Your solution for quality management in hospital groups

Your solution for quality management in hospital groups

Reference logo Asklepios
Barmherzige Brüder reference logo
Paracelsus reference logo
Reference logo Asklepios
Reference logo Agaplesion

Find out first-hand how hospital groups use roXtra to make their quality management systems (QMS) efficient and compliant. Whether KTQ, the ISO 13485 standard or G-BA - roXtra offers solutions that are specially tailored to the requirements of hospital groups.

In our blog, you can find out more about certification and re-certification, the implementation of quality management in hospital groups and practical application examples from the industry.

Picture of the Bezirksklinik Mittelfranken - picture was used as header in the user report.

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District clinics of Middle Franconia

To the report >

Picture of the Ulm University Hospital building

Successful validation results speak for themselves

Ulm University Hospital

To the report >

Quality management clinic groups

Special requirements for QM software in decentralized project processes

Asklepios clinics

To the report >

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> Certification & Standards

Support for quality management and certifications for hospital groups

Our software solutions make your daily operations as well as the certification and re-certification of your quality management system (QMS) easier. With roXtra, you can implement a large number of standards and regulations efficiently and in compliance with the rules - from DIN EN ISO 15224 to ISO 27001.

Quality management for hospital groups

  • KTQ certification: Cooperation for transparency and quality in healthcare
  • DIN EN 15224 Quality management systems for healthcare
  • ISO 7101 Quality management systems in healthcare - Requirements
  • DIN EN ISO 13485 Medical device quality management systems - Requirements for regulatory purposes
  • Claims of the Joint Federal Committee (G-BA), the German Hospital Federation (DKG) and the German Nursing Council (DPR)
  • NÖ BASIS ZERT

Risk management and security

  • DIN EN ISO 31000 - Guidelines for risk management
  • or ONR 49000 / ONR 49001 - Austrian risk management standard
  • Requirements for operators of critical infrastructures (KRITIS)
  • or IEC 80001 standard for risk management in networked medical technology
  • KonTraG - Law on Control and Transparency in the Corporate Sector (Corporate Govern
  • § Section 91 (2) AktG - Establishment of a risk management system (RMS) for listed companies

Quality management in general

  • DIN EN ISO 9000 and DIN EN ISO 9001 Quality management systems - Requirements
  • ISO 27001 - Information security management system (ISMS) / IT security

Document control

Process management

Action management

Risk management

Audit management

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