Quality Management System
Maintain quality and competence in your medical laboratory, meeting ISO 15189 requirements efficiently.
A state-of-the-art quality management software for medical labs
KaliLab is the quality management software that helps medical laboratories worldwide meet the ISO 15189 requirements.
ISO 15189 accreditation is a mark of quality internationally recognized that all medical laboratories aiming at meeting the highest quality standards are striving to achieve.
Using KaliLab to meet the requirements of ISO 15189, instead of relying on manual and paper-based processes, provides guidance throughout the entire accreditation process and saves time and effort, managing and rationalizing the processes required to maintain the accreditation.
A complete set of capabilities to help you meet the ISO 15189 requirements:
Key Benefits
- Boosts and accelerates laboratory accreditation to ISO15189
- Optimizes quality management in accordance with the Standard in each of its phases: pre-analytical, analytical and post-analytical
- Modular software that facilitates a scalable implementation
- Provides guidance throughout the entire accreditation process
- Saves time and effort, vs paper-based processes
- Enables to manage and streamline the processes required to maintain the accreditation
- Proven solution, implemented in more than 3,000 laboratories around the world
Key features
- Interconnected modules
- Document management
- Quality management
- Equipment management
- Human resources management
- Stock and order management
- Traceability of each action carried out in the software
- Interfaces with
- Temperature management softwares
- Quality sheets recording softwares (LIS)
- Economic & Financial management softwares (hospitals)
Product Information
FAQs
ISO 15189 is an internationally recognised standard that defines quality and competence requirements for medical laboratories. It ensures that labs deliver reliable, valid results while meeting regulatory and accreditation expectations. Compliance with this standard is essential for improving patient safety and maintaining trust.
Dedalus offers KaliLab, a comprehensive digital Quality Management System (QMS) designed to align with ISO 15189 requirements. KaliLab helps laboratories manage documentation, equipment, human resources, stock, audits, and training, enabling full traceability and streamlined compliance processes across all laboratory phases.
A laboratory QMS typically includes interconnected modules for:
- Document control
- Risk and incident management
- Training and competency tracking
- Equipment and resource monitoring
- Internal audits and continuous improvement
- Stock and order management
Yes. KaliLab is modular and highly scalable, making it suitable for laboratories of any size or type — from public hospital labs to private diagnostic centres and research facilities. It allows custom workflows and role-based access to match specific organisational structures.
Digitising QMS with KaliLab:
- Increases traceability of actions and decisions
- Reduces manual errors and administrative burden
- Improves audit readiness and accreditation performance
- Facilitates real-time monitoring of compliance metrics
- Enhances collaboration across teams and departments
Yes. KaliLab integrates with Laboratory Information Systems (LIS), temperature management tools, quality recording software, and hospital ERP platforms for economic and financial management. This ensures seamless data exchange and centralised quality oversight.
It is possible to request a product demonstration or receive support by filling out the “Contact Us” form on this page or by contacting your Dedalus sales representative.
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