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Management
The Quality Management Manual (QM Manual, QMM) in hand describes the quality policy and
the quality principles of Gesellschaft für Anlagen- und Reaktorsicherheit (GRS) gGmbH and the
quality management system (QM system) that has been defined for their realisation and has
been certified according to DIN EN ISO 9001:2015.
The Quality Management Programme (QM Programme) comprises the following internal QM
documents:
• Part 1: QM manual
• Part 2: Process descriptions
• Part 3: Technical instructions and standard documents
An integral part of the QM programme of GRS is formed by the Handbook of the Geoscientific
Laboratory of GRS (GRS Laboratory) that has been accredited according to DIN EN ISO/IEC
17025:2005 and the Handbook of the Inspection Body of GRS that has been accredited
according to DIN EN ISO/IEC 17020:2012.
The current version of the QM manual is considered as being in force from the moment it has
been approved.
The QM manual is saved in pdf format to the servers of GRS by the Key Quality Manager of
GRS (KQM) and is accessible via the intranet of GRS (http://grs-portal).
The central GRS intranet page on quality management gives all staff at GRS quick access to all
current versions of the internal QM documents. If required, the documents can be printed out.
Print-outs of internal QM documents have to be seen as being for information purposes and
only reflecting the status as at the time of their printing. As a rule, it is always the released
electronic version that is to be considered as formally binding. An integrated document
administration system ensures that any invalid versions of the internal QM documents remain in
existence over their entire period of retention.
Through the internal online news bulletin GRS-Intern, the staff of GRS are informed by the KQM
about the release of new versions of the QM manual. The release of an amended manual
automatically invalidates the previous version.
For better readability of the text, all references to functions in this manual are uniformly used in
the generic masculine form, e.g. Quality Manager of Division (QMD). This neutralising
formulation may equally refer to male and female individuals.
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TABLE OF CONTENTS
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1. BUSINESS POLICY
GRS directs its activities at controlling potential technical risks by a high level of safety culture
and minimising the risk to man and the environment. To this end, it assesses the safety of
technical installations and of corresponding preventive actions for hazard control and the
minimisation of risks, taking into account the latest assured scientific and technical results. It is
thereby guided by the most stringent national and international standards and contributes to
their further development.
The actions of the staff of GRS are based on the values contained in the following principles.
• GRS respects the social values and norms. The social ideals are responsibly included in the
business policy of GRS and the management of the company is made transparent.
• GRS respects and promotes environmental protection and implements environmental
objectives consistently in all internal and customer-related activities.
• GRS deals with issues of public debate. It takes justified criticism and the concerns of the
public into account in its key activities and projects. It actively contributes to public opinion
and decision-making by providing appropriate and technically correct information. It
respects the claim of the public to be given prompt, correct and comprehensible information
about safety-related facts.
• GRS is – as described in the articles of associations – a science and research institution. It
conducts its own as well as customer-initiated research in the fields of nuclear safety, waste
management, plant reliability and security, radiation and environmental protection. GRS
follows the national and international development of the state of the art in science and
technology and all rules and regulations that are relevant to its working areas. The
development of these issues is considered in the application-oriented work of GRS. GRS
uses secure data and verified and validated methods and models. GRS reveals the
boundaries and uncertainties of its work results.
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• GRS carries out its work according to the current state of the art in science and technology
by deploying technically competent staff. The tasks are performed in an efficient way and
aware of the required quality. Attitude and behaviour of its staff are characterised by:
• objectivity,
• consistency and vigilance,
• a critically questioning attitude,
• openness and transparency,
• know-how transfer,
• interdisciplinary communication,
• internationality,
• commitment and responsibility.
• GRS promotes creativity of its staff. It fosters performance and innovation potential of its
staff and supports their professional and personnel development.
• GRS is open to national and international scientific cooperation. It collaborates with
technically competent national and international partners to enhance its own technical
competence, substantiate its statements, and harmonise different requirements – especially
for nuclear safety and waste management – at international level. GRS therefore strives for
forming strategic alliances in order to use the available national and international scientific
potential effectively by way of synergy effects, e.g. by the concentration of resources.
• GRS presents the results of its work in a justified, conclusive, transparent and
comprehensible manner and communicates them to its customers in a way to draw direct
practical benefit.
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1.2 Statement of Commitment
The management system of GRS is based on the requirements of the DIN EN ISO 9001:2015
standard, the legal and commercial boundary conditions (such as DIN EN 16247-1) as well as
the GRS internal specifications (QM manuals according to ISO 9001, ISO 17020 and ISO
17025, organisation manual, etc.). GRS respects the Safety Standards of the IAEA, and
especially those of the Safety Guides for the management of regulatory bodies.
This quality management manual describes the quality management system (QM system)
established at GRS.
The terminology used within the framework of the QM system is based on the definitions of the
standards on quality management and is explained in a glossary pertaining to the QM manual.
The QM system applies to all areas of research and development, safety evaluation and project
coordination in the field of process- and reactor safety, waste management, final disposal,
decommissioning and environmental protection. It is considered as binding to and directly
applicable by all staff at all company locations. Where appropriate, it is made accessible also to
other interested parties.
The QM system applies to all core processes at GRS as well as to the management and
support processes implemented for their control and support.
The general management commits itself and all staff to adhering to the quality policy described
in this QM manual and to the continual improvement of the QM system. The quality policy
commits each member of staff to a way of working in which quality assurance represents an
important basis of the company's activities.
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2. CONTEXT AND COMPANY PROFILE
GRS has to consider and comply with the requirements and expectations of the interested
parties listed below which could affect the organisation. The relevant activities and
responsibilities are described in the QM manual and in process descriptions which are
accordingly communicated to the staff.
Shareholders
Executive Bodies
Staff
The permanent staff of GRS are highly qualified and come from different fields of science and
technology, among them physics, mechanical engineering, process engineering, materials
science, civil engineering, electrical engineering, reactor technology, meteorology, chemistry,
biology, mathematics, computer science, and earth sciences.
GRS thus covers the entire spectrum of qualifications that are requisite for all its activities.
Company Locations
GRS is headquartered in Cologne. Other company locations are Garching near Munich, Berlin
and Braunschweig. The company locations are equipped with high-performance IT systems and
are networked via an extensive communication platform that can be also used by its customers
under certain stipulated conditions.
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Customers
Being one of the Federal Government's authorised expert organisations, GRS provides the
Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety
(BMUB) and the Federal Office for Radiation Protection (BfS) at all times with available scientific
and technical expertise and conducts its own research and development work. GRS keeps at
hand a number of expert staff and the appropriate operational equipment commensurate to
longer-term requirements.
