NEW: the ISO 14001:2026, ISO/IEC 17020:2026 and FSSC 22000 V7 documentation kits are now available.
International standard recognized by ILAC, A2LA, ANAB, IAS, NIST: ISO/IEC 17025:2017 is the global reference for accreditation of testing and calibration laboratories.
Documentation kit · ISO/IEC 17025:2017

Your ISO/IEC 17025 documentation, without starting from scratch.

Word and Excel templates to structure your laboratory, build your accreditation dossier and prepare your assessment evidence.

  • Clauses 4 to 8 of the standard and accreditation body requirements
  • Impartiality, metrological traceability, uncertainty, method validation
  • 110 editable files and a requirement mapping
  • A2LA and ANAB: accreditation requirements integrated
Buy the kit · $389
License per legal entityInstant download30-day money-back guarantee
ISO/IEC 17025:2017 documentation kit
110
Documents included
5
Normative clauses covered
100%
Requirements mapped
A2LA
and ANAB requirements mapped
Who this kit is for

Built for laboratories performing testing, calibration or sampling.

Four profiles, one need: an ISO/IEC 17025 documentation base ready to adapt.

Testing laboratories

Physical, chemical, microbiological or biological testing, in-house or as a third-party provider.

TestingThird-partyA2LA, ANAB, IAS

Calibration laboratories

Dimensional, mass, temperature, pressure, electrical: SI traceability through NIST or another NMI.

CalibrationNIST traceabilityUncertainty

In-house industrial labs

QC labs inside plants, structured per ISO 17025 for customer, FDA or DoD requirements.

Quality controlManufacturingCustomer audits

Consultants and advisory firms

A validated 17025 base to start accreditation engagements without a blank page.

Client engagementsConsultant license on request

What is in the kit

110 documents organized by ISO/IEC 17025:2017 clause.

The kit covers clauses 4 to 8 of ISO/IEC 17025:2017: general, structural, resource, process and management system requirements. It also covers accreditation body requirements: mark use, change notification, scope extensions.

Master document list · ISO/IEC 17025:2017

Version 2.0, May 2026
110 documents · 69 Word · 41 Excel

Clause 4 · General requirements

11 documents · Impartiality and confidentiality: policies, risk analysis, declarations, confidentiality agreements.
  • W
    Impartiality Risk Analysis Procedure
  • W
    Periodic Impartiality Risk Review Procedure
  • W
    Confidential Information Management Procedure
  • W
    Communication Procedure for Legally Required Disclosure
  • W
    Standard Confidentiality Agreement, Personnel and Suppliers
  • X
    Register of Signed Confidentiality Agreements
  • X
    Register of Personnel Impartiality Declarations
  • X
    Impartiality Threats Register
  • W
    Personnel Impartiality Commitment Declaration
  • W
    Impartiality Policy
  • W
    Confidentiality Policy

Clause 5 · Structural requirements

6 documents · Legal identity, org chart, RACI matrix, job descriptions, accreditation scope, off-site activities.
  • W
    Activities Away from the Permanent Laboratory Procedure
  • W
    Laboratory Legal Identity Record
  • W
    Definition of the Accreditation Scope
  • W
    Job Descriptions (Technical Management, Quality Manager, Technicians)
  • X
    RACI Responsibility Matrix
  • W
    Organization Chart and Responsibilities

Clause 6 · Resource requirements

30 documents · Personnel and authorizations, facilities, equipment, metrological traceability, external providers.
  • W
    Personnel Competence Management Procedure
  • W
    Technical Personnel Selection Procedure
  • W
    Authorization and Supervision Procedure
  • W
    Environmental Conditions Monitoring Procedure
  • W
    Access Control to Technical Areas Procedure
  • W
    Equipment Fleet Management Procedure
  • W
    IQ OQ PQ Qualification Procedure
  • W
    Defective Equipment Control Procedure
  • W
    Metrological Traceability to the SI Procedure
  • W
    Selection of Accredited Calibration Providers Procedure
  • W
    Certified Reference Materials Procedure
  • W
    Critical Provider Evaluation Procedure
  • W
    New Equipment Receipt and Qualification Record (IQ-OQ-PQ)
  • W
    Method Authorization Record
  • W
    Annual Competence Evaluation Form
  • W
    Supplier Specification (Subcontracted Testing)
  • W
    Laboratory Facility Layout and Zoning
  • X
    Standard Environmental Conditions Record
  • X
    Personnel Training and Qualification Record
  • X
    Preventive and Corrective Maintenance Record
  • X
    Authorization Grid by Method and Technical Activity
  • X
    Supplier Evaluation and Monitoring Grid
  • X
    Qualified Suppliers List
  • X
    Training Plan and Qualification Plan
  • X
    Calibration and Intermediate-Check Plan
  • X
    Metrological Traceability Plan
  • X
    Equipment Logbook, Metrology Record
  • X
    External Calibration Certificates Register
  • X
    Register of Internal Calibrations and Intermediate Checks
  • X
    Subcontracted Testing Register

