Strategic Focus: Tying Industry Risk To Quality Management Requirements

Executive Summary

Industries with elevated quality risks – for example, pharmaceuticals and life sciences, automotive manufacturing, and food and beverage manufacturing – are subject to stringent quality management requirements. This is due to the complexity of their operations and the potential consequences of quality failures. These sectors must comply with rigorous regulatory standards that emphasize consumer safety, operational integrity and environmental protection. With strict regulatory frameworks and regulations such as good manufacturing practice (GMP), the General Food Law Regulation (GFLR), the IATF 16949 and the ISO 26262, firms face increased pressure to ensure they have adequate controls in place to minimize quality risk. This report identifies the critical factors – namely, end-user impact, component complexity and supply chain intricacy – that shape the heightened requirements for each vertical, underscoring the necessity for robust, technology-driven quality management systems (QMS) across these industries.