Contents
Introduction
This guide supports POCT services in aligning with ISO 15189:2022 requirements. The 2022 edition incorporates ISO 22870 for POCT, emphasises risk management, and offers greater flexibility in documentation.
Tailored to NHS workflows and UKAS accreditation, this page provides clause breakdowns, interactive tools and case studies to prepare for assessments.
- Explore key clauses and POCT duties
- Track progress with interactive checklists
- Learn from NHS case studies and examples
History of ISO 15189
POCT Accreditation Readiness Timeline
View timeline
Step 1: Gap Analysis (2–4 weeks)
Assess your current processes against ISO 15189:2022. Identify gaps in governance, training, verification and record keeping.
Step 2: Governance Setup (3–6 weeks)
Establish a formal POCT committee, appoint a POCT coordinator and integrate POCT into your QMS.
Step 3: Training Rollout (4–8 weeks)
Create device-specific training modules and schedule competency assessments.
Step 4: Method Verification (4–6 weeks)
Verify each POCT method to ensure accuracy and precision in your environment.
Step 5: QC & EQA Programs (2–3 weeks)
Implement QC routines and enroll in EQA schemes. Monitor results centrally.
Step 6: Data Management (2–4 weeks)
Ensure result traceability. Use middleware or manual logs if needed.
Step 7: Internal Audit (2 weeks)
Schedule audits to confirm conformance with ISO 15189. Address non-conformities.
Step 8: Apply for Accreditation (4–6 weeks)
When you are confident in compliance, apply to UKAS or your relevant body.
Step 9: UKAS Surveillance & Ongoing Review (yearly)
Maintain compliance through regular surveillance visits and continual improvement activities.
Glossary
Accreditation
Formal recognition that a laboratory is competent to carry out specific tests.
Analytical Measurement Range (AMR)
The span over which a test can accurately measure an analyte without dilution.
Calibration
Comparison of an instrument against a standard to check accuracy.
CAPA
Corrective and Preventive Action to address issues and prevent recurrence.
Conformity Assessment
Process of demonstrating that requirements are met.
Delta Check
Comparing current results with previous ones to detect anomalies.
EQA
External Quality Assessment – participation in a scheme to compare results with other labs.
FMEA
Failure Mode and Effects Analysis for proactive risk evaluation.
Internal Audit
A process of checking that quality procedures are being followed.
LIS
Laboratory Information System used to manage results.
Lot-to-Lot Verification
Confirming consistency across different reagent or device lots.
Matrix Effect
Interference in assay performance due to specimen components.
Middleware
Software linking POCT devices to hospital systems.
Nonconformity
Failure to meet a requirement of the standard or procedure.
Patient-Based Quality Control (PBQC)
Monitoring analytical performance using patient data trends.
POCT Champion
A staff member supporting POCT users in a particular area.
Quality Indicator
A measurable element of practice performance used to assess quality.
Root Cause
The underlying reason for a nonconformity.
Surveillance Visit
Periodic assessment by the accreditation body to verify ongoing compliance.
Traceability
Ability to trace the history, application or location of what is under consideration.
Verification
Confirmation that a device meets specified requirements in your environment.
Verification vs. Validation
Verification ensures fitness for use; validation confirms regulatory compliance.
Regulatory Bodies
| Organization | Role | Key Links |
|---|---|---|
| UKAS | Accreditation body for the UK | ukas.com |
| MHRA | Medical device regulation | gov.uk/mhra |
| CLSI | Laboratory practice standards | clsi.org |
| WHO | International health guidance | who.int |
Resources
View links
Standards & Regulations
- ISO 15189:2022 Official Page – official requirements
- ISO 22870:2016 POCT Standard
- UKAS Publications
Clinical Guidelines
EQA Providers
Quick Quiz: Test Your ISO 15189 Knowledge
- Which standard was incorporated into ISO 15189:2022 to cover POCT?
A. ISO 22870:2016 B. ISO 17025:2017 C. CLIA ’88 D. ISO 9001:2015Answer
A. ISO 22870:2016 was integrated into ISO 15189:2022 so that POCT is now fully covered.
- True or False: Each POCT method should participate in an External Quality Assessment program.
Answer
True. Regular proficiency testing demonstrates that POCT results match those of other accredited labs.