Clause 7 · Process requirements, 7.1 to 7.6

22 documents · Request review, methods, sampling, technical records, measurement uncertainty, decision rules.
  • W
    Review of Requests, Tenders, and Contracts Procedure
  • W
    Contractual Deviation Management Procedure
  • W
    Method Selection Procedure
  • W
    Method Validation and Verification Procedure
  • W
    Control of Deviations from the Method Procedure
  • W
    Sampling Procedure
  • W
    Handling, Transport, and Storage of Test Items Procedure
  • W
    Control of Technical Records Procedure
  • W
    Evaluation of Measurement Uncertainty Procedure
  • W
    Decision Rule and Guard Bands Procedure
  • W
    Standard Offer Review Form
  • W
    Sample Identification and Traceability Record
  • W
    Decision Rule Form (Client Agreement)
  • W
    Standard Method Validation File
  • W
    Technical Record Template (Bench Sheets)
  • W
    Standard Sampling Plan
  • X
    Sample Receipt and Circulation Register
  • X
    Uncertainty Budgets Calculated by Method
  • X
    GUM-Type Uncertainty Budget
  • X
    Receipt Deviations Register
  • X
    Register of Method Validations and Revalidations
  • X
    Register of Decision Rules and Client Agreements

Clause 7 · Process requirements, 7.7 to 7.11

21 documents · Validity of results, reports, opinions, complaints, nonconforming work, data and LIMS.
  • W
    Internal Quality Control Procedure
  • W
    Participation in Proficiency Testing Procedure
  • W
    Interlaboratory Comparisons Procedure
  • W
    Reporting of Results Procedure
  • W
    Opinions and Interpretations Procedure
  • W
    Complaint Handling Procedure
  • W
    Control of Nonconforming Work Procedure
  • W
    Control of Data and Information Management Systems Procedure
  • W
    Backup and Archiving Procedure
  • W
    Validation of IT Systems Procedure
  • W
    Accredited Test Report Template
  • W
    Calibration Certificate Template
  • W
    Laboratory IT Security Plan
  • X
    Completed Levey-Jennings Control Charts
  • X
    Internal Quality Control Record
  • X
    Levey-Jennings Control Chart Plan
  • X
    Register of Actions on Out-of-Tolerance Results
  • X
    Complaints Register
  • X
    Register of PT-ILC Results and Interlaboratory Comparisons
  • X
    Register of Opinions and Interpretations Issued
  • X
    Nonconforming Work Register

Clause 8 · Management system requirements

13 documents · Quality manual, document control, risks and opportunities, CAPA, internal audits, management review.
  • W
    Document Control Procedure
  • W
    Control of Quality Records Procedure
  • W
    Management of Risks and Opportunities Procedure
  • W
    Continual Improvement and CAPA Procedure
  • W
    Internal Audit and 17025 Checklist Procedure
  • W
    Management Review Procedure
  • X
    Multi-Year Audit Plan
  • X
    Corrective and Preventive Actions Register
  • X
    Internal Audits and Findings Register
  • X
    Management Reviews Register
  • X
    Document Management Register
  • X
    Risks and Opportunities Register
  • W
    ISO 17025 Laboratory Quality Manual

Accreditation body requirements · A2LA and ANAB

5 documents · Accreditation mark and symbol, change notification, scope extensions and reductions, scope history.
  • W
    Use of the A2LA-ANAB Accreditation Mark and Symbol Procedure
  • W
    Notification of Changes to the Accreditation Body Procedure
  • W
    Management of Scope Extensions and Reductions Procedure
  • X
    Accreditation Scope Register and Change History
  • X
    Register of Changes Notified to the Accreditation Body

Audit and control

2 documents · ISO/IEC 17025 internal audit grid and ISO 17025 to A2LA-ANAB requirements mapping.
  • X
    ISO 17025 to A2LA-ANAB Accreditation-Requirements Mapping
  • X
    ISO IEC 17025 2017 Internal Audit Grid
Full master document list, implementation checklist and one complete procedure in the free sample.
Why this kit exists

ISO/IEC 17025 accreditation cannot be prepared from a blank page.

