OPERATIONAL PROCEDURES

QOP-11-01 Controlled Environment Rev. B

QOP-12-01 Product Contamination Rev. A

QOP-21-01 Risk Management Rev. A

QOP-24-01 Device Recall and Advisory Notice Rev. A

QOP-31-01 Product Cleanliness Rev. A

QOP-32-01 Preservation of Product Rev. A

QOP-42-01 Quality System Documentation Rev. A

QOP-42-02 Control of Documents Rev. A

QOP-42-03 Control of Quality Records Rev. A

QOP-54-01 Quality Objectives Rev. A

QOP-56-01 Management Review Rev. A

QOP-57-01 Subcontractor Evaluation Rev. A

QOP-62-01 Training and Awareness Rev. A

QOP-63-01 Equipment Maintenance Rev. A

QOP-72-01 Order Processing for Catalog Products Rev. A

QOP-72-02 Order Processing for Custom Products Rev. A

QOP-72-03 Customer Feedback and Complaints Rev. A

QOP-73-01 Design Control Rev. B

QOP-74-01 Supplier Evaluation and Monitoring Rev. B

QOP-74-02 Purchasing Rev. A

QOP-74-03 Verification of Purchased Product Rev. A

QOP-75-01 Production Control (Form 75-01-1) Rev. A

QOP-75-02 Work Instructions Rev. A

QOP-75-03 Product Identification and Traceability Rev. A

QOP-75-04 Product Handling and Preservation Rev. A

QOP-75-05 Storage Areas Rev. A

QOP-75-06 Packaging, Labeling and Shipping Rev. A

QOP-75-07 Medical Device Labeling Rev. A

QOP-76-01 Measuring and Monitoring Equipment Rev. A

QOP-82-01 Customer Satisfaction Rev. A

QOP-82-02 Internal Quality Audits Rev. B

QOP-82-03 Statistical Process Control Rev. A

QOP-82-04 In-process Inspections Rev. A

QOP-82-05 Final Inspection Rev. A

QOP-83-01 Control of Nonconforming Product Rev. A

QOP-85-01 Continual Improvement Rev. A

QOP-85-02 Corrective and Preventive Action Rev. B

QOP-85-03 Vigilance Surveillance and Customer Complaints Rev. B