As part of ISO 13485 implementation of Quality Management Systems, it is a requirement for all internal audits to be performed on the systems processes and procedures, ensuring that the necessary standards are met. Any issues that arise should be corrected and actioned.
It can be challenging to recruit suitable persons within an organisation to perform internal audits, and it can sometimes be difficult to remove bias.
Here at Patient Guard, we offer an internal audit service. We perform the internal audits required for the proper management of the Quality System. This gives the company management peace of mind, knowing that the system is being appropriately audited. It also minimizes the likelihood of non-conformance’s being raised by the certification body during their annual surveillance visit or unannounced visits.