Scope
Inspire's Quality Management System is governed by 21 CFR 820, ISO 13485, and EU MDR. Every employee — clinical, commercial, R&D, IT, marketing — is part of the QMS. There is no 'not my job' in quality.
Reporting issues
Any potential product, complaint, or adverse event must be reported within 24 hours via the QMS portal (qms.inspiresleep.example). Reports made in good faith never trigger discipline — silence does.
Cleanroom & manufacturing
Cleanroom protocols (gowning, particulate, sign-in) are non-negotiable. Deviations escalate to your shift lead first, then to Quality. Recall-related actions follow the standalone Field Action SOP.
Training
Annual GMP and complaint-handling training is mandatory and tracked in Workday. Failure to complete by the deadline blocks production system access.
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