1. Training Course on Integrated Management System for Regulatory Body
Module 3: Prerequisites for Effective IMS (in line with the safety standards using DS456)
(11) The IMS Hierarchy of Documentations

2. Objective - 1 Objective of this presentation is to present :
The need for establishment of the documentation which defines the management system of an organisation;
Requirements for developing management system documentation posed by IAEA standards and international standards;
A practical example of management system documentation.
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3. Contents Introduction Responsibilities (Vertical Commitment)
IAEA Requirements and Guidance
Documentation Pyramid
Preparation of Documentation
Balance Between Written Procedures and Training
Summary
References
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4. Introduction - 1
The management system should be documented in order to establish the overall control to achieve the organizational goals.
The management system documentation should be developed in accordance with the requirements of:
IAEA safety standards, namely GSR Part 2;
And may take into consideration other appropriate standards, e.g. ISO 9001.
IAEA Training Course on IMS Module 3

5. Introduction - 2
The documentation of the management system must reflect:
The characteristic of the organization and its activities;
The complexities of processes and their interaction;
The competence of employees.
Each organization should determine the extend of teh documentation required and the media to be used.
Iso
IAEA Training Course on IMS Module 3

6. Responsibilities (Vertical Commitment)
Management level
Documents
State (parliament, government)
or the Ministry ►
Declaration by the Government,
Legislation (laws and decrees) + +
Regulator authority
(board/commission)) ►
Strategy of the regulator (vision, mission, values and policies) + + ►
High (senior) management
Management System Manual + + ►
Middle management
Strategies and procedures + + ►
Methodical instructions, internal guidance
Lower management
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7. IAEA Requirements and Guidance - 1
GSR Part 2 “Leadership and Management for safety”, Requirement 8 “Documentation of the management system” defines that the documentation of the management system shall include the following:
Policy statements of the organization;
Values and behavioural expectations;
The description of the organization and its structure;
IAEA Training Course on IMS Module 3

8. IAEA Requirements and Guidance - 2
GSR Part 2, cont.
The description of the responsibilities, accountabilities, levels of authorities including all interactions of those managing, performing and assessing work;
The description of all processes;
The description of how the management system complies with regulatory requirements that apply to the organization;
IAEA Training Course on IMS Module 3

9. IAEA Requirements and Guidance – 3
GSR Part 2, cont.
A description of the interaction with interested parties and with external organizations.
IAEA Training Course on IMS Module 3

10. IAEA Requirements and guidance - 4
GSR Part 2, cont.
The documentation of the management system shall be developed to be understandable to those who use it.
Documents shall be readable, readily identifiable and available at the point of use.
IAEA Training Course on IMS Module 3

11. IAEA Requirements and guidance - 5
GS-G-3.1 promotes a three level structure of documentation in order to :
Enable clarity;
Avoid repetition;
Establish the amount of information and the level of detail appropriate to each type of document:
By using cross-references between specific documents at the different levels.
IAEA Training Course on IMS Module 3

12. Documentation Pyramid - 1
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13. Documentation Pyramid - 2
Level 1
Provides an overview of how the organization and its management system are designed to meet its policies and objectives;
Defines what will be done and why.
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IAEA Training Course on IMS Module 3

14. Documentation Pyramid - 3
Information provided at level 1:
Vision, mission, values and goals of the organization;
Policy statements of the organization;
Organizational structure;
Levels of authority and responsibilities and accountabilities of senior management and organizational units;
Structure of the management system documentation;
IAEA Training Course on IMS Module 3

15. Documentation Pyramid - 4
Information provided at level 1, cont.:
An overview of the organization’s processes;
Responsibilities of owners of the processes;
Arrangements for measuring and assessing the effectiveness of the management system.
IAEA Training Course on IMS Module 3

16. Documentation Pyramid - 5
The most senior managers in the organization should ensure that level information is distributed to individuals for the purposes of implementation and that its contents are effectively understood and implemented.
IAEA Training Course on IMS Module 3

17. Documentation Pyramid - 6
Level 2:
Provides a description of the processes to be implemented to achieve the policies and objectives and the specification of which organizational unit is to carry them out;
Defines who, where, and when will do.
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IAEA Training Course on IMS Module 3

18. Documentation Pyramid - 7
Information provided at level 2:
The process map of the management system, including the interactions between processes;
The responsibilities and lines of communication;
Internal and external to the organization in each area of activity.
IAEA Training Course on IMS Module 3

19. Documentation Pyramid - 8
Information provided at level 2, cont.:
Measurable objectives specifying which activities are to be carried out and controlled and who is responsible and accountable;
Activities to ensure that work is dealt with in a safe, systematic and expeditious manner. These activities should be identified in advance and planned.
IAEA Training Course on IMS Module 3

