MedAccred Quality Systems Audit Criteria Released

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MedAccred Quality Systems Audit Criteria Released

15 October 2015

On October 7 2015, the MedAccred Quality Systems (MQS) Audit Criteria AC8004 was released. The MQS audit criteria draws from ISO9001, AS9100, and ISO13485 and contains the essential elements of a quality system that a supplier should have in place (such as Management Review) in order to participate in a MedAccred critical process audit.

The publication of AC8004 follows the approval, in April 2015, by the MedAccred Management Council to establish a MedAccred Quality Systems (MQS) Task Group. This industry group is comprised of MedAccred Subscribers Depuy Synthes (Johnson & Johnson), Philips HealthTech and Stryker Corporation, as well as Participating Manufacturers (OEMs) Baxter Healthcare Corp., Becton, Dickinson & Co, Medtronic, Inc., and Supplier Solar Atmospheres.

Collectively, they established audit criteria AC8004 for those suppliers who do not have a valid quality management system certificate, such as ISO13485, ISO9001, AS9100, AC7004 or TS16949. A supplier with an MQS certification is eligible to receive a MedAccred critical process audit (e.g. PCBA, Sterilization, Welding, etc.). The MQS audit is conducted as a one-day add-on to the MedAccred critical process audit and the Task Group has agreed to accept Nadcap approved Aerospace Quality Systems (AQS) auditors for MQS.