On behalf of the Federal Ministry for Economic Affairs and Energy (BMWi), GRS supervises
reactor and basic safety research and conducts its own research and development work. By
further development of the state of the art in science and technology, it contributes to improved
analysis and assessment of safety and risks of technical plants and processes. Consequently, it
guarantees its independent expert competence and expertise.
GRS also works on behalf of other national and international organisations, which benefit from
the knowledge, methods and experience of GRS in order to fulfil their responsibilities for safety
and environmental protection.
IRSN
The French Technical Safety Organisation (TSO) IRSN (Institut de Radioprotection et de Sûreté
Nucléaire) is the prime partner of GRS. The purpose of the collaboration is to bring in the
scientific and technical expertise of GRS and IRSN into joint European projects. It furthermore
serves for the concentration of scientific and technical resources and the development of
common safety objectives. Together with other European technical safety organisations and
associated members they form the European Technical Safety Organisations Network
(ETSON).
RISKAUDIT
RISKAUDIT, a non-profit European Economic Interest Grouping (EEIG), was jointly founded in
1992 by GRS and its French partner IRSN with its head office in Paris. Currently, the activities
of RISKAUDIT are concentrated on the nuclear power plants in Central and Eastern Europe and
in the New Independent States. RISKAUDIT is the contractor mostly for joint EC and EBRD
projects of IRSN and GRS.
Other Partners
Furthermore, GRS closely collaborates with other European and international organisations
(e.g. EC, IAEA, OECD, ETSON). This commitment is also reflected by numerous bilateral
cooperation agreements.
Subcontractors and consortium members which are commissioned by GRS with solving specific
tasks on a project-related basis in agreement with the customer are also considered as GRS
partners.
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Customers
2.2 Organisation
Organisational Structure
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Project Organisation
The technical project leader (TPL) is responsible for planning, implementation, completion and
assessment of the project that he supervises. He is the contact person and the coordinator of
the technical work for the customer, partners and the GRS departments involved. Furthermore,
the technical project leader releases the technical part of the project results. Within the handling
of a project, the department head (DPH) is responsible for the technical release and quality of
his work packages.
In case of cross-divisional projects, the general management appoints the technical project
leader and the division head (DVH) responsible for the project. The latter is responsible for
supporting the technical project leader in the implementation of cross-divisional activities and
assessment of the overall project results. In case of projects that are of particular strategic
importance, the general management reserves the right to set up a specific project organisation
for the duration of the project.
For all other projects, the technical project leader is appointed by the division head responsible
for the project. For all project-related management and controlling tasks, the technical project
leaders are assisted by a project manager (PM) from the corresponding organisational units. If
large-scale projects deviate significantly from the line organisation of GRS, the organisation,
responsibilities and processes including the documentation are to be arranged accordingly.
The GRS mission statement describes the Corporate Identity of the company (vision and
mission) and presents the basis for the concrete objectives and strategies for achievement of
the targets (see Section 2.4). The mission statement of GRS is illustrated in Fig. 2.
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VISION
We want to be the first choice of customers
MISSION
from the public sector in Germany and
abroad who are in need of research, We protect man and environment
methods, analyses or assessments by advancing the safety of technical
to enhance the safety of nuclear and installations
non-nuclear installations.
• We want to consolidate and enhance the Our work is to comply with the highest
role of GRS as the German Federal scientific standards.
Government‘s central expert organisation.
• We want to strengthen the position of GRS To achieve this, we are guided by the
as an important research organisation following values:
both in Germany and abroad. • independence and objectivity,
• We want to further expand the role • common public interest,
of GRS as an internationally operating
• reliability and responsibility,
Technical Safety Organisation.
• alertness,
• We want to expand the involvement
of GRS in the non-nuclear field. • openness and appreciation.
Permanent progresses in science and technology as well as political and societal dynamics are
the crucial external factors challenging the GRS business policy. Against the background of the
changing political and legal boundary conditions regarding the peaceful use of nuclear energy at
home and abroad, the complexity of the interrelated problems in connection with future energy
policies – taking climate change into account, and the changing values in the world of work and
society – GRS faces today the following tasks:
• to retain and to enlarge its technical competence,
• to open up new environment-oriented fields of activity and services,
• to optimise its business processes, and
• to conduct its own research.
Ecological, economic and social aspects are considered in all strategic actions of GRS as the
basis for a sustainable development of the company. GRS is committed to adhering to socially
and environmentally relevant rules and standards (such as DIN EN 16247-1). The same is
expected of its subcontractors. The company places great value on energy efficiency and
encourages its staff to use recyclable products.
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As an expert organisation in nuclear safety and disposal research, GRS has a leading position
in Germany. Enhancement of its role in these fields at the European level within the framework
of ETSON is another strategic target of GRS.
The prerequisite to this is the development of a corporate and knowledge culture that will
encourage acquirement, development and transfer of scientific competence as well as creativity
and innovative capability. This process is supported by the GRS Development Centre.
Against this background, a target system has been developed from the mission statement,
revealing concrete targets and strategies for achievement of the targets (see Fig. 3).
Targets
• Research projects dealing with fundamental safety- • Application of know- • Participation in shaping • Efficient use of
related and scientific issues ledge and methods and of an European and resources
• Examination and clarification of safety issues provision of expert global TSO network • Improvement of
advice in the • Contribution in
requiring a long-term development of methods capacity management
environmental field establishing safety
• Advancement of the state of the art in science and • Business management
• Use of synergy effects standards
technology and project planning
• Advice in environmental • Acquirement and
• Active contribution to the shaping of the research development of
protection issues
and development landscape knowledge
• Research and
• Collaboration in drafting of safety requirements and • Reinforcement of
development work in
guidelines scientific kudos
radiation protection
issues • Effective human
resource development
Fig. 3: Target system of GRS with targets and strategies for achievement of the targets
The topics with different external and internal issues concern all GRS staff in accordance with
their respective responsibility within the process map of GRS.
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Mitigation of Disposal Risks
• Research projects dealing with fundamental scientific issues
• Advancement of the state of the art in science and technology
• Active contribution to the shaping of the research and development landscape
• Collaboration in drafting of safety requirements and guidelines
Ensuring Profitability
• Efficient use of resources
• Improvement of capacity management
• Compliance with project planning
• Compliance with the business plan
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2.5 Principles for Leadership and Commitment
According to its values, culture and quality policy, GRS has also set ambitious goals with regard
to leadership and commitment. The changing economic challenges are met with competent
teams of high individual responsibility.
