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Preco Earns ISO 13485:2003 Certification

Preco will be able to provide more contract manufacturing services and automated processing equipment to manufacturers of medical devices thanks to an intensive effort in the last quarter of 2010 to get the Somerset, Wisconsin facility ISO 13485:2003 certified. ISO 13485 is a quality management system standard tailored to the medical device market.

Preco submitted documents about its quality management system to TUV*, a third party certifier, in early December 2010. TUV then visited the Somerset plant January 18-21, 2011. At the end of the visit, following intensive interviews with many Preco factory employees and detailed reviews of Preco’s quality assurance and manufacturing procedures, TUV officials informed Preco that the company had passed the certification process.

"In fact, there was not a single finding of nonconformance, which is very significant." says Jodi Cotten, Quality Assurance Manager at Preco. Cotten led a project committee tasked with obtaining the certification. "We have been ISO 9001 certified since 2004, but 13485 is different," she says. "The ISO 13485 certification focuses on how effective we are in terms of being able to deliver and maintain consistent cost, quality, delivery and safety."

Preco undertook the 13485 certification process as a means to encourage continuous improvement and also to serve more customers in the medical device market. "We are seeing tremendous growth in our medical markets, and the ISO 13485 certification is an amplifier to our company’s commitment to continue this growth" says Mark Daun, Sales Manager for Preco's Contract Manufacturing Services.

"Preco's unique combination of expertise in precision registered lamination, laser processing, and rotary die converting is filling an apparent gap in the medical device market," Daun states. "We are finding that our customers really appreciate our willingness and desire to partner with them at the earliest stages of component design, many times offering help in materials selection, assembly configuration, and designing for manufacturability." Daun also states, "Being located in the greater Minneapolis area's 'LifeScience Alley' provides a great source of both potential customers, as well as vendors. Our ultimate goal is to develop long-term manufacturing partnerships, manage supply chains, and help bring products quickly and effectively through the design process to full production."

As a result of becoming ISO 13485:2003 certified, Preco has taken several steps to ensure that medical device manufacturers—as well as any other customers—can depend on Preco to deliver the highest quality products and services every time they place an order. Some of the most important new actions Preco has taken are:

  • Using a proactive risk management process to identify, in advance, any problems that might occur during the processing of parts in our factory to reduce the probability of quality issues and concerns
  • Strengthening maintenance protocols and procedures for in-house manufacturing equipment
  • Improving the monitoring of shelf life protocols for warehouse supplies
  • Adding resources to support continuous improvement activities
  • Establishing a task force to continuously reevaluate the effectiveness of Preco's state-of-the-art clean room.
  • Enhancing identification and traceability programs.

"We have always had a strong commitment to providing our customers with the highest quality available and doing the job right," says William Evans, Key Account Manager. "Our ISO 13485 Certification is positive confirmation that we were doing things right and it will ensure even more opportunities for us in the life science markets."

*Independent TÜVs (Technischer Überwachungsverein, English translation: Technical Inspection Association) were founded in the 1870s by the German steam boiler industry. These regional organizations helped regulate and supervise the safety of steam installations in the interest of public safety.

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