Swiss Approval Technische Bewertung S.A.


Guarantee of trust in the services of healthcare units

The healthcare sector is multi-dimensional and extremely complex regarding the determinants of quality and safety in its services, which is regulated both by international and national rules and by more specific regulatory frameworks – protocols.

According to the Eurobarometer and World Health Organization (WHO Facts) statistics for 2014, 20-40% of health expenditure is wasted due to poor quality of healthcare. Despite scientific and technological advances in the field of health services, well-informed ‘consumers’ (patients, health insurance organisations/ companies and corporate clients), recognising the risks of potential unsafe operation of health care providers, are becoming increasingly ‘cautious’ and as a result, healthcare facilities are looking for a recognition – ‘quality seal’ which is a ‘quality control and safety’ assurance mark for their services.

The DIN EN 15224 standard is the European framework of specifications for the development and implementation of management systems in health care services in order to respond adequately to the specific needs and circumstances of health care services (hospitals, clinics, inpatient and outpatient clinics, diagnostic centres) and specialised medical units such as IVF centres, dental centres, rehabilitation centres, etc.

The evaluation and certification procedures for these systems should be governed by a specialised approach, with substantial control and identification of the weaknesses of the systems in place and the deficiencies that put patient safety at risk, rather than simply being limited to a superficial inspection of general aspects of the operation of the facilities.

Swiss Approval’s teams of experts and inspectors for the DIN EN 15224 standard include healthcare professionals with international experience, and qualified system inspectors with long experience in healthcare service inspections. By virtue of its expertise and experience, Swiss Approval International developed guidelines for the analysis of the requirements and implementation of the principles of the standard, incorporating specific, internationally recognised quality assurance tools in healthcare and international best practices, based on the following principles:

  • The quality of healthcare can be ensured through a patient-centred concept regarding care that is patient-centred and delivered individually as appropriate for the particular person, at the appropriate time.
  • Reliability in healthcare services can be met by implementing risk identification and management procedures, adopting clinical safety and patient management protocols, and by mechanisms to evaluate clinical effectiveness and improve the quality of care provided.

When implementing management systems according to DIN EN 15224, patient safety is perceived as a primary objective by modern healthcare systems and therefore, it is considered necessary to develop a strong culture for the safety of the services provided entwined with the operational strategy of each healthcare facility.

Certification according to Swiss Approval’s guidelines for the implementation of the European Standard DIN EN 15224 is the leading way:

  • Effective management of patient safety risks and operational risk in healthcare organisations
  • Implementation of quality control procedures in healthcare to prevent errors and adverse events
  • Evaluation of clinical effectiveness
  • Adequate and up-to-date training of staff
  • Continuous improvement of clinical performance

Swiss Approval guarantees the provision of added value through its services to healthcare providers for an effective implementation of the European quality assurance criteria according to DIN EN 15224 with the aim of maximising benefits and objectively promoting quality and patient safety.