White Paper

Continuous Improvement Framework for Sterilisation Equipment Compliance Auditing in Australian Healthcare

October 2026

Disclaimer

This content is provided for information only. The authors make no representation or warranty regarding the accuracy, completeness or currency of the content. No information in this whitepaper should be construed as medical advice. Readers should seek appropriate professional guidance before acting on any information contained in this document. The authors expressly disclaim all liability for any direct or indirect loss or damage arising from the use of or reliance on this information.

Introduction

This paper sets out an audit and continuous improvement framework for sterilisers, washer-disinfectors and reprocessing processes in hospitals, aged care facilities and office-based practices. It defines the audit criteria, evidence, metrics, corrective action process and audit frequency, based on AS 5369:2023.

Requirements Basis

AS 5369:2023: Superseded AS/NZS 4187:2014 and AS/NZS 4815:2006, and applies to all facilities that reprocess reusable medical devices. It requires regular periodic audits to confirm that its requirements are met, documented findings, corrective action where required, and review of each corrective action for effectiveness. It sets no implementation timeframe and requires a risk-based approach.

NSQHS Standards: Hospitals and day procedure services are assessed against Action 3.17 of the Preventing and Controlling Infections Standard, which covers reprocessing of reusable equipment, instruments and devices. Australian Commission on Safety and Quality in Health Care Advisory AS24/01 requires a gap analysis against AS 5369:2023 and a compliance plan.

Other Settings: Residential aged care is assessed against the Aged Care Quality Standards, which include infection prevention and control. Registered dental practitioners must comply with the Dental Board of Australia infection control guidelines. Both settings apply AS 5369:2023 where devices are reprocessed.

Crosswalk: Map every audit item to the AS 5369:2023 clause it verifies. Update the audit tool when the standard or facility procedures change.

Audit Checklist

Master Checklist: Build one master checklist covering the full reprocessing cycle and the equipment quality system. Remove items that do not apply to a site and add site-specific items, e.g. bedpan washer-disinfector records for hospitals and aged care, and handpiece reprocessing for dental practices. Audit records and direct observation, not policy documents alone.

Hospitals: Audit the full CSSD workflow from point-of-use collection to sterile storage, all steam and low temperature sterilisers, washer-disinfectors, water treatment, and ward bedpan washer-disinfectors.

Aged Care: Audit bedpan washer-disinfector process records and maintenance, cleaning of commodes and shared equipment, storage of disinfected items, and contracts for any outsourced sterilisation.

Dental and Office-Based Practices: Audit small steriliser routine tests, cycle records, packaging and labelling, steriliser feedwater, maintenance and calibration records, and the reprocessing room layout.

Frequency: AS 5369:2023 does not set an audit frequency. Set it by risk and volume, e.g. monthly in a CSSD and quarterly in aged care and office-based practices. Review every process record at release in all settings. Increase frequency after a failed audit, an incident or a process change.

Metrics and Trend Analysis

Data Capture: Record each audit item as compliant, noncompliant or not applicable in a structured register so that results can be compared between periods, departments and sites.

Metrics: Define each metric with its calculation and target.

• Audit compliance rate, as compliant items divided by applicable items.

• Failed steriliser cycles per 100 cycles, by machine.

• Failed air removal and leak rate tests per month, by machine.

• Wet packs per 100 loads.

• Nonconforming items per 1,000 items processed, by cause.

• Preventive maintenance and calibration tasks past due.

• Water quality exceedances per quarter, by parameter.

• Repeat findings, and median days to close corrective actions.

Analysis: Plot each metric on a run chart. Investigate any metric outside its target, any adverse trend over three consecutive periods, and any item that fails in consecutive audits. Stratify by machine, shift, department and site to locate the source.

Reporting: Report results to the infection prevention or quality committee at least quarterly, and to reprocessing staff after each audit. Compare results between departments and sites within the organisation.

Improvement Cycle: Use a plan, do, study, act cycle. Plan an intervention from the data, implement it, re-audit the affected items, and either standardise the change or revise it.

Corrective Action

Containment: Act on critical findings during the audit. Quarantine items released without meeting the release criteria, recall any that have been distributed, and remove from service any machine operating outside its specification.

Corrective Action Register: Log each finding with its risk rating, owner, due date and status. For each nonconformity, AS 5369:2023 requires identification of its nature, an action plan, documentation of the action, evaluation of effectiveness, and additional action where required.

Root Cause Analysis: Analyse repeat and systemic findings with structured methods, e.g. five whys or cause and effect diagrams. Consider equipment condition, utilities, procedures, staffing, training and workload. Record preventive actions with the corrective actions.

