We’re ISO 13485:2016 Certified!

We are proud to announce that PCR Biosystems has achieved ISO 13485:2016 certification for our Quality Management System. It’s a great achievement that shows we are truly committed to excellence in the development, manufacture and supply of our reagents to the molecular diagnostics industry. 

What does the certification cover?

Our ISO 13485:2016 certificate is valid for the development, manufacture, sale and distribution of components and reagents for molecular biology diagnostics. You can view our certificate here

What does this mean for our customers?

Certification to this quality standard means our customers and collaborators can be assured that our products are designed, developed and manufactured with the highest levels of traceability, consistency and quality control.

What does this mean for PCR Biosystems?

This achievement confirms our commitment to being a trusted supplier in the development of molecular diagnostic tests. It means that we understand the requirements of our diagnostic partners and have robust processes in place to meet, and exceed, these requirements. 

Now that we’re certified, what’s next?

Adherence to the standards of ISO 13485:2016 compliments our existing ISO 9001:2015 certification, meaning we’ll continue to put continuous improvement and the needs of our customers at the heart of what we do. We’ll ask for your feedback, listen to what you have to say and strive to exceed your expectations.

How can I find out more?

For more information on our Quality Management System and ISO certifications, please get in touch with us using the details below:

T. +44 (0) 203 930 8101
[email protected]