Table 3.

Empirical Foundation of the Study

Documents identified, selected, read and analyzed:
2002	• Internal Control Regulations in the Healthcare Services (hereafter referred to as: Internal Control Regulation) [20] (2 pages)
2013	• Circula on management in hospitals, provided by the Ministry of Health and Care Services (the Ministry) [57] (5 pages) • Assignment letter of drafting a new Quality Improvement Regulation, sent from the Ministry to the Norwegian Directorate of Health (the Directorate) [58] (3 pages) • Project plan sent from (the Directorate to relevant stakeholders [59] (8 pages)
2014	• Invitation to give input to the Directorate’s draft of the new Quality Improvement Regulation [60] (2 pages) • Draft of the Hearing Memorandum sent to the Ministry, provided to them by the Directorate in cooperation with the Norwegian Board of Health Supervision (the Inspectorate) [61] (47 pages)
2015	• Final Hearing Memorandum submitted to relevant stakeholders, by the Ministry [37] (41 pages) • White Paper (NOU) [36] (344 pages, with exceptions)
2016	• Hearing Comments [62] (38 pages) • The Prerogative document for the Quality Improvement Regulation on management and quality improvement in the healthcare services, which stated the narrative of the facts and circumstances of its policies. Formal approval was given in Royal Assent [65] (4 pages)
2017	• Regulation on management and quality improvement in the healthcare services [34] (3 pages) • Guidelines relating to the Regulation on management and quality improvement in the healthcare services [66] (57 pages)
Individual Interviews (in total 7):
2018	• 3 interviews at the Ministry of Health and Care Services • 2 interviews at the Norwegian Directorate of Health • 2 interviews at the Norwegian Board of Health Supervision