Result of the implementation of a quality management system based on the ISO 9001:2015 standard in a surgical...

The implementation of Quality Management Systems (QMS) is one of the fundamental and future-oriented elements for the improvement of modern health systems. The objective of implementing a QMS in accordance with the requirements of the ISO 9001: 2015 Standard is to effectively carry out its activities, covering both technical and management aspects, guaranteeing the satisfaction of the needs and expectations of all its stakeholders, as well as compliance with legal and regulatory requirements. It must contemplate all those aspects that have an impact on the final quality of the product or service provided by the organization.

The main objective is to describe the process of implementing a QMS under the ISO 9001: 2015 Standard in the Surgical Intensive Care Unit of the General University Hospital of Elche and evaluate its results.

Carrying out and implementing a QMS in the Surgical Intensive Care Unit of the General University Hospital of Elche applying the points of the ISO 9001: 2015 Standard. The SGC has followed the benchmark of management by processes, identifying from its strategic core of mission, vision and values, the different processes involved and their interrelation reflected in the process map. Based on it, the necessary documents have been developed to describe the operation of the Unit both at an operational level through the key processes (admission and initial assessment of the patient, stabilization, follow-up, complementary tests, interconsultations, transfers and discharge) as well as which refers to procedures of a strategic or support type.

The strategic lines that marked the beginning of the deployment of our QMS were defined with the drafting of 7 objectives, achieving 100% compliance. The key processes (7) that described the functioning of our organization were elaborated, as well as those of a strategic type (14) and support or support (5), complemented with 55 medical and nursing protocols. 20 monitoring indicators were analyzed: 6 organizational and planning type, and 14 clinical. 46 incidents were detected in the first year of implementation of the QMS that were analyzed by the Quality Commission, emerging 7 corrective actions. 14 improvement actions were developed after the application of the AMFE methodology for key processes, achieving an average of greater than 70% effectiveness after reassessment. From the analysis of patient and family satisfaction through SAIP case management, 41 of a total of 52 cases were acknowledgments in writing.

Implementing a QMS in our Surgical Intensive Care Unit has made it possible to define the strategic lines of our organization, develop objectives, establish monitoring indicators, standardize the work of the Unit through procedures and protocols, increase safety at work through the use of lists of verification, initiate improvement actions to strengthen the weak points of the QMS itself, as well as know the degree of satisfaction and needs of our patients and the personnel who work in it.