Quality & Standards

Basko Healthcare has named “quality” to one of its basic values and is always working on where the work processes can lead to improvement. The ISO 9001 certification of our organisation, and the CE marking of the products, support this view.
ISO 9001:2008
In April of 1997 Basko Healthcare has acquired its ISO 9001:2008 status. Certification for us, as manufacturer of medical products, guarantees that we consciously work on quality management and are continuously working on product innovation in order to guarantee and improve our quality level. ISO 9001:2008 guarantees the quality of our services. This certification performed well, but we have chosen to replace it with a standard which we believe is even more in line with the regulations for medical devices. .
ISO 13485:2016
Since October 2017 Basko Healthcare has also received its ISO 13485: 2016 certification. The ISO 13485 standard ensures European harmonization of regulations for the quality of medical devices. A good way to comply with both legislation and product safety and customer requirements. With this standard, we as Basko Healthcare want to impose a number of specific requirements on us as a manufacturer of medical devices. These requirements are about:    
  • registrations relating to customer and legal requirements
  • research and development
  • maintain technical data
  • labeling and packaging
  • product identification and traceability
  • risk management
  • control of specific environmental conditions
  • control of changes during the design, development and production process
CE-Marking European Directives 93/42/EER
The medical products of Basko Healthcare comply with all the requirements of the European Directive 93/42/EER and with legislation regarding medical products. Product developments within Basko Healthcare are tested based on the current requirements and subjected to a conformity assessment before a CE-mark is assigned .