1 publication

• Published Subscription Review Article 20 Jun 2024

  Navigating Risk-Based Approaches in Quality Assurance: Strategies, Implementation, and Impact

  By Patil Divyashree Kantilal, Divyani Rajender Patil, Mahale Devendra S, Amit Kumar R Dhankani, Mansi A Dhankani, S.P. Pawar

  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 →