Notes 4. Business ethics & governance 4.1 A quality mindset 4.1.1 Hearing Aids When it comes to ensuring quality and safety of Demant hearings aids, we are committed to comply with the regulatory requirements. Our Quality Policy covers activities supporting development, manufacturing, marketing and servicing of our products. We continually improve the effectiveness of our Quality Management System (QMS). The managerial responsibility of product quality and safety is defined and described in all concrete and relevant procedures. However, the overall responsibility lies with Demant Manage- ment, who enact, this responsibility through an annual man- agement meeting and management reviews to assess general state of quality and set the direction for the coming year. More- over, management responsibility is present by means of key document approval. Before a product enters the marked, the quality and safety is documented in order for it to be reviewed and approved by Management. Throughout the development of a product, the quality and safety of the final product has a high focus. The management responsibility is present here as the approval of the key docu- ments are done by management. Quality Management System Our QMS is audited both internally by our audit team and externally by our notified body as well as maintained to reflect the development and changes of our organisation. During the product development process, reliability require- ments are defined. Our requirements are based on standards, regulations and our long experience with making hearings aids, but also considers specific design for the individual prod - uct. The products are tested against these requirements during development. At the end of the development process, final ver - ification testing of production equivalent products is performed to secure safe and effective products. From the start of employment, employees have a CV and a job description which are assessed to evaluate the training plan related to the job function. Each manager establishes a training plan securing training ahead of performing any critical quality and safety activities. The training is documented, and we evaluate the training performance and effectiveness. All employees having a role in the processes and procedures in QMS are automatically trained, and their ‘Read and Under- stood’ are recorded. All complaints are handled in our complaint system and processed in a uniform and timely manner. Our complaint handling procedure ensures that all complaints on products marketed and sold are registered, evaluated and investigated. We have a monthly focus on complaints that are trending and make sure to inform Demant Management in case of a devia- tion of the quality target at hand. Regulatory inspections In case of an incident, we assess if it classifies as reportable to relevant health and/or national authorities to take appropriate actions. We have a dedicated procedure in our QMS, which ensures the right coordination and execution based on nation- al regulations. Each incident is handled in our CAPA (Corrective and Preventive action) system, which enables us to conduct a methodical risk analysis, a root cause analysis, a corrective action of the issue and ensure to prevent the issue to reoccur. Dedicated resources with relevant competencies are immedi- ately allocated to the task. Mitigating risks Our Restricted List offers instructions and information on how to categorise (Class I-IV) and use substances and raw mate- rials. It contains all the raw materials that are forbidden in our products or banned from production and is based on authority regulations (ROHS, REACH and Toys Directive). In case of con- flict minerals that are subjected to requirements of Dodd-Frank Section 1502 or Regulation (EU)2017/821, we request of our suppliers to declare relevant content. 199 Demant ∙ Sustainability Report 2021
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