QUALITY SYSTEM MANUAL

 

GENERAL

0.1       Index and Revision Status

0.2       Introduction                                                                                                          Rev. A

0.3       Exclusions                                                                                                            Rev. A

 

SECTION 1  - MEDICAL DEVICE WORK ENVIRONMENT

1.1       Controlled Environment                                                                                        Rev. B

1.2       Product Contamination                                                                                         Rev. A

 

SECTION 2  - MEDICAL DEVICE DESIGN AND DEVELOPMENT

2.1       Risk Management                                                                                                Rev. A

2.2       Design Validation                                                                                                 Rev. B

2.3       Design Change                                                                                                     Rev. A

2.4       Device Recall and Advisory Notice                                                                      Rev. A

 

SECTION 3  - MEDICAL DEVICE PRODUCTION, SERVICE, AND PRESERVATION

3.1       Cleanliness of Product                                                                                          Rev. A

3.2       Preservation of Product                                                                                        Rev. A

3.3.      Servicing                                                                                                              Rev. A

 

SECTION 4  - QUALITY MANAGEMENT SYSTEM

4.1       Quality System Processes                                                                                     Rev. A

4.2       Documentation and Records                                                                                 Rev. A

 

SECTION 5  - MANAGEMENT RESPONSIBILITY

5.1       Management Commitment                                                                                    Rev. A

5.2       Customer Focus                                                                                                   Rev. A

5.3       Quality Policy                                                                                                       Rev. A

5.4       Quality System Planning                                                                                       Rev. A

5.5       Organization and Communication                                                                          Rev. A

5.6       Management Review                                                                                            Rev. A

5.7       Contract Review                                                                                                  Rev. A

 

SECTION 6  - RESOURCE MANAGEMENT

6.1       Provision of Resources                                                                                         Rev. A

6.2       Competence, Awareness and Training                                                                  Rev. A

6.3       Infrastructure                                                                                                        Rev. A

6.4       Work Environment                                                                                               Rev. A

 

SECTION 7  - PRODUCT REALIZATION

7.1       Planning of Product Realization                                                                             Rev. A

7.2       Customer-related Processes                                                                                 Rev. A

7.3       Design Control                                                                                                     Rev. A

7.4       Purchasing                                                                                                           Rev. A

7.5       Operations                                                                                                           Rev. A

7.6       Monitoring and Measuring Equipment                                                                   Rev. A

 

SECTION 8  - MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1       Planning of Monitoring and Measurement                                                              Rev. A

8.2       Monitoring and Measurement                                                                               Rev. A

8.3       Control of Nonconforming Product                                                                       Rev. A

8.4       Analysis of Data                                                                                                   Rev. A

8.5       Continual Improvement                                                                                        Rev. A

 

OPERATIONAL PROCEDURES AND FORMS

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-32-1        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

FRM-54-01      Quality Objectives project sheet                                                             Rev. A

QOP-56-01      Management Review                                                                              Rev. A

FRM-56-02      Management Review                                                                              Rev. A

FRM-62-01      Training                                                                                                  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

FRM-73-01      Design Project Plan                                                                                Rev. A

FRM-73-02      Engineering Change Request                                                                   Rev. A

FRM-74-01      Supplier Audit and Checklist                                                                  Rev. A

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

QOP-74-02      Purchasing                                                                                             Rev. A

FRM-74-02(a)  Purchase Order List                                                                               Rev. A

FRM-74-02(b)  Approved Supplier List                                                                          Rev. A

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

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

FRM-75-01      Work Order                                                                                          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

FRM-82-01      Audit Nonconformity Report                                                                  Rev. A

QOP-82-03      Statistical Process Control                                                                      Rev. A

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

QOP-82-05      Final Inspection                                                                                      Rev. A

FRM-82-05(a)  Final Inspection of Airbrush Liposculptor                                                Rev. A

FRM-82-05(b)  Final Inspection of Intellimotion Controller                                              Rev. A

FRM-82-05(c)  Airbrush Liposculptor Quality Assurance Batch Report                           Rev. A

FRM-82-05(d)  Final Inspection of Airbrush Reusable Uncoated Outer Cannula              Rev. A

FRM-82-05(e)  Final Inspection of Airbrush Reusable Uncoated Inner Cannula               Rev. A

FRM-82-05(f)   Final Inspection of Airbrush Reusable Coated Inner Cannula                   Rev. A

FRM-82-05(g)  Airbrush Reusable Outer Uncoated Cannula Batch Report                      Rev. A

FRM-82-05(h)  Airbrush Reusable Uncoated Inner Cannula Batch Report                       Rev. A

FRM-82-05(i)   Airbrush Reusable Coated Inner Cannula Batch Report                          Rev. A

FRM-82-05(j)   Final Inspection of Airbrush Reusable Multicore Assembly                      Rev. A

FRM-82-05(k)  Final inspection of Airbrush Reusable Coated Outer Cannula                  Rev. A

FRM-82-05(l)   Airbrush Reusable Coated Outer Cannula Batch Report                         Rev. A

FRM-82-05(m) Final Inspection of Airbrush Disposable Multicore Assembly                   Rev. A

FRM-82-05(n)  Airbrush Reusable Multicore Assembly Batch Report                             Rev. A

FRM-82-05(o)  Airbrush Disposable Multicore Assembly Batch Report                          Rev. A

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

FRM-83-01      Product Nonconformity Report                                                              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

FRM-85-02      Customer Complaints                                                                             Rev. A

FRM-85-01      Corrective/Preventive Action Request                                                     Rev. A