Decree No. 358 / 2016 Coll.
Ordinance on quality assurance and technical safety requirements and assessment and verification of conformity of selected equipment
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Order
Effective from 01.01.2017
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358
DECLARATION
of 17 October 2016
on quality assurance and technical safety requirements and assessment and verification of conformity of selected equipment
The State Office for Nuclear Safety sets out, pursuant to § 236 of Act No. 263 / 2016 Coll., the Atomic Act, for the implementation of § 24 (7), § 56 (2), § 57 (3), § 58 (9) and § 59 (4):
Subject matter
This decree provides:
(a) the content of the list of selected installations;
(b) the scope and manner of ensuring the quality of the equipment selected in its design, production, assembly, provision, commissioning and operation process;
(c) the types of records of the quality assurance of the selected equipment and the manner in which they are maintained;
(d) the technical requirements for the selected equipment and part of the selected equipment;
(e) requirements for the method of ensuring compliance of the selected equipment and part of the selected equipment with the technical requirements;
(f) requirements for documentation to ensure compliance of the selected equipment and part of the selected equipment with the technical requirements;
(g) the procedures and scope for assessing the conformity of the selected equipment with the technical requirements;
(h) the requirements for documenting the conformity assessment of the selected equipment with the technical requirements;
(i) the individual procedures that may be applied to assess the conformity of the selected equipment with the technical requirements;
(j) the scope and method of checking the conformity of the equipment operated with the technical requirements;
(k) the method of documentation and the content of the documentation for checking the conformity of the equipment operated with the technical requirements; and
(l) the conditions for the assessment of technical safety which must be fulfilled for the issue of a binding opinion by the Office under Article 58 (3) of the Atomic Act.
Terms
For the purposes of this decree:
(a) pressure equipment of a selected device loaded with pressure of the working medium with a maximum working pressure exceeding 0,05 MPa, including elements connected to the components of the pressurised equipment, safety and pressure equipment and other equipment ensuring its operation;
(b) by assembly of pressure equipment a set of several parts, at least one of which is a pressure device which:
1. are connected and implemented in such a way that they are compatible with each other;
2. perform a specified safety function only if all parts of this file are present;
3. are fitted by one supplier; and
4. Serves for joint use as a whole;
(c) by repairing the selected device by intervening in the operated selected device to remove its non-compliant state or the impact of ageing, in which the selected device may be retrofitted to meet the requirements set out in the technical specification of the selected device; and
(d) by maintaining the selected equipment, the activity carried out on the operated selected equipment or part thereof in order to maintain the safe and operable condition of that installation or the activity associated with the replacement of the part of the selected equipment in a detachable manner, unless it is a repair.
Content of the list of selected devices
(1) The list of selected devices must clearly identify the individual selected devices in the text section and indicate the safety class to which they are included.
(2) The drawing part of the list of selected devices shall include:
(a) schematically displayed technological systems and components of nuclear installations containing selected installations;
(b) the security classes of each selected installation are distinguished and the boundaries between the selected installation and other installations or other parts of the construction of the nuclear installation are highlighted; and
(c) identify the selected installations and other data from which their function and location within the nuclear installation are 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 which ensure the performance of safety functions and other systems, equipment 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 equipment shall indicate the selected equipment for which, pursuant to Article 12 (2), the conformity assessment of the selected equipment with the technical requirements ("conformity assessment ') is carried out by an authorised or accredited person.
Scope and method of quality assurance in the process of designing the selected equipment
(1) When designing a selected device, which includes its development, design and design (hereinafter referred to as the design process), the output documentation of the design process (hereinafter referred to as the design of the selected device) shall be processed.
(2) The design process and the design of the selected equipment shall comply with the technical requirements for the selected equipment and part of the selected equipment referred to in Section 9.
(3) Verification of the design process must be carried out
(a) the persons who carried out the design process; and
(b) persons who did not participate in the design process.
(4) The design of the device selected shall specify the following:
(a) acceptance criteria for monitoring and assessing reliability;
(b) criteria for the acceptability of parameters monitored in the controlled ageing process;
(c) the conditions for treatment and operation;
(d) acceptance criteria relating to the performance of the safety function;
(e) a list of the parts of the device selected; and
(f) the technical regulations, technical standards or technical conditions to be applied.
Scope and method of quality assurance in the production and assembly process of the selected equipment
(1) Prior to the start of the production and assembly process of the selected equipment and part of the selected equipment, all technical documentation of the selected equipment as set out in Annex 3 to this Regulation shall be provided to carry out the process.