An approach for the orientation and the assessment of the staff is described in the following
basic principles.
Mutual Trust
Trust is the prerequisite for successful collaboration. Anyone who has a positive view of others
and has confidence in their capabilities to solve the problem will arouse the will to achieve a
good performance and to accept responsibility.
Openness
Successful collaboration calls for an open, frank, and objective kind of communications.
Openness in discussion overcomes the distance between people who work together in a wide
variety of fields. Frank, open discussion at an early stage prevents conflicts.
Partnership
Successful collaboration within GRS is based on the ability to deal with one another in a
partner-like way and to form effective teams. The best possible solution will be attained when all
the disciplines affected are integrated into the GRS vision. This will also achieve the highest
possible level of acceptance and consensus. We aim in our internal working relationships to
treat everyone as if he were a customer. We carry out our work to the expected level of quality.
In any case of dissatisfaction, the cause will be immediately sought and permanently eliminated.
Team-oriented Work
Teamwork is an essential requirement for innovation and for solving complex sets of problems.
It provides the effective environment for knowledge exchange. In addition, self-reliance is to be
consolidated. It is an essential element for improvement of motivation and for development of a
corporate culture that encourages innovation and creativity and allows an unhindered flow of
information.
Knowledge Exchange
The staff is reliant on knowledge and information of each other. That makes sharing and
exchanging knowledge and information indispensable. Consistent encouragement of such
exchange contributes to both personnel development and the efficiency of GRS.
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Diversity of Opinion
Diversity in thinking and perception offers a valuable opportunity for avoiding subjective and
incomplete results. Therefore, different technical and personal perceptions are used as
approaches to solutions and decision-making.
Innovation
The swift implementation of new ideas and improved ways of solving problems are essential
requirements for ensuring the future of GRS. That is why the willingness and courage are
expected from each and every one to push for new ideas and changing processes and to
overcome all obstacles that inevitably arise in a process.
Suitability
If GRS is to be successful it will have to assign people to each task that have the required
technical suitability for the task to be done. This suitability determines the delegation of
responsibilities and functions and at the same time ensures equality of opportunity.
Management
Managers and subordinates develop shared goals that represent a challenge. The individual is
required to develop a personal view of demanding tasks with which the goals can best be
achieved. The performance of each individual and to the same extent of the team is recognised
and assessed in discussion between superiors and their staff.
Personnel Development
The performance of each staff, including his performance as a manager, has to be assessed
carefully in a dialogue. That is the only way in which it is possible to find out what is necessary
for each person’s further development. Even critical discussions with subordinates are held in
such a way that they will feel properly respected and will not only be told what their strengths
are but will also have the right to learn about their weaknesses. Good performance is rewarded
with praise and acknowledgement. Superiors should be open-minded and in turn allow their
staff to evaluate them.
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3. MANAGEMENT SYSTEM
GRS has defined its business processes for the qualification of its products and its customer
satisfaction based on DIN EN ISO 9001:2015. The structure of the management system of GRS
with the QM system certified according to DIN EN ISO 9001:2015, the Inspection Body
accredited according to DIN EN ISO/IEC 17020:2012, the GRS Laboratory accredited according
to DIN EN ISO/IEC 17025:2005 and the company structure described in the Organisation
Manual is shown in Fig. 4. For the technical work, the Safety Standards of IAEA are respected.
Scope
QM GRS Organisation
Programme
ISO 9001 GRS Organisation
with restrictions on
Inspection Body and
QM Manual Geoscientific Laboratory
Core Processes
GRS – Geoscientific
Laboratory
Support Processes
Technical Instructions
Inspection Body Geoscientific Laboratory
ISO 17020 ISO 17025
Inspection Body Manual Geoscientific Laboratory Manual
Sub-Core Process “Inspection”
Standard Documents Sub-Core Processes Laboratory
Operating Procedures Operating Procedures
Standard Document Templates Standard Document Templates
Organisation Manual
The quality management system (QM system) of GRS establishes the procedures and
responsibilities for all processes developed from the company's mission statement (see
Section 2.3) which have an influence on the quality of the services and products. This ensures a
systematic approach during the planning, control, assurance and improvement of quality.
This process-oriented structure is based on the cycle for continual improvement of the QM
system outlined in Fig. 5.
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Fig. 5: Continual improvement of the QM system [from DIN EN ISO 9001:2015-11; the
numbers in brackets refer to the Sections of this Standard]
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3.2 Process Map
The process structure of GRS comprises the process types “management processes”, “core
processes”, and “support processes”. These processes are depicted in Fig. 6 in the form of a
process map. The procedures to be applied specifically are put in concrete terms in technical
instructions, standard documents, and in guidelines. Sections 4, 5 and 6 contain detailed
descriptions of these processes.
Sustainability
Business Planning
and Resource
and Management
Management
Core Processes
Company Process
Communication Management
Project
Management IT Management
and Controlling
Knowledge
Risk Management
Management
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Management Processes (MP)
The management processes contribute to the definition of quality policy and quality objectives.
They ensure the systematic control and management of the core and support processes and
comprise all elements with regard to the responsibility of the top management.
• MP 01: Business Strategy and Development
• MP 02: Business Planning and Management
• MP 03: Sustainability and Resource Management
• MP 04: Company Communication
• MP 05: Process Management
The core processes comprise all elements of product realisation to fulfil the customer's
requirements.
• CP 01: Safety Analyses, Expert opinion, Expertise
• CP 02: Advice and Assistance
• CP 03: Research and Development
• CP 04: Programme Coordination
• CP 05: Project Management Agency
The support processes provide the resources for the execution of the core and management
processes.
• SP 01: Project Management and Controlling
• SP 02: Human Resources Development
• SP 03: Knowledge Management
• SP 04: IT Management
• SP 05: Purchasing
• SP 06: Risk Management
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3.3 Responsibilities and Authorisations
In addition to the allocation of the line managers, technical project leaders, project managers
and quality managers, the GRS management processes are operationally and structurally
supported by steering committees such as the management conference and programme groups
as well as by the risk commission.
In order to improve the planning and control of the contents of the GRS annual work plan for the
different customers and for the development of future strategies in the different fields of work,
the programme groups “Reactor Safety”, “Disposal”, “Decommissioning and Dismantling” and
“International Affairs and Sales Management” are deployed.
The weekly Jour Fixe Management Conference (JF-MC) is the integral advisory board to the
general management in all business matters. It serves, inter alia, to monitor potential cross-area
risks as well as corrective and preventive actions. For case-specific discussions, additional
members than those as described in the Organisation Manual (see Section 2.3.1) may take part
in the JF-MC.
