FDA Quality Management System Regulation QMSR
Aligns FDA device quality management system requirements with ISO 13485 principles.
Sectors
Articles (31)
Scope.Definitions.Quality system.Management responsibility.Quality audit.Personnel.Design controls.Document controls.Purchasing controls.Identification.Traceability.Production and process controls.Inspection, measuring, and test equipment.Process validation.Receiving, in-process, and finished device acceptance.Acceptance status.Nonconforming product.Corrective and preventive action.Device labeling.Device packaging.Handling.Storage.Distribution.Installation.General requirements.Device master record.Device history record.Quality system record.Complaint files.Servicing.Statistical techniques.