GS-R-3 vs. ISO 9001:2008 Requirements - 4 MANAGEMENT SYSTEM (GS-R-3, DS456) 1.Management system - general GS-R-3, DS456 are based on the principle of an integrated management system, where safety is an overriding priority in the implementation of the management system. MANAGEMENT SYSTEM (ISO 9001) ISO 9001:2008 is a quality standard and has no requirement to integrate different aspects such as safety, health environmental, security quality and economics into one management system. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 5 MANAGEMENT SYSTEM (GS-R-3) 1.Management system - general GS-R-3 is safety standard focused on providing safety in nuclear and radiation activities. MANAGEMENT SYSTEM (ISO 9001) ISO 9001:2008 is a general quality management standard focused on providing products and services. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 6 MANAGEMENT SYSTEM (GS-R-3 , DS456 ) 2. Safety culture GS-R-3, DS456 promote a strong safety culture as an integral part of an management system. 3. Graded approach GS-R-3 states that the application of management system requirements shall be graded. MANAGEMENT SYSTEM (ISO 9001) Safety culture is not the requirement of ISO 9001:2008. ISO 9001:2008 has not an explicit requirement related to grading. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 7 4. Exclusion of requirements GS-R-3 , DS456 do not make provision of exclusion of any of its requirements. 5. Management system documentation 1. IAEA GS-R-3 , DS456 do not specify the procedures to be documented, but requires the management system to include the following: ISO 9001:2008 allows the exclusion of requirements. 1. ISO 9001:2008 requires the quality management system to include: - Documented statements of a quality policy and quality objectives; IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 8 5. Management system documentation, cont. - The policy statements of the organization; - A safety policy (DS 456) A description of the management system; A description of the structure of the organization; A description - A quality manual; - Documented procedures for: - Control of documents; - Control of records; - Internal audit; - Control of non-conforming product; - Corrective action; - Preventive action. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 9 5. Management system documentation, cont. - The policy statements of the organization; - A safety policy (DS 456) A description of the management system; A description of the structure of the organization; - A quality manual; - Documented procedures for: - Control of documents; - Control of records; - Internal audit; - Control of non-conforming product; - Corrective action; - Preventive action. IAEA Training Course on IMS Module 2 6

GS-R-3 vs. ISO 9001:2008 Requirements - 10 5. Management system documentation, cont. A description of how MS complies with al regulatory requirements that apply to the organization; A description of the functional responsibilities, accountability, levels of authority and interactions of those managing, performing and assessing work; IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 11 5. Management system documentation, cont. A description of the processes and supporting information explaining how work is to be prepared reviewed, carried out, recorded, assessed and improved; IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 12 5. Management system documentation, cont. A description of the interaction with interested parties and external organizations; Records, specified in the process documentation, that are required to demonstrate that the process results have been achieved; Etc. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 13 MANAGEMENT RESPONSIBILITY 1. Management commitment IAEA GS-R-3, DS456 places requirements on all levels of management. In IAEA GS-R-3 DS456 senior management has a number of responsibilities not specified in ISO 9001:2008 such as: ISO 9001:2008 places requirements only on top management. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 14 MANAGEMENT RESPONSIBILITY 1. Management commitment, cont. - developing organisational policies not limited only to quality policy; - developing the goals, strategies, plans and objectives of the organization in an integrated manner… IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 15 2. Satisfaction of interested parties 1. IAEA GS-R-3 DS456 requires senior management to consider the expectations and the satisfaction of interested parties in the processes of its management system. 2. Customer satisfaction 1. ISO 9001:2008 focuses only on customers. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 16 2. Satisfaction of interested parties, cont. 2. IAEA GS-R-3 DS456 addresses - customer satisfaction by requiring the enhancement of interested party satisfaction, as long as safety is not compromised. - Interactions with interested parties shall be integrated into the management system. 2. Customer satisfaction, cont. 2. Requirement for customer satisfaction is a part of the monitoring and measurement of the performance of the quality management system. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 17 RESOURCE MANAGEMENT 1. Provision of resources IAEA GS-R-3, DS456 places the responsibility specifically on senior management to provide the resources necessary to carry out the activities of the organization and to establish, implement, assess and continually improve the management system. ISO 9001:2008 places this responsibility on the organization, but requires top management to ensure that responsibilities and authorities are defined for this and other activities. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 18 1. Provision of resources, cont 2. Management of information and knowledge 3. IAEA GS-R-3 highlights the requirement to manage information and knowledge as a resource. 1. Provision of resources, cont. 3. ISO 9001:2008 has several requirements to manage information, but it has no requirement for knowledge management. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 19 PROCESS IMPLEMENTATION 1. IAEA GS-R-3 adopts the process approach. 2. IAEA GS-R-3 puts a strong focus on processes, requiring a graded application of management system requirements to the products and activities of each process. 1. ISO 9001:2008 adopts the process approach. 2. ISO 9001:2008 considers processes needed for product realization and focuses mainly on product quality. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 20 PROCESS IMPLEMENTATION 3. IAEA GS-R-3, DS456 have a specific requirement for a designated individual (process owner) with the authority and responsibility for developing, documenting, monitoring and promoting improvement of each process. 3. ISO 9001:2008 does not have a specific requirement for the process owner to be responsible and accountable for each process. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 21 MEASUREMENT, ASSESSMENT AND IMPROVEMENT 1. Self-assessment IAEA GS-R-3, DS456 require senior management and management at all other levels of the organization to carry out self- assessments to evaluate not just the performance of work but also the improvement of the safety culture. ISO 9001:2008 has no equivalent requirements for self-assessment. IAEA Training Course on IMS Module 2

GS-R-3 vs. ISO 9001:2008 Requirements - 22 MEASUREMENT, ASSESSMENT AND IMPROVEMENT 2. Analysis of data IAEA GS-R-3, DS456 does not have specific requirements on data collection and analysis of data to monitor the effectiveness of the management system. ISO 9001:2008 states that the organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system. IAEA Training Course on IMS Module 2 19