General Management
• Establishment and announcement of the quality policy and quality principles
• Implementation of the QM system
• Release of the QM manual and of new core processes
• Periodic assessment of the QM system within the context of the management reviews
• Appointment of the Key Quality Manager
• Appointment of the technical project leader and the division head responsible for the project
in case of cross-divisional projects
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The technical project leader has the following tasks:
• Preparation of technical proposals and submission to the persons with responsibility for
acquisition as well as support during acquisition
• Initiation of appointment of the project manager and project staff
• Preparation of the offer in cooperation with the technical departments (incl. project file card
with APM) and arranging verification of the offer by the persons involved
• Allocation of the work packages/departmental tasks – where necessary – to the departments
at the project start on the standard document “Work package description/Departmental task”
(assignment)
• Timely delivery of up-to-date information, documents and supplements to the parties involved
• Monitoring of compliance with the project targets and finding solutions if deviations from the
targets are identified
• Preparation and monitoring of compliance with quality assurance (QA) planning
• Preparation of the overall results using the technical contributions of the persons involved
• Technical release of the overall results with regard to the project target
• Compliance with the requirements for project reporting (periodic reports, final report) in
accordance with the contract
• Maintaining the subject-based documentation in the project files (see also TI 10 “Electronic
Project Files”)
• Evaluation of experience gained from project implementation and transfer of important
knowledge
• Presentation of results to the customer in consultation with those involved
• Further development of core processes in collaboration with the QMD and DPH / DVH
The task of the project manager is the support of the technical project leader in all phases of
the project, particularly in:
• Offer drafting and cost planning
• Contract verification
• Monitoring of the proper use of the project funds
• Reporting
• Subcontracting
• Project-oriented control statistics (basis: PKS)
• Coordination discussions with the customer regarding project and contractual issues,
particularly regarding amendments
• Correct accounting of unused annual funds
• Documentation (Project Centre): Implementation and maintaining of the electronic project
files, management of the main folder
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Key Quality Manager (KQM)
• Introduction, monitoring and further development of the QM system
• Monitoring of certification prerequisites according to DIN EN ISO 9001:2015
• Verification and release of the core processes
• Verification and release of the support processes and technical instructions including the
standard documents
• Issue and administration of all QM documents
• Central coordination of the auditors’ activities
• Planning, monitoring and assessment of internal audits
• Organisation, coordination and assessment of external audits
• Report to the general management concerning the efficiency of the QM system
(management review)
• Proposing formulations of qualitative and quantitative quality objectives as well as possible
ways of implementing them
• Appointment of the auditors in consultation with the division heads
Quality Manager of the Divisions (QMD) and Persons Responsible for Processes and
Technical Instructions
• Annual assessment of the achievement of objectives of all processes relevant to the
divisions in consultation with the DVH
• Verification, implementation and training in use of QM documents
• Further development of the core processes with TPL / DPH / DVH
• Further development of the support processes and technical instructions
• Contacts in matters relating to the QM system
The individual persons responsible for the processes and technical instructions are listed in
Annex 1.
Auditors
• Planning, performing, documentation and evaluation of internal audits
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3.4 Documentation of the QM System
In the QM programme, the internal QM documents are subdivided into three hierarchical levels
(see Fig. 7).
QM Programme
refers to
Part 3
Specification of the measures
which are determined Technical Instructions refer to
The responsibilities and procedures for implementation of the general principles laid down in the
QM manual are described in the process descriptions.
Some principles, special sub-processes and procedural stages laid down in the QM manual and
in the process descriptions are further specified in technical instructions and, if necessary, in
guidelines.
The standard documents include all GRS forms, formal documents, standard contracts, etc. to
be used as stipulated templates within the context of project management in order to guarantee
the up-to-date status and uniformity of the records and documents used.
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3.5 Control of QM Documents
Internal QM Documents
For each internal QM document, the person responsible for drafting, amendment, verification,
release and archiving is defined. It is ensured that all documents are to be verified by persons
who have not drafted these documents. Each step is confirmed in the central data processing
system.
All QM documents are labelled with unique identifications. They are registered in a central
database in the GRS Portal. The entire staff of GRS has access to the printable current version
of these documents. Printed documents are to be regarded as information copies and only
correspond to the current status at the time of issue. The staff are informed of the issue of new
or amended documents. Invalid documents are deleted from the current document database.
Each QM document is checked regularly and updated, if necessary. Modifications are only
performed by the organisational unit that drafted the original document.
Verified process descriptions, technical instructions and standard documents are released by
the KQM.
External recipients of the QM manual receive each newly issued version if an update service is
agreed with them.
External QM Documents
If necessary, current versions of laws and ordinances, official regulations, and standards are
provided by GRS. The requesting person proves the validity of the documents (e.g. by means of
an Internet search).
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If the customer's own specific guidelines and standards are to be observed in line with the
contract with the customer, the customer is in responsibility for the validity of these documents.
Standard documents for project management prescribed by the customer (e.g. by the EC) are
not subject to the internal control. These documents are assigned to the relevant project and
accordingly stored, e.g. in the central database in the GRS Portal. More details are specified in
technical instruction TI 08 “Control of Documents and Records”.
Quality records are considered as evidence documents within the QM system. In all process
descriptions and technical instructions, the respective document to be drafted and archived as
well as the responsibility for and duration of archiving are laid down in a process-specific
manner under the heading “Documentation”. Insofar as personal data in documents are
involved, the appropriate requirements of the Federal Data Protection Act are complied with.
All records are clearly labelled in a way to allow allocation to project, customer, supplier, author
and date, etc. and are archived in a retrievable manner. The archiving period is based on the
requirements derived from legal standards and technical rules, insofar as specific contractual
agreements have not been made.
The records are kept under appropriate ambient conditions, in order to avoid impairment or
damage, loss or unauthorised access.
The “Electronic Project Files” (TI 10) are available for project-related documentation. The
electronic project files consist of a main folder in which all documents relevant to the contract
are stored and of a project folder in which the technical documents and work results are
recorded. The main folder is managed under the responsibility of the project manager and the
project folder under the responsibility of the technical project leader.
GRS has established the following management processes within the context of the QM system
(see Fig. 8):
• Business Strategy and Development (MP 01)
• Business Planning and Management (MP 02)
• Sustainability and Resource Management (MP 03)
• Company Communication (MP 04)
• Process Management (MP 05)
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Programme Groups Communication Tools
Sounding
Board
Sustainability
Business Planning
and Resource
and Management
Management
Company Core
Kernprozesse
Processes Process
Communication Management
Management Process MP 01 “Business Strategy and Development” describes the vision and
mission of the company, determination of aims, and derivation of strategies for their
implementation (see Fig. 3 in Section 2.4).
