NEW: the ISO 14001:2026, ISO/IEC 17020:2026 and FSSC 22000 V7 documentation kits are now available.
ISO/IEC 17043:2010 → 2023 transition: the first edition is no longer recognized under the ILAC MRA since May 31, 2026.
Documentation kit · ISO/IEC 17043:2023

Your ISO/IEC 17043 documentation, without starting from scratch.

Word and Excel templates to structure your proficiency testing activity, document your PT schemes and prepare your accreditation assessment.

  • Clauses 4 to 8 of the 2023 edition, clause by clause
  • Assigned value, homogeneity, stability and scores per ISO 13528:2022
  • 103 editable files and a requirement mapping
  • ILAC MRA: accreditation standard for proficiency testing providers
Buy the kit · $489
License per legal entityInstant download30-day money-back guarantee
ISO/IEC 17043:2023 documentation kit
103
Documents included
5
Normative clauses covered
100%
Requirements mapped
ILAC
MRA arrangement integrated
Who this kit is for

Built for organizations operating or preparing a proficiency testing program.

Four profiles, one need: an ISO/IEC 17043 documentation base ready to adapt.

PT providers in initial accreditation

Public or private bodies preparing a first accreditation application under the 2023 edition.

Metrology institutesFederationsFederal agencies

PT providers moving from 2010 to 2023

A system to realign with clauses 4 to 8: impartiality, risks, information management.

Accredited under 2010Gap analysis

Labs organizing ILCs

ISO/IEC 17025 accredited laboratories organizing interlaboratory comparisons for partners or customers.

ISO/IEC 17025Interlaboratory comparisons

Accreditation consultants and advisory firms

A validated base to start engagements with proficiency testing providers.

Client engagementsConsultant license on request

What is in the kit

103 documents organized by ISO/IEC 17043:2023 clause.

The kit covers clauses 4 to 8 of ISO/IEC 17043:2023. It integrates the statistical methods of ISO 13528:2022: assigned values, standard deviation for proficiency assessment, z-scores.

Master document list · ISO/IEC 17043:2023

Version 2.0, May 2026
103 documents · 64 Word · 39 Excel

Clause 4 · General requirements

9 documents · Impartiality, threat analysis, conflicts of interest, confidentiality, management commitment.
  • W
    Impartiality Risk Analysis Procedure
  • W
    Confidential Information Management Procedure
  • W
    Personnel Confidentiality Undertaking
  • W
    Impartiality Policy
  • W
    Management Impartiality Commitment Statement
  • W
    Annual Impartiality Review Minutes
  • X
    Signed Confidentiality Agreements Register
  • X
    Declared Conflicts of Interest Register
  • X
    Impartiality Threats Register

Clause 5 · Structural requirements

5 documents · Legal status, org chart, key roles, accredited PT activities, signature delegation.
  • W
    Delegation of Authority and Signature Procedure
  • W
    Description of Accredited PT Activities
  • W
    PTP Legal Status and Organization Chart
  • W
    Governance Rules of Procedure
  • W
    Job Descriptions for Key Roles

Clause 6 · Resource requirements

15 documents · Qualification and competence, facilities, subcontracting, external providers, calibration, equipment.
  • W
    Subcontracting Procedure (Item Production, Analyses)
  • W
    Equipment Management Procedure (cross-reference to ISO IEC 17025 §6.1.2)
  • W
    Measurement Method Validation Procedure (Item Characterization)
  • W
    External Products and Services Evaluation Procedure
  • W
    Ongoing Competence Monitoring Procedure
  • W
    Calibration and Metrological Traceability Procedure (cross-reference to ISO IEC 17025 §6.1.2)
  • W
    PT Personnel Qualification Procedure
  • W
    Facilities and Environmental Conditions Control Procedure
  • X
    Calibration and Metrological Traceability Record
  • X
    Training and Authorizations Plan
  • X
    Personnel Competence and Authorizations Register
  • X
    Equipment Register (Inventory, Calibrations, Checks)
  • X
    Competence Grid (Designer, Coordinator, Statistical Evaluator)
  • X
    Evaluated Subcontractors and External Providers Register
  • X
    Environmental Conditions Register (Temperature, Humidity, Access)

