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