ISO certification is one of the markers that hospitals can use when trying to decide which companies to trust with their business. Recently, Technical Prospects, a third-party parts provider based in Wisconsin, became ISO 9001:2015 certified.

HealthCare Business News reached out to Jeffrey Rindfleisch, the company’s vice president of operations, to find out what that process was like and what certification actually means for their customers.

HCB News: Your company has specialized in medical imaging parts, training and support for 20 years. How will your recent ISO 9001:2015 certification impact the service you provide?
Jeffrey Rindfleisch: Technical Prospects has a long history of providing quality parts, technical support and more recently training to the medical imaging community. ISO 9001:2015 is the latest revision to the ISO 9001:2008 standard requiring significant changes to our quality management system.

Because the 2015 version of the standard focuses so heavily on continuous improvement, it uses the Plan-Do-Check-Act cycle of process improvement and it complements perfectly with Lean Enterprise initiatives undertaken by the company. In effect, Lean Enterprise supports ISO 9001:2015 and vice versa.

Medical imaging parts suppliers play an important role in affecting equipment uptime. By effectively adopting and implementing the standards for ISO 9001:2015, and using them to drive continuous improvement of repair and refurbishment processes, certified parts suppliers will be able to lower defect rates and improve overall quality.

HCB News: For providers who don't know, what does ISO 9001:2015 certification mean?
JR: ISO is the International Standards Organization composed of the national standards bodies of more than 160 countries. ISO 9001 was first published in 1987 and establishes methodologies for creating a quality management system. The quality management system defines all the processes and procedures the organization takes to assure final products, in this case refurbished and repaired medical imaging parts, meet customer expectation and perform as intended.

The 2015 revision to the standard requires a commitment by senior management of the company to support and guide the company in its quality objectives. It further provides for a means to manage quality through rigorously defined processes and a focus on continuous quality improvement. Compliance to the standard requires utilizing scheduled internal audits, done by staff who are specifically trained to perform this function.

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.