This Standard includes requirements for establishing a quality management system (QMS) that addresses safety of patients, personnel, families, vendors, third parties, and visitors in a perioperative environment including requirements for a) establishing a QMS; b) occupational health and safety (OHS); c) policies and standard operating procedures (SOPs), clinical practice standards, and documentation; d) personnel qualifications and training; e) work areas and equipment; f) infection prevention and control; g) evaluation and purchase of medical devices; and h) management and prevention of patient safety incidents.