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Quality Assurance

K-Kolor's Policy is to produce quality pad printing on medical devices and medical assemblies through dedication of developing and maintaining exemplary customer relationships and communications that enable us to:

• Meet or Exceed our Customers' Requirements and Specifications
• Comply with All Environmental, Statutory, and Regulatory Requirements.

We accomplish the fulfillment of these requirements by adhering to our management system and operational methods, which recognize customer satisfaction as a primary goal. Our Quality Assurance program is committed to ensuring excellence in specification adherence for each customer by delivering

• Lot Control Integrity
• Incoming Material Inspection – for quality and surface energy
• Optimum Ink Selection – best suited for material and application
• Optimal Material Surface Preparation – to ensure ink adhesion
• Handling Consistency
• Product Traceability and
• Quality System Maintenance.

At K-Kolor, our medical device printing and assembly specialists strive to continually improve the effectiveness of our quality management system and commitment to customer satisfaction through monitoring our performance against established objectives and through leadership that promotes employee involvement. This concept represents our commitment to quality and an ever-increasing need to deliver quality goods and services to a growing and demanding customer base.

K-Kolor helps make your path to FDA approval easier through our adherence to current
U.S. FDA Quality System Regulations (QSR). To learn more about our quality assurances and medical device printing/marking best practices, contact K-Kolor.

View Printable ISO certification...

• ISO 9001:2008