20. Documentation Pyramid - 9
Level 3:
Provides detailed instructions and guidance that enable the processes to be carried out and specification of the individual or unit that is to perform the work.
Defines how the activities are to be performed.
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IAEA Training Course on IMS Module 3

21. Documentation Pyramid - 10
Information provided at level 3:
Detailed working documents which consists of a wide range of documents;
These documents prescribe the specific details for the performance of tasks by individuals or by small functional groups or teams;
The type and format of documents at this level can vary considerably, depending on the application involved.
IAEA Training Course on IMS Module 3

22. Documentation Pyramid - 11
Information provided at level 3, cont.:
The primary consideration should be to ensure that the documents are suitable for use by the appropriate individuals and that the contents are clear, concise and unambiguous, whatever the format is.
IAEA Training Course on IMS Module 3

23. Documentation Pyramid - 12
Records
Are part of the management system documentation;
Provide objective evidence of activities performed or results achieved.
IAEA Training Course on IMS Module 3

24. Practical example of MS documentation
The SNSA management system is defined in five levels
0. level
Organisational procedure
Mission
Vision
Values
Policy statement
MANAGEMENT MANUAL
Strategic plan
Annual plan
Organisational instruction
Organizational Procedures document core processes management processes and supporting processes 30 documents
Organizational Instructions describe in detail the performance of a particular process activity. 90 documents
Records provide the evidence of conformity to requirements.
Management Manual describes the SNSA management system.
1. level Q
2. level OP
3. level ON
0. LEVEL provides a framework for establishing and reviewing quality objectives.
Level 0 consists of:
mission
vision
values
quality policy
quality objectives
1. LEVEL
management manual which describes the SNSA management system,
The Management Manual was prepared in 2005 and updated in September
2006 when the second edition of the Management Manual was issued.
The third edition was issued just before certification audit at the end of 2007.
SNSA strategic plan,
SNSA annual plan.
2. LEVEL
Procedures which document core processes and supporting processes.
3. LEVEL
Working instructions which describe in detail the performance of a particular
process activity
4. LEVEL
Required records which provide an evidence of conformity to requirements of
the QM system
Records
4. level
IAEA Training Course on IMS Module 3

25. Preparation of Documentation - 1
The document control process should be established in advance and defined in:
The procedure related to preparation of the management system documentation
The content of documents should be determined with the participation of the individuals who will use them to do their work and of other individuals whose work will be affected by the documents;
These individuals should also be consulted during subsequent revisions of the documents.
IAEA Training Course on IMS Module 3

26. Preparation of Documentation - 2
For detailed working documents, there should be a period of trial use, and validation should be carried out and recorded to determine the accuracy of the documents.
Changes should then be made, as necessary, to ensure the effective communication of expectations.
IAEA Training Course on IMS Module 3

27. Balance Between Written Procedures and Training - 1
The management system documentation should reflect:
The characteristics of the organization and their activities;
The complexity of processes and their interaction.
Management system documentation should be prepared:
With a purpose and clear objective;
Stable as much as possible, updated when is really needed.
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28. Balance Between Written Procedures and Training - 2
The amount of the management system documentation should reflect the size of the organization.
Limited management system documentation can lead to lack of transparency and inconsistent implementation of management system and its processes. On the other hand to many management system documentation can lead to inflexible management system.
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29. Balance between written procedures and training - 3
Always consider whether a written procedure is necessary or whether training, and communication is a better solution.
Source of
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30. Summary
The management system should be described by a set of documents that establish the overall controls and measures to be developed and applied by an organization.
The documentation of the management system should be appropriate to the organization and to the work that it performs, should be readily understandable to users and user friendly.
The content of documents should be determined with the participation of the individuals who will use them to do their work and of other individuals whose work will be affected by the documents.
IAEA Training Course on IMS Module 3

31. References
IAEA Safety Standard GSR Part 1 Governmental, Legal and Regulatory Framework for Safety, IAEA, Vienna (2010);
IAEA Safety Standards Series No. GS-R-3, The Management System for Facilities and Activities, IAEA, Vienna (2006);
IAEA Safety Standards Series No. GS-G-3.1, Application of the Management System for Facilities and Activities, IAEA, Vienna (2006);
IAEA TECDOC – 1090 (Quality Assurance within Regulatory Bodies), IAEA June 1999;
IAEA Safety Standards GSR 3 Part 2, Leadership and Management for Safety, IAEA June 2016;
ISO, Quality Management Systems — Requirements, ISO 9001:2008, ISO, Geneva (2008);
ISO, Quality Management Systems — Requirements, ISO 9001:2015, ISO, Geneva (2015);
ISO Quality Management Systems –Fundamentals and vocabulary (ISO 9000:2005).
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