From the August 2017 issue of HealthCare Business News magazine


HCB News: Why was now the right time to become certified?
JR: We have a strategic planning process we go through, and on an annual basis we set goals for three years, and one year, out.

We knew that we had to migrate to a new standard. The question for us was whether or not to be certified to the ISO 9001:2015 standard or to become certified under the ISO 13485 standard, which is the medical equipment manufacturer standard. We looked at both standards and came to the conclusion that 13485 didn’t really fit our business model because we don’t manufacture medical equipment. We repair and resell OEM equipment parts.



In order to get to the 2015 standard we utilized Fox Valley Technical College. They have staff that help companies migrate from ISO 9001:2008 to [the] 2015 standard. We also attended a couple [of] seminars to get us up to speed on what the changes were and how to migrate from one to the other.

At first it looked like a daunting task, but the more we got into it the more we realized it was doable, so we set some specific goals and timelines for completion.

HCB News: How long did the entire process take?
JR:In total, it took about six months to convert our QMS from ISO 9001:2008 to ISO 9001:2015 and become certified under that standard.

HCB News: Last year the FDA rekindled a discussion about third-party health care companies and the safety of the services they provide. Do you think changes are needed to increase patient safety?
JR: If you read through some of the comments in the docket and, in particular, the comments by IAMERS and the comments by AAMI, I think they do a good job of encapsulating where Technical Prospects stands.

I think there is definitely a role for regulation within the medical imaging manufacturers, but given that we are not manufacturers of medical equipment – we are providing a part that meets OEM standards – I’m not sure about the benefits of regulation. Having said that, if regulations should come, I feel we will be in a better position to meet those requirements having a roobust quality management system certified to ISO 9001:2015.

HCB News: Anything else you want to mention?
JR: I would say in closing that this was a company effort driven by senior management, but with involvement by everyone in the company. to bring about this certification and as a company As a whole, we are extremely proud of the achievement. It’s not a once-and-done. We will look for ways to continually improve on our quality management system. It’s a part of our culture.

I don’t think there’s any question that the business we’re in is getting more competitive. and in order to compete, We feel that one of the true differentiatorss is consistently meeting our customers’ expectations. As a company, we’ve always been committed to quality and we felt that by becoming certified and using the ISO standard as a means of documenting all of our processes that we would demonstrate to our customers the commitment we have at the highest level to providing quality parts.

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