Quality
SPSA is committed to quality standards set by organizations such as AAMI and ASHRAE. SPSA validates customer quality and regulatory product requirements and is FDA compliant. All medical products are processed in areas that are temperature, humidity and air pressure controlled. SPSA offers decontamination, assembly/inspection, sterilization, and distribution services. All facility areas are controlled, segregated and monitored closely to maintain compliance. Quality inspections are performed before, during, and after processing; and decontamination and sterilization results, such as biological testing, are analyzed, recorded, and provided to our customers.
All processes are reviewed by our Quality Assurance team and only released to shipping if all parameters, protocols, procedures, and product validations are accomplished. To complete our process, all items are carefully inspected before being issued to final pouching and cart loading followed by delivery back to our customers.
SPSA is currently preparing for certification to the Medical Device Quality Management System Standard, ISO 13485:2016, in early 2024.
SPSA is committed to meet or exceed quality standards set by organizations such as AAMI, AORN, and ASHRAE. SPSA validates customer quality and regulatory product requirements and is FDA compliant. All medical products are processed in areas that are temperature, humidity and air pressure controlled. Our processing begins in a segregated room established specifically for successful decontamination processing. After washing in either an automated thermal or chemical disinfection process, all medical devices and instruments are passed into a controlled access room dedicated to clean inspection, fit and function testing, assembly, and packing. A quality inspection is performed to ensure the items are appropriate for sterilization in either our pass-through steam or low temperature sterilizers. After sterilization, all items are held in a quarantine area for cool down and biological testing results recording.
All processes are reviewed by our Quality Assurance team and only released to shipping if all parameters, protocols, procedures, and product validations are accomplished. To complete our process, all items are carefully inspected before being issued to final pouching and cart loading followed by delivery back to our customers.
