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Johannesen, Dag Tomas Sagen - One of the best experts on this subject based on the ideXlab platform.
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Certification for Quality in Hospitals. Exploring adoption, approaches and processes of ISO 9001 quality management system Certification
'Springer Science and Business Media LLC', 2020Co-Authors: Johannesen, Dag Tomas SagenAbstract:Introduction: ISO 9001 quality management system Certification programs are used internationally to ensure, regulate and drive quality improvement in healthcare. Certifications are often described interchangeably with accreditation and positioned within external assessment programs. These external assessments programs are mostly acted by a non-state actor. Globally, the number of hospital Certification and accreditation programs has grown tremendously the last two decades. As a governance strategy, it may constitute a move away from the state as the only actor performing regulatory control. To become certified, hospitals need to adjust their systems to meet the requirements of the ISO 9001 standards. Hospitals are then assessed for compliance with the standard by auditors from an independent Certification Body and provided with an attestation if they comply. The Certification program is intended to assure patients and other stakeholders that hospitals can deliver expected and reliable services. The ISO 9001 standard applies to all sectors and proposes generic requirements for organizational structures and systems to continuously manage and improve quality. Certification bodies are themselves subject to external assessment by a national accreditation Body, according to an international ISO standard. The standard sets requirements for the Certification bodies’ system, process and practices to provide ISO 9001 Certifications. Norwegian clinics and hospitals have no clear history for Certification or accreditation, despite several initiatives. The first ISO 9001 Certification initiatives started almost two decades ago and have been subject to different policy debates. The goal of the government’s National Health and Hospital Plan for 2016−2019 was to introduce a system for quality Certification. The ISO 9001 Certification was highlighted since it contained many of the same elements for quality improvement as the national internal control regulation. However, no national system has yet been established. We lack evidence that Certification has a direct impact on clinical outcomes, but there are many indicators that Certification has fostered organizational change and has positive implications for quality and safety management. We still know little about why health care organizations adopt Certification, how Certification processes unfold and are understood, and the methods and approaches used by Certification bodies, such as role repertoire, auditor’s conduct (e.g., inspection or guidance) and assessment practice. Aim: This thesis aimed to develop knowledge about: 1) external drivers and internal processes in hospital Certification, by exploring Certification processes in hospitals; 2) the scope, understanding and practice of Certification processes and the Certification regime, by exploring the perspectives of a Certification Body and the international standards and guidances; 3) the possible contributions to performance improvement from Certification processes in hospitals, by exploring characteristics in approaches to ISO Certification and examine whether these approaches can support resilience in healthcare. Method: This thesis consists of two case studies. Case 1 was designed as an explanatory retrospective single-case design study of a first-time ISO 9001 Certification process (years 2008-2012) in an emergency department. Data was collected through documentary sources and interviews and analyzed using a narrative approach. A sensemaking framework was applied to explore change processes. Case 2 was designed as an embedded (multiple units) single-case study. Three units were addressed: 1) auditors’ interaction with hospitals in Certification processes; 2) one Certification Body’s Certification approach; and 3) the Certification approach in international standards and guidances. Data was collected through documentary sources, interviews, and observations. Theoretical (deductive) thematic analysis was performed to analyze all the data. An auditor typology framework was applied to explore the auditors’ conduct while auditing, and a governance and resilience perspective was adopted to examine Certification approaches across units
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Exploring hospital Certification processes from the Certification Body’s perspective - a qualitative study
'Springer Science and Business Media LLC', 2020Co-Authors: Johannesen, Dag Tomas Sagen, Wiig SiriAbstract:Hospital Certification is an external assessment mechanism to assure quality and safety systems. Auditors representing the Certification Body play a key role in Certification processes, as they perform the assessment activities and interact with the involved healthcare organizations. There is limited knowledge about the approaches and methods that auditors use, such as role repertoire, conduct, and assessment practice. The purpose of this study was to explore auditors’ practice in hospital Certification processes, guided by the following research questions: What styles do auditors apply in hospital Certification processes, and how do auditors perceive their role in hospital Certification processes? Methods The study was performed in two stages. In the first stage, non-participant observations (59 h) were conducted, to explore the professional practice of three lead auditors in Certification processes of Norwegian hospitals. In the second stage, semi-structured interviews were conducted with these three observed lead auditors. The role repertoires and conducts identified were analyzed by using a deductive approach according to a surveyor (equivalent with auditor) styles typology framework. Results Two distinct auditor styles (“explorer” and “discusser”) were identified among the three studied auditors. Both styles were characterized by their preference for an opportunistic and less structured type of interview practice during Certification audits. All three auditors embedded a guiding approach (reflections about findings, stimulate improvements, experience transfer from other industries) to their perception and practice of Certification audits, interacting with the auditees. The use of group interviews instead of individual interviews during Certification audits, was the rule of their professional practice. Conclusion The auditors’ perceptions and styles demonstrated a multifaceted Certification reality, in contrast to what is often presumed as consistent, stringent and independent practices. These findings may have implications for reliability judgements when developing hospital Certification programs, and for the refinement of the current framework used here to study the different auditing practices.publishedVersio
