Keeping on their toes

Cook Canada’s Regulatory and Quality team completes first virtual audit

Cook Canada’s Regulatory and Quality team is a small group. The three of us—Greg LeBlanc, Elaine Large, and Jeevika Sivakumaran—have to keep on our toes. Since we help with just about anything that touches on regulatory or quality for Canada—be it premarket or postmarket, in-house or in partnership with other Cook entities—every day is different and there is always something new happening.

On the quality side of things

Recently, on the quality side of things, we had our annual ISO 13485 surveillance audit. In order to keep our ISO 13485 Quality Systems certification up to date, ever year we have to undergo an audit by our certification body. This year was our first experience with a virtual audit. Due to the COVID-19 pandemic, traveling is difficult for the auditors, and hosting an onsite audit can be equally challenging for the company being audited. Therefore, both auditing organizations and client companies have had to adapt and take advantage of technology that allows audits to go forward without the usual face-to-face component.

We didn’t quite know what to expect—every audit is a little different—but fortunately we had some experience in working with Cook Group manufacturers that had undergone their own virtual audits, within the past few months. Of course, there are also our own internal audits which we have been conducting virtually in large part as well. We were prepared for the auditor to request electronic copies of documents that they would ordinarily review in hard copy and got busy scanning records that, up to that point, only existed in paper form. We were also prepared with webcams both for interacting with the auditor and for showing documents live should it be easier than scanning at the time.

A look at the audit

The audit itself was conducted across Webex over the course of two days with several breaks in between. It followed a normal structure: we were given the audit plan, and we worked through it in sequence. The auditor asked questions, we answered them and provided the necessary supporting evidence in the form of the relevant documents. Fortunately, our preparation seemed to pay off; we were generally able to provide the auditor with the needed materials on the spot. It helped the audit move very quickly, and we were done ahead of schedule.

In the end, the virtual model worked very well, and we ended up with no audit non-conformances cited. We were very pleased with that result, of course! The virtual model stood up very well, and we think it will likely carry forward in some form into the future, even when we are all able to travel again.