Quality management system
Gram Commercial A/S has a fully integrated, certified quality management system which meets the requirements for quality management systems contained in DS/EN ISO 9001 and for medical equipment contained in ISO 13485.
In addition, we work to the requirements contained in the Danish Ministry of the Interior and Health’s executive order no. 1263 of 15 December 2008, annex V and VII, concerning medical devices.
This management system is currently being developed and we expect to obtain certification in the fourth quarter of 2013.
The quality management system shall ensure:
・ that we always provide products and services that meet customer requirements and applicable regulatory demands, and
・ that customer satisfaction is strengthened, among other things through continuous improvements to the system and through assured compliance with customer requirements and relevant regulatory demands.
The scope of the quality management system (DS/EN ISO 9001) is:
・ the development, production, sale, installation and service of refrigerator and freezer appliances for professional use.
The scope of the quality management system for medical devices (DS/EN ISO 13485) is:
・ the sale, production and service of refrigerator and freezer appliances for the storage of blood products.
The scope of the quality management system for products to be CE marked according to the Danish Ministry of the Interior and Health's executive order no. 1263 of 15 December 2008, annex V and VII, is planned to be:
・ the manufacture and final inspection of refrigerator and freezer appliances for the storage of human blood in Class IIa.