The FDA has a requirement, in 21 CFR 820.20, for a Management Representative. This individual “irrespective of other responsibilities, shall have established authority over and responsibility for: Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and Reporting on the performance of the quality system to management with executive responsibility for review.”
Having a Management Representative is also a requirement of ISO 9001:2008*. The requirements in this document are:
- to make sure the company’s quality management system (QMS) is established, implemented and maintained;
- convey the performance of the QMS to top management;
- promote the awareness of customer requirements; and
- to act as a liaison with any regulatory bodies in regards to the QMS.
While both regulations require the Management Representative be a member of management, there are no defined skills, knowledge base or abilities that are necessary to fill this role. Also, even though the individual in this role is typically a Quality Manager, this is not mandatory.
*Note: Having a Management Representative is not a requirement in ISO 9001:2015. The thought behind this is that even though the duties previously held by this individual are still required, the preference is to have top management handle these responsibilities directly in order to be more engaged in the management system.