Internal Audits of the System and/or Product

An audit is a “systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled” (ISO 19011). System Audit emphasis on the comprehensiveness and effectiveness of implemented procedures against specified management standards and customer-specific requirements to determine the quality capability of the QMS. Product audit goal is to check the compliance of the product with established specifications by assessing the quality characteristics of finished products or semi-finished products. The auditors in our team conduct fully independent remote or on-site quality system audits either for companies with ISO 13485 certification already implemented or looking to prepare and get ready for the first ISO 13485 certification audit.