5 normative clauses, roughly twenty sub-clauses. Each calls for procedures, technical records and evidence of competence.

17025-specific

Generic templates fall short

ISO 9001 derivatives ignore impartiality, SI traceability, method validation, uncertainty, decision rules and proficiency testing.

A2LA, ANAB, IAS

Assessments are technical

Run by domain-specialist assessors. An incomplete dossier leads to major findings and longer accreditation timelines.

RFQs

Customers require accreditation

Industrial buyers, federal agencies (FDA, EPA, DoD, DOE) and government contracts increasingly write it into technical requirements.

$15,000 to $30,000

A consulting engagement is costly

20 to 60 consultant days. The kit provides the written base, your budget goes to method validation and assessment preparation.

Clause-by-clause mapping

Every ISO/IEC 17025 requirement → one document in the kit.

Clause by clause, the normative text and the documents provided. This is what a technical assessor or a customer asks to see first.

4.1
Impartiality: risk identification, personnel commitments, periodic threat analysis
Impartiality policyRisk analysisPersonnel commitmentThreat registerRisk review
4.2
Confidentiality: information management, agreements, legal disclosure obligations
Confidentiality policyInformation managementStandard NDALegal disclosure procedure
5.1 to 5.7
Structural requirements: legal entity, organization, responsibilities, scope, off-site activities, technical management
Legal entity sheetOrganization chartRACI matrixJob descriptionsAccreditation scopeOff-site activities
6.2
Personnel: competence, selection, training, qualification, authorization, supervision
Competence managementPersonnel selectionTraining planAuthorization gridCompetence evaluationAuthorization & supervision
6.3
Facilities & environmental conditions: adequacy, monitoring, access control
Facility planEnvironmental monitoringAccess controlConditions record
6.4
Equipment: selection, calibration, verification, IQ/OQ/PQ qualification, maintenance, defective equipment handling
Equipment fleet managementEquipment logbookCalibration planIQ/OQ/PQ qualificationDefective equipment
6.5
Metrological traceability: linkage to the SI (NIST traceability for US labs), CRMs for cases under § 6.5.3 (NIST SRMs), selection of accredited providers, documented chain
SI traceabilityCRM (§ 6.5.3)Provider selectionLinkage planCertificates register
6.6
Externally provided products and services: evaluation, specifications, monitoring, qualification
Provider evaluationProvider specificationsMonitoring gridApproved providers list
7.1
Review of requests and contracts: capability, method, decision rule, contractual deviations
Request reviewTender review formDeviation managementDecision rule
7.2
Selection, verification and validation of methods: scope, performance, deviations
Method selectionValidation / verificationValidation fileMethod deviations
7.3 to 7.4
Sampling and handling of test items: representativeness, transport, storage, identification, receipt deviations, chain of custody
Sampling procedureSampling planHandling & storageItem identificationReceipt deviations
7.5 to 7.6
Technical records & measurement uncertainty evaluation (GUM, NIST TN 1297)
Technical recordsBench sheetsUncertainty evaluationGUM uncertainty budgetDecision rule
7.7
Ensuring the validity of results: internal QC, control charts, proficiency testing, interlaboratory comparisons
Internal QCControl charts (Levey-Jennings, Westgard)Proficiency Testing (PT)Interlab comparisonsOut-of-tolerance results
7.8 to 7.10
Reporting of results, opinions and interpretations, complaints, nonconforming work: content, processing, investigation
Report issuingAccredited test report templateCalibration certificateOpinions & interpretationsComplaint handlingComplaints registerNonconforming work
7.11
Control of data and information systems: validation, backup, LIMS data integrity (FDA 21 CFR Part 11 for regulated labs)
Data controlBackup & archivingIT systems validationIT security
8.1 to 8.9
Management system (Option A): documentation, document control, risk-based thinking, CAPA, scheduled internal audit, management review (15 inputs in § 8.9.2)
Lab quality manualDocument controlQuality recordsRisk & opportunitiesImprovement & CAPAInternal audit & checklistMulti-year audit planManagement review
A2LA / ANAB
Accreditation body requirements (A2LA, ANAB or another ILAC MRA signatory): use of the accreditation symbol, notification of changes, scope extensions and reductions, scope history
A2LA-ANAB accreditation mark and symbol procedureChange notification procedureScope extensions and reductions procedureAccreditation scope registerISO 17025 to A2LA-ANAB mapping matrix
Not included
Documents specific to each laboratory, each method, and each piece of equipment, which must be produced case by case by your technical team based on your accreditation scope
Complete validation protocols (per method)Quantified uncertainty budgets (per method)External calibration certificates (per equipment)Filled-in control charts (per analysis)External PT reports (per scope domain)Detailed accreditation scope file (A2LA / ANAB scope template)Filled-in equipment qualification results
XThe kit also contains an Excel mapping matrix (ISO 17025 to A2LA-ANAB accreditation requirements), to complete with your own documents.

