Build your A2LA / ANAB / NVLAP PT provider accreditation dossier in weeks, not months.
The ISO/IEC 17043:2023 package is for any organization that designs, organizes, and operates proficiency testing (PT) schemes or interlaboratory comparisons (ILC), whether in the initial accreditation phase, transitioning from the 2010 edition, or pursuing reaccreditation.
Public or private organizations that organize proficiency testing schemes and prepare their first A2LA / ANAB / NVLAP accreditation application under ISO/IEC 17043:2023. Metrology institutes, professional federations, research bodies, federal agencies (CDC, FDA, NIST, EPA, USDA).
PT providers already accredited under the 2010 edition who must align their system with the new CASCO structure (Clauses 4 to 8), strengthened impartiality requirements, risk-based thinking, and information management. Critical given the May 31, 2026 ILAC deadline already passed.
Laboratories accredited under ISO/IEC 17025 that organize interlaboratory comparisons for partners or customers, and that wish to formalize their program within a fully documented ISO/IEC 17043 framework. Common in clinical (CAP, CLSI), environmental (NELAC), and pharma sectors.
Quality accreditation consultants and PTP advisory firms who want a validated documentation foundation to start engagements quickly with proficiency testing providers (consultant license available on request).
ISO/IEC 17043:2023 contains 5 normative clauses (4 to 8) aligned with the CASCO structure common to all conformity assessment standards. Each requires written procedures, documented risk analysis, and statistical evidence of competence. Building all this in-house takes 6 to 10 months and exposes you to major nonconformities during the accreditation assessment.
Most online templates are derivatives of ISO/IEC 17025 adapted at the margins. They ignore PTP-specific requirements: statistical scheme design (ISO 13528:2022), PT item preparation and homogeneity, participant performance evaluation (z-scores, En numbers, zeta scores), inter-participant confidentiality management.
ILAC enforced a 3-year transition period from the publication of ISO/IEC 17043:2023. Since May 31, 2026, accreditation under the 2010 edition is no longer recognized under the ILAC MRA. PTPs that haven't transitioned have lost international recognition of their schemes — a major commercial issue.
Laboratories accredited under ISO/IEC 17025 can only use their participation in a PT scheme as proof of competence to A2LA / ANAB / NVLAP if the PTP itself is accredited under ISO/IEC 17043. Without accreditation, the PTP's offering is structurally devalued. CLIA-regulated labs in the US have specific PTP requirements.
A complete ISO/IEC 17043 implementation engagement billed by a specialized firm represents 20 to 50 days of intervention. The documentation package gives you the complete written foundation — you keep your budget for statistical processing, scheme validation, and accreditation assessment.
The package covers the 5 normative clauses of ISO/IEC 17043:2023 (Clauses 4 to 8) plus the statistical methods of ISO 13528:2022 (results processing, assigned values, z-scores, standard deviation for proficiency assessment).
ISO/IEC 17043:2023 was published on May 8, 2023 and adopted by the ILAC MRA Arrangement as the single accreditation reference for proficiency testing providers since May 31, 2026. Below is the clause-by-clause mapping between the standard and the documents provided — this is what an A2LA / ANAB / NVLAP assessor expects to see first.
| Clause | ISO/IEC 17043:2023 requirement | Documents provided in the package |
|---|---|---|
| 4.1 — 4.2 | General requirements: impartiality (identification and control of threats), confidentiality of participant information | Impartiality policy Impartiality risk analysis Confidentiality commitment Confidential information management Impartiality threats register Top management statement |
| 5.1 — 5.7 | Structural requirements: legal status, responsibility, organizational structure, scope of PT activity | Status & organization chart Job descriptions PT activities description Governance charter Authority delegation |
| 6.1 — 6.4 | Resources: qualified personnel, facilities and environmental conditions, externally provided products and services (metrological traceability and equipment are required by reference to ISO/IEC 17025 via Clause 6.1.2) | Personnel qualification Training plan & authorizations Competence grid Facilities control Subcontracting External evaluation Calibration & traceability (NIST) Equipment management |
| 7.1 — 7.3 | PT scheme design and planning: request review, statistical design, item preparation, homogeneity and stability, handling, storage, distribution | Design & planning Standard scheme plan PT item preparation Homogeneity study Stability study Handling & storage Packaging & shipping |
| 7.4 | Operations and statistical processing: contract review, assigned value determination, statistical analysis, performance evaluation, reports | Contract review Assigned value Statistical analysis Performance evaluation Outliers Report templates Amended report Participant communication |
