Diseño de un Manual de BPM bajo la Integración ISO 9001, ISO 22000 y el Sistema HACCP en la Industria Alimentaria Ecuatoriana

Abstract

Safety management requires a shift from reactive inspections to preventive systems, which depend on integrated regulatory frameworks. In Ecuador, small and medium-sized enterprises (SMEs) face bureaucratic and economic barriers to complying with the requirements of the national health authority and adopting global standards. Given this difficulty, the hypothesis is that an integrated manual adapted to the operational reality of SMEs will simplify the burden of record keeping and facilitate regulatory compliance. This research adopted a qualitative documentary design developed in three phases: documentary review to identify regulatory convergences using a comparative matrix, structural design of the system based on the flow of production processes, and operational adaptation of international requirements. The results show that compliance with local regulations serves as a direct basis for global standards, eliminating redundancies through the technical-legal matrix. Based on this, a central document was structured that proposes simplified guidelines, such as unified sanitation formats, supplier evaluation methodologies based on historical performance, and visual flowcharts for deviation control. It is concluded that the translation of complex technical regulations into executable operational tools effectively breaks down barriers to adoption in smaller organizations.