Technical compliance

The points an experienced ISO/IEC 17025 assessor checks.

Ten technical points A2LA and ANAB assessors verify first. The kit addresses them one by one.

Impartiality risk analysis

Financial, commercial and ownership relationships identified, not a statement of principle.

4.1

Metrological traceability to the SI

Documented chain through accredited calibration providers, calibration uncertainty in the budget.

6.5

Validation or verification

Standard method (ASTM, EPA, AOAC, USP): verification. Non-standard or in-house: full validation.

7.2

Uncertainty per the GUM

Type A and Type B components combined in a budget, expanded with a coverage factor k=2.

7.6

Decision rules and guard bands

Agreed with the customer before contract, applied in the statement of conformity.

7.1.3, 7.8.6

Proficiency testing

Multi-year plan covering the full scope, documented actions on unsatisfactory results.

7.7.2

Control charts

Levey-Jennings, Westgard rules or equivalent, alarm and reaction criteria per method.

7.7.1

LIMS validation

IT systems validated before use, automated calculations tested, data integrity, audit trail.

7.11

Flexible or fixed scope

Know the difference, change methods only within the limits of an accredited flexible scope.

Accreditation body

Management review: 15 inputs

Full agenda from a to o, action follow-up from one review to the next.

8.9.2
ILAC

ISO/IEC 17025: international recognition

A2LA, ANAB, IAS and NVLAP accreditation benefits from ILAC multilateral recognition: your accredited reports are usable worldwide.

ILAC MRA (worldwide)A2LAANABIASNVLAP (NIST)APAC (Asia-Pacific)EA (Europe)IAAC (Americas)
Lab flash audit

Where do you stand today?

Answer the 14 questions clause by clause to get your ISO/IEC 17025 maturity score. Instant result, free, no personal information required.

Question 1 / 14
Section 4.1: Impartiality
0
/ 100

Buy the ISO 17025 Package · $389
Deployment process

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

1
Day 1

Download

Full ZIP: 110 Word and Excel documents.

2
Weeks 1 to 4

Customization

Logo, org chart, target scope, equipment, providers, accreditation body.

3
Weeks 5 to 16

Technical validation

Method validation, uncertainty budgets, IQ/OQ/PQ, control charts, proficiency testing.

4
Weeks 16 to 24

Application and assessment

Internal audit with the kit's checklist, corrective actions, application to the accreditation body.

Typical timeline: 16 to 24 weeks to an assessment-ready state, about 12 for the most structured organizations.
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 labs that adopted it say.

★★★★★

The kit saved us time on the documentation. The GUM uncertainty budget template gave us a base, the method-by-method budgets were still ours to build.

M
Megan
Lab Director · Calibration laboratory, USA
★★★★★

The authors know lab accreditation. The impartiality risk analysis and the decision rule procedure fit our pharma testing scope after some adaptation.

R
Robert
Quality Manager · Pharma testing lab, USA
★★★★★

The writing no longer started from zero. The A2LA and ANAB mapping helped structure our application, adapting it to our sites took real work.

D
David
Technical Director · Environmental testing lab, Canada
★★★★★

Word files that are easy to rework, neutral layout, accurate metrology terminology. Customization and method validation take time, and the kit says so clearly.

A
Amanda
Quality Director · Materials testing lab, 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 17025 accreditation?

No. It provides the documentation ISO/IEC 17025:2017 requires. Accreditation also depends on method validations, uncertainty budgets, control charts, proficiency testing and the on-site assessment.

Are the documents editable?

Yes. 69 Word files and 41 Excel files, no locked PDFs. Neutral layout, ready for your logo and references.

Does the kit help with method validation?

It includes a validation and verification procedure, a standard validation file and a register of validations. Filled-in validation studies depend on your methods, matrices and equipment: they remain yours to produce.

Does the license cover several sites?

It covers one legal entity, with unlimited internal use. Multi-site 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 17025 accreditation foundation. Ready today.

110 Word and Excel documents, instant download after payment.

Buy the kit · $389
30-day money-back guaranteeInstant download12 months of updates
ISO/IEC 17025:2017 documentation kit