs and their importance in terms of nuclear safety and radiation protection;
(b) classification of sources of ionising radiation, how they are handled and the category of workplace on which radiation activities are carried out;
(c) the way in which nuclear materials and radioactive waste are managed, laid down by other legislation1); and
(d) the classification of selected equipment in the security classes referred to in Section 12.
General requirements for the quality system
The quality system shall:
(a) determined processes and activities relating to the quality of items, including products affecting nuclear safety or radiation protection (hereinafter referred to as "processes and activities"), their inputs and outputs, including their possible impact on nuclear safety or radiation protection;
(b) a sequence and interaction of processes and activities,
(c) processes and activities planned, managed, carried out, verified and evaluated in order to achieve the quality of the item, taking into account its importance in terms of nuclear safety or radiation protection;
(d) the acceptance criteria and methods used for planning, managing, implementing, verifying and evaluating processes and activities;
(e) the organisational structure and the way in which it is changed, including the rights, obligations and interrelationships of persons planning, managing, implementing, verifying or evaluating the processes and activities to ensure their effective synergies;
(f) the method of communication within the organisational structure and the way of communication with persons different from the body implementing the quality system involved in the implementation of the processes and activities or to which processes and activities are directed;
(g) lay down requirements for suppliers involved in the implementation of processes and activities;
(h) monitoring and control of processes, activities, their inputs and outputs with a view to meeting their quality requirements to demonstrate compliance with the requirements prescribed in the quality system documentation;
(i) the method and criteria for the systematic evaluation of the quality system in terms of its effectiveness; evaluation of the quality system is carried out
1. self-assessment by the persons responsible for the activities referred to in Article 5 in their controlled areas of the quality system; and
2. independent evaluation by persons who are not involved in the planning, management or implementation of the process or activity under evaluation,
(j) the provision of personnel, technical, material and financial resources, including an appropriate working environment, necessary to maintain and improve the quality system and to carry out processes and activities and to establish, maintain and continuously improve their effectiveness;
(k) measures are applied to improve the quality of nuclear safety or radiation protection items;
(l) improved quality system by applying corrective and preventive measures based on the results of the evaluation.
Requirements for quality system documentation
(1) Anyone who introduces a quality system must document it. The quality system documentation shall include:
(a) a document describing the quality system with regard to the general requirements referred to in Article 3;
(b) documented procedures describing the processes and activities under the quality system and their management and implementation;
(c) working documents following the documented procedure, detailing the method of planning, verifying, implementing, evaluating and managing the process or activity and evaluating the quality system, including their outputs or product specifications; the working documents are in particular instructions, instructions, operating regulations, training rules, plans, programmes, documentation for production or drawings on any medium; and
(d) records showing the activities carried out or the results achieved in meeting the requirements of the quality system or of the individual items affecting nuclear safety and radiation protection as laid down in the documented procedures or in the working documents.
(2) The documentation of the quality system must be:
(a) understood, complete, unambiguously identifiable, traceable and available as applicable to all persons carrying out the relevant activities;
(b) prior to introduction, subject to review in terms of suitability, adequacy, effectiveness, clarity, accuracy and completeness and approved by the persons designated for this purpose; and
(c) securely stored and archived for a period specified by other legislation (m2) or, if the archiving period for a particular document is not so determined, for a period determined by a documented procedure for the archiving process; the archiving period of records for the quality assurance of the selected equipment is set out in Section 13 (2).
Persons in the quality system
(1) The persons responsible for the quality system must be designated
(a) maintaining the quality system in accordance with the general requirements referred to in Article 3;
(b) documentation of the process referred to in Article 4 (1) (b) to (d);
(c) ensuring effective interaction and interprocess links;
(d) ensuring and documenting compliance of the process output with the requirements for such output set out in the quality system documentation;
(e) monitoring and recording of process progress;
(f) solving non-conformities of processes and their outputs;
(g) evaluation of the effectiveness of the process and its changes; and
(h) promoting the improvement of the process.
(2) Persons designated under the quality system referred to in paragraph 1 shall have the rights and the obligations necessary to carry out the activities entrusted to them.
