Getinge 2022 Annual Report

Getinge 2022 Annual Report Introduction Strategy Corporate Governance Annual Report Sustainability Report Other information Contents Quality Culture PRODUCT QUALITY, SAFETY OF HEALTHCARE PROFESSIONALS AND PATIENTS Getinge's offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile repro- cessing and life science. This means that the majority of the com- pany's products contribute directly or indirectly to public health. Product quality is an essential aspect in ensuring the well-being of patients. Regulatory conformance for all products is mandatory in the highly regulated healthcare and life science industry. Getinge's Commitment • • Ensure product quality and regulatory compliance Continuously improve products, services and processes Advancing the offerings through customer insights and innovation Progress 2022 Getinge strives to achieve >70% index for improved customer quality, in 2022 the result was 64% (Average for all quarters 2022, see page 137 for details). The index is based on regular internal surveys for which respondents rate their level of awareness about the quality strategy and commitment in relevant initiatives and changes to quality related KPIs. The indicator has been introduced in 2022, therefore there is no data available for 2021. In 2022, 52,328 customer trainings have been facilitated. Responsibility for operational quality was moved from central functions to the respective business areas. A corporate electronic document control system was launched for improved product registration and the customer-complaints system was automated. Management approach All production sites are audited and certified to ISO 9001 or ISO 13485 (medical device quality) as well as ISO 14001 standards. As part of the effort to maintain high quality standards, it is important that employees understand quality management and therefore quality management training for employees is provided as well as insights on product safety-related performance. Managing impact and risk In its most extreme, the risk of not conforming with product quality regulations and management could result in detrimental life-threatening results. This means that ensuring the company follows all regulations and management systems is essential. The risks associated with quality are mitigated by ISO 13485 certification, training of staff to ensure understanding of the system and continuous focus on improved quality. Getinge is actively remediating identified quality concerns, for more information see pages 50-54 and pages 60-62. Responding to customer complaints and continuously improving is also an essential aspect of mitigating these risks. GRI 416: Customer Health and Safety 416-1 Assessment of the health and safety impacts of product and service categories Health and safety impacts are assessed for improvement in all significant product and service categories (those that have a CE certification, covering -80% of all Getinge products). Assessing the health and safety impacts of Getinge products is mandatory and part of the certification processes required by market regulation. 416-2 Incidents of non-compliance concerning the health and safety impacts of products and services i. In 2022 there was one incident of non-compliance with regulations resulting in a penalty ii. In 2022 there was one incident of non-compliance with regulations resulting in a warning iii. In 2022 there have been zero incidents of non-compliance with voluntary codes. 138

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