We perform audits in: ISO 9001; ISO 13485; ISO 17025, 21 CFR 820
Whether a client needs to complete an internal, supplier, or Mock audit, we are able to assist. We offer value-added QMS audits, where the focus is ensuring that our clients and their suppliers complies with quality agreements, standards and regulations. Our audits are performed by a team of global experienced and certified IRCA auditors. Audits are guided by best practices, as well as experience and recent industry trends. We manage the entire process, from making all arrangements, completing, and reporting to final follow-up.
The purpose of a mock audit is to determine whether an organization is prepared for a full Stage II audit in compliance with standards specified by a third-party Certified Body (CB) or regulatory requirements by e.g. FDA. Mock audits are performed in compliance with FDA auditing standards by former US FDA field investigators, via our partner (Supaso International). The mock audit aids your company in preparing for an actual formal audit process. It ensures that your organization continuously complies with specified policies, procedures, and external requirements in meeting company goals and objectives. It is an opportunity to identify and implement necessary improvements to the management system.