MedAccred publishes audit criteria for medical injection molding

Criteria established by leading medtech OEMs

The MedAccred Plastics Task Group has released its first set of audit criteria. AC8160 MedAccred Audit Criteria for Injection Molding will 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 audit is designed to robustly assess a company's ability to consistently manufacture components that conform to the applicable technical specifications and customer requirements.

Audit stock art
Image courtesy Stuart Miles/freedigital
photos.net.

MedAccred (Warrendale, PA) is a medtech-industry-managed program that provides supply chain oversight via standardized audit criteria. It is administered by Performance Review Institute (PRI), a not-for-profit organization that also supports the Nadcap accreditation program for the aerospace industry. Modeled after this successful 25-year-old program, MedAccred audits replace some of the routine critical process supplier audits conducted by many OEMs and contract manufacturers with a single audit, according to the organization.

The new audit criteria for plastics processing were developed by the MedAccred Plastics Task Group, which is composed of technical experts from Johnson & Johnson, Philips, Stryker Corp., Baxter Healthcare, Becton, Dickinson & Co., Boston Scientific, Medtronic, Mack Molding, BMP Medical and MTD Micro Molding.

PRI's Executive Vice President and Chief Operating Officer, Joseph Pinto, noted the importance of the new audit criteria for the MedAccred program, commenting: “The field of plastics manufacturing is extensive and involves a significant number of device manufacturers and their respective supply chains. Accreditation to AC8160 will enable companies to demonstrate their commitment to quality and their process expertise to existing and prospective customers."

PlasticsToday spoke with task group members Ed Kangas of BMP Medical and John Hastings of Johnson & Johnson about the MedAccred program at the Medical Design & Manufacturing West event in Anaheim, CA, in February about the initiative’s origin and objectives: “BMP Medical first injection molder to complete MedAccred audit program.”

Companies interested in gaining accreditation for plastics injection molding are encouraged to contact Justin McCabe, PRI's Plastics Staff Engineer for more information. Companies achieving accreditation will be listed on MedAccred's Qualified Manufacturers List.

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