Process and Document Change: Where the fix changes a procedure, update the procedure under document control, train affected staff, and add the change to the next audit. Where the change affects a validated process, assess it and repeat IQ, OQ or PQ as required.

Verification: Close a corrective action only after a follow-up audit or record review confirms it has been effective.

Escalation: Escalate findings that require capital, staffing or service changes to the governance committee with the audit data, failure history and risk rating.

Reporting Culture: Report findings against processes and systems rather than individuals, and encourage staff to report deviations and propose fixes.

Training

Requirements: AS 5369:2023 requires a formal orientation and training program, trained and competent staff, and competency reassessment at intervals defined by the facility. Its guidance recommends annual training in infection prevention and control and in occupational exposure procedures.

Modules: Structure training in modules that follow the workflow, each with learning objectives and an assessment.

• Standards, NSQHS requirements and the facility audit criteria.

• Cleaning, washer-disinfector operation, process record checks and water quality.

• Inspection, assembly, packaging and labelling.

• Steriliser operation, routine tests, chemical indicators of Types 1 to 6 to ISO 11140-1, biological indicators and load release.

• Sterile storage, transport and handling.

• Documentation, traceability, quarantine and recall.

• Work health and safety and exposure management.

• Self-audit and response to audit findings.

Link to Audit: Deliver targeted training for each audit finding attributed to practice, then verify by observation. Use recall and failed-cycle drills to assess response to non-routine events. Record all training and assessments.

Qualifications: Specify HLT37015 Certificate III in Sterilisation Services for technicians and HLT47015 Certificate IV for team leaders where the employer requires a qualification.

Monitoring Tools

Instrument Tracking Systems: Scan device sets at each stage of reprocessing, link each set to its cycle record and release, and hold sets automatically when a step or test result is missing. Record nonconformances as quality events in the system and use its reports for audit evidence.

Equipment Data: Export cycle records electronically from sterilisers and washer-disinfectors to the tracking or records system. Confirm controller clocks are correct. Review cycle data weekly for parameter drift.

Electronic Audit Tools: Use audit software or forms that timestamp entries, attach photographs, standardise findings, score results and create corrective actions directly from noncompliant items. Schedule audits, calibration, maintenance and requalification with automatic reminders.

Dashboards: Display the defined metrics, overdue tasks and loads awaiting release on a dashboard reviewed daily by supervisors and quarterly by the governance committee.

Small Sites: Use structured electronic logs with mandatory fields and alerts for missed daily tests in place of paper logbooks.

Consumables: Track lot numbers and expiry dates of indicators and packaging, and set minimum stock levels so that monitoring is never interrupted.

Scaling by Risk

Consistent Outcomes: Apply the same acceptance criteria in every setting. Implementation may differ, e.g. an electronic tracking system in a CSSD and a structured log in a small practice, but each must provide the same evidence.

Tiered Model: Allocate audit effort by risk and volume.

• Tier 1: CSSDs and other high-volume reprocessing. Frequent audits, dedicated auditors, electronic tracking and monthly metric review.

• Tier 2: Day procedure units and larger practices. Regular audits, shared auditors and periodic external review.

• Tier 3: Low-volume sites and outsourced services. Self-audit against the master checklist with periodic central audit.

Organisation Standards: Define requirements that apply at every site, e.g. requalification within 12 months, calibration within interval and traceability for critical devices.

Outsourced Reprocessing: Audit the contract, the provider's accreditation and audit evidence, indicator checks on receipt, and transport conditions.

Rescaling: Move a site to a higher tier when its risk increases, e.g. when it introduces complex surgical devices or a new reprocessing process. Rotate auditors between sites and share effective tools across the organisation.

Key Actions

• Crosswalk: Map every audit item to an AS 5369:2023 clause.
• Audit Evidence: Audit validation, routine test, calibration, maintenance, water quality and release records, and observe practice.
• Measure: Track defined metrics on run charts and investigate adverse trends.
• Correct: Contain critical findings immediately, analyse root causes, and close actions only after verification.
• Train: Link training to audit findings and verify by observation.
• Scale: Set audit frequency and depth by risk, with consistent acceptance criteria at every site.

References

1. Standards Australia. AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities.
2. Australian Commission on Safety and Quality in Health Care. National Safety and Quality Health Service Standards.
3. Australian Commission on Safety and Quality in Health Care. Advisory AS24/01 Requirements for reprocessing of reusable medical devices in health service organisations.
4. Australian Commission on Safety and Quality in Health Care. Transitioning from AS/NZS 4187:2014 to AS 5369:2023, August 2024.
5. ISO 11140-1 Sterilization of health care products, Chemical indicators, Part 1: General requirements.