Note: See the actual standard for a complete description of the requirements.
AS9100 Revision B Clauses |
AS |
Summary of Requirements |
4. Quality Management System |
|
|
4.1 General Requirements |
|
Implement quality system and continually improve it |
4.2 Documentation Requirements |
* |
|
4.2.1 General |
* |
Include the required documents and records |
4.2.2 Quality Manual |
*S |
Establish and maintain a quality manual |
4.2.3 Control of Documents |
S |
Ensure documents are at right revision in right places |
4.2.4 Control of Records |
*S |
Identify records and keep as evidence of conformity |
4.3 Configuration Management |
*S |
Use product configuration management process |
5. Management Responsibility |
|
|
5.1 Management Commitment |
|
Show evidence of top management commitment |
5.2 Customer Focus |
|
Meet the requirements and satisfy your customers |
5.3 Quality Policy |
|
Have top management express quality intentions |
5.4 Planning |
|
|
5.4.1 Quality Objectives |
S |
Set measurable targets for products and processes |
5.4.2 Quality Management System Planning |
S |
Carry out plans for quality system and its processes |
5.5 Responsibility, Authority, and Communication |
|
|
5.5.1 Responsibility and Authority |
|
Make sure everyone knows their duties and roles |
5.5.2 Management Representative |
* |
Appoint a manager as focal point for quality system |
5.5.3 Internal Communication |
S |
Keep everyone informed of system effectiveness |
5.6 Management Review |
|
|
5.6.1 General |
S |
Review the quality system at planned intervals |
5.6.2 Review Input |
|
Ensure the required agenda topics are covered |
5.6.3 Review Output |
|
Record the decisions and actions from reviews |
6. Resource Management |
|
|
6.1 Provision of Resources |
|
Provide necessary resources to meet requirements |
6.2 Human Resources |
S |
|
6.2.1 General |
|
Ensure everyone working in system is competent |
6.2.2 Competence, Awareness, and Training |
|
Train personnel and recognize their contributions |
6.3 Infrastructure |
S |
Provide facilities, equipment, and support services |
6.4 Work Environment |
*S |
Manage combination of human and physical factors |
| 7. Product Realization |
|
|
7.1 Planning of Product Realization |
*S |
Plan and develop processes for product realization |
7.2 Customer-Related Processes |
|
|
7.2.1 Determination of Product Requirements |
|
Define customer, regulatory, and own requirements |
7.2.2 Review of Product Requirements |
* |
Review requirements before committing to customer |
7.2.3 Customer Communication |
S |
Talk to customers about products and complaints |
7.3 Design and Development |
|
|
7.3.1 Design and Development Planning |
*S |
Plan design stages, activities, and responsibilities |
7.3.2 Design and Development Inputs |
S |
Identify and review input requirements for design |
7.3.3 Design and Development Outputs |
*S |
Prepare design outputs and approve before release |
7.3.4 Design and Development Review |
* |
Review ability of design results to meet requirements |
7.3.5 Design and Development Verification |
*S |
Verify the design outputs meet input requirements |
7.3.6 Design and Development Validation |
*S |
Validate the product is okay for application or use |
7.3.6.1 Documentation of Verification and Validation |
* |
Ensure results show product meets all requirements |
7.3.6.2 Verification and Validation Testing |
* |
Ensure test plans and procedures are documented |
7.3.7 Control of Design and Development Changes |
*S |
Review, verify, and validate any design changes |
7.4 Purchasing |
|
|
7.4.1 Purchasing Process |
*S |
Evaluate, select, monitor, and control your suppliers |
7.4.2 Purchasing Information |
*S |
Create purchase orders describing supplier products |
7.4.3 Verification of Purchased Products |
*S |
Check purchases to ensure they meet requirements |
7.5 Production and Service Provision |
|
|
7.5.1 Control of Production and Service Provision |
*S |
Plan and control production and service activities |
7.5.1.1 Production Documentation |
*S |
Carry out production operations per approved data |
7.5.1.2 Control of Production Process Changes |
*S |
Document changes and assess for adverse results |
7.5.1.3 Control of Production Equipment and Tools |
*S |
Validate equipment, tools, and programs before use |
7.5.1.4 Control of Work Transferred Temporarily |
*S |
Define process to validate quality of transferred work |
7.5.1.5 Control of Service Operations |
* |
Approve repair schemes and analyze in-service data |
7.5.2 Validation of Production & Service Processes |
*S |
Validate the process if you can’t check the product |
7.5.3 Identification and Traceability |
*S |
Identify the product and its inspection and test status |
7.5.4 Customer Property |
* |
Exercise care with any customer property |
7.5.5 Preservation of Product |
*S |
Handle, store, package, and protect the product |
7.6 Control of Monitoring and Measuring Devices |
*S |
Calibrate measuring equipment for valid results |
8. Measurement, Analysis, and Improvement |
|
|
8.1 General |
*S |
Plan, measure, analyze, and improve processes |
8.2 Monitoring and Measurement |
|
|
8.2.1 Customer Satisfaction |
|
Ask customers what they think about your products |
8.2.2 Internal Audit |
* |
Evaluate conformity and effectiveness of system |
8.2.3 Monitoring and Measurement of Processes |
*S |
See if processes are achieving planned results |
8.2.4 Monitoring and Measurement of Product |
*S |
Verify products meet acceptance criteria |
8.2.4.1 Inspection Documentation |
*S |
Document measurement requirements for product |
8.2.4.2 First Article Inspection |
*S |
Inspect representative item from first production run |
8.3 Control of Nonconforming Product |
*S |
Prevent use or delivery of nonconforming product |
8.4 Analysis of Data |
|
Analyze effectiveness and identify improvements |
8.5 Improvement |
|
|
8.5.1 Continual Improvement |
|
Continually improve effectiveness of quality system |
8.5.2 Corrective Action |
*S |
Fix detected problems and prevent recurrence |
8.5.3 Preventive Action |
|
Avoid potential problems by preventing occurrence |
