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 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.

The Stage 2 audit is a complete evaluation of your company??s Quality Management System including those areas reviewed during the Stage 1 assessment. The focus is on ensuring that policies and procedures are effectively implemented and your Quality Management System is suitable and effective in supporting your company??s quality policy and objectives.

During the audit, daily meetings will be held between the audit team and your management team to discuss audit progress and any concerns that may have arisen.

To complete the certification process:

• The audit team will gather sufficient objective evidence to support a conclusion that your management system has been documented and effectively implemented in accordance with the ISO standard.
• The audit team will access appropriate quality records providing evidence of the effectiveness of your program.
• The audit team will inspect facilities and interview personnel verifying that your Quality Management System has been implemented and is being maintained.
• The audit team will document any nonconformances and discuss resolution with members of your management team.

Upon completion of the audit, a closing meeting will be held with management reviewing any findings and explaining actions needed to successfully complete the certification. At the end of this meeting you will receive a copy of the auditor??s recommendations.

Upon review of the lead auditors recommendations and resolution of any required corrective actions, AMTec??s certification committee will authorize issuance of a certificate of registration.

You can assist us in the following ways!

• Provide an escort for each auditor during all on site activities.
• It is important that your Management Representative be available during all phases of the Registration Assessment.
• Provide a room or work area for the audit team to use during on site activity.

To ensure that your Quality Management System is effectively maintained, AMTec performs regular surveillances of your system. At your option, surveillance audits may be conducted at either six or twelve month intervals. Surveillance audits follow the same general format as the Stage 2 registration assessment.

AMTec will contact you in advance of any proposed surveillance visit to establish the schedule and verify audit planning information.

Maintaining certification requires that your entire quality management system be reassessed at the end of each three year cycle. The reassessment audit must be completed before the expiration date of your certificate. After successful completion of all reassessment processes, AMTec will issue a new Certificate of Registration.

Any and all information that comes into possession of AMTec, its employees and agents, throughout the entire registration process described herein, except as required by the Law of the Land, and the relevant Accreditation Authorities, will be treated as strictly confidential. AMTec will not share any information with a third party without prior written consent of the Client.