Quality
Management systems, processes and documentation that genuinely improve patient care.
- ISO 9001, ISO 7101, PN-EN 15224
- Processes, indicators, documentation
- Ongoing system oversight
Areas of support
Three areas, one coherent system
Safety
Clinical risk, adverse events, data protection and business continuity.
- Risk management
- Adverse events
- Information, data and AI
Compliance
Accreditation, regulations and audits that confirm requirements are met.
- CMJ accreditation
- MDR i ISO 13485
- Audits and standards map
Accreditation and management systems
From gap analysis and a standards map, through implementation and training, to audits and ongoing oversight.
CMJ
Compliance
CMJ accreditation
Preparing healthcare providers for accreditation against the standards of the Centre for Quality Monitoring in Healthcare (CMJ), and helping them maintain the standards after the survey.
- Self-assessment against the standards, with a digital form and action plan
- An internal quality system in line with the Polish Act on Quality in Healthcare and Patient Safety
- Preparing teams and documentation for the accreditation survey
- Support in preparing for JCI accreditation
ISO 9001 | EN 15224Quality
Quality management system
- Implementation and certification: from gap analysis to the certification audit, including ISO 7101
- Ongoing QMS oversight: support for the quality representative, management reviews, objectives and indicators
- Documentation and processes: procedures, process mapping and metrics
- Digital support for the system: we select modern IT solutions to match each facility’s needs
ISO 14001Compliance
Environmental management system
- Implementing an environmental management system
- Emissions reporting and ESG requirements
- Sustainability policies
ISO 27001Safety
Information security management system
- Protecting medical records and hospital systems
- Rules for using AI tools and DPIA assessments
- GDPR and AI Act requirements
ISO 22301Safety
Business continuity management system
- Plans for outages, cyber incidents and mass-casualty events
- Business impact analysis for key processes
- Testing and exercising continuity plans
ISO 45001Safety
Occupational health and safety management system
- Implementing an occupational health and safety system to ISO 45001
- Occupational risk assessment
- Safety training for clinical teams
ISO 13485Compliance
Medical device quality management system
- MDR and IVDR requirements
- Documentation for organisations working with medical devices
- Supplier audits (to ISO 19011)
Across all areas
- Risk management ISO 31000, ISO 14971
- Adverse events reporting, root cause analysis, corrective actions
- Audits internal and supplier audits, preparation for external audits
- Compliance map the facility’s standards and requirements with implementation status
- Training internal auditor, quality management, standards
Example cooperation model
Four stages, from diagnosis to continual improvement
- 01
Diagnosis
Gap analysis, a standards map for the facility, interviews with the team and a document review.
- 02
Design
Implementation plan, schedule, allocation of responsibilities and choice of tools.
- 03
Implementation
Documentation, training, tool configuration and trial audits.
- 04
Oversight and improvement
Management reviews, indicators, periodic audits and updates.
Certification, accreditation survey and software licence fees are settled separately, directly with the body or supplier. We also help link quality and IT projects to funding calls under Poland’s Recovery and Resilience Plan (KPO), EU Funds and the Medical Fund.