Certified quality assurance in medical technology

Arta Plast is specialised in development and production of medical technology. Our quality system is ISO 13485:2003 certified.

The quality system covers all Arta Plast operations from development of products to production. The system purpose id to meet customer demands effectively.

External audits. Arta Plast is audited annually by Intertek to ensure our quality system meets all regulations.

We are regularly inspected by Anticimex, the fire brigade and the environmental health department.

Internal audits: We conduct regular audits of our quality assurance system.

Production hygiene: We produce in dedicated premises and according to laid-down routines to ensure production meets our hygiene standards.

Clean room. Arta Plast offers production and assembly in clean room, class 8 qualified as per ISO 14644.

Quality checks: Arta Plast conduct quality checks of produced parts to ensure customer requirements are met.

Certification: We are pleased to certify our products and the materials we use, e.g. REACH and RoHS.

Suppliers: All suppliers of materials for our processes are regularly updated and inspected.

For more information about quality please mail qa@artaplast.se

 

Download certificate:
ISO-13485-Certificate-0105535-01