In the context of strategy development, strategic aims are set by the General Management
(GM) supported by the executive level. They are specified and differentiated by operational
aims, if necessary. The management conference and the programme groups “Reactor Safety”,
“Disposal”, “Decommissioning and Dismantling” and “International Affairs and Sales
Management” assist the general management in establishing technical fields of activity and
future strategies. The “GRS Strategy” is shaped in key issues of GRS and documented in the
GRS Portal.
The general management reports the status and future development of the company to the
supervisory board on a quarterly basis.
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4.2 Business Planning and Management (MP 02)
The GRS annual work plan consists exclusively of project-financed assignments that are
handled in accordance with core processes CP 01 to CP 05. The aim of management process
MP 02 “Business Planning and Management” is the provision of a sufficient and evenly
distributed workload among the technical divisions of GRS at the given financing situation. For
this purpose, a capacity management process has been developed (see TI 11 “Capacity
Management”). Regular communication between the technical divisions and the project
management division aim at implementing necessary project modifications. Furthermore, the
implementation and planning process takes places in regular coordinating discussions with
major customers (e.g. BfS, BMUB and BMWi). Within GRS, the project modifications are
documented in the “Project Centre” (see TI 10 “Electronic Project Files”). Compensatory
measures between the divisions are implemented in the Jour Fixe Management Conference
(JF-MC).
For GRS, classified as a scientific and research institution according to German fiscal
standards, the non-profit factor (indicator D6) is of particular importance. It must be higher than
50 % of the GRS overall turnover. Further details are described in the technical instruction TI 12
“Categorisation of GRS Projects”.
Target values for the indicators are laid down annually by the general management with support
of the executive level.
Monthly reports on the current progress of achievement of targets are issued by the division
“Projects Law International Affairs” (i.a. PD Report). Analyses based on these reports show
current needs for countermeasures in case of deviating trends.
The summary assessment of target value achievement by the GM based on the data and
analyses compiled by the KQM is performed annually and reflected in the management review.
This is regulated in further detail in technical instruction TI 01 “Performance of Management
Reviews”.
GRS has a central project control system (PKS) for effective business planning and
management. The PKS makes it possible to draft medium and long-term forecasts and capacity
analyses of the different organisational units. Furthermore, target-performance comparisons can
be made concerning the performance status of individual projects (down to work package level).
The results of the data analysis constitute effective project controlling and therefore serve for
business management – particularly in capacity management matters. This is regulated in
further detail in technical instruction TI 11 “Capacity Management”.
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Further Mitigation of Contribution to Maintenance Ensuring
development of disposal risks achieve the and further profitability
Targets
A1 B1 C1 D1
Number of final reports submitted Number of Staff training Productivity
environmental
projects
A2 C2 D2
Number of publications Internal Billable work
in scientific journals assessment of
training
programmes
A3 C3 D3
Number of presentations at Human (Company)
conferences and workshops resources capacity
development
Indicators
plan
A4 D4
Participation in international Uniformity of
and national committees capacity
A5 D5
Number of code transfers Degree of
fulfilment
A6 D6
Non-profit factor
Number of offers (new
customers, successful offers)
D7
Adherence to
deadline
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4.3 Sustainability and Resource Management (MP 03)
The necessary human, material and financial resources are regularly determined with
consideration of social, societal and ecological aspects. In order to increase customer
satisfaction through fulfilment of customer requirements, these resources are made available
within the context of economic, investment and finance planning.
Furthermore, the top management provides the necessary infrastructure for the acquirement of
technical information.
Human Resources
At all levels within GRS, actions are taken to ensure that all staff possess the required
qualifications for the assigned activities and are regularly trained and instructed with regard to
the position-relevant aims, contents and requirements for the implementation of the QM system.
Measures are taken to provide adequate expertise on the basis of expert opinions to the
customers. The modular training programme (basic and advanced) for newly recruited
employees of GRS is updated regularly (see SP 02 “Human Resources Development” and
SP 03 “Knowledge Management”).
Material Resources
All necessary means required to perform the position-relevant activities are made available to
the staff (see also SP 05 “Purchasing”). The working conditions correspond to all national safety
regulations that apply to the respective workplace. The staff’s working environment is arranged
according to the currently applicable aspects of the health and safety regulations. By external
data processing contracts, a comprehensive and current software and hardware support is
guaranteed (see also SP 04 “IT Management”).
External energy audits are regularly performed according to DIN EN 16247-1; they include a
situation analysis of the energy consumption at the different company locations as well as an
analysis of the savings potential. The aim is to strive for reduced consumption and a long-term
continual improvement of energy efficiency.
Financial Resources
A business plan is drafted for the company’s requirements in terms of financial, task-oriented
and human resources, based on anticipated revenues and expenditure. The supervisory board
approves the business plan annually.
Based on the approved business plan, the general management compares actual revenues and
expenditure with the planning. In case of deviations, countermeasures are adopted. The data
required for business management are supplied by the “Project Management” and “Finance
Department” organisational units.
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Technical Information and Knowledge Management
For the preservation and provision of information and knowledge, GRS uses to a broad extent
web-based platforms, such as the “GRS Portal”, which is used as the company's intranet, and
the extranet “InfoServer” platform, for collaboration and knowledge-sharing with its partners. In
addition, it uses a variety of databases and portals for specific application purposes. The
support process SP03 “Knowledge Management” describes the rules and tools on knowledge
identification, acquirement and development, conservation and distribution.
Addressing both risks and opportunities establishes a basis for increasing the effectiveness of
the management system, achieving improved results and preventing negative effects.
It is necessary to prevent risks from becoming problems for the company's existence.
Therefore, risks have to be identified, unnecessary risks avoided, and potential damages
minimised as far as possible.
Hence, the risk management system of GRS (see SP 06 “Risk Management”) aims to identify
potential risks in time and to provide information to the general management in order to avert
damage to GRS by appropriate measures, if necessary, and to meet reporting requirements to
the supervisory board and other interested parties.
In order to ensure effectively that staff are free from commercial, financial or other constraints
and influences on their services provided, provisions have been created to prevent corruption;
these are laid down in the Organisation Manual of GRS (see Section 5.2). All staff are obliged to
adhere to the guidelines for preventing corruption. Any cases of suspicion of corruption must be
investigated. The Corruption Prevention Manual of GRS also includes a self-obligating Code of
Conduct for all staff, a guideline for superiors for dealing with corruption risks, and another
guideline for accepting rewards and gifts.
