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ROI CalculatorOutsourced Supplier Quality refers to the processes, controls, and oversight a company implements to ensure that products, components, or services provided by external partners meet recognized quality, safety, and regulatory standards. Under ISO 9001:2015 and ISO 13485:2016, the responsibility for quality remains with the company, even if the work is outsourced, meaning external suppliers must be managed as an extension of the internal QMS.