An introduction on the API and overview of the API Monogram Program
Catalysts necessitating changes to the 9th Edition
Q1's layout and terminology / definitions / abbreviations, as well as their application
Normative references
Product specifications
The "process approach" to quality management
Quality objectives
Management responsibility
Competency requirements
Control of documents
Risk assessment and management
Design input
Contingency planning
Calibration, accuracy vs. minimum test pressures
Management of change (MOC)
Customer satisfaction process
Internal audits
Corrective action and root cause analysis
Annex A