Within the context of the internal company communication, the business processes are
presented transparently. The general management reports about any significant developments
in the company. Furthermore, internal communication is an important element with regard to
maintaining competence and transferring knowledge. In cooperation with the KQM and the
QMD, the general management ensures that efficient communication takes place with regard to
the QM system.
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Internal communication at GRS is based on meetings (e.g. weekly management conferences,
regular divisional and departmental meetings), training and information events (e.g. staff
meetings, GRS Colloquia, EUROSAFE, communication forums, Sounding Board), regulated
information services (e.g. GRS Annual Report, PD Report) and an up-to-date information
service for the staff on the intranet (e.g. GRS-Intern). The transparency of the business
activities of GRS towards the supervisory board and other interested parties is improved
through the application of the Public Corporate Governance Code (PCGK).
The respective persons responsible for operational and organisational structure pass on the
relevant information concerning decisions and actions to the staff timely.
GRS ensures comprehensible and publicly effective external presentation of the company as
the central technical and scientific organisation in the field of nuclear safety and security. This
includes press work to explain complex technical issues as well as design of the Website and
use of the Internet as a communication platform. The uniform approach to media enquiries is
regulated in the form of a business directive (see Organisation Manual, Section 3.6.1). In
accordance with its corporate purpose, i.e. to promote scientific progress in the field of nuclear
safety, radiation protection and environmental protection in dialogue with the public and in
particular with interested professionals, GRS publishes the results of its (own) research projects
as well as other technical information.
The general management is responsible for the process-oriented quality management system
that follows the rules of the PDCA cycle, which is applied to all processes (see Fig. 10).
Quality Quality
Improvement Requirements
Act Plan
Check Do
Quality Quality
Verification Generation
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The process cycle comprises the following stages in the QM system:
The PDCA cycle is implemented at all levels of the hierarchy and serves as a basis for a
continual improvement process. The implementation of the PDCA cycle in process
management is illustrated in Fig. 11.
Based on the vision and mission of GRS and its quality policy and principles, the qualitative and
quantitative objectives are determined annually for the following year (quality requirements). As
part of the planning process (“Plan”), indicators are defined to monitor the achievement of
targets. Here, a distinction is made between qualitative indicators and quantitative indicators
(key figures). The annual target value specifications and the procedures for documenting the
review of targets are carried out by the general management.
The process realisation for the concrete improvement of processes in qualitative and
quantitative terms is carried out at the working level – regarding the core processes as part of
projects – according to the requirements of process planning and is regularly reviewed on the
basis of predefined indicators (quality generation: “Do”).
Process Planning
Quality Objectives
Plan
Quantitative Indicators
Qualitative Indicators
(Key Figures)
Process Realisation Do
Potential for Potential for
Improvement Improvement
Qualitative Assessment Quantitative Determination
(e.g. Internal Audits) (Target-Performance Comparison)
Check
Process Evaluation
Analysis
and Assessment Act
Process Improvement
Management Review
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The achievement of targets is reviewed at the quality verification step (“Check”). The process
evaluation is a target-performance comparison of the determined company key figures with the
corresponding quantitative target values. The effectiveness of processes will continue to be
qualitatively assessed, e.g. during the planned QM internal audits (see TI 02 “Internal Audits”)
or reviews by the overall internal audit service. If necessary, additional unscheduled internal
audits are carried out.
The results of these analyses and assessments as well as the audit results of the internal audit
service allow conclusions about the quality of work results and the degree of customer
satisfaction. Based on these conclusions, precise corrective actions and improvement
measures are developed and implemented for process improvement (quality improvement:
“Act”).
An example of the interaction of the individual processes and process steps as well as their
dependences is shown in Fig. 12.
Quality Assurance
Customer Satisfaction
TI 03
Requirements
Customer
TI 10
Setting of the Project Portal Documentation in Main and Project Folder
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5. CORE PROCESSES
GRS has established the following core processes (CP) within the context of the QM system:
All projects / products of GRS are based on the state of the art in science and technology.
Through intensive training and education as well as by applying the current rules and
regulations, the GRS staff are imparted the appropriate competence (see also SP 02, SP 03
and TI 03).
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5.1 Safety Analyses, Expert Opinion, Expertise (CP 01)
Customer
Target
Scope
• Information Notices
• IRS and INES reports
• Safety-related statements
• Evaluation of operating experience from Information Notices
• Probabilistic Safety Analyses (PSA)
• Expert opinions according to Section 20 of the Atomic Energy Act (§ 20 AtG)
• Expert opinions not according to Section 20 of the Atomic Energy Act (§ 20 AtG)
(e.g. for BMWi, ONR or ANVS)
• Generic analyses
This is specified in further detail in the process description CP 01 “Safety Analyses, Expert
Opinion, Expertise”.
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5.2 Advice and Assistance (CP 02)
Customer
Target
• Advice and Assistance of the customer or third parties on behalf of the customer with
regard to
• determination of the state of the art in science and technology,
• know-how transfer,
• obtaining of reliable and purposive evidence,
• enhancement of nuclear safety, security, and waste management (national and
international).
Scope
• Technical and operational support of the ministries in their national and international
activities
• Technical support of the ministries in their rule-making functions
• Technical support of third parties in enhancing nuclear safety, security, and waste
management (national and international)
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5.3 Research and Development (CP 03)
Customer
Target
Scope
• New and further development of methods and models
• Expansion of the scope of application of methods and models
• Verification and validation
• Qualification of methods and models
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5.4 Programme Coordination (CP 04)
Customer Products,
Request, Programme Presentation
Results Final
Programme Proposal
Framework Documentation
Customer
Target
Scope
This process is to be applied to projects and work orders for technical support to the
customer in
• international programme coordination (e.g. nuclear safety in INSC and other countries),
• coordination of research programmes (e.g. research programmes of the EC,
national programmes of the BMUB, BMWi, BMBF),
• coordination of technical support programmes (e.g. INSC, G8GP, IAEA).