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Certification as support for resilience? Behind the curtains of a Certification Body — a qualitative study
'Springer Science and Business Media LLC', 2020Co-Authors: Johannesen, Dag Tomas Sagen, Lindøe, Preben Hempel, Wiig SiriAbstract:Background Certification in healthcare often involves independent private sector bodies performing legally required or voluntary external assurance activities. These Certification practices are embedded in international standards founded in traditional beliefs about rational and predictable processes for quality and safety improvement. Certification can affect organizational and cultural changes, support collaboration and encourage improvement that may be conducive to resilient performance. This study explores whether ISO 9001 quality management system Certification can support resilience in healthcare, by looking at characteristics in the objectives, methods, and practice of Certification from a Certification Body’s perspective. Methods One of Norway’s four Certification bodies in healthcare was studied, using an explorative embedded single-case design. The study relies on document analysis of the international standards and associated guidances for the performance of Certification bodies and thematic analyses of data from 60 h of observations of auditors in three Certification processes and nine qualitative interviews with managers and personnel from the Certification Body. Results from the analyses were compared to identify discrepancies between the written and perceived Certification approach and practice. Results Standards and guidances for Certification embed an elasticity between formal and consistent assessments of nonconformities in organizations and emphasize holistic approaches that brings added value. Auditors were then left with the latitude to navigate their auditing strategy during interaction with the auditees. Members of the Certification Body perceived and practiced a holistic and flexible auditing approach using opportunities to share knowledge, empower and make guidance for improvement. Conclusions ISO Certification expects structures and systems to ensure consistent and objective Certification processes. At the same time, it embodies a latitude to adopt flexible and context-specific Certification approaches, as demonstrated by a Certification Body in this study, to give added value to the certified organizations. Such an ISO 9001 Certification approach may support resilient performance in healthcare by nurturing the potential to respond and learn. These results are important for further development of methods that Certification bodies use in the auditing encounter.publishedVersio
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Exploring hospital Certification processes from the Certification Body’s perspective - a qualitative study
BioMed Central, 2020Co-Authors: Johannesen, Dag Tomas Sagen, Wiig SiriAbstract:Hospital Certification is an external assessment mechanism to assure quality and safety systems. Auditors representing the Certification Body play a key role in Certification processes, as they perform the assessment activities and interact with the involved healthcare organizations. There is limited knowledge about the approaches and methods that auditors use, such as role repertoire, conduct, and assessment practice. The purpose of this study was to explore auditors’ practice in hospital Certification processes, guided by the following research questions: What styles do auditors apply in hospital Certification processes, and how do auditors perceive their role in hospital Certification processes? Methods The study was performed in two stages. In the first stage, non-participant observations (59 h) were conducted, to explore the professional practice of three lead auditors in Certification processes of Norwegian hospitals. In the second stage, semi-structured interviews were conducted with these three observed lead auditors. The role repertoires and conducts identified were analyzed by using a deductive approach according to a surveyor (equivalent with auditor) styles typology framework. Results Two distinct auditor styles (“explorer” and “discusser”) were identified among the three studied auditors. Both styles were characterized by their preference for an opportunistic and less structured type of interview practice during Certification audits. All three auditors embedded a guiding approach (reflections about findings, stimulate improvements, experience transfer from other industries) to their perception and practice of Certification audits, interacting with the auditees. The use of group interviews instead of individual interviews during Certification audits, was the rule of their professional practice. Conclusion The auditors’ perceptions and styles demonstrated a multifaceted Certification reality, in contrast to what is often presumed as consistent, stringent and independent practices. These findings may have implications for reliability judgements when developing hospital Certification programs, and for the refinement of the current framework used here to study the different auditing practices
Wiig Siri - One of the best experts on this subject based on the ideXlab platform.
