Donatelle Upgrades Early to New Iso Standards

September 11, 2017

Donatelle received certification to ISO 13485-2016 and ISO 9001-2015 – more than a year ahead of the transition deadline.

“We elected to adopt the new standards far ahead of the deadline because we are committed to giving our partners the absolute quality they need to go to market with confidence,” said Matt Knutson, Director of Quality for Donatelle.

The revisions for ISO 13485-2016 and ISO 9001-2015 focus on several key factors largely geared toward creating global consistencies, strengthening risk management and improving overall quality.

  • ISO 13485:2016 in brief – These revisions address the latest industry developments in quality management, technology and regulatory requirements, with an aim to help organizations improve processes, better manage risks and improve overall quality.
  • ISO 9001:2015 in brief – These revisions follow the same structure as other ISO management system standards to make it easier for companies using multiple management systems. It also increases the emphasis on risk-based thinking.

For more information on the new ISO standards, visit

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Donatelle adheres to the industry’s best practices and regulatory requirements, and has more than 50 years of helping the industry’s leading companies bring innovative devices and components successfully to market

Learn more about Donatelle’s end-to-end capabilities. Contact us at 1.651.633.4200.