Operating processes and quality management systems
AKERN has been developing medical solutions dedicated to body composition since 1980.
Our Quality Management System, structured in compliance with ISO 9001 and ISO 13485, allows continuous improvement of all our processes, products and services.
ISO 13485 in particular establishes a “quality system for medical device manufacturers” and these complex regulations cover all aspects: from design to after-sales service and including manufacturing, traceability and safety checks.
Every single device produced by AKERN for bioimpedance analysis is checked twice: once on leaving production and again at certification. All documentation relating to these checks is stored for a minimum of five years.
Quality control covers all aspects, from regulatory affairs to operational processes and is part of an integrated system created with the aim of eliminating any risks related to use, and to constantly increase devices performances.
AKERN relies on qualified and certified suppliers with particular focus on Italian materials and suppliers.
The quality system requires that devices and their critical components are traceable. The entire production and distribution supply chain is traceable thanks to serial or batch numbers that enable the identification of components that have displayed problems, either in terms of safety or integrity and quality. All devices undergo electromagnetic compatibility and electrical safety tests. Latest devices also undergo stress tests during the design stage to verify reliability.
AKERN is renowned for the quality of its products. That is why the company management has drawn up a corporate policy document aimed at constant monitoring of the quality of our products.
AKERN is committed to observing the highest ethical standards as well as all standards, laws, regulations, codes and company procedures to which our business sector and corporate policy refer.
For anyone wishing to report any breaches of compliance, a dedicated email address is available: firstname.lastname@example.org.
All AKERN solutions are certified CE MEDICAL DEVICES. AKERN devices are designed and produced in Italy and are certified as Class IIA medical devices, in accordance with Directive 93/42 EEC as amended since 1998.
AKERN controls every step of the production and distribution chain and has chosen to adopt the highest standards for the certification process, working with the notified certification body Bureau Veritas.