(2) In the manufacture and assembly of the selected equipment,
(a) proceed in accordance with the design of the device selected;
(b) the technical specifications available for the selected equipment and its changes;
(c) checks are carried out to verify compliance of the selected installation or part thereof with the technical requirements;
(d) the method and course of production and assembly of the selected equipment and part of the selected equipment, including checks, are documented in accordance with the requirements laid down in the design of the selected equipment;
(e) the manner and extent of the examination, verification and validation of the selected equipment,
(f) the selected equipment is identified and maintained in an unmistakable manner;
(g) the available information on the current or previous status, location and use of the selected equipment or the current or previous way of handling it, unless it is a selected installation in accordance with § 12 (3) (e); and
(h) the part of the device selected which is separately supplied in a state enabling verification of the production and assembly process of that part.
(3) After the production or assembly of the selected device has been completed,
(a) checks are carried out on the selected equipment to verify compliance with the technical requirements; and
(b) a final assessment is carried out to verify the conformity of the selected installation with the requirements specified in the design of the selected installation and in the documentation for its manufacture or installation; the final assessment of the pressure equipment assembly shall be carried out after the assembly of the pressure equipment assembly as a whole.
(4) The requirements for the checks and final assessment referred to in paragraph 3 are set out in Annex 6 to this Decree.
Scope and method of quality assurance in the process of procuring the selected equipment and part of the selected equipment
(1) Before procuring a selected device and part of the selected device,
(a) in the procurement documentation, the requirements for the selected equipment and parts of the selected equipment; and
(b) the method of selection and the criteria for evaluating the supplier of the product or service (the supplier).
(2) When procuring the selected device and part of the selected device,
(a) the supplier is evaluated and selected in accordance with the selection method established and the evaluation criteria;
(b) review of the supplier's documentation on the quality assurance of the selected equipment and part of the selected equipment in terms of its accuracy and completeness;
(c) specify the manner and extent of notification of non-conformity by the supplier and the manner in which they are addressed; and
(d) arrangements have been made for the supervision of the supplier, consisting of continuous monitoring and control of processes with regard to compliance with the quality assurance requirements of the selected equipment and part of the selected equipment with the supplier.
Scope and method of quality assurance in the process of putting into service and operation of the selected equipment
(1) When putting into service and operating the selected equipment,
(a) the identification of the selected device and the use of the replacement part of the selected device is documented;
(b) available information on the current and previous status, location and use of the selected device or the current and previous treatment of the selected device;
(c) the design, implementation and maintenance of the plans and programmes for putting the selected equipment into service and its operation;
(d) the identification of the selected equipment allocated in the manufacture or installation is maintained;
(e) the implementation of the activities carried out in accordance with the programmes for putting the selected equipment into service;
(f) the implementation of the activities is planned and carried out in accordance with internal rules and other documentation for operations, including plans and operational control programmes for selected installations, pre-operational and operational programme for controlled ageing and plans and control programmes for the maintenance, repair or modification of selected installations, and the technical requirements laid down in this Decree;
(g) the repair, maintenance or modification of the selected equipment is carried out in accordance with the requirements laid down in the repair, maintenance or modification documentation of the selected equipment;
(h) ensure that the handling and storage of the selected equipment are carried out in such a way as to prevent damage, misuse or destruction of the selected equipment or parts thereof; and
(i) an assessment of the conformity of the change of the selected device, which is the subject of a change in the design of the selected device.
(2) The requirements of paragraph 1 do not apply to the selected equipment referred to in Article 12 (3) (e).
Types of quality assurance records of the selected equipment and their management
(1) The quality assurance of the selected equipment must be documented in particular:
(a) records concerning specific processes;
(b) records of assessments and assessments of non-conformities,
(c) records showing compliance with the quality requirements of the selected equipment, including the requirements for the qualification of personnel carrying out checks and verification of the design of the selected equipment, the quality of its part and the materials used for its manufacture; and
(d) records showing the removal of the identified defects of the selected installation and the way in which it is corrected and records of the non-deleted defects and the way in which they are monitored and evaluated.
(2) The quality assurance record of the selected equipment is permanent or temporary.
