ISO 9001:2015
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Navigating Risk-Based Approaches in Quality Assurance: Strategies, Implementation, and Impact
Abstract: This review investigates the implementation of a risk-based approach within Quality Management Systems (QMS) as stipulated by ISO 9001:2015 regulations. It scrutinizes the challenges organizations encounter when transitioning to ISO 9001-2015 requirements, particularly focusing on the alignment of conceptual frameworks and processes among stakeholders. A key objective of this review is to propose a refined definition of "quality risk" and "risk-based thinking in QMS" to address the idiosyncratic characteristics of …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 2, 2024 Read article