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5.5 Project Management Agency (CP 05)
Customer
Target
• Purposive quality-controlled fulfilment of the task (intended purpose) of the Federal Budget
with projects of the project management agency “Reactor Safety Research”
• Quality-controlled technical and administrative support of projects, from their planning to the
application of their results
Scope
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6. SUPPORT PROCESSES
GRS has defined the following support processes within the scope of the QM system:
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6.1 Project Management and Controlling (SP 01)
Contract
Offer Project Start Project Project Project
Acquisition Negotiation /
Processing and Planning Performance Documentation Completion
Verification
Customer
Target
Scope
The scope extends to all projects to be managed by GRS in the entire process sequence,
i.e. in the sub-processes of
• acquisition,
• offer processing,
• contract negotiation/verification,
• project start and planning,
• project performance,
• project documentation,
• project completion
and concerns all organisational units involved. This is regulated in further detail in process
description SP 01 “Project Management and Controlling”.
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6.2 Human Resources Development (SP 02)
Staff
Target
• Planning and performance of advanced training measures in order to guarantee the staff's
necessary state of knowledge (“state of the art in science and technology”).
Scope
This process description applies to all staff involved in the planning, performance and
documentation of advanced training measures.
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6.3 Knowledge Management (SP 03)
Knowledge Management
Strategic Elements
Operational Elements
Target
• Applying and further developing of the state of the art in science and technology with regard
to all technical activities
• when working on concrete projects (project-related),
• and generally when acquiring, maintaining, developing and applying the technical
competence of GRS (non-project-related).
Scope
The scope extends to all processes related to in the process description SP 03 “Knowledge
Management”. In particular, it is an essential part of all core processes.
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6.4 IT Management (SP 04)
IT IT IT IT IT
Strategy Planning Provision Operation Optimisation
Customer
Target
• Optimum consultation and support of the technical and central services divisions and their
departments in the description and implementation of their requirements for IT
• Continuous increase in quality of the services provided by the IT provider on the basis of the
IT service agreement
• Development of the best-possible business relationships with the IT provider
Scope
• IT strategy
• IT planning
• IT provision
• IT operation
• IT optimisation
The process requirements apply to all staff at all company locations who are directly or indirectly
involved in IT management and are applied to the performance agreements described in the IT
service agreement.
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6.5 Purchasing (SP 05)
Supplier
Target
Scope
This process description is applicable to all organisational units involved in the purchasing
process.
However, this does not cover purchasing transactions of the travel office (travel documents,
hotel reservations, etc.) and job advertisements by the Human Resources Department.
For project-specific subcontracting (in agreement form), the provisions are laid down in SP 01
“Project Management and Controlling”.
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6.6 Risk Management (SP 06)
Staff,
Department / MC Jour Fixe,
Risk General
Division Head, General Commission Management
General Management
Management
Interested Parties
Target
The risk management system of GRS aims to identify potential risks in time and to provide
information to the general management in order to prevent damage from GRS by appropriate
measures and to comply with the reporting requirements to the supervisory board. In this
system, the subsidiaries of GRS are to be adequately involved, too.
Risk management should also ensure the application of a uniform and systematic method of
identifying and analysing as well as of assessing, controlling and communicating of the risks
and finally the documentation of their careful dealing.
Scope
The risk management system is addressed to the entire organisation. Every member of staff
within his own area of responsibility is encouraged to avoid or reduce risks according to the
requirements described in SP 06 and to communicate risks to his superiors.
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7. MEASUREMENT, ANALYSIS AND IMPROVEMENT
Regular measurements and assessments are conducted at GRS with regard to both process
realisation and efficiency of the processes. For this purpose, different improvement tools are
employed (see Fig. 24). The results of these measurements and assessments provide
indications of the quality of the work results and the degree of customer satisfaction. They are
also used as a basis for a continual improvement process.
Business
Management
Strategy and
Reviews
Development
Internal Audits
Business Planning
and Management Technical Quality
Assurance of
Work Results
Sustainability
and Resource
Control of
Management
Documents and
Records
Company
Communication Indicators
Process Capacity
Management Management
Core Processes
Project Management and Controlling
IT Management Purchasing
Risk Management
Fig. 24: Improvement tools of GRS for the measurement and assessment of the
management, core and support processes
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7.1 Monitoring and Measurement of the Work Results
The effectiveness of the processes is regularly verified within the context of process
management (see Section 4.5) aiming at continual improvement.
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Internal and External Audits
The audits to be performed internally every year are planned by the KQM in coordination with
the auditors. The audit plan has to be approved by the general management. The audit plan
comprises among other aspects:
• the organisational units to be audited,
• the audit dates,
• the QM processes and documents to be supervised.
According to the audit plan, the auditing is performed by the auditors on the basis of prepared
checklists. The auditors have to be independent from the organisational units to be audited. The
results obtained from the internal and external audits including any deviations observed are
documented in an audit record. If necessary, corrective actions are determined jointly by the
leader of the audited organisational unit and the auditor and their implementation is monitored
by the KQM.
The KQM conducts a superordinate audit assessment which also includes the results of
external audits by customers and certifiers for example, reports to the general management on
the efficiency of the QM system and proposes improvement measures if appropriate. This is
regulated in further detail in the technical instruction TI 02 “Internal Audits”.
Process Measurements
An important component of the PDCA cycle is quality verification with the aid of process
measurement (see Section 4.5).
For process evaluation, indicators are defined based on the strategic aims (including
operational objectives if appropriate) which are quantified by key figures (business key figures,
project management and controlling key figures etc.). The target value specifications and their
verification are established at regular intervals by the committees of GRS. A detailed description
of the indicators is contained in TI 09 “Indicators”.
Product Measurements
GRS products consist primarily of expertise, expert opinions, statements and technical reports
(e.g. GRS reports) as well as code developments. Their release is performed according to
quality criteria, which are described in TI 03 “Technical Quality Assurance of Work Results” and
require the customer’s approval. GRS reports are documented and made available centrally.
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7.4 Continual Improvement
The results of the analyses and assessments from project and process measurements form the
basis for establishment and implementation of improvement measures, geared to the GRS
quality objectives.
When implementing these measures, a distribution of the capacity among all organisational
units as evenly as possible will be sought within the framework of business planning and
management (see Section 4.2). This is regulated in further detail in technical instruction TI 11
“Capacity Management”.
As part of the management review, a periodic review of the management system is carried out.
This is regulated in further detail in technical instruction TI 01 “Performance of Management
Reviews”.
The identified potential for improvement, which is documented in the management reviews and
in the audit records, is used for developing suitable purposive actions that are adopted into the
management system and implemented in the organisation.
