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Quality Management

Fluortek maintains an ISO 13485 quality system to ensure that all products and processes consistently adhere to the strict requirements of the medical device industry.

Our highest priority is to continually exceed our customers’ expectations by providing quality products and outstanding customer service.

  • ISO 13485:2016 Registered by Eagle Registrations
  • Quality assurance designed into everything we do, from order entry to contract review, document control, training programs, and validation of our systems
  • ERP and Quality module data collection systems track processes to monitor ongoing quality
  • Corrective and preventative action (CAPA) system integrated into our ERP system
  • Thorough segregation of any nonconforming product tracked by electronic traceability
  • Controlled documentation supporting all of our quality systems


We will produce products that meet our customers’ requirements.

Our Quality Management System provides compliance to customer requirements and ISO 13485. We are committed to maintaining effectiveness of this Quality Management System.

Continuous improvement is demonstrated by periodically reviewing quality objectives, our documents, and also this policy for suitability and compliance.

This policy is communicated during new associate orientation and ongoing training for all associates.