| Audit Area | Audit Point | Conformance (Y/N) | Comments / Evidence |
|---|---|---|---|
| Quality Management System | Is there a documented Quality Management System? | ||
| Is the QMS regularly reviewed and updated? | |||
| Document Control | Are documents reviewed and approved prior to issue? | ||
| Are obsolete documents promptly removed? | |||
| Supplier Management | Are suppliers evaluated and selected based on quality criteria? | ||
| Is there a process for managing supplier non-conformance? | |||
| Process Control | Are key processes identified and monitored? | ||
| Are process changes documented and approved? | |||
| Non-conformance & Corrective Action | Are non-conformances recorded and analyzed? | ||
| Are corrective actions implemented and verified? | |||
| Calibration & Equipment | Is there a schedule for equipment calibration? | ||
| Are calibration records maintained? |