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What is ISO 13485?

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. This standard focuses on the process approach and facilitates combined medical device requirements.​

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​​Differences between ISO 13485 and ISO 9001

​The ISO 13485 standard is built on the ISO 9001 standard, but has some different requirements. In particular, it differs in maintaining quality compliance and efficiency, as opposed to the general focus on continuous improvement in ISO 9001. Also, unlike general customer satisfaction, there are differences in the requirements to satisfy customer requirements and needs.

 

​Documents and Records

​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 ISO 9001.

 

​Approach

The core philosophy of GRC Certification Institute is built on experienced auditors in the field of medical devices. It focuses on identifying key points of the quality management system, notifying risks of non-conformities, and ensuring compliance. Additionally, it takes into account parameters for process evaluation and a feedback system.

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