Precisely. Within ISO 9001/13485 certified companies, an individual (usually head of quality/regulatory) is designated the Quality System Management Representat

Precisely. Within ISO 9001/13485 certified companies, an individual (usually head of quality/regulatory) is designated the Quality System Management Representative. This individual is explicitly powered by the chief executive with the "responsibility and authority to ensure proper functioning of the quality system" and expected to 'pull the plug' when quality/compliance is at risk.