Am currently looking at the requirements for Section ISO9001 2015 - Section 8.4.3, and am struggling to determin the exact requirements. The context in which it is written suggests this should be applied to "Sub-Contracted" processes or activities, and not to the purchasing of for example raw materials for use in the process. As a business we do not outsource any process to an external provider am therefore wondering whether we need to include the provision within our procedures. If it should be applied to both outsourced processes and Purchased items, then any assistance as to how you can apply this to the suppliers of off the shelf suppliers would be appreciated. Any advice would be most welcome.