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Six months before audit<br />

Audited institution<br />

Request for audit submitted including<br />

completed application form<br />

Audit team<br />

No action<br />

Audit body<br />

Agreement<br />

Five months before audit<br />

Audited institution<br />

No action<br />

Audit team<br />

Agreement<br />

Audit body<br />

Form audit team and<br />

designate leader<br />

Four months before audit<br />

Audited institution<br />

Set audit date;<br />

Inform other departments<br />

of schedule<br />

Audit team<br />

Set audit date<br />

Audit body<br />

Set audit date;<br />

Initiate travel and accommodation<br />

arrangements for team;<br />

Initiate equipment calibration<br />

Three months before audit<br />

Audited institution<br />

Respond with requested<br />

information sent to audit team<br />

Audit team<br />

Send request for<br />

information to institution<br />

Audit body<br />

Introduce audit team to<br />

institution<br />

Send copy of application<br />

form to team<br />

Two months before audit<br />

Audited institution<br />

Respond with requested<br />

information sent to audit team<br />

members<br />

Audit team<br />

Members request<br />

additional information<br />

from institution if needed<br />

Audit body<br />

Confirm travel and<br />

accommodation<br />

arrangements for team<br />

Two weeks before audit<br />

Audited institution<br />

Confirm address details for<br />

sending of test equipment<br />

Audit team<br />

Members request<br />

additional information<br />

from institution if needed<br />

Audit body<br />

Confirm address details<br />

and send test<br />

equipment<br />

Audit visit<br />

Audit team + institution<br />

Draft report completed and reviewed with institution<br />

Two weeks after audit<br />

Audited<br />

institution<br />

Audit team<br />

Responds to audit body<br />

Audit body<br />

Reviews report and communicates with<br />

audit team and institution if necessary<br />

Six weeks after audit<br />

Audited<br />

institution<br />

Audit team<br />

Notified of report authorization<br />

Audit body<br />

Authorized report sent to institution<br />

After receiving the audit report<br />

Audit team<br />

Prepare response plan<br />

Audit body<br />

Monitor response<br />

FIG. 2. Time-line of clinical audit process.<br />

68

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