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.
Lean 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
ISO Certified:
- ISO9001:2015 Quality Management Systems
- ISO13485:2016 Medical Devices Quality Management System
- FDA Registered Facility
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
