FEDERAL ENVIRONMENTAL, INDUSTRIAL
AND NUCLEAR SUPERVISION SERVICE
ORDER
dated February 3, 2012. N 80
ABOUT APPROVAL OF THE PROVISION ON QUALITY MANAGEMENT SYSTEM
OF THE FEDERAL ENVIRONMENTAL, INDUSTRIAL AND NUCLEAR SUPERVISION SERVICE
IN THE FIELD OF STATE REGULATION OF SAFETY IN THE USE OF ATOMIC ENERGY
According tothe “Provision on the Federal Environmental, Industrial and Nuclear Supervision Service”,
approved by the Decree of the Government of the Russian FederationNo.401,dd. July 30, 2004,we hereby order as follows:
1. The enclosed Provision on quality management system of the Federal Environmental, Industrial and Nuclear Supervision Service in the field of state regulation of safety in the use of atomic energy shall be approved.
2. OrderoftheFederalEnvironmental, IndustrialandNuclearSupervisionService datedJune 24, 2008, No 442 “About approval of and putting into effect of Provision on quality management system of the Federal Environmental, Industrial and Nuclear Supervision Service in the field of state regulation of safety in the use of atomic energy” shall be repealed.
Head of the Federal Environmental,
Industrial and Nuclear Supervision Service
N.G. KUTYIN
Approved by
the Order of the Federal Environmental,
Industrial and Nuclear Supervision Service,
dated February 3, 2012, No 80
PROVISION ON QUALITY MANAGEMENT SYSTEM
OF THE FEDERAL ENVIRONMENTAL, INDUSTRIAL AND NUCLEAR SUPERVISION SERVICE
IN THE FIELD OF STATE REGULATION OF SAFETY IN THE USE OF ATOMIC ENERGY
Policy
in the field of quality management for state
regulation of safety in the course of use of atomic energy
PolicyoftheFederalEnvironmental, IndustrialandNuclearSupervisionServiceinthefieldof qualitymanagementforstateregulationofsafetyinthe course ofuseofatomicenergyistobecreatedandimplemented onthebasisoffundamentalprinciples,provisionsandrequirementsidentified and established by the Constitution of the Russian Federation, the federal laws, international conventions, decrees and executive orders of the President of the Russian Federation, and by other regulatory legal acts of the Russian Federation applied in the field of the use of atomic energy and with due consideration of the IAEA recommendations and of other international organizations.
Mainpurposespursuedby Rostechnadzor inthecourseofimplementation of stateregulationofsafety in the use of atomic energy are as follows:
forming of requirements which adherence to guarantees provision of safety to the employees (personnel) of nuclear facilities, to public and environment from inadmissible impact ofradiation exposure in the course of atomic energyuse for peaceful purposes, and prevention of unauthorized management with nuclear and radioactive materials and radioactive waste;
supervision over implementation of these requirements.
Aimingtoachievethepurposesprovided,Rostechnadzorisfollowing the established procedure to implement regulatory and legal framework with regard to safety in the course of the use of atomic energy, licensing activity (permits issue) and the federal state supervision in the field of the use of atomic energy.
ForthispurposeRostechnadzorcreatesandconsistentlyimprovesSystem on quality management that satisfies the requirements of regulatory legal acts applied in the field of the use of atomic energy and the IAEA recommendations.
ThegroundsforimplementationoftheprovisionsofthepresentPolicyinthefieldofqualitymanagement – isthe comprehension reached by the every employee of Rostechnadzor for its personal responsibility for the quality of his/her own work and for safety of nuclear facilities.
ThemanagementstaffofRostechnadzor takesallreasonableeffortsfor strictimplementationandimprovement of the present Policy in the field of quality management to the effect that it corresponds with modern requirements and to make it effective.
I. General provisions
1. The presentProvision on quality management system of the Federal Environmental, Industrial and Nuclear Supervision Service in the field of state regulation of safety in the use of atomic energy (hereinafter referred to as - Provision) is developed:
1) incorrespondencewiththerequirementsof regulatory legal acts of Rostechnadzor;
2) inpursuanceofrecommendationsfromWesternEuropean Nuclear Regulators Association (WENRA) and documents of the IAEA:
а) IAEA Safety Requirements“The management system for facilities and activities”, N GS-R-3;
б) IAEA Safety Guideline“Application of the management system for facilities and activities”, N GS-G-3.1.
2. ThepresentProvisiondefinesgeneralprinciples fororganizationofqualitymanagementsystemoftheFederal Environmental, Industrial and Nuclear Supervision Service in the field of state regulation of safety in the use of atomic energy.
