Several limitations in this thesis needs special attention. Some issues are already mentioned above (4.6 & 4.7), but a brief overview is needed.
There is limited research on ISO 9001 certification practices in healthcare in Norway, and this thesis is a novel work in these perspectives. The thesis is therefore explorative in nature. Despite the explorative nature, the thesis has applied several theoretical foundations in order to guide the study and analysis.
There is a risk that the theoretical perspectives chosen in such novel work do not capture important elements of the certification practices that it intended to do. E.g. theory driven categories adopted form regulation theory were used to analyze the certification body’s and auditors’ conduct in certification processes and the normative standards as guidance for certification.
The narrative in case 1 constructed retrospectively of the certification process in an emergency department was a story but not necessarily the whole story or the real story in an objectivist sense. The narrative may have discriminated the complexity of multiple, simultaneous and various narratives and sensemaking processes that were worked out within the organization, or captured internal elements that were not caused by the process under study [118, 213]. The meaning making processes were studied within a single emergency department in a single hospital in Norway. The sample size is a limitation for generalizations from this study.
Further, as discussed above (4.6), the number of informants included in each case study are small, and only one certification body is included. Even though
Discussion
characterizations of the participants and context, consideration should be taken when generalizing from this thesis.
This thesis has not studied how the specific clauses in the ISO 9001 standard were assessed and translated by auditors and the auditees during the certification processes. Neither does the study include the specific changes or outcomes in the hospitals from the different certification processes observed, besides that all the hospital organizations were certified. Cautions must be taken of the relationship between the certification approaches and process and the actual outcomes in the organizations.
Discussion
Conclusion
7 Conclusion
I will conclude by revisiting the research questions and their contributions to the aim of the thesis. Moreover, I propose possible directions for future research.
The first aim was to develop knowledge about external drivers and internal processes in hospital certification. Answers to research questions i and ii improve our understanding of how cues provided by external pressure and institutional structures, meet the micro-level change processes in organizations involved in adoption of ISO 9001 certification.
i. How do external environments contribute to an adoption of ISO 9001 certification in an emergency department?
This thesis identified two situationally specific triggers and two institutional triggers in the external environment that contributed to an adoption of ISO 9001 certification. The two situationally specific triggers were: 1) that nonconformities during a national supervision, mirrored known challenges in the emergency department, prompting a search for change by the management;
and 2) an external offer to take part in a pilot project for ISO 9001 certification became a quick and plausible option for the emergency department. The two institutional triggers were the current regulation for quality management (internal control regulation) in healthcare and the ISO 9001 standard and certification process. These stable institutional structures were perceived as ambiguous and provided cues that enabled the emergency management’s sense making processes and their own search for control.
ii. How does local management make sense of the certification process?
By combining sensemaking theory with institutional theory, this thesis demonstrated that the ambiguous institutional structures inherent in health care regulations and the ISO 9001 standard set in motion important sensemaking processes around continuity and change. Preferably, ISO 9001 certification processes, unlike health care regulations, involved predictable external auditing that integrated direct feedback to the ambiguous change processes. This was
Conclusion
acknowledged by the emergency department as important and useful for improvement.
The second aim of this thesis was to develop knowledge about the scope, understanding and practice of certification processes. Answers to research questions iii – vi added to this knowledge by demonstrating that the international ISO 9001 certification regime stressed consistency and objectivity while opening for flexible and context-specific audit approaches. Further answers contributed to the identification of adaptable auditing styles involved in hospital certifications and showed that a certification body included both assessment and guidance to their understanding and practice of ISO 9001 certification processes in hospitals. The thesis also extends the application of the theoretical auditor style framework.
iii. What styles do auditors apply in hospital certification processes?
By adopting an auditor typology framework, this thesis identified auditor styles characterized by their preference for an opportunistic and less structured type of interview practice during ISO 9001 certification in hospitals. Guidance and stimulation for improvement were also incorporated into the auditors’
assessment style. Further, this thesis identified that the auditors used group interviews, instead of individual interviews as defined by the auditor typology framework that was applied. Therefore, an additional dimension of group interview practices was proposed, to refine the auditor style typology.
iv. How do auditors perceive their role in hospital certification processes?
This thesis identified that the auditors perceived their auditing role in coherence in terms of how they practiced their audit style. They all perceived both assessment of conformity to the ISO 9001 standard and guidance for improvement as embedded parts of their auditing role.
v. What auditing approach for certification bodies is embedded in standards and guidance notes for ISO 9001 certification?
This thesis shows that the international standards and guidance for ISO 9001 certification expected certification bodies to have structures and systems in
Conclusion
time, they gave auditors the latitude to adopt a flexible and context-specific audit approach, in order to add value during certification processes.
vi. How do managers and auditors of a certification body perceive and practice the certifications?
The members of a certification body explored in this thesis acknowledged and navigated their sharp end certification approach holistically, integrating both assessment and guidance. They also perceived their own formal structures and management system for ISO 9001 certification as important for reliable certifications, and to be formalized to a greater extent than the sharp end practices of certification auditing.
The third aim of this thesis was to develop knowledge about possible contributions to performance improvement. By exploring characteristics of ISO 9001 certification approaches in hospitals, this thesis identified flexible and adaptable certification processes that may support and nurture resilient performance of healthcare organizations undergoing certification processes.
In addition, this thesis proposes a model of the accredited ISO 9001 certification regime that may be helpful in future studies and development of ISO 9001 certification practices in hospitals.