Qualified Manufacturers List Publicly Available Through MedAccred Program

The MedAccred program is now giving all stakeholders access to its Qualified Manufacturers List (QML), following a recommendation from the new Best Practices in Supply Chain Resiliency and Quality Working Group. The working group comprises leading medtech OEMs, contract manufacturers, suppliers, government, and industry associations, and is chaired by the MedAccred program.
 
Accredited companies included in the QML are elite within the medical device industry, having achieved MedAccred Accreditation after meeting stringent critical process audit requirements, set by MedAccred OEM Subscribers—Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics and Stryker. Until now, the QML has only been accessible to OEM Subscribers of the MedAccred program, but implementation of the working group recommendation changes that, so that anyone can access the records.
 
“Expanding access to the MedAccred Qualified Manufacturers List will be of immense value to the medical device industry, and to a range of other stakeholders, as we continue to work together towards improving product quality and patient safety. Anyone viewing this list can be assured that these companies are the very best performers in the world,” said Bob Lizewski, vice president, MedAccred, and chair of the Best Practices in Supply Chain Resiliency and Quality Working Group.
 
The list will be of interest to Quality, Procurement, and Research and Development personnel, regulators, and many others, as it provides an invaluable resource for identifying supplier quality, sourcing suppliers, and conducting research and development, among other activities.
 
The QML has many advanced search capabilities and can be accessed by visiting, and registering on, the EAN platform.
 
The list includes companies accredited to the following critical processes: cable and wire harness, heat treating, plastics extrusion, plastics injection molding, plastics mechanical assembly, printed boards (bare boards), printed circuit board assembly, sterile device packaging, sterilization, and welding.
 
The QML contains the Accredited supplier company name, manufacturing location, and critical process scope. Only current MedAccred Subscriber companies have full visibility of the audit details for each Accredited supplier, which includes Non-Conformance Report details, objective evidence, timeliness of audit responses, and other key audit information that supports their supply chain oversight activities.
 
MedAccred is a medical device industry-managed, critical process supply chain oversight program that reduces risk to patient safety, assures quality products and verifies compliance with requirements. OEM subscribers fund and manage the accreditation program and determine audit criteria, interview and select auditors, and determine which suppliers are granted accreditation. 
 
MedAccred is administered by the Performance Review Institute (PRI), a not-for-profit trade association started in 1990. PRI is a global administrator of industry-managed critical process accreditation programs focused on improving process and product quality with collaboration among stakeholders in industries where safety and quality are shared goals.