- ISO 15189:2022 puts increased emphasis on which of the following?
A. Risk management and POCT oversight
B. Eliminating quality control checks
C. Reducing staff training requirements
D. Minimizing documentation needsAnswer
A. The standard is more risk-based and explicitly includes POCT.
- Before using a new POCT device for patient samples, what must be done?
A. Use it immediately if it’s CE-marked
B. Verify or validate its performance in your setting
C. Only install it – no further checks
D. Nothing specialAnswer
B. Verification ensures the device provides accurate results in your environment.
- What is metrological traceability?
Answer
The property of a measurement to be related to national or international standards through an unbroken chain of calibrations.
- How often should competency be assessed?
Answer
At least annually or according to local policy.
- Why are EQA schemes important?
Answer
They demonstrate that POCT results are comparable with other laboratories.
- When should management review occur?
Answer
Typically annually, but more frequently if issues arise.
- What is a corrective action?
Answer
An action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
- What document outlines responsibilities between a ward and the laboratory?
Answer
A POCT service agreement.
- Why is traceability important?
Answer
It ensures that results can be linked back to devices, reagents and operators.
- Give an example of a quality indicator for POCT.
Answer
Turnaround time or number of QC failures.
- Who is typically responsible for reviewing POCT performance?
Answer
The POCT committee and lab management.
- How can connectivity improve patient safety?
Answer
Automatic result transfer reduces transcription errors and delays.
FAQ
Do we need a separate quality manual?
ISO 15189:2022 no longer requires a single quality manual but you must document your quality management system.
How often should we run QC?
QC frequency depends on test volume, analyte stability, device risk and manufacturer guidance. High-risk or high-volume testing may require QC each shift, while low-risk assays can be monitored daily or weekly if justified.
Who reviews EQA data?
A qualified person, such as the POCT coordinator, must review results and implement corrective actions if needed.
What is a POCT coordinator?
An individual responsible for overseeing POCT operations, training and quality assurance.
How do we store control materials?
Follow manufacturer instructions and monitor storage temperatures.
Can POCT devices connect to the LIS?
Yes, many modern devices support connectivity via middleware, allowing automatic result upload.
Is remote training effective?
Remote modules can complement face-to-face training but should include competency checks.
How long should we keep records?
Retention times vary; keep QC and maintenance records according to national regulations, often at least two years.
QC Frequency Estimator
Calculate quality control intervals based on your workload and risk profile using our online adviser.
ISO 15189 requires QC frequency to be justified. Guidance: Westgard QC, IFCC 2025, SIPMeL Q19.
Detailed Clause Breakdown
Clause 4 – General Requirements
This clause covers impartiality and confidentiality. POCT Perspective: ward staff may feel pressured for rapid results, so clear policies protect integrity.
- Establish impartiality policies.
- Train operators on confidentiality.
- Use secure data systems.
| Action | Responsible Staff | Evidence |
|---|---|---|
| Issue conflict-of-interest forms | Quality Manager | Signed forms |
| Audit confidentiality training | POCT Lead | Training records |
| Check data access rights | IT Support | Access logs |
Clause 5 – Structural Requirements
Defines responsibilities, organizational structure and resource management. POCT Perspective: decentralized testing sites must be linked into the laboratory quality system.
- Maintain an up-to-date organogram.
- Ensure sufficient staffing levels.
- Provide ongoing professional development.
| Action | Responsible Staff | Evidence |
|---|---|---|
| Create POCT committee charter | Lab Director | Charter document |
| Assign device superusers | POCT Coordinator | Role descriptions |
| Review staffing at each site | Service Manager | Staffing plan |
Clause 6 – Resource Requirements
Covers personnel, equipment, facilities and environmental conditions. POCT Perspective: many locations may store consumables and devices so inventory control is vital.
- Document qualifications for each role.
- Calibrate environmental monitoring devices.
- Maintain clean testing areas.
| Action | Responsible Staff | Evidence |
|---|---|---|
| Maintain asset register | POCT Administrator | Inventory list |
| Log fridge temperatures | Nursing Staff | Temp logs |
| Perform device maintenance | Biomedical Scientist | Service records |
Clause 7 – Process Requirements
Addresses pre-analytical, analytical and post-analytical processes. POCT Perspective: clear workflows ensure bedside testing matches laboratory quality.
