ISO 13485 Surveillance Audit Results

ISO 13485 audit – ZERO major corrective actions + ZERO minor corrective actions

Only one area of improvement was suggested in our recent audit. Our auditor really valued our customized naming conventions as they more accurately describe what we do in each of those areas and suggested that we should ask our certification body to change the generic headings to our for our next audit. This is a pretty remarkable accomplishment. That tells us the ISO 13485 QMS we have developed works well for all stakeholders and as such, they really leverage it daily as the asset it as become for our firm.

So how did we have such a strong audit performance? There are a few of the key reasons why our ISO 13485 surveillance audit was so strong.  Below we highlight the core pillars of  how we built such a strong and mature QMS that works so well for our needs and meets our clients where it needs to.

1️⃣ Flexibility: Generally not the word that comes to mind when folks think of regulation and quality management systems. It is important to understand, however, that the the standards are not overly prescriptive. They tell you WHAT you need to do, but HOW you deliver that result is up to your organization.

2️⃣ Continuous Improvement: Our QMS has now gotten to the point where many of the elements of risk that are being caught by our processes are considered edge cases. Whenever one of these arises, we assess how we could have caught the error and what process or processes in combination could catch such an edge case moving forward.

3️⃣ User Centric: All design at Cortex puts the user at the centre of the experience we are designing. Our QMS is no different. It was designed for and by the folks who leverage it everyday to de-risk and create efficiencies within the development process. This user focus has led to team members really leaning into our QMS as the asset that it has become. The result of them doing so is stronger product development and a compliance that led to a perfect audit.

Huge congratulations go out to our Regulatory and Quality Manager – Paul Needler, Office Manager – Kirstie Dyment and Founder and Chief Product Officer – Dylan Horvath for their leadership in the building, maintaining and refinement of one of our most important assets!

Another post that may be of interest on a similar topic is:

User Experience Gets Deprioritized In Medical Device Development (cortex-design.com)