An audit provides you with feedback with regards to the processes and workflows within an organisation. These audits show improvement potentials and will let you become more efficient. Audits based on norms such as ISO 9001, ISO 13485, ISO 14001 or ISO 28001 will furthermore ensure your compliance with the respective regulatory requirements. These topics are typically linked to the services we provide in the areas of Quality Assurance or Process Management.

The ISO 9001 norm standardises the fundamental aspects of a management system to ensure a comprehensive and efficient process landscape. When an organisation is part of the production of Medical Devices, they will most likely follow the ISO 13485 norm to have a compliant quality management system and adhere to regulatory requirements. Other common norms such as ISO 14001 for Environmental Management or ISO 28001 for Security Management focus in their respective fields and provide a framework of processes for these management systems.

As a solution provider, we either support you in a preparation for an audit with focus on ISO 13485 for Medical Devices or we conduct these audits for your organisation. An audit is a tool to give an organisation an outside view on compliance relevant topics which can be very helpful, especially being in a highly regulated environment such as Medical Devices.

To realise your potentials, we provide with services in the areas of Strategic Solutions, Agile Project Management, Traditional Project Management, Communication, Coaching and Workshop Moderation.

As rameus solutions, we can focus on your potentials to achieve a higher degree of maturity, gain efficiency and ensure compliance. 

Feel free to contact us if you have an inquiry. We will gladly get back to you.