Implementation of a QMS in accordance with DIN EN ISO 13485

A client operating in the field of in vitro diagnostics sought support from EXCO in implementing a quality management system in accordance with DIN EN ISO 13485, as the company was aiming to achieve certification of its QMS.

EXCO advised the client on the necessary steps for establishing a quality management system in accordance with DIN EN ISO 13485. As part of the project, all required QMS documentation was to be implemented, while also taking into account the additional requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

In collaboration with EXCO, a project plan and an overview document covering the requirements of DIN EN ISO 13485:2016 + AC:2018 + A11:2021 were created. Based on the project plan and in accordance with the standard requirements, the QMS documentation was developed, including procedures, work instructions, and a quality management manual. At the same time, the client's existing documentation was analysed, and the practical implementation within the company was taken into consideration and incorporated into the documentation. The additional requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices were also taken into account.

Regular meetings were held to discuss questions relating to the created documents and the overall project status. The completed QMS documentation was then implemented within the company, and employees were subsequently trained on the newly introduced documents.

• Creation of a project plan
• Analysis of the client's existing processes
• Standards research and interpretation
• Research activities relating to regulatory requirements

• Reliable implementation through expert consultancy and standards-compliant documentation development
• Time savings in research activities and their implementation

A company that develops and manufactures in vitro diagnostic devices for research institutions