News

We are now ISO 9001:2015 and 13486:2016 certified!

13.08.2018

We are very proud to announce that after months of hard work, Cosylab is certified with the latest ISO 9001:2015 and ISO 13485:2016 standards!

 

What is ISO Certification and why it matters?

The International Organization for Standardization, better known as ISO, is an independent, non-governmental international organization with a membership of 161 national standards bodies.

Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.

International Standards make things work. They give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade.

We welcome the careful scrutiny of third party assessors, as their certification is there as a reassurance to our customers of our high standards.

ISO certification is not easy to obtain, and our ISO certification ensures a high level of quality assurance at every stage of your project. Our ISO certification qualifies that our internal systems are effective, consistent and efficient.

You can also be confident that we will strive for continuous improvement as part of our ongoing commitment to help our customers compete. Instead of viewing certification as an end result, we see it as the beginning of our challenge to maintain momentum and further improve our quality system.

About ISO 9001:2015 and ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 9001:2015 specifies requirements for a quality management system when an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.