Both the FDA’s Quality System Regulation (Part 820) and the ISO 13485 Standard require manufacturers to establish a method for performing internal audits of their Quality Systems. It is also a requirement for manufacturers to have control over their suppliers of both products and services. Audits are one of the more effective ways of controlling suppliers. It is not; however, required that the audits be performed by an employee of the manufacturer; therefore, in the case of smaller companies who may not have the resources, or even larger companies who have strained resources, this requirement can cost-effectively be handled by someone from Regulatory Insight. Note – the FDA Quality System Regulations and ISO 13485 Standard do not allow for auditors to audit themselves or their own work. Additionally, many companies have their own internal auditors and supplier auditors, but desire that an independent audit be done to gain assurance that their own internal and/or supplier audit program is effective. Regulatory Insight also performs independent audits for companies in anticipation of an impending FDA inspection or an impending ISO 13485 assessment. This enables the company to be optimally prepared for the FDA inspection or the ISO 13485 assessment. Lastly, some FDA inspections result in a mandate by the FDA that the company hire an independent auditor to verify that the company has taken the necessary corrective action as a result of the non-compliances identified in the FDA inspection. Regulatory Insight can handle those audits for your company. Even when such mandates are not made by the FDA, and following an ISO 13485 assessment that does not typically result in the same mandate, companies often hire the services of Regulatory Insight to audit and confirm that their corrective actions are adequate.