| Clause |
Heading |
Additional topics |
| 4.2.1 |
Documentation
requirements |
QMS requirements of
regulator authorities
Access to documentation by personnel
Access
to documentation by customers and regulators |
| 4.2.2 |
Quality
manual |
Relationship
between procedures and AS9100 requirements |
| 4.2.3 |
Control
of documents |
Coordination
of document changes |
| 4.2.4 |
Control
of records |
Supplier records
Availability
of records |
| 4.3 |
|
Configuration
management |
| 5.5.2 |
Management
representative |
Organizational
freedom |
| 7.1 |
Planning
of product realization |
Operation
and maintenance resources |
| 7.2.2 |
Review
of requirements related to the product |
Review
of risks |
| 7.3.1 |
Design
and development planning |
Structure of work
elements
Work element tasks and resources
Work element review
Task
definition |
| 7.3.3 |
Design
and development outputs |
Key characteristics
Manufacturing,
operating and maintenance data |
| 7.3.4 |
Design
and development review |
Stage
authorization |
| 7.3.6 |
Design
and development validation |
Documentation of
verification and validation
Verification
and validation testing |
| 7.3.7 |
Control
of design and development changes |
Customer
and regulator approval of changes |
| 7.4.1 |
Purchasing
process |
Responsibility for
purchased products
Register of approved suppliers
Supplier performance review
Supplier
approval authority |
| 7.4.2 |
Purchasing
information |
Requirements
for identification, acceptance, nonconforming material, changes, rights
of access and requirement flow-down |
| 7.4.3 |
Verification
of purchased product |
Verification activities
Use of incoming product
Supplier test reports
Delegation of verification activities
Customer
verification at source |
| 7.5.1 |
Control
of production and service provision |
Planning for key
characteristics
In-process verification points
Tooling
design and manufacture
Product accountability
Evidence of completion
Foreign objects
Monitoring and control of utilities
Workmanship criteria
Production documentation
Production process changes
Production equipment, tools and NC machines
Work transfer to external facilities
Service
operations |
| 7.5.2 |
Validation
of processes |
Criteria for
qualification and approval
Documented
process specifications |
| 7.5.3 |
Identification
and traceability |
Configuration
identification
Control of acceptance media
Traceability |
| 7.5.5 |
Preservation
of product |
Cleaning
Foreign objects
Sensitive products
Safety warnings
Shelf life
Hazardous
materials |
| 7.6 |
Control
of monitoring and measuring devices |
Device registers
Calibration process
Environmental requirements
Recall
methods |
| 8.2.2 |
Internal
audits |
Audit
tools and techniques |
| 8.2.3 |
Monitoring
and measurement of processes |
Process
nonconformity |
| 8.2.4 |
Monitoring
and measurement of product |
Key characteristics
Sampling inspection
Use of product
Inspection documentation
First
article inspection |
| 8.3 |
Control
of nonconforming product |
Disposition authority
Authorization use of nonconforming product
Scrapped product
Reporting
of nonconforming product |
| 8.5.2 |
Corrective
action |
Supplier
non-conformities
Non-fulfilment
of corrective actions |
