ISO 13485: QUALITY MANAGEMENT FOR MEDICAL DEVICES
To implement ISO 13485 is to develop a quality management system for medical devices and related services to then demonstrate that the organization is able to provide products and services for medical devices and at the same time evaluate their ability to consistently provide these products and services in line with the characteristics of the organization and its multiple risks, threats and opportunities. All this fulfilling the requirements of the client and all the relevant regulatory requirements. In that sense, in 1998 Asisthos SRL made its first certification of the pioneering Standard in this sense, ISO 46002: 1996 (Quality systems, Medical devices, Particular requirements for the application of the EN ISO 9002 Standard) through the Notified Body. 0318, the Spanish Agency of Medicines and Health Products. From that moment and in pursuit of the goal of constant improvement, year after year we achieved and exceed the harsh requirements of the inspections of the Notified Body to, in a continuous manner, recertify the successive revisions and updates of the standard, being Asisthos SRL the only Company that provides sterilization for third parties in Argentina, fulfilling and certifying this recognized international standard.