To the average person, the word “quality” means something subjective. To us though, the word “quality” has an objective meaning.
At Laserage, our quality policy is known as “Focus on Excellence”:
- Focus on Excellence means quality is the responsibility of all Laserage employees, who all understand the impact they have on quality.
- We exceed customer requirements, principally by using quality tools such as corrective and preventative action, first article inspection, first part setup, process capability analysis, process monitoring, process validation, risk management, and statistical process control.
- We continuously improve by utilizing Six Sigma and Lean Methodologies.
- We meet or exceed ISO and regulatory requirements.
Our quality management system begins with our quality manual, which outlines our goals, processes, and procedures for compliance and quality management. As part of the Laserage Quality System, the Laserage quality manual is organized according to the requirements of ISO 9001 (with additional documentation prescribed by ISO 13485 applicable to medical device components). It reads in part:
- Our Quality Policy is achieved through the total commitment and cooperation of our employees, suppliers, and customers.
- Our Mission is to focus our attention on consistently meeting or exceeding all the requirements of our customers through continuous improvement and by building a supplier base dedicated to the same mission, while meeting any applicable regulatory requirements.
- Our Vision is to be recognized as the largest, highest quality, best valued, most responsive, full service laser processing company in the world for the benefit of our customers, shareholders, and employees.
Laserage is ISO 9001 certified, which sets out the criteria for a quality management system, for products and components (as well as ISO 13485 certified for medical device components).
Laserage offers a full range of process validation services through our Quality Engineering and Product Engineering teams to support all aspects of our manufacturing capabilities. Laserage teams will work with you to determine your validation needs. Validation services include:
- Master Validation Plan
- Design of Experiment
- Measurement System Analysis
- Operational Qualification
- Performance Qualification
- Control Plan
Quality support equipment is available throughout our facility, including: automated optical inspection equipment (AOI), image recognition systems, digital microscopes, other optical comparators, microscopes, and gauging devices. We utilize the latest inspection systems, including programmable CNC optical instrumentation (up to 256x magnification), programmable pattern recognition systems, digital toolmakers microscopes (up to 400x), stereo zoom microscopes (up to 40x), and a wide range of hand tools to meet your specifications. Our Quality Team regularly performs GR&R, MSA, and FAI along with OQ and PQ to compliment your growth from R&D to fully documented validation and volume production. Functional testing equipment such as Axial Load, Stress Strain, and Austenite Transformation Temperature (Af) are also close at hand.
Still, a really successful quality program is more than just good procedures and equipment; it relies on attention to detail, from quote to delivery. As any good lean manager knows, success is a direct result of a motivated staff and the commitment to excellence exhibited by the management team. Each Laserage employee has both the authority and the obligation to act on quality problems that he or she may come across at any time.