Traceability is ensured by recording all equipment and components in our accounts system for equipment.
Our policy is to be receptive to the opinions of the authorities and manufacturers, and to comply with relevant standards in respect of patient-related equipment.
The operational side is based on demands made on care providers and departmental managers in SoSFS 2001:12, "Statute regarding responsibility for use of medical technology products" [Föreskrift om ansvar för användning av medicintekniska produkter] in the Swedish National Board of Health and Welfare Statute Book, in which MTA is named as a good partner to the operation.
In 2005 MTA was certified to the following standards:
SS-EN ISO 13485:2003
Medical devices - Quality management systems - Requirements for regulatory purposes
SS-EN ISO 9001:2000
Quality management systems - (Model for quality assurance in customers service and improvements)