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Exploring hospital Certification processes from the Certification Body’s perspective - a qualitative study
'Springer Science and Business Media LLC', 2020Co-Authors: Johannesen, Dag Tomas Sagen, Wiig SiriAbstract:Hospital Certification is an external assessment mechanism to assure quality and safety systems. Auditors representing the Certification Body play a key role in Certification processes, as they perform the assessment activities and interact with the involved healthcare organizations. There is limited knowledge about the approaches and methods that auditors use, such as role repertoire, conduct, and assessment practice. The purpose of this study was to explore auditors’ practice in hospital Certification processes, guided by the following research questions: What styles do auditors apply in hospital Certification processes, and how do auditors perceive their role in hospital Certification processes? Methods The study was performed in two stages. In the first stage, non-participant observations (59 h) were conducted, to explore the professional practice of three lead auditors in Certification processes of Norwegian hospitals. In the second stage, semi-structured interviews were conducted with these three observed lead auditors. The role repertoires and conducts identified were analyzed by using a deductive approach according to a surveyor (equivalent with auditor) styles typology framework. Results Two distinct auditor styles (“explorer” and “discusser”) were identified among the three studied auditors. Both styles were characterized by their preference for an opportunistic and less structured type of interview practice during Certification audits. All three auditors embedded a guiding approach (reflections about findings, stimulate improvements, experience transfer from other industries) to their perception and practice of Certification audits, interacting with the auditees. The use of group interviews instead of individual interviews during Certification audits, was the rule of their professional practice. Conclusion The auditors’ perceptions and styles demonstrated a multifaceted Certification reality, in contrast to what is often presumed as consistent, stringent and independent practices. These findings may have implications for reliability judgements when developing hospital Certification programs, and for the refinement of the current framework used here to study the different auditing practices.publishedVersio
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Certification as support for resilience? Behind the curtains of a Certification Body — a qualitative study
'Springer Science and Business Media LLC', 2020Co-Authors: Johannesen, Dag Tomas Sagen, Lindøe, Preben Hempel, Wiig SiriAbstract:Background Certification in healthcare often involves independent private sector bodies performing legally required or voluntary external assurance activities. These Certification practices are embedded in international standards founded in traditional beliefs about rational and predictable processes for quality and safety improvement. Certification can affect organizational and cultural changes, support collaboration and encourage improvement that may be conducive to resilient performance. This study explores whether ISO 9001 quality management system Certification can support resilience in healthcare, by looking at characteristics in the objectives, methods, and practice of Certification from a Certification Body’s perspective. Methods One of Norway’s four Certification bodies in healthcare was studied, using an explorative embedded single-case design. The study relies on document analysis of the international standards and associated guidances for the performance of Certification bodies and thematic analyses of data from 60 h of observations of auditors in three Certification processes and nine qualitative interviews with managers and personnel from the Certification Body. Results from the analyses were compared to identify discrepancies between the written and perceived Certification approach and practice. Results Standards and guidances for Certification embed an elasticity between formal and consistent assessments of nonconformities in organizations and emphasize holistic approaches that brings added value. Auditors were then left with the latitude to navigate their auditing strategy during interaction with the auditees. Members of the Certification Body perceived and practiced a holistic and flexible auditing approach using opportunities to share knowledge, empower and make guidance for improvement. Conclusions ISO Certification expects structures and systems to ensure consistent and objective Certification processes. At the same time, it embodies a latitude to adopt flexible and context-specific Certification approaches, as demonstrated by a Certification Body in this study, to give added value to the certified organizations. Such an ISO 9001 Certification approach may support resilient performance in healthcare by nurturing the potential to respond and learn. These results are important for further development of methods that Certification bodies use in the auditing encounter.publishedVersio
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Exploring hospital Certification processes from the Certification Body’s perspective - a qualitative study
BioMed Central, 2020Co-Authors: Johannesen, Dag Tomas Sagen, Wiig SiriAbstract:Hospital Certification is an external assessment mechanism to assure quality and safety systems. Auditors representing the Certification Body play a key role in Certification processes, as they perform the assessment activities and interact with the involved healthcare organizations. There is limited knowledge about the approaches and methods that auditors use, such as role repertoire, conduct, and assessment practice. The purpose of this study was to explore auditors’ practice in hospital Certification processes, guided by the following research questions: What styles do auditors apply in hospital Certification processes, and how do auditors perceive their role in hospital Certification processes? Methods The study was performed in two stages. In the first stage, non-participant observations (59 h) were conducted, to explore the professional practice of three lead auditors in Certification processes of Norwegian hospitals. In the second stage, semi-structured interviews were conducted with these three observed lead auditors. The role repertoires and conducts identified were analyzed by using a deductive approach according to a surveyor (equivalent with auditor) styles typology framework. Results Two distinct auditor styles (“explorer” and “discusser”) were identified among the three studied auditors. Both styles were characterized by their preference for an opportunistic and less structured type of interview practice during Certification audits. All three auditors embedded a guiding approach (reflections about findings, stimulate improvements, experience transfer from other industries) to their perception and practice of Certification audits, interacting with the auditees. The use of group interviews instead of individual interviews during Certification audits, was the rule of their professional practice. Conclusion The auditors’ perceptions and styles demonstrated a multifaceted Certification reality, in contrast to what is often presumed as consistent, stringent and independent practices. These findings may have implications for reliability judgements when developing hospital Certification programs, and for the refinement of the current framework used here to study the different auditing practices
Dag Tomas Sagen Johannesen - One of the best experts on this subject based on the ideXlab platform.
