ISO 15189:2022 vs ISO 15189:2012 — Key Changes Every Lab Must Know
ISO 15189:2022 represents the most significant revision of the medical laboratory quality standard in a decade. If your lab holds NABL accreditation under ISO 15189:2012, you are required to transition to the 2022 version.
ISO 15189:2022 represents the most significant revision of the medical laboratory quality standard in a decade. If your lab holds NABL accreditation under ISO 15189:2012, you are required to transition to the 2022 version.
The new standard was published in December 2022 and NABL has begun requiring all newly accredited and re-accredited laboratories to comply with ISO 15189:2022. Labs accredited under the 2012 version have a transition period, but the clock is ticking.
Top 10 Key Changes in ISO 15189:2022
1. Risk-Based Thinking is Now Central
ISO 15189:2022 places risk management at the heart of the QMS. Labs must now formally identify risks and opportunities across all processes — from sample collection to result reporting — and document mitigation actions.
2. Impartiality Requirements Are Explicit
The 2022 version adds a dedicated clause (Clause 4.1) on impartiality, requiring labs to identify threats to impartiality (e.g., commercial pressure, financial relationships) and implement safeguards.
3. Patient-Focused Approach
ISO 15189:2022 introduces stronger requirements for patient involvement, including provisions for patients to have access to their own examination results and the right to request information about the laboratory’s processes.
4. Expanded Competency Requirements
The competency framework is more rigorous. Labs must demonstrate competency not just at initial hire but at regular intervals, with documented assessment methods including observation of work performance, review of test results, and proficiency testing.
5. Digital / Point-of-Care Testing (POCT) Included
The 2022 standard explicitly addresses point-of-care testing and near-patient testing, which were not covered in the 2012 version.
6. Measurement Uncertainty — Stronger Requirements
The approach to measurement uncertainty is more prescriptive. Labs must calculate and report expanded uncertainty for all quantitative tests.
7. Information Management System (LIS/LIMS) Requirements
There are enhanced requirements for laboratory information systems, including validation requirements, data integrity, and cybersecurity considerations.
8. Supplier and Referral Lab Management
The 2022 version has clearer requirements for monitoring the performance of external suppliers and referral laboratories, including criteria for selection and ongoing evaluation.
9. Feedback and Complaint Handling
The standard now requires a more structured approach to patient and user feedback, with linkage to the corrective action process.
10. Post-Examination Processes
Stronger requirements for result review, critical value notification, result release, and retention of examination material.
How to Transition to ISO 15189:2022
- Conduct a gap analysis between your current QMS and the new requirements
- Update your Quality Manual to reflect the 2022 structure
- Revise affected SOPs (particularly risk management, impartiality, competency assessment)
- Train all staff on the key changes
- Conduct an internal audit against ISO 15189:2022
- Apply to NABL for reassessment under the new standard
Ease Care Consultancy specialises in ISO 15189:2022 transition support. Contact our team for a free gap assessment.
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