Clinical pathways are used as a method of organizing care processes. Although they are used worldwide, the concept remains unclear, with little understanding of what exactly is being implemented. A recent systematic review revealed that, although a tool exists to score the instrumental qualities of clinical pathways, no tools are available to assess how the clinical pathway influences the process of care. These tools are needed for a better understanding of the impact of clinical pathways on the length of hospital stay and patient outcomes. In this study, a Care Process Self-Evaluation Tool (CPSET), based on the clinical pathway concept, for assessing the organization of the process of care has been developed and tested. Qualitative and quantitative methods, involving 885 professionals and patients, were used in the development and validation. The CPSET is a valid and reliable 29-item instrument for assessing how the process of care is organized. The CPSET has five subscales: patient-focused organization, coordination of care, communication with patients and family, cooperation with primary care and monitoring/follow-up of the care process. The CPSET can be used in the audit and accreditation of care processes and will help managers and clinicians to understand better how care processes are organized.