(d) records needed to provide evidence that the realisation processes and resulting product meet requirements. The output of this planning shall be in a form suitable for the manufacturer's method of operations. The manufacturer organisation shall establish documented requirements for risk management (as per the IS or ISO 14971) throughout product realisation. Records arising from risk management shall be maintained. 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product: The manufacturer shall determine-— (a) requirements specified by the customer, including the requirements for delivery and post-delivery activities; (b) requirements not stated by the customer but necessary for specified or intended use, where known; (c) statutory requirements related to the product; and (d) any additional requirements determined by the manufacturer.