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November 2018

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Colburn Manufacturing Achieves ISO 9001:2015 and ISO 13485:2016

Colburn Manufacturing Company, Inc. has been awarded ISO 9001:2015 and ISO 13485:2016 certification from TUV SUD America, Inc. Certification demonstrates Colburn Manufacturing meets the criteria set by The International Organization for Standards and passed the audit, displaying zero nonconformities to the new standards. Colburn had previously been certified under both ISO 9001:2008 and ISO 13485:2003.

The standard ISO 9001:2015 applies to Colburn's quality management and quality assurance systems. By meeting the standards set forth by ISO, Colburn reaffirms its commitment to providing components that meet rigorous standards of quality and safety, as well as consistently high levels of customer satisfaction. It also demonstrates Colburn's dedication to continued growth and development in servicing the industry and its employees.

The new ISO 9001:2015 standard calls to an additional focus on risk management over the previous ISO 9001:2008. Colburn demonstrates processes to address issues as they might arise in risk management including preventative actions.

The standard ISO 13485:2016 applies specifically to Colburn's credentialing for manufacturing CNC Swiss precision machined parts for the medical industry. The new standard furthers the development of risk management and risk-based decision making as a focal point in the medical industry.

Liz Larson, Director of Operations, has furthered her education, becoming a certified ISO 13485:2016 Internal Auditor (TPECS) through BSI Group America.

For more information contact:

Colburn Manufacturing Company, Inc.

7341 Commerce Lane NE

Fridley, MN 55432


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