Quality & Risk
Management Representative
In one line
Member of management appointed to ensure QMS processes are established and report on QMS performance.
Definition
Required by ISO 13485 §5.5.2 and 21 CFR 820.20(b)(3), the management representative has explicit authority to ensure QMS effectiveness and to escalate issues to top management.
Beyond escalation, the role reports on QMS performance and improvement needs and promotes awareness of regulatory and customer requirements. Under the QMSR it is carried through ISO 13485 clause 5.5.2 rather than the old 820.20(b)(3). It differs from the EU MDR's person responsible for regulatory compliance, though small companies sometimes give both roles to one person.
Why it matters
Often confused with the Quality VP - the role is about authority and reporting line, not title.
Common pitfalls
- •A common pitfall is conflating the Management Representative role with a specific job title, such as Quality VP, rather than focusing on the required authority and responsibilities.
- •Failing to grant the Management Representative sufficient independence or direct access to top management can undermine the effectiveness of the role and QMS oversight.
- •Inadequate documentation of the Management Representative's appointment, responsibilities, and authority can lead to non-conformities during audits.
- •Assuming the Management Representative is solely responsible for all quality matters, rather than promoting a company-wide culture of quality, is a common misconception.
Sources
- ISO 13485:2016 · ISO
- MDIC Case for Quality · MDIC
- FDA - Quality Systems · FDA