Precision, Inc. received the ISO 9001:2008 and ISO 13485: 2003 Medical Industry
Minneapolis, MN — November 29, 2010
Minneapolis, MN – Precision, Inc. is a global leader in providing magnetic components, innovative wound coils and other value added assemblies used in demanding applications for the medical, avionics, alternative energy and other general industrial control markets. The Company has received certifications in ISO 9001:2008 and ISO 13485:2003 for all U.S. locations. Precision has gained a reputation for developing innovative processes to meet customers’ atypical requirements in critical applications for these market segments and has award winning technologies applicable to power factor correction and the audio market. The same processes and documentation are required in all of Precision’s global facilities.
President, David Anderson stated that “The ISO certifications applicable to our domestic locations are but one instance of our ongoing commitment to a high level of customer satisfaction, product and process quality, continuous improvement, as well as statutory and regulatory compliance. We have doubled the size of our clean room and developed a global supply chain that assures us that our sourced materials are also from ISO certified suppliers.”
ISO 9001:2008 certification covers Precision’s procedures and processes regarding customer collaboration, design configuration, manufacture, global distribution, and service in the supply of the Company’s products and services. The Company has found the guidelines in ISO 9001:2008 to be beneficial in maintaining consistency and managers have been challenged to continually evaluate processes and to make improvements in overall operating efficiencies.
The ISO 13485:2003 certification is based upon ISO 9001:2008 but specifies additional quality management system requirements applicable to regulated medical device manufacturers and their suppliers. For example; all raw materials used in Precision’s components for medical device equipment are traceable back to the source. All medical customers are assured that our procedures and processes meet the same rigid standards as required in their systems.
Anderson further stated “We are committed to our medical market customers and want to ensure our quality management system consistently meets their requirements. We have the quality systems and technical resources in place to provide innovative magnetic applications and value added assemblies for the medical industry.”
Both certifications are effective November 16, 2010 and require both ongoing internal audits of the Company’s procedures and processes as well as independent annual audits.
ISO certification demands that Precision’s records, regardless of the functional area within the company, demonstrate evidence of activities performed and results achieved according to defined procedures. “Quality records minimize the need and expense for customers to conduct onsite ISO audits”, says Anderson, “…because Precision’s ISO certification validates the Company’s compliance to required documentation.”
Lyle Shaw, Executive V.P., says “We always had the ability to deliver high quality precision products…This has been evidenced by the receipt of multiple awards for Quality from our customers. What the ISO requirement changes at Precision, is, not only the way we document our activities throughout the processes, but the fact that we consistently validate compliance through the audit process. ISO procedures and documentation make it easy for customers to understand and verify that Precision’s processes are effectively generating high quality and reliable products”.
The ISO certification for medical device equipment manufacturing also positively affects military, aerospace, industrial controls and other specific customers where the need for documentation and specific procedures are a requirement. There is a definite carryover to all facets of the organization. The ISO 13485 certification emphasizes staff training and provides more risk assessment. In the end it helps to meet necessary FDA requirements”.
Certifications were issued by TUV SUD America, Inc. TUV is a globally recognized testing, inspection and certification organization, known by reputation and experience, within Precision’s customers’ industries. For an in-depth overview of the standards and the certification process, please see TUV SUD America’s website.
To learn more about Precision, Inc., products and certifications, call Lyle Shaw and/or David Anderson at: 763-561-6880.