The management representative is a central part of the ISO 13485 quality system.

QMS Management Representative Responsibilities

Top management must appoint a member of management who has the authority and responsibility to ensure the processes that are needed for the QMS are documented, report to top management on the effectiveness of the QMS, and ensure the promotion and awareness of the QMS throughout the organization.

Statement of Appointment

This is easily accomplished by creating a statement of appointment, having top management sign it and placing it in the management representatives training file. In addition, an asterisk or other footnote is typically annotated to the management representative in the organization chart.

Other Requirements

It is important to note that the management representative does not have to be dedicated to quality, specifically the standard notes they may have other responsibilities. It is also important to note that he management representative must be a member of management. Small organizations often make the error of appointing an employee that is not a member of management, and this is a problem because they have given this person the responsibility without the authority.