Posted on 10 Dec,2025
Latest Changes in ISO/IEC 17025 & ISO 15189 Standards
What’s New in ISO/IEC 17025 (2017)
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.
What’s New in ISO 15189:2022 (Medical
Laboratories)
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).
Why These Changes Matter for Accreditation
Bodies
·
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.