After several months of preparation, the AdvantaPure high purity products division of NewAge® Industries, Inc. has received ISO 9001:2015 certification. This updated certification helps demonstrate the company’s commitment to quality and its ability to consistently provide products that meet its customers’ stringent requirements.
AdvantaPure manufactures AdvantaSil™ platinum-cured silicone tubing and reinforced hose, AdvantaFlex® tubing, and Single-Use molded manifold assemblies and components for the biopharm, pharmaceutical and clean application industries. The new certification also applies to the company’s Verigenics® division, which offers RFID technology that enables medical device, pharmaceutical and other regulated companies to track and authenticate consumables, assets and equipment.
“Previously, our AdvantaPure and Verigenics divisions held ISO 9001:2008 certification,” said Mary Marcus, Director of Quality. “Our leadership team determined that we needed to update our certification promptly to show our customers that they can depend on receiving the same high quality products time and time again.”
Differences between the ISO (International Standards Organization) 9001:2008 requirements and those for ISO 9001:2015 include an increased focus on risk-based thinking and assessment, greater emphasis on leadership involvement and more focus on supply chain. ISO 9001:2015 also uses simplified language and updated terminology.
Team members at NewAge Industries initially met in mid-2016 to begin reviewing the new requirements. The group consisted of team leaders, internal quality auditors and managers who worked on process flow charts, quality manual revisions, work instructions and the company’s Business Management System. Once tasks were completed, a registrar’s audit took place, resulting in receipt of the ISO 9001:2015 upgrade.
“This certification was a big undertaking,” stated Marcus. “It involved dozens of team members, working individually and in groups, to understand the new requirements and then put plans and actions into place to ensure compliance.”