(Meets 42 CFR 84 requirements)

• Quality Manual

• Quality Control Plan with Sampling Requirements to MIL-STD-105D

• Design and Development procedure

• Control of Documents, Data, and Records procedure

• Control of Purchasing (Supplier Qualification)

• Product Identification and Traceability procedure

• Control of Production Procedure

• Inspection and Test procedure

• Control of Equipment (Calibrations and Maintenance) procedure

• Control of Nonconforming Product procedure

• Corrective Actions (CAPA) procedure

• Inventory and Handling Controls procedure

• Internal Audits procedure

• Training procedure