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Quality Manual
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SECTION 0 - INDEX AND REVISION STATUS |
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SECTION 1 - SCOPE |
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1.1 |
Quality Policy |
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1.2 |
Introduction |
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1.3 |
Application |
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1.4 |
Exclusions |
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SECTION 2 - REFERENCE DOCUMENTS
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SECTION 3 - TERMS AND DEFINITIONS |
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SECTION 4 - QUALITY MANAGEMENT SYSTEM |
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4.1 |
Quality System Processes
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4.2 |
Documentation and Records |
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SECTION 5 - MANAGEMENT RESPONSIBILITY |
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5.1 |
Management Commitment |
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5.2 |
Customer Focus |
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5.3 |
Quality Policy |
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5.4 |
Quality System Planning |
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5.5 |
Organization and Communication |
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5.6 |
Management Review |
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SECTION 6 - RESOURCE MANAGEMENT |
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6.1 |
Provision of Resources |
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6.2 |
Competence, Awareness and Training |
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6.3 |
Infrastructure |
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6.4 |
Work Environment |
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SECTION 7 - PRODUCT REALIZATION |
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7.1 |
Planning of Product Realization |
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7.2 |
Customer-related Processes |
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7.3 |
Design Control |
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7.4 |
Purchasing |
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7.5 |
Production Control |
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7.6 |
Monitoring and Measuring Equipment |
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SECTION 8 - MEASUREMENT, ANALYSIS AND IMPROVEMENT |
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8.1 |
Planning of Monitoring and Measurement |
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8.2 |
Monitoring and Measurement |
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8.3 |
Control of Nonconforming Product |
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8.4 |
Analysis of Data |
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8.5 |
Continual Improvement |
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Operational Procedures |
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QOP-42-01 |
Control of Documents |
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QOP-42-02 |
Device Master Record |
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QOP-42-03 |
Control of Records |
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QOP-56-01 |
Management Review |
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QOP-62-01 |
Competence, Awareness and Training |
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QOP-63-01 |
Equipment Maintenance |
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QOP-64-01 |
Production and Work Environment |
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QOP-71-01 |
Production Planning
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QOP-71-02 |
Process Risk Management
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QOP-72-01 |
Order Processing and Review |
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QOP-73-01 |
Design Control |
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QOP-73-02 |
Design Risk Management |
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QOP-73-03 |
Control of Design and Process Changes |
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QOP-74-01 |
Supplier Evaluation and Monitoring |
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QOP-74-02 |
Purchasing |
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QOP-74-03 |
Verification of Purchased Product |
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QOP-75-01 |
Production Work Order and History Record |
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QOP-75-02 |
Cleanliness and Contamination of Product |
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QOP-75-03 |
Validation of Processes and Software
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QOP-75-04 |
Installation and Servicing |
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QOP-75-05 |
Product Identification and Traceability |
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QOP-75-06 |
Labeling and Packaging |
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QOP-75-07 |
Storage and Distribution |
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QOP-76-01 |
Measuring and Monitoring Equipment |
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QOP-82-01 |
Feedback and Customer Satisfaction |
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QOP-82-02 |
Internal Quality Audits |
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QOP-82-03 |
In-process Inspections |
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QOP-82-04 |
Final Acceptance Inspection |
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QOP-83-01 |
Control of Nonconforming Product |
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QOP-84-01 |
Analysis of Data |
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QOP-85-01 |
Continual Improvement
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QOP-85-02 |
Device Recall and Advisory Notices
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QOP-85-03 |
Customer Complaints |
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QOP-85-04 |
Corrective and Preventive Action |
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Manual Records/Forms
(These forms are included in the MS Word file set)
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QF-42-01-1 |
Document Control Master List |
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QF-42-02-1 |
Device Master Record Index |
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QF-56-01-1 |
Quality Objectives Records |
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QF-73-01-1 |
Design Project Plan and Schedule |
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QF-73-01-2 |
Design Review Report |
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QF-73-02-1 |
Design Risk Analysis |
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QF-73-03-1 |
Engineering Change Request |
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QF-75-01-1 |
Production Work Order |
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QF-75-04-1 |
Service Report |
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QF-82-02-1 |
Internal Audit Plan |
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QF-82-02-2 |
Audit Finding Report |
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QF-82-02-3 |
Internal Audit Checklist (separate product) |
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QF-83-01-1 |
Product Nonconformity Report |
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QF-85-03-1 |
Corrective Action Request |
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ISOXpress Software Records/Forms
(These electronic forms and reports are included in the Complete System Software)
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QF-42-01-1 |
Document Control Records |
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QF-56-01-1 |
Management Review Reports |
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QF-56-01-2 |
Quality Objectives Records |
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QF-62-01-1 |
Training Program Records |
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QF-62-01-2 |
Personnel Training Records |
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QF-62-01-3 |
Competency Certification Program Records |
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QF-62-01-4 |
Personnel Competency Certification Records |
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QF-74-01-1 |
Approved Supplier List |
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QF-74-01-2 |
Supplier Nonconforming Product Records |
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QF-74-01-3 |
Supplier Corrective Action Requests |
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QF-76-01-1 |
Measuring Equipment Records |
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QF-82-02-1 |
Internal Audit Plans |
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QF-82-02-2 |
Internal Audit Reports |
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QF-82-02-3 |
Internal Audit Finding Reports |
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QF-83-01-1 |
Product Nonconformity Reports |
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QF-85-02-1 |
Customer Complaint Reports |
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QF-85-03-1 |
Corrective/Preventive Action Requests |
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