| Preparation of initial certification audit |
Opening of process |
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Appointment and communication of audit team for stages 1 and 2 |
| Stage 1 audit (on site) |
Opening meeting* |
| |
Examination of documents (manual, procedures, IA, MRM, etc) |
| |
Assessment of location and site specific conditions |
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Assessment of QMS implementation level and preparedness for stage 2 audit |
| |
Collection of information related to scope, processes, legal aspects, exclusions, etc. |
| |
Review allocation of resources for stage 2 audit and define details |
| |
Closing meeting* |
| |
Send stage 1 audit report to the Organisation |
| |
Send QMS audit programme to the Organisation, considering needs of the client to resolve areas of concern identified during stage 1 audit |
| Stage 2 audit (on site) |
Opening meeting |
| |
Check implementation of effective actions related to outcome of stage 1 |
| |
Verification of effective implementation, effectiveness and related evidence of QMS including legal compliance |
| |
Performance monitoring, measuring, reporting and reviewing against key performance objectives and targets |
| |
Internal closing meeting & Classification of findings |
| |
Preparation of the audit report & closing meeting |
| |
Deliver copy of QMS audit report to the Organisation |
| Action subsequent to the audit |
Control and confirmation of the Audit report |
| |
Acceptance of corrective action proposals |
| |
Preparation of the surveillance audit plan |
| |
CDC Recommendation |
| |
Printing and dispatch of certificate and surveillance audit plan |
| |
Check that documentation is complete, closure of process |