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Annex 1: Correlation Matrix: Processes – Technical Instructions
Management Processes
SP 02,
Sustainability and Resource SP 03,
MP 03 GM-KQM X −
Management SP 05,
SP 06
TI 01, TI 02,
MP 05 Process Management GM-KQM X
TI 09
Core processes
Safety Analyses, Expert Opinion, Rainer
CP 01 X TI 03, HB-IB
Expertise Wenke
Florian
CP 02 Advice and Assistance X TI 03, TI 11
Rowold
Abdelaziz
Research and Development Lazaar / TI 03, TI 08,
CP 03 X TI 10, HB-GL
(Models, Methods) Johannes
Droste
Hartmuth
CP 04 Programme Coordination X TI 03, TI 08
Teske
Wolfram
CP 05 Project Management Agency X TI 03, TI 08
Harms
Support processes
TI 01, TI 03,
Peter TI 07, TI 10,
SP 01 Project Management and Controlling X
Baltes TI 11, TI 12,
HB-GL
Holger
SP 02 Human Resources Development X −
Johann
Matthias
SP 03 Knowledge Management X TI 03, TI 10
Otto
Engin
SP 04 IT Management X −
Kardes
Gerald
SP 05 Purchasing X HB-GL
Diepolder
Christoph
SP 06 Risk Management X TI 11
Vieten
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Persons
Technical instructions
responsible
Carla Eibl-
TI 01 Performance of Management Reviews
Schwäger
Johannes
TI 02 Internal Audits
Droste
Rainer
TI 03 Technical Quality Assurance of Work Results
Wenke
Pascal Vogt /
TI 07 Project Management for EC-INSC Projects
Sebastian Stransky
Johannes
TI 08 Control of Documents and Records
Walter
Marcus
TI 09 Indicators
Fillbrandt
Karsten
TI 10 Electronic Project Files
Schüler
Marcus
TI 11 Capacity Management
Fillbrandt
Christoph
TI 12 Categorisation of GRS Projects
Vieten
Abdelaziz
TI 13 Technology Transfer / Technical Support
Lazaar
Persons
Handbooks
responsible
Tina Scharge /
HB-GL Handbook of the Geoscientific Laboratory of GRS
Johannes Droste
Helge Moog /
HB-IB Handbook of the Inspection Body of GRS
Johannes Droste
Dirk-Alexander
Handbook of the Software Management Group: Quality Assurance Measures Becker /
HB-SMG
for the Development of Computer Codes at GRS Walter
Klein-Hessling
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Annex 2: Glossary – Abbreviations
ABFE General conditions for research and development contracts of BMUB and BMWi
(„Allgemeine Bedingungen für Forschungs- und Entwicklungsverträge”)
AtG Atomic law („Atomgesetz“)
BEBF Provisions for research and development contracts of grant recipients of the
Federal Ministry of Education and Research
BEFT Provisions for research and development contracts of grant recipients and
contractors of the Federal Ministry of Education and Research
BfS Federal Office for Radiation Protection („Bundesamt für Strahlenschutz“)
BMBF Federal Ministry of Education and Research („Bundesministerium für Bildung und
Forschung“)
BMUB Federal Ministry for the Environment, Nature Conservation, Building and Nuclear
Safety („Bundesministerium für Umwelt, Naturschutz, Bau und Reaktor-
sicherheit“)
BMWi Federal Ministry of Economic Affairs and Energy („Bundesministerium für
Wirtschaft und Energie“)
CP Core Process
DAkkS National accreditation body for the Federal Republic of Germany (“Deutsche
Akkreditierungsstelle GmbH”)
DIN German Standards Institute („Deutsches Institut für Normung e. V.“)
DPH Department Head
DVH Division Head
EBRD European Bank for Reconstruction and Development
EC European Commission
EEIG European Economic Interest Grouping
EN European Standard
ETSON European Technical Safety Organisations Network
GM General Management
GRS Gesellschaft für Anlagen- und Reaktorsicherheit gGmbH
G8GP Group of 8 Global Partnership
HB-GL Handbook of the Geoscientific Laboratory of GRS
HB-IB Handbook of the Inspection Body of GRS
HB-SMG Handbook of the Software Management Group
HRD Human Resources Department
IAEA International Atomic Energy Agency
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IB Inspection Body of GRS
IBM Inspection Body Management comprising the Technical Manager and his
alternate
INSC Instrument for Nuclear Safety Cooperation
IRSN Institut de Radioprotection et de Sûreté Nucléaire
ISO International Organisation for Standardisation
IT Information Technology
IT-SP IT Service Provider
JF-MC Jour Fixe Management Conference
KQM Key Quality Manager
LIMS Laboratory Information and Management System
LM Laboratory Management comprising the Laboratory Manager and his alternates
LoI Letter of Intent
MF Main Folder
MP Management Process
OECD Organisation for Economic Cooperation and Development
PD Project Department (Dep. 501/502)
PKS Project Control System (“Projektkontrollsystem”)
PM Project Manager
PoE Programme of Excellence
PSA Probabilistic Safety Analysis
OU Organisational Unit
QA Quality Assurance
QM Quality Management
QMD Quality Manager of the Division
QMM Quality Management Manual
QM-SC Quality Management Steering Committee
RA Riskaudit GRS/IRSN International
SD Standard Document
SfR T-Systems Solutions for Research GmbH (central IT service provider of GRS)
SP Support Process
TI Technical Instruction
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ToR Terms of Reference
TPL Technical Project Leader
TSO Technical Safety Organisation
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Annex 3: Glossary – Definitions of Technical Terms
(according to DIN EN ISO 9000:2015 and DIN EN ISO 9001:2015)
Audit findings Results of the evaluation of the collected audit evidence against
audit criteria. Audit findings indicate conformity or nonconformity.
Audit findings can lead to the identification of opportunities for
improvement or recording good practices.
Context of the organisation Combination of internal and external issues that can have an effect
on an organisation’s approach to developing and achieving its
objectives.
Corrective action Action to eliminate the cause of a nonconformity and to prevent the
recurrence.
Design and development Set of processes that transforms requirements into specified
characteristics or into the specification of a product, process or
system.
Effectiveness Extent to which planned activities are realised and planned results
achieved.
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Infrastructure System of facilities, equipment and services needed for the
operation of an organisation.
Interested party Person or organisation that can affect, be affected by, or perceive
itself to be affected by a decision or activity (e.g. customers,
owners, people in an organisation, providers, bankers, regulators,
unions, partners or society that can include competitors or
opposing pressure groups).
Issues Positive and negative factors or conditions that are relevant to the
purpose and strategic direction of an organisation and affect its
ability to achieve the intended results of its quality management
system.
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Quality Degree to which a set of inherent characteristics of an object fulfils
requirements.
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Top Management Person or group of people who directs and controls an
organisation at the highest level.
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