3. ThepresentProvisionisconsideredtobealegalactinthesphereofqualitymanagementto be applied in the field of state regulation of safety in the course of the use of atomic energyfor the employees of:
1) Departmentonsafetyregulationofnuclearpowerplantsand nuclear research installations;
2) Departmentonsafetyregulationofnuclearfuelcyclefacilities, nuclearpowerinstallationsofships and radiation-dangerous facilities, for supervision over accounting for and control of nuclear materials and radioactive substances and over physical protection;
3) Department on state supervision over construction;
4) interregionalterritorialbodiesof Rostechnadzor onsupervisionover nuclear and radiation safety;
5) territorialbodieswhichperformstatesupervisionoverconstructionandre-construction of nuclear facilities;
6) structuralsubdivisionsofRostechnadzorHeadquarterswhichperforminteractionwithstructural subdivisions and territorial bodies of Rostechnadzor, listed in sub-paragraphs 1 - 5 of the present paragraph, as well as:
а) Administration and General ServicesDepartment;
b) Oversight and Licensing Support Department;
c) Financial Department;
d) LegalDepartment;
e) DepartmentonInternationalRelations.
4. ThesystemonqualitymanagementofRostechnadzor inthesphereofstateregulationofsafetyin the course of the use of atomic energy (hereinafter referred to as -the system of quality management) covers:
1) organizationalstructureofRostechnadzor, its’ employees authorities and responsibility;
2) processes, proceduresandresourcesrequiredandefficienttoachievegoalsidentifiedbythePolicyinthefieldofqualitymanagement for the state regulation of safety in the course of the use of atomic energy (hereinafter referred to as - Policyinthefieldofqualitymanagement);
3) qualitymanagementsystemsofinterregionalterritorial bodiesofRostechnadzoronsupervision overnuclearandradiationsafety, territorialbodiesofRostechnadzorimplementingstatesupervision over constructionduring construction and re-construction of nuclear facilities, as well as quality management systems from the subordinated organizations, which are developed and implemented on the basis of the present Provision and Policy in the field of quality management.
5. The structure of the System on quality management includes the following processes:
5.1. Main processes:
1) "Regulatory and legal framework with regard to safety in the field of the use of atomic energy";
2) "Licensing(permits issue) activity in the field of the use of atomic energy ";
3) "The Federal state supervision in the field of the use of atomic energy".
5.2. Management processes:
1) "Recourses management ";
2) "Evaluation of quality management system".
5.3. Supporting processes:
1) "Оrganization and carrying out of scientific research";
2) "International activity";
3) " Documentation management ".
The block diagram of interactions between the processes included into the system on quality management is presented in Appendix to the present Provisions.
6. The system onquality management is intended for implementation of Rostechnadzor authorities on safety regulation in the course of the use of atomic energy; it is being implemented during achievement of the following tasks:
1) provisionofthecommonunderstandingofthekey-aspects of safety culture applied in the system of Rostechnadzor;
2) promotionofconstructiveandcriticalattitudeofRostechnadzoremployees towards provision of adequate quality of work during their implementation of official duties;
3) determinationofconditionsand requirements to employees required for successful accomplishment of the tasks assigned.
7. Thefollowing provisions (principles) are fundamentalsofthesystemonqualitymanagement:
1) enhancementandimprovementofeffectivenessofthestatepolicyandregulatoryand legal framework within the limits of the established sphere of activity;
2) separationofjurisdictions betweenRostechnadzor, otherauthoritiesforstate regulation of safety in the course of the use of atomic energy and organizations with activity is concerned with the use of atomic energy;
3) interactionofRostechnadzorwithotherauthoritiesforstate regulation of safety in the course of the use of atomic energy, authorities for management of the use of atomic energy, and with the interested legal entities and individuals;
4) prohibitionforRostechnadzorwithin its implementation of state regulation of safety in the course of the use of atomic energy ofunreasonablerestrictionof activity performed byoperatingorganizationsorbyotherorganizations that are performing works and rendering services in the field of the use of atomic energy;
5) applicationofthegradedapproachforidentificationofscopesandformsofthestateregulationofsafetyinthe course ofatomicenergyuse according to the potential danger and safety level condition at nuclear facilities (hereinafter referred to as -NF);
6) provisionoftransparencyofactivityonnuclearandradiationsafetyregulationon the basis of accessibility ofinformation concerned with condition of nuclear and radiation safety and Rostechnadzor activity (excluding information considered to be the state secrets);
7) provisionoftheadequatequalityoftheregulatoryactivitybygood faith fulfillment of obligations and office duties by all employees of Rostechnadzor;
8) liabilityoftheauthorsforthestandardofperformancein the course of regulatoryactivitycarrying out and independently from the responsibility of persons implementing works’ quality control;
9) observanceofprofessionalstandardsofethicsandbusiness behaviour rules by all employees of Rostechnadzor;
10) provisionbyall-levelsmanagementstaffandwithinthelimitsoftheircompetenceofplanningofactivity thatenvisagesadequatepreparationtoworks’ implementation, sharing of responsibility and periodical reporting about all works performed and with analysis of these works results;
11) Head of Rostechnadzor promotionofemployeesthatare activelyapplying and perfecting the system on quality management; it shall be performedwithintheestablishedprocedure.
