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Posted on 10 Dec,2025
Although ISO/IEC 17025 hasn’t been revised since 2017, this version introduced several important changes compared to the older 2005 edition—and these remain the current reference for most accreditation bodies. Here are the key changes:
1. Scope Expansion
o The 2017 version explicitly covers sampling in addition to testing and calibration.
o This means labs doing sampling (before testing or calibration) must also satisfy relevant competence requirements.
2. Risk-Based Thinking
o Introduces the concept of risk-based thinking into the management system.
o Labs are expected to identify and address risks and opportunities that could affect conformity of results.
3. Process Approach
o The standard aligns more with modern management system standards (like ISO 9001) by adopting a process-based structure.
o Emphasis shifts from rigidly defining every task to focusing on process outcomes.
4. Stronger IT / Digital Focus
o Recognizes the use of computer systems, electronic records, and electronic reporting.
o Labs must ensure integrity, security, and traceability of electronic data.
5. Updated Terminology
o Terminology is aligned with the International Vocabulary of Metrology (VIM) and ISO/IEC conformity assessment terms.
o This helps harmonize communication between labs, assessors, and accreditation bodies.
6. Re-structured Standard
o The standard's structure has been redesigned to align with other ISO and conformity assessment standards (e.g., ISO 9001, ISO/IEC 17000 series).
o Makes it easier for labs that have multiple accreditations or certifications to integrate systems.
ISO 15189 was revised more recently (2022), and these changes are quite significant, especially from the perspective of accreditation bodies evaluating medical labs. Here are the most important updates:
1. New Edition & Transition Timeline
o ISO 15189:2022 replaces ISO 15189:2012.
o Many accreditation bodies (via ILAC) require labs to transition by December 2025.
2. Alignment with ISO/IEC 17025 & ISO 9001
o The structure of ISO 15189:2022 is much more aligned with ISO/IEC 17025:2017 and ISO 9001.
o This helps in harmonizing management systems across different types of labs (clinical + testing).
3. Risk-Based Approach
o There’s a stronger and more explicit emphasis on risk management, particularly related to patient safety.
o Laboratories are expected to identify, assess, and act on risks that could affect test results, patient wellbeing, or lab operations.
4. Point-of-Care Testing (POCT) Integration
o Requirements that were earlier in a separate standard (ISO 22870:2016) for POCT are now incorporated directly into ISO 15189:2022.
o This means labs that do POCT no longer need separate accreditation just for ISO 22870 — they must comply under ISO 15189:2022.
5. Less Prescriptive Language / More Flexibility
o The standard uses less rigid / more flexible language, giving labs some freedom in how they meet requirements.
o Rather than mandating a “quality manual,” it allows documentation in formats that suit the lab (even without a single manual).
6. Stronger Focus on Patient Safety & Quality Outcomes
o More explicit requirement that labs consider patient risk in all processes.
o Encourages continuous improvement in terms of patient care, not just technical performance.
7. Aligned with Other Clinical Standards
o References other relevant ISO standards: risk management aligned with ISO 22367, sample collection / transport aligned with ISO 20658, and safety aligned with ISO 15190.
o This cross-reference helps labs build a more integrated and coherent quality system.
8. Transition & Accreditation Implications
o Accreditation bodies are already assessing labs against the new standard in transition assessments.
o If labs don’t transition by the deadline, they may lose recognition under international mutual recognition arrangements (like ILAC MRA).
· Stronger Technical Risk Evaluation: With risk-based thinking, assessors need to evaluate how labs identify and mitigate risks related to quality, data integrity, and (for clinical labs) patient safety.
· Digital Systems Assessment: Because the standards explicitly mention electronic records and computer systems, accreditation assessors must be competent to audit digital workflows, data security, and traceability.
· Harmonized Audit Structure: Aligning ISO 15189 with ISO 17025 / ISO 9001 makes it easier for ABs that accredit both medical and test/calibration labs to streamline assessments.
· POCT Inclusion: For labs doing point-of-care testing, ABs will need to check POCT processes as part of 15189 audits — this changes the accreditation scope.
· Flexibility in Documentation: Less-prescriptive documentation means ABs must pay more attention to how labs demonstrate compliance, not just check fixed documents.
· Transition Risk: ABs must manage and monitor the transition of existing accredited labs to the new ISO 15189:2022 standard, including nonconformities, timelines, and scope updates.
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