Processes and activities
(1) The planning, management, verification, implementation and evaluation of processes and activities in the quality system must be carried out by persons with qualifications appropriate to the type and importance of their activities. This qualification shall be achieved by establishing the lowest permissible qualification requirements for such persons, ensuring their training and evaluating the effectiveness of the training so that they are able to carry out the assigned activities and are aware of the impact of their activities on nuclear safety or radiation protection. The qualifications of such persons, including their education and training, shall be documented.
(2) Processes and activities must be planned and implemented under the following conditions:
(a) documented procedures and working documents relating to items affecting nuclear safety or radiation protection are available;
(b) the implementation of processes and activities complies with the requirements of documented processes and working documents for processes and activities;
(c) equipment suitable for the implementation of processes and activities is used and the necessary working conditions and environment for their implementation are ensured;
(d) monitoring and checking of the properties of an item affecting nuclear safety or radiation protection;
(e) the production, monitoring, measuring or testing equipment shall be maintained in a state enabling the item affecting nuclear safety or radiation protection to be consistently compliant with the requirements laid down therein; the monitoring, measuring and testing equipment shall be checked, calibrated and maintained by procedures ensuring that the measurement uncertainty corresponds to the required measurement capability; and
(f) changes in processes and activities shall be made only on the basis of a proposal, justified and evaluated for the purpose of the change and its impact on nuclear safety or radiation protection, and demonstration of the effect of the change on the level of nuclear safety and radiation protection after its implementation.
(3) Each quality system process shall be evaluated in terms of efficiency. The assessment of the process efficiency shall be carried out by comparing the process outputs with the requirements laid down in the quality system documentation.
(4) Processes and activities must be subject to review to confirm the suitability, adequacy and effectiveness of an item affecting nuclear safety or radiation protection ("review"), verification to confirm compliance of an item affecting nuclear safety or radiation protection with its characteristics ("verification") and validation to confirm compliance of an item affecting nuclear safety or radiation protection with the requirements for its intended use ("validation"). For the review, verification and validation of processes and activities, a timetable, scope, manner of review, verification and validation and acceptance criteria shall be established and documented and the responsibility of persons for meeting these criteria shall be determined. The review, verification or validation of processes may be carried out only by persons responsible for the activities referred to in Section 5, and at the same time by persons who are not involved in the process or activity. The results of the review, verification and validation of processes and activities shall be documented in the form of records.
(5) Where control points are specified in the process or activity in documented procedures or working documents, the process or activity may not be continued without the demonstrable consent of the designated person, issued on the basis of a check of the status or outcome of the check.
(6) The requirements for processes carried out by suppliers shall be indicated in the quality system documentation referred to in Article 4 (1).
Requirements for certain processes relating to the product
(1) The process of design of the product, including the development, construction and design of the product, (hereinafter referred to as the "design process") must be carried out under the following conditions:
(a) a review of the input of the design process in terms of nuclear safety and radiation protection is carried out to evaluate their compliance with the requirements of other product-related legislation and the agreed specifications;
(b) a review of the design process is carried out to evaluate the ability of the design process to meet the requirements set out in the inputs and requirements which are a prerequisite for the intended use of the product;
(c) verification of the design process is carried out to determine whether the outputs from the design process meet the applicable regulatory requirements and specified specifications relating to the product with regard to nuclear safety and radiation protection, and whether a way of addressing deviations from those requirements is established;
(d) the final exit documentation of the design process shall be prepared, including an indication of its changes in form which will enable it to be verified in relation to the design process inputs by qualified persons involved in its processing or by independent qualified persons; and
(e) validation of the design process is carried out to determine whether the proposed product meets the requirements for intended use in terms of nuclear safety or radiation protection, according to the final output documentation of the design process.
(2) The production process of the product must continue under the following conditions:
(a) the product specification, including its amendments, complies with technical regulations, technical conditions or technical standards which contain the applicable requirements of other legislation in terms of nuclear safety and radiation protection;
(b) the production method of the product is documented in accordance with the requirements set out in the final product design output documentation;
(c) the nature, manner and extent of the examination, verification and validation of the product, including the acceptance criteria, are established before its intended use;
(d) the product is identified and maintained in an unmistakable manner;
(e) information is available on current or past status, location and use of the product or on current or previous treatment of the product at any time during the production process;
(f) the product is delivered in a condition enabling verification; and
(g) the conformity of the product with the requirements specified in the documented procedures and working documents for its production is documented by records.
