As a first step in the certification process, AMTec will perform a Stage 1 Registration Assessment. This review is conducted on site and focuses on determining the implementation status of your quality management system. This assessment helps indentify any activities necessary for full compliance with requirements and helps establish an appropriate schedule for your final certification audit.
The Stage 1 assessment follows an audit format and includes:
- Verification of audit planning information
- Review of key processes and performance
- Facility tour
- Document review
- Evaluation of internal audits
- Planning and preparedness for the Stage 2 audit
Documents reviewed during the Stage 1 assessment will include:
- Quality manual
- Standard operating procedures
- Management review records
- Internal audit reports
- Corrective and preventive action records
At a closing meeting, results of the audit will be presented. AMTec will document any concerns that would or could be nonconformances at the final audit. It is not required that you respond to AMTec regarding any Stage 1 findings.
The final step in the Stage 1 process is determination of preparedness for the final Stage 2 audit. If agreed between you and AMTec’s lead auditor that all requirements are adequately addressed, planning and scheduling for the Stage 2 audit is confirmed.