AdvantaPure manufactures AdvantaSil platinum cured silicone tubing and reinforced hose, AdvantaFlex tubing, and single use moulded 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 enabling medical device, pharmaceutical and other regulated companies to track and authenticate consumables, assets and equipment.
Mary Marcus, Director of Quality at AdvantaPure, said: “Previously, our AdvantaPure and Verigenics divisions held ISO 9001:2008 certification. 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 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.
