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Setting Up the Quality and Environmental Management System of Food and Drug Administration Philippines

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The ISO 9001:2015 standard has undergone its first amendment, effective February 22, 2024, aimed at integrating considerations for climate change within the organizational context. While this amendment does not mandate re-certification for ISO-certified companies, organizations are required to demonstrate evidence of considering the potential effect of climate change in their Quality Management System (QMS) when evaluating both internal and external factors.

The key additions introduced in the amendment pertain to Clause 4.0. Firstly, the end of Clause 4.1 states, "The organization shall determine whether climate change is a relevant issue." Additionally, a note has been appended to the end of Clause 4.2, indicating that "Relevant interested parties may have requirements related to climate change."

While compliance with this amendment does not necessitate certification or re-certification, the industry is anticipating the forthcoming revision of the ISO 9001:2015 standard, expected to be released in 2026. Certified companies will be obliged to adopt the new standard and undergo re-certification during a three-year transition period following its release.

Setting Up the Quality and Environmental Management System of Food and Drug Administration Philippines

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