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Certification as support for resilience behind the curtains of a Certification Body a qualitative study
BMC Health Services Research, 2020Co-Authors: Dag Tomas Sagen Johannesen, Preben Hempel Lindøe, Siri WiigAbstract:Certification in healthcare often involves independent private sector bodies performing legally required or voluntary external assurance activities. These Certification practices are embedded in international standards founded in traditional beliefs about rational and predictable processes for quality and safety improvement. Certification can affect organizational and cultural changes, support collaboration and encourage improvement that may be conducive to resilient performance. This study explores whether ISO 9001 quality management system Certification can support resilience in healthcare, by looking at characteristics in the objectives, methods, and practice of Certification from a Certification Body’s perspective. One of Norway’s four Certification bodies in healthcare was studied, using an explorative embedded single-case design. The study relies on document analysis of the international standards and associated guidances for the performance of Certification bodies and thematic analyses of data from 60 h of observations of auditors in three Certification processes and nine qualitative interviews with managers and personnel from the Certification Body. Results from the analyses were compared to identify discrepancies between the written and perceived Certification approach and practice. Standards and guidances for Certification embed an elasticity between formal and consistent assessments of nonconformities in organizations and emphasize holistic approaches that brings added value. Auditors were then left with the latitude to navigate their auditing strategy during interaction with the auditees. Members of the Certification Body perceived and practiced a holistic and flexible auditing approach using opportunities to share knowledge, empower and make guidance for improvement. ISO Certification expects structures and systems to ensure consistent and objective Certification processes. At the same time, it embodies a latitude to adopt flexible and context-specific Certification approaches, as demonstrated by a Certification Body in this study, to give added value to the certified organizations. Such an ISO 9001 Certification approach may support resilient performance in healthcare by nurturing the potential to respond and learn. These results are important for further development of methods that Certification bodies use in the auditing encounter.
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exploring hospital Certification processes from the Certification Body s perspective a qualitative study
BMC Health Services Research, 2020Co-Authors: Dag Tomas Sagen Johannesen, Siri WiigAbstract:Hospital Certification is an external assessment mechanism to assure quality and safety systems. Auditors representing the Certification Body play a key role in Certification processes, as they perform the assessment activities and interact with the involved healthcare organizations. There is limited knowledge about the approaches and methods that auditors use, such as role repertoire, conduct, and assessment practice. The purpose of this study was to explore auditors’ practice in hospital Certification processes, guided by the following research questions: What styles do auditors apply in hospital Certification processes, and how do auditors perceive their role in hospital Certification processes? The study was performed in two stages. In the first stage, non-participant observations (59 h) were conducted, to explore the professional practice of three lead auditors in Certification processes of Norwegian hospitals. In the second stage, semi-structured interviews were conducted with these three observed lead auditors. The role repertoires and conducts identified were analyzed by using a deductive approach according to a surveyor (equivalent with auditor) styles typology framework. Two distinct auditor styles (“explorer” and “discusser”) were identified among the three studied auditors. Both styles were characterized by their preference for an opportunistic and less structured type of interview practice during Certification audits. All three auditors embedded a guiding approach (reflections about findings, stimulate improvements, experience transfer from other industries) to their perception and practice of Certification audits, interacting with the auditees. The use of group interviews instead of individual interviews during Certification audits, was the rule of their professional practice. The auditors’ perceptions and styles demonstrated a multifaceted Certification reality, in contrast to what is often presumed as consistent, stringent and independent practices. These findings may have implications for reliability judgements when developing hospital Certification programs, and for the refinement of the current framework used here to study the different auditing practices.