(3) The process of procuring the product shall be carried out under the following conditions:
(a) the documentation for procurement sets out the correct and complete product requirements, including requirements for the scope of product quality assurance. The procurement documentation shall also specify the notification and resolution requirements for identified non-conformities,
(b) supervision of suppliers is carried out during the procurement process;
(c) requirements for the selection and evaluation of suppliers of the product are laid down in advance according to their ability to supply the product; the suppliers of the product are selected and evaluated on the basis of these requirements; and
(d) the conformity of the products supplied with the prescribed procurement requirements is documented by the records available before the product is used.
(4) Processes and activities in the transport, storage and maintenance of the product must be carried out in a way that prevents damage, undesirable use or destruction of the product.
(5) The requirements for processes whose compliance with these requirements cannot be fully verified by a follow-up check or test of the product, in particular for welding, forming, non-destructive testing, heat treatment, software generation or computer equipment, the performance of medical exposure of patients, hereinafter referred to as "specific processes," must be laid down in the product specification for which specific processes are to be used. Specific processes shall only be managed, verified, implemented and evaluated by sufficiently qualified persons whose knowledge and skills must be regularly and demonstrably tested. Only technical equipment for which compliance with the requirements for specific processes is regularly checked may be used to perform specific processes. There shall be records of compliance with the qualification requirements and verification of compliance with the requirements for specific processes.
Management of non-conformities, rectification and preventive measures against non-conformities
(1) Processes and activities, their inputs and outputs, which are not in conformity with the requirements set out in the documentation referred to in Section 4 ("non-compliant item") are subject to a non-conformity management process.
(2) The procedure for the management of non-conformity in the quality system must be carried out in accordance with the requirements of Section 6 (2) and the documented procedure for the management of non-conformity, which must specify:
(a) requirements for the identification of non-conformity without delay after its detection and documentation;
(b) requirements for the procedure for reporting non-conformity to the responsible persons of the body implementing the quality system;
(c) ways of dealing with the non-compliance and requirements to prevent the inappropriate use of the non-compliant item, including a non-compliance plan; and
(d) requirements for assessing the consequences of non-conformity and possible other consequences for nuclear safety or radiation protection when using a non-compliant item.
(3) In order to correct non-conformities, compliance with the documented procedure for the management of non-conformities must be ensured
(a) review of the non-compliant item;
(b) analysis of the cause of the disagreement;
(c) the determination of the way in which disagreements are resolved;
(d) an assessment of the need for measures to prevent repeated occurrence of non-conformity; and
(e) the identification, documentation and introduction of corrective measures proportionate to the consequences of non-conformity.
(4) In order to exclude non-conformities that could arise ("potential non-conformities"), a documented procedure must be established and implemented to exclude potential non-conformities, which sets out requirements for:
(a) search for potential disagreements and their possible causes;
(b) an assessment of the need for measures to avoid potential discrepancies; and
(c) identifying, documenting and introducing preventive measures appropriate to the possible consequences of potential non-conformity; in order to identify preventive measures, use is made of its own operational experience and operational experience of other bodies, where available.
(5) The corrective or preventive measures put in place shall be continuously monitored and evaluated in terms of their status of implementation and effectiveness.
Quality system for performing or providing radiation activities
(1) The quality system for performing or providing radiation activities at Category IV workplaces must comply with the requirements of Sections 3 to 8.
(2) The quality system in carrying out or providing radiation activities at Category III workplaces must comply with the requirements of Sections 3 (a) to (h), 3 (i) (1) and (j) to (l), 4, 5, 6 (1) to (5), 7 (3) (a), (c) and (d), 4 and 5, 8 (1) to (3) and 5.
(3) The quality system in carrying out or providing radiation activities at Category II workplaces and in carrying out personal dosimetry and other services relevant to radiation protection must meet the requirements of Sections 3 (a) to (h), (i) (1) and (j) to (l), 4, 5, 6 (1) to (3), 5, 7 (3) (a) and (d), 4 and 5, 8 (1) to (3) and 5.
(4) The quality system in the performance or provision of radiation activities at Category I workplaces and in the training of selected staff must comply with the requirements of Sections 3 (a) to (h), (j) and (k), 4, 5 and 8 (1).
