Quality Management Systems to ISO 13485: 2016

ISO 13485 is the internationally accepted standard a medical device organisation can implement to demonstrate compliance with MedTech legislations.

Obtaining ISO 13485:2016 Certification with Eurofins E&E CML Ltd allows you to demonstrate worldwide recognition for your organisation’s compliance with the ISO 13485 requirements.

Eurofins E&E UK can provide certification to ISO 13485:2016 through Eurofins E&E CML Ltd. Full details of the Scope of Accreditation held by Eurofins E&E CML Ltd can be found here.

What is ISO 13485?

EN ISO 13485 is the medical device industry’s harmonised quality management system (QMS) standard.

It has been written to specify the requirements for an organisation to design and implement a quality management system that can demonstrate its ability to provide medical devices and other related services that consistently meet customer and applicable regulatory requirements.

At the core of ISO 13485 is Patient Safety. The primary purpose of the standard is to ensure that all aspects of organisations’ medical devices are consistent. Key focus areas include product design and development, manufacturing and production, distribution and storage, installation, and disposal.

By meeting the requirements of ISO 13485 and obtaining certification to the standard, an organisation can demonstrate that it can meet the regulatory and customer requirements for the markets into which the products will be placed.

How is ISO 13485 different from ISO 9001?

ISO 13485 is a stand-alone QMS standard based on ISO 9001:2008 (superseded by ISO 9001:2015).

Based on the ISO 9001 principles of ‘Plan, Do, Check, Act’, it is designed for regulatory compliance. It is more prescriptive and requires a much more robust and thoroughly documented Quality Management System than ISO 9001.

How can Eurofins E&E Ltd help?

Our team can provide you with a comprehensive and detailed path to ISO 13485:2016 Certification for manufacturers of Medical Devices. Contact the Eurofins E&E UK Medical Device Certification team for more information.

Eurofins E&E CML Ltd is accredited (UKAS 8175) to provide certification to ISO 13485:2016. Eurofins E&E UK consists of Eurofins Electrical and Electronic UK Ltd, Eurofins E&E CML Ltd and AQL EMC Ltd.