- Verify sample identification and labelling.
- Check reagent expiry dates.
- Record results accurately in the LIS.
| Action | Responsible Staff | Evidence |
|---|---|---|
| Use patient ID checks | Ward Staff | Sample logs |
| Maintain reagent inventory | POCT Coordinator | Expiry log |
| Upload results electronically | IT Support | LIS audit trail |
Measurement Uncertainty in POCT
Measurement uncertainty (MU) expresses how confident we are in a result. Even small errors can affect immediate treatment decisions at the bedside.
Why it matters:
- Required by ISO 15189:2022 Clause 7.6
- Supports risk assessments and verification studies
- Helps clinicians interpret results near decision limits
- Improves comparability between devices and sites
How to Estimate MU
- Use internal QC data for repeatability.
- Assess reproducibility with EQA or multi-operator checks.
- Estimate bias using reference methods.
- Calculate combined uncertainty:
uc = √(repeatability² + bias²) - Apply coverage factor (k=2) for 95% confidence:
U = uc × k
Example: SD=0.2, Bias=0.1 ⇒ uc=0.224, U≈0.45. Report as “5.6 mmol/L ±0.45”.
See Westgard guidance and IFCC MU documents for more detail.
Clause 8 – Management System Requirements
Focuses on quality management, documentation and continual improvement. POCT Perspective: management should regularly review ward performance data.
- Implement corrective and preventive action (CAPA) procedures.
- Hold regular management review meetings.
- Monitor quality indicators for POCT.
| Action | Responsible Staff | Evidence |
|---|---|---|
| Track nonconformities | Quality Manager | CAPA logs |
| Review KPIs quarterly | POCT Committee | Meeting minutes |
| Update policies | POCT Lead | Document register |
Clause 8.3 – Document Control
POCT procedures must be kept up to date and readily available at testing sites.
- Version control for SOPs.
- Remove obsolete instructions from circulation.
- Use electronic document management where possible.
| Action | Responsible Staff | Evidence |
|---|---|---|
| Review SOPs annually | POCT Lead | Review logs |
| Archive old documents | Quality Officer | Archive index |
| Publish updates online | IT Support | Document portal |
Clause 8.5 – Improvement
Organizations should continually improve the POCT service using feedback and audit findings.
- Collect user feedback after training.
- Track corrective actions to completion.
- Share lessons learned in staff meetings.
| Action | Responsible Staff | Evidence |
|---|---|---|
| Issue satisfaction surveys | POCT Coordinator | Survey summaries |
| Monitor CAPA effectiveness | Quality Manager | CAPA reports |
| Update improvement log | Management | Meeting records |
More Case Studies
Case Study 1: Improving Turnaround Time
Problem: Slow reporting from the laboratory delayed care in the emergency department.
Action: Introduced blood gas analyzers connected to the LIS.
Outcome: Turnaround time dropped from 20 min to under 5 min.
Case Study 2: Community Clinic Success
Problem: Difficulties distinguishing bacterial from viral infections.
Action: Deployed rapid CRP testing and trained nurses.
Outcome: Reduced unnecessary antibiotics.
Case Study: Improving POCT Governance
Problem: Lack of oversight of QC and training.
Action: Implemented a POCT dashboard for real-time monitoring.
Outcome: QC failures fell by 30% and accreditation achieved quicker.
Case Study 3: Data Management Overhaul
Problem: Manual transcription errors complicated audits.
Action: Adopted middleware to capture results automatically.
Outcome: Traceability improved and audits became easier.
Case Study 4: Rural Outreach Program
Problem: Limited access to testing in remote communities.
Action: Mobile clinics equipped with portable analyzers.
Outcome: Earlier detection of chronic diseases.
Case Study: NHS Training and Audit Success
Problem: Inconsistent operator competency records.
Action: Revamped training program and audit schedule.
Outcome: Compliance scores rose 15% with more confident staff.
Case Study: Traceability Failure Resolved
Problem: Reagent lot numbers were missing during accreditation.
Action: Introduced barcode scanning and routine checks.
Outcome: Full traceability satisfied assessors.
Case Study: HbA1c Testing in GP Surgeries
Problem: High rate of sample rejection and repeat testing.
Action: Introduced operator training, daily QC checks and LIS integration.
Outcome: 43% reduction in invalid tests within 3 months.
