At Laserage, our quality policy is summed up as a “Focus on Excellence.”
What does this mean to our customers and our employees?
- Our Focus on Excellence means quality is the responsibility of all Laserage employees. Every single Laserage employee understands the impact they have on quality.
- Laserage exceeds all customer requirements, all the time. We achieve this by using the highest quality tools and practices, such as corrective and preventative action (CAPA), first article inspection, first part setup, process capability analysis, process monitoring, process validation, risk management (FMEA), and statistical process control.
- Laserage is committed to continuous improvement utilizing Six Sigma and Lean methodologies.
- Laserage meets ISO and regulatory requirements.
Laserage is registered to ISO 13485:2003 for medical device components and to ISO 9001:2008 for all other products and components. To ensure compliance to both standards, we regularly conduct internal and external audits. External audits are performed twice annually by an independent licensed ISO registrar, and internal audits are performed quarterly by trained Laserage personnel. Additionally, customers audit us on a regular basis and provide feedback for continuous improvement to our quality systems.
Venta Medical, based in northern California, also holds an ISO 13485:2003 certification for laser processing and assembling of medical devices and sub-assemblies. The Venta Medical facility is also FDA registered because of the cleanroom device assembly capabilities as a medical device contract manufacturer.
We offer a full range of process validation services through our Quality Engineering and Product Engineering teams, to support all aspects of our manufacturing capabilities. Our teams will work with you to determine your validation needs. Our validation services include:
- Master Validation Plan
- Design of Experiment (DOE)
- Measurement System Analysis (MSA)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Control Plan
Note: Equipment Qualification (IQ) is performed on all new processing equipment after installation.
Laserage utilizes state-of-the-art inspection equipment, including:
- Automated Optical Inspection Equipment
- Programmable Pattern Recognition Systems
- Optical Binocular Microscopes
- Optical Digital Microscopes
- High Strength Tensile Testing