ISO 9001 is the most widely used International standard in the world. It streamlines and documents Arctiko’s working processes and ensures that production always meets the high quality expectations of Arctiko’s partners.
Arctiko uses the ISO 9001 standard in all business processes within R&D, sales, marketing, manufacturing and with continuous monitoring and optimization of business processes and manufacturing methods. This ensures that in all areas, not just commercial applications, Arctiko will meet customer expectations/requirements in communications, documentations, deliveries and administration.
ISO 13485 is a standard for the design and manufacture of medical equipment. It is an independent standard certification that is generally harmonized with ISO 9001. The standard has been prepared in accordance with the European Commission with a view to the essential requirements of EU directives for medical devices and CE marking.
For Arctiko, the ISO 13485 is a quality management system ensuring that our products meet the EU directive 93/42/EEC for medical devices. Class I devices are approved by Arctiko, whereas Class II equipment must be approved by an external certification company. For both classifications, Arctiko has prepared a technical file verifying that the equipment meets the essential requirements of EU directive 93/42/EEC for medical devices and CE marking.
Certification ensures that when choosing Arctiko products classified as Class I and II medical devices, Arctiko’s customers can trust our statements of high quality at all times.
Medical devices directive
Again Arctiko has raised the bargain and achieved the EU directive 93/42/EEC for medical devices & CE marking for Class II equipment.
This ensures that Arctiko partners and customers at any time can trust our statements of high quality when choosing Arctiko products which are classified as Medical devices class I and Class II. Having this certification is also known as a “Symbol of Safety” worldwide.