Quality Manual & Quality Policy Design for Small and Mid-Sized Companies: Lean but Compliant Approaches In the regulated environments of pharmaceuticals, biotechnology, and medical devices, the design of a quality manual and quality policy is critical for ensuring compliance with standards such as ISO 13485 and regulations set forth by the FDA and EMA/MHRA. This article provides a step-by-step tutorial on how small and mid-sized companies can effectively design their quality manual and quality policy while remaining compliant with regulatory expectations. Step 1: Understanding the Purpose of the Quality Manual and Quality Policy The first step in quality manual and…