| 7.5 — 7.7 | PT scheme process control (technical records, data and information control, process surveillance, nonconforming work), complaints handling, appeals handling | Technical records Data control (ALCOA+) IT security Process surveillance Nonconforming work Complaints management Appeals management Complaints & appeals register |
| 8.1 — 8.9 | Management system: Option A (direct implementation of Clauses 8.2 to 8.9) or Option B (recognized ISO 9001 system), documentation, records, risks and opportunities, improvement, corrective actions, internal audits, management review (15 mandatory inputs in Clause 8.9.2) | Quality manual & policy Document control Records management Risks & opportunities Continual improvement Internal audit Clause-by-clause checklist Management review (15 inputs) CAPA |
| Operational tools | Day-to-day operational forms and records: registration, protocol, results entry, z-score calculation, designer qualification, scheme risk analysis, master list, NC register | Participant registration Scheme protocol Results entry Z-score calculation (Excel) Designer qualification Scheme risk analysis Master document list NC register |
| ILAC framework & standards | Mapping matrices and interpretation guides: mapping, transition 2010 → 2023, ISO 13528 / ISO 17034 cross-walk, ILAC P9 & G8, lexicon | ISO 17043 mapping Transition 2010→2023 13528/17034 cross-walk ILAC P9 guide ILAC G8 guide PT lexicon |
| Not included | Documents specific to each scheme and each technical domain — which must be drafted case by case by your team based on the nature of your PT items and the analytical domain covered | Specific technical protocols (per scheme) Lab analytical methods and SOPs PT item technical sheets (per lot, per matrix) Specific matrix and formulation studies Participant agreements (per scheme) Calibration certificates of reference materials used Statistical analysis plans for qualitative schemes |
Beyond the clause-by-clause mapping, here are the technical rigor points that PTP Quality Managers, technical coordinators, and experienced accreditation assessors verify first.
ISO/IEC 17043 is the accreditation reference recognized by all signatories of the ILAC MRA Arrangement. A compliant package positions you for accreditation recognized in all signatory countries worldwide.
| Criterion |
QSE Academy ISO 17043 $689 |
Free templates $0 |
PTP consulting firm $12,000 — $30,000 |
|---|---|---|---|
| PTP-specific (not generic ISO/IEC 17025) | ✓ | ✗ | ✓ |
| Coverage of 5 normative clauses 17043:2023 | ✓ 100% | Partial | ✓ 100% |
| ISO 13528:2022 alignment (PT statistics) | ✓ Included | ✗ | Per engagement |
| Transition matrix 17043:2010 → 2023 | ✓ Excel matrix | ✗ | Per engagement |
| Editable Word format, neutral charter | ✓ | Variable | ✓ |
| Delivery time | Instant | Instant | 6 to 10 months |
| Money-back guarantee | ✓ 30 days | ✗ | ✗ |
| Statistical validation of specific schemes | On you | On you | Included |
Answer the 14 questions clause by clause to get your ISO/IEC 17043:2023 maturity score. Instant result, free, no personal information required.
The package isn't just delivered. Here is the concrete path to bring it into production in your proficiency testing provider organization, step by step.
Secure payment, immediate access to the full package as a ZIP. Within minutes you have the 103 Word documents, the ISO 17043 mapping matrix, the ISO 13528 statistical tools (z-score Excel), and the user manual.
Adapting the documents to your PTP organization: logo, organization chart, accreditation scope (PT scheme types: chemistry, microbiology, clinical, environmental), real equipment, regular providers, target accreditation body (A2LA, ANAB, NVLAP). Plan 2 to 4 weeks for thorough customization.
Designer qualification, pilot PT scheme operation, homogeneity / stability studies, statistical validation (z-scores, En numbers), participant feedback, mock assessment. The package gives you the framework; the technical and statistical work is yours (the highest-value PTP work).
Submit application to A2LA / ANAB / NVLAP, document review, on-site assessment, witness assessment of a live PT scheme. Internal audit using the ISO 17043 checklist provided in the package. Identification of remaining gaps, corrective action plan, accreditation decision.
You have 30 days to download the package, review its content, open the documents, and verify that the writing quality matches your expectations. If something is off, you write us an email — no justification needed — and the refund is processed within 5 business days. That simple.
The PTP accreditation landscape evolves with new ILAC guidance, ISO 13528 revisions, and emerging technical standards. The package you buy today shouldn't become obsolete in 6 months. That's why updates are included.
The package already integrates ISO/IEC 17043:2023, ISO 13528:2022, ILAC P9, ILAC G8, ALCOA+ data integrity, and current A2LA / ANAB / NVLAP accreditation requirements. In case of new ILAC guidance, ISO 13528 revisions, accreditation body policy revisions, or significant new technical guidance, you receive package updates free of charge for 12 months after your purchase.