(3) A permanent record of the quality assurance of the selected equipment is:
(a) design of the selected device,
(b) a record of the review of the accuracy and completeness of the quality assurance documentation of the selected supplier's equipment;
(c) a record of the current technical condition of the selected installation after its completion;
(d) a record of the current technical condition of the selected installation after its installation and inspection;
(e) a record that the selected equipment is operated, maintained or subjected to checks in accordance with technical requirements, technical specifications, operational control programme, operational programme of controlled ageing, maintenance programme, maintenance procedures or regulatory requirements;
(f) an alert documenting that the person planning, managing or evaluating the processes relating to the design, manufacture and assembly, procurement, putting into service or operation of the selected equipment or part thereof complies with the qualification requirements;
(g) a record documenting the planning and carrying out of maintenance, repair or modification of the selected equipment, including a quality certificate for the spare parts used;
(h) a record documenting that the quality of the equipment originally incorporated, the device being repaired or replaced or the device being changed is in accordance with the technical requirements and technical specifications of the device being selected; and
(i) an alert documenting that the correction of non-conformity has been ensured and preventive measures taken against such non-conformity.
(4) A temporary record of the quality assurance of the selected equipment shall be a record of the quality assurance of the selected equipment which is not a permanent record of the quality assurance of the selected equipment.
(5) A permanent record of the quality assurance of the selected equipment shall be kept from the design of the selected equipment throughout its lifetime.
(6) The records of the quality assurance of the selected equipment shall be kept to the extent and in a way that it is possible to assess at any time whether the condition of the selected equipment or part thereof complies with the relevant technical requirements.
(7) Records from the production and assembly and procuring of the selected equipment must be made during the production and assembly and assembly of the selected equipment and completed before the start of the phase of putting the selected equipment into service.
(8) Records from the start-up stage of the selected equipment shall be made during the start-up of the selected equipment and completed before the start of operation of the selected equipment.
(9) The records shall also include the manner and extent of repair, maintenance or modification of the selected equipment.
Technical requirements for selected equipment and part of selected equipment
The technical requirements for the selected equipment and the part of the selected equipment to be used in its design, manufacture, assembly, putting into service and operation are set out in Annex 1 to this Decree.
Requirements for the method of ensuring compliance of the selected equipment and parts of the selected equipment with the technical requirements
(1) The compliance of the selected equipment and part of the selected equipment with the technical requirements (hereinafter referred to as "compliance assurance") must be carried out and documented in such a way as to ensure the supporting documents and documents necessary to ensure technical safety.
(2) Anyone proposing, producing, assembling, putting into service or repairing a selected installation or part of a selected installation, or maintaining it, and the holder of the authorisation pursuant to § 9 (1) (b) to (h) of the Atomic Act is obliged to provide the supplier with information on the selected installation or part of it, including the type, quantity, condition and time of delivery and the level of quality of the selected installation or part thereof, according to its classification in the safety class.
(3) In ensuring compliance, the authorisation holder shall ensure:
(a) a supply system with the necessary resources and with external and internal communication, including a system of independent mutual control;
(b) the preparation and review of documentation on the quality assurance of the selected equipment and programmes of controlled ageing;
(c) control mechanisms and means of communication within the supply chain for the selected installation or part thereof;
(d) the introduction of a system of checks on the selected installation or part of the corresponding life cycle stage of the selected installation to verify compliance with the prescribed procedures and records of checks;
(e) checking the progress of activities on a selected installation corresponding to the life cycle stage of the selected installation or part thereof under the independent control system of the permit holder and the independent control system of the supplier;
(f) making a final assessment of the selected installation with the technical requirements laid down in the procedures for the production, assembly or repair of the selected installation;
(g) documenting the final assessment of the selected installation as referred to in (f);
(h) verification of compliance with the technical requirements laid down in the maintenance procedures of the selected equipment by the supplier performing the maintenance of the selected equipment;
(i) documentation of verification of compliance with the technical requirements referred to in (h); and
(j) the availability of documentation relating to the selected installation or part thereof corresponding to its actual execution to a pre-determined extent.
(4) The verification of the quality of the materials used and the accuracy and completeness of the technical documentation, the repair and maintenance documentation and the accompanying technical documentation of the selected equipment, including the verification of the final assessment procedures, shall be carried out by natural persons for the selected equipment referred to in Article 12 (2) or part thereof, which:
(a) have achieved a higher education or degree of higher vocational education by successfully completing an accredited training programme in the field of engineering, electrical, construction, or, where appropriate, of a relative, through which they have acquired the theoretical expertise necessary for the performance of these activities, or through a degree of secondary education with a graduate examination in the field of engineering, electrical, construction, or related, and through which they have acquired the theoretical expertise necessary for the performance of those activities; and
(b) have at least five years of experience in the relevant field, if they are individuals with a secondary education degree with a graduate examination, at least three years of experience in the relevant field, if they are individuals with a higher vocational education degree or at least two years of experience in the relevant field, if they are individuals with a higher education degree.
