Throughout our many years working in the healthcare industry, we have created and refined a systematic, phased approach to regulatory compliance auditing based off of ISO 19011:2018 Guidelines for Quality Management Systems Audit and our experience in FDA and other healthcare regulations.
Our goal is ensure consistent delivery of to-quality service to ensure we meet and exceed your quality objectives. Experience has shown that successful partnerships require clear and constant communication before, during, and after an audit. The typical process we follow is shown below:
