BSI Regulatory Services (Medical Devices) Certification Business Policy

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.

BSI makes publicly accessible information about the certification status of each of its clients through the Certificate and Client Directory. This shows whether a certificate is current, suspended or has been withdrawn in the last month.

BSI Regulatory Services (Medical Devices) may suspend a client's certification under certain circumstances and on a case by case basis. Under suspension, the client's certification is invalid until the suspension is lifted. Such suspension will be made clear on the BSI client directory.

If you are a certified client of BSI Regulatory Services (Medical Devices) and have a disagreement concerning a decision related to your certification that you have been unable to resolve either through your Auditor/Scheme Manager or with the local management of your BSI office, you may make an appeal against that decision. You must contact BSI with written notice of appeal within 21 days of receipt of the outcome intended to be appealed. The notice must be addressed to BSI Regulatory Services Head of Compliance and Risk (MedDevComplianceandRisk@bsigroup.com).

Appeals will be investigated according to the BSI Regulatory Services appeals procedure, in compliance with the accreditation/ regulatory rules governing BSI. The decision made by BSI, which is the subject of the appeal, will remain in force pending the outcome of the appeal, which the Client and BSI each agree shall be final.

BSI welcomes all feedback on its performance, processes and procedures and is eager to improve these wherever possible.

If you are a certified client of BSI Regulatory Services and are dissatisfied with its products or services, please submit your complaint to BSI Regulatory Services Head of Compliance and Risk
(MedDevComplianceandRisk@bsigroup.com). We will ensure we understand your concerns fully and deal with the complaint fairly and promptly. You will be kept informed of progress, and we will reply as soon as the complaint has been fully investigated.

Complaints about a certified client should also be submitted in writing, as above. Having confirmed that the subject client is certified by BSI, the complaint will be investigated, and appropriate action will be taken if and when considered necessary. However, BSI is restricted from sharing information regarding the outcome of complaints about certified clients due to reasons of confidentiality between BSI and the client in question.

BSI will not make complaints against itself or any of its client's public unless required to do so by a court of law.

Whilst every effort is taken to meet the high standards expected of us, sometimes things can still go wrong. When this occurs, we need to be informed so that we can put things right and prevent further shortcomings in the future.