Clause 7 · Design and production of PT items

12 documents · Planning, statistical design, item preparation, homogeneity, stability, storage, shipping.
  • W
    PT Item Preparation Procedure
  • W
    Statistical Scheme Planning Procedure (PT Design)
  • W
    Homogeneity Study Protocol (ISO 13528 Annex B)
  • W
    Item Handling and Storage Procedure
  • W
    Packaging, Labeling, and Shipping Procedure
  • W
    Stability Study Protocol (ISO 13528 Annex B)
  • W
    PT Scheme Design and Planning Procedure
  • W
    Proficiency Testing Scheme Plan Template
  • X
    Stability Study Record (Short-Long Term)
  • X
    Homogeneity Study Record (Raw Results + ANOVA)
  • X
    Item Handling and Storage Record
  • X
    Shipment and Acknowledgment of Receipt Record

Clause 7 · Contracts, evaluation and reports

13 documents · Request review, assigned value, statistical analysis, scores, outliers, reports, communication.
  • W
    Performance Evaluation Procedure (z, z', zeta scores)
  • W
    Issuance of an Amended Report Procedure
  • W
    Review of Requests, Tenders, and Contracts Procedure
  • W
    Communication to Participants Procedure
  • W
    Statistical Analysis Procedure (ISO 13528)
  • W
    Determination of the Assigned Value Procedure
  • W
    Outlier Identification Procedure
  • W
    Request-Offer-Contract Review Form
  • W
    PT Scheme Report Templates
  • X
    Assigned-Value Determination Record
  • X
    Performance Evaluation Record (z, z prime, zeta scores)
  • X
    Participant Communication Register (Announcements, Notices)
  • X
    Participant Contracts and Agreements Register

Clause 7 · Process control, complaints and appeals

13 documents · Technical records, data and information, nonconforming work, complaints, appeals.
  • W
    Appeals Handling Procedure (7.7)
  • W
    Process Monitoring Procedure (Clause 7.5.3)
  • W
    Control of Data and Information Procedure (Clause 7.5.2)
  • W
    Protection of Client Property and Participant Data Procedure
  • W
    Complaint Handling Procedure (7.6)
  • W
    Information Security of Systems Procedure (Clause 7.11)
  • W
    Control of Technical Records Procedure (Clause 7.5.1)
  • W
    External Communication Procedure (ANAB-ILAC Accreditation Symbol, Public Statements)
  • W
    Control of Nonconforming Work Procedure (Clause 7.5.4)
  • X
    PT Data Access Register (logs, authorizations)
  • X
    Information Security Incidents Register
  • X
    Statistical Tools Validation Record (Spreadsheets, Software)
  • X
    Complaints and Appeals Register

Clause 8 · Management system

16 documents · Manual, document control, risks and opportunities, continuity, corrective actions, audits, management review.
  • W
    Document Control Procedure
  • W
    Records Management Procedure
  • W
    Management Review Procedure (15 Inputs, 8.9.2)
  • W
    Internal Audit Procedure
  • W
    Corrective Action Procedure (CAPA)
  • W
    Risks and Opportunities Analysis Procedure
  • W
    Continual Improvement Procedure
  • W
    PTP Quality Manual and Quality Policy (Option A compliant)
  • W
    PTP Business Continuity Plan (BCP)
  • W
    Management Review Minutes Template (15 Inputs, Clause 8.9.2)
  • W
    Internal Audit Report Template
  • X
    Risks and Opportunities Register (scoring + treatment)
  • X
    QMS Changes Register (change management)
  • X
    Management Reviews Register (history + decisions)
  • X
    Corrective Actions Register (CAPA, effectiveness follow-up)
  • X
    Internal Audits Register (program + findings follow-up)

Operational tools

12 documents · Participant enrollment and contract, standard protocol, results entry, z-score calculation, scheme registers.
  • W
    Standard PT Scheme Participant Contract
  • W
    Standard Scheme Protocol
  • W
    Participant Scheme Enrollment Form
  • W
    Scheme Designer Qualification Form
  • W
    PT Scheme Risk Analysis Form
  • X
    In-Progress Scheme Deviations Register
  • X
    Participants per Scheme Register
  • X
    Participant Result-Entry Sheet
  • X
    PT Schemes Register (Master Catalog by Year)
  • X
    Z-Score Calculation Table (Excel)
  • X
    PT Items Register (Lots, Batches, Codes)
  • X
    Nonconformity Tracking Register

