Quality Objectives in Standardized Quality Management Systems.

Abstract

The effectiveness of a quality management system consistent with the ISO 9001 standard depends on how quality objectives are established and pursued. The aims of this article are to identify quality objectives in selected certified organizations providing medical services, assess their compliance with the requirements of the ISO 9001 standard, and determine factors influencing such objectives. The first theoretical part of the article is based on a systematic literature review. The empirical part contains an analysis of documentation related to quality management systems and conducted audits. The data were collected during 42 quality management system audits conducted in 16 health care organizations in the years 2015-2020. Uncategorized interviews were conducted with quality management system representatives. The data were verified by interviews with 6 management system auditors having at least 15 years' experience in auditing health care organizations. The assessment of the methodological correctness is based on the ISO 9001:2015 standard criteria. The most frequently formulated quality objectives include improving customer satisfaction, task-based objectives related to planned works, improvements, and development of new medical services. The quality objectives fulfill the requirements of the ISO 9001 standard. However, they are not ambitious. The most significant factors influencing the processes of goal setting are economic (financial incentives, available resources for modernization), social (community needs), and managerial (the scope of performed analyses, the quality of the audit process, and the calculation of necessary effort). Health care organizations need to pursue more ambitious objectives, intensify the use of performed medical analyses, and integrate quality objectives into management remuneration systems.