The accreditation standard for proficiency testing providers — organisations running the interlaboratory comparison schemes that accredited laboratories across the UAE and Saudi Arabia depend on to demonstrate ongoing analytical competence.
ISO/IEC 17043:2023 specifies requirements for the competence of proficiency testing providers. Proficiency testing (PT) — called external quality assessment (EQA) in clinical laboratory medicine — is the mechanism by which laboratories are evaluated through interlaboratory comparisons. PT providers design, organise, and report on schemes where multiple laboratories analyse the same test items, with results assessed against assigned values and statistical criteria. As the UAE and Saudi Arabia's laboratory accreditation infrastructure expands, the demand for regionally based, ISO/IEC 17043-accredited PT providers is growing significantly.
ESMA, DAC, and SAAC all require that ISO 17025 and ISO 15189-accredited laboratories participate in proficiency testing from ISO/IEC 17043-accredited providers. Without accredited regional providers, UAE and Saudi laboratories must use expensive international PT schemes — creating both cost and logistical challenges for specialised matrices relevant to the region.
Regulatory and Legal Compliance — UAE
| Regulatory Framework | How This Standard Applies |
|---|---|
| ESMA Accreditation Requirements for PT | ESMA-accredited laboratories must participate in PT from ESMA-recognised or ILAC MRA-signatory accredited providers |
| DAC Laboratory Accreditation Requirements | DAC-accredited ISO 17025 and ISO 15189 laboratories must demonstrate EQA/PT participation from accredited providers |
| DHA (Dubai Health Authority) Clinical Laboratory Requirements | DHA-licensed medical laboratories must participate in EQA through appropriate accredited schemes |
Regulatory and Legal Compliance — Saudi Arabia
| Regulatory Framework | How This Standard Applies |
|---|---|
| SAAC Laboratory Accreditation Requirements | SAAC-accredited laboratories require PT participation from ISO/IEC 17043-accredited or equivalent providers |
| CBAHI Medical Laboratory EQA Requirements | CBAHI hospital accreditation laboratory standards require EQA participation from accredited providers |
| SFDA Laboratory Quality Requirements | SFDA-regulated testing laboratories require proficiency testing participation |
Where This Is Most Relevant — Key Locations
| Location | Industry / Application Context |
|---|---|
| UAE — Clinical chemistry and medical laboratories | DHA-licensed and DOH-licensed hospital and diagnostic laboratories across all UAE emirates |
| UAE — Food testing laboratories (DM-approved, ADAFSA) | Food chemistry, microbiology, and allergen testing PT schemes for UAE food testing facilities |
| UAE — Environmental chemistry laboratories | Water quality, soil, and air quality PT schemes for environmental compliance testing |
| Saudi Arabia — Clinical and hospital laboratories | CBAHI and SAAC-accredited medical laboratories across Riyadh, Jeddah, and Dammam |
| UAE — Petroleum analysis laboratories (ADNOC supply chain) | Petroleum product quality and composition PT schemes for Aramco and ADNOC-qualified testing laboratories |
What the Standard Requires
| Requirement Area | What It Means in Practice |
|---|---|
| PT scheme design | Analytes, matrices, assigned value method, statistical approach, frequency, reporting format |
| Test item preparation | Homogeneity and stability testing; assigned value determination through reference methods or consensus |
| Statistical analysis | z-scores, En numbers, or % recovery as appropriate; robust statistics for contaminated data sets |
| PT report content | Assigned value, uncertainty, individual results, performance scores, anonymised participant comparison |
| Participant confidentiality | Individual results anonymised using code numbers — data security requirements documented |
Why Nathan ISO Consulting — What We Do Differently
PT scheme accreditation requires specific statistical methodology knowledge beyond general management system expertise. Nathan ISO Consulting brings ISO Guide 35 statistical knowledge and accreditation body expertise to ISO/IEC 17043 projects.
| What We Do Differently | How It Benefits Your Project |
|---|---|
| We know the 2023 edition requirements | ISO/IEC 17043:2023 introduced strengthened traceability and statistical requirements. We work to the current standard — not the 2010 edition |
| We design PT schemes with correct statistical methodology | Robust statistics, assigned value determination, and performance criterion selection are technical decisions requiring specialist knowledge |
| We prepare schemes for specific analytes and matrices | Petroleum, clinical chemistry, and environmental chemistry PT schemes have different assigned value approaches |
| We know what DAC and ADAS assessors examine in PTP assessments | Including technical evaluation of statistical methodology — we prepare specifically for this component |
Frequently asked questions
An organisation designing and running interlaboratory comparison schemes used to assess laboratory performance. ISO/IEC 17043 accreditation gives laboratories confidence PT results provide meaningful performance evidence.
ISO 17025 and ISO 15189 require PT participation from accredited or recognised providers. ESMA, DAC, and SAAC all specify this requirement.
The value attributed to the measurand in the PT test item against which participant results are compared. Established through reference measurement, consensus, or formulation.
A performance statistic: z = (x - X) / σ*. |z| ≤ 2 is satisfactory; 2 < |z| < 3 is questionable; |z| ≥ 3 is unsatisfactory. The most widely used PT performance statistic.
Statistical methods insensitive to outliers in participant data, used to estimate consensus assigned values without being distorted by poorly performing laboratories.
Strengthened requirements for traceability of assigned values, updated statistical requirements, and revised scheme design documentation.
Enough for valid statistical analysis — typically 8–10 minimum for robust statistics. Fewer participants should use reference measurement-based assigned values.
Yes — many PT providers include accredited laboratories. The PT function must be managed with independence from routine testing activities to prevent conflicts of interest.
Eight to fourteen months. Stability studies for test item preparation often drive the timeline.
Yes. Clinical chemistry EQA scheme design — biochemistry, haematology, immunology — is within Nathan's PT scheme design capability.
Talk to Nathan ISO Consulting
Tell us which analytes, matrices, and laboratory sectors your schemes cover. We scope the ISO/IEC 17043 accreditation project from there.
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