TRUMPF Medical Systems' Charleston SC Facility Receives ISO Certification

Charleston, SC – TRUMPF Medical Systems, Inc., part of the global TRUMPF Group and a leader in LED Surgical Lights, ceiling-mounted Equipment Management Systems and Surgical Tables, has announced its Charleston, South Carolina manufacturing facility has received ISO 13485 Certification. ISO 13485 is an international standard that requires a manufacturer to demonstrate comprehensive quality management systems suitable for manufacturing medical devices.  

According to Andy Reding, President and CEO of TRUMPF Medical Systems, Inc., ISO certification offers customers an added level of confidence that they will consistently receive the quality products and service that he feels the market has come to expect from TRUMPF.

“To be truly competitive in today’s market, a company must have a quality system governing all phases of its business operations,” says Reding. “ISO certification independently confirms that such systems are in place here at TRUMPF. It also speaks to our commitment to keep the bar high, as we strive for continuous improvement in everything we do.”

Lindsey Ronnenberg, TRUMPF’s Manager, Quality and Regulatory Affairs, echoed that sentiment, saying the decision to pursue the optional third-party accredited certification is consistent with the TRUMPF Group’s expectation of its manufacturing facilities and its overall commitment to quality. The TRUMPF Group operates 60 subsidiaries globally and TRUMPF Medical Systems is represented in more than 80 countries.

Building products for America in America

A leading technology company, TRUMPF Medical Systems custom designs, manufactures and installs innovative products and systems used to improve safety, efficiency and patient care. In 2009 as the market’s response to TRUMPF products increased and expansion was called for, the company opted to remain in its long-time home city of Charleston, S.C. relocating locally to a new, custom built 27,000 square-foot facility. The new space, with room for further expansion, allowed TRUMPF Medical Systems to consolidate its HQ operations and manufacturing under one roof.

According to Reding, both the manufacturing expansion and the ISO certification replicate a successful strategy used by the TRUMPF Group globally. “By placing the highest quality manufacturing locally, we can reduce costs and optimize product availability and service. We are building products for the American market in America.” Reding points out that the concept has also been proven locally by other leading companies, such as BMW, that have moved manufacturing to South Carolina.”

From expansion to certification:
highest quality standards are maintained

Not only TRUMPF’s manufacturing capability, but all aspects of its product support were put to the test through the ISO certification process. “It goes well beyond just the manufacturing process,” says Ronnenberg. “The accrediting company’s auditors are concerned with efficiency, controlled processes, policies, procedures and documentation, as well as how well your people are following through. Quality control, responding to customer issues, and surveying and tracking customer satisfaction are all key: the accreditation evaluates the systems that support the whole life cycle of each product.”

Since manufacturing began, in early 2011, TRUMPF has more than doubled its output of LED Surgical Lights and ceiling-mounted Equipment Management Systems. Going forward facility output is expected to further increase, more than tripling initial levels. And, since ISO certification is required for a number of international markets exporting products manufactured in Charleston is possible.