What does ISO certification mean for parts providers and their customers?

What does ISO certification mean for parts providers and their customers?

by Gus Iversen, Editor in Chief | August 04, 2017
Parts And Service
Jeffrey Rindfleisch
From the August 2017 issue of HealthCare Business News magazine

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?

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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.

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