Tel. +82-70-4799-7450
ISO 13485:2016 and EN ISO 13485:2016 are standards specifically designed for the needs of developers, manufacturers, service providers, installers and other activities and services related to medical devices. The above-mentioned European standards (EN) can also be used in combination with the 93/42/EEC Directive, the 90/385/EEC Directive and the 98/97/EC Directive to demonstrate compliance with some of the quality system requirements for the EC Declaration of Conformity. These standards focus on a process approach and facilitate combined medical device requirements .
The ISO 13485 standard is based on the ISO 9001 standard, but has some different requirements. In particular, it differs from ISO 9001 in that it generally focuses on maintaining quality conformity and efficiency, rather than on continuous improvement. It also differs from general customer satisfaction in that it focuses on satisfying customer requirements and needs.
The scope of records and documentation required varies by country. There is a greater focus on European and international MEDDEV regulatory requirements and traceability of all process steps. The scope of documentation and records is more than double that of ISO9001.
The basic philosophy of GRC Certification is based on experienced auditors in the medical device field. It identifies critical points in the quality management system, informs of risks of non-compliance, and ensures compliance. It also considers parameters and feedback systems for the evaluation of the process.
