customer requirements and applicable regulatory requirements are identified and taken into account.The requirements explicit or implicit need or expectation (see also ISO 9000, 3.6.4) of ISO 13485 apply exclusively to the quality management system set of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) and its processes activities that transform inputs into outputs (see also ISO 9000, 3.4.1) : Requirements explicit or implicit need or expectation (see also ISO 9000, 3.6.4) related to products any outcome of a process or activity (see also ISO 9000, 3.7.6) are specified by the customer anyone who receives a product (see also ISO 9000, 3.2.4), by the company or a regulation.
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