Abilia is now certified according to ISO 13485, the international standard for quality management systems for medical devices. The certification was performed by the prestigious Bureau Veritas.
To be able to deliver medical devices strict requirements in all parts of a product’s life cycle are needed, from development, production, sales, distribution, installation, and to service of these products. The certification is an acknowledgment that Abilia can fulfill both user and regulatory requirements in an efficient and systematic way.
Basically, it is all about securing that the user needs are met to the largest extent possible and that the process is performed in a reliable way.
”For us within Abilia it is key to put the user in focus and to ensure quality over time as our assistive tools support people with disabilities to become independent and participate in society. Therefore, it is very important to invest in both systems and competence that create value for our customers and users. For us as an organization it is a support to simplify and improve our ways of working”, says Tove Christiansson, CEO Abilia.
Sven Blomberg, COO Abilia, says ”The main reason to be certified according to ISO is the safety of the users and this is also why it is key for our customers. A quality management system that has been through such a tough review means safety for our customers when procure assistive tools for people with special needs.”
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