Top management

ISO 14971 gives top management specific duties: providing resources, defining the policy for risk acceptability criteria and reviewing the suitability of the risk management process. ISO 13485 gives it the duties of management review and the quality policy.

person or group of people who directs and controls a manufacturer (3.9) at the highest level [SOURCE: ISO 9000:2015, 3.1.1, modified — “An organization” replaced by “a manufacturer”, Notes to entry deleted.]

ISO 14971:2019, clause 3.29