In this episode of the Quality Hub podcast, Xavier Francis discusses ISO 9001 Clause 6.3 on Change Management with Brian Smith and Brian Smatko both from Core Business Solutions. The conversation emphasizes the importance of planning and managing changes within a Quality Management System (QMS) to avoid unintended consequences and maintain consistency. They highlight that major changes, such as new equipment or process modifications, should be addressed in management reviews, considering multiple factors like and potential impacts on other processes. Proper documentation, communication, and addressing resistance to change are crucial to ensure smooth transitions and maintain the integrity of the QMS.
Helpful Resources:
https://www.thecoresolution.com/iso-9001-clause-6-3-explained
For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015
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ISO 9001 Standards: https://www.thecoresolution.com/iso-90012015-standard-1
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