Cortex Design Passes ISO 9001:2015 Surveillance Audit

We’re happy to share a big announcement from the team: Cortex has passed our ISO 9001:2015 Surveillance Audit – remotely!

Last year, Cortex announced a big step forward: ISO 9001:2015 certification. This was the result of a deep analysis of our processes in everything we do. We dove deep into our playbook, identified gaps between our standards and ISO 9001:2015 requirements, and created an action plan to systematize our policies, procedures and work requirements to make sure that every Cortex activity supports our quality objective.

This work culminated in the development and implementation of a Quality Management System (QMS) — a comprehensive system that measures and documents every process of our business to drive our customers’ success, all on the basis of continuous improvement.

This year, we put that QMS to the test.

The surveillance audit is a spot check to make ensure that our quality system achieves what it sets out to do, within compliance of the ISO 9001:2015 standard. Cortex’s Quality Management Team spent a full day with an independent auditor from TÜV SÜD, a leading certification firm, to:

• provide proof from the past year that we’ve followed the procedures outlined in our Quality Management System
• show those procedures’ effectiveness, and
• demonstrate areas where we have identified improvement.

This was done with the goal of showing what we’ve long held as a core value: that our services and processes are truly — certifiably — client focused.

We’re happy to say that we passed with flying colours.

This year presented a slightly different challenge. Given the ongoing necessity of physical distancing due to COVID-19, we conducted our audit remotely, using an online review of documentation and site specific audit using video conference. A big thanks to the team at TÜV SÜD for their flexibility in this process, as well as to Paul Needler, our resident ISO regulatory guru.

Over the past several years, Cortex has worked to become a one-stop shop for both design and regulatory. Many elements of a regulatory road map are baked into any given product at the design stage, so our clients benefit from incorporating compliance into the design process as early as possible. We’re happy to offer our clients product-specific feasibility and regulatory “go to market” reports — whether the project is a medical device following the ISO 13485 path, or a non-medical product that wishes to comply with ISO 9001. We’ve also added the capability to build Quality Management Systems for our clients who want to equip their companies to control and improve quality in their own processes.

Congratulations to the Cortex team for all their hard work! They’ve worked tirelessly to make Cortex a premier design firm in Canada, and we couldn’t be more proud of the results.

Cortex Design’s full quality policy is as follows:

Cortex Design develops human-centred products that improve people’s lives.  We visualize human experiences, design the products that support those experiences, and manufacture the solution.  Cortex seeks to understand our client’s challenges with an empathy-led research and discovery process. We champion the user in all aspects of our work, from initial research to final engineering and production.

Cortex has built and implemented a Quality Management System (QMS) based on ISO 9001:2015 to articulate our design process. This QMS supports Cortex’s mission to produce human-centred products and exceptional customer experiences for our clients. Our QMS is backed by efficient internal processes, highly qualified staff, and our leadership’s commitment to continuous improvement.

Cortex drives its customers’ success by setting and fulfilling clear and measurable goals that include timelines, costs, and product requirements. Cortex commits to its quality objectives by measuring our goals at each project phase, and using that feedback in our Quality Management Reviews.

Want to understand our process further? Check our our Methodology Page, or download our e-book: How to Make Profitable Projects for more info!