Your solution for quality management in hospital groups
Your solution for quality management in hospital groups
Many thanks for the always very prompt support, the friendly and above all competent staff.
Matthias Scheck, Department for Organizational Development and Patient Safety at the Barmherzige Brüder Regensburg Hospital
success stories
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.
Special requirements for QM software in decentralized project processes
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One software, many application areas.
Effective document control with roXtra
With roXtra document management , you can keep track of your documentation - from creation to archiving, locally and from any location. Whether in inpatient care, in medical care centers (MVZ), in specialized clinics or in central administration, with roXtra you and your employees always have access to the current and valid version of your documents.
Your advantages with roXtra in the area of document control:
- Individual approval workflows: Customizable to your processes and standard requirements.
- Audit-proof versioning: automatic storage and archiving.
- Rule-compliant document management: For all guidelines, e.g. ISO 13485 or GxP.
- Rely on a future-proof software solution to make your QM processes in your hospital group efficient, compliant and transparent.
Efficient and digital process management for hospital groups
Digitize and automate the internal processes of your hospital group with roXtra Processes. Thanks to graphical modeling according to BPMN 2.0, rules, responsibilities, tasks and input fields for different processes and forms (e.g. in patient care or administration) can be defined intuitively and controlled efficiently.
roXtra Processes enables you to design your processes efficiently, digitally and in compliance with regulations - perfectly adapted to the requirements of your hospital group.
With the Flowchart Designer, you can create simple models such as flowcharts, organization charts or mind maps in no time at all and make your processes easy to understand for everyone involved.
With the Flowchart Designer, you can create simple models such as flowcharts, organization charts or mind maps in no time at all and make your processes easy to understand for everyone involved.
Advantages of process management with roXtra:
- Transparency and clarity: Visualization of complex processes such as conformity assessment procedures or post-market surveillance.
- Continuous improvement (CIP): Optimize processes and make them sustainably efficient.
- User-friendliness: Intuitive design and fast implementation of your requirements.
Risk management for hospital groups
With roXtra Risks, you can reduce the effort involved in risk management in your hospital group. Identify and manage risks centrally in order to carry out an effective and high-quality risk analysis. roXtra supports all common standards and specifications, such as ISO 31000, ISO 15224, ISO 9001 and ISO 27001.
Patient safety is the top priority in the healthcare sector. Many regulations therefore require a risk management system to support ongoing operations. This allows you to prevent and avoid clinical risks (e.g. poor hygiene, mix-ups, misdiagnoses, etc.) as well as non-clinical, commercial risks in the future.
Your benefits with roXtra risks:
- Efficient risk identification: identify and analyze risks at an early stage.
- Customization: Flexibly define risk categories and valuation cycles.
- Clear control: matrices and risk reports for comprehensive reporting.
- Rapid integration of measures: derive and link measures directly.
Effective audit management with roXtra audits
Audits are a central component of quality management in hospital groups. With roXtra Audits, you can optimize your audit processes and work independently of location and even offline.
The software supports you in auditing management systems in accordance with ISO 19011 and other relevant standards such as ISO 9001, ISO 13485, ISO 17025 or ISO 14001. You maintain an overview of past, current and planned audits and can specifically identify non-conformities and potential for improvement. Defined immediate, corrective and preventive measures can be documented directly in the context of the audit.
Your advantages with roXtra Audits:
- Efficiency and transparency: Document and initiate immediate, corrective and preventive measures directly in the context of the audit.
- Systematic implementation: Access your questionnaire from any location - even offline.
- Optimized planning: Maintain an overview of past, current and planned audits.
Action management for clinic groups
With roXtra measures, you can eliminate deviations, minimize risks and comply with standards such as ISO 13485. The software enables structured planning, implementation and tracking of immediate, corrective and preventive actions (CAPA).
Thanks to digital support, you can keep track of all measures, document them seamlessly and ensure compliance with regulatory requirements as well as continuous improvement in your hospital group.
Your advantages with roXtra measures:
- Central management: Clearly record and control all measures.
- Automatic effectiveness check: Sustainable implementation through planned checks.
- Simple evaluation: Filter lists of measures and export them as Excel, Word or PDF.
- Cross-module: Linking for consistent documentation.
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 wide range 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 the Healthcare Sector
- DIN EN 15224 Quality management systems for the health care sector
- ISO 7101 Quality management systems in healthcare - Requirements
- DIN EN ISO 13485 Medical devices Quality Management systems - Requirements for regulatory purposes
- Claims of the Federal Joint Committee (G-BA), the German Hospital Federation e.V. (Deutsche Krankenhausgesellschaft – DKG) as well as the German Nursing Council e.V. (DPR)
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 (CRITIS)
- 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
roXtra supports you with the following solutions:
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