Dynal Bead Based Separations (formerly Dynal Biotech ASA) is certified according to the quality standard ISO 9001 (since 1996) as well as ISO 13485 (since 2003), and follows the requirements of cGMP when necessary. The quality system is maintained in order to meet both the ISO standard and the Medical Device Directive in Europe. When necessary, products are developed, manufactured and controlled in line with the US regulation cGMP.
All critical working processes are continuously monitored to secure documented evidence that the specified quality is achieved. In these areas, the data are analyzed and improvement activities are decided using the Corrective and Preventive Action System (CAPA).
Quality audits are carried out to verify that all activities comply with existing quality documentation and that the quality system is efficient and user-friendly. Four types of audits are defined:
- Internal quality audits of all departments based on a yearly audit plan.
- Audits from customers.
- Audits of suppliers.
- Audits from independent certifying bodies (FDA, Det Norske Veritas, etc.).