BSI Group

BACKGROUND

Introduce your business and what you do there.

I’m the director of operations at MED49, a healthcare provider software company.

OPPORTUNITY / CHALLENGE

What challenge were you trying to address with BSI Group?

We needed the OntarioMD certification and for that, we needed ISO 13485 certificate. ISO 13485 is a certificate for medical device manufacturers but because we’re a software company in the healthcare sector, it also applies to us as well.  

SOLUTION

What was the scope of their involvement?

BSI Group audited our company to see if we’re compliant with the requirements of ISO 13485 so they can issue us a certificate of compliance. They worked remotely. The audit was done in two stages. 

Stage one is going through our policies and procedures to make sure we have a management system in our company. That involves a remote audit. The second audit is going into details and seeing if we have the documentation of those policies and procedures and if we’re implementing those.

That is usually done in-person for companies that have actual medical device productions, but since we’re a software company, they were able to do it remotely as well.

What is the team composition?

I worked with someone who audited us for stage one and stage two. She was the assigned auditor. There was another person who got our information and assigned an auditor for us.

How did you come to work with BSI Group?

We wanted an auditor for the ISO and we did a Google search and went through their website. We found different companies and chose BSI Group because most of the big companies use them.

How much have you invested with them?

We have invested $40,000.

What is the status of this engagement?

Our engagement ran from September-December 2020.

RESULTS & FEEDBACK

What evidence can you share that demonstrates the impact of the engagement?

We didn’t have any specific criteria for success. BSI Group's responsibility is to audit us and make sure we’re meeting the requirements. The scope of work for them is small and clear.

How did BSI Group perform from a project management standpoint?

Their project management skills were good. Two weeks before the audit, we expected them to contact and remind us but they didn’t. I’d give them 4/5 stars. They were good though. It wasn’t a major issue.

What did you find most impressive about them?

They were very straightforward. It was very clear what was being done and what their expectations of us were.

Are there any areas they could improve?

They can be a little better at communicating the dates and reminding us of the dates. It’s just a small issue. They were very good overall.

Do you have any advice for potential customers?

Since it’s an audit, make sure you’re ready for the audit. Have an internal audit performed before going for the main audit.