|
Quality Manual
|
|
SECTION 0 - INDEX AND REVISION STATUS |
|
SECTION 1 - SCOPE |
|
1.1 |
Quality Policy |
|
1.2 |
Introduction |
|
1.3 |
Application |
|
1.4 |
Exclusions |
|
SECTION 2 - REFERENCE DOCUMENTS
|
|
SECTION 3 - TERMS AND DEFINITIONS |
|
SECTION 4 - QUALITY MANAGEMENT SYSTEM |
|
4.1 |
Quality System Processes
|
|
4.2 |
Documentation and Records |
|
SECTION 5 - MANAGEMENT RESPONSIBILITY |
|
5.1 |
Management Commitment |
|
5.2 |
Customer Focus |
|
5.3 |
Quality Policy |
|
5.4 |
Quality System Planning |
|
5.5 |
Organization and Communication |
|
5.6 |
Management Review |
|
SECTION 6 - RESOURCE MANAGEMENT |
|
6.1 |
Provision of Resources |
|
6.2 |
Competence, Awareness and Training |
|
6.3 |
Infrastructure |
|
6.4 |
Work Environment |
|
SECTION 7 - PRODUCT REALIZATION |
|
7.1 |
Planning of Product Realization |
|
7.2 |
Customer-related Processes |
|
7.3 |
Design Control |
|
7.4 |
Purchasing |
|
7.5 |
Operations |
|
7.6 |
Monitoring and Measuring Equipment |
|
SECTION 8 - MEASUREMENT, ANALYSIS AND IMPROVEMENT |
|
8.1 |
Planning of Monitoring and Measurement |
|
8.2 |
Monitoring and Measurement |
|
8.3 |
Control of Nonconforming Product |
|
8.4 |
Analysis of Data |
|
8.5 |
Continual Improvement |
|
|
|
|
Operational Procedures |
|
QOP-42-01 |
Control of Documents |
|
QOP-42-02 |
Control of Records |
|
QOP-56-01 |
Management Review |
|
QOP-62-01 |
Competence, Awareness and Training |
|
QOP-63-01 |
Equipment Maintenance |
|
QOP-71-01 |
Planning of Product Realization
|
|
QOP-72-01 |
Order Processing and Review |
|
QOP-73-01 |
Design Control |
|
QOP-74-01 |
Supplier Evaluation and Monitoring |
|
QOP-74-02 |
Purchasing |
|
QOP-74-03 |
Verification of Purchased Product |
|
QOP-75-01 |
Work Order and Production Records |
|
QOP-75-02 |
Validation of Processes
|
|
QOP-75-03 |
Work Instructions |
|
QOP-75-04 |
Product Identification and Traceability |
|
QOP-75-05 |
Storage, Handling and Preservation |
|
QOP-75-06 |
Packaging and Shipping |
|
QOP-76-01 |
Measuring and Monitoring Devices |
|
QOP-82-01 |
Customer Satisfaction |
|
QOP-82-02 |
Internal Quality Audits |
|
QOP-82-03 |
In-process Inspections |
|
QOP-82-04 |
Final Inspection |
|
QOP-83-01 |
Control of Nonconforming Product |
|
QOP-85-01 |
Continual Improvement
|
|
QOP-85-02 |
Customer Complaints |
|
QOP-85-03 |
Corrective and Preventive Action |
|
|
|
|
Manual Forms
(printable, manual forms)
|
|
QF-73-01-1 |
Design Project Plan and Schedule |
|
QF-73-01-2 |
Design Review Report |
|
QF-73-01-3 |
Engineering Change Notice |
|
QF-75-01-1 |
Production Work Order |
|
QF-82-02-1 |
Internal Audit Checklist |
|
|
|
|
Electronic Forms
(data entry forms in ISOXpress software)
|
|
ER-42-01-1 |
Document Control Record (ISOXpress Document Control module) |
|
ER-56-01-1 |
Management Review Record (ISOXpress Management Review module) |
|
ER-56-01-2 |
Quality Objective/Target Record (ISOXpress Management Review module) |
|
ER-62-01-1 |
Training Program Record (ISOXpress Training module) |
|
ER-62-01-2 |
Training Event Record (ISOXpress Training module) |
|
ER-62-01-3 |
Competency Certification Program Record (ISOXpress Training module) |
|
ER-62-01-4 |
Competency Certification Record (ISOXpress Training module) |
|
ER-62-01-5 |
Personnel Training/Competency Record (ISOXpress Training module) |
|
ER-74-01-1 |
Supplier Control Record (ISOXpress Supplier Control module) |
|
ER-74-01-2 |
Supplier Nonconformity Record (ISOXpress Supplier Control module) |
|
ER-74-01-3 |
Supplier Corrective Action Request Record (ISOXpress Supplier Control
module) |
|
ER-76-01-1 |
Measuring Equipment Record (ISOXpress Measuring Equipment module) |
|
ER-82-02-1 |
Internal Audit Record (ISOXpress Internal Audit module) |
|
ER-82-02-2 |
Internal Audit Plan Record (ISOXpress Internal Audit module) |
|
ER-82-02-3 |
Internal Audit Finding Record (ISOXpress Internal Audit module) |
|
ER-83-01-1 |
Nonconforming (NC) Product Record (ISOXpress Nonconforming Product module) |
|
ER-85-02-1 |
Customer Complaint Record (ISOXpress Customer Complaints module) |
|
ER-85-03-1 |
Corrective/Preventive Action Record (ISOXpress Corrective Action module) |