Quality Management System
The Accellent Quality Management System outlined in the Quality Manual is structured to comply with the latest standards:
- Food & Drug Administration (FDA) 21 CFR Part 820 Quality System Regulation (QSRs)
- International Standard ISO 13485
- International Standard EN ISO 13485
- International Standard ISO 9001
- International Standard ISO 14971AS9100 B
- European Community Medical Device Directive (MDD) 93/42/EEC (including all amendments)
- Canadian Medical Device Regulations SOR 98/282
- Japanese Pharmaceutical Affairs Law (PAL)
Where other national standards or regulations require adherence, they too will be applied, but only to the appropriate technology or market segment.
The Accellent Quality Management System ensures customers receive the same high standards with respect to quality results, regulatory compliance, systematic monitoring and continuous improvement throughout Accellent. While remaining in compliance with Global Regulatory requirements, we maintain flexibility within our system to accommodate our customer's quality needs.
TÜV SÜD America Inc. and TÜV SÜD Product Service GmbH are leaders in medical device Quality Management System certification and are the Quality System certification body and Notified Body for Accellent. All Accellent facilities are registered according to the scope of work at the site. Accellent’s Corporate Quality Management System works to standardize operating procedures, reduce inspection cost and minimize auditing activities for our customers. Please see Certifications & Standards to download ISO Certifications.