Should Audits Be Unannounced?
The Recommendation Requires Unannounced Audits for All Legal Manufacturers Who Certify Under One of the European Medical Device Directives (Aimdd, Mdd, and...
The recommendation requires unannounced audits for all legal manufacturers who certify under one of the European Medical Device Directives (AIMDD, MDD, and IVDD). ... An unannounced audit can be nerve-wracking for even the most buttoned-up organizations, but there's a lot you can do to prepare yourself and your staff.
Why should audits be unannounced?
Unannounced audits are designed to ensure that a product is being manufactured in compliance with the quality management system. Companies selected for audit must provide full access to their manufacturing processes, as well as quality, batch, and purchasing records.
How often do unannounced audits occur?
They have to be performed at least once every three years, last at least a whole day, and should be conducted by a team of at least two auditors. They may take place on the premises of the manufacturer, of critical subcontractors, or of crucial suppliers. 2 Regulations Are unannounced audits part of a new requirement?
Alexander Ross has covered the video game industry for a decade, writing deep dives on game design, esports tournaments, VR developments, and gaming culture.
