ABSTRACT

There are three main areas that the organization should focus efforts when preparing for a Quality Systems Audit: Documentation, Employees and Escorts. Much of this preparation will occur as the company establishes the quality system. Employees throughout the organization must be prepared for the upcoming audit to be sure that they are ready as well. The escorts will accompany the auditors at all times during their visit and be the main interface between them and the organization. Escorts should speak to these key people prior to the audit to ensure that they understand the audit process and are prepared to deal with the auditors. Surveillance audits are conducted in the same manner as a certification audit except that the audit will cover fewer elements. The elements to be audited will rotate for each visit with the exception of the four elements mentioned earlier; Management Review, Quality System, Corrective Action and Internal Audits.