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. In the case of CE marking and UKCA marking these meet the appropriate EU and UK Regulations. This confidence depends upon many factors, including the competence of management and staff, integrity, 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 Global Impartiality Stakeholder Network (GISN) whose primary role is to safeguard BSI's impartiality.
BSI is committed to act impartially in all activities it undertakes.
BSI understands its obligations for impartiality, including defining its impartiality policy and is committed to mitigating any risk to impartiality for the services it provides. This also includes a review of its impartiality risk analysis at least once a year.
BSI has formal rules and/or contractual conditions to ensure that all BSI staff regardless of type of activity they perform, act in an impartial manner.
It is recognized that the source of revenue for BSI is its client paying for certification and that this is a risk to impartiality.
To obtain and maintain confidence, it is essential that BSI's decisions are based on objective evidence of conformity (or nonconformity) obtained by BSI, and that its decisions are not influenced by other interests or by other parties or by the fees paid.
BSI Staff are not:
- The designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess, nor the authorized representative of any of those parties. Such restriction does not preclude the purchase and use of assessed devices that are necessary for the operations of the notified / approved body and the conduct of the conformity assessment, or the use of such devices for personal purposes.
- Involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which they are designated, nor represent the parties engaged in those activities.
BSI Staff do not:
- Engage in any activity that may conflict with their independence of judgement or integrity in relation to the work conducted by BSI.
- Offer or provide any services which may jeopardize the confidence in their independence, impartiality or objectivity. In particular, they do not offer or provide consultancy services to the manufacturer, its authorized representative, a supplier or a commercial competitor as regards the medical devices requirements for the design, construction, marketing, installation, use or maintenance/servicing of devices or processes under assessment, and are not linked to any organization which itself provides medical devices consultancy services.
BSI Staff being former employees of a medical device manufacturer or a former consultant to a medical device manufacturer are not involved in any assessment of that manufacturer or companies in the same group of companies for at least three years.
BSI Staff are not involved in any assessment of organisations or companies that they have a financial interest in, including those stemming from grants and fundings by organizations / Institutions to which a person belongs (e.g., academia/hospitals).
BSI Staff performance objectives and remuneration are not linked to any aspect of successful completion of conformity assessment for a manufacturer or the number of conformity assessments carried out.
BSI staff 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.
The EU Notified Body & UK Approved Body top-level management impartiality declaration can be found here.