CRISAM DIN EN 15224 Knowledge Pack

The CRISAM® DIN EN 15224 Knowledge Pack contains components and control objectives for maintaining a DIN EN 15224 compliant clinical risk management by taking account of the quality management system.

Key features and benefits

  • Takes into account the requirements of standard DIN EN 15224.
  • Unified view of clinical processes and clinical risk management processes.
  • Compliance check against requirements of DIN EN 15224 at the push of a button.
  • Identifies gaps which have to be closed through appropriate measures in order to meet the requirements of standard DIN EN 15224.

Medical adaptation of quality management standard

The DIN EN 15224 is an industry-specific standard for quality management in healthcare and translates the general ISO 9001:2008 into a tailored quality management standard for clinical purposes. The main difference between the two standards is the significant extension regarding demands for risk management and patient safety. The implementation of 11 predefined quality features, which is required according to DIN EN 15224 is addressed holistically by CRISAM® through specified control objective questions.

With the CRISAM® DIN EN 15224 Knowledge Pack the fulfilment of specific requirements for patient safety and the management of clinical risks in the planning, execution and control phase is systematically analysed.

Certification option

Recognised certification bodies can apply the standard DIN EN 15224 for the certification of healthcare facilities.

Reporting und Compliance

The CRISAM® Explorer has already integrated the relevant risk and quality management reports and thus enables the detection and evaluation of weaknesses which need to be eliminated.


Figure 1: Reports relevant to risk and quality management

By means of compliance reports, which are based on facts and figures and supported by visuals, the CRISAM® DIN EN 15224 Knowledge Packs serve to identify the degree of fulfillment of the requirements set by the standard DIN EN 15224. 


Figure 2: Spider chart for visualising the compliance

System requirements

CRISAM® Explorer