What is Performance Qualification?
Performance Qualification is a way to understand your process, not just test your equipment.
Performance Qualification provides documented evidence that a reprocessing process continues to consistently achieve its required outcome under the conditions in which it is actually used.
Reliable reprocessing depends on more than the equipment itself. Water quality, steam quality, load configurations, cycle parameters, packaging and day-to-day operating practices can all influence results.
That’s why SVA looks beyond the machine to understand the performance of the entire reprocessing process. Our testing helps healthcare organisations identify risk, demonstrate compliance and build confidence in their processes.
SVA provides Performance Qualification testing in accordance with AS/NZS 5369:2023 and applicable ISO and EN Standards.
Performance Qualification across the reprocessing pathway
SVA provides Performance Qualification and specialist testing services across all stages of reusable medical device reprocessing.
The ‘why’ beyond the result
Performance Qualification provides important evidence about process performance, but understanding the result is where the real value lies.
When issues are identified, SVA helps determine the factors contributing to the outcome, whether they relate to equipment, services, process configuration, water quality, steam quality or operational practices.
Our reports provide clear results, supporting evidence and practical recommendations to help healthcare organisations understand risk and make informed decisions.
Independent by design
We test reprocessing machines. We don’t sell them.
Independence is fundamental to SVA’s approach to Performance Qualification. Our findings are not influenced by equipment sales, manufacturer relationships or product preferences. We follow the evidence and report what we find, clearly and objectively.
When a result doesn’t meet expectations, our focus is not simply on documenting the outcome. It’s on understanding what happened, identifying contributing factors and helping clients determine the most appropriate next step.
Our priority is the integrity of the process and the safety of the patients who rely on it.
The expertise behind the work
Performance Qualification often sits at the intersection of several disciplines. SVA brings them together. SVA’s in-house laboratory enables advanced diagnostics of process residuals, including residual protein and endotoxin residuals. We partner with accredited laboratories for water quality, total organic carbon, bacterial culturing and biofilm analysis.
This integrated approach provides a more complete picture of the factors influencing reprocessing outcomes within the practical realities of healthcare reprocessing.
Our multidisciplinary team brings expertise across:
- decontamination science
- microbiology and chemistry
- biomedical and healthcare engineering
- CSSD and clinical management
- reusable medical device reprocessing
- water treatment and steam systems
- Standards and compliance
reprocessing machines certified each year
EXPERIENCE ACROSS AUSTRALIA
Since 2005, in every state and territory
Today, our team works with healthcare organisations in every Australian state and territory, across metropolitan, regional and remote locations, with experience across all major brands and types of reprocessing equipment.
how we work
A clear, evidence-based process
We test, design and resolve — the complete path from a reprocessing question to a certified answer.
