Impartiality
Our management system certification, European CE certification (2797) and UKCA certification (0086) aim to inspire confidence from the public and interested parties that an organization and/or its medical devices certified by BSI fulfil specified requirements. And in the case of CE and UKCA meets the appropriate EU and UK Regulations. This confidence depends upon many factors, including the competence of management and staff, impartiality and the perception of impartiality and the avoidance of conflicts of interest. To that end, BSI follows the principles set out in ISO/IEC 17021-1:2015, the EU Medical Devices Regulations and UK Regulations. In addition, BSI has an appointed independent impartiality network whose primary role is to safeguard BSI's impartiality.
All BSI Regulatory Services (Medical Devices) staff, including its top management, are required to declare any interests that may conflict with impartiality requirements. Any potential conflicts of interest are managed according to internal procedures that meet relevant standards and regulations. Where a conflict of interest is identified and is required to be made public, BSI will do so in an appropriate manner.