Medical injection molders can now make sure they are meeting industry-wide standards with the latest audit criteria from supply chain auditor MedAccred.
The MedAccred Plastics Task Group released its first set of audit criteria, AC8160 MedAccred Audit Criteria for Injection Molding, on June 29, to be used during MedAccred audits conducted at companies manufacturing resin based components via various processes including injection molding, insert molding, overmolding, injection blow molding, transfer molding and compression molding. The audits will “robustly assess a company's ability to consistently manufacture components that conform to the applicable technical specifications and customer requirements,” according to a MedAccred statement.
The audit criteria were developed by the MedAccred Plastics Task Group, comprised of technical experts from OEMs and molders including Johnson & Johnson, Stryker Corp., Becton, Dickinson & Co., Boston Scientific Corp., Medtronic, Mack Molding Co., MTD Micro Molding and others.
MedAccred, based in Warrendale, Pa., is a relatively new industry-managed approach to supply chain oversight and accreditation. The program conducts in-depth critical process audits on behalf of the medical device industry, replacing many routine critical process supplier audits conducted by OEMs and contract manufacturers with a single audit. It is administered on behalf of the medical device industry by the non-profit Performance Review Institute (PRI).
“The field of plastics manufacturing is extensive and involves a significant number of device manufacturers and their respective supply chains,” Joseph Pinto, PRI executive vice president and chief operating officer, said. “Accreditation to AC8160 will enable companies to demonstrate their commitment to quality and their process expertise to their existing and prospective customers.”