The QM software for the
healthcare sector
The QM solution for the healthcare sector
success stories
Find out first-hand how our customers use roXtra to make their quality management efficient, compliant and future-proof. Whether ISO 9001, KTQ or comprehensive risk management - roXtra offers customized solutions for the specific requirements of QM software in the healthcare sector.
Our blog provides you with valuable insights into accreditation and re-accreditation, the practical implementation of quality management in clinics as well as best practices and application examples from the industry.
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One software, many application areas.
Efficient quality management
With roXtra document control, you can maintain an overview of your document control system in the hospital - from creation to archiving, locally and regardless of location. Regardless of whether you are in the hospital area, the institute, the medical care center (MVZ) or in the office, with roXtra you and your employees always have access to the valid version of your documents.
The review and approval of new and revised work and process instructions, for example, is structured, comprehensible and transparent. During certification, you can quickly and easily provide your auditor with an overview of all relevant documents and structured quality reports, including important meta information (e.g. resubmission date, status and revision).
Digitally control and optimize healthcare processes
Optimize and automate your process management with the roXtra Processes module and bring your applications and forms "to life" digitally. From vacation requests, CAPA notifications and quality assurance to change management, complaint management and the implementation of continuous improvement measures - you can easily map your individual forms and processes.
To illustrate your processes, for example in the form of flowcharts, we offer you the Flowchart Designer, the ideal alternative to visualization programs such as Microsoft Visio. Create clear graphics to illustrate, for example, the structure of your EFQM model or critical control points that require special attention with regard to patient safety.
Structured risk management for clinics
With roXtra Risks, you can reduce the amount of work required for your cross-company risk management. Identify and manage potential risks centrally for an effective, qualitative risk analysis in your hospital. roXtra supports the current standards and regulations (e.g. ISO 31000 or ONR 49001, ISO 15224, ISO 9001 and ISO 27001 / IEC 8001).
In healthcare, patient safety is the top priority. Risks cannot be completely eliminated - but effective risk management supports the avoidance, reduction, optimization and transfer of risks. Many regulations therefore require a risk management system to support ongoing operations. In this way, you can prevent and avoid clinical risks (e.g. inadequate hygiene, mistaken procedures, incorrect diagnoses, etc.) as well as non-clinical, business risks (e.g. the loss of customers and thus a financial risk) in the future.
Professionally managing audits in the healthcare sector
Audits are an essential part of your work as a quality manager and internal auditor?
Systematic audit management is your most powerful tool as an auditor!
Increase the effectiveness and quality of your own work with the roXtra Audits module. The software supports you in auditing management systems according to the specifications such as those of ISO 19011.
Thanks to roXtra Audits, you work with a system and access the questionnaire for conducting audits regardless of location, even offline. In this way, you increase internal efficiency and diligence when conducting audits. At the same time, your team and you gain an overview of the status of past, current or pre-planned audits.
Focus on identifying internal nonconformities and areas for improvement. Defined immediate, corrective and preventive actions are documented and started directly in the context of the audit. No matter whether DIN EN ISO 9001, ISO 13485, DIN EN ISO/IEC 17025 or ISO 14001: roXtra helps you to meet the various requirements of current standards with flying colors in order to do a really good job.
Action management in clinics
Effective action management with roXtra measures is essential in hospitals to eliminate deviations, minimize risks and meet the requirements of standards such as ISO 9001, DIN EN 15224 and ISO 31000. With a structured approach, immediate, corrective and preventive actions (CAPA) can be efficiently planned, implemented and tracked.
A digitally supported system ensures complete documentation and transparent monitoring of all measures, thereby increasing patient safety, promoting continuous improvement and ensuring compliance with legal and regulatory requirements.
Your advantages with roXtra measures:
- Cross-module: Linking for consistent documentation.
- 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.
Support for quality management and certification in clinics
Our software solutions support you in daily system operation as well as during certification and re-certification of your Quality Management system. With roXtra, the implementation of a multitude of standards and regulations becomes a breeze.
Quality management standards
- DIN EN ISO 9000 and DIN EN ISO 9001 Quality Management systems - Requirements
- 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
Risk management standards
- DIN EN ISO 31000 - Guidelines for risk management
- ONR 49000 / ONR 49001 - Austrian risk management standard
- IEC 80001 standard for risk management in networked medical technology
- Section 91 (2) AktG - Establishment of a risk management system (RMS) for listed companies
Information security management
- ISO 27001 - Information Security Management System (ISMS) / IT Security
Specific guidelines and laws
- Requirements for operators of critical infrastructures (CRITIS)
- Claims of the Federal Joint Committee (G-BA), the German Hospital Federation e.V. (Deutsche Krankenhausgesellschaft – DKG), the German Accreditation Body GmbH (DAkkS), the German Nursing Council e.V. (DPR) as well as the Initiative Quality Medicine (IQM)
- KonTraG - Law on Control and Transparency in the Corporate Sector (Corporate Governance)
roXtra supports you with the following solutions:
Quality management software in hospitals
A hospital is a healthcare center where patients trust that all processes will run smoothly and that medical care will be provided optimally. In order to guarantee this patient orientation and safety as well as a high quality of treatment, reliable quality management (QM) tailored to internal hospital processes is essential. QM in healthcare is an ongoing process that requires systematic and continuous evaluation. It serves to improve the quality of products and services and helps to achieve better results.
The solution: roXtra as QM software for clinics.
We configure the system specifically to your requirements, allowing you to implement your corporate design as well as regulatory and technical requirements. Maintain an overview thanks to your individual folder structure or display the documents according to standard structures (e.g. KTQ, ISO 9001, ISO 7101, DIN EN 15224, Onkozert and DIN 6870) at the click of a mouse. The QM software for clinics also meets the requirements of the GxP-regulated environment. 🗎Here you will find an overview of how the criteria of the EU-EMP guidelines (Annex 11) and the guidelines of the German Medical Association (Rili-BÄK), for example, are implemented. The focus here is clearly on patient safety. We are also happy to support you with implementation, validation, certification and throughout the entire system operation.
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