ILAC framework and references

5 documents · 2010 to 2023 transition matrix, ISO 13528 and ISO 17034 mapping, ILAC P9 and G8 guides, glossary.
  • W
    ILAC G8 Interpretation Guide (Statement of Conformity)
  • W
    ILAC P9 Interpretation Guide (PT Participation)
  • W
    PT Glossary (Key Terms from ISO IEC 17000 and VIM)
  • X
    ISO 17043 2010 to 2023 Transition Matrix
  • X
    ISO 17043 to ISO 13528 and ISO 17034 Mapping

Audit and control

3 documents · Clause-by-clause audit checklist, mapping matrix, master list.
  • X
    Master Document List
  • X
    ISO IEC 17043 2023 Mapping Matrix
  • X
    ISO IEC 17043 2023 Clause-by-Clause Audit Checklist
Full master document list, implementation checklist and one complete procedure in the free sample.
Why this kit exists

A PTP accreditation dossier cannot be drafted from a blank page.

5 normative clauses, 4 to 8. Each calls for procedures, documented risk analysis and statistical evidence.

ISO 13528

Generic templates ignore PT activity

ISO/IEC 17025 derivatives: nothing on statistical design, item homogeneity, participant performance scoring or confidentiality.

Since May 31, 2026

The 2010 edition is no longer recognized

End of the 3-year ILAC transition: accreditation under the 2010 edition is no longer recognized under the ILAC MRA.

ISO/IEC 17025

Participants expect an accredited provider

Accredited labs use PT participation as evidence of competence. Without ISO/IEC 17043 accreditation, the PTP offer loses value.

$12,000 to $30,000

A consulting engagement is costly

20 to 50 consultant days. The kit provides the written base, your budget goes to statistics and scheme validation.

Clause-by-clause mapping

Every ISO/IEC 17043:2023 requirement → one document in the kit.

Clause by clause, the normative text and the documents provided. This is what an A2LA or ANAB assessor asks to see first.

4.1 to 4.2
General requirements: impartiality (identification and control of threats), confidentiality of participant information
Impartiality policyImpartiality risk analysisConfidentiality commitmentConfidential information managementImpartiality threats registerTop management statement
5.1 to 5.7
Structural requirements: legal status, responsibility, organizational structure, scope of PT activity
Status & organization chartJob descriptionsPT activities descriptionGovernance charterAuthority delegation
6.1 to 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 qualificationTraining plan & authorizationsCompetence gridFacilities controlSubcontractingExternal evaluationCalibration & traceabilityEquipment management
7.1 to 7.3
PT scheme design and planning: request review, statistical design, item preparation, homogeneity and stability, handling, storage, distribution
Design & planningStandard scheme planPT item preparationHomogeneity studyStability studyHandling & storagePackaging & shipping
7.4
Operations and statistical processing: contract review, assigned value determination, statistical analysis, performance evaluation, reports
Contract reviewAssigned valueStatistical analysisPerformance evaluationOutliersReport templatesAmended reportParticipant communication
7.5 to 7.7
PT scheme process control (technical records, data and information control, process surveillance, nonconforming work), complaints handling, appeals handling
Technical recordsData controlIT securityProcess surveillanceNonconforming workComplaints managementAppeals managementComplaints & appeals register
8.1 to 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 & policyDocument controlRecords managementRisks & opportunitiesContinual improvementInternal auditClause-by-clause checklistManagement 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 registrationScheme protocolResults entryZ-score calculation (Excel)Designer qualificationScheme risk analysisMaster document listNC 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 mappingTransition 2010→202313528/17034 cross-walkILAC P9 guideILAC G8 guidePT 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 SOPsPT item technical sheets (per lot, per matrix)Specific matrix and formulation studiesParticipant agreements (per scheme)Calibration certificates of reference materials usedStatistical analysis plans for qualitative schemes
XThe kit also contains an Excel mapping matrix (ISO/IEC 17043:2023 mapping matrix), to complete with your own documents.

Technical compliance

The points an experienced ISO/IEC 17043 assessor checks.

Ten requirements of the 2023 edition assessors verify first. The kit addresses them one by one.

Risk-based impartiality

Threats identified on an ongoing basis, personnel relationships included, effect eliminated or minimized.

4.1

Assigned value justified per scheme

ISO 13528 routes: formulation, participant consensus, expert laboratories, reference method.

7.2.3

Homogeneity and stability of items

Risk-based criteria, assessed for every round once items are packaged in final form.

7.3.2

Standard deviation for proficiency assessment

Method documented per scheme, robust statistics such as Algorithm A per ISO 13528.