Ton Trapman - One of the best experts on this subject based on the ideXlab platform.
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a safety concept for an iec 61508 compliant fail safe wind power mixed criticality system based on multicore and partitioning
International Conference on Reliable Software Technologies, 2015Co-Authors: Jon Perez, David Gonzalez, Salvador Trujillo, Ton TrapmanAbstract:The development of mixed-criticality systems that integrate applications of different criticality levels (safety, security, real-time and non-real time) in a single embedded system can provide multiple benefits such as product cost-size-weight reduction, reliability increase and scalability. However, the integration of applications of different levels of criticality in a single embedded system leads to several challenges with respect to safety Certification standards. This research paper describes a safety concept for a fail-safe wind turbine mixed-criticality control system based on multicore partitioning that meets IEC-61508 and ISO-13849 industrial safety standards. The safety concept has been positively assessed by a Certification Body.
Siri Wiig - One of the best experts on this subject based on the ideXlab platform.
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Certification as support for resilience behind the curtains of a Certification Body a qualitative study
BMC Health Services Research, 2020Co-Authors: Dag Tomas Sagen Johannesen, Preben Hempel Lindøe, Siri WiigAbstract:Certification in healthcare often involves independent private sector bodies performing legally required or voluntary external assurance activities. These Certification practices are embedded in international standards founded in traditional beliefs about rational and predictable processes for quality and safety improvement. Certification can affect organizational and cultural changes, support collaboration and encourage improvement that may be conducive to resilient performance. This study explores whether ISO 9001 quality management system Certification can support resilience in healthcare, by looking at characteristics in the objectives, methods, and practice of Certification from a Certification Body’s perspective. One of Norway’s four Certification bodies in healthcare was studied, using an explorative embedded single-case design. The study relies on document analysis of the international standards and associated guidances for the performance of Certification bodies and thematic analyses of data from 60 h of observations of auditors in three Certification processes and nine qualitative interviews with managers and personnel from the Certification Body. Results from the analyses were compared to identify discrepancies between the written and perceived Certification approach and practice. Standards and guidances for Certification embed an elasticity between formal and consistent assessments of nonconformities in organizations and emphasize holistic approaches that brings added value. Auditors were then left with the latitude to navigate their auditing strategy during interaction with the auditees. Members of the Certification Body perceived and practiced a holistic and flexible auditing approach using opportunities to share knowledge, empower and make guidance for improvement. ISO Certification expects structures and systems to ensure consistent and objective Certification processes. At the same time, it embodies a latitude to adopt flexible and context-specific Certification approaches, as demonstrated by a Certification Body in this study, to give added value to the certified organizations. Such an ISO 9001 Certification approach may support resilient performance in healthcare by nurturing the potential to respond and learn. These results are important for further development of methods that Certification bodies use in the auditing encounter.
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exploring hospital Certification processes from the Certification Body s perspective a qualitative study
BMC Health Services Research, 2020Co-Authors: Dag Tomas Sagen Johannesen, Siri WiigAbstract:Hospital Certification is an external assessment mechanism to assure quality and safety systems. Auditors representing the Certification Body play a key role in Certification processes, as they perform the assessment activities and interact with the involved healthcare organizations. There is limited knowledge about the approaches and methods that auditors use, such as role repertoire, conduct, and assessment practice. The purpose of this study was to explore auditors’ practice in hospital Certification processes, guided by the following research questions: What styles do auditors apply in hospital Certification processes, and how do auditors perceive their role in hospital Certification processes? The study was performed in two stages. In the first stage, non-participant observations (59 h) were conducted, to explore the professional practice of three lead auditors in Certification processes of Norwegian hospitals. In the second stage, semi-structured interviews were conducted with these three observed lead auditors. The role repertoires and conducts identified were analyzed by using a deductive approach according to a surveyor (equivalent with auditor) styles typology framework. Two distinct auditor styles (“explorer” and “discusser”) were identified among the three studied auditors. Both styles were characterized by their preference for an opportunistic and less structured type of interview practice during Certification audits. All three auditors embedded a guiding approach (reflections about findings, stimulate improvements, experience transfer from other industries) to their perception and practice of Certification audits, interacting with the auditees. The use of group interviews instead of individual interviews during Certification audits, was the rule of their professional practice. The auditors’ perceptions and styles demonstrated a multifaceted Certification reality, in contrast to what is often presumed as consistent, stringent and independent practices. These findings may have implications for reliability judgements when developing hospital Certification programs, and for the refinement of the current framework used here to study the different auditing practices.