Quality Management System

Schedule A Conversation

Quality Management System

D&K Engineering is committed to our clients’ success through a shared commitment to safety, innovative and cost-effective solutions, continuous improvement, and to maintaining the effectiveness of our quality and regulatory systems.

ISO Certified:

Best Practices

  • Dedicated Quality Organization
  • Quality Organization Separate from Manufacturing
  • Executive Management Reviews
  • Quality checks integrated into the Production Process
  • Internal Audits and CAPAs
  • Document Control

D&K Engineering’s Quality Systems-Optimized To Manage In A High-Change Environment

D&K Engineering has a proprietary information system that links all the key elements of product design and manufacturing in a seamless system that enables complete tracking and traceability from early design through continuous manufacturing and after-market support.

Benefits of the D&K Engineering Quality System

  • World Class ERP – Batch or Continuous production
  • Systems validated to meet medical device control requirements
  • Effective Change Management – at all stages of the PRP
  • Optimized to manage change
  • Fast NPI processes
  • Team based access and controls provide client access and confidentiality
  • Systems operate transparently across all D&K sites

Required Quality System elements are developed and tested, for each product, in the NPI phase to achieve program quality objectives and metrics