(5) Annex No 2 to this Decree lays down requirements for the way in which conformity is ensured
(a) when designing, manufacturing and assembly of the selected equipment and part of the selected equipment;
(b) when the selected equipment and part of the selected equipment are put into service; and
(c) when operating the selected equipment and part of the selected equipment with technical requirements.
Requirements for documentation of compliance of the selected equipment and part of the selected equipment with technical requirements
(1) The method of design, manufacture, assembly and modification of the selected equipment and part of the selected equipment must be documented to enable conformity assessment to be carried out.
(2) Compliance shall be documented in the compliance documentation in accordance with the requirements laid down in:
(a) Annex 3 to this Decree, if it is on the technical documentation of the selected equipment; and
(b) in Annex 4 to this decree, if it is on the accompanying technical documentation of the selected equipment.
(3) The compliance documentation shall be kept throughout the life of the selected installation.
Procedures and scope for assessing compliance of the selected equipment with technical requirements
(1) Conformity assessment must be carried out before the selected installation is used in a nuclear installation.
(2) The person authorised to carry out the conformity assessment
(a) selected equipment classified in Security Class 1 which forms the boundary of the primary cooling circuit of the nuclear reactor (hereinafter referred to as the primary circuit),
1. pressure vessels, tanks and chillers, including a pressure vessel of a nuclear reactor and a steam generator, operating with radioactive substances having a maximum working pressure exceeding 0,05 MPa and having a volume greater than 10 l; and
2. pumps, pipes and fittings operating with radioactive substances having a maximum working pressure exceeding 0,05 MPa and having a rated luminous intensity greater than DN 70;
(b) selected equipment classified in Security Class 2
1. pressure vessels, tanks and chillers of systems providing nuclear reactor cooling, volume compensation, hermetic space cooling, emergency replenishment, primary circuit cooling and cleaning of the working medium of the pressure circuit operating with radioactive substances with a maximum working pressure exceeding 0,05 MPa and having a volume greater than 10 l;
2. pumps, pipes and fittings of systems ensuring the cooling of the nuclear reactor, volume compensation, hermetic space cooling, emergency replenishment, primary circuit cooling and cleaning of the working medium of the pressure circuit operating with radioactive substances with a maximum working pressure exceeding 0,05 MPa, whose nominal brightness is greater than DN 70;
3. pressure equipment constituting a protective envelope system, including those ensuring the hermeticity of the protective envelope in a basic project accident;
4. pressure equipment for the secondary cooling circuit of a nuclear reactor (hereinafter referred to as the "secondary circuit") where the maximum working pressure of the working medium at working temperature exceeds 4 MPa and whose nominal luminous intensity is greater than DN 200;
5. packaging files for the transport, storage and storage of spent nuclear fuel; and
6. the reinforced concrete construction of the building of the nuclear reactor, including the outline of the installation hatch of the nuclear reactor building, and the steel lining defining the hermetic space; and
(c) selected equipment classified in Security Class 3
1. pressure vessels, tanks and chillers of systems providing normal replenishment, boron regulation and cooling of spent nuclear fuel storage facilities operating with radioactive substances with a maximum working pressure exceeding 0,05 MPa, having a volume greater than 10 l;
2. pumps, pipes and fittings of systems providing normal replenishment, boron regulation and cooling of spent nuclear fuel storage facilities operating with radioactive substances with a maximum working pressure exceeding 0,05 MPa, whose nominal clearance is greater than DN 70; and
3. secondary circuit pressure equipment where the maximum working pressure of the working medium at working temperature above 100 ° C exceeds 4 MPa and whose nominal luminous intensity is greater than DN 200.
(3) Conformity assessment by the manufacturer or importer
(a) a selected device with parameters lower or equal to the values set out in paragraph 2;
(b) electrical equipment selected and automated process control systems selected, including their software (hereinafter referred to as control equipment);
(c) a selected installation which is part of the construction part of a nuclear installation (hereinafter referred to as "the selected construction installation") classified in Security Class 3;
(d) other selected equipment classified in Security Class 2 or 3, if not for the selected equipment referred to in paragraph 2; and
(e) a selected device to cover the fuel element and the design of the fuel file.