Case Study: ICU VBG Traceability
Problem: Manual entry of VBG results caused data loss.
Action: Implemented barcode readers and direct middleware upload.
Outcome: 100% traceability and compliance on audit.
Top 10 Mistakes in POCT Accreditation
- Poor documentation control leading to outdated SOPs.
- Insufficient training or competency checks for operators.
- Missing traceability of results to devices and reagents.
- Failure to investigate QC failures promptly.
- Lack of regular management review meetings.
- Inadequate method verification before clinical use.
- Neglecting participation in EQA schemes.
- Unclear roles and responsibilities within the POCT team.
- Inconsistent maintenance and calibration records.
- Overlooking risk assessments for new devices or locations.
Common POCT Nonconformities
Incomplete device verification reports
Ensure each new device has documented precision, accuracy and range studies.
Unrecorded QC failures or absence of CAPA
QC failures must be logged and investigated with corrective and preventive actions.
SOPs not version-controlled
Use a document register and remove obsolete procedures from circulation.
Untrained operators using devices
Maintain competency records and restrict access until training is complete.
EQA not reviewed or acted on
Document review of external quality assessment results and follow up on poor performance.
References
- International Organization for Standardization. ISO 15189:2022 Medical laboratories – Requirements for quality and competence.
- WHO Laboratory Quality Management System Handbook.
- UKAS Publication LAB 15 – Application of ISO 15189.
- RCPath Guidance on POCT Governance.
Risk Management
Risk management should be embedded in the POCT program. Techniques such as FMEA (Failure Mode and Effects Analysis) help identify potential failures before they affect patients.
Data Integrity
Electronic records must be secure and traceable. Audit trails should show who made changes and when. Use role-based access to limit editing rights.
Staff Engagement
Regular meetings with POCT users encourage feedback and highlight training needs. Consider appointing ward-based POCT champions.
Clause Reference Table
| Clause | Topic | POCT Focus | Example Evidence |
|---|---|---|---|
| 4 | Impartiality & confidentiality | User access controls | Signed COI forms |
| 5 | Structure & responsibilities | POCT committee charter | Organization chart |
| 6 | Resources | Training matrices | Competency files |
| 7 | Process requirements | Device verification | Validation reports |
| 8 | Management system | CAPA records | Quality meeting minutes |
| 8.3 | Document control | Versioned SOPs | Document register |
| 8.5 | Improvement | Tracking CAPA | Improvement log |
Best Practices for POCT
- Document corrective actions and monitor their effectiveness.
- Participate in EQA schemes for every POCT method.
- Monitor quality indicators like turnaround time and QC failure rate.
- Validate LIS/middleware auto-upload after firmware updates.
- Document backup QC procedures for LIS or device outages.
- Use delta checks or patient-based QC in critical care.
- Schedule quarterly POCT governance meetings across clinical teams.
- Plan for regular review of risk assessments as new devices appear.
- Maintain an up-to-date inventory of devices and reagents.
- Schedule routine refresher training and include ward champions.
- Use middleware to reduce manual transcription of results.
- Integrate POCT policy into the laboratory quality manual.
- Engage clinical staff in quality meetings to review POCT performance.
- Use dashboards to visualize training status and QC trends.
- Share lessons learned from errors across all departments.
- Appoint dedicated POCT coordinators for high-use areas.
Technological advancements are rapidly changing the POCT landscape. Miniaturized biosensors, connectivity and data analytics will enable faster and more reliable results. Laboratories must stay informed about emerging technologies and evaluate them for accuracy, usability and integration with existing systems.
Artificial intelligence may assist in result interpretation, while smartphone-based devices could expand access in remote areas. However, maintaining quality and regulatory compliance remains essential.
Device Verification Checklist
| Task | Status | Notes |
|---|---|---|
| Review manufacturer documentation | ||
| Perform precision studies | ||
| Compare accuracy with reference method | ||
| Assess reportable range | ||
| Document environmental requirements | ||
| Train operators on verification protocol | ||
| Compile verification report |
Feedback
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Closing Thoughts
ISO 15189:2022 sets a high bar for POCT services. By following the guidance on this page and embracing interactive tools, organizations can enhance patient care and achieve lasting quality improvements.
Stay informed, stay compliant, and keep innovating.