II. MainprocessesoftheSystem on quality management
8. The process"Regulatory and legal framework with regard to safety in the field of the use of atomic energy"
8.1. Thecontent/scope (purposes) oftheprocess"Regulatory and legal framework with regard to safety in the field of the use of atomic energy"–development and approval of regulatory legal acts of Rostechnadzor (or introduction of amendments into effective regulatory legal acts), including:
1) federalrulesandregulationsinthefieldoftheuseofatomicenergy in compliance with legislation of the Russian Federation;
2) AdministrativeRegulationsofRostechnadzorfor performing of the state functions (state functions presentation);
3) requirements to the structure and contents of documents, substantiating safety ensuring of nuclear installations, radiation sources, storages of nuclear materials and radioactive substances, storages of radioactive wastes and (or) safety within the frames of activities performed in the field of use of atomic energy that are necessary for licensing of activities in this field, as well as the procedure for execution of the review of the above-mentioned documents;
4) other regulatory legal acts within the established sphere of activity in correspondence with “Provision on the Federal Environmental, Industrial and Nuclear Supervision Service” approved by the Decree of the Government of the Russian Federation dated July 30, 2004, No 401.
8.2. Themainresultsandthe effectivenessindicatorsofthisprocessarelisted as follows:
1) preparationofthesubstantiatedand specificrequirementsforsafetyensuringof NFandtypes of activity in the field of the use of atomic energy;
2) timelinessofadoptionofthe requisitemeasuresforperfectionofregulatoryandlegal framework on the grounds of regulatory activity analysis fulfilled in the sphere of the use of atomic energy;
3) preparationandapprovalofregulatorylegalactsthatinclude procedures for performing of tasks, functions and authorities entrusted to Rostechnadzor;
4) considerationofnationalandinternationalexperienceofworkincludingrecommendations from international organizations on issues of state regulation of safety in the field of the use of atomic energy.
8.3. Thefollowingactsidentifyprocedure for this process performance:
1) Federal law dated November 21, 1995. No 170-FZ "On the use of atomic energy";
2) “Provisionondevelopmentandapprovalofthefederalrulesandregulationsinthefieldoftheuseofatomic energy”, approved by the Decree of the Government of the Russian Federation dated December 1, 1997, No 1511;
3) “Rules for development of legal acts of the federal executive authorities and for their state registration”, approvedbytheDecreeoftheGovernmentoftheRussianFederation,dated August13, 1997, No 1009;
4) “Provision on the Federal Environmental, Industrial and Nuclear Supervision Service”, approved by the Decree of the Government of the Russian Federation dated July 30, 2004, No 401;
5) DecreeoftheGovernmentoftheRussianFederationdatedMay16, 2011, No 373 "On development andapprovalof the Administrative regulations for performing of the state functions and of the Administrative regulations for presentation of state services ";
6) “Provisiononprocedureofregulatorydocumentsdevelopmentofthe Federal Environmental, Industrial and Nuclear Supervision Service”, approved by the Order of Rostechnadzor dated April 14, 2005, No 219;
7) “Rulesondevelopmentandamendingofsafetyregulationprovisionsfornuclearfacilities” (SafetyGuidelines), approved by the Order of Rostechnadzor dated January 13, 2010, No6;
8) “Theprocedureforthefederalrulesandregulationdevelopmentbythe Federal Environmental, Industrial and Nuclear Supervision Service and the requirements for their execution and data presentation”approved by the Order of Rostechnadzor dated January 24, 2011, No 27.
9. The process “Licensing of activity (permits issue) in the field of the use of atomic energy ":
9.1. Thecontent/scope (purposes) ofthe"Licensing ofactivity (permits issue) in the field of the use of atomic energy”process:
1) granting of a right to the operating organizations (hereinafter referred to as - OО), as well as to organizations performing works and rendering services in the field of the use of atomic energy, to performa particular (specific) type of activity upon the condition to guarantee safety of NF and of works under implementation (services rendered) by means of licensing to perform activities in the field of the use of atomic energy (hereinafter referred to as – licenses);
2) grantingofarighttoperformworksin the field of the use of atomic energy to the NF personnel by means of issue of relevant authorizations (permits).