Requirements for the content of the quality assurance programme for permitted activities pursuant to § 9 (1) (a) to (g), (i), (j), (n) and (r) of the Atomic Act
(1) The quality assurance programme must document the quality system in place. The content of the quality assurance programme for authorised activities referred to in § 9 (1) (a) to (g), (i), (j), (n) and (r) of the Atomic Act shall comply with the requirements of § 4 (2) and shall be subject to regular revisions which shall bring it into line with any changes made to the quality system.
(2) The quality assurance programme shall contain:
(a) the identification details of the body whose quality system is documented by the quality assurance programme (hereinafter referred to as "the promoter"); for a legal person, the business name, registered office, form and identification number, if assigned; for a natural person, the name and surname, the date of birth and the address of the place of permanent residence or other residence in the Czech Republic or the address of residence outside the Czech Republic,
(b) the object, place and extent of the activity of the petitioner;
(c) except for post III and lower category, identification data for direct suppliers of products used by the petitioner; for a legal person, the business name, registered office, form and identification number, if assigned; for a natural person, the name and surname, the date of birth and the address of the place of permanent residence or other residence in the Czech Republic or the address of residence outside the Czech Republic,
(d) a list of the processes and their related activities covered by the quality assurance programme, indicating the processes and activities carried out in a supplier's way;
(e) documented procedures or references to such procedures with their unambiguous identification;
(f) a description of the quality system of the petitioner including:
1. the responsibilities, rights and obligations and the mutual relations of the persons planning, managing, verifying, implementing, evaluating the processes and activities;
2. the mutual relations and the breakdown of services or working groups involved in the planning, management, verification, implementation and evaluation of processes and activities, including the management and communication arrangements within the body and with its suppliers;
3. the principles of ensuring the quality system requirements and quality assurance of processes, activities and products relating to authorised activities, including references to documented procedures;
(g) with the exception of post III and lower category, the scope and method of application of the requirements of this Decree to the quality system and to the quality assurance of suppliers, including the method of evaluation of the quality system and quality assurance verification of these suppliers;
(h) the method and frequency of independent evaluation by quality system verifications, including the method and form of recording of the results of such examinations; and
(i) the manner and frequency of the quality assurance programme revisions.
Requirements for the content of the quality assurance programme for the authorised activity pursuant to § 9 (1) (l) of the Atomic Act
The content of the quality assurance programme for the authorised activity pursuant to § 9 (1) (l) of the Atomic Act is laid down in § 4 (2) of Decree No. 145 / 1997 Coll., on the registration and control of nuclear materials and on their further definition, as amended.
Criteria for the classification and distribution of selected equipment into safety classes
Selected devices are classified and divided into security classes 1, 2 and 3. The Annex sets out the criteria for the classification and distribution of selected equipment into safety classes.
Essential quality assurance requirements for selected equipment with regard to their classification in safety classes
(1) When ensuring the quality of the selected equipment, the documentation of the quality system processed in accordance with Section 4 relating to the processes and activities of design, manufacture, putting into service, operation or decommissioning of the selected equipment, in particular the records relating to the selected equipment, shall be used.
(a) concerning the specific processes referred to in Article 7 (5);
(b) classified in safety class 1 or 2, showing compliance with the quality requirements of the selected equipment and the verification of the final output documentation of the design process of the selected equipment with regard to compliance with all acceptance criteria imposed on the selected equipment, its parts and the materials used for its manufacture; or
(c) classified in the safety class 1 or 2 under stressed pressure of the working medium, documenting defects detected by inspection and removal, the method of repair of this selected device and the consciously retained permissible defects which are further monitored.
(2) When ensuring the quality of the selected equipment, records shall be made showing compliance with the quality requirements of the selected equipment in an extent and in a manner that enables the condition of the selected equipment to be assessed at any time. Those records and records referred to in paragraph 1 shall be safely stored and archived throughout the life of the selected installation, starting from the design of the selected installation and its parts, to its decommissioning.
(3) During the design process of the selected device, the final output documentation of the design of the selected device included in the safety class 1 or 2 shall be specified.
(a) the criteria for monitoring the lifetime of the selected installation, the conditions for handling and operating the selected installation; and
(b) the acceptability criteria necessary to fulfil its safety functions.
(4) The documentation of the quality system of the supplier of the selected equipment shall be reviewed to the extent agreed in advance in order to meet the quality requirements for items affecting nuclear safety or radiation protection in accordance with the assessment aspects referred to in Section 4 (2) (b). This review shall be recorded.