ISO 13528

Performance scores

z, z' and zeta scores: choice documented according to the scheme and participant uncertainty.

7.4.2

Metrological traceability

Measurements per ISO/IEC 17025, reference materials produced per ISO 17034.

6.1.2, 6.1.3

Complaints and appeals, two procedures

Separate processes, decisions made or approved by people not involved.

7.6, 7.7

Information management system

Validated before use, protected from unauthorized access, tampering and loss.

7.5.2

Management review: 15 inputs

Inputs a to o, including risk identification results and process surveillance.

8.9.2

Transition from 2010 to 2023

Transition matrix, new or strengthened clauses: impartiality, risks, information.

Matrix MAT-002
ILAC

ISO/IEC 17043:2023: international recognition

The accreditation standard recognized by all signatories of the ILAC Mutual Recognition Arrangement, in the US and worldwide.

United States (A2LA, ANAB)Canada (SCC)United Kingdom (UKAS)European Union (DAkkS, EA MLA)Asia-Pacific (JAB, CNAS, NATA)Latin America (INMETRO, EMA)ILAC MRA (worldwide)
PTP flash audit

Where do you stand today?

Answer the 14 questions clause by clause to get your ISO/IEC 17043:2023 maturity score. Instant result, free, no personal information required.

Question 1 / 14
Clause 4: General requirements
0
/ 100

Buy the ISO 17043 Package · $489
Deployment process

From order to accreditation-ready, here is the route.

1
Day 1

Download

Full ZIP: 103 Word and Excel documents.

2
Weeks 1 to 4

Customization

Logo, org chart, scheme types, technical fields, providers, accreditation body.

3
Weeks 5 to 16

Pilot scheme

Designer qualification, pilot round, homogeneity and stability studies, statistical validation.

4
Weeks 16 to 24

Application and assessment

Internal audit with the kit's checklist, corrective actions, on-site and witness assessment.

Typical timeline: 16 to 24 weeks to an assessment-ready state, 12 for the most structured organizations, up to 36 from scratch.
Need a hand? Our consultants can tailor the kit to your site and support the rollout, on quote.
Request a quote
They use the kit

What PTPs that adopted it say.

★★★★★

A real time saver on the writing. The procedures follow the 2023 structure, and the ISO 13528 tools gave us a base to adjust to our environmental schemes.

M
Megan
PT Coordinator · Environmental PTP, USA
★★★★★

The 2010 to 2023 transition matrix made our gap analysis easier. We could focus the effort on the strengthened clauses, including impartiality and appeals.

R
Robert
Quality Manager · Clinical PTP, USA
★★★★★

A solid documentation base. The homogeneity and stability protocols still had to be adapted to our microbiology items, and that is where our team came in.

D
David
Technical Director · Microbiology PTP, Canada
★★★★★

Word files that are easy to rework, accurate PT vocabulary, explicit ISO 13528 references. The performance evaluation procedure needed only minor adjustments.

A
Amanda
Statistical Lead · Chemistry PTP, UK
Risk-free

30-day guarantee, no questions asked.

30-day money-back guarantee

You test the package. If you change your mind, we refund you.

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.

Frequently asked questions

Answers to your most common questions.

Is the kit enough to get ISO/IEC 17043 accreditation?

No. It provides the documentation for clauses 4 to 8. Accreditation also depends on your schemes: statistical design, homogeneity and stability studies, rounds already operated, witness assessment.

Are the documents editable?

Yes. 64 Word files and 39 Excel files, no locked PDFs. Neutral layout, ready for your logo and references.

Does the kit cover ISO 13528:2022?

Yes: assigned value, homogeneity and stability, statistical analysis, z, z' and zeta scores, outliers. A z-score calculation spreadsheet is included.

Does the license cover several entities?

It covers one legal entity, with unlimited internal use. Multi-entity groups or consulting firms: contact us for a suitable license.

When will I receive the files?

As soon as payment is confirmed: a link on the confirmation page and by email. ZIP organized in folders by document type.

What if the kit does not suit me?

You have 30 days to review it. Write to support@qse-academy.com explaining what does not meet your needs: the refund is issued to your original payment method, 4 to 5 business days after processing.

Take the next step

Your ISO/IEC 17043:2023 PTP accreditation foundation. Ready today.

103 Word and Excel documents, instant download after payment.

Buy the kit · $489
30-day money-back guaranteeInstant download12 months of updates
ISO/IEC 17043:2023 documentation kit