| Preparation of scope extension audit |
Opening of process |
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Review of client request for scope extension |
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Allotment of new File #, if necessary |
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Send document review comments to organisation, if any |
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Appointment and communication of audit team for the audit |
| Document Review |
Verify adequacy of documents for scope extension (manual, procedures, exclusions, etc.) |
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Send document review comments to organisation, if any |
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Confirmation of review of document review comments and action taken by organisation |
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Dispatch scope extension audit programme to the Organisation |
| Scope Extension audit |
Opening meeting |
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Verification of effective implementation and related evidence of scope extension |
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If scope extension audit is performed in conjunction with Surveillance audit, requirements of 5.1.2 shall also apply |
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Internal closing meeting & Classification of findings |
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Preparation of the audit report |
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Closing meeting |
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Deliver copy of audit report to the Organisation |
| Actions following the audit |
Control and confirmation of the audit report |
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Acceptance of corrective action proposals |
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Modification of the surveillance audit plan, if required |
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CDC Recommendation |
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Print and send the certificate and surveillance audit plan |
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Check documentation complete, close process |