(5) In the process of putting into service and operation of the selected equipment,
(a) documented means of ensuring the identification of the selected device and the acquisition and retention of information on the current or past condition, the location and use of the selected device or the current or previous treatment of the selected device at any time during the putting into service and operation process;
(b) elaborated, implemented and maintained plans and programmes for carrying out checks on selected installations and plans and programmes for carrying out maintenance, repair and reconstruction of the selected equipment; and
(c) ensure the use of spare parts of the selected equipment which meet the requirements set out in the specification of the selected equipment.
Scope and manner of implementation of the list of selected devices
(1) Selected installations must be clearly identified before being procured for nuclear installations and must be documented for each nuclear installation in the form of a list of selected installations.
(2) The list of selected devices must identify the individual selected devices in the text section, indicating their safety classes, and shall be broken down by the selected devices in terms of the fulfilment of their safety functions. The drawing part of the list of selected devices shall include:
(a) schematically displayed technological systems and components containing selected equipment, with a distinctive marking of their safety classes and highlighting the boundaries between the selected equipment and other equipment or other parts of the construction; and
(b) the identification data of the selected installations and other data from which the function of the selected installation in the system or the location of the selected installation within the construction of the nuclear installation is clearly evident.
(3) The list of selected devices must include rules for:
(a) the identification of the boundaries between the systems, equipment or parts of the construction of a nuclear installation providing safety functions and other systems of the plant or parts of the construction of a nuclear installation; and
(b) the identification of the boundaries between the different security classes of the selected installations.
(4) The list of selected installations at the design stage of the nuclear installation shall correspond to the agreed project documentation and to the actual implementation of the nuclear installation at the operating stage of the nuclear installation.
(5) Before carrying out a project change in a nuclear installation concerning a selected installation, it shall be established whether the consequences of its implementation will adversely affect nuclear and technical safety and whether changes will occur in the list of selected installations.
Transitional provisions
(1) The quality system and quality assurance programmes must comply with the requirements of this Decree no later than two years after its entry into force.
(2) The quality assurance of selected installations shall be brought into conformity with the requirements laid down in this Decree no later than two years after the entry into force of this Order.
Repeal
Decree No 214 / 1997 Coll., on quality assurance for activities related to the use of nuclear energy and irradiated activities and on the setting of criteria for the classification and distribution of selected equipment into safety classes, is hereby repealed.
Efficacy
This Decree shall take effect on 1 May 2008.
President:
Ing. Drábová, Ph.D. v. r.
Annex to Decree No 132 / 2008 Coll.
Criteria for the classification and distribution of selected equipment into safety classes
1. Criteria for the classification and distribution of selected equipment into safety classes for nuclear installations involving a pressure water reactor
1.1. Selected devices classified in Security Class 1 are devices forming the limit of the pressure circuit of the nuclear reactor coolant, except those devices whose damage can be compensated by a normal coolant replenishment system.
1.2. Selected devices included in Security Class 2 are nuclear fuel coverage, equipment constituting the limit of the nuclear reactor coolant pressure circuit which does not belong to Security Class 1 and equipment fulfilling the safety functions of the system of which they are part, and equipment
1.2.1. for the decommissioning of the nuclear reactor, where appropriate, so as to avoid maximum project accidents as a result of expected operational events, and for the decommissioning of the nuclear reactor to mitigate the consequences of maximum project accidents;
1.2.2. to maintain sufficient coolant for cooling the core of the nuclear reactor during emergency conditions in which the pressure circuit of the nuclear reactor has not been breached and after these conditions have been resolved,
1.2.3. to ensure the removal of heat from the core of the nuclear reactor in breach of the coolant pressure circuit boundary in order to reduce damage to nuclear fuel;
1.2.4. for the removal of residual heat from the core of the nuclear reactor during all operational conditions and under emergency conditions where the integrity of the coolant pressure circuit boundary has not been breached;
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Regulation Information
| Citation | Decree No. 132 / 2008 Coll., on the quality system for the implementation and provision of activities related to the use of nuclear energy and radiation activities and on the quality assurance of selected equipment with regard to their classification in safety classes |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.04.2008 |
|---|---|
| Effective from | 01.05.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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