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    BSI Regulatory Services (Medical Devices) Certification Business Policy

    Our mission is to empower you to inspire trust, foster excellence, and ensure safety in your organization; driving positive change for a better world.

    Our mission is to empower you to inspire trust, foster excellence, and ensure safety in your organization; driving positive change for a better world.

    BSI Assurance UK Ltd, BSI Group The Netherlands B.V. and BSI Group America Inc. are third party accredited/ recognised certification bodies (UKAS, RvA, and MDSAP) that supply management systems assessment, certification and regulatory compliance services. 

    BSI and its international subsidiary companies also provide accredited third party testing, certification, inspection, and validation/verification services in support of global market access requirements. On site activities are limited to auditing, product inspection, witness testing, and reporting compliance or non-conformities, and are always conducted with a client representative present. 

    BSI Group The Netherlands B.V. is a fully designated EU Notified Body (Notified Body 2797), delivering rigorous independent regulatory and quality management reviews and product certifications to support CE marking and EU market access.

    BSI Assurance UK Ltd also operates as UK Approved Body, providing conformity assessment services under UK regulation to support UKCA marking and compliance.

    Impartiality

    Our management system, testing, inspection, verification, and 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 product certified by BSI fulfil specific requirements. In the case of CE marking and UKCA marking these meet the appropriate EU and UK Regulations, Directives respectively. 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 standards 17021-1, 17065, 17025, 17020, 17029 as applicable and EU and UK regulatory frameworks. In addition, BSI has appointed an 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 the type of activity they perform, act in an impartial manner. It is recognised 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.

    Certifications

    Upon successful completion, BSI issues a conformity assessment certificate against product legislation and/or normative documents as required by the scheme. BSI makes accessible information about the certification status of each of its clients through the Certificate and Client Directory.

    Expanding or Reducing the Scope of a Certification

    We understand that organizations change, and this may sometimes require an extension or reduction in the scope of a certification. Please speak to your usual BSI contact if you need to expand or reduce the scope of your BSI certificate. Once we fully understand the extent of the change we can inform on the next steps.

    Suspension policy

    BSI may suspend or revoke a certificate if in its reasonable opinion the client does not comply with the requirements for the relevant legislation or scheme, or fails to comply with any of its obligations under the Contract, or uses BSI’s services in such a manner that may be misleading or that may bring BSI into disrepute. Under suspension, the certification of a client’s product or management system is invalid until the suspension is lifted.

    Customer Feedback Policy and Procedure for Regulatory Services

    BSI is committed to providing an efficient and responsive service to our customers and stakeholders. We welcome all feedback on performance, processes and procedures to improve and prevent further shortcomings in the future.

    Appeals Process

    An appeal is a formal request for reconsideration of any decision made by BSI concerning certification process. For instance, an appeal against a nonconformity raised by an auditor during an assessment. 

    Clients who disagree with a certification-related decision and are unable to resolve the issue through their Auditor/Scheme Manager or local BSI office management, may submit a formal appeal. Appeals must be submitted in writing within 21 days of receiving the decision being contested.

    The notice must be addressed to the BSI RS Compliance and Risk Administrator: rscomplianceandrisk@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 under appeal will remain in force pending the outcome of the process, which both the Client and BSI agree shall be final.

    Complaints

    A complaint is an expression of dissatisfaction, other than an appeal, by any person or organization, to BSI, relating to the activities or behaviour of someone working on behalf of BSI or the products or services of BSI. Complaints must be addressed to the BSI RS Compliance and Risk Administrator: rscomplianceandrisk@bsigroup.com.

    We will ensure we understand your concerns fully and deal with the complaint fairly and promptly. You will be kept informed of the progress, and we will reply as soon as the complaint has been fully investigated.

    For complaints regarding a certified client, please submit them in writing to the same address. Once we verify that the client is certified by BSI, we will investigate the complaint and take appropriate action if necessary. However, due to confidentiality, we cannot disclose the outcome of complaints concerning certified clients.

    Public knowledge of complaints

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

    For more information on BSI Certification & Accreditation Business Policy click here.

     

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