9.2. Typesofactivitiestobesubjectforlicensing by Rostechnadzor within the limits of own competence:
siting, construction, operationanddecommissioningof nuclear installations, radiation sources, storages for nuclear materials and radioactive substances, storage facilities of radioactive wastes;
nuclearmaterialsandradioactivesubstancesmanagementincludingexplorationandproductionofuraniumores; duringnuclearmaterialsandradioactivesubstancesproduction, use, reprocessing and storage;
radioactivewastemanagementduringstorage, reprocessing, transportation and disposal;
useofnuclearmaterialsand (or) radioactivesubstancesinthecourseofimplementation of research and development and development and engineering works;
designandconstructionofnuclearinstallations, radiation sources, storages for nuclear materials and radioactive substances, storage facilities of radioactive wastes;
constructionandmanufacturingofequipmentfornuclearinstallations, radiation sources, storages for nuclear materials and radioactive substances, storage facilities of radioactive wastes;
execution of the review of design, construction and process documentation, as well as documentation, substantiating nuclear and radiation safety of nuclear installations, radiation sources, storages of nuclear materials and radioactive substances, storages of radioactive wastes and safety of management with nuclear materials, radiation substances and radioactive wastes.
9.3. Themainresults, efficiencyandeffectivenessindicatorsofthisprocessarelisted as follows:
1) inthecourseoflicensegrantingtoOO, andtoorganizationswhich are performing works and rendering services in the field of the use of atomic energy:
а) provisionofcompleteness of the analysis for compliance of the package of application documentation with the requirementsestablished;
b) objectiveness of the overall assessmentof documentationpresented by the Applicant;
2) havinggrantedthelicensetoOOandtoorganizationswhich are renderingservicesandperforming works in the field of the use of atomic energy:
а) provisionofcompletenessofthe analysisofthe license conditions fulfillment;
b) provisionofcompletenessofthe analysisofcompliancewith requirements to NF safety ensuring.
9.4. Thefollowingactsidentifyprocedure for this process performance:
1) Federal law dated November 21, 1995. No 170-FZ "On the use of atomic energy";
2) “Provisionsonlicensingofactivityinthefieldoftheuseofatomicenergy”, approvedby the Decree of the Government of the Russian Federation, dated July 14, 1997. No 865;
3) “The procedure for issuance of the permits that give rights to the employees of research reactors, critical and sub-critical test facilities to perform works in the field of the use of atomic energy”, approved by the Order of the Ministry of Natural Resources and Environment dated May 17, 2010. No 165;
4) “The procedure for issuance of the permits that give rights to the employees ofnuclear power plants to perform works in the field of the use of atomic energy”,approved by the Order of the Ministry of Natural Resources and Environment, dated January 29, 2009. No 13;
5) “The procedure for issuance of the permits that give rights to the employees of nuclear fuel cycle facilities with nuclear-hazardous and radiation-hazardous areas, of the enterprises (organizations) operating industrial reactors, of the enterprises (organizations) that are performing transportation of nuclear materials, radioactive substances or the products made on their basis, to perform works in the field of the use of atomic energy”, approved by the Order of the Ministry of Natural ResourcesandEnvironment,datedJuly 22, 2009. No 222;
6) “The procedure for issuance of the permits that give rights to the employees of storage facilities of radioactive waste (the specialized enterprises on radioactive waste management) and the enterprises (organizations, institutions) operating radiation sources,to perform works in the field of the use of atomic energy”, approvedbytheOrderoftheMinistryofNaturalResourcesandEnvironment,datedMarch 26, 2010. No 90;
7) “The procedure for issuance of the permits that give rights to the employees ofships with nuclear power installations, to the employees ofenterprises of the shipbuilding industry that are performing construction and repair of civil ships with nuclear power installations, to the employees ofenterprises (organizations) operating test benches of nuclear power installations,to perform works in the field of use of atomic energy”, approvedbytheOrderoftheMinistryofNaturalResourcesandEnvironmentdatedJune 1, 2010. No 189;
8) “AdministrativeregulationsoftheFederalEnvironmental, IndustrialandNuclearSupervisionServiceforperformingofthestatefunctionon licensing of activities in the field of the use of atomic energy”, approvedbytheOrderoftheMinistryofNaturalResourcesandEnvironment,datedOctober 16 2008. No 262.
