Process and Production Control

Customer Requirements

Supplier Quality

Identification / Traceability

Design Control

Risk Management

Inputs / Outputs

Verification / Validation

Product Surveilance

Complaint Handling

Risk Monitoring

Vigilance

Resources

Personnel Competency

Infrastructure

Work Environment

Management Responsibility

Management Review

Inspection readiness

Internal Audit

Corrective and Preventive Action

Eliminate Noncomformities

QMS Improvement

Verify Effectiveness

Change Management

Design Change Management

QMS Change Management

Risk Review