Our commitment to quality requires that we always reach for excellence in the quality of the products and services we provide to our customers. Our vision for quality is a single sentence that becomes a powerful tool in the hands of our employees:
All of our products are rigorously inspected to ensure unmatched quality. Our QC formula is at work at every step of the manufacturing process, including:
International Standards
LSL is MDSAP (ISO 13485:2016) certified. We employ superior in-house IQC based on ANSI/ASQC Z1.4 standards..
Inspections
While every component is inspected in our Niles, IL facility, critical components are subject to more rigorous IQC (incoming quality control). In fact, as much as 100% of select critical component are tested. We empower all of our employees to reject non-conforming materials during the assembly/packaging process, ensuring that our entire workforce is dedicated to producing the highest quality devices. Our finished QC and bench-testing ensures conformance to design criteria and our own demanding standards of workmanship. We use our own proprietary QC equipment, all located in our Niles, IL facility, to test every shipment to our internal standards.
Traceability
Every product that undergoes some “value-added” work (i.e. inspection, assembly, packaging) receives a lot number incorporated into the product end label. (Virtually every LSL product undergoes some “value-added” work).
The six digits of the lot number indicate: year, month, facility, and number of lot for the month. Lot number tracking enables LSL to quickly isolate and correct any problems that may occur. It provides you with that extra assurance you expect from your sterile product.
Domestic Content
We maintain both foreign and domestic Quality Control facilities – something few in the industry offer. Every critical inspection, assembly, and packaging function is performed in our Niles, IL facility to ensure complete control and unsurpassed performance. We hire locally, keeping jobs in the US and promoting loyalty and teamwork amongst our staff. This helps ensure that we provide the best products and support services to our customers.
Test Equipment
LSL utilizes a wide array of proprietary machines that test everything from seal strength, seal integrity, pull strength, and compression. For example, our irrigation bulb endurance machines test our bulbs to a destructive 30,000 cycles – 3x the industry standard. We test our sterile and non-sterile packaging for seal strength and integrity using validated methods and test equipment in accordance with the ANSI and ISO standards.