MRPC, a fully integrated contract manufacturer of medical device assemblies and components, recently completed the ISO 13485:2016 recertification process, extending their accreditation through September 3, 2027. The ISO certification includes all three of their medical manufacturing facilities.
ISO 13485 is an international standard outlining the requirements for Quality Management System in the medical device industry and covers the entire life cycle of a device, from design, development, production, installation, and servicing.
“Holding the ISO 13485;2016 certification signifies to our current and prospective customers that we have a Quality Management System in place, and highlights that we have procedures in place for the quoting process, product development, production, shipping, quality and other processes,” said Eric Powers, VP of Quality Assurance. “But ISO is more than a quality system, it’s a full business system that has essentially become a prerequisite for medical device manufacturers.”
MRPC implemented corporate-wide standardization of Quality Management Systems several years ago. All three locations follow a standard quality manual, departmental procedures and corporate work instructions. This standardization enables the company to reduce waste and create alignment on company objectives and customer programs.
MRPC was one of the first manufacturing companies in the state of Wisconsin to gain ISO 13485 certification in 2009 and has held the certification for the past fifteen years. MRPC’s longevity in utilizing the ISO System and strong procedural foundation has helped create a quality approach that is second to none, and one that customers appreciate.
In addition to the ISO 13485:2016 certification, MRPC is MedAccred® Injection Molding accredited, offers FDA Registration (as a contract manufacturer), NSA compliance capabilities and is NSF certified.
MRPC’s ISO 13485:2016 and MedAccred certification are available for download on the MRPC website.