Designing a Quality Management System for the Sterilization Service within a Healthcare Center in Córdoba

GALLARDO GALLEGOS G, VEGA EM, ORTIZ C

Córdoba

Congreso; Tercera Reunión Internacional de Ciencias Farmacéuticas; 2014

Healthcare organizations are nowadays forced to provide proof of a safe and high quality service delivery.Every single department within a hospital, specially the Sterilization Service (SS), must align with a set ofrules and specifications that lead to a continual improvement of the services they provide.The Standard ISO9001 implementations not only leads to a better understanding of the current servicelevel, but also allows the identification of potential changes, and fulfil legal and technical requirements as well as customer expectations. This implementation permits re-classify existing procedures and createnew procedures focused on the Process Approach to Management defined on ISO9001.This paper aims to design a Quality Management System (QMS) to be implemented in the SSof ahealthcare organization in Córdoba.To carry out the development of the QMS the following tasks were performed:?Review of existing processes and activities within the SS, classifying them and identifying criticalactivities.?Writing of documents.?Definition of work instructions along with detailed activities and records for Key, Support andManagement processes.?Design of the Quality Manual (QM) based on ISO9001 requirements.?Design of the necessary documents to fulfil the standard ISO9001.This work involved the design of the documentary base of a QMS, the elaborated documents are:?1QM?8 Required Procedures.?27 Work Instructions.?3 Job Descriptions.?8 Process forms?10 Product forms.?65 Records.Among the 27 Work Instructions, the followings are important to highlight:1. Sanitary Conditions Assessment (Sanitary Profile).2. Hazard analysis and critical control points3. Integrated Pest Control.4. Control Panel.5. Pharmacoeconomics Assessment.The 115 documents designed and prepared are the basis for an integrated management system thatensures the quality of the products and services offered by the SS.The adoption of a QMS lead to a differentiation from other traditional services by systematicallyorganizing what is "intuitively" done.