10. The process "The Federal state supervision in the field of the use of atomic energy".
10.1. Thecontent/scope (purposes) oftheprocess "TheFederalstatesupervisioninthefieldoftheuseofatomicenergy"–checkingoffulfillmentbyOOaswellasbyorganizationswhicharerenderingservicesandperformingworksinthefieldoftheuseofnuclearenergyofrequirementstosafetyensuring, confirmationofcompletenessandreliabilityofinformationonsafetyconditionpresented toRostechnadzorandtakingactionsonprevention, revealing and well-timed elimination of violations in the course of safety ensuring.
10.2. Rostechnadzorperformsoversightandsupervision over:
1) over adherence to the regulations and rules in the field of the use of atomic energy, over conditions of permits (licenses) for performance of works in the field of use of atomic energy;
2) over nuclear safety, radiation safety, technical safety and fire safety at nuclear facilities;
3) over physical protection of nuclear installations, radiation sources, storage facilities for nuclear materials and radioactive substances, over the systems of the state unified accounting and control of nuclear materials, radioactive substances and radioactive wastes;
4) over fulfillment of the Russian Federation international obligations related to safety in the field of use of atomic energy;
5) over condition of anti-terrorist protection of nuclear installations, radiation sources, storage facilities for nuclear materials and radioactive substances;
6) over adherence (within the limits of competence) to the requirements of the legislation of the Russian Federation in the field of radioactive wastes management;
7) over timely return of the irradiated fuel assemblies of nuclear reactors and the derived products to the supplier country, which is contracted by the RF on the basis of an international treaty that envisages import of irradiated fuel assemblies of nuclear reactors to the RF for interim storage and recycling on condition of return of the derived products (within the limits of competence).
10.3. Themainresults, efficiencyandeffectivenessindicatorsofthisprocessarelisted as follows:
1) efficientresponseofRostechnadzoronviolationsinthefieldofthe useofatomicenergy; comprehensive, full-scopeand reliablerevealing of these violations causes; correspondence of time frames for violations causes elimination and sanctions adopted with their nature and hazard impact to safety;
2) improvementoftheoversightandsupervisionactivityindicatorswith the help oforganizationandcarrying out of checking (inspections) in correspondence with plans and programs of inspections under development;
3) implementationbytheOOaswellasbyorganizationswhicharerenderingservicesandperformingworksinthefieldoftheuseofatomicenergyof restrictive, preventive, and compensating measures directed at elimination of both violations revealed and its causes in compliance with inspections results and evaluation of these measures efficiency and effectiveness;
4) full-scopeandwell-timedimplementationbyOOaswellasbyorganizationswhicharerenderingservicesandperformingworksinthefieldoftheuseofatomicenergyof instructions issued and elimination of reasons of the violations revealed.
10.4. Thefollowingactsidentifyprocedure for this process performance:
1) Federal law dated November 21, 1995. No 170-FZ "On the use of atomic energy";
2) Federal law dated December 26, 2008 No. 294-FZ “On Protection of Rights of Legal Entities and Individual Entrepreneurs When Implementing the State Control (Supervision) and Municipal Control”;
3) FederallawdatedDecember30, 2009. No 384-FZ "Technical Regulations on safety of buildings and civil structures";
4) “Provision on the Federal State Supervision in the Field of Use of Atomic Energy”, approved by the Decree of the Government of the Russian Federation, No 401 dated July 30, 2004;
5) “Provisiononimplementationofthestate supervision over constructionin the Russian Federation”, approved by the Decree of the Government of the Russian Federation dated February 1, 2006. No 54;
6) “Provisiononorganizationofthestatesupervisionoversafetyin the course of the use of atomic energy”, approved to the Order of Gosatomnadzor dated December 17, 1998. No 99;
7) “Instructiononimplementationofsupervisionoversafetyinthecourseoftransportationofnuclearmaterials”, approvedbytheOrderofRostechnadzor, datedAugust26, 2004. No 14;
8) “The procedure for checking in the course of implementation of state supervision over construction and rendering of a conclusion about compliance of the capital construction objects which have been built,reconstructed and repaired, with the requirements of Technical Regulations (rules and regulations), other legal acts and design documentation”,approvedbytheOrderofRostechnadzor, datedDecember 26, 2006. No 1129;
9) “Theprocedureforworks forming and management in the course of implementation of state supervision over construction”, approvedbytheOrderofRostechnadzor, datedDecember26, 2006. No 1130;
10) “Theprocedureforkeepingofgeneraland (or) specialregistrationbookforaccountingofworksimplementationduringconstruction, reconstruction, capital repair of the capital construction objects”, approvedbytheOrderofRostechnadzor, datedJanuary12, 2007. No 7;