ISO 13485 Medical Sector Quality Management System

ISO 13485 Medical Sector Quality Management System

For those who work on medical devices, it determines the specific requirements required by the quality system.

The EN 46000 Standards (EN 46001 and EN 46002), published in 1993 and including the sterilization process transferred to the EN 550 series for medical device manufacturers, explain the quality system requirements for all medical devices. In order to implement EN 46000 Standards together with ISO 9001: 2008 Quality Management System, ISO 13485 Quality Management System has been established in the Medical Sector.

ISO 13485 Quality Management System Standard in the Medical Sector; manufacturers, distributors, importers and exporters and organizations providing these services have been established in order to structure. This system is in compliance with the EU Medical Devices Directive and is implemented together with the CE brand.

TS-EN-ISO 13485: 2003 standard is an international standard based on the TS-EN-ISO 9001: 2008 standard, which contains special requirements for medical devices. It is based on the TS-EN-ISO 9001:2008 standard. Dec.

This standard covers the quality management system requirements for an organization that must prove its ability to provide medical devices and consistently meet customer needs and regulatory requirements applicable to medical device-related services. The main purpose of this standard is to facilitate harmonized medical device legislation requirements for quality management systems.