Core Questions (GSR Part 1 and GS-R-3) Primary Module ... - STUK

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Management). QID SQID QTYPE References True Subsidiary Question Next Question 16 16.10 Text Safety Standards Series No. GS-R- 3;para 5.6 Describe arrangements that ensure the documentation for each process is consistent with other relevant documents and specifies the records required to demonstrate that the process results have been achieved. SQID 16.11 In the guide of each process it is described how the documentation and records should be kept. The records of core processes are listed in STUK 1.2 appendix 2 and support processes in appendix 3. The word processor has templates to which all documentation is done (e.g. own template for management system guides). QID SQID QTYPE References True Subsidiary Question Next Question 16 16.11 Text Safety Standards Series No. GS-R- 3;para 5.4 Safety Standards Series No. GS-R-3;5.6 How have the process measurement criteria been established and what are the arrangements for monitoring and reporting on the performance of the processes? SQID 16.12 The measurement criteria for each process are presented in the process description of relevant guide. The performances of processes are described in annual reports and there are reviewed at Management group meetings as stated in Guide STUK 2.5 (Management Group). The Performance is also monitored yearly at STUK level and department level at management reviews as stated in Guide STUK 6.4 (Management Reviews and Corrective actions). QID SQID QTYPE References True Subsidiary Question Next Question 16 16.12 Text Safety Standards Series No. GS-R- 3;para 5.6 How are improvements in processes determined and promoted? SQID 16.13 Guide STUK 2.3(Management by Results: System description) states how the annual and strategic planning is managed. The flow-chart of the process is in appendix 2. The quality Management guides (STUK 6.1- STUK 6.5) states how the performance evaluation is done. QID SQID QTYPE References True Subsidiary Question Next Question 16 16.13 Text Safety Standards Describe how each process, including any subsequent SQID
Series No. GS-R- 3;para 5.6 changes to it, is aligned with the goals, strategies, plans and objectives of the regulatory body. 16.14 See answer to SQID 16.1 QID SQID QTYPE References True Subsidiary Question Next Question 16 16.14 Text Safety Standards Series No. GS-R- 3;para 5.6 How are the responsibilities and authorities for the development of the processes assigned within the management system? SQID 16.15 STUK 1.4 (Updating and Distributing the Quality Manual) states the responsibilities of management system development. Process owners are responsible for the development of processes (see SQID 16.5). QID SQID QTYPE References True Subsidiary Question Next Question 16 16.15 Text Safety Standards Series No. GS-R- 3;para 5.7-8 What verification activities and evaluations are conducted to confirm the adequate performance and ensure the effectiveness of each process and how are the responsibilities for verification specified? SQID 16.16 The principles of internal and external evaluations are presented in Quality Management guides (STUK 6.1-6.5). The process owner is responsible for the development of process as stated in Guide STUK 1.2 (Description of quality system). The quality manager and quality group also participates in the verification. The internal audits are arranged according to audit plan. Roughly 10-20 audits are arranged yearly. Also external auditing is required to some activities, see SQID 16.16. Large scale independent evaluations that have been done during past decade are for example IRRT 2000 and follow-up 2003, IPPAS 2008, Research evaluation 2005 and 2010. QID SQID QTYPE References True Subsidiary Question Next Question 16 16.16 Text Safety Standards Series No. GS-R- 3;para 5.7-8 What are the processes and activities within processes for which independent verification activities are required? SQID 16.17 Finnish Accreditation organization FINAS is carrying out annual assessments in STUK’s accreditated laboratories and similarly Center of metrology and accreditation (MIKES) is assessing DOS -laboratory.
Page 1 and 2: Core Questions (GSR Part 1 and GS-R
Page 3 and 4: processes. The requirements and wor
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Page 7 and 8: 3 3.3 Text Safety Standards Series
Page 9 and 10: these audits yearly. The work, howe
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Page 39 and 40: QID SQID QTYPE References Primary Q
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Page 51 and 52: Enter notes or comments here QID SQ
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Page 55 and 56: manager is also responsible for the
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Core Questions (GSR Part 1 and GS-R-3) Primary Module ... - STUK

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