Armonización entre la norma ISO 9001:2015 sistema de gestión de la calidad. Requisitos y la resolución 1403 de 2007 para aplicación en droguerías. Caso droguería y perfumería Farmavillas SAS

Abstract

The high-level structure of the management systems has within its attributes the ability to harmonize and guarantee the evaluation of the conformity of companies of all types and sizes. In Colombia, since the last 20 years, it has developed legal requirements focused on improving quality. In terms of services and the safe handling of medications, a regulatory evolution that undoubtedly improves the conditions in the pharmaceutical service considered by the World Health Organization as a basic health service, this development focuses on organizing the processes of druggists retailers aligning their offer of services and medicines. The investigation was carried out in a chain of retail drug stores which obtained unfavorable results in terms of inventory management and compliance with a legal requirement associated with quality management Resolution 1403 of 2007, supported by the need to prevent sanctions for the company and the interest of the group of shareholders in implementing standardized norms aligned to the strategy, the development of a methodological tool was proposed that would favor the management of the drugstore in terms of the establishment of processes and objectives focused on improving corporate performance supported by the NTC ISO 9001 : 2015 The objectives of this research work were to design the harmonization of the requirements of resolution 1403 of 2007 and those of the quality management system based on ISO 9001: 2015 for the improvement in the management of the processes of the Farmavillas drugstore chain., compatible with the high-level structure of management systems and the legal requirements associated with the retail drug sector, seeking to strengthen processes, providing modeling opportunities to all types of retail pharmacy in Colombia, identifying and controlling risks, generating opportunities for obtain social economic benefits for those who are interested in its implementation. The project was developed in three stages in which a comparison process of resolution 1403 of 2007 and the NTC ISO 9001:2015 was generated, allowing quantitative and qualitative identification of similarities and differences between the requirements analyzed, once the comparison exercise was developed. the “ISO 9001:2005 Standard Harmonization Guide” was developed. A quality management system based on the quality management system and resolution 1403 of 2007 applicable to the retail drug sector in Colombia”, which was based on the PHVA cycle generating guidelines and recommendations that any type of retail drug store planning, implementation and management of the NTC ISO 9001: 2015 guaranteeing compliance with the legal requirements established in Resolution 1403 of 2007, in the development of the third stage, the formulation of a sequential scheme of the stages required for the development of the System was carried out of quality management in the service, in accordance with the harmonization of the legal standard Resolution 1403 of 2007 and the NTC ISO 9001: 2015, to facilitate the future implementation of the requirements established in the guide.