(4) The conformity assessment of the selected installation referred to in paragraph 2 (c) may be carried out by an accredited person if the conformity assessment is carried out in accordance with the procedure referred to in Article 15 (1) (e) (1).
(5) In the case of an assessment of the conformity of the assembly of pressure equipment, the assembly shall be assessed as a whole. In assessing the conformity of the pressure equipment assembly, the results of the conformity assessment of each selected device, which are parts of the pressure equipment assembly, shall be used. The conformity assessment of the pressure equipment assembly shall be carried out taking into account the most important safety class to which one of the selected devices, which are parts of the pressure equipment assembly, is included.
(6) A conformity assessment shall be carried out for each part of the device selected separately produced or assembled after manufacture to the extent appropriate to that part of the device selected; This does not apply to parts of a selected device classified in Class 2 or 3 for which the conformity assessment is not prescribed in the design of the selected device to the extent corresponding to that part of the chosen device. In assessing the conformity of the selected equipment, the results of the conformity assessment of the individual parts of the selected equipment separately produced or assembled after production shall be used. The conformity assessment of a part of the selected installation referred to in paragraph 2 (b) may also be carried out by the operator of the selected installation if:
(a) conformity assessment carried out in accordance with the procedure laid down in Article 15 (2) (b) (1); and
(b) the operator of the selected installation shall assess compliance only with the part of the selected installation intended solely for its use.
(7) Conformity assessment shall be carried out including the assessment of source materials and semi-finished products with the technical requirements for such materials and semi-finished products.
(8) A single conformity assessment procedure may always be carried out by only one person carrying out the conformity assessment. Where a combination of conformity assessment procedures is prescribed, individual conformity assessment procedures may be carried out by different persons.
(9) The conformity assessment of pressure equipment safety equipment shall be carried out at least at the same level as the conformity assessment of the equipment selected to protect it.
(10) The conformity assessment procedure of the authorised person, accredited person and operator of the selected installation shall meet the requirements of:
(a) technical standards relating to the competence, consistent activity and impartiality of the bodies carrying out certification of products, processes and services as regards the conformity assessment procedures referred to in Parts 3 to 11 of Annex 7 to this Regulation;
(b) technical standards containing general criteria for the competence of the inspection bodies and for the impartiality and consistency of their inspection activities, as regards:
1. reconciliation of procedures according to section 6.5 And Annex 2 to this Order,
2. the activities listed in points 8.3, 13.6, 13.9.1 and 13.11 of Part A of Annex 2 to this Decree;
3. the conformity assessment procedure set out in Part 2 of Annex No 7 to this Regulation,
4. the procedure for assessing the conformity of part of the selected equipment by the operator as set out in Part 12 of Annex 7 to this Regulation.
(11) Compliance with the requirements of the conformity assessment procedure referred to in paragraph 10 shall be demonstrated by accreditation in accordance with the Act on Technical Requirements for Products.
(12) The condition of the technical safety assessment by the applicant for authorisation, which must be fulfilled for the issue of a binding opinion by the Authority under Paragraph 58 (3) of the Atomic Act, is that the requirements of paragraphs 10 and 11 are met.
Conformity mark
(1) The manufacturer or importer of the selected device or part of the chosen device must ensure, in the course of carrying out the conformity assessment, the marking of the selected device or part of the selected device with the manufacturer's identification; Where the participation of an authorised or accredited person is provided for in the conformity assessment procedure, identification of that person shall also be attached.
(2) The marking of conformity shall confirm the conformity of the selected device or part of the selected device with the technical requirements and compliance with the chosen conformity assessment procedure laid down in this Regulation.
(3) The mark of conformity shall be affixed to the device or part of the device selected in an indelible and legible manner and shall not be less than 5 mm in size. The conformity mark may be marked in the accompanying technical documentation of the selected device or part of the selected device, if it does not allow its connection to the selected device or part of the selected device of their design or dimensions, or if it is not accessible after installation of the selected device or part of the selected device.
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Regulation Information
| Citation | Decree No 358 / 2016 Coll., on requirements for quality assurance and technical safety and assessment and verification of conformity of selected equipment |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.11.2016 |
|---|---|
| Effective from | 01.01.2017 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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