Department of Media and Social Sciences, The Faculty of Social Sciences, University of Stavanger, 4036, Stavanger, Norway.
Department of Health and Nursing Science, University of Agder, 4604, Kristiansand, Norway.
BMC Health Serv Res. 2020 Aug 8;20(1):730. doi: 10.1186/s12913-020-05608-5.
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.
医疗保健认证通常涉及独立的私营部门机构开展法律要求或自愿的外部保证活动。这些认证实践根植于国际标准，这些标准建立在关于质量和安全改进的理性和可预测过程的传统信念之上。认证可以影响组织和文化变革，支持协作并鼓励改进，这可能有助于提高弹性绩效。本研究从认证机构的角度探讨了 ISO 9001 质量管理体系认证是否可以通过关注认证的目标、方法和实践的特征来支持医疗保健中的弹性，研究采用探索性嵌入式单案例设计。该研究依赖于对国际标准和相关认证机构认证指南的文件分析，以及对来自三个认证过程的 60 小时审计员观察和与认证机构管理人员和人员的九次定性访谈的数据的主题分析。对分析结果进行了比较，以确定书面和感知认证方法和实践之间的差异。
认证的标准和指南在组织中正式和一致地评估不符合项之间嵌入了弹性，并强调了带来附加值的整体方法。然后，审计员在与被审计方互动时，拥有了调整其审计策略的回旋余地。认证机构的成员认为并采用了一种整体而灵活的审计方法，利用分享知识、赋予权力和提供改进指导的机会。
ISO 认证期望有结构和系统来确保一致和客观的认证过程。同时，它体现了采用灵活和特定于上下文的认证方法的余地，正如本研究中的认证机构所展示的那样，为认证组织带来附加值。这种 ISO 9001 认证方法可以通过培养应对和学习的潜力来支持医疗保健中的弹性绩效。这些结果对于进一步开发认证机构在审计过程中使用的方法非常重要。