The package gives you the complete documentation foundation required by ISO/IEC 17043:2023 and aligned with the major US-relevant accreditation bodies (A2LA, ANAB, NVLAP). To obtain accreditation, you also need to fill in the documents with your real data (pilot scheme operation, homogeneity / stability studies, statistical validation), demonstrate technical and statistical competence, and pass an on-site assessment plus a witness assessment of a live PT scheme. The package saves you the 6 to 10 months of writing work. Statistical validation work and assessment readiness remain your work (typically 12 to 16 additional weeks).
Yes — the deadline has already passed. ILAC enforced a 3-year transition period from the publication of ISO/IEC 17043:2023 (May 8, 2023). Since May 31, 2026, accreditation under the 2010 edition is no longer recognized under the ILAC MRA. PTPs that haven't transitioned have lost international recognition of their schemes. The package includes a complete transition matrix 2010 → 2023 identifying the new and strengthened clauses (impartiality, risks, information management) to accelerate your transition.
All three are recognized signatories to the ILAC MRA, so any accreditation under one of them is internationally recognized. A2LA is the largest US lab accreditation body with a strong PTP program covering chemistry, microbiology, environmental, and clinical schemes. ANAB (ANSI National Accreditation Board) is a major alternative, particularly strong in calibration-related PT and forensic schemes. NVLAP (NIST National Voluntary Laboratory Accreditation Program) operates specific PT programs (asbestos, energy efficiency). The package documents are agnostic and adapt to whichever body you choose.
Yes. The package includes a statistical analysis procedure (ISO 13528:2022 aligned), a z-score calculation Excel spreadsheet, an assigned value determination procedure, an outlier identification procedure (Hampel, Grubbs, Cochran), and a performance evaluation procedure covering z-scores, z'-scores, ζ (zeta) scores, and En numbers. The package also includes the homogeneity and stability study protocols aligned with ISO 13528 Annex B.
Most free templates are derivatives of ISO/IEC 17025 adapted at the margins. They ignore PTP-specific requirements: statistical scheme design (ISO 13528), PT item homogeneity and stability, assigned value determination, performance scoring (z, z', zeta, En), inter-participant confidentiality, transition from the 2010 edition. The QSE Academy package is written specifically for ISO/IEC 17043:2023 + ISO 13528:2022 + ILAC P9 / G8 and includes the verifiable clause-by-clause mapping plus the transition matrix.
Plan 2 to 4 weeks to customize the documents: logo, organization chart, accreditation scope (PT scheme types: chemistry, microbiology, clinical, environmental, calibration), specific equipment, regular providers, target accreditation body. Then plan statistical validation and pilot scheme operation: designer qualification, pilot PT scheme, homogeneity / stability studies, statistical validation, participant feedback — that's 12 to 16 additional weeks depending on scope complexity.
All policies, procedures, and templates are delivered in fully editable Microsoft Word (.docx) format. The mapping matrices (ISO 17043, transition 2010→2023, ISO 13528 / ISO 17034 cross-walk) and the statistical tools (z-score calculator, NC register, complaints register) are delivered in Excel (.xlsx) format. No locked PDFs, no proprietary software dependency. The graphic charter is neutral, ready to receive your logo and colors.
The package includes a PT scheme design and planning procedure, a standard PT scheme plan template, the homogeneity and stability study protocols (ISO 13528 Annex B), an assigned value determination procedure, and a scheme risk analysis form. It does NOT include filled-in scheme designs, since these depend on your specific PT items, matrices, analytical methods, and target measurands. The package gives you the structural and methodological framework; the technical scheme design work itself remains yours.
The $689 license covers a single legal entity, with unlimited internal use (all your PTP personnel can use the package). For multi-site rollout, a group with multiple subsidiaries, or consulting use across multiple clients, contact us for an adapted license.
Yes. The package already integrates the latest 2025-2026 PTP accreditation landscape (ISO/IEC 17043:2023, ISO 13528:2022, current ILAC P9 and G8, A2LA / ANAB / NVLAP requirements). In case of significant ILAC guidance updates, ISO 13528 revisions, accreditation body policy revisions, or new technical guidance documents, you receive package updates free of charge for 12 months after your purchase.
You're covered by a 30-day money-back guarantee, no conditions. You write us a simple email — no justification required — and the refund is processed within 5 business days.
103 documents, 5 ISO/IEC 17043 normative clauses covered (4 to 8) + ISO 13528:2022 alignment + transition matrix 2010→2023 + clause-by-clause matrix included. Instant download after payment.
QSE Academy supports quality managers, SMEs, and consultants in accelerating their ISO standards implementation through ready-to-use documentation, targeted training programs, custom documentation services, and compliance tools.
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