DuPont Spectrum
Spectrum Plastics Group, a DuPont business · ISO 13485 2021, 12 months · FSSC 22000 2019, 6 months · 13 sites in 10 states
The challenge
Bringing 13 sites under one medical-device quality system: controlling design files, purchasing, complaints and CAPA records, qualifying and monitoring suppliers across a complex supply chain, and keeping practices consistent site to site.
What AEC did
Multi-site gap assessment, harmonised QMS documentation and records, design, purchasing, complaints and CAPA processes, supplier qualification and monitoring, risk management across product realisation, site training and internal auditor development, multi-site internal audits and management review, and certification audit support.
Certified at first attempt, no major nonconformities. ISO 13485 opened access to medical device makers that require certified suppliers. Earlier, FSSC 22000 at Pleasant Prairie, Wisconsin gave the site GFSI-recognised certification to supply food-contact packaging to major food brands.