Quality System Documentation for NIOSH Submission

(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