At IcareLabs, making lab work easy starts with delivering the quality, consistency, and reliability eyecare professionals can count on.
From our user-friendly online portal to our state-of-the-art laboratory and in-house lens production, we continue to invest in the technology, people, and processes that help us better serve independent eyecare professionals.
Now, we’re taking another important step forward: IcareLabs is working toward ISO 13485 compliance.
What Is ISO 13485?
ISO 13485 is an internationally recognized quality management standard for organizations involved in medical devices and related products and services.
For an optical laboratory, a strong Quality Management System (QMS) helps ensure the processes behind ophthalmic lens manufacturing are documented, controlled, measured, and consistently followed.
Put simply:
Making a great lens once is one thing. A strong quality system is about creating the processes needed to make great lenses consistently, and identifying, correcting, and preventing problems when they occur.
What Does That Look Like at IcareLabs?
Working toward ISO 13485 compliance strengthens many of the processes already happening throughout our laboratory, including:
- Traceability: Maintaining records throughout the manufacturing process to help identify materials, equipment, inspections, and other important production information.
- Standardized processes: Following documented procedures throughout surfacing, coating, finishing, inspection, packaging, and shipping.
- Quality controls: Checking lenses at critical stages of production to ensure they meet established specifications.
- Equipment maintenance and calibration: Routinely maintaining and verifying manufacturing and measuring equipment to support accurate results.
- Employee training: Ensuring team members are properly trained and qualified for the work they perform.
- Corrective action: Investigating quality issues, identifying root causes, and implementing solutions designed to prevent recurrence.
- Continuous improvement: Using production data, customer feedback, audits, and quality objectives to identify opportunities to improve.
What Does ISO 13485 Mean for Our Customers?
For the eyecare professionals who trust IcareLabs with their patients’ eyewear, our work toward ISO 13485 compliance is ultimately about confidence.
Confidence that your optical lab has established processes designed to support consistent quality, accurate manufacturing, product traceability, and continuous improvement.
You have a practice to run and patients to care for. Your optical laboratory should make your job easier—not add another layer of complexity.
That’s why we’re continuing to invest in the systems behind every lens we produce.
Our Commitment to Quality
Our ISO 13485 journey began with establishing our Quality Policy and building a formal Quality Management System around the work we perform every day.
The IcareLabs Quality Policy:
IcareLabs is committed to providing ophthalmic products that meet customer, statutory, and regulatory requirements while maintaining the effectiveness of our quality management system, providing a framework for establishing and reviewing quality objectives, and continually improving it to enhance customer satisfaction through precision, consistency, and reliable turnaround.
Working toward ISO 13485 compliance is another step in the continued evolution of IcareLabs—and another way we're strengthening the quality and reliability our customers depend on.
Because making lab work easy isn't just about convenience. It's about giving you confidence in the lab behind every pair of lenses.
