IBBAB - Quality
IBBAB quality policy:
IBBAB - Ingenjörsfirman Björn Bergdahl AB shall design, develop manufacture and market medical devices and other qualified products with the quality expected by the customer.
This shall mainly be achieved through:
- quality, in the form of reliability, lifetime and favorability for use and maintenance as well as safety for all users, shall be aspired to be superior in the products of the company compared to competitors.
- all IBBAB personnel shall develop and use their competence and common sense to achieve quality in their work.
- customers are met in the expected way
- all regulatory requirements shall be fulfilled.
IBBAB´s quality managemnet system is certified according to ISO 13485:2012, including product development and production. (See the certificates below, click for a larger image)
IBBAB quality system and production also fulfills the requirements of the FDA QSR (Quality System Regulations).