Audit Preparation

CSSD Audit Preparation Guide

Start with the audit scope, the reporting period and the evidence requested by the relevant standard or institution. Assign an owner to each record category. This makes preparation a controlled review rather than a last-minute search through separate files.

Define the scope of the review

Start with the audit scope, the reporting period and the evidence requested by the relevant standard or institution. Assign an owner to each record category. This makes preparation a controlled review rather than a last-minute search through separate files.

Create an evidence inventory

An inventory shows which records are available and which need review. Use the requirements that apply to your institution when setting the final list.

Test a traceability sample

Select a representative set or instrument record and follow its history through the recorded workflow. Check the links between identifiers, timestamps, processing records and handovers. Document missing links instead of filling gaps with assumptions.

Review exceptions before the audit

Identify incomplete records, unresolved discrepancies and corrective actions that lack follow-up. Assign responsibilities and dates for review. Confirm that a correction addresses the underlying issue and that its evidence can be retrieved.

Demonstrate reporting with a real question

Ask the team to retrieve the evidence for a specific period, instrument or set. SterilO demonstrations can use those questions to show record searches and reporting workflows. Software supports preparation; audit conclusions depend on the institution’s practices and evidence.