ISO 13485:2016 Yönetim Sistemleri Belgelendirmesi

ISO 13485 is a standard for the quality management system, specifically designed for the industry of medical devices, which covers aspects of ISO 9001 and additional industry requirements for medical devices.

ISO 13485: 2016 had been agreed with three medical devices, EU, therefore the certification according to this standard, accredited certification body, such as AQSCERT Product Service, automatically demonstrates compliance with specific clauses in these directives.

Why are you certified its quality management system?

Certification of quality management system, in particular for medical devices, ISO 13485 proves beneficial, and in many cases essential, for medical companies which export their products to the world market. In the European Union implementation of EU directives (e.g. Directive on active implantable medical devices Directive medical devices Directive the in vitro diagnostics) allows free trade of medical devices. A significant part of the demonstration of compliance with the requirements of the EU Directive is the establishment and independent assessment of the quality system.