ISO 15189:2022 Consultant — Transition and New Accreditation
ISO 15189:2022 is the current standard for medical laboratory quality and competence. Whether you are transitioning from ISO 15189:2012 or seeking first-time accreditation, Ease Care Consultancy provides expert, doctor-led support.
Key Changes in ISO 15189:2022
- Risk-based thinking now central to QMS
- Stronger impartiality requirements
- Expanded competency framework
- Point-of-care testing explicitly covered
- Enhanced measurement uncertainty requirements
- Digital/LIS requirements formalised
Our ISO 15189:2022 Transition Service
We conduct a comprehensive gap analysis between your current QMS and ISO 15189:2022, update your documentation, retrain your staff on the new requirements, and support you through the NABL transition assessment.