MCD are ISO 13485:2016 Certified

17 Jan 2019 0 Comments 0 Trackbacks Jessica Harland

MC Diagnostics are delighted to announce that our Quality Management System has been certified to ISO 13485:2016 by the  leading UK Based EU Medical Body, BSI.

What is ISO 13485:2016?

ISO 13485 is a stand-alone, international quality standard which supports Medical Device manufacturers to implement Quality Management Systems, that establishes and maintains effectiveness to their processes. Specifically, ensuring consistent design, development, production and delivery of Medical Devices that are safe and to their intended purpose.

What does this mean for our customers?

By obtaining this quality standard accreditation, this demonstrates MC Diagnostics true understanding of the requirements and highlights our commitment to conduct high-level quality control, product traceability, risk-management and the importance of meeting customer and regulatory requirements. Overall, giving our customers peace of mind that our products are designed, manufactured and delivered to a high-standard but also, that we are in full control of our processes.

What’s next for MC Diagnostics?

We at MC Diagnostics, are very proud to have our Quality Management System compliant to ISO 13485:2016. The ‘quality-culture’ adapted by our team has led to this milestone being reached, achieving one of MC Diagnostics core business quality objectives.

The next step for MC Diagnostics is to continue to improve our existing products and processes, taking an active role in Post-Market Surveillance, whilst remaining to be a trusted and high-valued company, where quality is kept at its core.

Katee Houston - Quality Assurance Manager, MC Diagnostics


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