​​

What is ISO 13485?

ISO 13485:2016 and EN ISO 13485:2016 are standards specifically designed to meet the needs of developers, manufacturers, service providers, installers, and other activities and services related to medical devices. The mentioned European standards (EN) can be used in conjunction with directives 93/42/EEC, 90/385/EEC, and 98/97/EC to demonstrate compliance with certain quality system requirements for the EC Declaration of Conformity. This standard emphasizes a process approach and facilitates combined medical device requirements.​

​

Differences Between ISO 13485 and ISO 9001

The ISO 13485 standard is built upon the ISO 9001 standard, but there are several different requirements. Particularly, ISO 13485 focuses on maintaining the suitability and effectiveness of quality rather than on continual improvement, which is generally emphasized in ISO 9001. Additionally, unlike general customer satisfaction, there are differences in the requirements to meet the needs and expectations of customers.

 

Documentation and Records

The scope of required documentation and records is influenced by the country. Greater emphasis is placed on the traceability of all procedural steps in accordance with European and international MEDDEV regulatory requirements. The scope of documentation and records is more than double that of ISO 9001.

 

Approach

The fundamental philosophy of GRC Certification Body is based on auditors experienced in the field of medical devices. It aims to identify critical points of the quality management system, notify potential nonconformities, and ensure compliance. It also considers parameters and feedback systems for the evaluation of processes.

​