ISO 15189:2022
ISO 15189 is the international standard specifying requirements for quality and competence in medical laboratories. The 2022 edition introduced significant updates, including stronger patient-focused requirements and a revised quality management framework. It is the most widely recognised medical laboratory accreditation standard in the world.
For African laboratories, ISO 15189 accreditation opens doors to international partnerships, government procurement, and patient confidence. It demonstrates that your laboratory produces accurate, reliable results consistently, regardless of volume or complexity.
How Elmenta supports you
- Gap analysis against ISO 15189:2022 clauses
- Quality Manual and documentation development
- Staff training on QMS principles and SOPs
- Method validation and QC programme setup
- Internal audit cycle, minimum one full cycle
- Management review and CAPA demonstration
- Mock audit and findings remediation
- Accreditation body application and submission
- On-site assessment and corrective responses
College of American Pathologists
CAP accreditation is one of the most globally recognised marks of laboratory excellence. Built on a comprehensive checklist system developed by pathologists and laboratory scientists, it demonstrates that your laboratory meets the highest standards of accuracy, reliability and patient safety.
CAP-accredited laboratories are recognised by international health organisations, research institutions and insurance bodies worldwide. For African laboratories with regional or international ambitions, CAP accreditation is a powerful signal of quality and technical competence.
How Elmenta supports you
- CAP checklist selection for your laboratory type
- Gap analysis against applicable checklist items
- Documentation and SOP development
- Proficiency testing enrollment and participation
- Personnel records and competency assessment
- Mock inspection using CAP checklist format
- Inspector visit preparation and staff coaching
- Corrective action response and follow-up
Joint Commission (TJC)
The Joint Commission and Joint Commission International set rigorous standards for laboratory services within hospital and clinical settings. TJC accreditation covers pre-analytical, analytical and post-analytical processes, with a strong emphasis on patient safety and continuous quality improvement.
Hospital laboratories seeking TJC or JCI accreditation must demonstrate integrated quality systems that align with the wider hospital framework. Our consultants understand both the laboratory and the clinical context, so your lab contributes to and benefits from the full institutional accreditation.
How Elmenta supports you
- Laboratory chapter review against TJC standards
- Integration with the hospital-wide quality programme
- Tracer methodology preparation
- Staff interview and survey readiness training
- Document review and policy alignment
- Mock survey using tracer patient methodology
- Corrective action plan and evidence preparation
ISO manuals and supporting documentation
Every engagement leaves your laboratory with a complete, audit-ready document set, written to be used by your team rather than filed away for the assessor.
- ISO 9001 Quality Manual
- ISO 15189 Quality Manual
- ISO 22735 Documentation
- Procedure Manuals
- Safety Manuals
- IQCPs
- Standard Operating Procedures (SOPs)
- Training Plans
- Staffing Plans
- POCT Programme Policy
- Delegation Matrix
- Quality Improvement Plans